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July 14th, 2020

Podcast 270: Is healthcare privacy possible if “all data are health data”?

(1 votes, average: 5.00 out of 5)

Don’t expect HIPAA regulations to protect your “digital health footprint” from prying eyes.

Every time you swipe your card to buy goodies at the supermarket (are you risking diabetes with all that ice cream?), or binge-watch that kinky series (how’s your mental health these days, really?), or let your step-tracker show you’ve fallen off the pace (can you afford those extra pounds?), there’s another little distinguishing feature added to your footprint.

This weeks’s guest, Dr. David Grande, and his associates asked a group of experts what they thought about all this accumulating personal data that’s outside HIPAA’s purview.

Listen in.

(Running time: 20 minutes)

Dr. Grande’s paper in JAMA Network Open

Franklin Foer’s Atlantic essay on the downside of Big Data’s help in the pandemic

New York Times‘s privacy project

TRANSCRIPT:

Joe Elia:  You’re listening to Clinical Conversations. I’m your host Joe Elia. This week’s chat isn’t about COVID-19 (or maybe it is really, but we’ll get back to that).

What we’re pursuing here is this: You know all that data you’re constantly contributing to what we call the “digital realm”?  You know, your Whole Foods discounts from your Amazon Prime account to your Netflix records from all that binge watching, the GPS navigation stuff? Well, who’s guaranteeing the privacy of all those data points? Not HIPAA. They’ve got your medical records covered, but what about the other stuff that points at your health status? The groceries, the streaming selections, the places you visit in your free time.

Our guest this week has concluded that you’re creating what he calls a “digital health footprint” with all that data — that, in fact, all data are health data. Dr. David Grande is the first author on a recent JAMA Network Open paper on all this. In it, his team surveyed a couple of dozen experts on privacy and data mining to gauge their thoughts and their concerns.

Dr. Grande is a physician at the Leonard Davis Institute of Health Economics at the University of Pennsylvania and in the Division of General Internal Medicine at the Perelman School of Medicine there. Welcome, Dr. Grande.

Dr. David Grande: Thank you.

Joe Elia:  I hope I didn’t overstate or sensationalize your conclusions in the introduction. What got you interested in this whole question?

Dr. David Grande:  You know going back years I’ve been interested in some of the ways in which marketing to doctors happens, marketing to patients happens; and what’s really happened over the last 10 years is all of that’s become supercharged by data. And a lot of it, when you’re talking about patients and consumers these days, marketing in health and healthcare is becoming supercharged by all those digital footprints that people are leaving behind. And while we may not necessarily think about our trip to the grocery store or the things we post on social media as being things that are fundamentally about health, when you talk to data scientists they’ll tell you oh it’s very much about health. Our ability to make inferences about health from all of that is extremely powerful today.

Joe Elia:  Can you tell us briefly how you went about interviewing a couple of dozen experts, as I’m recalling, and why you undertook the study?

Dr. David Grande:  Sure. Well, I think everybody — at some high level consumers have some level of awareness now of kind of the fact that people are being tracked in various ways. But frankly, it’s really hard to understand every time you sign up for something or use a new piece of technology it asks you to turn things on and off and you really don’t know what to make of it. And so we really wanted to talk to experts in the field to try to understand what is going on in the technology industry. And the data scientists and people who understand regulation and whatnot, like, how should we understand what’s going on out in the world in terms of data mining and the collection of people’s digital footprints?

And not surprisingly, you know, what we heard is it’s everywhere. It’s what we expected to hear to some extent.

But then the second part of that conversation was really focused on two things. One is, is it possible anymore to draw a line between health and non-health or has that become an artificial distinction? And then second, what are some of the, like, key big problems and challenges that we see that may need to be addressed by regulators? What is unique about this space? And that really was the focus of our conversation.

Joe Elia:  And you interviewed a variety of people. Can you give us a sense of what fields they came from?

Dr. David Grande:  Yeah. They’re certainly people who have been in the area of kind of thinking about privacy law and ethical issues around privacy. But then we also talked to people who are involved in digital technology and designing products in various ways. And trying to understand some of the decision-making that goes on and how those products are designed and engineered and where data comes into play. We talked to people who do sort of like predictive analytics in healthcare and how that world’s kind of vastly expanding now in terms of thinking about all the data inputs that go into predictive algorithms. We see that in healthcare delivery, but then of course we certainly see it in consumer products and advertising. So we tried to go pretty broad to really, you know, get a lot of perspectives.

Joe Elia:  So you talked with people dealing with ethics as well as data mining, so you got a wide range of expertise there. Having done all of that interviewing what were the principal conclusions that you arrived at?

Dr. David Grande:  Sure. So, that first question that I mentioned about can we draw a line anymore between health and non-health data? It was interesting. So even these experts in the field that we talked to, we actually had them answer some questions and kind of rating different kinds of sources of data and say how do you think about this one? Does it sound very health-related or not very much so? And actually [they] did rate some very high and some very low. So things like your Fitbit or food you buy at the grocery store people could say yeah I can see that’s health-related. And then, other things like your E-ZPass in your car or your other things with your travel habits or maybe things about your email or texting habits and things like that people were like “Maybe that’s not as health-related.”

But then when we actually dug into the conversation almost everyone we talked to was like “You really can’t draw a line.” I mean, when you think about modern data science today it’s really not about a single piece of data anymore. It’s not about just exactly what your language was on social media. But it’s linking that to a whole range of other things, which creates very powerful predictive capabilities. I mean now, we hear a lot of people talking about being able to make clinical diagnoses, you know? And so, I think one of the people said something like taking consumer grade data and turning it into a medical grade diagnoses and seeing that that’s quite possible now with a lot of data that people don’t really think of that way.

And so that was really an interesting part of the conversation. Again, I think if you ask consumers the same thing they would probably say yeah I can see these things as very health-related or not very health-related. But then again when you really look under the hood it’s really an artificial distinction.

Joe Elia: Let’s do a thought experiment. If I had enough data points, if you had enough data points about me and you knew my dietary habits, my exercise habits from my bicycle odometer, you had access to my travel through E-ZPass, et cetera, and you were a hospital administrator in the marketing department and you said “You know this guy Joe Elia? I’ve looked at his CVS records he’s not on any antidiabetic drugs, he’s sort of fallen off on his bicycling and he’s tending to drive himself places now. Maybe what we could market to him is a kind of a screening exercise for type 2 diabetes.”

And before I knew what was going on I’d have an email from David Grande saying “Joe, why don’t you come in for free screening?” I mean, that’s quite possible isn’t it?

Dr. David Grande: Oh, absolutely. I mean, again, there’s not a lot of transparency behind a lot of what’s going on in the companies who aggregate this data and use that to generate ads. But people are seeing it, you know, the output of that has become more evident, I think, to a lot of consumers. They say, “Hey it’s kind of weird I went on the internet yesterday, you know, looking for X, Y or Z and gee-whiz like suddenly I’m being approached today.” How else would that have happened? So, it’s becoming much more commonplace, I think, for people to have the experience that you just described.

I think what’s really hard to know is the accuracy of those analytics and those predictive models that are happening these days. We have some examples in research where people have validated ways of, for example, making a diagnosis of clinical depression. But we know very little in the advertising industry about how exactly they’re crunching data and deciding that you, Joe, have progressive diabetes or maybe a new diagnosis of diabetes. We don’t really know. All we know is that sometimes something shows up on a webpage you’re browsing or in your email inbox and you have to try to deduce why that happened.

Joe Elia:  One of your experts said something, commented something that I circled because I thought, “Oh this is so true.” And the quote is that “it would be very odd if someone followed you around making notes of everywhere you went and how much money you spent, and what you saw and who you interacted with. We would call it stalking, right? but in the digital world that’s accepted behavior.”

Dr. David Grande: Yeah, it’s commonplace and it is odd, right? You know there’s a level of surveillance in the marketplace now that I think no one ever would’ve dreamed was possible a decade or two ago. And I think if someone had told you that that’s what would be happening in the year 2020 — if we had this conversation in the year 2000 — they wouldn’t have believed you, probably, and secondly they would’ve said that’s outrageous we would never let that happen. But instead what we have seen happen is, because it’s so baked into all the things we use in the world it’s unavoidable now. Like, you would have to disconnect yourself from modern society at this point to really not be contributing data in this way. It’s not really a choice that consumers have anymore.

Joe Elia:  Yeah, it’s Orwellian. It’s actually infra Orwellian or super pro-Orwellian.

Dr. David Grande: Yeah.

Joe Elia:  We’ve gone beyond good old George.

And thinking back only seven years to the Snowden revelations in 2013 about how the government was, you know, it had access to all of our communications.

Actually, Snowden had a recent interview in which he said COVID-19 actually might be another way, another goad for the high tech companies to have more information about you. And in fact a couple of the high tech companies are getting together and saying “Yeah we’ll help contact tracing.”

Well, wait a minute. Okay, so when the pandemic goes away we’re going to have this method of tracing people’s contacts? And in a free society that’s not a problem. In the repressive society, and I’m thinking of you know facial-recognition technology in use in China, you know, North Korea, other places that can be dangerous. And so how is it that we can say okay you can use it for this purpose, for contact tracing in a pandemic, but you can’t use it for contact tracing politically?

Dr. David Grande:  Yeah, that’s a great question. I mean, I kind of look at this question and say that what we’re allowing to happen now in the private sector is complete Wild West. Like, the technology companies right now, at least in the American context, are largely unfettered — they can do almost anything. We really have no strong privacy regime around these questions in America. On the other hand we do apply a fairly, we apply a lot more scrutiny around these issues where government may be involved in some way that could actually have immense social benefits. So if we take COVID as an example I tend to believe that if we use these technologies responsibly we can make an enormous difference in the impact of the pandemic.

Now, the question is how do you avoid “mission creep”?, which is I think what you’re really asking. And I think for that to happen you need to write some pretty ironclad regulations about how you’re going to use these technologies so that they do get turned off.

Now, again, you have to maintain the kind of political energy when push comes to shove to actually turn them off. But you know what Google and Apple have done, and we can speak separately about what their motives might be for doing this, but what they have done is they’ve put forward a model that involves far more privacy protections around these COVID uses than what would be routine with other uses of technology.

So specifically, they are just making changes to their operating system and they are saying that for this to work a public health entity has to layer an app on top of that technology.

So the phone itself, there’s no app operating in the background of your iPhone that’s doing contact tracing. A public health agency has to put an app on top of that functionality in the operating system. But then they’re also saying we are not going to allow your phone to actually automatically transmit your personal information to the public health authorities it stays locally on your phone. And actually public health officials are not happy about that. Because one of the ways that contact tracing works is that you actually notify the public health authorities and you share data.

So there’s almost an odd paradox here but the world hasn’t faced a health crisis like this in a very long time. We have these digital tools that are now very powerful and it’s really public health that we’ve decided to take a firm stand on privacy about as opposed to all these other commercial applications where we seem to be a-okay with the status quo. So it’s a fine line to balance because, again, you get back to the mission-creep issue and it’s hard to turn that stuff off once you turn it on, but there are probably ways to do it.

Joe Elia:  Yeah. Well, you would think that there would be legislative ways to do it, except that the legislators are subject to lobbying. And so if you have the companies that are at risk from this legislation writing or helping to write the regulations then there could be backdoors left open. I mean, I don’t want to sound totally paranoid, but a little paranoia is a good thing, I think.

Dr. David Grande:  I do think though, back to that, I think the bigger issue of what’s going on is whether or not these technology companies are hopeful that by being seen as altruistic and responsible in some way that it will leave them in a better place in terms of what kinds of regulations they may face in the future. And that would be a mistake, like, we shouldn’t use a little bit of responsible behavior during the COVID pandemic to justify not taking actions at a later point.

Joe Elia:  So what would you like to see happen, Dr. Grande, as a result of your raising these issues?

Dr. David Grande:  Well, again, I’m actually not a legal expert by any means. But in talking to a lot of the folks that we did, I mean certainly the European Union has blazed a trail in this space. You know some of the people we interviewed who are really experts on international law and policy in this space talked about how the US really stands out in the world by taking this very sector-specific approach to privacy. So we have HIPAA, right, and we have GINA that protects genetic information. There is no place in the US federal government where anyone’s thinking about these issues across the economy.

You know, we’ve got people who think about health privacy at the Department of Health and Human Services, but it’s not the Department of Health and Human Services that can ultimately address this issue. And I think a lot of other countries around the world do specifically have privacy officers, agencies and whatnot to really come up with a more holistic way to think about these issues. Because we’ve moved far past, as I mentioned earlier, the idea that like health privacy can all be addressed through a health agency because it really is ubiquitous now.

And I think for many people and I think a lot of consumers — I don’t know this for sure — but I think if you asked them and said, “What do you worry more about, like, the privacy of the last blood pressure reading in your doctor’s visit or the social media posts and whether they reveal something about your mood?” And I think people would be more worried about their social media posts and their mood and people using that information in ways that they would rather not. So we have a lot to learn from the EU. I think we’re still seeing how that it’s relatively new, seeing how it’s going to play out in terms of the behavior of these companies. But we certainly need to start taking a similar direction here in the US.

Joe Elia:   And speaking of behaviors have you modified any of your own behaviors over time? Have you thrown away your GPS or your cell phone? Or have you stopped using Netflix or Amazon or going to Whole Foods?

Dr. David Grande:  I’ve tried. But I go back to my earlier point, which is it’s become almost impossible to be a modern day consumer and not leave these footprints behind. Even if you think about the basics of using a smartphone these days, God forbid you turn off all this functionality. Your phone’s going to tell you pretty much every day that you know you need to turn this thing back on or it won’t work properly. You know it’s like do you want to allow it once? Do you want to allow it always? And then when you know you allow it once is it really once? Is the app still operating in the background? You really have to become a computer scientist now to even interpret what you’re saying yes or no to anymore. And I think it’s asking a lot of consumers, but I’ve tried. I certainly have tried, but it’s a frustrating endeavor.

Joe Elia:  Well, I want to thank you, Dr. Grande, for talking about your work with me today.

Dr. David Grande:  Oh, absolutely, my pleasure.

Joe Elia:  That was our 270th podcast. They’re all available free at podcasts.jwatch.org. We come to you from the NEJM Group and our executive producer is Kristin Kelley. I’m Joe Elia. Thanks for listening.

July 6th, 2020

Podcast 269: The pandemic in Texas is like a “slow-rolling level 6 hurricane”

(1 votes, average: 2.00 out of 5)

We interview Dr. Michael Gonzalez, a Houston-based emergency physician, who describes the situation there as “an ongoing, slow-rolling, level 6 hurricane that just isn’t gonna go away and, more importantly, isn’t gonna tell us when landfall is coming and when it’s gonna be over.”

How are his patients reacting to this surge? What does he do to prepare himself for a shift in the emergency department? Is there enough PPE to go around?

Listen in.

Running time: 25 minutes

Other interviews on Covid-19 in this series:

  1. Dr. Anthony Fauci
  2. Dr. Susan Sadoughi
  3. Dr. Matthew Young
  4. Dr. Julian Flores
  5. Dr. Kristi Koenig
  6. Dr. Renee Salas
  7. Drs. Andre Sofair and William Chavey
  8. Dr. Comilla Sasson
  9. Dr. John Jernigan
  10. Dr. Ivan Hung
  11. Dr. Steven Fishbane

TRANSCRIPT 

Joe Elia:

You’re listening to Clinical Conversations. I’m your host Joe Elia.

 

Here we are still swimming in the sea of numbers generated by the COVID-19 pandemic: numbers of confirmed cases, numbers of tests, fatality rates per 100,000 population, et cetera.

 

With so many numbers you’d think your high school math teacher would suddenly appear and solve the equation — but there is no equation, only patients and clinicians. And that’s what Dr. Ali Raja, my cohost, and I are going to focus on this time. We’ll avoid numbers if we can.

 

We’ve invited a Houston emergency physician, Dr. Mike Gonzalez, to talk with us. As you’ve doubtless heard Houston and Texas in general have achieved the dubious achievement of being a new hotspot for COVID-19.

 

Welcome Dr. Gonzalez.

 

Dr. Michael Gonzalez:

Thank you. Great to be with you.

 

Dr. Ali Raja:

Hi, Mike. As a native Houstonian with lots of family still in town, I’ve got to ask, how are y’all doing down there?

 

Dr. Michael Gonzalez:

Yeah, thanks for asking. It is a challenge.

 

We are in the unfortunate position of sort of living the reality — of seeing the manifestations of what you know many of our colleagues, family members, brothers and sisters have gone through in other parts of the country. And you know it is disheartening to know that we’ve had months and months to prep, to learn and to now find ourselves in the situation of living through the very same problems.

 

So, you know, for a while there we were, I’ve got to tell you, somewhat optimistic that maybe we weren’t going to have the surge that everybody saw, that many of parts of the country kind of lived through. There was a lot of very hopeful optimism but many of us and I will fully admit to being one of the very sort of pessimistic “Hey we need to keep an eye on this and it’s not time to celebrate.”

 

So I think professionally, to break your question up into two parts, professionally I think like most emergency physicians who feel like, you know, we were built for this and this is our time to face the challenge head-on. My teams are ready. They have, you know like I said, been watching, waiting, learning, preparing. Professionally, I think we’re in about a good a place as we can be. Personally, for mostly the reason that I worry more about my family, friends, neighbors who are not medical and who have a really hard time, I think, parsing out the difference between what we know is the reality inside the four walls of the hospital and what they see on the news and what they hear in the community and what they see on the street. And I think one of the biggest struggles personally that I’ve faced is trying to get all of those things to align. And to really sort of get people to understand that this is serious, this is lethal, and it has longstanding implications that I think the world is still struggling with.

 

Dr. Ali Raja:

Right, we’re still figuring all this out. You mentioned being an emergency physician, and obviously you and I have known each other for a very long time. In addition to being an emergency physician you’re also an educator of other physicians, of paramedics, of EMTs. Can you tell us what it’s like for new residents, new paramedic students, new EMT students who are just starting in the journey? Can you tell us what it’s like for them — the ones you’re teaching right now?

 

Dr. Michael Gonzalez:

So I think I’ve honestly found that I pull, honestly, from my military training and really do sort of emphasize that this battle in many ways is fought on the front of preparation, and there is bedside care that we can certainly deliver optimally. Make sure we’re resuscitating, make sure we’re doing all the clinical things that as emergency physicians, like, as I said this is what we were built for and this is what we were trained for. But in many ways this battle, this virus is really confronted in all of the steps leading up to that in the form of the PPE that has, you know, become one of the major concerns, in terms of getting the rooms ready, in terms of getting enough hospital staff, enough, you know, equipment, enough gloves.

 

Like, all of those things that we for so long took for granted in the civilian world we are now facing. And the reason I say military training and from deployments where it was not an assumption that we had enough IV starting kits. It was not an assumption that we had the appropriate antibiotics. So all of that sort of training and background is really stuff that I had, in many ways, hoped to not face again [they] are right back on the forefront. And so for most of the time that I’ve spent with trainees at various levels it really is sort of reinforcing those lessons of preparation, right? And preparation, you know, in many clinical settings is one of the important P’s that we always emphasize, right?

 

Dr. Ali Raja:

Right.

 

Dr. Michael Gonzalez:

But in this setting it really is true and it’s down to the bedside level of “Do you have everything you need before you go in the room?” For the nurses, “Do you have all of your IV blood tubing starts, everything that you need before you walk in? Because you can’t come out again.” And so really I find myself, you know, going back to lessons that I learned way too long ago and really kind of reemphasizing basic important things like preparation and equipment.

 

Joe Elia:

Dr. Gonzalez, in this turmoil that you face it probably feels different now than it has recently. So has your routine changed over the past few weeks? How do you prepare for the clinical day?

 

Dr. Michael Gonzalez:

That’s a good question, Joe. I think that my routine probably hasn’t changed substantially in terms of getting ready for work. Getting ready is really, you know, unchanged I think for me. I think the only thing that probably has changed is, like for many of us, instead of wearing my own scrubs I change into hospital scrubs upon arrival in the clinical setting because I don’t want to take those things home. And so I find myself kind of, you know, still wearing scrubs generally into the department, but changing upon arrival. And then, again, kind of reminiscing back to military training and background in deployments, you know, I find myself [asking] “Do I have my scrub cap? Do I have my goggles?” And all those things have to be in place before I kind of get ready to go, you know, in the box or in the room or on the floor, depending on which part of the unit I’m working in.

 

And so I think a lot of that, again, is sort of familiar, to me at least, and for me it’s almost a warm blanket of “I know how to do this.” And I think I’ve heard it repeatedly from military colleagues that you know this is a very familiar setting in terms of facing an enemy that sometimes you can’t see, you don’t know where they’re coming from and it could be anywhere. It’s a sort of familiar feeling. The biggest thing, I think, is really afterwards. After a shift it is, you know, in a non-COVID time that you know I find myself sort of talking about now nostalgically, even though it was really only months ago. It’s really, you know pre-COVID you know you would get off shift, change quickly sometimes and go directly to meet family or friends for dinner, for a beer, or whatever the case might be. And now it’s truly sort of a more extended process.

 

And again I link it back to the checklist sort of mentality of, you know, “Did I take all that equipment off?” I’ve got my shoes off, I’ve got my scrubs off, I changed into you know whatever I wore into the hospital. In the car or once I get home certain things come off as I’m getting into the house. If my family members are awake, which I tend to work kind of a nightshift, you know, so that I don’t always cross over with my family — and that was even pre-COVID. So I don’t get a lot of the immediate need for hugs at the door, which I love, but in this time of COVID I think it’s really nice that I don’t have to deal with that. I get the dog barking sometimes when I get home, but otherwise it’s really more of I can kind of sneak into the house, get everything off and get immediately into the shower.

 

And then even before I get into the shower it’s a matter of getting the clothing bundled up separated from my family’s clothing so that I can make sure that we’re maintaining as many boundaries as we can from this thing. And again because having lived through a completely different world and a different environment it feels very much like the pre- and post-flight checklist of a previous world that I’ve done before and I can do. And I know, like, for me I know I can do it I’ve been through it. I see the struggles personally on my family and my spouse who is also a physician, but who is not in the emergency department.

 

And my kids, especially, like it’s really starting to wear on them. You know “Why can’t we go X, Y, Z? Why can’t we go to the movies? Why can’t we go to the arcade?” Like, that is getting hard.

 

Joe Elia:

This isn’t the question about whether you read the New England Journal of Medicine, so that’s not what we’re asking here. What I’d like to know is — and the information about this virus is changing all the time — is there a place that you’d go to just too brief yourself occasionally on “What’s the new stuff I should know about?”

 

Dr. Michael Gonzalez:

You know that’s a great question, Joe. I honestly read a variety of journals, the New England Journal one of them of course, and a couple of different emergency medicine sources. But really, honestly, lately because this has been moving so fast and, really, seems to be there was a period of time where I felt like it was changing by the hour, that honestly this is one of those times that social media has really come to the forefront. And I’m one of those people that’s fairly active on it. I absolutely have a group of trusted colleagues that we have formed both a public as well as a private discussion group to kind of update each other, follow-up on what’s going on and also provide the support that I think is just becoming more and more important as this thing seems to just morph and go from one area of the country to another. And I’m certainly hoping that we don’t, you know, send it back to other parts of the country but I have real fear and an anxiety about that, that this is going to just bounce back and forth as the fall and winter and more traditional infectious-like illness season comes back.

 

Dr. Ali Raja:

Let me ask. Taking it back a little bit to social media, because you and I have talked about this on Twitter and other places, you mentioned PPE recently and how it’s become a concern and you just talked about that. I understand that there’s a lot of connotations and background here, but let me just ask do you have enough PPE for your staff? And even if you do what’s the situation like in Houston? Are hospitals having to reuse it yet?

 

Dr. Michael Gonzalez:

I thank you for the question, Ali. I think that there has been a lot of work that has gone into making sure that we have the equipment that we need across multiple fronts, agencies, hospitals. I think that we, for now, and I always say that with excruciating care and in every meeting and every chance I get to express a concern or voice about this topic it’s always “for now” because it’s an important caveat that we are looking at what the numbers are doing. And they are constantly changing and they are looking worse than ever and so for me it is a constant. I do feel like as one of the leaders in various organizations, I do feel like that is my job. That is my responsibility to sort of speak up, make sure that people know that I really want to know what models are you using?

Because if you’re looking at a trend from the last two weeks that’s not going to work.

 

We’re in a completely different place now and so our modeling, our structures in terms of our supply chain, I think have been worked out. The single biggest thing that I worry about and this is true that we’ve heard from colleagues all over is the N-95 mask. I think we are good in terms of other very equally vital components but the N-95, as you know, is our unique sort of last line of defense before we inhale this virus. And so it is exceedingly important and I do worry that we are only okay in our supply status because of the reprocessing programs that are going on all over the country. And I certainly appreciate the people that worked that out and demonstrated it could be done safely. But I do have some anxiety and worry for my team about an instrument that was, as everybody knows, never designed to be reused. It was never designed to be reprocessed and so if you ask me about a single thing that keeps me up at night that’s it.

 

Dr. Ali Raja:

What about bed space? And I say that because earlier today I heard that, I don’t know if it’s level two or surge level two, but I’ve heard that Houston’s in the situation. I keep up with this because as I mentioned my parents live in town and if they get sick they’re going to need an ICU. I’ve heard that now you’ve reached ICU capacity and you’re starting to get creative around making new ICU space at least citywide, if not individual hospitals. How are things looking in terms of ICU and floor bed capacity?

 

Dr. Michael Gonzalez:

Yeah, we have attracted a lot of attention nationally and regionally for all the wrong reasons. I think that the bed capacity situation has certainly been on the radar for both myself and a variety of other leader’s way above me, right? And so this is something that we are closely monitoring for sure. The phases have been something that has been developed by the leadership out of the TMC organization that I don’t have direct links to. So it has been interesting to watch their messaging and how that has been perceived and understood or perhaps misunderstood. I do think that at a more local level and speaking to colleagues we are absolutely seeing adjustment inside the hospital of both elective surgery patterns, outpatient procedures, to make space available. As an emergency physician, right, we want our patients to get — once we’ve stabilized them —  diagnosed or at least [having] gotten the diagnostics done and we can hand off to our in-the-hospital colleagues. We want those patients to go upstairs as quickly as possible.

 

Because as has been well documented over multiple years of research and well proven that the single biggest obstacle of ED throughput is boarding time and how many patients are waiting. And so we, for the most part in the City of Houston, have hospitals that operate pretty darn efficiently. And so our board times are pretty limited in most facilities. We certainly have challenges here and there and you know different events, different periods of time where maybe due to staffing upstairs that there may be obstacles, but this is the first time that we’ve really been faced with a complete regional attack on those resources. And all of those resources are being demanded everywhere at the same time. So even during the closest other example is Harvey, which is not that long ago, and we had hospitals that were completely taken offline because of plumbing problems or disaster flooding — people couldn’t get in there or out.

 

But even then we are fortunate in the region to have 40 plus hospitals that we were able to flex and move patients around so that, for the most part, there was only a couple of days where certain facilities were really pushed to the limits on capacity. This as many of our colleagues from all over the country have already faced this, as you know better than anyone, right, this is an ongoing, slow-rolling, level six hurricane that just isn’t gonna go away. And more importantly, isn’t gonna tell us in advance when landfall is coming and when it’s gonna be over. And so, you know, there’s a dire need for the resources across the entire community. I know that many of our hospital partners and hospital colleagues all over the city are absolutely being creative in terms of freeing up existing bed space, both ICU, step-down, floor beds and freeing that space up from other procedural-type settings. And they are also looking at creating additional capacity.

 

So everyone in the medical community knows that capacity is one of those really difficult things to define because of how many patients move back and forth ICU to IMU, IMU to ICU and that is not always predictable. So I totally understand how difficult it is to put numbers — especially numbers reported to the public — around something that is so complicated. But at the same time I also feel like the public deserves to know that we are doing everything we possibly can and now including cancelling or postponing elective procedures to make room where I think there may have been some perceived resistance to do that from some of the hospitals in the Houston area.

 

Joe Elia:

Dr. Gonzalez, tell me about your patients. For instance, are they older or younger than you imagined that they would be and what’s their attitude? Do they come in surprised to find themselves in this “hurricane”?

 

Dr. Michael Gonzalez:

Yeah. So let me give you a little perspective on that, that early on I think there was a lot of surprise, so I’m talking very early April, May there was surprise: “I’ve heard about this and didn’t know it could happen to me.” And that was predominantly older, let’s say, over the age of 50.

 

And I think that, that has really dramatically changed to we are seeing a wider swath of age groups that are coming in because they feel terrible. And largely the people that we are seeing in the emergency department are not coming asking to be tested; they are coming because they feel awful.

 

And overwhelmingly, most of those people have now, at this stage in the past month, they know or they have an idea of where this came from. Either in the form of I’ve heard now that, “That person that I was with was positive” or “I went to this event, this party, this thing and it’s two weeks later or 17 days later and here I am. And I worried about it but I did it anyway.” I’ve heard it repeatedly and I can tell you that it is of course always an honor to take care of our patients and try and do the best we can to treat them medically, comfort them.

 

But this thing and because of the way this virus works it is a challenge to provide the same level of what I think all of us want to do. Because sometimes all you can is hold their hand and although we do that, we continue to do that, sometimes looking people in the eye, holding their hand, patting their shoulder and particularly not having family members available to help in the comfort and sometimes even, you know, providing just reassurance that we’re doing everything we can has been a real challenge. And that, I think, is taking a huge toll on healthcare providers all over and we are just sort of uncovering this raw nerve of we are really putting ourselves out there emotionally further than, I think, we’ve ever been asked to do because family members can’t be at the bedside. And so, back to your question, I think yes for sure we’re seeing a slightly skew younger over the past two weeks, let’s say, I’d use that as a timeline. But it is absolutely people come in who feel just awful and scared and you can see it in their faces when they arrive.

 

Dr. Ali Raja:

So, Mike, this is a really tough time but we know that like all things this will pass. And whether it’s a temporary lull or whether or not we finally get a handle on this we’re going to have a time at some point, weeks, months from now where things are better. Have you promised yourself a little bit of a reward after this? A new bicycle, a vacation in remote Canada far, far away from large medical centers? What are you going to do when all this calms down?

 

Dr. Michael Gonzalez:

I have given myself pause and freedom to think about that only because it has become a frequent topic around the dinner table. I told you my family and my kids have really sort of been struggling with this and as I have mentioned on social media I have become a Fortnite player with my kids.

 

Dr. Ali Raja:

Nice.

 

Dr. Michael Gonzalez:

Terrible, terrible, subpar they would tell you, Fortnite player. But that has been one of the things that you know we introduced them to, hesitantly, but now we enjoy playing together. And so that has been one of the joys of this thing, one of the small victories. They’ve admitted me to their team, so that’s a nice little…

 

Dr. Ali Raja:

That’s a win. That’s a dad win right there.

 

Dr. Michael Gonzalez:

Yes, exactly, a dad win. Exactly. But I think to your question, yes, we are really looking forward and are actively discussing and exploring options all the time about a vacation. And you know I am very mindful of my colleagues who both, you know, every team member in the hospital. And so I want to make sure that they’re obviously taken care of before I even think about taking my own time off. But there will be a long vacation at some point at the end of this, on the other side of this, let me say. And I am very optimistic, Ali, yes we will all get there.

 

Joe Elia:

Dr. Gonzalez, thank you very much for speaking with us today and good luck in the coming weeks.

 

Dr. Michael Gonzalez:

Thank you both. Thanks so much for giving me a chance to share our experience in Houston.

 

Joe Elia:

Of course.

 

That was our 269th podcast and they’re all available free at podcasts.jwatch.org. We come to you from the NEJM Group and our executive producer is Kristin Kelley. I’m Joe Elia.

 

Dr. Ali Raja:

And I’m Ali Raja. Thanks for listening.

June 29th, 2020

Podcast 268: Cannabis and road accidents — is there an association?

(2 votes, average: 4.50 out of 5)

This time Dr. Ali Raja and Joe Elia talk with two authors of a study that found disparate effects on traffic deaths from the legalization of recreational cannabis. The two states under study, Colorado and Washington, were compared, not with each other, but with a composite of states that most closely resembled what Colorado and Washington would be if they hadn’t passed legalization. The states were thus compared against their “doppelgangers.”

Colorado showed an increase of roughly 75 additional traffic deaths per year, while Washington didn’t show any substantial effect. How can this be so, and what are the implications for states with legalization already in place or contemplating it?

Links:

JAMA Internal Medicine study

JAMA Internal Medicine editorial

Running time: 20 minutes

 Transcript:

Joe Elia: You’re listening to Clinical Conversations. I’m your host, Joe Elia.

Earlier this week, JAMA Internal Medicine published two reports and an editorial about the association of legalized recreational marijuana and its possible effect on traffic fatalities.

One report found an increased traffic fatality rate in four states that had legalized recreational use of the drug. The increase was measured relative to a control group of states that hadn’t legalized.

The other study examined the effect in two states, Colorado and Washington, and it found disparate results using a so-called synthetic control comparison.

Two authors of that paper have kindly agreed to discuss their results with me and Dr. Ali Raja, Editor-in-Chief of NEJM Journal Watch Emergency Medicine.

Our guests, Dr. Julian Santaella-Tenorio and Dr. Magdalena Cerda, are both with the Center for Opioid Epidemiology and Policy at New York University School of Medicine. Dr. SantaellaTenorio is also with Universidad del Valle in Cali Colombia. I’d like to welcome you both to Clinical Conversations.

Dr. Ali Raja: We both really enjoyed reading your study. For our listeners, can you give us a thumbnail sketch of your conclusions and findings?

Dr. Julian Santaella-Tenorio: We found that after controlling for all of these factors in generating a synthetic control for each one of the exposed states, which are Colorado and Washington state, we found that traffic fatalities were increasing in the post-law period — that’s from 2014 to 2017 — in Colorado but not in the synthetic control, but we didn’t see that in Washington state.

We just saw that in the post-law period the traffic fatality trajectories were the same for Washington state and for the synthetic control for that state.

Dr. Ali Raja: Were you surprised at the disparity between Washington state and Colorado?

Dr. Julian Santaella-Tenorio: It was surprising to see this kind of different effect. We were thinking that we’re going to see the same effect, right?, like increases in fatalities in both states that were enacting these laws. However, we thought that, after looking at the details, that the industry in Colorado is much bigger and it has many more dispensaries compared to Washington state. If you do that per capita, you see that it is much bigger in Colorado than in Washington state, and the other thing that we were trying to plot is for why this is the case in Colorado but not Washington is that we see that many of the states that are around Colorado don’t have these kind of laws and there could be a lot of kind of this tourism going into Colorado, but that’s not likely the case in Washington state.

Dr. Magdalena Cerda: And you also see, in Colorado, you see an increase in use of marijuana after the opening of legal retail sales and you don’t see the same in Washington. So, that also supports, I think, the focused increase in traffic fatalities in Colorado.

Joe Elia: Dr. Cerda, why did you choose synthetic controls which compared each state individually with a kind of, as I was thinking about it, a doppelganger state? You know, an identical state, but that state hadn’t implemented recreational cannabis laws. Why did you take that approach?

Dr. Magdalena Cerda: Yeah. That’s a great question, and so the reason is that we want to make sure –right?, because of the high policy relevance of this question — we want to make sure we get the answer right and we want to make sure that any kind of increase that we see in traffic fatalities after legalization is really due to the law and not to other things that might be different between Colorado, say, and other states, right?

Because we do know that states don’t randomly choose to legalize or not. In fact, there are many reasons why they do, and those reasons are different between states that choose to legalize or not, and it makes it difficult to figure out if it’s really the effect of the law.

So, the nice thing about synthetic control group approach is that we can use a data-driven procedure to figure out which states basically match what would have happened in Colorado, say, or what would have happened in Washington had the law not been passed, and that’s what we want to know, right? We want to figure out okay, well, what would have happened in Colorado had the law not been passed and what actually happened?

So, is what happened greater? Is their increase greater than what would have happened without the law? Yes or no, and that gives us a much better answer about whether it’s really the law and not something else. So, that’s why we chose to use that approach.

Joe Elia: I noticed that you have a table of the states that you used to synthesize the controls from, and Colorado’s state, I believe, the heaviest burden fell on New Jersey, I think, for Colorado, and for Washington, California was the closest comparison. Can you just give me a sense of why, for instance, California related more to Washington than say New Jersey did?

Dr. Magdalena Cerda: We used a range of different characteristics of these states and we combined them to figure out okay, given the combination of multiple characteristics that we think might be related to why certain states passed this law and why other states didn’t, which states were most similar to, say, Washington when you consider the combination of all of these laws together, and so it ended up that California was the best match for Washington and New Jersey was for Colorado, and so it’s not any one…the really nice thing actually about this approach is that it allows you to figure out, you know, not just the single isolated contribution of any one feature but account for the complexity of features, right? The complexity of factors that lead states to choose to enact this law or not, and it’s really a combination of factors that gives more weight to some states than others when you do the comparison.

Dr. Julian Santaella-Tenorio: And the good thing about this is that you’re not picking states to be the controls for your exposed state, for example, Colorado. The algorithm does it for you and it’s trying to find the best combinations of different states that will give the best match for that exposed state, for Colorado, for example. So, it’s an iteration process that will try to find the best combined group of states that will actually give you the synthetic Colorado that you want to use.

Dr. Ali Raja: Probably, hopefully many of our listeners will go back to JAMA Internal Medicine and read your article, but just because some of them may not have yet, let’s talk a little bit about the extent of the effect in Colorado, which we’ve mentioned a few times. You saw an uptick in motor vehicle deaths. What was your estimate of that uptick?

Dr. Julian Santaella-Tenorio: We saw that there was an average for the four years in the post-law period of 75 excess deaths, and if you look at each specific year you see that for 2014 there’s 37 excess deaths, and if you look into 2015, it’s 63 deaths. In 2016, it’s 78, and finally in 2017, it’s 123 excess deaths of the 648 that were reported by the CDC and by the four years’ data that we used. So, it’s an important proportion of the total deaths that were observed for Colorado in those years.

Joe Elia: Can we talk a little bit about, relative to death, are there offsetting benefits to be found in those 75 deaths? For instance, is there less crime surrounding illegal use of cannabis, or is there less driving under the influence of alcohol if you’ve legalized cannabis? Have these tradeoffs been studied?

Dr. Julian Santaella-Tenorio: So, we did a study back in 2016 trying to identify the effects of medical marijuana laws and traffic fatalities, and we did see that there was an overall reduction in traffic fatalities across these states that were enacting these laws.

The hypothesis that we had, and it was based also in another study by Anderson and collaborators showing the same effect, that perhaps marijuana was reducing alcohol use and was reducing the risk of people driving on roads being impaired by alcohol. However, that might be the case for medical marijuana laws, but might not be the case for recreational laws because it’s a totally different scenario.

You have dispensaries that are selling to anyone over the age limit. You have availability just skyrocket, and that could play different when you talk about like driving under the effects of marijuana and also the risk to driving. So, the thing is that marijuana competing with alcohol with medical marijuana laws could be one part of the study, but once you have such great availability of marijuana due to these new recreational laws, then the substitution effect might not be occurring, and you can have like a lot of people driving under the effects of both marijuana and alcohol, and we have different studies, like randomized controlled studies, showing that when you use both of these substances at the same time the risk for having a severe traffic event increases by a lot.

Dr. Magdalena Cerda: I would like to say though that at the same time, it is true that we just looked at one outcome, which is traffic fatalities, and so this doesn’t in any way mean that there aren’t very, you know, clear benefits of legalization in other areas. In no way does it mean that we are, you know, we’re trying to make a case against legalization. It’s just that we were focusing on this one particular outcome.

Joe Elia: You can be forgiven for defending it. However, I’m a bicyclist and I bike in Boston a lot, and I’ve noticed that I’m smelling a lot more marijuana coming out of car windows than I’m comfortable with smelling. So…

Dr. Ali Raja: As a bicyclist, I’m sure that’s of utmost concern. You’re right. It definitely has picked up.

Joe Elia: Dr. Cerda, what do you think are the next steps in your research?

Dr. Magdalena Cerda: So, I think, you know, one of the really interesting pieces of this paper is the fact that we found different effects in different states, right? Because that means that it’s not just legalization yes or no, it’s really about how legalization happens that probably makes a difference, and so I think one of the key questions that we need to figure out is what types of legalization approaches lead to increases in traffic fatalities and which type of legalization approaches don’t, right?

So, we need to figure out things like, you know, in terms of density of stores, taxation and the impact on pricing, advertising. So, really trying to identify the different aspects of legalization policy and figure out which ones are the ones that are driving or what combination of policies are really driving an increase in fatalities so that we can figure out potentially what are the types of legalization models that can avoid such unintended consequences.

Dr. Ali Raja: You know, on a little bit of a lighter note. All of us in academics went into our specific topic area for different reasons, and so if you imagine yourself at a family gathering for a holiday, and your friends and family ask you well, what do you do and why did you go into that, is there a story, or why do you tell them that you started researching this particular topic?

Dr. Julian Santaella-Tenorio: When I was doing my DrPH studies at Colombia University, I had this methods exam at the qualifying exams, right, and this was one of the questions that we were thrown at this exam, and I remember being really interested in answering this question, and then decided to start putting together databases and methods to be able to answer this question. So, to that I would say, like the first term paper that I had put together for passing this exam, and then continue and developed this nice paper that we published back in 2016, and I wanted to see the other effects of recreational marijuana laws, and I got Magdalena to be convinced that this was a good idea and to join in this effort.

Joe Elia: Dr. Cerda, what do you tell families at gatherings about why you’re doing what you do?

Dr. Magdalena Cerda: Well, you know, as a public health researcher I find this fascinating, and I feel like it’s my responsibility to figure out what the public health implications of these laws are. Particularly, I think what really fascinates me is not so much about what happens with legalization, but rather trying to figure out what types of models of legalization have been adopted across the United States and in different countries in the world to figure out: Are there ways that we can legalize safely? That is, are there ways that we can legalize and minimize public health consequences, and so to figure out and to use our capacity as researchers to figure out, you know, what are the unintended consequences and what do different experiences in different states and in different countries tell us about the best way to do it to protect public health?

Joe Elia: So, you’re both assuming, I think, that people are going to use cannabis, and your interest is in how do you make that possible and safe, as well as enjoyable or…

Your department encompasses both epidemiology and public policy, and so Dr. Cerda, what would you like to see change regarding that?

Dr. Magdalena Cerda: In terms of policy for marijuana, you mean?

Joe Elia: Yes.

Dr. Magdalena Cerda: I think it’s a good question. I think as…well, several things.

One is, as states legalize, I think there needs to be tight regulation around zoning of retail outlet stores, tight regulation and constraints on advertising of the product, investment in a lot of the taxes earned from sales in prevention, particularly in schools and targeted towards adolescents so that we can prevent unintended increases in early initiation of marijuana use.

Also, I think there needs to be use of those dollars for greater investment in treatment for people who are experiencing problems with cannabis use. So, I think it’s, you know, tighter regulation of access to marijuana and advertising, as well as investment in prevention and treatment.

Joe Elia: Okay, and just to be clear about the roles on the paper, Dr. Santaella-Tenorio, you’re the first author?

Dr. Julian Santaella-Tenorio: Yes.

Joe Elia: And Dr. Cerda was the senior author?

Dr. Julian Santaella-Tenorio: Yes.

Dr. Magdalena Cerda: Yes.

Joe Elia: Correct, and Dr. Cerda got the money together?

Dr. Magdalena Cerda: Yeah. Yeah. So, yes.

Joe Elia: Okay.

Dr. Magdalena Cerda: That’s part of what I did.

Joe Elia: All right. I just wanted to make the roles clear.

Dr. Julian Santaella-Tenorio: So, there’s something that I wanted to say, and is that so when we published our study on medical marijuana laws back in 2016, a lot of people complained about these results and it was kind of like we are saying that it’s safe to drive under the influence of marijuana, right? Because we saw reduction in fatalities, and we got a lot of emails and complaints like that, and I just want to point this out and is that it’s not that these findings at the population level when we were looking at states or say anything about the individual risk of marijuana use, right, but people sometimes get confused with that.

So, what we’re showing is not that if you smoke marijuana you have an increased risk of getting into an accident that will kill you. We’re saying is that, on average, states that passed these laws, such as Colorado, we see that at the population level there’s an increase in fatalities, which is totally different from the individual risk.

Joe Elia: Okay, and Dr. Raja, you’re an emergency department physician. Have you seen any effect? Do you see more people coming in with effects of having used recreational cannabis?

Dr. Ali Raja: It’s a good question, and, Dr. Santaella-Tenorio, you’re right. This is a very polarizing issue and people bring their own biases to it, and they take your conclusions and based on what they inherently believe, they’ll see them as either positive or negative, whereas you’re presenting data at a population level.

I’ll say individually, my patients…Massachusetts has always, at least that in the 12 years that I’ve been here, there’s been a lot of cannabis use in Massachusetts. That’s gone up over the past few years because of legalization, but there’s still only a handful, less than 10, maybe even less than five, I haven’t kept up, dispensaries in the state. So, it’s much more similar to Washington than it is to Colorado. When you get off the plane at the airport in the Colorado, there’s basically a dispensary at every corner, whereas in Massachusetts, although it is legal, it is still not widely available, and so I haven’t seen that much of a change in the patients that are actually presenting to my emergency department. Good question though, Joe.

Joe Elia: Well, I want to thank you very much, Dr. Santaella-Tenorio and Dr. Cerda, for sharing your insights with us today.

Dr. Magdalena Cerda: Thank you. Thank you so much for this…

Dr. Julian Santaella-Tenorio: Thank you. Yeah, thank you for inviting us.

Joe Elia: Okay. Thank you.

That was our 268th episode. They are all available free at Podcasts.Jwatch.org. We come to you from the NEJM group, and our executive producer is Kristin Kelley. I’m Joe Elia.

Dr. Ali Raja: And I’m Ali Raja.

Joe Elia: Thanks for listening. Dr. Ali Raja: Thanks for listening.

May 19th, 2020

Podcast 267: Acute kidney injury in COVID-19 — how one New York system dealt with it

(14 votes, average: 3.36 out of 5)

The novel coronavirus obviously has devastating effects on the lungs, but other, less immediately visible attacks occur — notably to the kidneys.

Dr. Steven Fishbane (a nephrologist) and his colleagues have just published their findings based on a survey of some 5500 patients with COVID-19 admitted to a metropolitan New York health system. Acute kidney injury developed in about one third of the group, and it was very common (almost 90%) among those requiring mechanical ventilation.

But beyond these clinical features, I wanted to ask Dr. Fishbane about how he and his staff prepared for the viral onslaught, and especially what lessons he takes from the experience.

Running time: 21 minutes

Links:

Kidney International study

Other interviews in this series on COVID-19

  1. Dr. Anthony Fauci
  2. Dr. Susan Sadoughi
  3. Dr. Matthew Young
  4. Dr. Julian Flores
  5. Dr. Kristi Koenig
  6. Dr. Renee Salas
  7. Drs. Andre Sofair and William Chavey
  8. Dr. Comilla Sasson
  9. Dr. John Jernigan
  10. Dr. Ivan Hung

TRANSCRIPT

Joe Elia:

You’re listening to Clinical Conversations. I’m your host, Joe Elia.

Our first encounters with COVID-19 often focused on the lungs and respirators. Now, that view has widened to take in things like kidney and coagulation disorders.

One large study of kidney complications has recently been published in Kidney International, and we have one of its authors with us. Dr. Steven Fishbane and his colleagues looked at the clinical outcomes in some 5400 COVID-19 patients admitted to roughly a dozen hospitals in the Northwell Health system in metropolitan New York. Their report offers important clinical insights, which we’ll talk about, but it will also be interesting to hear how the group coped with the sudden sharp demand for kidney replacement therapy.

Dr. Fishbane is Chief of Nephrology at Northwell Health. He also serves as Professor of Medicine at Zucker School of Medicine at Hofstra/Northwell.

Welcome to Clinical Conversations, Dr. Fishbane.

Dr. Steven Fishbane:

Thank you. Pleasure to be with you.

Joe Elia:

The Kidney International paper spans roughly one month’s experience — March of this year — with COVID-19. Before we move on to your experience in preparing for it, would you very briefly tell us what you found, clinically, in your…?

Dr. Steven Fishbane:

Right. So, in this study, and to put it in perspective for you, so, COVID-19 moved into New York with such an explosive rate in March, in particular, that you know it greatly overwhelmed the ability of the health systems, which just managed to get their way through, but for us at the time of the writing of this article, it was based on the first 5,449 patients, which now we, as a health system, have treated 15,000 patients, but in the study, the primary findings, I think, which were important to us was first being able to describe the number of patients who have COVID-19 admitted to hospitals. That’s important to describe is that 36.6 percent developed acute kidney injury, and people had been kind of waiting on that number, in that out of China and Italy, the numbers for acute kidney injury look like they were lower, and anecdotally, we, in the US, were experiencing what we thought were higher numbers, and we were just waiting for a rigorous look at it.

So, yeah, and it turned out that we found that a substantially higher number of patients were at least being reported in our study as being higher. That now has come out in some other work out of the United States, and then we had a number of other findings, I think, that were really interesting, as well, but you know, I think the first really important point was to remember, as you pointed out earlier, this is a respiratory illness. It is a remarkably focused, serious respiratory illness, but we are learning that it does affect other organs, as well. So, here, it’s the kidneys that are being demonstrated, as you pointed out, coagulopathic problems. Here, it’s the kidneys that are turning out to be an important secondary problem.

Joe Elia:

So, the number of people with acute kidney injury were found to be roughly the same as yours in a paper being published later today in The Lancet, from New York City, from Columbia. So, same general catchment area and your numbers are very similar.

In reading [your] paper, and I want to focus on the paper a little bit more, 90 percent, roughly 90 percent of patients on mechanical ventilation developed acute kidney injury as opposed to about 20 percent of those not on mechanical ventilation, and so, and the concordance or the concurrence of those things, of people going on mechanical ventilation and requiring or being recognized as having acute kidney injury was pretty close, wasn’t it?

Dr. Steven Fishbane:

Yeah. Right, and so, you know, this is one of those areas in research that I find to be particularly interesting in that, you know, think of it: We are at that point as this research is being conducted, we are so deeply involved with the intense care for these very sick patients. So, you would think that something like that, the concordance of respiratory failure and acute kidney injury would be very self-evident and intuitive and obvious to us, and yet, although I think we might’ve been experiencing that clinically, it wasn’t really until I remember one moment looking at the data where it suddenly occurred to me this is really remarkable.

There’s two things happening. One is that there’s a real concordance in terms of bad kidney injury right about the time that respiratory failure is occurring and that for patients with COVID disease at home, kidney disease is probably not an issue at all. For people with COVID disease who are in the hospital but without respiratory failure, it’s really not a very significant problem, but we found that bad kidney injury, severe kidney injury, kidney injury requiring dialysis was really limited to patients who required mechanical ventilation, and you know that is important in terms of some of the inferences that one can draw based on that. So, a long-winded answer to your question that, yes, very tied together, acute respiratory failure and kidney injury, as well.

Joe Elia:

Well, you know, as I was reading your paper, I was thinking, clinically, when somebody’s evaluating a patient, if that patient is having trouble breathing, you’re not looking at their kidneys. You’re looking at the fact that this patient is apparently drowning, and you’re trying to do something about it, but there were a lot of patients who were admitted to the hospital but who were not part of your study, and the reason for the exclusion was that they had had fewer than two creatinine measurements, I think, during their hospitalization. So, you didn’t feel that it would be fair to evaluate them, and it made me think, “Yeah, the clinicians are focusing on keeping the patient breathing, and those kidney functions are being evaluated in the course of further clinical care.” But I think what you’re saying is clinicians should keep an eye out on kidney function with COVID-19 patients.

Dr. Steven Fishbane:

Right. So, that’s clearly the case that although we need to be laser-focused on the care of the respiratory illness, because ultimately this is such a potent respiratory organism, but it does cause injury to other systems. We’re seeing this unusual syndrome in children right now, but you know to a much greater extent and not in the realm of rare conditions but rather a very common injury that goes along with the respiratory disease is kidney disease. We understand that now. We understand that patients need to be monitored very carefully in terms of the development of kidney disease and then the difficult decisions that go along with management, do you use dialytic support, et cetera.

Joe Elia:

Let’s move away from your findings regarding acute kidney injury and let’s talk about logistics a little bit. When did you realize that this kidney service might be overwhelmed, and how did you prepare for it?

Dr. Steven Fishbane:

So, it was in mid-March that we saw that New York was quickly just having an explosion in infections. New York was essentially becoming what Wuhan was to China in terms of the rate of infection, and you know, at that point, I think people understood the fact that there was a real risk of really overwhelming the health system, and if the virus has another surge in the fall, we’ve got to, again, be very careful with respect to that, but we recognized, I remember the moment when we realized that the rates were increasing so quickly that for the 10 percent of patients that have bad enough disease to require hospitalization and then for the percentage of those that are going to have bad kidney disease with it, we really had to model out what this could look like.

So, as we got into April and May, if it took a relatively benign course, what it might look like, if it took a middle-road course, and if it took a severe road, what it would look like in terms of potential resource needs. So, we modeled it out. It did end up being the most severe possible course that it could have taken, and at that point, we did a lot of purchasing based on our worst scenarios, renting, purchasing, but getting the types of equipment that were going to be very important in terms of being able to provide dialysis services, and the type of dialysis, also, that we do in the most critically ill patients, which is continuous renal replacement therapy, or CRRT therapy, and making sure that our hospitals would have enough of that type of equipment.

And we really strongly went with a mantra from the beginning here that we’ve got to be able to, to the greatest extent possible, try to cure the underlying respiratory infection, the respiratory infection, and we’ll succeed in patients. We won’t succeed in other patients, unfortunately, but that we never want this secondary problem of kidney disease to limit the patient’s outcomes. We want to make sure that we have the resources that we need to be able to treat the kidney part of it, and yet, by the middle of April, I think everybody through New York was running on fumes and came very close to hitting that point of not being able to keep up with the kidney aspects of the disease.

Joe Elia:

Yes, and you had to move clinicians around the system, too, didn’t you, to have enough nephrologists where you needed them?

Dr. Steven Fishbane:

Right. So, you know, I think a lot of health systems experienced this difficult and really painful issue in the New York area. I don’t know if this occurred a lot outside of New York but that there simply were not enough intensivists. There were not enough hospital medicine doctors. So, think of it, you know, this way, our largest hospital out of 23 hospitals is North Shore University Hospital. It’s 865 patients, you know, probably four intensive care units, and before you knew it, the whole hospital was basically an intensive care unit. I mean units that had been classic medical-surgical units were being converted into intensive care units, and there weren’t enough intensivists to be able to care for these patients. So, from specialties that were suddenly less busy, for example, gastroenterologists were not doing a lot of colonoscopies and other procedures, orthopedic surgeons and other surgeons were not doing a lot of elective surgery, and so a lot of people were brought out of necessarily areas of comfort for them.

Tom McGinn, who’s the chairman of medicine and associate chief of staff for the health system, you know, I think in a very touching way, put forth the fact in March that a lot of us were going to have to get out of our comfort zones and get into areas of treating patients, and you know it ended up, I think, for a lot of people that were redeployed into front-line care for intensive care and for hospital medicine care of less sick COVID patients, it ended up, I think, being a really energizing, a very, you know, I think in some ways exciting but very sad, very sad labor that people were involved in. For nephrologists, it was a little bit different. Some of our people got redeployed, but because so much of our work exploded in the hospitals that we were really redeploying our people from office into hospital care.

Joe Elia:

Did you have enough personal protective equipment, PPE, so called, and…?

Dr. Steven Fishbane:

Yes. So, I think that we were fortunate that for all aspects of protective equipment, there was enough. Now, you know, as you probably know, by late March, I think everybody was worried about would there be enough ventilators, would there be enough masks, would there be enough face guards, would there be enough of everything? And you know, I think that New York State was very helpful in this regard. Our health system senior leadership worked very, very hard and long hours to try to make sure that the PPE was there.

So many people, so many doctors, were making a sacrifice, so many nurses making a sacrifice to be at the front lines here and to be able to provide the PPE that was required was so important more in terms of just how people felt about the work and the confidence. So, it’s such an important question, and you know, I think the leadership in New York State, the senior leadership for this health system, and I think for most health systems in New York really did a very good job of keeping us there, but we have to remember, you know, that if you let this pandemic explode out again in too large of a way, there’s always that risk of running short on PPE, and you know I think we saw from some other countries just how bad that can get.

Joe Elia:

If you could advise systems that will be facing a second wave, which we hope will not happen, what lessons did you learn from this wave that you’re going to carry forward with you even into the non-pandemic world?

Dr. Steven Fishbane:

Yeah. So, I think there’s a few lessons here that are important. You know the first is that plan in advance. To the greatest extent possible, don’t try to manage something that is just pulling you along, you know, the proverbial tiger by the tail. Try to stay ahead of it. Use data. I mean we were at the point, at least on the renal side, of every single day, understanding how many nurses did we have available, how many machines, the amount of disposables that are available. At the health system level, that means understanding the number of doctors, nurses that you have to be able to care for critically ill patients.

And you know I would like to add, you know, a third part of it, not just that real-time awareness and management but communication, communication, because it, you know, did come at a time that physician burnout in the United States was already something of an issue, I think it’s fair to say, and having that great physician leadership, which we have a lot of in our health system, to really keep the spirits up of people, and I think, you know, as we’re getting late in the course of this, at least first wave. We had a call last night where we were talking, and there was really a lot of gratitude about the importance of just talking and talking and providing support for not just physicians, of course, but nurses and everybody who’s involved at the front lines of care to be successful. Now, if there should be a second wave, that’s going to be hard, right? That will be you ran on fumes and adrenaline the first time through. The second time through, it’s going to take a tremendous amount of support, but we learned a lot the first time through, I think, to help everybody around the country.

Joe Elia:

If you could say something to the staff that went through these couple of months with you, what would you say?

Dr. Steven Fishbane:

You know I just have learned and have developed such an incredible sense of gratitude for people that have left young children at home, babies at home, that have elderly parents that they’re caring for, that have spouses with medical conditions that have gone willingly to the front lines and very few people that were not willing to do that but just the amazing gratitude for the courage, for the fact that this reenlivens in us the reasons that us as physicians, as nurses, as other healthcare providers, went into healthcare in the first place. It’s terrible that we’ve had to go through this for the patients, most of all, of course, and their families, but you know, I think a real awakening in all of us and you know maybe it takes every once in a while a certain wake-up call about why, why this calling is so important, and I hope young people going into medicine understand that, Joe.

Joe Elia:

I wanted to ask you, Dr. Fishbane, what in your life prepared you for this challenge, do you think?

Dr. Steven Fishbane:

Maybe this is the best answer to your question. You know my training was during the AIDS epidemic, and I think that, at that point in my career, as a trainee, I didn’t really appreciate because this was the normal for me as a trainee, and yet, you know, I think for me and for some of my contemporaries, you know, that was very good preparation, but I think for everybody who has lived through challenges in their lives and they know they can get through it with courage and with, you know, working together, as a team, and feeling that camaraderie and collaboration of working together. It’s so important, right?

Joe Elia:

I want to thank you, so much, Dr. Steven Fishbane, for sharing your experience with us.

Dr. Steven Fishbane:

Great. What a pleasure to speak to you. Thank you.

Joe Elia:

That was our 267th episode. The whole lot is searchable and available free at podcasts.jwatch.org. We come to you from the NEJM group, and our executive producer is Kristin Kelley. I’m Joe Elia. Thanks for listening.

May 10th, 2020

Podcast 266: Interferon and early treatment in COVID-19 bring good outcomes

(12 votes, average: 3.67 out of 5)

A combination of three antivirals — Kaletra (which is lopinavir plus ritonavir) and ribavirin — when given early and with interferon significantly reduces viral shedding, disease symptoms, and hospital stay in  patients with COVID-19 when compared with a control regimen of Kaletra alone. The drugs are active against other coronaviruses, but the key factors seem to be interferon and promptness of treatment.

When the triple-drug combo was administered without interferon 7 days or more after the onset of symptoms, the results were no better than with Kaletra alone. Prof. Ivan Hung, the lead author on the report, explains that the researchers were afraid of prompting a cytokine “storm” if interferon was given after 6 days of symptoms — they’re not sure that that reluctance was well founded now. In any case, no patients died in either group.

The study was conducted in Hong Kong and has just been published in The Lancet. (An earlier study by another group published in the New England Journal of Medicine found no special benefit from Kaletra alone — a result seemingly confirmed by this study in The Lancet.)

We were able to interview Prof. Hung over ZOOM from Hong Kong, where he was about to enjoy a Mother’s Day lunch with his mom. It was very generous of him.

Prof. Hung’s article in The Lancet

NEJM study on Kaletra’s ineffectiveness against COVID-19

Running time: 14 minutes

Links to other interviews in this series:

  1. Dr. Anthony Fauci
  2. Dr. Susan Sadoughi
  3. Dr. Matthew Young
  4. Dr. Julian Flores
  5. Dr. Kristi Koenig
  6. Dr. Renee Salas
  7. Drs. Andre Sofair and William Chavey
  8. Dr. Comilla Sasson
  9. Dr. John Jernigan

Transcript __________________

Joe Elia: ________You are listening to Clinical Conversations. I’m your host, Joe Elia.

A study out of Hong Kong, just published in The Lancet, shows that a combination of three antiviral drugs has the effect of shortening the time from the start of COVID-19 treatment to when nasopharyngeal swabs are free of virus. The researchers used a combination of three drugs, all of which have shown activity against coronaviruses related to SARS-CoV-2. Some patients also received interferon.

The regime was compared against a regime using only two of the antivirals and no interferon.

The study’s first author, Professor Ivan Hung, has kindly agreed to talk with us. Professor Hung is with the State Key Laboratory of Emerging Infectious Diseases, Carol Yu Center for Infection, at the University of Hong Kong.

Welcome, Professor Hung, and thank you for agreeing to talk with us.

Professor Ivan Hung: ________Thank you, Joe. Very kind of you.

Joe Elia: ________Previous work on 2003 SARS and 2012 MERS was key here, wasn’t it?

Professor Ivan Hung: ________Absolutely. Yes.

Joe Elia: ________And can you briefly explain the rationale for using the three drugs that you did?

Professor Ivan Hung: ________Yes, the choices of the three drugs are based on our previous research, published in 2003 and also in, subsequently in 2015. The two studies were based on…in 2003, we were using the Kaletra, which is the lopinavir/ritonavir, together with the ribavirin, in patients with SARS in 2003. And we were able to demonstrate that with that combination that patients clinically, they actually performed better with fewer complication of ARDS and also fewer mortalities. Nevertheless, it was a pilot study.

Subsequently, we did another study on marmoset, which is the, you know, the South American monkey, and we did, in that animal model, we were able to demonstrate by using either interferon or with the Kaletra, we were able to suppress the virus and with better survival in the monkey model. And that’s the reason why we choose to use the interferon beta-1b, the Kaletra, and also the ribavirin as our combination for this antiviral.

Joe Elia: ________And you say in the paper, the interferon jumpstarts the immune system. It can, it has that effect. So, you limited the use of interferon to those whose symptoms had emerged less than seven days before starting treatment.

Professor Ivan Hung: ________Yes.

Joe Elia: ________And why did you limit it to early diagnosis?

Professor Ivan Hung: ________We worried about the pro-inflammatory effect of the interferon, and as we know that from, you know, other studies, we know that the viral load actually peaks in the COVID-19 very early, 24 to 48 hours from symptom onset. So, that’s why we chose, we decided to use the interferon within seven days because we worried that if we would give it to patients who presented to us late, beyond seven days, there would be an adverse effect of having activating the inflammatory cytokine storm in these patients, and it might worsen their clinical presentation.

Joe Elia: ________Just because it, as you say, it jumpstarts the immune system, and you don’t want to put it into overdrive, I guess.

Professor Ivan Hung: ________Absolutely. Yes, that’s the reason.

Joe Elia: ________It seems very important to start treatments, at least with the triple regimen of antivirals, within seven days. Is it because the viral load peaks early?

Professor Ivan Hung: ________Yes. From our research in influenza and also other respiratory viruses, we know that if you have treatment very early on, within the seven days from symptom onset, we will be able suppress the viral load, you know, especially for the first few days. By suppressing the viral load, you actually prevent complication from happening in the second week, which is usually complicated with activation of the immune system and you have the cytokine storm, and that is when you get most of your complications, including your severe pneumonia, your respiratory failure, followed by multi-organ failures.

So, it is key, in fact, to treat COVID-19 or influenza within the first few days, or at least within the first week from symptom onset. So, that is very, very important.

Joe Elia: ________And some people who received the triple drug regimen started the drug regimen after the seven days of symptoms. They started…

Professor Ivan Hung: ________No, in this trial, we actually just give two drugs for those who were presented beyond, seven days or beyond. So, in fact, in the treatment arm for those who presented seven days or beyond, we did not give the interferon because of the adverse effects that we worry about from inflammatory effect. So, we only give the Kaletra and the ribavirin for those late presenters.

Joe Elia: ________Let me just be clear. Some of the patients received the Kaletra and ribavirin, but not interferon.

Professor Ivan Hung: ________Yes. Yes.

Joe Elia: ________Okay.

Professor Ivan Hung: ________That is within the combination group, but those patients who presented seven days or beyond, we only give the Kaletra and ribavirin without interferon because of fearing the pro-inflammatory effect of the interferon. In the control group, we only give the Kaletra as a control.

Joe Elia: ________In your table that you describe the results, I think it’s Table 3 or something, the people who received the triple drug regimen, the combo, the combination regimen, and not interferon, did not do significantly better than the people [on the two-drug regimen]…

Professor Ivan Hung: ________Absolutely.

Joe Elia: ________Okay.

Professor Ivan Hung: ________The table is based on subgroup analysis, so we actually split the group back according to when they actually presented with the symptoms, so…which was the fairer comparison, because for those who actually take the triple therapy with interferon, there are 52 of them within the combination group, and we compared these to the control, which is 24 of them who was also presented in the control group within seven days. So, that is the fairer control, a fairer comparison. Whereas, for those who only received the two drugs, that means that they present seven days or beyond, they are compared with the control, with the only-Kaletra group, and there’s no difference between the two groups.

Joe Elia: ________Right. Right. There were no statistically significant [differences]…

Professor Ivan Hung: ________Absolutely. And that actually proved that interferon probably is the big, you know, the backbone of the triple therapy.

Joe Elia: ________Yeah. Well, it’s either interferon or early treatment.

Professor Ivan Hung: ________Yes. As I say, I think it’s both.

Joe Elia: ________Yeah. Yeah. So, it’s…

Professor Ivan Hung: ________If you compared with the control, it would actually show a difference, so…which is also an extra treatment. So, that means interferon is likely to be the key factor.

Joe Elia: ________Yes. Okay. And so, you didn’t use a placebo, and you mentioned in the discussion that there’s a reluctance to use a placebo…

Professor Ivan Hung: ________No. We discussed this in our treatment panel or committee within our hospital authority, and in fact, all the panel members said, you know, placebo is…will not be accepted by the patient, given our painful experience in SARS. So, that’s why we have the Kaletra as the control rather than placebo.

Joe Elia: ________I see. And now, did the results surprise you? Were you expecting that interferon would have the effect that it did have?

Professor Ivan Hung: ________The result was more or less what we expected, although we were a little bit surprised in terms of the difference between the combo and the control in terms of the viral suppression.

Joe Elia: ________Yeah, the shedding was shortened among the combo receivers, recipients from seven days versus twelve days with the controls.

Professor Ivan Hung: ________Yes.

Joe Elia: ________The symptom alleviation, symptoms were alleviated in the combo group in four days versus eight days in the controls.

Professor Ivan Hung: ________Indeed, yes.

Joe Elia: ________And the hospital stay was much shorter. It was nine in the combo group and about fifteen in the controls.

Professor Ivan Hung: ________In the control, yes.

Joe Elia: ________So, yeah. Something was at work, and so…but the two variables seem to be time and interferon.

Professor Ivan Hung: ________Absolutely.

Joe Elia: ________That’s right. So, are you doing more studies on trying to resolve the, trying to get a finer…?

Professor Ivan Hung: ________Yes. Yeah. Yeah, several things we are trying to do in the, you know, in another trial, which we just started, even though we have no patients now in Hong Kong. I think the limitations in our first study is that is all mild cases, mild-to-moderate cases that we have. Most of them come in with the NEWS score of 1 or 2, and the other problem, of course, is that we have very few severe cases, probably because we hospitalize our patients very early on and treat them, most of them, within the first week. So, that’s why we have very few severe cases, including we have, you know, less than 1,000 cases in Hong Kong, confirmed cases. Less than 3% was in the ICU, so…and it’s also, you know, less than 0.4% in terms of mortality. So, it’s very difficult to…you know, we want to recruit severe cases, but we couldn’t.

So, the next step, of course, is to see whether this regimen works in severe cases, if we have more severe cases in the coming winter, or that is that we will be looking at whether we can actually use interferon in patients who presented beyond seven days, which we think that this is not a, you know…a lot of the pro-inflammatory adverse effect is not a problem anymore. We can actually give interferon for patient who present beyond seven days. So, we’ll be looking at that, as well.

Joe Elia: ________But if you were looking for severe cases, then you would need to look no further than Boston. So, are you working with colleagues internationally at all, or…?

Professor Ivan Hung: ________Yes, we have collaborators in Europe, in UK, and also in US, which we’ve communicated with. So, you know, we will be very happy to look for further trials with our collaborators, you know, in the coming winter when more cases evolve.

Joe Elia: ________Have you started using the regimen…you don’t, you say you don’t have any severe cases at the university now. Have you started using the regimen on other patients in other hospitals in Hong Kong?

Professor Ivan Hung: ________Well, in fact, for this trial, we have included six major hospital, public hospital in Hong Kong that actually cover around 75% of the population in Hong Kong. So, in fact, we actually recruited most of the patients in the first, you know, two months up to the 20th of March, of all our confirmed cases. We only have our second wave, you know, in the late March, where we have a surge of cases from about 200 up to, now, 1,000 confirmed cases a day, and so, we have recruited more or less all the patients, a majority of the patients that we have in Hong Kong. So, if we are looking for, you know, more severe cases, then probably we have to look somewhere else with collaborators in other parts of the world.

Joe Elia: ________You mentioned a term I’m not familiar with. You call it NEWS2. It’s a National Early Warning…

Professor Ivan Hung: ________Indeed. National Early Warning Score 2, which was developed in the UK for assessing especially respiratory illnesses affecting with…presented even earlier. And that allows us to compare, you know, the treatment and the control arm in subsequent observations.

Joe Elia: ________So, the severity of the pulmonary…

Professor Ivan Hung: ________Indeed.

Joe Elia: ________Okay. So, pardon my ignorance about that. I want to thank you for speaking with me today, Professor Hung.

Professor Ivan Hung: ________Thank you, Joe. Very kind of you. And Happy Mother’s Day.

Joe Elia: ________Happy Mother’s Day to you. I hope you enjoy it.

That was our 266th episode. All the rest can be found at podcasts.jwatch.org. We come to you from the NEJM group, and our executive producer is Kristin Kelly. I’m Joe Elia. Thank you for listening.

May 1st, 2020

Podcast 265: COVID-19 in skilled nursing facilities

(7 votes, average: 4.14 out of 5)

We (Dr. Danielle Bowen Scheurer and Joe Elia) talk with Dr. John Jernigan of the CDC COVID-19 Investigation Team, which recently published its findings on the spread of COVID-19 in a Seattle-area skilled nursing facility.

Most intriguingly, over half the patients who tested positive were asymptomatic at the time of their first testing, and a few hadn’t developed any symptoms a week after their positive tests.

The results are instructive to those working in facilities such as this, whose patients are vulnerable to bad outcomes.

Running time: 17 minutes

Links:

New England Journal of Medicine report

MMWR report

Links to other interviews in this series:

  1. Dr. Anthony Fauci
  2. Dr. Susan Sadoughi
  3. Dr. Matthew Young
  4. Dr. Julian Flores
  5. Dr. Kristi Koenig
  6. Dr. Renee Salas
  7. Drs. Andre Sofair and William Chavey
  8. Dr. Comilla Sasson

Transcript 

TRANSCRIPT

Joe Elia:__________You’re listening to Clinical Conversations. I’m Joe Elia. I’m joined this time by Dr. Danielle Bowen Scheurer, a colleague from earlier podcasts. Dr. Scheurer is a hospitalist and professor of medicine at the Medical University of South Carolina where she serves as chief of quality, safety, experience, and population health. That’s kind of a full plate, Danielle. Welcome back.

Dr. Scheurer:__________Thanks.

Joe Elia:__________We’re talking about COVID-19 again this week. It’s the disease whose effects you can see just by looking out the window: People walking in the streets with masks now seem unremarkable. And speaking of streets, there are hardly any cars out there.

What you can’t easily see, however, is who’s infected and who isn’t, and that’s the point of our interview with Dr. John Jernigan of the Centers for Disease Control and Prevention. He and his team have studied an early focus of the pandemic in the US — a skilled nursing facility in King County of Washington State, which neighbors Snohomish County where another such facility had just recorded the country’s apparent first outbreak. Their recent reports in MMWR and the New England Journal of Medicine show how difficult this disease is to screen for.

Dr. Jernigan is an epidemiologist with the CDC COVID-19 Investigation Team, and he also has a teaching appointment at Emory University School of Medicine, both in Atlanta.

Welcome to Clinical Conversations, Dr. Jernigan.

Dr. Jernigan:__________Thank you so much. Pleasure to be with you today.

Dr. Scheurer:__________Hi, Dr. Jernigan. It’s Danielle Scheurer. I’ve read your study with a lot of enthusiasm. It’s very interesting and impactful, so we just wanted to kind of walk through it and ask a couple of questions. So in summary, your team tested almost 90 residents in this facility with really good technique and of those who tested positive, over half had no symptoms at the time of testing and even a few hadn’t developed symptoms even a week after the testing. So as this was all unfolding and you’re reflecting on what you found, how surprised were you and your team with these results?

Dr. Jernigan:__________Thank you, Danielle, for that question. We were pretty surprised. As a little background, I was part of the CDC team that was deployed to Seattle when the outbreaks were first recognized there, when the first cases in Seattle were being recognized. I was in charge of a team that was over infection control for both acute care and long-term care, but it became apparent pretty quickly that long-term care was the place where we were seeing large and rapid outbreaks. So we began to support the investigation of some of those outbreaks as a way of helping prevent transmission.

One of the early observations: we sort of learned that some of the cases we were finding didn’t seem to have a lot in the way of symptoms. This was a very important issue because most of our infection control strategies rely on symptoms to identify residents or patients who might have infection and where to guide your testing and where to guide your isolation and prevention strategy. So we said we need to find out how widespread this is.

So we started doing these point-prevalence surveys. As you point out, we were quite surprised to learn that over half of the infections that we identified in these populations were asymptomatic at the time of the testing. This is a big problem in infection control. How can you separate those that are infected from those that are not if you can’t really tell based upon your symptoms? So we were quite surprised, to answer your question.

Joe Elia:__________The takeaway from your studies, in my mind, seems to be if I can caricature it: “Listen, clinicians, this disease doesn’t announce itself. You have to assume everyone is positive.” Is that fair?

Dr. Jernigan:__________In this particular population in this particular setting, I think that once you identify a case in your facility, yes, you need to assume that every resident in that facility may be infected. If that’s the case then you have sort of two choices going forward in terms of any transmission. One, you treat everybody in the facility the same way with regard to use of, for example, personal protective equipment, which can be a burdensome thing to do. It requires a lot of personal protective equipment, which is an issue.

As you know, there have been shortages nationwide, and particularly for many long-term care facilities, they have had trouble getting enough personal protective equipment. So that’s one issue. Basically isolate everybody, treat everybody a if they’re infected. Or you test everybody so that you can tell, as you point out, who’s infected, who’s not. Separate those that are infected into a certain cohort so you can put them in the same place in the building, assign certain staff to them, focus a lot of your personal protective equipment use there. Then for residents who are not infected to another place where hopefully you can protect them a little bit better.

Dr. Scheurer:__________And a follow-up on that, in your experience, how prepared do you think most facilities are to do quick and reliable widescale testing?

Dr. Jernigan:__________So this has been a real issue. As you know, there have been testing shortages and in fact when we first made this observation that was a big problem. We felt like testing all residents — and for that matter all healthcare providers — could be very helpful but testing availability really didn’t allow that. Now even at a week since that time testing availability has improved substantially, and so some skilled nursing facilities find themselves in states and other jurisdictions who have testing capacity that will allow taking this approach. Others are still struggling to do that. We hope that testing capacity will continue to improve such that if it turns out that this strategy does prove to be effective that more and more facilities will be able to utilize this strategy.

Dr. Scheurer:__________Even the ability to do the actual test aside, the collection methods are pretty cumbersome as well, right?

Dr. Jernigan:__________It is pretty labor intensive to collect the specimen. Even that is potentially changing a little bit with changes and recommendations of how tests can be performed, whether or not you have to do a nasopharyngeal swab, which is originally that’s what the recommendation was. So it takes a certain skillset and level of training to acquire those. CDC has just amended its recommendation such that swabs to the anterior nares are probably acceptable, which simplifies things a little bit in terms of being able to collect the specimen, but still you have to have the swabs, and you have to have the viral transport media, and you have to have a laboratory who can process these specimens and process them quickly. So there have been challenges in all of those elements. It can be a pretty difficult thing to do. I will say that I believe that capacity is improving pretty rapidly.

Dr. Scheurer:__________Which is great and definitely welcome news for the vulnerable population. Can you expound also a little bit about how you guys define symptoms and how that definition is changing and evolving?

Dr. Jernigan:__________Right. So when we started out this investigation not much was really known about this disease. Originally, the symptoms that were used to guide testing and to identify people who had been exposed and who you thought might be infected were essentially fever, cough, and shortness of breath. So we used essentially that for our definition of kind of typical symptoms.

But part of this investigation (and many others) is showing that there are lots of other less typical symptoms that are a manifestation of this disease. So on the one hand, you have people with sort of kind of the classic, cough, fever, shortness of breath. On the other end of the spectrum you have people who have no symptoms and then in between you have lots of other things.

We think especially in the early phases the illness can present quite subtly with maybe just a headache or myalgias or a little bit of chills, sometimes a little nausea, sore throat. What we’ve learned since then, which wasn’t appreciated when we started the study, the sudden loss of smell or sense of taste may be associated with this. So the sort of menu of symptoms that can be a manifestation of early parts of this illness has expanded pretty substantially.

Dr. Scheurer:__________Do you think there is a logical role for serologic testing in long-term care facilities right now or in the future.

Dr. Jernigan:__________So I’m glad you asked that question. I think there is potential great promise from use of serology to help guide these sorts of strategies, but I don’t think we are there yet. There are a number of different platforms out there. Some perform better than others. There’s also the question of what the presence of antibodies means. Are they neutralizing antibodies or not? Does the presence of these antibodies confer a protection against reinfection? What are the correlates of protection? I think these are all ongoing questions that we need to answer. I think there are many, many people out there working very hard to answer these questions and we hope they will have answers in the relatively near-term. I think at this moment today, our stance — and I guess this is my personal opinion — is that I don’t think we’re ready to use the results of serologic testing to make clinical or infection control or public health decisions. We might be there very soon, but I don’t think we’re there today.

Joe Elia:__________The editorial in the New England Journal of Medicine argues that we must be especially cautious until we can test widely and reliably. Did your team have a reaction to the editorial? Did they share their…

Dr. Jernigan:__________No. We have no interaction with the authors. We saw it when it was published or shortly before. If your question is more broadly about how to relax social distancing measures, et cetera and so forth and the relationship between available testing and that, I’m really not the person to focus on that. My focus is specifically on infection control and long-term care facilities and the relationship of testing and testing availability to that with regard to controlling transmission in long-term care facilities, which, by the way is a really high priority thing, as I think I might have mentioned already.

When SARS COV2 is introduced into these settings it can spread very rapidly and very widely and it can cause great morbidity and mortality in this very vulnerable population. But in addition, more than just protecting these residents and these patients it’s important for the regional healthcare system. What we observed in Seattle is that a large outbreak in even a single skilled nursing facility puts great strain on local hospitals in terms of their ICU bed capacity, et cetera and so forth. What’s more is that when a patient in a long-term care facility gets admitted to a hospital with COVID-19 sometimes it’s difficult to get them discharged, because long-term care facilities may be reticent to accept someone who is positive and may still be shedding virus, et cetera. So not just to protect those residents but it’s also to protect the local healthcare system.

So I think preventing transmission here in these settings should be a high priority. So back to the question of the relationship of that priority and testing. We think that our results suggest that testing can be an important tool to help control spread in these settings, and we agree with the writers of the editorial that the sooner that we can make improved testing capacity to the point that we can use it in these settings in that way the better.

Joe Elia:__________Thank you. I just wanted to ask a final question. What were your team’s reactions to the findings that you made? Were they astonished to see this?

Dr. Jernigan:__________I would say we were very surprised. The potential implications of the findings were immediately obvious to us. It seemed clear that a test-based strategy may be a very important approach and yet we were concerned that testing capacity at that point in time was not sufficient to allow that. We’ve been working since that time to partner with facilities and public health jurisdictions that have been increasing their test capacity and to partner with them in implementing this strategy and learning along with them about the best ways to actually go about implementing it.

For example, if you go out and you test everybody once, is that sufficient? There’s some early clues that that may not be sufficient, because if you test anybody on a given day and they’re negative it could be that they’re actually infected but they’re still in their incubation period and not shedding virus — at least to the extent that can be picked up by the test. That suggests that you may need to go back and do a repeat test and make sure that you haven’t missed any of those patients who are incubating. The findings from our study sort of hinted early on that that in fact was the case. So we were working with these partners to implement the strategy and learn lessons as we go with regard to the best way to implement it, the most efficient way to implement it, what the barriers to implementation are, what the facilitators to successful implementation are, and hopefully we can parlay all that information into better and refined guidance from CDC on how to proceed with this prevention strategy.

Joe Elia:__________My last question was going to be, what do you think your team would like to see as a result of your work? I think you’ve just answered that question.

Dr. Jernigan:__________Yes. I think that’s right. We would like to see testing availability that allows long-term care facilities the option of using a test-based infection control strategy. They have the resources they need to not only do the testing but it’s important to emphasize that they need to have the resources to take the appropriate action based upon the test and be planning about how to cohort patients or cohort residents, and make sure they have appropriate PPE, all these sorts of things. All the testing in the world…you can do all the testing in the world but it won’t help you if you can’t take the appropriate action that should be taken based upon the results.

Joe Elia:__________We want to thank you for your time with us today, Dr. Jernigan.

Dr. Scheurer:__________Thank you so much.

Dr. Jernigan:__________Thank you.

Joe Elia:__________That was our 265th conversation. This and all the others are available free at Podcasts.JWatch.org. We come to you from the NEJM Group. The executive producer is Kristin Kelly. I’m Joe Elia.

Dr. Scheurer:__________And I’m Danielle Scheurer.

Joe Elia:__________Thanks for listening.

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