SCCM Resource Library-Response to Emerging Infectious Threats: Learning From Influenza, Ebola, and COVID-19

Response to Emerging Infectious Threats: Learning From Influenza, Ebola, and COVID-19

Video Transcription

My name is Dr. Ryan Maves, and I have the pleasure of moderating this upcoming session titled Response to Emerging Infectious Threats, Learning from Influenza, Ebola, and COVID-19.  We have a great panel of expert speakers today who will be discussing different aspects of pandemic planning and how they affect both critical care and public health.  Our first speaker will be Dr. John Gallagher, a clinical nurse specialist at Penn Presbyterian Medical Center, who will be speaking to us on lessons learned in respiratory pandemics  and key strategies for every hospital of the future. He'll be followed by Dr. David Wong from UPMC Presbyterian, who is a professor of critical  care medicine, emergency medicine, and clinical and translational science, and who is co-PI of the RemapCAP COVID trials at the UPMC Health System.  Dr. Wong will be speaking about challenges in pragmatic, adaptive clinical research during a pandemic and how to set up your system for success.  Following Dr. Wong, we'll have Dr. Ramesh Adalja coming from Johns Hopkins. Dr. Adalja is a senior scholar at the Johns Hopkins Center for Health Security, where  his work is focused on emerging infectious disease, pandemic preparedness, and biosecurity.  Dr. Adalja served on government panels tasked with developing guidelines for the treatment of plague, botulism, and anthrax, and is a spokesman for the Infectious Diseases Society  of America. Dr. Adalja will be speaking about combating infectious pathogens during research limitations and whether our response is improving.  Following Dr. Adalja, we'll have Ms. Cheryl Mejia, who is a staff nurse, be speaking to us about Infected 2, when the health care team becomes a patient, and looking at the  impact of pandemic disease on members of the team caring for patients, both at how it affects response and what we can do to reduce the risk to our colleagues and ourselves.  Lastly, I'll be speaking about the mass casualty incidence process and how that applies to infectious pandemics. Thank you very much, and I hope you enjoy our session.  Hi, my name is John Gallagher, and I am the clinical nurse specialist at the Penn-Presbyterian Medical Center, as well as trauma program manager for the Division of Trauma Surgical  Critical Care. I have nothing to disclose during this presentation. This session is on the challenges and future lessons learned for respiratory pandemics,  and the challenges that I outline here are ones that were not only noted during the COVID pandemic, but also in the future. We had a limited understanding of the disease.  Much of the treatment strategies that we used were based on our experience because there was limited evidence early on.  We had to expand our critical care staffing, our units, and also we had limited and variable equipment and supplies that were available, and these were also changing throughout the  pandemic. When we think of the resources surrounding disaster and in the pandemic, we really can  put them into the three main categories that many are familiar with, which is staffing, space, and supplies, also known as stuff.  We also don't think much about the information and education that's required, and during the pandemic and in future pandemics, this is a key thing that would be needed is rapid  information availability and education for those who are caring for patients. When we look at what resources were available to us early on and some of the things that  became available over time, we did and were familiar with the tiered staffing model that was put forth by Society of Critical Care Medicine and adopted toward the pandemic and  was very useful and used by many institutions, as well as the need to expand our ICU space, and the thing that we really focused on with our resources were availability of PPE and  the need for ventilators. This is something that as time went on, we realized we had a variable need, but also  a lot of different types of machines were needed and a lot of different types were available to us. Our education needs really surrounded the disease itself. Not much was known.  There were evolving treatments, most of them based on experience. We expanded our critical care staffing, our units, and also had to train on various types  of equipment, and so an example of some of the things that came out early based on the experience of clinicians, especially in Europe, were things such as the ARDS polar phenotypes.  We started to hear the term type L and type H, type L being low elastance, low VQ ratio, low lung weight, low lung recruitability, in patients that we would have thought, based  on their picture, should have had the traditional ARDS picture but did not, and so this was  valuable to people who were starting to see and clinicians starting to see this, especially  over time as we started to encounter this because these patients behaved much differently, so getting this information as quickly as possible so people could change their treatment  strategy was important and would remain important. A lot of what we did initially was adapt what we know.  Many are familiar with the surviving sepsis guidelines and how they were adapted to coronavirus-19  and how those things, as we looked through them, were adapted not with tremendous amounts of evidence but based on what we knew and what we thought should be done and how this  would work out for us. There was adaption and innovation, and the picture that you see here is the use of the  CPAP hoods, courtesy of one of my colleagues at Penn, and this was described, the experience was described in a letter to the editor, and you can see the reference there, and what  changed over time has been an adaption and changes to the hood. You can see the picture on the right is the newer version with a valve on it to allow  airflow in because most of the airflow, at least on the helmet to the left, was related to the gas flow in of at least 50 liters per minute that was required to wash out CO2.  So this is an adaption of something that had been used before COVID, had been used in Europe, and how might we use it in the future?  It's not something we would traditionally use, but something that we had available. Down the bottom on the right side of the slide, you can see this Venturi, which was used and  could be used outside of the ICU should this helmet be used in large quantities, and there  were two options here, and depending on the amount of flow that you needed into the Venturi, you could use two gas flow sources.  But this was not the first time that CPAP helmets were described. In fact, I have two studies listed here, one out of the University of Chicago, that showed  how this helmet could be used instead of a face mask for, and affecting the rate of endotracheal intubation in patients with ARDS.  So this was an adaption in the moment, based on experiences in Europe, but also based on  previous literature, and it's important that we think of these things as potential innovations and things that could be used in the pandemic.  Now one of the things that we ran into, and I know a number of institutions also experienced  this, was the decrease in the number of rooms that had either negative pressure or hepatofiltration.  These are portable units that were used in our ICU, also in our ER, and can be used to turn any ICU room into a filtration room for air exchange in patients where we're worried  about aerosolization and airborne particles. These are very effective and allowed us to expand our ICU capacity, and even to areas  potentially which were not ICUs, but floor beds, which required this. The one thing that was interesting, at least in the Philadelphia area, and we saw this  in trauma centers throughout the United States, is an effect where violent injury and violence increased during the pandemic, at least in the first several months.  The article that you see here, Trauma Center Activity and Surge Response During Early Phase of the COVID-19 Pandemic, the Philadelphia story, was published in the Journal of Trauma.  It's the experience of the level one trauma centers and pediatric centers in the city of Philadelphia during the early pandemic.  Although trauma volume was down by 20%, gunshot wounds were up, and this correlated with COVID-dense city regions.  There were over 1,400 cases, patients that were COVID-positive, and 23% of them required ventilation.  We discussed these on weekly calls, talking about our observations, experiences, and best practices, and this was very helpful as we navigated this.  Trauma centers operated very successfully during this time, but this was not something that we expected to see, and was actually a side effect of the pandemic as people were  isolated, resources were down for mental health, people were in close quarters, jobless rates went up, and these are some of the reasons that were speculated as to why this violence  increases. We also saw an increase in the number of car accidents and pedestrians struck because of  the number of cars that were not on the street, and then there was a lot of cars, a lot of speeding, and people probably not paying close attention.  This was something that we didn't really think of as a side effect of a pandemic, but something that we observed over time. We changed the way we did our trauma resuscitations.  You can see this picture of a trauma bay that is set up for isolation with ICRA barriers, and this allowed for caring of patients who need to be isolated.  All patients were patients under investigation, especially those that could not talk to us. The picture on the right shows the increase in PPE.  This is one of our trauma techs, has underneath the regular mask a N95 mask, so either N95 or PAPR used for all that were around the bedside, with a full face shield as well.  So all of these patients were swabbed, even those going emergent to the operating room, and during the time they were in the OR, we would receive the results, which would determine  what unit they were going to should they be COVID positive. One thing that was interesting is that a lot of attention was given to ventilator need,  and if you think about this, the respiratory therapists were probably the ones that we would have had a relative shortage compared to need.  Expansion of all the support strategies, multiple types of ventilators, potential for multiple  patients on a single ventilator, and then the tiered model, where experienced therapists would be overseeing less experienced personnel.  So never was it more important to have experienced respiratory therapists, but their need and expansion could have been a problem.  However, one of the things that was applied, at least in our institution, was telemedicine,  where a therapist was placed 24-7 in the EICU, covering the six hospitals and 320 beds, and this experience was outlined in a letter to the editor of the Journal of Cardiothoracic  and Vascular Anesthesia, and there were over 900 interventions by these therapists over time as they oversaw and assisted in the care of the critically ill patient.  Now the professional organizations, probably one of the most valuable things that we did during this time was Society of Critical Care Medicine, American Association of Critical  Care Nurses, and others had resource centers set up with resources that many of us are familiar with, but provided a repository of information and changing information over time.  The American Association of Critical Care Nurses, out of this came a micro-credential, which is a validation of knowledge related to COVID-19 pulmonary and ventilator care,  and provided the courses free for members and non-members to improve knowledge around pulmonary organs and ventilator resources, and also provided resources to support also  not only for clinical, but also mental health and well-being. Institutions did similar things, this is a screenshot of ours, and this was a go-to website  for people to be able to see the resources that we had. So how do we maintain Lessons Learned?  What's the role of the federal, state, local government, professional organizations, and healthcare systems? Well there's a model for this.  The NASEM paper, which was a national trauma care system integrating military and civilian trauma systems to achieve zero preventable deaths, was designed to have a partnership  between the military and civilian entities so that we could maintain the knowledge that was gained by the military and that knowledge in the civilian trauma systems to bring those  two together, sharing aims, infrastructure, design, data, best practices, and personnel.  And if you think about this, this was an opportunity that was very unique and time-sensitive,  and how do we maintain our knowledge and what we know and what was learned during the pandemic so that it's not forgotten the next time that we need it?  Concept of focused empiricism is something that was used not only during this time for the military but also what we used and maybe didn't think of it as such in the early pandemic  where we used the best data available combined with experience. When this is done is when high-quality data is not available, urgency to improve outcomes  is important because of high morbidity and mortality, and data collection is possible. And if you think about how this was done by the military, what they learned with use of  tourniquets, whole blood, and combat gauze, and other techniques, including rapid transport, was actually studied and benefits shown and then applied to the civilian sector.  So similarly, what we've learned during this pandemic with data collected, small series data, letters to the editor, experiences that may not be large, randomized, controlled trials  are valuable in collating and curating our experiences with this. The government's role is an organization of response efforts and supplies, and we realize  that that will take some time and that institutions may be on their own for a period of time. Funding, guidelines through the CDC and NIH, very valuable.  The FDA providing emergency use authorizations, and the strategic national stockpile providing supplies as needed.  Professional organizations who've done what they've done so well by maintaining and developing  evidence-based guidelines, providing educational resources, and collating and curating the experiences and best practices of both members and non-members.  So in our most recent Region 2 and 3 AACN meetings, a lot of the experiences of members were very similar and were provided, and it's probably best for us to capture these so that  we can use them in the future. And also, what are the future threats? In healthcare systems, memorializing successful practices and processes, because you will need them again.  Remember how you did things, what worked, what didn't work, updating your hazard vulnerability analysis to include pandemic considerations, and including these in your drills.  Often we do disaster drills specific, and it might be an all-hazards approach where we look at car accidents, we look at terrorist attacks, but what about pandemics and how  would we do that? This can be a tabletop, maybe it's something that's done every other year, but realizing  that what you learned was valuable and what your system learned was valuable, and how do you apply that over time? Also, most important, is resilience of our staff.  With this two-tiered approach with the pandemic, spring and fall, people are exhausted, they're stretched thin, and how do we maintain our resilience?  Because our most valuable resource is our people. And there's several initiatives that are outlined here that were very well done, that you can  find as a resource, and most importantly, taking care of our people. I've left on this last slide resources available from all the different organizations through links.  All of them are quite good, they're updated on an ongoing basis, and an area where if you're looking to start as to how to put processes in place, you can start here.  So I want to thank you for your time, and we would be happy to answer any questions after the session.  Hello, my name is David Wong, I'm a professor at the University of Pittsburgh, and I'll be talking today about implementation of the Pragmatic Adaptive Remap COVID Trial, how  to set up your system for success. These are my and the trial's funding, and I'll be summarizing today a manuscript our  group has in press, in trials, that you can look up after the talk for further details. So for the next 20 minutes, I'll briefly discuss the background of the trial, talk about how  we implemented the trial at the UPMC Health System, and then conclude with thoughts on how you might implement the trial at your hospital.  So for the last several decades, every time there's a potential novel therapy, there's this fundamental tension between learning versus doing.  On the left, in clinical research, there's an impulse to randomize out of an intense desire to generate future knowledge, while on the right, there's often an impulse to  give the novel treatment out of an intense desire to treat patients, particularly those you are responsible for.  The reasons for this generation of these parallel worlds and separation of them, if you will, are many.  First, the Belmont Report, the Fundamental Texts of Research Ethics, recommends they be kept separate, and each world has different duties and incentives.  But having this parallel world infrastructure creates significant inefficiencies, which while they've been tolerated for decades, have become intolerable in a pandemic when  one both has to learn as well as do. So what if you could learn while doing? So on the left, clinical researchers can make trials friendlier.  We can design trials with smoother logistics that don't get in the way of patient care,  and then design the study such that it provides higher odds that your patient will get a novel treatment, and then if they get a novel treatment, a higher probability that it works.  And the researchers can unify. Does the world need 100 different trials of hydroxychloroquine, or would it be better to have a couple well-designed, well-powered ones?  On the right, the clinical enterprise can do things such as leverage the electronic health record system. Systems can also reflect on equipoise.  Is it always a good idea to just give the treatment, or might it be better to do it in the context of a trial?  And then individual providers can explain these complex issues to patients. In the middle, institutions can reduce barriers between these two worlds and enable and incentivize  collaboration. So one specific approach to learning while doing is called REMAP, which stands for Randomized Embedded Multifactor Adaptive Platform Trial.  So none of these individual letters are unique. It's the package together which is unique and maximizes efficiency. So randomization, we all know what that is.  It's the most powerful way to develop causal inference, as it controls for both measured and unmeasured confounders.  Embedded refers to embedding research trial processes into routine clinical care processes. For example, embedding research order sets into the electronic health record.  Multifactorial refers to a design that tests multiple novel treatments at the same time,  which then has the pleasant benefit that most patients will receive at least one novel therapy. Adaptive means that the trial learns as it goes, and that it adapts, such that every  time the coin is flipped, so to speak, for each patient, it's actually a weighted coin, weighted towards the best performing arm at that time.  The platform trial is a perpetual trial. The trial never ends, as long as the disease exists and ideas for fighting it exist.  This has the huge benefit that there's no administrative interruptions. So together, ReMAPs is unique for maximizing efficiency.  ReMAP-CAP is a global adaptive platform trial for severe pneumonia admitted to the ICU, and it was launched in 2016 with funding from these countries.  At the center is the core protocol, which lays out the basic overall structure and processes, while at the right, in purple, are appendices for each novel intervention.  And then importantly, there is a pre-specified pandemic appendix that was generated just in case another pandemic broke out.  This was created because of the experience in H1N1, which was that by the time the study was designed, IRB contracts approval, et cetera, was ready, and the study was ready to open,  many patients were missed, and relatively few patients were enrolled in the studies. So conversely then, using the pre-specified pandemic appendix, ReMAP-CAP flipped in February  2020, and became ReMAP-COVID. And this did three things. It added a moderate state that allowed all hospitalized patients, including those on the floor, to be enrolled.  It added novel treatment domains for COVID-19. And then it enabled new sites to join the ReMAP network. So ReMAP-COVID at UPMC represents the first U.S. site.  Our sponsor is GCARD, the Global Coalition for Adaptive Research, which also sponsors innovative trials in cancer. The IRB is the University of Pittsburgh and the Western IRB.  And we launched at all UPMC hospitals on the Cerner, and then later the Epic EHR systems. We also serve as the U.S. Regional Coordinating Center.  So you may be thinking, this all sounds great, but what about a whole host of practical as well as theoretical considerations?  And I'll be remiss if I pretended that we'd solved all of them, but I'm going to share with you how we implemented the trial at UPMC.  Certainly, when I first heard the concept of ReMAP several years ago, I had very much the same concerns.  So while back in the spring, it was a bit of building the plane while flying it, I sat down with my co-PI, Dr. Brian McVeary, and colleagues at UPMC and elsewhere to think  about the various tasks that were executed in order to implement the trial. They clustered around these six themes, which I'll cover now. The leadership engagement.  We did have a couple of advantages. A big one was that there was already a prior UPMC ReMAP trial of a completely different  condition, but then nonetheless, the concept of ReMAP and some structure was not new. We also had an existing University of Pittsburgh Clinical and Translational Science Institute,  which serves as an umbrella of sorts for clinical research processes. We did have some disadvantages.  At least back in March, the number of COVID-19 trials and opinions actually greatly exceeded the number of patients we had at that time.  We had multiple discussions with both administrative and clinical leaders, informatics groups, blood bank, and many others.  This resulted in a relatively large sense of unity and then importantly, access to infrastructural resources.  So UPMC Health System committed to ReMAP COVID and granted us access to resources, and while  at the University of Pittsburgh CTSI centralized COVID-19 research to provide a sense of prioritization and unity.  As for trial embedment, we first started with thinking how to embed the trial into routine care processes.  So we engaged health system-wide administrative groups and information dissemination vehicles.  This was crucially important because, as we remember back in the spring, there was really a deluge of information with daily, if not more often, emails from health systems.  So we worked hard to embed concise talking points about the trial into these daily information blasts from the health system leadership.  We also partnered with the UPMC Pharmacy and Therapeutics Committee, which independently decided that a remap would be the only route for novel treatments, remap and other trials,  if the patient was trial-eligible. This was important because this meant that no UPMC physician could, for example, just  prescribe hydroxychloroquine, but would have to do it in the context of the trial. And the clinical pharmacies agreed to dispense what's called IND-exempt, basically already  FDA-approved drugs used in the context of the trial. And then we piggybacked on the growing telemedicine footprint.  At the same time, we worked to embed the trial into our electronic health record. So the concept was a one-stop shop for both care and research.  So we generated a COVID-19 management portal that served the greater UPMC mission for COVID-19. And then individual clinicians could click on this tab that would provide them access  to COVID-19 order sets, information resources, and a launchpad to remap. And at the center of the launchpad is what we call an intake form, which asks providers  to complete a couple of basic epidemiologic questions. So that way UPMC could provide mandatory data reporting to CDC and others.  And then we also asked individual clinicians to ask the patients or the representative one question. There are no known treatments, which was true back in March, for COVID-19.  Would the patient like to hear about potential additional therapies? And if they said yes, then this gave us permission to approach them.  So then we generate this remote consent process, which is a bit complicated, but I'll walk you through it.  So after the patient or representative agreed to talk to us, and the clinician indicated  so in the electronic intake form, this automatically generated an email to our research staff who reviewed and confirmed eligibility, often with a study physician and sometimes with  a bedside physician. Research staff would then make a quick phone call to the patient or a family member.  And if they were willing to further discuss, research staff would initiate a video consent process for face-to-face discussion, and then would patch in a physician to complete the  mandatory in the state of Pennsylvania physician consent process. And then the research coordinator would also provide, in a separate electronic platform,  an electronic signature ability, which both the patient and the treating physician would electronically sign.  An enrollment form would then be completed by the clinical research coordinator, uploaded  to the electronic health record, which would then activate the embedded Remap COVID protocol, and notify the provider to sign the order as long as he or she was okay with it.  So then after enrollment, response adaptive randomization, the weighted coin flip that  I discussed earlier, occurs, followed by pop-up order sets to be signed by the treating physician, and then automated data capture via the electronic health record.  We launched the trial with our local University of Pittsburgh IRB, using repurposed FDA-approved  drugs, at that time hydroxychloroquine and corticosteroids, not only because there was an intense interest at that time in those two drugs, but also because they are FDA IND  investigational new drug exempt, which simplifies implementation. As we now seek to expand the trial across the U.S., we've partnered with the central  IRB at WUR, working closely with our sponsor GCAR, and have added experimental drugs for immunomodulation with industry partners, for which an IND is required.  In terms of modification of traditional trial management, there's a lot of adapting with adaptive trials, and not just with the biostats.  So for example, every time a domain is dropped or added, you're essentially starting and  stopping a new trial, with new inclusion criteria, exclusion criteria, sometimes screening processes, different interventions, etc.  All these need to be carefully taken into account, and so you basically never cruise, as you often do with the traditional non-adaptive trial.  We've also adapted our data process workflow for collection, evolving platforms, and export.  And then for monitoring, like much in 2020, monitoring now has to be done remotely, which is efficient, but has to be done carefully.  And then for adverse event monitoring, we use a combination of automated electronic health record polls, manual monitoring, and clinical feedback.  And then lastly, alignment with other COVID-19 studies. So the main point is that individual UPMC-specific studies can be layered on top, but with a  common intake through the common COVID-19 portal, and using the same remap infrastructure,  with each study tailored to the PI's specific interests and opportunities, principal investigator. And the PI's can also share in the extracted EHR data elements for efficiency.  So the way that it works at UPMC is that remap provides the core infrastructure, with the remap domains on the left, but with what we call UPMC menial domains on the right,  most notably NIH trials, for which we serve as a site. So as of December 26, 2020, we've enrolled 339 patients across 21 UPMC hospitals, which  represent both community and academic sites. And we're very pleased about this, because that means we've been able to offer the  trial and the novel interventions to patients, not only in the academic shops, but also in the community, which will also generate more generalizable data.  As of today, we're enrolling in three domains, anticoagulation in partnership with the NIH ACTIV-4 trial and the Canadian ATT&CK trial, vitamin C in partnership with the Canadian  LOVIT trial, and immunomodulation with industry partners. And again, all of our activity is together with the global RemapCAP trial, of which we are one part of.  So now we're looking to expand both the number of U.S. sites, as well as the number of domains, as we fully anticipate that one of these domains at least will drop in the  months to come, as did hydroxychloroquine and corticosteroids. So if you're interested in joining the trial, I wanted to discuss RemapCOVID at your hospital,  how you might go about implementing the study. And I would start with these two themes. First, leadership, essential to engage the key stakeholders, and ask, is there a centralized  COVID-19 infrastructure, not only for clinical care, which I'm sure there is, but also for research. And then work to align institutional and trial goals.  So for example, would the P&T committee and physicians in general at your hospital be willing to accept restriction of novel therapies to be done inside of a trial, and thus these  treatments would be randomized, rather than just have random treatments at large. And then I would share a vision of Remap post-COVID.  Hopefully later this year, COVID would just be another diagnosis, and not the center of our existences.  And then RemapCOVID could most notably easily flip back to RemapCAP, good old pneumonia, regular pneumonia.  And then beyond that, there's a vision that Remap could serve other conditions as well, as Remap is really just a philosophy and then operational structure to maximize conduct  of large, efficient, pragmatic adaptive trials. As for alignment with other COVID-19 studies, this is a very important issue, as there's  already lots of COVID-19 trials active, perhaps, at your site. And I think two philosophical points bear mentioning. One is that a rising tide lifts all boats.  And then two, to quote a famous Pittsburgher, completely unironically, Mr. Rogers' sharing is caring.  So in terms of specific logistics for alignment, I think these three domains are most prominent. First, bandwidth.  We all know that everyone is stretched thin in these times, but Remap's study and protocol is quite open to co-enrollment, and some of the domains come with funding.  As for screening and consent, you could piggyback, for example, on existing infrastructure. For example, you could have joint screening efforts, and then either joint consent, or  potentially a handoff, so to speak, or referral after the existing infrastructure has already completed their consent.  At UPMC, we use both models, whichever fits best for our colleagues conducting other COVID-19 studies. But throughout, it's really about looking for the win-win.  So for example, shared off-hour weekend coverage, shared funding, particularly if a study allows co-enrollment, and then again, the vision of Remap post-COVID.  As for trial embedment, I would start with thinking about how to embed the trial into routine clinical care processes for information dissemination, order entry, patient-provided  communication, pharmacy issues, and even opportunities of patient contact regarding willingness to discuss research.  And then if you have the resources, embed them into your electronic health record system. We can definitely share the coding we've developed for Cerner and Epic.  And while it will definitely require upfront IT support, and therefore engagement from your system's leadership, this will yield large downstream efficiencies, not only for  Remap COVID itself, but also for likely future, not only trials, but QI initiatives, as pretty much all health systems are trying to evolve into a so-called learning health system.  That said, you can definitely launch without EHR embedment. You can definitely launch the trial using traditional means.  As for remote consent and enrollment, I'll just say that technology will technology. So I would recommend doing as we did, and doing mock enrollments, just to make sure  that all the tech pieces are actually working. I'll consider multiple software platforms, and then after picking your main choice, having  the others as backup options, because you never know. Sometimes though, you will have to engage with very busy bedside providers, and their  business has to be greatly respected, but sometimes patients, for example, they don't have their own smart devices, or particularly if they're elderly, they have trouble navigating  the various buttons. Try to piggyback on existing institutional resources, hospital iPads, telemedicine, etc.  And FDA does allow for COVID-19 research, a specific form of telephone consent. You could also do traditional in-person consent and enrollment.  Obviously, then you have to follow all personal protective equipment, PPE rules, and can be  done certainly by bedside providers, if they have the bandwidth, as is done in the UK with the recovery trial, or potentially by research staff, though this will require additional  PPE and training sometimes. And lastly, for regulatory compliance and oversight, I would engage your local IRB to  partner with our central IRB, and recommend that you keep in close contact with us as the regional coordinating center for the U.S., as well as GCAR, our sponsor, and we'll  do everything we can to simplify these important components of trial implementation.  And lastly, in terms of modification of traditional trial management, again, if feasible, I would  try to launch and leverage your existing EHR, but you can definitely start the trial with  traditional trial tools, which we will provide, randomization via an interactive web response system, and data entry via an electronic case report form.  Thank you very much, and please feel free to contact me at my email below. Thank you. Hi. My name is Amish Hidalga.  I'm a senior scholar at the Johns Hopkins Center for Health Security, and a practicing infectious disease critical care and emergency medicine physician in the Pittsburgh area.  Thank you for this invitation to speak to you. Just a little bit about the Center for Health Security.  It is a public health think tank that's focused on pandemics, emerging infectious disease biosecurity, and last year I came and I spoke about COVID-19 when it was basically the only  session on COVID-19, and a lot has happened. And I'm going to try and focus now on what we've learned and how that interfaces with hospital capacity.  So again, thank you, and I hope this is interesting to all of you. So the first thing I want to go through is just the outline of what I'm going to speak about.  So I'm going to talk about the situation with emerging pathogens. Why there is a resource limitation that we continually seem to face in the United States  and around the world with this coronavirus. And then talk a little bit about the current emergency preparedness paradigm.  Talk a little bit about what's happened during this pandemic, and think about the future and how this doesn't happen again.  So the first thing I want to talk about is the fact that emerging infectious diseases are not going to be something that is completely irrelevant.  This is going to be something that we continually face, and just to take you a little bit into history and anthropology, we basically have a world of emerging pathogens.  This planet is full of bacteria, viruses, fungi, protozoa, and some other species, including us. And if you think about how the human race has evolved, we basically went from nomads  that went from place to place to a situation where then we discovered agriculture about 10,000 years ago, and people started to stay in the same place for periods of time.  Pollution density increased, animal exposures increased, people went to the bathroom in the same place that they were, and we basically had the age of pestilence and famine.  Then we went through the industrial revolution, and that was the age of receding epidemics as sanitation and hygiene increased, making infectious disease something of the past.  And then eventually we also had the discovery of vaccination, the discovery of antibiotics like penicillin, and we really had a time where we didn't really have many infectious  disease threats. But over the last several decades, we've seen globalization, urbanization, and aging  of the population, and aging is really important when it comes to COVID-19, and we're in this age of degenerative and man-made diseases. So this is something we're going to face.  COVID-19 is a wake-up call, but it's not the only pandemic threat we will face. And you have to remember that humans have only lived a very, very small proportion of  our existence in an urban global arena. Most of our genes have been adapted for nomadic life, for hunter-gatherer life.  So this is going to be something that we continually face, and that's why the threat of pandemics will not recede, and we have to get this right.  And it's very important, as we've seen with COVID-19, that this isn't just a task for infectious disease physicians, but critical care physicians play a major role in preparedness  for epidemics and pandemics. So this next slide just shows you one of the trends that we're seeing. And if you look at the map, you see megacities all over the world.  Megacities are going to be really infectious disease hotspots, because you've got high population density, people interacting a lot.  You may have wet markets in some of those places, as we saw in parts of China during the beginning of this COVID-19 pandemic.  And if a virus or a pathogen that spreads efficiently from human to human takes hold in a megacity, it's going to have very little barriers to its spread.  So the rise of megacities is something to keep on your radar as a harbinger for pandemics, and megacities are really going to need to invest in public health infrastructure to  be able to have an early warning when these viruses or bacteria, whatever they might be, start to spread, because they will sort of be the canaries in the coal mine, and they  will likely face the brunt of infectious diseases in the future. So another point I wanted to bring about with thinking about infectious disease threats is a little bit of math.  So in the prior eras, if somebody was traveling from one part of the world to the other, they came on a steamship, or they came on foot.  So your travel time was very long, longer than your incubation period. So you got sick on your trip, and you either died or you recovered, and the disease kind of stayed with you.  But when incubation periods are longer than travel time, meaning an incubation period of 14 days is longer than a flight between the United States and anywhere in the world,  you're going to see importations of diseases. So that's really, really an important factor, because viruses now do not travel at the speed  of a steamship, they travel at the speed of a jetliner. And that means we're going to continually see importations of diseases from one part  of the world to the other part of the world. So no part is really isolated, and what's going on in Africa or Asia is relevant to  what's going on in the middle of the United States, because you could have a case of something there within a matter of days.  The next point I want to talk about is, you know, how do we predict when pandemics are going to occur? What is it about certain pathogens?  And this is some work that I've worked, that I've been kind of immersed in for several years.  And there is really an alchemy of a pandemic pathogen, basically kind of a crude formula to think about what can cause a pandemic and what cannot.  And a few things I wanted to highlight, you know, one is efficient transmissibility from human to human.  So a disease has to be able to get from person to person to be able to cause a pandemic. That's why diseases like Ebola, which don't transmit efficiently from human to human,  could never cause a pandemic. They might be scary and deadly, but they're not pandemic potential pathogens.  Respiratory transmitted viruses do have that characteristic, and that's why respiratory viruses are such a threat. You only need to have a moderate fatality rate.  If you look overall at the CFR or the IFR of this coronavirus, it's less than 1%, but yet it caused a global pandemic that was very, very hard to control.  The other thing is being contagious during your incubation period. If people don't know that they are sick, if people don't have symptoms, but yet can spread  it, that makes a disease virtually uncontrollable. And with this coronavirus, we learned that there were people that were contagious during  your incubation period, especially those pre-symptomatic individuals. It's made control very, very difficult.  The same is true also of people with mild illnesses, people who can go about their activities of daily life, but still spread it. That's very efficient for a pathogen.  You also need to have an immunologically naive population. You shouldn't have cross-immunity in the population if you're thinking about something being a pandemic pathogen.  And of course, with COVID-19, there was really a naive population. The other human coronaviruses didn't provide sufficient cross-protectivity to stop this from becoming a pandemic.  No vaccines or treatments, and the ability to evade the host immune response. All of that's important, and there are many different pathogens that could fall into this,  but they do tend to fall onto certain viral families, specifically RNA viruses that are spread through the respiratory route.  For those that are interested in more reading, that's a report that I wrote called The Characteristics of Pandemic Pathogens.  If you just Google that in my name, you'll be able to get that report, which talks a lot about this type of reasoning when it comes to pandemic preparedness. So what else?  What was the perfect storm that led us to where we were with COVID-19? You have to remember that public health is undervalued and under-resourced.  There is no town that is bragging about their public health department. Nobody is saying, we prevented this many cases of gonorrhea or this many cases of syphilis.  That's never on someone's billboard or any mayor's or county executive's reelection campaign. It's not something that people think about, and public health has moved a lot away from  its communicable disease core to other issues. So the communicable disease core, the reason why public health departments were founded,  are not often considered flashy or sexy to advertise or to fund those parts, but those are the ones that are crucial.  They're really part of national security, and we have to start thinking about public health as part of national security, because if you don't invest in public health, you  will get to the same situation again and again and again. We often think that everything that public health does, it's not really seen.  We don't see the cases of syphilis that are prevented or the cases of hepatitis C. We often take for granted that our public health departments do this, and I think we can no  longer do that. We have to make sure that they're well-resourced and that they are given priorities. We also have an issue with the infectious disease workforce.  Infectious disease is one of the lowest paid medical specialties. It is a cognitive specialty. There have been shortages.  Many hospitals do not have an infectious disease doctor, so there's a lot of things that had a role in why we are in the situation that we're in, and these things, now there is an  opportunity to try and remedy them and fix them as we're trying to fortify our pandemic preparedness.  The other issue is hospital capacity, and it's interesting because many of us think of this as being a fixed type of quantity, that it's not something that you can expand.  I'm talking to you now on Zoom. What did Zoom do during this pandemic? They expanded their capacity.  Hospitals don't do that as much, and I think there's a lot of societal and bureaucratic constraints that I think we have to think about.  We have trends in healthcare to operate at or near capacity, almost like a hotel. An empty hospital bed doesn't make money for hospitals, so we've seen overall a trend in  closures of hospitals. For example, in New York City, St. Vincent's Hospital closed, and that decreases the number  of beds that you have available when you need them in a sustained surge like a pandemic or even a severe flu season.  If you look back at the flu season a couple of years ago, New York City got hit hard. The closures of hospitals really have an impact, and I think that because we operate this way,  we're always going to have this problem. Many hospitals also are faced with state laws where they have to have a certificate of need  filled out that if they want to open new beds or build a new hospital or build a new wing, they have to show that they need that wing.  Their competitors are allowed to object and say, no, you don't need that thing. You can't have that kind of a paradigm if you want to be prepared for a pandemic.  You can't have hospitals, their expansion plans being objected to by their competitors because when you're trying to think about hospital capacity, even today in my hometown  of Pittsburgh, there is a hospital trying to be built in one of the suburbs, and you have a zoning board blocking it.  In the middle of a pandemic, they are still blocking a hospital being built because of zoning issues. I think that the bureaucracy to build a new hospital needs to go away.  Some other countries, for example, in China, they build a hospital in a matter of weeks when they need a capacity. We could never do that.  Just imagine about how many local governments and committees and policies you'd have to try to navigate to do that fast. It's just not something that could happen.  We also have issues with staffing. I think that this is something that is a little bit harder, but I think there are ways to do it.  We could open up our immigration to allow more people from outside the country to help with staffing. We can graduate students a little bit earlier.  We can have nurse practitioners, physician's assistants, practice at their full scope of practice, something that I advocate anyway,  but that's definitely something we need to think about. We have to make it easy to augment staffing because it's not just space, it's also trying to make sure  that we have enough people to staff those beds. So that's something that's going to be really important to think about is fortifying the workforce for pandemics.  And you have to remember also that we do have events where hospitals are put under pressure, but we don't have what are called sustained surges.  We see an acute surge when there is a hurricane or when there might be a mass casualty incident, but a sustained surge really needs to take into account  how we can reconfigure the hospital system so that we don't have this crisis happening all the time.  And then staffing is, and I talked a little bit about staffing already. A couple of other points to make about hospital emergency preparedness. It's often an afterthought.  It's something that's not valued by hospital administrators. They often do it to check a box. They focus mostly on mass casualties. So for example, mass shooting events,  not on sustained surges, not on pandemics.  There is a hospital preparedness program at HHS-ASPR, which I think needs to be fortified and needs to be more funded and hospitals need to engage more with it.  And there also are rules from CMS and the Joint Commission about emergency preparedness, which I think really need to be revisited and fortified.  We've seen a lot of different tactics that have occurred during this pandemic. So for example, reclaiming unused space, an unused wing of the hospital, for example,  fortifying your supply chain to make sure you have enough PPE, for example, expanding the scope of care for floors and step-down units,  keeping people that aren't usually on a step-down unit in a step-down unit. Nursing ratios can be altered. Using other providers in the ICU,  hospitalists, anesthesiologists, et cetera, to augment your critical care staffing needs. Expanding the scope of practice of APPs, alternative care sites, telemedicine,  home treatment, for example, sending patients home with oxygen.  Another point I wanted to talk about are healthcare coalitions. And this is when hospitals, competing hospitals in a metropolitan area, band together to kind of pool their resources  during crises. And it's part of the HPP program. But what we've seen so far is it's not really working so well, that we're not seeing hospitals  kind of pool their resources in many parts of the country. And this sort of happened organically during 2009 H1N1 with ECMO, for example,  but it's not something that we're seeing really work in a cohesive manner all over the country the way we want it to, because we aren't seeing kind of sharing of load.  We're definitely seeing suburban hospitals and rural hospitals having difficulty transferring patients to major centers.  So what happened during this pandemic? How did we get the way we got? A lot of evasions, testing foul-ups that happened. We weren't able to test.  We didn't protect nursing home residents, even though we knew that they were going to be especially vulnerable. We had lots of undetected chains of transmission  that bubbled into hospitals. There wasn't really federal government support. And we saw, like I said, a big breakdown in the hospital coalitions. We also had issues with masks.  For example, after H1N1, the face masks were not replenished. We've also seen hospitals, like I said, not be very aggressive with trying to transfer patients  outside of their system, which is something you cannot do during a pandemic.  We have had some good things, real-time learning, oxygen delivery strategies, non-invasive ventilations, high-flow nasal cannula proning. We've got quick clinical trial data  on drugs like remdesivir and dexamethasone, HOMO-2 therapy I mentioned earlier. But there's been a lot of trade-offs between short and long-terms.  And I think we've learned that this isn't sustainable. You cannot stop replacing aortic valves. You cannot stop psychiatric care. You cannot stop opioid use disorder care.  You cannot sacrifice the long-term to the short-term. And I think we're getting better at trying to strike that balance, but it is something very difficult.  I also wanted to mention futile care. I think there is a tremendous amount of futile care, and that's not something that's new to this audience,  because we've had guidelines from the SCCM, and I think a lot of our capacity issues could be addressed with better policies around futile care.  I think it's much different with COVID-19 than it would be if people had pneumococcal pneumonia. And I think we really need to revisit futile care guidance  and really get better at implementing it so that we don't run ourselves into capacity because of this.  We also have the concept of crisis standards of care, and I just wanted to draw your attention to a report that the Center for Health Security released.  We wanna make sure that this is something that we address and that hospitals aren't left kind of dangling, not knowing when they should be on crisis standards of care  versus the normal standard of care, and that needs to be announced not just to hospitals, but to individual clinicians. They need a lot of situational awareness,  and I would just draw your attention to this report.  So what's next? I do think that we do have an opportunity to fix gaps. There is this window that we need to really fortify our hospitals and pandemic preparedness.  We need to think about the fact that we are going to have another pandemic, and we cannot allow this to happen again. And I think we also need to start thinking  about a system of care for infectious disease emergencies and fortify hospital coalitions so they do pool their resources and share their load. So thank you very much.  I hope that was useful. That's my email and my Twitter account. And again, thank you for this opportunity.  Hi, my name is Dr. Ryan Maves. I'm an infectious disease and critical care physician at the Naval Medical Center in San Diego, California, and an associate professor of medicine  at the Uniformed Services University. I'm going to be talking to you today about the mass casualty incident process and infectious pandemics and how these two systems of care  interplay with one another. I have no relevant financial conflicts of interest. These views are mine and do not necessarily reflect  the official position or policy of the Department of Navy, Department of Defense, nor of the United States government. So we are now into the second year  of the current COVID-19 pandemic at the time of this presentation. I think we all recall March of 2020 in the United States and over the course of the summer into August of 2020,  when we read reports like this in the paper of massive outbreaks at small border hospitals in the Texas Rio Grande Valley, how the Texas Medical Center reached 98% ICU capacity  and how earlier in the pandemic, the governor of New York declared a disaster as fear grew over lacks of ventilators.  More recently in Southern California, just North of where I live, CNN reports about a human disaster unfolding in Los Angeles as emergency medical services have had to reduce  and modify services in light of the overwhelming demand for emergency and hospital care.  So this leads us to a discussion of a concept called crisis standards of care. The Institute of Medicine in 2009 defined this as, and I quote,  a substantial change in usual healthcare operations and the level of care it is possible to deliver, which is made necessary by a pervasive or catastrophic disaster.  This implies an all disaster approach, not specific for pandemics, for trauma, for natural disasters, but a concept to be used anytime we have a setting  where the demand for healthcare services exceeds the available supply.  The goal of crisis standards of care is to do the best possible job in meeting standards of care in a crisis. The goal is not to provide less care to patients.  The goal is not to decide who is delivered to die. The goal is to reduce our ethical burden to our patients, to ourselves, and to society  by providing ways to provide the most care possible to the greatest number of people.  The Institute of Medicine went on to describe crisis standards of care as a forced choice based on the emerging situation and that failing to make substantive adjustments  to care operations is very likely to result in greater death, injury, or illness. So this leads us to what we'll call the three pillars of resource allocation,  stuff, staff, and space, that I suspect most of the audience has heard in the course of their clinical work over the past year, if not beforehand. This stuff refers to things  such as ventilators, dialysis machines, the associated consumables, medications, and PPE. Staff, which increasingly in COVID times is turning out to be our most limiting feature,  includes us, so acute care trained physicians, nurses, advanced practice providers, respiratory therapists, pharmacists, EMTs, and the other critical supporting staff  are housekeepers, our administrators, who may also be personally impacted, not only at work, but at home. And then lastly, space, physical ICU and ward beds,  alternate sites of care, such as tent hospitals, places within the hospital, such as PACUs and operating rooms where critical care can be provided in some manner.  And then in the case of COVID, the availability of negative pressure rooms. Overarching all three of these things are systems and then what we'll call C3,  communications, command, and control, that govern how we utilize these other three features.  Now, when we look at mass casualty triage, this is a dynamic process. And this slide is actually borrowed from the SECM's  fundamental critical care support course focusing on resource limited settings. So in mass casualty triage, we have this notion of quote, dime,  where patients are identified as being delayed,  immediate, minimal, or expectant. This is a dynamic process. It was modified according to available resources and over time. So patients can be described as having minimal needs,  small cuts, bruises, and fractures, delayed, where they have surgical needs or other interventional needs, but a delay in that will not risk lifelimit or eyesight.  And then immediate, where there's an immediate require surgical care within minutes to hours  in order to save lifelimit eyesight.  If surgical care is unavailable  or if the injuries exceed the resources available, then patients are considered to be expectant. This is, again, in a focused mass casualty.  And when we look at mass casualty triage and how we organize these sorts of systems, both in the military and in civilian settings, there's an acronym called S.A.L.T.,  sort, assess, life-saving interventions, and then treat or transport, where we start by identifying patients by the urgency of their needs.  And then move them through a pathway  in order to identify what interventions we can provide at the time. That could be if they have minor injuries only, they could be considered delayed or minimal.  If there is a need to provide life-saving interventions and those interventions are available, given current resources, that patient is immediate.  If those resources are unavailable, that patient is considered expectant.  Now we compare this to what we see in a pandemic disaster. So in a conventional disaster, such as an explosion, such as a natural disaster like a wildfire or a hurricane,  casualties are often as high as the hundreds. These are mostly trauma patients. They're generally presenting to the nearest hospital to the disaster.  Emergency surgery, mental health services tend to be in the greatest demand, and the event recovery may begin hours to days  after this focused, highly acute, highly localized disaster. This is where the most localized event takes place. We compare this then to a pandemic disaster,  such as COVID-19, such as Ebola in West Africa, back in 2014, 2015, where casualties are in the thousands or greater at the time of this writing. Mortality in the United States  is approximately 350,000 and counting. These are mostly medical patients. They're presenting to many hospitals. There is not a real geographic limitation anymore.  Emergency and inpatient services, they're in the greatest demand, and event recovery may require months or longer. And again, at the time of this talk,  we have not yet begun our recovery from COVID-19.  So when we look at how crisis standards of care overlap on this concept, we see that centers can move from conventional to contingency to crisis.  And this depends on the available space, staff, and stuff that we have to provide care. So under conventional levels of surge, we are using usual patient care spaces maximized.  We may be calling in some additional staff. In general, we're looking at about a 20% increase in the typical capacity of critical care services at a given hospital.  That's using local resources. When we move into contingency, we're looking at repurposing of spaces. So PACUs, other monitored units for ICU level care,  we're perhaps bringing in additional staff. In the critical care setting, we may be relying on our critical care surgeons to care for medical patients.  We may be relying on anesthesiologists more for procedures and the like. In this setting, we can perhaps double our usual capacity, but this requires regional and state coordination  to be effective. And this is where issues of systems of care and command and control come into play. In crisis standards, we're looking at nontraditional areas for critical care.  We are looking at insufficient numbers of ICU available staff. There is a significant change in the usual standards of care. We can perhaps increase our capacity by up to 200%,  but this level of disaster requires greater than just a regional response, greater than just a state or county response.  This is just a flow sheet. This is from Dr. Mike Christian, which explains this imbalance between supply and demand and how we can affect these imbalances.  What are the inputs we can place into increased supply and the staff and space using C3 and systems to regulate those supplies? And then what can we do with demand?  Public health control measures to reduce the incidence of disease, changes in therapies, scientific advances to improve the care of patients to hopefully reduce the demand.  And then ultimately, if all else fails, triage, prioritizing whom we can care for most effectively.  So again, in crisis standards of care, we are looking at conventional contingency and crisis levels. Our challenge right now as a society  is that we remain in a chronic contingency state. And this is distinct from a typical mass casualty setting where you have a discrete finite period of disaster  followed by a period of recovery. We're in this chronic contingency and we are having to constantly adapt and modify our practices as a result.  So that gets us back to those three pillars of resource allocation we discussed before. In terms of stuff in a chronic contingency, the scope of the contingency  could make our shortages chronic. We have to reallocate equipment as we can between more and less affected areas. But when you have a widespread geographic disaster,  finding a place that is less affected to support a place that is more affected can become an increasing challenge. We can reduce our demand for stuff  by shifting from single use to reusable equipment. NIOSH, for example, is conducting ongoing studies of elastomeric N95s, which would be a reusable form of PPE.  Staff, we have issues of caregiver fatigue, burnout among frontline staff. There are issues of personal risks. Hopefully ongoing vaccination programs will mitigate these.  And then we have on the flip side, we have increasing experience with the care of COVID patients. We are getting better at this. And as part of that,  that has an impact on the mortality of our patients. In terms of space, we've become very efficient at converting areas to negative pressure.  We're seeing ward to ICU conversions and back. And also our hospitalist colleagues are getting more accustomed to an increased level of acuity on the wards,  which mitigates some of those effects of space.  So how do we operate this from a systems level? What we need is a system of regionalization of care. The decision to initiate crisis standards of care  is not an institutional decision. One hospital does not make this decision. This needs to be coordinated with existing robust communications  between healthcare systems in a given region. There are a number of excellent examples of this. Early in the pandemic, the Washington State Department of Health  helped establish the Northwest Healthcare Network in the greater Seattle area and in Western Washington to coordinate this. The University of Minnesota,  in collaboration with the Minnesota Department of Health, led by Dr. John Hick, among others, has established a very robust system within the state of Minnesota.  The idea behind this is load leveling to transfer patients from overwhelmed to less burdened hospitals to the greatest extent possible to permit the borrowing of durable equipment,  such as ventilators and dialysis machines, to permit loans and purchases of consumables in an organized manner to minimize hoarding and the impacts of panic buying by institutions.  And if anything good comes of COVID, one of the things is throughout much of the country, we are seeing examples where competing health systems within a given region have learned  to collaborate together in this unprecedented crisis.  So some examples of some of the issues of staff and space we've faced as a country. Ventilator shortages were a concern very early on. Ventilator models are available  through the Strategic National Stockpile. Dr. Jeff Dichter and Dr. Richard Branson, among other co-authors,  produced a manuscript published in CHEST that compares the different types of ventilators available in the Strategic National Stockpile.  Unfortunately, not all of them are well-suited for the care of patients with COVID, although they could conceivably be used for, say, the neurologically injured patient,  reducing the demand for full-feature ventilators. Medications are a challenge because of the low incentive to produce certain less profitable drugs  and the increased demand that we have seen with COVID patients requiring prolonged hospitalization. Increased demand for neuromuscular blockade agents.  Increased demand for other sedating agents.  Disruptions in supply chains due to pandemic-related business practices by international firms. All of these things affect what kind of care we can provide,  and managing them requires some degree of international or national or state or regional coordination. So pandemic triage, then. What happens when we run out of the three S's?  So pandemic triage is going to differ from traditional mass casualty triage. Like I said before, this is not geographically restricted.  It is more difficult to obtain external resources in many cases, and our goal is not so much transferring people to unaffected areas as to load level within a region  to the greatest extent possible, so that if one hospital has no ICU beds and another hospital has five ICU beds, we can move some things around  to redistribute the care of patients throughout a region. Surge responses that we described, these methods to increase the three S's, should seek to avoid the need for triage  to the greatest extent possible. Now, a lot of early writing about triage, and ongoing, has looked at ventilators and what happens when we run out of the last ventilator,  although increasingly, staff appear to be our most limited resource. And early in the pandemic in New York City, hemodialysis machines were a particularly limiting feature.  So any scarce resource can be limiting. Dialysis, remdesivir, oxygen in Los Angeles at the time that I record this, high-flow nasal cannula machines.  Levels of surge and the need for triage will change over time in a pandemic, where we start at very low levels on the left-hand side of this figure.  As caseloads increase, we move through conventional to contingency to a major surge, to a crisis setting, where different levels of triage may be necessary  throughout the course of an emergency in order to provide different levels of care, depending on different resources. And that's a dynamic decision that needs to be made,  again, at a regional level, not at an institutional level.  So what do we do with pandemic triage? Well, our first thing is to try to avoid it. If necessary, though, there are a number of different approaches to this,  and I will admit there's a fair bit of controversy about how to best apply triage in a way that is equitable, particularly in light of the numerous injustices  that we have seen in our societies, especially for the most hard-hit populations in the United States, people of color in particular.  How do we make sure that we are providing the best care to all people in a way that is fair and equitable? So there is sort of a fundamental decision we have to make  in establishing a triage system, is our goal to save the most lives or the most life years, particularly considering the increased mortality in COVID-19 among older patients.  Triage principles need to apply to all patients potentially being admitted to the ICU, not just those COVID. And we have to remember our obligation to care for all patients.  So even those who are not able to receive critical care resources need to receive the best palliative and supportive care possible,  that crisis standards of care are still standards of care.  There are a number of algorithms that have been published by states and in the medical literature. These generally try to assess some sort of odds of survival.  So long-term survival, looking at things such as ASA scores, frailty indices, comorbidity indices, markers of short-term survival, such as things like SOFA scores  and other physiological scores, and then looking at patients who have a very low likelihood of surviving, regardless of what interventions we give. These would be patients  with catastrophic intracranial hemorrhage or prolonged coma following cardiac arrest. There are considerations for tiebreakers for certain populations, children, pregnant women,  first responders, potentially.  The data for physiologic-based scoring, such as SOFA scores, tends to be relatively poor. And there's a lot of interest in moving away from those  as a particular system of selecting for whom to care. This all needs to be done in a systematic way. And the goal in triage teams is to remove that decision  from the bedside clinician as great as possible. I'll admit this has been very challenging for health systems to implement, but the idea is to have a clear algorithm  and a triage officer who can make these sorts of decisions regarding resource allocation, ventilators, hemodialysis, and such, based on a system that is clear, transparent,  with community involvement, and hopefully with a timeliness that is actionable.  So there are a number of ethical challenges in critical care triage. The role of age, do we look at years of life or do we look at the right of people  to move through different life stages? School, through early adulthood, through parenthood, through older adulthood, through their years as elderly people.  How do we incorporate pediatric patients and pediatric hospitals into triage? How do we make sure that we avoid disproportionate impacts on communities of color and fair treatment  for those with disabilities?  So what would constitute a successful response? Effective communications between health systems and within health systems, both at the state, region, and hopefully national levels.  Coordination, having the localities foster teamwork between systems in advance of a time of crisis. And I am proud to say that here in San Diego County,  where I currently live and work, San Diego County Health Systems, we're able to do this in advance so that as our surges have come,  these systems of communication have been very effective. And then accurate inventory of resources. In order to know how we are going to allocate  scarce resources, we need to know how much we have at different settings. So knowing how many beds we have, both routine and surge, how many vents, how many dialysis machines,  what kind of staff are available and who's available to augment that staff if necessary. Ideally, setting up systems to train, let's call them critical care adjacent people,  hospitalists, medical surgical nurses, respiratory therapists who don't do a lot of work in the unit, anesthesiologists, acute care surgeons  and the like, who can augment critical care needs as necessary as surges come and go. I want to acknowledge my many friends and coauthors who have helped me with this.  Doctors Devereaux, Dichter, Evans, Uppel, Mukherjee, Christian, Geiling, Ferraro, Drees, Hicks, Branson, Kasun, Niven, Inav, Simpson, Sprung and many, many more.  I can be reached at this email address. I just wanted to, as a reminder at the end to let everyone know that a little over a hundred years ago  our society went through this once before. We've gotten through this before, we will get through this again. Thank you very much.  Hi, and thank you to everyone and thank you to the conference organizers for the opportunity to participate in this year's Congress in this session.  I am here with my co speakers again I'm Dr. Ryan Maves, the moderator for this session here with Dr. Gallagher, Dr. Wong and Dr. Adalja, and we have a number of great questions  in the chat, and we're going to go through those, and we'll keep going until we're done, or until, until we've run out of time.  So first question from the chat is about system resilience and this is for Dr. Gallagher. How can you know we discussed a lot about how systems can improve over time and these  responses, you know, what would be some examples of how systems can health systems can capture this kind of data specifically identifying things that work well in crisis and things  that have worked less well. That's a great question. I think that every institution and organization has handled this a little bit differently.  There was a lot of learning on the fly. I can say for my organization. One of the things that we did at Penn Medicine was there was a critical care Alliance COVID-19  task force that really kind of centralized what the learning was the experiences of the organization and how things changed over time.  I think this is where things that worked were brought things that maybe were needing to be fine tuned were changed, and every organization has those, those types of things that they  do. I think that also through our professional organizations, what was found is that having focus groups and bringing people together who may have had similar circumstances and  I mentioned through ACN, we had the regional meetings and what was happening is you started to hear common themes, things that people did well, things that we could share.  And so I think between the organizations themselves, each organization or health system may do that.  But then also leveraging the professional organizations as well to have those forums, maybe after the factor at halfway points to, to invite people to come in and to talk  about what worked well in their organizations. I think you find commonalities and also things that need to be changed. Excellent. Thank you. Thank you very much.  For Dr. Wong, you know, the remap cap trial and remap COVID trial is obviously a very complex and very large undertaking.  One of the challenges I think in interpreting this, this sort of study has been, you know, it's evolution over time.  It's a very sophisticated statistics used, for example, can you, and you discuss this in your talk already, but in terms of, for example, managing the confounders, I mean,  for example, how, you know, all cause mortality in the ICU seems to be decreasing over time in COVID. How do you account for that in remap cap and remap COVID? Sure.  So all the stats are handled by a company called Berry Consultants led by Dr. Scott Berry. And it's basically a single Bayesian adaptive stats model that can, that can handle all  the confounders. So for example, so for example, time, time is a, time is a factor, a variable in the model the same way, the same way that, that, that ages.  And then if there's, if there's a hypothesis that a given intervention may have interactions  with another intervention, for example, that can be established a priori or, or post hoc. And then one of the advantages in the model is that all the patients are used in order  to establish, in order to best estimate the primary outcome. So for example, even if, so, so for example, even if a given patient was only enrolled  into say vitamin C, that patient's demographics and information can feed into the, into the overall model. Okay. Well, thank you very much.  For Dr. Adaljit, you know, one of the, one of the questions that came through the chat was about thoughts about the higher mortality earlier in the pandemic versus later in the  pandemic, where, as we just mentioned, how it seems that ICU mortality is decreasing. Do you have any thoughts about why this might be?  And what the, the, the questioner asked specifically about, you know, unconventional therapies  tried earlier on some of which, you know, we're probably on a fairly reasonable physiologic basis and others, which I think we can agree in retrospect, we're not.  Do you have any thoughts about the impact of that, or do you think that the higher mortality is just a result of surge of hospitals being overwhelmed?  I think it's a couple of things. I do think that the number one thing likely was a severity bias in the data, because remember  back in March, February, April, even today, we still can't test everybody that we want to test.  And there were times where we're telling people where you have mild cases, and I did this to many patients, you probably have COVID, I'm not going to test you.  So they don't get put into the denominator. So we had the wrong denominator for a long, long time, which skewed the case fatality or infection fatality rates.  Then I do think it was the fact that in the very beginning, we had no idea what was going on with some of these patients if they, for example, were crashing, is it because they  got a secondary bacterial pneumonia? Is it because they've progressed? Did they get, did they have a heart attack? Did they have a PE?  Then we started to figure out, oh, these people do clot, maybe they need to be on anticoagulants.  They don't really get that many secondary bacterial infections, their cytokine storm. So all of that, I think, played a role in the very beginning.  And we were also ventilating, we're putting people on mechanical ventilators almost reflexively if they were on six liters or more early on in the pandemic. So that played a role.  But I think we got better at taking care of these patients, and we also did see some decrease in the surge that you were seeing.  So both, I think it was kind of multifactorial, but we got better at taking care of these patients. We learned more about it. We weren't as inundated.  And I think we started to use better treatments. We got dexamethasone, and I think that made a big role.  So I think it was what we expected to happen, but I still think there is a severity bias in the data because we're still not testing enough, and I think that's always going to  be the case in a pandemic, that you're going to get a skewed view. I just remember what happened in 2009, H1N1, when we were hearing about people in Mexico  dying in ICUs, and everybody was very, very panicked, but we didn't realize that there was such a severity bias in the data that it wasn't as bad as it was. Yeah. Yeah, absolutely.  And how about, this is sort of actually for the whole group, how have, if you could go back a year and tell the February 2020 version of yourself one thing about a therapy you're  going to get very excited about is, you're on the wrong track. What would it be? I mean, I think for myself, it's probably going to be early intubation.  Just like Dr. Adalja was saying, that I think early on, a lot of us thought that we, for staff safety reasons, we should secure the airway quickly, and clearly that is radically  different now in terms of our practices. But Dr. Gallagher, how about in your health system? Have you noticed anything that you wish you could undo from the day, from a year ago?  I think similar to you, some of what have been using some of the non-invasive therapies,  kind of the high-fluorinase cannula, we knew those things were helpful in the general population, but the fear of aerosolization and such probably limited the early use.  And I think it was out of protection to staff, and also knowing that if you delayed intubation that those people needed it, that their outcomes may not be as good.  But there probably were some opportunities there, and that's something that I've heard from other colleagues as well across the nation. Yeah, yeah. Dr. Wang?  Yeah, definitely early intubation, and then a bit of a recency bias, but I think we definitely  saw throughout at least our healthcare system random use of therapeutic anticoagulation rather than randomized, and then the recent press release from the multi-platform trial  from Remap Active and ATT&CK, although of course it's just preliminary data, was really quite shocking, particularly the result for ICU patients where therapeutic anticoagulation  was actually futile and possibly harmful, although pleasantly benefited in moderate patients. So, I think it once again showed the value of just being humble and not guessing and  randomizing. Absolutely. Dr. Adalja?  I think what I would think is the biggest lesson from treatments is probably that there wasn't going to be an off-the-shelf antiviral that was going to work, that it was going  to take some time before we actually, and we still don't have a good antiviral to change the course of the infection.  That hydroxychloroquine wasn't going to be something that was a miracle drug. Even remdesivir wasn't something that was earth-shattering, and I think it makes sense  because those are repurposed drugs. They weren't designed for coronaviruses, they weren't designed for COVID-19, and I  think when you think about viral therapies or targeting the virus, all of it is rational drug design.  If you think about our hepatitis C drugs, they're based exactly on hepatitis C, so it was going to take some time to find something.  So, I think putting a lot of effort into finding things to modulate the immune response like dexamethasone, I think that would have been much more ... I think a lot of us had a lot  of enthusiasm about remdesivir, and I think that kind of has petered away now. It's mostly just a marginal benefit, and I think it makes sense because it's very hard  to make a specific antiviral for a virus that had no coronavirus antivirals at all forever. Yeah. Yeah.  I will say that I still think there is a good role for remdesivir, but I certainly agree  that at a critical care congress, the benefit is less marked in the critically ill population,  whereas the benefit is much stronger in folks who are sort of ward sick and not unit sick. But I think it's also consistent with what we see with other respiratory viral infections,  that antivirals are generally not earth shattering, I think exactly as you say. All right. So, I'll take the next question.  There is a question about kind of medical operations coordinating centers and whether or not and how we can coordinate that kind of load leveling across regions, and is there  a standardized model that we could use, or is there more of a homegrown option? And I will say that I think there are some very good examples of regional models that  we should be using or at least looking at as ways to establish standard systems of coordinating care across regions, and that's probably a role that's like HHS and ASPR is going to  have to take to implement. But again, I think very early in the pandemic, the Washington State model is a very good one. Minnesota has an excellent one.  In San Diego County, we were lucky that it's a large area, but a geographically kind of distinct area.  You know, we've got Camp Pendleton kind of preventing Los Angeles from enveloping us, and we're fortunate that we actually had to take this for a test spin early on with Remdesivir  allocation that San Diego County Public Health and the Department of Health and Human Health Services here in San Diego County was able to coordinate between all of the different  health systems in the county, getting us together very early before our first surge, unfortunately,  but fortunately learning from the lessons of our colleagues in New York, Washington State, and elsewhere, where we had regular meetings between all of the major private  and federal health systems, so including the DOD, the VA, UCSD, Scripps, Sharp, and the  others, Kaiser, with regular meetings discussing this is our capacity, this is our capability, this is our availability.  And then when the first federal allocations of Remdesivir became available, we had a platform to figure out, okay, how are we going to share this resource among one another?  And in retrospect, you know, we probably, you know, there are things we could have done a little differently in retrospect, but the process was very sound.  And actually, just as a, not as a system standpoint, but just as a human standpoint, I have to say that coming away from that experience, I expected there to be a fight.  You know, I expected us to go into those meetings with different health systems kind of fighting over this scarce resource.  But it was entirely the opposite, that in fact, the generosity of the different systems and making sure that other, you know, other health systems, other hospitals not in their  system had a reasonable and fair share based on their burden of disease was huge. And I think that that coordination is on some part the result of the fact that the conversations  began early and not in a time of crisis. And if there's anything that we can learn from kind of medical operations coordinating  centers is to have them up early and in place so that people know each other, so that there  are relationships built, that there is a working system in place, so that when the crisis hits, that is not your first introduction to everybody. Yeah. All right.  We have a question for Dr. Gallagher. It's about a very pointed thing about trauma, which is COVID testing and trauma.  How, what are your thoughts about how COVID testing affected trauma care? You showed a great slide showing everyone all PPE'd up and I'll say that in one of the  hospitals where I work at, we have a very similar system and a level one trauma center here in San Diego.  What's your impression of how that COVID testing has affected the flow of trauma care and in terms of applications of that?  How do you think that that testing has led to any delays in care, any changes in interventions or perhaps even improvements? That's a great question.  So when we started to see these patients come in, the organization was very committed to treating every one of these patients as a patient under investigation.  Many of the patients come in, they are unable to communicate. So if they couldn't answer our questions, we treated anyone who was non-communicative  as potential and they had a rapid COVID test done immediately. So even your gunshot wounds that were going right to the operating room, a quick test,  a quick swab on the way out and we didn't necessarily have those results for a while. So all of those patients were taken to the trauma OR, which was set up for COVID.  Every one of them was considered COVID positive. Some were, some were not. But it really was to give us an idea of where they needed to go afterwards, which unit where  they're going to go to. And so it didn't impede the flow at all. And some of our colleagues within the state, I showed you the one barrier set up in the trauma bays.  You know, they're usually big open areas and how do you kind of isolate that and treat everyone? The entire team is N95, double masks, full face shields or pappers for intubation.  This was something that was established very early on in our PPE, how we approached it changed over time, but we didn't see any delays based on that.  And it was really the commitment of the institution was our now to the operating room is going to get there as fast as our fetal carriers and we will attempt to swab them before we  left. So for that way, I would say it, it did not impede care at all. And in many ways helped us to know what the plan of action might be.  I will tell you that most of the patients who we saw that arrived and turned out to be positive, turned out to be COVID positive, but they were not necessarily symptomatic.  So they tended to be there for their injuries and happened to be positive. That's often been our experience here as well, that a lot of our, you know, trauma transfers  and the like are incidentally have COVID. So valuable from an infection prevention standpoint, but yeah, excellent. Thank you, sir. Dr. Wang, just kind of curious.  So with, you know, with we, I'm thinking about tocilizumab right now and, and thinking about,  you know, we have some very, some relatively kind of small, but more traditional clinical trials that are posing, you know, say negative results with, with tocilizumab and we have  some larger adaptive studies. Thinking of remap, I'm thinking of solidarity, I'm going to say recovery recently reported some benefit from tocilizumab as well.  How do we reconcile that? Right? Because you've got these really, you know, kind of more classically kind of tightly contained RCTs.  And then we have these very large, very flexible, but you know, very large number of studies that are posing response.  You know, and I think this is just part of clinical trials, right? You're going to get positive results. You're going to get negative results.  How would the, what would you tell to a, a kind of the, you know, to, to the hardworking busy intensivist who has to make these decisions to the bedside, who maybe doesn't have the  time that say you or I have to, to spend on the literature intensely in terms of where should, how do we reconcile this? Yeah.  So it's always tricky when trials have different results. I have to say that when the corticosteroid result from REMAP and the other trials came  out and were in line with recovery, there was a great exhalation of relief that we, that, that together there was a clear, simple message with, I think, I think in general  for all trials, it's really about in terms of does this trial apply to my patients? It's really about as simple as looking at table one demographics and ask yourself, do  these patients in table one look like my patients? Which is related, but which is related to what, what are the eligibility criteria, but,  but the actual thing is what kind of patients are actually enrolled. So the other, there are, there was, there's always subtle differences or not so subtle  differences between different trials. So I think some of the earlier TOSI patient, sorry, TOSI trials that they had, they had different criteria. They were less sick, more sick.  And, and to me, that's, that's the simplest way to, to try and make sense of, of, of differing data.  And then from a practical point of view, TOSI is at least my institution, not hugely available. There's not buckets of TOSI lying around.  So we continue to enroll patients into other immunomodulator trials. Thank you very much, sir.  So Dr. Adalja, we have a very practical question here is what is in our, it says federal or state local stockpiles.  I certainly want to ask you what is in the, what is in the state and local stockpile in, in California or in Wyoming or something, but, you know, perhaps a chance to discuss  like what's in the strategic national stockpile, you know, what's in the SNS. So this is sort of a hard question to answer because a lot of that is classified.  So I would say in general, what we'll find are mechanical ventilators, you'll find personal protective equipment there.  You will find certain standard medical equipment that you would expect for any type of surge.  And then there are going to be specific countermeasures against certain threats in the strategic national  stockpile largely was developed or in augmented based on the threat from, that's from bioterrorism.  So you could imagine countermeasures against anthrax like Cipro and doxycycline things against smallpox, including smallpox vaccines, antibiotics for plague and, and for tularemia  as well as botulism antitoxin that those are the types of things. And then also things for nuclear nuclear attacks.  So there might be things like neupogen that for, for supporting patients that are neutropenic treatments for burns, all of all of those types of things, potassium iodide, some of  the other antidotes for all of those types of threat agents that we think about. That's primarily what's in there when it comes to medicines.  There's even chest tubes in there because of anthrax, pleural effusions. It's hard to know exactly because it's some of this is classified and some of it isn't  very, it shifts over time, but that's generally what's in there. The quantities and all of that are not really well established or available to the general public.  And I think it is an important thing. And one of the things that I think is that's really essential about it is that it needs to be replenished.  And we know, for example, that the N95s are not replenished after H1N1 and that it can get, that it can get bared.  It's something that is in the headlines when there's an anthrax attack. But people don't fund these things or think about them strategically when things are not in the headlines.  And it goes through this kind of boom and bust cycle. So I do think one of the lessons from COVID is that we have to have this strategic national stockpile much more robust,  much more real-time inventory so that we know what's in there. At least the people that need to know know what's in there.  And that we're continually evaluating to make sure that they have the essential ingredients to what would be necessary in any kind of all-hazards pandemic response.  Or for some other type of thing, a nuclear event, radiation, a weather emergency. Excellent. Thank you, sir. A question from Orlando Gardner.  How can we standardize care for COVID between high-income countries and low- and middle-income countries considering approaches are different due to vast differences in resources?  And LMIC may favor improving treatments such as hydroxychloroquine and ivermectin. I may take a stab at this one. And then I certainly welcome the inputs from all of you as well.  You know, I mean, it's not surprising that we have, you know, differing levels of outcomes from clinical trials conducted for treatment of COVID in different countries.  We talked earlier about remdesivir. You know, the Act 1 showed a benefit, and that was a trial done largely in, you know, in industrialized, relatively wealthy countries.  Most in the U.S., but also in Europe, in Singapore, in Japan, in South Korea, as well as in Mexico City, and I believe there's sites in Canada.  So there's a fairly homogeneous acceptable level of standard of care there. And then when you replicate that therapy in countries with differing standards of care  and more constrained resources, and I'm thinking of the Solidarity trial from WHO, for example, none of the interventions in Solidarity showed any benefit  on any patient-centered outcome. But I think, and I think those of us in critical care, that shouldn't be a shock to us,  that there are a number of therapies that, for the critically ill, that show, that are at least widely accepted, fluid resuscitation, for example,  showing at least in retrospective series some degree of benefit. I realize the Clover trial and the Pedal Network is looking into this in U.S. settings,  but when you look at fluid resuscitation, even through relatively modest amounts of volume  in low-middle-income countries, I'm thinking of the FEAST trial, of course, which is in children,  but there are other trials done in Uganda and Zambia that have shown increased mortality, or at best, no benefit to relatively modest volume resuscitation in sepsis in LMIC.  Why is that? I don't think anyone really knows. My hypothesis for that is that we may be seeing  trials of delayed fluid resuscitation, we're just causing reperfusion injury at that point,  but that's unknown. But that idea, that different interventions will have different benefits  in different settings, depending on your baseline standard of care and other endemic health problems,  shouldn't shock us. So, ivermectin is one specific question that the questioner had, there was another ivermectin question. I will tell you personally that after hydroxychloroquine,  and I, like Dr. Adalja, I'm also an ID-trained intensivist and I still practice infectious  diseases, much as Dr. Adalja does. The burden of evidence in my mind for an intervention like  ivermectin having activity in COVID is very high, right? This is a drug I used to treat scabies,  right? This is a drug I used to treat, used to treat, you know, strontuloides. And when,  and when we try to apply that signal, that may work for a virus, you know, it's a pretty high  burden of proof to overcome there. And there have been trials of it looking at, in dengue based on  a putative antiviral effect, and say there was a fairly large RCT for ivermectin in dengue that  came out recently, which showed a decrease in viral load, a decreased NS1 antigen, but no  actual improvement in recovery time or no actual improvement in any patient-centered outcome.  So when I hear things like ivermectin and you see that there have been at least four, you know,  reasonably sized RCTs in low middle income countries purporting a benefit for COVID-19,  I'm sure those are well-conducted trials. I think there's a couple in Iraq, there's one in Egypt,  there's one in Bangladesh. And I know that the University of Liverpool is working on the WHO meta-analysis looking at that. And then there's the ICON study, which is a retrospective  series done in Florida. But the fact that an intervention may have some benefit in a resource-constrained setting, or conversely that a benefit that a relatively expensive drug like  remdesivir, if you're having a hard time getting oxygen to patients, if you're having a hard time  getting DVT prophylaxis to patients, if your nursing care is having a hard time keeping up,  maybe a relatively expensive drug like remdesivir isn't going to help you very much.  Right? And so I think when we try to standardize care between high income countries and low middle  income countries, that may not be the right question. I think the question is, what is the  best care that we can provide with the resources we have? And if you're practicing in a setting  where your resources are extremely limited, then, you know, then focus on the things that we're  pretty sure help. Good oxygen therapy, good nursing care, DVT prophylaxis, early recognition  of clot and treatment of clot when it arrives. Dexamethasone, inexpensive, low-risk interventions.  And maybe the other stuff can wait. Let's focus on the basics. But that's probably the central  lesson of COVID really, isn't it? That the things that we've found that work are core critical care  interventions, low tidal volume ventilation, DVT prophylaxis, et cetera, et cetera. So I'm not sure  that we need a unified standard of care so much as we need to identify what is the best care we  can give with the resources we have. And if those resources are constrained, working in the future  to improve those resources, but not necessarily, but recognizing that the way that I practice in  San Diego is not necessarily the way that my friends in Peru, where I used to work, practice  today. I'm sure they're more alike than different, but they may differ. They may differ. And that's  okay, as long as we're all doing the best we can with what we got. You know, Ryan, if I could-  Any thoughts about that? I have two thoughts, Ryan, is one, even within the United States,  there's variation in care between hospitals. Like not every hospital, for example, is expected to  have an ECMO, the ECMO capability. So regardless of which country, having some system of  regionalization or referral or telemedicine or whatnot, because obviously there's going to be  differences even within a country. And then second, American Journal of Tropical Medicine  Hygiene published a nice collection of articles for managing COVID-19 in LMICs. They did. It's very nice. Agreed. I'm sorry. I didn't mean to cut you off, David. I apologize.  Oh, no, that's all right. Yeah, it was a very nice collection.  All right. I'm going to loop back to, you know, let me make sure that there have been no additional ones. I apologize. During my soliloquy, I did not check the chat.  Okay. So here's one kind of for the group. And I think this is one that touches on all of our interests. Are there ways that artificial intelligence and technology can help public  health under resourcing? And can private companies invest and partner with public health preparedness?  I'm going to start that one with Dr. Adalja and see if you have any thoughts about that. I think the answer is yes. But I think you have to remember that many of our public health  agencies, not counting the CDC, but at the local and county level, they don't, they're still using  you know, very old data, fax machines, and they can't plug into these fancy Cerner and  Epic electronic medical records. So they don't have that. They're so far behind, been so long neglected that it's going to take some time to be able to even plug into those  new technologies. So I think what we have to really think is we have to digitize our public health agencies. We have to bring all those tools because it makes it easier. If you can  have somebody make your contact tracing easier because people are using apps and they download all the phones that they've been near, like they do in places like South Korea,  that's really great. Here, it turns into a conspiracy theory if you try to do something like that. But I downloaded the Pennsylvania app to tell when I've been around somebody.  That's really useful. I think anything that makes their job easier, because you have to remember  that they are not valued. They have never had enough resources ever. We're seeing kind of decades and decades of neglect. So I do think that all the stuff that we do from Amazon to  Apple, all of that could really infuse public health and bring it into the 21st century. So  it's not pencil and paper chasing around typhoid Mary, that we're doing it in a much more modern  way. So I do think that the potential is really, really huge. And I think this is the window to do  this. We have to talk to people who are funding health departments at the state level, at the  federal level, and use this opportunity to say, this is a core national security asset. Look  what happened. How many trillions of dollars were lost in the US economy? How many hundreds of  thousands of lives were lost? If we would have had a much better public health infrastructure,  none of this, this would have been so much, much more easier. Look at the way Taiwan handled it.  I think this really is an opportunity that we can't squander, or this is going to happen again.  I believe the vice president of Taiwan is an epidemiologist, or was an epidemiologist as well, which... He has a PhD in epidemiology,  and not to be political, but our vice president at the time was a little bit different than... A slightly different educational background, yes.  Brian, if I can jump in, I think it's a really great question outside of my expertise.  I just had two thoughts. One is I completely agree with Amish's thoughts. Keep saying that  same message, Amish. But it really reminds me of sewage, and basic infrastructure, right? Pipes,  water pipes, and whatever. Then with the same existential issue of how much private companies should be involved in water, and dams, and bridges, and all that. It's probably a great  question for some economic forum, which I'm sure there's a lot of work being done in this area.  Absolutely. Absolutely. Well, thank you both very much. I was at a panel some time ago, where one of the speakers commented that from a logistics standpoint, he was speaking about  vaccine allocation and vaccine distribution, but the truth holds that we shouldn't be having quite  the challenges we're having with vaccine distribution in a country where Amazon can calculate down to the minute how long it's going to take me to ship an ACDC t-shirt to my house.  I'm paraphrasing a bit, but still an interesting thought.  All right. That, and I apologize to people who have... Actually, one last question is, what constitutes crisis standards of care? A questioner asks, national definition of what  constitutes crisis standards of care that can be operationalized at the individual hospital level?  Too many individual institutions are afraid to make that call for fear of medical legal  retribution thoughts. I'm going to turn this over to the group, but I'm going to lead in a bit  because that was my talk. One of the things about operationalizing crisis standards of care  at the individual hospital level is that that decision should not be made at the individual  hospital level, that in general, crisis standards of care and their establishment needs to be made  by some sort of regional authority, be that a county, a state, or even national, or in other  countries, a provincial level, federal level, whatever the local system is. My hospital shouldn't declare crisis standards on its own and nor should any of yours, but part of the  challenge with establishing crisis standards of care as a question is exactly the concern about the legal implications of that, that can a physician, can a hospital be sued,  can a nurse be sued, can a pharmacist be sued, because we withheld in a crisis a,  in our opinion, futile intervention in an overwhelmed health system. One of the things that's been written into a number of  professional society recommendations, including by ACCP, by SCCM, by AACN, and others, is some manner of legal protection for clinicians and for health systems in the  setting of crisis standards of care. I will say I'm not sure how well those actually pan out in  practice, right, knowing that early kind of triage documents by certain states were the result  of lawsuits from groups concerned about, and very reasonably concerned about, the rights of people, for example, living with disabilities and how triage protocols would affect them.  And then on top of that, you have issues with, you know, just equity, in terms of not just equity of age, equity for people living with disabilities, but equity for people of color,  knowing that those are the groups who've been hit hardest by the pandemic and a number of  triage systems, there's concern that they may disproportionately impact them above, you know,  more, you know, among other groups. So yeah, legal protection would need to be part of it, but I think we also have to appreciate that legal protection from prosecution and legal  protection from lawsuits are not the same thing, but also that crisis standards of care are still  meant to be standards of care and that they are not a reason to abdicate our responsibility to  care for all patients as equitably and efficiently as we can under difficult circumstances.  There is a definition, the National Academies of Medicine published it a number of years ago,  but it is available and you can read it, but obviously it has to be adapted for the circumstance.  So what would be a crisis standard of care during COVID is not the same as crisis standard of care  after an earthquake or a hurricane. I hope that addressed it and certainly any comments from my  fellow speakers, I'd welcome them. I might just add that in the state of Pennsylvania,  there's something that was created called the Ethical Allocation Framework for Emerging Treatments of COVID-19. And it basically creates a weighted lottery for limited resources and  weighted towards certain communities that have been most hard hit as well as essential workers,  because you need people to, you need staff. And it does not specifically say, oh my goodness,  you're age over X, you're out. It's an overall model, if you will. And because it's a weighted  lottery, it also can provide some degree of pseudo-randomized knowledge to generate future  knowledge. But the foundation of it is ethics. It is not meant to be a research project per se. Amish, any thoughts?  One of the things I think that we learned is that hospitals never, sometimes they have this  reticence to declare formal crisis standards of care occur, but you kind of slide into that  when it gets busy on an individual clinician level and you don't really know that that's happening or it's just, you make do with what you're doing. And in the round table that we  had at the Center for Health Security, where we talked to New York City intensivists, they really  talked about this, that it was hard for them to decide whether this was a busy Saturday night  versus something that's gotten worse and it's changed. And I think there has to be some kind  of empowerment of the individual clinician to kind of ring the bell that this is not something  sustainable, that this is not normal, because we've all worked where we say, okay, we can keep  that patient in the PACU overnight until somebody moves out, or you do something, or we can have  BiPAP running on the floor because it's busy. But I don't, that's a hard part to me is understanding how to make that gradation or how to make that, when is too much, and when,  it's very clear when you're Elmhurst in Queens, but how do you know at another hospital  that you're doing things that aren't the standard of care and you're not just kind of hustling to  put it together? That to me, I think is always going to be the question of when you actually  cross that threshold, because it's kind of slow. It's not so stark as people think it might be.  Yeah, absolutely. All right. So a couple last questions, and then I think we're going to be  out of time. Thank you to everyone for all of these, all of these great questions. We have a  comment from our colleagues who's a recovery trial investigator in the UK, that Colchicine is being  investigated by the recovery trial and data should be available soon. So that'll be interesting and  certainly very exciting. There's some specific questions about certain kind of what we'll call high yield items in the strategic national stockpile, such as RRT and CRRT and ECMO,  and whether they're in there. I am pretty sure ECMO circuits are not part of the strategic  national stockpile, but I will admit that I am not sure. There's a question about whether some of  the ventilators are produced last year under the Defense Production Act made by GM and Ford,  if they were distributed to ICUs and were actually used. I know that I can't say necessarily for the  GM or the Ford ones, but I know that a number of those were distributed. But one of the challenges  with those, and Rich Branson, I mentioned this in my talk, has a very nice paper about this,  it was in chest, about how a number of these ventilators are not suitable for the care of ARDS  patients. And so that we have to perhaps revisit what those requirements are. A number of these  are relatively simple ventilators that may be able to provide a fairly low level of support, although a number of them are comparatively full-featured. But I believe some of those  were used, and I'm pretty sure that a number of them were used in New York early on.  Not the GM and the Ford ones, but the ones that were already in there, like the EMV pluses, for example.  Actually, Ryan, if I could answer one of the questions. Somebody asked regarding  the, okay, so seeing earlier in the pandemic, there were unconventional interventions and therapies getting clearance for use in what seemed to be a panic reaction.  Yeah, we did touch on that one, actually, but please. Oh, okay. I'm sorry about that. Any recognition of how to prevent that from ever happening again?  I think you're referring to the serial EUAs that were being offered. Certainly, there's a lot of thought now that instead of so many emergency use authorizations,  there should be emergency decreases in the burden of executing randomized trials,  because there is an enormous amount of administrative burden for typical trials,  such that it would establish the goal of getting the drugs out into the community faster, but then at least do it in a randomized way to generate actual knowledge.  Absolutely. That's a great point, that in terms of is there a way to streamline while still  maintaining, while still upholding our duties to do ethical research, is there a way to streamline  the administrative apparatus required? Absolutely. That's a great point. Thank you very much.  Well, I think we are just about out of time, so I think we can call this an afternoon. Thank you, again, to SCCM and to the program chairs for the opportunity to give this talk,  and thank you to my co-speakers for the opportunity to be with you all today.  Just so you know, any questions that we didn't have a chance to address, there are a number of  them left. You can still submit them, and we will respond to you online with those answers in a timely manner. Thank you, again, and have a great Congress.  Thanks, everybody, and feel free to email me if you'd like to join the remap trial. Thank you. Excellent.

Video Summary

The video provides a transcript of four speakers discussing pandemic planning, response to infectious threats, and crisis standards of care during the COVID-19 pandemic. The speakers emphasize the importance of understanding the disease, expanding critical care capacity and staffing, and addressing challenges in equipment and supplies. They also discuss the challenges of conducting clinical research during a pandemic and the need for effective communication and coordination in healthcare systems. The video addresses the differences between conventional and pandemic disasters and the challenges they present in terms of high caseloads and demand for medical care. It explores the implementation of crisis standards of care and the role of technology and artificial intelligence in public health response. The speakers highlight the importance of collaboration between hospitals, the government, and professional organizations to effectively respond to emerging infectious threats. Additionally, the video touches on legal and ethical considerations in crisis standards of care and the need for protection for healthcare professionals and health systems. Overall, the video provides insights into the complexities of pandemic planning, crisis standards of care, and resource management during a public health emergency.

Asset Subtitle

Crisis Management, Infection, 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 Discuss challenges of allocating scarce medical resources and performing real-time surveillance and interventional research during infectious pandemics Demonstrate strategies for clinical process change, collaboration, and innovation for hospitals and healthcare systems during infectious pandemics Review methods to support care of patients with infectious pathogens when resources are limited Demonstrate the lessons learned from caring for infected healthcare professionals Compare and contrast leadership of mass casualty incidents and delivering critical care during infectious pandemics

Lessons Learned in Respiratory Pandemics: Key Strategies for Every Hospital of the Future John J. Gallagher

Challenges and Pragmatic Adaptive Clinical Research During a Pandemic: How to Set Up Your System for Success David T. Huang

Combating Infectious Pathogens During Resource Limitations: Is Our Response Improving? Amesh Adalja Central Command: How Mass Casualty Incident Process Applies to Infectious Pandemics Ryan Maves

Meta Tag

Content Type Presentation

Knowledge Area Crisis Management

Knowledge Area Infection

Knowledge Level Intermediate

Knowledge Level Advanced

Membership Level Select

Tag COVID-19

Tag Resource Allocation

Tag Facilities Management

Year 2021

Keywords

pandemic planning

infectious threats

crisis standards of care

COVID-19 pandemic

critical care capacity

equipment and supplies

clinical research

effective communication

healthcare coordination

pandemic disasters

high caseloads

crisis standards implementation

technology in public health

collaboration between hospitals

legal considerations

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