Opinion

The data are shocking: Almost 35,000 U.S. syphilis cases by mid-July 2022 with the highest rates per/100,000 population in Nevada (n = 21), California (n = 19), and Mississippi (n = 16). Excluding Nevada, California, and Oklahoma, rates over 12/100,000 were concentrated in the southernmost U.S. states. Overall, the 2,268 congenital syphilis cases in U.S. children born in 2021 was a 6% increase over 2020, and a 680% increase over 2012. (Note: All 2021 data are not yet available because of public health STI resources being diverted to COVID-19 control.) A telling number is the 166 congenital syphilis deaths in babies born in 2021 – a 1,000% increase over 2012. Another concern is that 50% of U.S. counties reported at least one congenital syphilis case in 2019 – the last time frame from which county-specific data are available.  

Syphilis afflicts the underserved and underprivileged more than other demographic groups, particularly when public health budgets are not adequate (funding for public health STI prevention/treatment efforts has lagged for more than a decade), and/or when public health emergencies such as the pandemic divert public health resources away from STI prevention/treatment efforts. 
As pediatric care providers, we can help by heightening our vigilance and appropriately testing for and treating syphilis, particularly in newborns/infants, regardless of where we work. And we can advocate for increased public health STI funding allocation whenever possible. It is a smart economic move because it costs nearly 1,000 times more to manage congenital syphilis and its sequelae than to prevent or treat it. 

Christopher J. Harrison, MD, is professor, University of Missouri Kansas City School of Medicine, department of medicine, infectious diseases section, Kansas City. He has no financial conflicts of interest.

The data are shocking: Almost 35,000 U.S. syphilis cases by mid-July 2022 with the highest rates per/100,000 population in Nevada (n = 21), California (n = 19), and Mississippi (n = 16). Excluding Nevada, California, and Oklahoma, rates over 12/100,000 were concentrated in the southernmost U.S. states. Overall, the 2,268 congenital syphilis cases in U.S. children born in 2021 was a 6% increase over 2020, and a 680% increase over 2012. (Note: All 2021 data are not yet available because of public health STI resources being diverted to COVID-19 control.) A telling number is the 166 congenital syphilis deaths in babies born in 2021 – a 1,000% increase over 2012. Another concern is that 50% of U.S. counties reported at least one congenital syphilis case in 2019 – the last time frame from which county-specific data are available.  

Syphilis afflicts the underserved and underprivileged more than other demographic groups, particularly when public health budgets are not adequate (funding for public health STI prevention/treatment efforts has lagged for more than a decade), and/or when public health emergencies such as the pandemic divert public health resources away from STI prevention/treatment efforts. 
As pediatric care providers, we can help by heightening our vigilance and appropriately testing for and treating syphilis, particularly in newborns/infants, regardless of where we work. And we can advocate for increased public health STI funding allocation whenever possible. It is a smart economic move because it costs nearly 1,000 times more to manage congenital syphilis and its sequelae than to prevent or treat it. 

Christopher J. Harrison, MD, is professor, University of Missouri Kansas City School of Medicine, department of medicine, infectious diseases section, Kansas City. He has no financial conflicts of interest.

The data are shocking: Almost 35,000 U.S. syphilis cases by mid-July 2022 with the highest rates per/100,000 population in Nevada (n = 21), California (n = 19), and Mississippi (n = 16). Excluding Nevada, California, and Oklahoma, rates over 12/100,000 were concentrated in the southernmost U.S. states. Overall, the 2,268 congenital syphilis cases in U.S. children born in 2021 was a 6% increase over 2020, and a 680% increase over 2012. (Note: All 2021 data are not yet available because of public health STI resources being diverted to COVID-19 control.) A telling number is the 166 congenital syphilis deaths in babies born in 2021 – a 1,000% increase over 2012. Another concern is that 50% of U.S. counties reported at least one congenital syphilis case in 2019 – the last time frame from which county-specific data are available.  

Syphilis afflicts the underserved and underprivileged more than other demographic groups, particularly when public health budgets are not adequate (funding for public health STI prevention/treatment efforts has lagged for more than a decade), and/or when public health emergencies such as the pandemic divert public health resources away from STI prevention/treatment efforts. 
As pediatric care providers, we can help by heightening our vigilance and appropriately testing for and treating syphilis, particularly in newborns/infants, regardless of where we work. And we can advocate for increased public health STI funding allocation whenever possible. It is a smart economic move because it costs nearly 1,000 times more to manage congenital syphilis and its sequelae than to prevent or treat it. 

Christopher J. Harrison, MD, is professor, University of Missouri Kansas City School of Medicine, department of medicine, infectious diseases section, Kansas City. He has no financial conflicts of interest.

This video transcript has been edited for clarity.

Robert D. Glatter, MD: Welcome! I’m Dr Robert Glatter, medical advisor for Medscape Emergency Medicine. Today we have a distinguished panel joining us to discuss an important legal decision resulting in a criminal conviction, involving a medical error due to administration of the wrong medication by a critical care nurse that led to a patient’s death.

Joining us to discuss this case is Dr. Megan Ranney, professor of emergency medicine and the academic dean at Brown University School of Public Health. Also joining us is Dr. Jane Barnsteiner, emeritus professor at the University of Pennsylvania School of Nursing and an expert on patient safety, quality improvement, and system modeling. Welcome to both of you.

Jane Barnsteiner, PhD, RN: Thank you.

Megan L. Ranney, MD, MPH: Thank you. It’s a joy to be with you.

Dr. Glatter: Let’s discuss this very tragic case involving RaDonda Vaught, who was an ICU nurse who was recently convicted in Tennessee of criminally negligent homicide and gross neglect of an impaired adult. She accidentally administered a paralytic medication, vecuronium, instead of a sedative, Versed, which was ordered to sedate a 75-year-old patient who had a brain bleed and TBI. She was scheduled to have a PET scan. After receiving the wrong medication and not really being monitored in any true way, just being in the care of an MRI tech, she suffered cardiac arrest and subsequently died.

Dr. Ranney, I want to begin with you. I saw on Twitter that you had written something that really stuck with me. I’ll quote you. “A culture of safety is one in which the system that allowed the mistake to happen is changed, not one in which the individual is scapegoated. And a culture of safety correlates with better patient outcomes that we know. This verdict is the opposite.”

I’ll let you explain from here. The system issue is the medication dispensing cabinet, in my mind, and there was a medication override. The question is, how was this override allowed to occur in the first place?

Dr. Ranney: My goodness, overrides happen every single day across this country, dozens of times a day in any particular shift. I would think of the system as being much bigger than just the Pyxis or that kind of automated dispensing cabinet, but around the larger system of the verbal orders, the time pressures that the nurse is under, the fact that the nurses are with a trainee, the fact that they’re being asked to operate outside of their normal environment by going down to MRI. There’s a series of issues.

Just as we thought about the Swiss cheese model for COVID-19, that model originated when we talked about patient safety and medical errors. It is a Swiss cheese of circumstances that allows this type of tragic error to occur.

Many of us have worked for years on trying to change the system from one of punishing people, changing it from that punitive system, to rather a system where we can do root-cause analysis, allow people to disclose errors, and allow us to inquire as to what are those series of Swiss cheese holes that allowed this mistake or any other to happen.

When you punish people, you lead them to hide their mistakes instead of allowing them to disclose them and allowing that important inquiry to happen. That’s why this is just so harmful to that culture of safety that so many of us are trying to create.

Dr. Glatter: It’s a chilling verdict in so many ways. I’m right on the same page with you, having worked for so long in the emergency department and seeing nurses that are overtaxed, overburdened, but also on patient floors. This goes to an ICU-type environment where this woman was having a nonemergent head scan and required some sedation.

The question I want to get to is how the system allowed the nurse to dispense this medication —though she was distracted, she’ll admit that. Jane, I want to get to you on this. How can we avoid this? What are the system checks that can be done in some fashion to make this safer and to avoid this tragic error?

Dr. Barnsteiner: First of all, I would say that you do not put in a major change, as they were doing with their EPIC system, as a big bank where you do the change through the entire organization. You do it in one area where you get the whole system smoothed out and all the errors taken care of so that you’re not having a problem like they had through their entire organization, which required overrides multiple times a day.

One of the things that’s been recommended is that these systems, like the Pyxis system, require the first five letters of a medication to be entered into the system so that when you have multiple medications where the first two letters are the same, the chances of pulling out the wrong medication are much smaller.

There’s a question of whether this medication, vecuronium, should have even been in this machine. You can have high-alert medications like this in baggies that have written on the front of the bag, “This is a high-alert medication. It requires two independent double checks.” These are all the things that will help alert the fatigued or distracted nurse or physician and will make things safer. There are many things that can be put into place.

Dr. Glatter: It’s almost like a hard stop. This is a different class of medication. Even if the nurse had a lapse and didn’t realize that, there should have been a hard stop asking whether you want this class. A sedative and a paralytic are two very different medications.

I’m not trying to assign any blame here. I’m just trying to look at mechanics of what happened and how we can put in place methods to avoid these types of errors where a system clearly is overtaxed and overburdened. Is it an artificial intelligence alert? Is it a pharmacy alert that goes out? Is it a Vocera message that gets triggered? It’s something to stop the nurse from doing something where they know better.

She’s used Versed before, apparently, and knows it’s a liquid and doesn’t have to be reconstituted. In my mind, as a practicing doctor for a long time, I see this and I see how it can happen. There are ways I think we can address it. Megan, I want to bring you into this and get your viewpoint.

Dr. Ranney: We’re working in an environment right now — and obviously, this happened pre-COVID — where medicines are constantly in short supply and we’re constantly dealing with substitutions of one for another. This has worsened during COVID, but it existed in the pre-COVID era as well. We’d have time periods where, like today, we’re out of D50 and we have to use D10, or we have a different formulation of a common antibiotic.

I could totally imagine that this nurse had been exposed to multiple medication substitution and so they were rushing; they thought, well, they just put one thing in instead of another and didn’t make that kind of cognitive connection.

What we know so well from our studies of human factors, engineering, and the way that systems work is that when someone is cognitively overloaded and constantly having to think outside the box and make decisions, particularly when they’re exposed to a new system for ordering medicine, there’s only so much that the brain can do at a time. This person was set up for this type of error.

Again, not to say that they didn’t do something wrong. That’s why we have a civil system. That’s why we have licensing. That’s why we have malpractice. To call this a criminal error when they were working within a system that had all these other problems where they were constantly having to make do for system failures, it’s almost inevitable that at some point something really horrible happened.

I’m sorry that it was this nurse, and how horrible for the patient and the family. I’m not excusing that. You can totally imagine, as a practicing physician, nurse, or anyone else in the healthcare system, how this happened.

Dr. Barnsteiner: The other part of it was that they did not have in place, at this time, the barcoding system in this particular patient area. What nurses are used to doing is when they have to pull a medication, they’re using the barcoding system to coordinate with what’s in the electronic health record, with the medication, and with the person’s ID band.

Those are all well-known safety checks that obviously were used to being used by this nurse in the critical care unit but that weren’t available in this MRI area. That is something that absolutely is a system failure. Those kinds of safety systems have to be available at any place in a health system where medications are being delivered.

Dr. Glatter: I think that’s an important point. Here, we have a technology that can supersede the ability of a human to make a mistake, and to have that in place is very critical. I want to go back to the idea of medical malpractice vs homicide charges.

Megan, you made a point of this. This nurse is now an example of someone who went to trial and was convicted, and it could have a chilling effect on healthcare providers. Pre-COVID, post-COVID, it is just chilling. It makes people want to leave the field. It causes PTSD. The psychiatric downstream effects of such an error are just immense.

I don’t know how the district attorney went for criminal charges here. I’m not an attorney and we don’t have a legal expert with us. For this to have happened is just setting precedent that it’s okay to have the effect of making so many people leave the field.

Dr. Ranney: I’m not a lawyer, but I’ve certainly been on the front lines, not only for the past 2 years during COVID but for almost 20 years prior to that. I will say that these types of errors are never-events that sit with our colleagues and friends for their entire career. No one goes into medicine intending to hurt someone. The system fails us and fails the patient.

There are certainly examples of intentional harm, and those people deserve to be prosecuted. This type of thing where a system let them down, again, should require an inquiry of the system. Don’t punish the individuals to the point of putting them in jail.

I think about my last few months working in the emergency department and what my nurses, in particular, have said to me. They worry that they’re going to lose their license and their ability to practice because of the horrific circumstances that we’ve been working in — the understaffing, the lack of access to standard medications, the long wait times, and on and on. They’re not able to take care of patients the way that they’ve been taught to do.

They’re worried already about the downstream effects on their sense of self, as well as on their ability to maintain their livelihood. When you put something like this on top of it, where again, an unintentional error that was potentiated by a somewhat broken system or by a series of Swiss cheese holes that just happened to line up, what message does that send to my nursing colleagues who have stayed on the front lines and who know that they have not been able to provide the standard of care that they’re used to?

Dr. Barnsteiner: On Friday, I did a program on fair and just culture with three health systems and a university school of nursing. Already, some of the faculty reported that students are talking about transferring to another major outside of the School of Nursing because of their worry about this particular guilty verdict.

The other thing is that we already have a tremendous shortage of nurses. We’ve seen many people leave the profession or retire in the past couple of years, and this is only going to compound it further. It is a sobering message that the public can’t afford to have, actually, because this will impact the quality of care and the safety of care that can be delivered to people and families as a result of not having sufficient numbers of professionals to deliver care.

Dr. Glatter: That’s such an important point. In any high-reliability organization, a culture of safety is key. There are tenets we try to adhere to. When we have people leaving the field after seeing a case like this, it’s chilling. We have to re-educate the public and we need to have a realignment of how errors are handled.

This is just the beginning. Her sentencing is going to be in about a month, and we’ll see what happens on reckless homicide charges and neglect. I think there’s going to be a follow-up to this and we’re going to need to discuss this more.

I just wanted to get a couple of takeaways for our audience to just really sear in the brain what we can learn from such an event.

Dr. Ranney: The big takeaway, to me, is the importance of us both continuing to use our voices and working across professional boundaries to help to create this culture of safety, one in which we all feel safe and supported in advocating for systems that work for us. We cannot ask nurses, respiratory technicians, radiology technicians, physicians, or anyone else within the healthcare system to work unsupported, and we have to recognize the degree to which we are all interdependent. My biggest takeaway is for us to use our voices together.

Dr. Barnsteiner: The takeaway that I would have from this, and what I’m working with a number of health systems on, is to have the chair of the board, the CEO of the hospital, the chief medical officer, and the chief nursing officer together promulgate a statement that is sent out to all employees to discuss this verdict and to say what they’re doing to promote a high-reliability organization and a fair and just culture. They should also ask for open conversation and for employees to let the top leadership know any concerns that they have about vulnerabilities in the system. It’s extremely important right now with this verdict that the leaders in healthcare settings, as well as in education settings, let people know what they’ll be doing to protect their employees.

Dr. Glatter: Jane and Megan, I want to thank you so much for such an important discussion that was very informative. I think there’s going to be a follow-up to this that’ll be very, very important. Thanks again.


Robert D. Glatter, MD, is assistant professor of emergency medicine at Lenox Hill Hospital in New York City and at Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York. He is an editorial advisor and hosts the Hot Topics in EM series on Medscape. He is also a medical contributor for Forbes. Dr. Glatter has disclosed no relevant financial relationships.

Megan Ranney, MD, MPH, is professor of emergency medicine and the academic dean at Brown University School of Public Health in Providence, Rhode Island. She is the director and founder of the Brown Emergency Digital Health Innovation (eDHI) program. She is also chief research officer for the American Foundation for Firearm Injury Reduction in Medicine, the country’s only nonprofit committed to reducing firearm injury through the public health approach, and a founding partner of GetUsPPE.org, dedicated to matching donors to health systems in need of protective equipment. Dr. Ranney has disclosed the following relevant financial relationships: Serve(d) as a speaker or a member of a speakers bureau for: Medscape; Merck.

Jane Barnsteiner, PhD, RN, is an emeritus professor at the University of Pennsylvania School of Nursing and an expert on patient safety, quality improvement, and system modeling. In addition to her teaching responsibilities, she was director of translational research at the Hospital of the University of Pennsylvania. Jane was one of the developers of the Quality and Safety in Education for Nurses (QSEN) initiative and is co-editor of Quality and Safety in Nursing: A Competency Based Approach to Improving Outcomes, published by Wiley. She has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

This video transcript has been edited for clarity.

Robert D. Glatter, MD: Welcome! I’m Dr Robert Glatter, medical advisor for Medscape Emergency Medicine. Today we have a distinguished panel joining us to discuss an important legal decision resulting in a criminal conviction, involving a medical error due to administration of the wrong medication by a critical care nurse that led to a patient’s death.

Joining us to discuss this case is Dr. Megan Ranney, professor of emergency medicine and the academic dean at Brown University School of Public Health. Also joining us is Dr. Jane Barnsteiner, emeritus professor at the University of Pennsylvania School of Nursing and an expert on patient safety, quality improvement, and system modeling. Welcome to both of you.

Jane Barnsteiner, PhD, RN: Thank you.

Megan L. Ranney, MD, MPH: Thank you. It’s a joy to be with you.

Dr. Glatter: Let’s discuss this very tragic case involving RaDonda Vaught, who was an ICU nurse who was recently convicted in Tennessee of criminally negligent homicide and gross neglect of an impaired adult. She accidentally administered a paralytic medication, vecuronium, instead of a sedative, Versed, which was ordered to sedate a 75-year-old patient who had a brain bleed and TBI. She was scheduled to have a PET scan. After receiving the wrong medication and not really being monitored in any true way, just being in the care of an MRI tech, she suffered cardiac arrest and subsequently died.

Dr. Ranney, I want to begin with you. I saw on Twitter that you had written something that really stuck with me. I’ll quote you. “A culture of safety is one in which the system that allowed the mistake to happen is changed, not one in which the individual is scapegoated. And a culture of safety correlates with better patient outcomes that we know. This verdict is the opposite.”

I’ll let you explain from here. The system issue is the medication dispensing cabinet, in my mind, and there was a medication override. The question is, how was this override allowed to occur in the first place?

Dr. Ranney: My goodness, overrides happen every single day across this country, dozens of times a day in any particular shift. I would think of the system as being much bigger than just the Pyxis or that kind of automated dispensing cabinet, but around the larger system of the verbal orders, the time pressures that the nurse is under, the fact that the nurses are with a trainee, the fact that they’re being asked to operate outside of their normal environment by going down to MRI. There’s a series of issues.

Just as we thought about the Swiss cheese model for COVID-19, that model originated when we talked about patient safety and medical errors. It is a Swiss cheese of circumstances that allows this type of tragic error to occur.

Many of us have worked for years on trying to change the system from one of punishing people, changing it from that punitive system, to rather a system where we can do root-cause analysis, allow people to disclose errors, and allow us to inquire as to what are those series of Swiss cheese holes that allowed this mistake or any other to happen.

When you punish people, you lead them to hide their mistakes instead of allowing them to disclose them and allowing that important inquiry to happen. That’s why this is just so harmful to that culture of safety that so many of us are trying to create.

Dr. Glatter: It’s a chilling verdict in so many ways. I’m right on the same page with you, having worked for so long in the emergency department and seeing nurses that are overtaxed, overburdened, but also on patient floors. This goes to an ICU-type environment where this woman was having a nonemergent head scan and required some sedation.

The question I want to get to is how the system allowed the nurse to dispense this medication —though she was distracted, she’ll admit that. Jane, I want to get to you on this. How can we avoid this? What are the system checks that can be done in some fashion to make this safer and to avoid this tragic error?

Dr. Barnsteiner: First of all, I would say that you do not put in a major change, as they were doing with their EPIC system, as a big bank where you do the change through the entire organization. You do it in one area where you get the whole system smoothed out and all the errors taken care of so that you’re not having a problem like they had through their entire organization, which required overrides multiple times a day.

One of the things that’s been recommended is that these systems, like the Pyxis system, require the first five letters of a medication to be entered into the system so that when you have multiple medications where the first two letters are the same, the chances of pulling out the wrong medication are much smaller.

There’s a question of whether this medication, vecuronium, should have even been in this machine. You can have high-alert medications like this in baggies that have written on the front of the bag, “This is a high-alert medication. It requires two independent double checks.” These are all the things that will help alert the fatigued or distracted nurse or physician and will make things safer. There are many things that can be put into place.

Dr. Glatter: It’s almost like a hard stop. This is a different class of medication. Even if the nurse had a lapse and didn’t realize that, there should have been a hard stop asking whether you want this class. A sedative and a paralytic are two very different medications.

I’m not trying to assign any blame here. I’m just trying to look at mechanics of what happened and how we can put in place methods to avoid these types of errors where a system clearly is overtaxed and overburdened. Is it an artificial intelligence alert? Is it a pharmacy alert that goes out? Is it a Vocera message that gets triggered? It’s something to stop the nurse from doing something where they know better.

She’s used Versed before, apparently, and knows it’s a liquid and doesn’t have to be reconstituted. In my mind, as a practicing doctor for a long time, I see this and I see how it can happen. There are ways I think we can address it. Megan, I want to bring you into this and get your viewpoint.

Dr. Ranney: We’re working in an environment right now — and obviously, this happened pre-COVID — where medicines are constantly in short supply and we’re constantly dealing with substitutions of one for another. This has worsened during COVID, but it existed in the pre-COVID era as well. We’d have time periods where, like today, we’re out of D50 and we have to use D10, or we have a different formulation of a common antibiotic.

I could totally imagine that this nurse had been exposed to multiple medication substitution and so they were rushing; they thought, well, they just put one thing in instead of another and didn’t make that kind of cognitive connection.

What we know so well from our studies of human factors, engineering, and the way that systems work is that when someone is cognitively overloaded and constantly having to think outside the box and make decisions, particularly when they’re exposed to a new system for ordering medicine, there’s only so much that the brain can do at a time. This person was set up for this type of error.

Again, not to say that they didn’t do something wrong. That’s why we have a civil system. That’s why we have licensing. That’s why we have malpractice. To call this a criminal error when they were working within a system that had all these other problems where they were constantly having to make do for system failures, it’s almost inevitable that at some point something really horrible happened.

I’m sorry that it was this nurse, and how horrible for the patient and the family. I’m not excusing that. You can totally imagine, as a practicing physician, nurse, or anyone else in the healthcare system, how this happened.

Dr. Barnsteiner: The other part of it was that they did not have in place, at this time, the barcoding system in this particular patient area. What nurses are used to doing is when they have to pull a medication, they’re using the barcoding system to coordinate with what’s in the electronic health record, with the medication, and with the person’s ID band.

Those are all well-known safety checks that obviously were used to being used by this nurse in the critical care unit but that weren’t available in this MRI area. That is something that absolutely is a system failure. Those kinds of safety systems have to be available at any place in a health system where medications are being delivered.

Dr. Glatter: I think that’s an important point. Here, we have a technology that can supersede the ability of a human to make a mistake, and to have that in place is very critical. I want to go back to the idea of medical malpractice vs homicide charges.

Megan, you made a point of this. This nurse is now an example of someone who went to trial and was convicted, and it could have a chilling effect on healthcare providers. Pre-COVID, post-COVID, it is just chilling. It makes people want to leave the field. It causes PTSD. The psychiatric downstream effects of such an error are just immense.

I don’t know how the district attorney went for criminal charges here. I’m not an attorney and we don’t have a legal expert with us. For this to have happened is just setting precedent that it’s okay to have the effect of making so many people leave the field.

Dr. Ranney: I’m not a lawyer, but I’ve certainly been on the front lines, not only for the past 2 years during COVID but for almost 20 years prior to that. I will say that these types of errors are never-events that sit with our colleagues and friends for their entire career. No one goes into medicine intending to hurt someone. The system fails us and fails the patient.

There are certainly examples of intentional harm, and those people deserve to be prosecuted. This type of thing where a system let them down, again, should require an inquiry of the system. Don’t punish the individuals to the point of putting them in jail.

I think about my last few months working in the emergency department and what my nurses, in particular, have said to me. They worry that they’re going to lose their license and their ability to practice because of the horrific circumstances that we’ve been working in — the understaffing, the lack of access to standard medications, the long wait times, and on and on. They’re not able to take care of patients the way that they’ve been taught to do.

They’re worried already about the downstream effects on their sense of self, as well as on their ability to maintain their livelihood. When you put something like this on top of it, where again, an unintentional error that was potentiated by a somewhat broken system or by a series of Swiss cheese holes that just happened to line up, what message does that send to my nursing colleagues who have stayed on the front lines and who know that they have not been able to provide the standard of care that they’re used to?

Dr. Barnsteiner: On Friday, I did a program on fair and just culture with three health systems and a university school of nursing. Already, some of the faculty reported that students are talking about transferring to another major outside of the School of Nursing because of their worry about this particular guilty verdict.

The other thing is that we already have a tremendous shortage of nurses. We’ve seen many people leave the profession or retire in the past couple of years, and this is only going to compound it further. It is a sobering message that the public can’t afford to have, actually, because this will impact the quality of care and the safety of care that can be delivered to people and families as a result of not having sufficient numbers of professionals to deliver care.

Dr. Glatter: That’s such an important point. In any high-reliability organization, a culture of safety is key. There are tenets we try to adhere to. When we have people leaving the field after seeing a case like this, it’s chilling. We have to re-educate the public and we need to have a realignment of how errors are handled.

This is just the beginning. Her sentencing is going to be in about a month, and we’ll see what happens on reckless homicide charges and neglect. I think there’s going to be a follow-up to this and we’re going to need to discuss this more.

I just wanted to get a couple of takeaways for our audience to just really sear in the brain what we can learn from such an event.

Dr. Ranney: The big takeaway, to me, is the importance of us both continuing to use our voices and working across professional boundaries to help to create this culture of safety, one in which we all feel safe and supported in advocating for systems that work for us. We cannot ask nurses, respiratory technicians, radiology technicians, physicians, or anyone else within the healthcare system to work unsupported, and we have to recognize the degree to which we are all interdependent. My biggest takeaway is for us to use our voices together.

Dr. Barnsteiner: The takeaway that I would have from this, and what I’m working with a number of health systems on, is to have the chair of the board, the CEO of the hospital, the chief medical officer, and the chief nursing officer together promulgate a statement that is sent out to all employees to discuss this verdict and to say what they’re doing to promote a high-reliability organization and a fair and just culture. They should also ask for open conversation and for employees to let the top leadership know any concerns that they have about vulnerabilities in the system. It’s extremely important right now with this verdict that the leaders in healthcare settings, as well as in education settings, let people know what they’ll be doing to protect their employees.

Dr. Glatter: Jane and Megan, I want to thank you so much for such an important discussion that was very informative. I think there’s going to be a follow-up to this that’ll be very, very important. Thanks again.


Robert D. Glatter, MD, is assistant professor of emergency medicine at Lenox Hill Hospital in New York City and at Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York. He is an editorial advisor and hosts the Hot Topics in EM series on Medscape. He is also a medical contributor for Forbes. Dr. Glatter has disclosed no relevant financial relationships.

Megan Ranney, MD, MPH, is professor of emergency medicine and the academic dean at Brown University School of Public Health in Providence, Rhode Island. She is the director and founder of the Brown Emergency Digital Health Innovation (eDHI) program. She is also chief research officer for the American Foundation for Firearm Injury Reduction in Medicine, the country’s only nonprofit committed to reducing firearm injury through the public health approach, and a founding partner of GetUsPPE.org, dedicated to matching donors to health systems in need of protective equipment. Dr. Ranney has disclosed the following relevant financial relationships: Serve(d) as a speaker or a member of a speakers bureau for: Medscape; Merck.

Jane Barnsteiner, PhD, RN, is an emeritus professor at the University of Pennsylvania School of Nursing and an expert on patient safety, quality improvement, and system modeling. In addition to her teaching responsibilities, she was director of translational research at the Hospital of the University of Pennsylvania. Jane was one of the developers of the Quality and Safety in Education for Nurses (QSEN) initiative and is co-editor of Quality and Safety in Nursing: A Competency Based Approach to Improving Outcomes, published by Wiley. She has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

This video transcript has been edited for clarity.

Robert D. Glatter, MD: Welcome! I’m Dr Robert Glatter, medical advisor for Medscape Emergency Medicine. Today we have a distinguished panel joining us to discuss an important legal decision resulting in a criminal conviction, involving a medical error due to administration of the wrong medication by a critical care nurse that led to a patient’s death.

Joining us to discuss this case is Dr. Megan Ranney, professor of emergency medicine and the academic dean at Brown University School of Public Health. Also joining us is Dr. Jane Barnsteiner, emeritus professor at the University of Pennsylvania School of Nursing and an expert on patient safety, quality improvement, and system modeling. Welcome to both of you.

Jane Barnsteiner, PhD, RN: Thank you.

Megan L. Ranney, MD, MPH: Thank you. It’s a joy to be with you.

Dr. Glatter: Let’s discuss this very tragic case involving RaDonda Vaught, who was an ICU nurse who was recently convicted in Tennessee of criminally negligent homicide and gross neglect of an impaired adult. She accidentally administered a paralytic medication, vecuronium, instead of a sedative, Versed, which was ordered to sedate a 75-year-old patient who had a brain bleed and TBI. She was scheduled to have a PET scan. After receiving the wrong medication and not really being monitored in any true way, just being in the care of an MRI tech, she suffered cardiac arrest and subsequently died.

Dr. Ranney, I want to begin with you. I saw on Twitter that you had written something that really stuck with me. I’ll quote you. “A culture of safety is one in which the system that allowed the mistake to happen is changed, not one in which the individual is scapegoated. And a culture of safety correlates with better patient outcomes that we know. This verdict is the opposite.”

I’ll let you explain from here. The system issue is the medication dispensing cabinet, in my mind, and there was a medication override. The question is, how was this override allowed to occur in the first place?

Dr. Ranney: My goodness, overrides happen every single day across this country, dozens of times a day in any particular shift. I would think of the system as being much bigger than just the Pyxis or that kind of automated dispensing cabinet, but around the larger system of the verbal orders, the time pressures that the nurse is under, the fact that the nurses are with a trainee, the fact that they’re being asked to operate outside of their normal environment by going down to MRI. There’s a series of issues.

Just as we thought about the Swiss cheese model for COVID-19, that model originated when we talked about patient safety and medical errors. It is a Swiss cheese of circumstances that allows this type of tragic error to occur.

Many of us have worked for years on trying to change the system from one of punishing people, changing it from that punitive system, to rather a system where we can do root-cause analysis, allow people to disclose errors, and allow us to inquire as to what are those series of Swiss cheese holes that allowed this mistake or any other to happen.

When you punish people, you lead them to hide their mistakes instead of allowing them to disclose them and allowing that important inquiry to happen. That’s why this is just so harmful to that culture of safety that so many of us are trying to create.

Dr. Glatter: It’s a chilling verdict in so many ways. I’m right on the same page with you, having worked for so long in the emergency department and seeing nurses that are overtaxed, overburdened, but also on patient floors. This goes to an ICU-type environment where this woman was having a nonemergent head scan and required some sedation.

The question I want to get to is how the system allowed the nurse to dispense this medication —though she was distracted, she’ll admit that. Jane, I want to get to you on this. How can we avoid this? What are the system checks that can be done in some fashion to make this safer and to avoid this tragic error?

Dr. Barnsteiner: First of all, I would say that you do not put in a major change, as they were doing with their EPIC system, as a big bank where you do the change through the entire organization. You do it in one area where you get the whole system smoothed out and all the errors taken care of so that you’re not having a problem like they had through their entire organization, which required overrides multiple times a day.

One of the things that’s been recommended is that these systems, like the Pyxis system, require the first five letters of a medication to be entered into the system so that when you have multiple medications where the first two letters are the same, the chances of pulling out the wrong medication are much smaller.

There’s a question of whether this medication, vecuronium, should have even been in this machine. You can have high-alert medications like this in baggies that have written on the front of the bag, “This is a high-alert medication. It requires two independent double checks.” These are all the things that will help alert the fatigued or distracted nurse or physician and will make things safer. There are many things that can be put into place.

Dr. Glatter: It’s almost like a hard stop. This is a different class of medication. Even if the nurse had a lapse and didn’t realize that, there should have been a hard stop asking whether you want this class. A sedative and a paralytic are two very different medications.

I’m not trying to assign any blame here. I’m just trying to look at mechanics of what happened and how we can put in place methods to avoid these types of errors where a system clearly is overtaxed and overburdened. Is it an artificial intelligence alert? Is it a pharmacy alert that goes out? Is it a Vocera message that gets triggered? It’s something to stop the nurse from doing something where they know better.

She’s used Versed before, apparently, and knows it’s a liquid and doesn’t have to be reconstituted. In my mind, as a practicing doctor for a long time, I see this and I see how it can happen. There are ways I think we can address it. Megan, I want to bring you into this and get your viewpoint.

Dr. Ranney: We’re working in an environment right now — and obviously, this happened pre-COVID — where medicines are constantly in short supply and we’re constantly dealing with substitutions of one for another. This has worsened during COVID, but it existed in the pre-COVID era as well. We’d have time periods where, like today, we’re out of D50 and we have to use D10, or we have a different formulation of a common antibiotic.

I could totally imagine that this nurse had been exposed to multiple medication substitution and so they were rushing; they thought, well, they just put one thing in instead of another and didn’t make that kind of cognitive connection.

What we know so well from our studies of human factors, engineering, and the way that systems work is that when someone is cognitively overloaded and constantly having to think outside the box and make decisions, particularly when they’re exposed to a new system for ordering medicine, there’s only so much that the brain can do at a time. This person was set up for this type of error.

Again, not to say that they didn’t do something wrong. That’s why we have a civil system. That’s why we have licensing. That’s why we have malpractice. To call this a criminal error when they were working within a system that had all these other problems where they were constantly having to make do for system failures, it’s almost inevitable that at some point something really horrible happened.

I’m sorry that it was this nurse, and how horrible for the patient and the family. I’m not excusing that. You can totally imagine, as a practicing physician, nurse, or anyone else in the healthcare system, how this happened.

Dr. Barnsteiner: The other part of it was that they did not have in place, at this time, the barcoding system in this particular patient area. What nurses are used to doing is when they have to pull a medication, they’re using the barcoding system to coordinate with what’s in the electronic health record, with the medication, and with the person’s ID band.

Those are all well-known safety checks that obviously were used to being used by this nurse in the critical care unit but that weren’t available in this MRI area. That is something that absolutely is a system failure. Those kinds of safety systems have to be available at any place in a health system where medications are being delivered.

Dr. Glatter: I think that’s an important point. Here, we have a technology that can supersede the ability of a human to make a mistake, and to have that in place is very critical. I want to go back to the idea of medical malpractice vs homicide charges.

Megan, you made a point of this. This nurse is now an example of someone who went to trial and was convicted, and it could have a chilling effect on healthcare providers. Pre-COVID, post-COVID, it is just chilling. It makes people want to leave the field. It causes PTSD. The psychiatric downstream effects of such an error are just immense.

I don’t know how the district attorney went for criminal charges here. I’m not an attorney and we don’t have a legal expert with us. For this to have happened is just setting precedent that it’s okay to have the effect of making so many people leave the field.

Dr. Ranney: I’m not a lawyer, but I’ve certainly been on the front lines, not only for the past 2 years during COVID but for almost 20 years prior to that. I will say that these types of errors are never-events that sit with our colleagues and friends for their entire career. No one goes into medicine intending to hurt someone. The system fails us and fails the patient.

There are certainly examples of intentional harm, and those people deserve to be prosecuted. This type of thing where a system let them down, again, should require an inquiry of the system. Don’t punish the individuals to the point of putting them in jail.

I think about my last few months working in the emergency department and what my nurses, in particular, have said to me. They worry that they’re going to lose their license and their ability to practice because of the horrific circumstances that we’ve been working in — the understaffing, the lack of access to standard medications, the long wait times, and on and on. They’re not able to take care of patients the way that they’ve been taught to do.

They’re worried already about the downstream effects on their sense of self, as well as on their ability to maintain their livelihood. When you put something like this on top of it, where again, an unintentional error that was potentiated by a somewhat broken system or by a series of Swiss cheese holes that just happened to line up, what message does that send to my nursing colleagues who have stayed on the front lines and who know that they have not been able to provide the standard of care that they’re used to?

Dr. Barnsteiner: On Friday, I did a program on fair and just culture with three health systems and a university school of nursing. Already, some of the faculty reported that students are talking about transferring to another major outside of the School of Nursing because of their worry about this particular guilty verdict.

The other thing is that we already have a tremendous shortage of nurses. We’ve seen many people leave the profession or retire in the past couple of years, and this is only going to compound it further. It is a sobering message that the public can’t afford to have, actually, because this will impact the quality of care and the safety of care that can be delivered to people and families as a result of not having sufficient numbers of professionals to deliver care.

Dr. Glatter: That’s such an important point. In any high-reliability organization, a culture of safety is key. There are tenets we try to adhere to. When we have people leaving the field after seeing a case like this, it’s chilling. We have to re-educate the public and we need to have a realignment of how errors are handled.

This is just the beginning. Her sentencing is going to be in about a month, and we’ll see what happens on reckless homicide charges and neglect. I think there’s going to be a follow-up to this and we’re going to need to discuss this more.

I just wanted to get a couple of takeaways for our audience to just really sear in the brain what we can learn from such an event.

Dr. Ranney: The big takeaway, to me, is the importance of us both continuing to use our voices and working across professional boundaries to help to create this culture of safety, one in which we all feel safe and supported in advocating for systems that work for us. We cannot ask nurses, respiratory technicians, radiology technicians, physicians, or anyone else within the healthcare system to work unsupported, and we have to recognize the degree to which we are all interdependent. My biggest takeaway is for us to use our voices together.

Dr. Barnsteiner: The takeaway that I would have from this, and what I’m working with a number of health systems on, is to have the chair of the board, the CEO of the hospital, the chief medical officer, and the chief nursing officer together promulgate a statement that is sent out to all employees to discuss this verdict and to say what they’re doing to promote a high-reliability organization and a fair and just culture. They should also ask for open conversation and for employees to let the top leadership know any concerns that they have about vulnerabilities in the system. It’s extremely important right now with this verdict that the leaders in healthcare settings, as well as in education settings, let people know what they’ll be doing to protect their employees.

Dr. Glatter: Jane and Megan, I want to thank you so much for such an important discussion that was very informative. I think there’s going to be a follow-up to this that’ll be very, very important. Thanks again.


Robert D. Glatter, MD, is assistant professor of emergency medicine at Lenox Hill Hospital in New York City and at Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York. He is an editorial advisor and hosts the Hot Topics in EM series on Medscape. He is also a medical contributor for Forbes. Dr. Glatter has disclosed no relevant financial relationships.

Megan Ranney, MD, MPH, is professor of emergency medicine and the academic dean at Brown University School of Public Health in Providence, Rhode Island. She is the director and founder of the Brown Emergency Digital Health Innovation (eDHI) program. She is also chief research officer for the American Foundation for Firearm Injury Reduction in Medicine, the country’s only nonprofit committed to reducing firearm injury through the public health approach, and a founding partner of GetUsPPE.org, dedicated to matching donors to health systems in need of protective equipment. Dr. Ranney has disclosed the following relevant financial relationships: Serve(d) as a speaker or a member of a speakers bureau for: Medscape; Merck.

Jane Barnsteiner, PhD, RN, is an emeritus professor at the University of Pennsylvania School of Nursing and an expert on patient safety, quality improvement, and system modeling. In addition to her teaching responsibilities, she was director of translational research at the Hospital of the University of Pennsylvania. Jane was one of the developers of the Quality and Safety in Education for Nurses (QSEN) initiative and is co-editor of Quality and Safety in Nursing: A Competency Based Approach to Improving Outcomes, published by Wiley. She has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The data on cross-protection against gonorrhea by outer membrane vesicle (OMV)–based meningococcal B vaccine continue to look encouraging from a recent study in Clinical Infectious Diseases (2022; doi: 10.1093/cid/ciac436). The authors report matched-cohort study data involving over 33,000 teens/young adults followed at Kaiser Permanente Southern California during 2016-2020. Like the studies above, chlamydia-infected patients (n = 26,471) served as negative controls for the 6,641 gonorrhea patients. The researchers compared chances of getting gonorrhea vs. getting chlamydia in light of having previously gotten C4MenB vaccine (OMV-based) or MenACWY vaccine (not OMV-based). The authors reported gonorrhea incidence rates of 2.0/1,000 person-years (95% CI, 1.3–2.8) in 4CMenB vaccinees vs. 5.2 (4.6–5.8) for MenACWY recipients. An adjusted analysis revealed 46% lower gonorrhea rates in 4CMenB vs. MenACWY vaccinees. There was no difference in chlamydia rates.

We await prospective controlled data to validate these observational studies. However, it is intriguing that OMV-based meningococcal vaccine may be a two-fer vaccine with partial cross protection against gonorrhea because of outer membrane protein similarities between the two pathogens. These data seem worth sharing with families who are making decisions about whether to vaccinate their children against B strains of meningococcus whether or not the child has already had conjugate MenACWY.

Christopher J. Harrison, MD, is professor, University of Missouri Kansas City School of Medicine, department of medicine, infectious diseases section, Kansas City. He has no financial conflicts of interest.

The data on cross-protection against gonorrhea by outer membrane vesicle (OMV)–based meningococcal B vaccine continue to look encouraging from a recent study in Clinical Infectious Diseases (2022; doi: 10.1093/cid/ciac436). The authors report matched-cohort study data involving over 33,000 teens/young adults followed at Kaiser Permanente Southern California during 2016-2020. Like the studies above, chlamydia-infected patients (n = 26,471) served as negative controls for the 6,641 gonorrhea patients. The researchers compared chances of getting gonorrhea vs. getting chlamydia in light of having previously gotten C4MenB vaccine (OMV-based) or MenACWY vaccine (not OMV-based). The authors reported gonorrhea incidence rates of 2.0/1,000 person-years (95% CI, 1.3–2.8) in 4CMenB vaccinees vs. 5.2 (4.6–5.8) for MenACWY recipients. An adjusted analysis revealed 46% lower gonorrhea rates in 4CMenB vs. MenACWY vaccinees. There was no difference in chlamydia rates.

We await prospective controlled data to validate these observational studies. However, it is intriguing that OMV-based meningococcal vaccine may be a two-fer vaccine with partial cross protection against gonorrhea because of outer membrane protein similarities between the two pathogens. These data seem worth sharing with families who are making decisions about whether to vaccinate their children against B strains of meningococcus whether or not the child has already had conjugate MenACWY.

Christopher J. Harrison, MD, is professor, University of Missouri Kansas City School of Medicine, department of medicine, infectious diseases section, Kansas City. He has no financial conflicts of interest.

The data on cross-protection against gonorrhea by outer membrane vesicle (OMV)–based meningococcal B vaccine continue to look encouraging from a recent study in Clinical Infectious Diseases (2022; doi: 10.1093/cid/ciac436). The authors report matched-cohort study data involving over 33,000 teens/young adults followed at Kaiser Permanente Southern California during 2016-2020. Like the studies above, chlamydia-infected patients (n = 26,471) served as negative controls for the 6,641 gonorrhea patients. The researchers compared chances of getting gonorrhea vs. getting chlamydia in light of having previously gotten C4MenB vaccine (OMV-based) or MenACWY vaccine (not OMV-based). The authors reported gonorrhea incidence rates of 2.0/1,000 person-years (95% CI, 1.3–2.8) in 4CMenB vaccinees vs. 5.2 (4.6–5.8) for MenACWY recipients. An adjusted analysis revealed 46% lower gonorrhea rates in 4CMenB vs. MenACWY vaccinees. There was no difference in chlamydia rates.

We await prospective controlled data to validate these observational studies. However, it is intriguing that OMV-based meningococcal vaccine may be a two-fer vaccine with partial cross protection against gonorrhea because of outer membrane protein similarities between the two pathogens. These data seem worth sharing with families who are making decisions about whether to vaccinate their children against B strains of meningococcus whether or not the child has already had conjugate MenACWY.

Christopher J. Harrison, MD, is professor, University of Missouri Kansas City School of Medicine, department of medicine, infectious diseases section, Kansas City. He has no financial conflicts of interest.

When benzodiazepines were first introduced, they were greeted with enthusiasm. Librium came first, in 1960, followed by Valium in 1962, and they were seen as an improvement over barbiturates for the treatment of anxiety, insomnia, and seizures. From 1968 to 1982, Valium (diazepam) was the No. 1–selling U.S. pharmaceutical: 2.3 billion tablets of Valium were sold in 1978 alone. Valium was even the subject of a 1966 Rolling Stones hit, “Mother’s Little Helper.”

By the 1980s, it became apparent that there was a downside to these medications: patients became tolerant, dependent, and some became addicted to the medications. In older patients an association was noted with falls and cognitive impairment. And while safe in overdoses when they are the only agent, combined with alcohol or opioids, benzodiazepines can be lethal and have played a significant role in the current overdose crisis.

Because of the problems that are associated with their use, benzodiazepines and their relatives, the Z-drugs used for sleep, have become stigmatized, as have the patients who use them and perhaps even the doctors who prescribe them. Still, there are circumstances where patients find these medications to be helpful, where other medications don’t work, or don’t work quickly enough. They provide fast relief in conditions where there are not always good alternatives.

In the Facebook group, “Psychiatry for All Physicians,” it’s not uncommon for physicians to ask what to do with older patients who are transferred to them on therapeutic doses of benzodiazepines or zolpidem. These are outpatients coming for routine care, and they find the medications helpful and don’t want to discontinue them. They have tried other medications that were not helpful. I’ve been surprised at how often the respondents insist the patient should be told he must taper off the medication. “Just say no,” is often the advice, and perhaps it’s more about the doctor’s discomfort than it is about the individual patient. For sleep issues, cognitive-behavioral therapy is given as the gold-standard treatment, while in my practice I have found it difficult to motivate patients to engage in it, and of those who do, it is sometimes helpful, but not a panacea. Severe anxiety and sleepless nights, however, are not benign conditions.

This “just say no, hold the line” sentiment has me wondering if our pendulum has swung too far with respect to prescribing benzodiazepines. Is this just one more issue that has become strongly polarized? Certainly the literature would support that idea, with some physicians writing about how benzodiazepines are underused, and others urging avoidance.

I posted a poll on Twitter: Has the anti-benzo movement gone too far? In addition, I started a Twitter thread of my own thoughts about prescribing and deprescribing these medications and will give a synopsis of those ideas here.

Clearly, benzodiazepines are harmful to some patients, they have side effects, can be difficult to stop because of withdrawal symptoms, and they carry the risk of addiction. That’s not in question. Many medications, however, have the potential to do more harm than good, for example ibuprofen can cause bleeding or renal problems, and Fosamax, used to treat osteoporosis, can cause osteonecrosis of the jaw and femur, to name just two.

It would be so much easier if we could know in advance who benzodiazepines will harm, just as it would be good if we could know in advance who will get tardive dyskinesia or dyslipidemia from antipsychotic medications, or who will have life-threatening adverse reactions from cancer chemotherapy with no tumor response. There are risks to both starting and stopping sedatives, and if we insist a patient stop a medication because of potential risk, then we are cutting them off from being a partner in their own care. It also creates an adversarial relationship that can be draining for the doctor and upsetting for the patient.

By definition, if someone needs hospitalization for a psychiatric condition, their outpatient benzodiazepine is not keeping them stable and stopping it may be a good idea. If someone is seen in an ED for a fall, it’s common to blame the benzodiazepine, but older people who are not on these medications also fall and have memory problems. In his book, “Being Mortal: Illness, Medicine, and What Matters Most in the End” (New York: Picador, 2014), Atul Gawande, MD, makes the point that taking more than four prescriptions medications increases the risk for falls in the elderly. Still, no one is suggesting patients be taken off their antidepressants, antihypertensives, or blood thinners.

Finally, the question is not should we be giving benzodiazepines out without careful consideration – the answer is clearly no. Physicians don’t pass out benzodiazepines “like candy” for all the above reasons. They are initiated because the patient is suffering and sometimes desperate. Anxiety, panic, intractable insomnia, and severe agitation are all miserable, and alternative treatments may take weeks to work, or not work at all. Yet these subjective symptoms may be dismissed by physicians.

So what do I do in my own practice? I don’t encourage patients to take potentially addictive medications, but I do sometimes use them. I give ‘as needed’ benzodiazepines to people in distress who don’t have a history of misusing them. I never plan to start them as a permanent standing medication, though once in a while that ends up happening. As with other medications, it is best to use the minimally effective dose.

There is some controversy as to whether it is best to use anxiety medications on an “as-needed” basis or as a standing dosage. Psychiatrists who prescribe benzodiazepines more liberally often feel it’s better to give standing doses and prevent breakthrough anxiety. Patients may appear to be ‘medication seeking’ not because they are addicted, but because the doses used are too low to adequately treat their anxiety.

My hope is that there is less risk of tolerance, dependence, or addiction with less-frequent dosing, and I prescribe as-needed benzodiazepines for panic attacks, agitated major depression while we wait for the antidepressant to “kick in,” insomnia during manic episodes, and to people who get very anxious in specific situations such as flying or for medical procedures. I sometimes prescribe them for people with insomnia that does not respond to other treatments, or for disabling generalized anxiety.

For patients who have taken benzodiazepines for many years, I continue to discuss the risks, but often they are not looking to fix something that isn’t broken, or to live a risk-free life. A few of the patients who have come to me on low standing doses of sedatives are now in their 80’s, yet they remain active, live independently, drive, travel, and have busy social lives. One could argue either that the medications are working, or that the patient has become dependent on them and needs them to prevent withdrawal.

These medications present a quandary: by denying patients treatment with benzodiazepines, we are sparing some people addictions (this is good, we should be careful), but we are leaving some people to suffer. There is no perfect answer.

What I do know is that doctors should think carefully and consider the patient in front of them. “No Benzos Ever For Anyone” or “you must come off because there is risk and people will think I am a bad doctor for prescribing them to you” can be done by a robot.

So, yes, I think the pendulum has swung a bit too far; there is a place for these medications in acute treatment for those at low risk of addiction, and there are people who benefit from them over the long run. At times, they provide immense relief to someone who is really struggling.

So what was the result of my Twitter poll? Of the 219 voters, 34.2% voted: “No, the pendulum has not swung too far, and these medications are harmful”; 65.8% voted: “Yes, these medications are helpful.” There were many comments expressing a wide variety of sentiments. Of those who had taken prescription benzodiazepines, some felt they had been harmed and wished they had never been started on them, and others continue to find them helpful. Psychiatrists, it seems, see them from the vantage point of the populations they treat.

People who are uncomfortable search for answers, and those answers may come in the form of meditation or exercise, medicines, or illicit drugs. It’s interesting that these same patients can now easily obtain “medical” marijuana, and the Rolling Stones’ “Mother’s Little Helper” is often replaced by a gin and tonic.

Dr. Dinah Miller is a coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins in Baltimore. Dr. Miller has no conflicts of interest.

When benzodiazepines were first introduced, they were greeted with enthusiasm. Librium came first, in 1960, followed by Valium in 1962, and they were seen as an improvement over barbiturates for the treatment of anxiety, insomnia, and seizures. From 1968 to 1982, Valium (diazepam) was the No. 1–selling U.S. pharmaceutical: 2.3 billion tablets of Valium were sold in 1978 alone. Valium was even the subject of a 1966 Rolling Stones hit, “Mother’s Little Helper.”

By the 1980s, it became apparent that there was a downside to these medications: patients became tolerant, dependent, and some became addicted to the medications. In older patients an association was noted with falls and cognitive impairment. And while safe in overdoses when they are the only agent, combined with alcohol or opioids, benzodiazepines can be lethal and have played a significant role in the current overdose crisis.

Because of the problems that are associated with their use, benzodiazepines and their relatives, the Z-drugs used for sleep, have become stigmatized, as have the patients who use them and perhaps even the doctors who prescribe them. Still, there are circumstances where patients find these medications to be helpful, where other medications don’t work, or don’t work quickly enough. They provide fast relief in conditions where there are not always good alternatives.

In the Facebook group, “Psychiatry for All Physicians,” it’s not uncommon for physicians to ask what to do with older patients who are transferred to them on therapeutic doses of benzodiazepines or zolpidem. These are outpatients coming for routine care, and they find the medications helpful and don’t want to discontinue them. They have tried other medications that were not helpful. I’ve been surprised at how often the respondents insist the patient should be told he must taper off the medication. “Just say no,” is often the advice, and perhaps it’s more about the doctor’s discomfort than it is about the individual patient. For sleep issues, cognitive-behavioral therapy is given as the gold-standard treatment, while in my practice I have found it difficult to motivate patients to engage in it, and of those who do, it is sometimes helpful, but not a panacea. Severe anxiety and sleepless nights, however, are not benign conditions.

This “just say no, hold the line” sentiment has me wondering if our pendulum has swung too far with respect to prescribing benzodiazepines. Is this just one more issue that has become strongly polarized? Certainly the literature would support that idea, with some physicians writing about how benzodiazepines are underused, and others urging avoidance.

I posted a poll on Twitter: Has the anti-benzo movement gone too far? In addition, I started a Twitter thread of my own thoughts about prescribing and deprescribing these medications and will give a synopsis of those ideas here.

Clearly, benzodiazepines are harmful to some patients, they have side effects, can be difficult to stop because of withdrawal symptoms, and they carry the risk of addiction. That’s not in question. Many medications, however, have the potential to do more harm than good, for example ibuprofen can cause bleeding or renal problems, and Fosamax, used to treat osteoporosis, can cause osteonecrosis of the jaw and femur, to name just two.

It would be so much easier if we could know in advance who benzodiazepines will harm, just as it would be good if we could know in advance who will get tardive dyskinesia or dyslipidemia from antipsychotic medications, or who will have life-threatening adverse reactions from cancer chemotherapy with no tumor response. There are risks to both starting and stopping sedatives, and if we insist a patient stop a medication because of potential risk, then we are cutting them off from being a partner in their own care. It also creates an adversarial relationship that can be draining for the doctor and upsetting for the patient.

By definition, if someone needs hospitalization for a psychiatric condition, their outpatient benzodiazepine is not keeping them stable and stopping it may be a good idea. If someone is seen in an ED for a fall, it’s common to blame the benzodiazepine, but older people who are not on these medications also fall and have memory problems. In his book, “Being Mortal: Illness, Medicine, and What Matters Most in the End” (New York: Picador, 2014), Atul Gawande, MD, makes the point that taking more than four prescriptions medications increases the risk for falls in the elderly. Still, no one is suggesting patients be taken off their antidepressants, antihypertensives, or blood thinners.

Finally, the question is not should we be giving benzodiazepines out without careful consideration – the answer is clearly no. Physicians don’t pass out benzodiazepines “like candy” for all the above reasons. They are initiated because the patient is suffering and sometimes desperate. Anxiety, panic, intractable insomnia, and severe agitation are all miserable, and alternative treatments may take weeks to work, or not work at all. Yet these subjective symptoms may be dismissed by physicians.

So what do I do in my own practice? I don’t encourage patients to take potentially addictive medications, but I do sometimes use them. I give ‘as needed’ benzodiazepines to people in distress who don’t have a history of misusing them. I never plan to start them as a permanent standing medication, though once in a while that ends up happening. As with other medications, it is best to use the minimally effective dose.

There is some controversy as to whether it is best to use anxiety medications on an “as-needed” basis or as a standing dosage. Psychiatrists who prescribe benzodiazepines more liberally often feel it’s better to give standing doses and prevent breakthrough anxiety. Patients may appear to be ‘medication seeking’ not because they are addicted, but because the doses used are too low to adequately treat their anxiety.

My hope is that there is less risk of tolerance, dependence, or addiction with less-frequent dosing, and I prescribe as-needed benzodiazepines for panic attacks, agitated major depression while we wait for the antidepressant to “kick in,” insomnia during manic episodes, and to people who get very anxious in specific situations such as flying or for medical procedures. I sometimes prescribe them for people with insomnia that does not respond to other treatments, or for disabling generalized anxiety.

For patients who have taken benzodiazepines for many years, I continue to discuss the risks, but often they are not looking to fix something that isn’t broken, or to live a risk-free life. A few of the patients who have come to me on low standing doses of sedatives are now in their 80’s, yet they remain active, live independently, drive, travel, and have busy social lives. One could argue either that the medications are working, or that the patient has become dependent on them and needs them to prevent withdrawal.

These medications present a quandary: by denying patients treatment with benzodiazepines, we are sparing some people addictions (this is good, we should be careful), but we are leaving some people to suffer. There is no perfect answer.

What I do know is that doctors should think carefully and consider the patient in front of them. “No Benzos Ever For Anyone” or “you must come off because there is risk and people will think I am a bad doctor for prescribing them to you” can be done by a robot.

So, yes, I think the pendulum has swung a bit too far; there is a place for these medications in acute treatment for those at low risk of addiction, and there are people who benefit from them over the long run. At times, they provide immense relief to someone who is really struggling.

So what was the result of my Twitter poll? Of the 219 voters, 34.2% voted: “No, the pendulum has not swung too far, and these medications are harmful”; 65.8% voted: “Yes, these medications are helpful.” There were many comments expressing a wide variety of sentiments. Of those who had taken prescription benzodiazepines, some felt they had been harmed and wished they had never been started on them, and others continue to find them helpful. Psychiatrists, it seems, see them from the vantage point of the populations they treat.

People who are uncomfortable search for answers, and those answers may come in the form of meditation or exercise, medicines, or illicit drugs. It’s interesting that these same patients can now easily obtain “medical” marijuana, and the Rolling Stones’ “Mother’s Little Helper” is often replaced by a gin and tonic.

Dr. Dinah Miller is a coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins in Baltimore. Dr. Miller has no conflicts of interest.

When benzodiazepines were first introduced, they were greeted with enthusiasm. Librium came first, in 1960, followed by Valium in 1962, and they were seen as an improvement over barbiturates for the treatment of anxiety, insomnia, and seizures. From 1968 to 1982, Valium (diazepam) was the No. 1–selling U.S. pharmaceutical: 2.3 billion tablets of Valium were sold in 1978 alone. Valium was even the subject of a 1966 Rolling Stones hit, “Mother’s Little Helper.”

By the 1980s, it became apparent that there was a downside to these medications: patients became tolerant, dependent, and some became addicted to the medications. In older patients an association was noted with falls and cognitive impairment. And while safe in overdoses when they are the only agent, combined with alcohol or opioids, benzodiazepines can be lethal and have played a significant role in the current overdose crisis.

Because of the problems that are associated with their use, benzodiazepines and their relatives, the Z-drugs used for sleep, have become stigmatized, as have the patients who use them and perhaps even the doctors who prescribe them. Still, there are circumstances where patients find these medications to be helpful, where other medications don’t work, or don’t work quickly enough. They provide fast relief in conditions where there are not always good alternatives.

In the Facebook group, “Psychiatry for All Physicians,” it’s not uncommon for physicians to ask what to do with older patients who are transferred to them on therapeutic doses of benzodiazepines or zolpidem. These are outpatients coming for routine care, and they find the medications helpful and don’t want to discontinue them. They have tried other medications that were not helpful. I’ve been surprised at how often the respondents insist the patient should be told he must taper off the medication. “Just say no,” is often the advice, and perhaps it’s more about the doctor’s discomfort than it is about the individual patient. For sleep issues, cognitive-behavioral therapy is given as the gold-standard treatment, while in my practice I have found it difficult to motivate patients to engage in it, and of those who do, it is sometimes helpful, but not a panacea. Severe anxiety and sleepless nights, however, are not benign conditions.

This “just say no, hold the line” sentiment has me wondering if our pendulum has swung too far with respect to prescribing benzodiazepines. Is this just one more issue that has become strongly polarized? Certainly the literature would support that idea, with some physicians writing about how benzodiazepines are underused, and others urging avoidance.

I posted a poll on Twitter: Has the anti-benzo movement gone too far? In addition, I started a Twitter thread of my own thoughts about prescribing and deprescribing these medications and will give a synopsis of those ideas here.

Clearly, benzodiazepines are harmful to some patients, they have side effects, can be difficult to stop because of withdrawal symptoms, and they carry the risk of addiction. That’s not in question. Many medications, however, have the potential to do more harm than good, for example ibuprofen can cause bleeding or renal problems, and Fosamax, used to treat osteoporosis, can cause osteonecrosis of the jaw and femur, to name just two.

It would be so much easier if we could know in advance who benzodiazepines will harm, just as it would be good if we could know in advance who will get tardive dyskinesia or dyslipidemia from antipsychotic medications, or who will have life-threatening adverse reactions from cancer chemotherapy with no tumor response. There are risks to both starting and stopping sedatives, and if we insist a patient stop a medication because of potential risk, then we are cutting them off from being a partner in their own care. It also creates an adversarial relationship that can be draining for the doctor and upsetting for the patient.

By definition, if someone needs hospitalization for a psychiatric condition, their outpatient benzodiazepine is not keeping them stable and stopping it may be a good idea. If someone is seen in an ED for a fall, it’s common to blame the benzodiazepine, but older people who are not on these medications also fall and have memory problems. In his book, “Being Mortal: Illness, Medicine, and What Matters Most in the End” (New York: Picador, 2014), Atul Gawande, MD, makes the point that taking more than four prescriptions medications increases the risk for falls in the elderly. Still, no one is suggesting patients be taken off their antidepressants, antihypertensives, or blood thinners.

Finally, the question is not should we be giving benzodiazepines out without careful consideration – the answer is clearly no. Physicians don’t pass out benzodiazepines “like candy” for all the above reasons. They are initiated because the patient is suffering and sometimes desperate. Anxiety, panic, intractable insomnia, and severe agitation are all miserable, and alternative treatments may take weeks to work, or not work at all. Yet these subjective symptoms may be dismissed by physicians.

So what do I do in my own practice? I don’t encourage patients to take potentially addictive medications, but I do sometimes use them. I give ‘as needed’ benzodiazepines to people in distress who don’t have a history of misusing them. I never plan to start them as a permanent standing medication, though once in a while that ends up happening. As with other medications, it is best to use the minimally effective dose.

There is some controversy as to whether it is best to use anxiety medications on an “as-needed” basis or as a standing dosage. Psychiatrists who prescribe benzodiazepines more liberally often feel it’s better to give standing doses and prevent breakthrough anxiety. Patients may appear to be ‘medication seeking’ not because they are addicted, but because the doses used are too low to adequately treat their anxiety.

My hope is that there is less risk of tolerance, dependence, or addiction with less-frequent dosing, and I prescribe as-needed benzodiazepines for panic attacks, agitated major depression while we wait for the antidepressant to “kick in,” insomnia during manic episodes, and to people who get very anxious in specific situations such as flying or for medical procedures. I sometimes prescribe them for people with insomnia that does not respond to other treatments, or for disabling generalized anxiety.

For patients who have taken benzodiazepines for many years, I continue to discuss the risks, but often they are not looking to fix something that isn’t broken, or to live a risk-free life. A few of the patients who have come to me on low standing doses of sedatives are now in their 80’s, yet they remain active, live independently, drive, travel, and have busy social lives. One could argue either that the medications are working, or that the patient has become dependent on them and needs them to prevent withdrawal.

These medications present a quandary: by denying patients treatment with benzodiazepines, we are sparing some people addictions (this is good, we should be careful), but we are leaving some people to suffer. There is no perfect answer.

What I do know is that doctors should think carefully and consider the patient in front of them. “No Benzos Ever For Anyone” or “you must come off because there is risk and people will think I am a bad doctor for prescribing them to you” can be done by a robot.

So, yes, I think the pendulum has swung a bit too far; there is a place for these medications in acute treatment for those at low risk of addiction, and there are people who benefit from them over the long run. At times, they provide immense relief to someone who is really struggling.

So what was the result of my Twitter poll? Of the 219 voters, 34.2% voted: “No, the pendulum has not swung too far, and these medications are harmful”; 65.8% voted: “Yes, these medications are helpful.” There were many comments expressing a wide variety of sentiments. Of those who had taken prescription benzodiazepines, some felt they had been harmed and wished they had never been started on them, and others continue to find them helpful. Psychiatrists, it seems, see them from the vantage point of the populations they treat.

People who are uncomfortable search for answers, and those answers may come in the form of meditation or exercise, medicines, or illicit drugs. It’s interesting that these same patients can now easily obtain “medical” marijuana, and the Rolling Stones’ “Mother’s Little Helper” is often replaced by a gin and tonic.

Dr. Dinah Miller is a coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins in Baltimore. Dr. Miller has no conflicts of interest.

Topiramate, introduced as an antiepileptic drug (AED), is currently most widely used for prevention of migraine headaches.

Because reproductive-aged women represent a population in which migraines are prevalent, clinicians need guidance to help women taking topiramate make sound contraceptive choices.

Several issues are relevant here. First, women who have migraines with aura should avoid estrogen-containing contraceptive pills, patches, and rings. Instead, progestin-only methods, including the contraceptive implant, may be recommended to patients with migraines.

Second, because topiramate, as with a number of other AEDs, is a teratogen, women using this medication need highly effective contraception. This consideration may also lead clinicians to recommend use of the implant in women with migraines.

Finally, topiramate, along with other AEDs (phenytoin, carbamazepine, barbiturates, primidone, and oxcarbazepine) induces hepatic enzymes, which results in reduced serum contraceptive steroid levels.

Because there is uncertainty regarding the degree to which the use of topiramate reduces serum levels of etonogestrel (the progestin released by the implant), investigators performed a prospective study to assess the pharmacokinetic impact of topiramate in women with the implant.

Ongoing users of contraceptive implants who agreed to use additional nonhormonal contraception were recruited to a 6-week study, during which they took topiramate and periodically had blood drawn.

Overall, use of topiramate was found to lower serum etonogestrel levels from baseline on a dose-related basis. At study completion, almost one-third of study participants were found to have serum progestin levels lower than the threshold associated with predictable ovulation suppression.

The results of this carefully conducted study support guidance from the Centers for Disease Control and Prevention that women seeking contraception and using topiramate or other enzyme-inducing AEDs should be encouraged to use intrauterine devices or injectable contraception. The contraceptive efficacy of these latter methods is not diminished by concomitant use of enzyme inducers.

I am Andrew Kaunitz. Please take care of yourself and each other.

Any views expressed above are the author’s own and do not necessarily reflect the views of WebMD or Medscape.

Andrew M. Kaunitz is a professor and Associate Chairman, department of obstetrics and gynecology, University of Florida, Jacksonville.

A version of this article first appeared on Medscape.com.

Topiramate, introduced as an antiepileptic drug (AED), is currently most widely used for prevention of migraine headaches.

Because reproductive-aged women represent a population in which migraines are prevalent, clinicians need guidance to help women taking topiramate make sound contraceptive choices.

Several issues are relevant here. First, women who have migraines with aura should avoid estrogen-containing contraceptive pills, patches, and rings. Instead, progestin-only methods, including the contraceptive implant, may be recommended to patients with migraines.

Second, because topiramate, as with a number of other AEDs, is a teratogen, women using this medication need highly effective contraception. This consideration may also lead clinicians to recommend use of the implant in women with migraines.

Finally, topiramate, along with other AEDs (phenytoin, carbamazepine, barbiturates, primidone, and oxcarbazepine) induces hepatic enzymes, which results in reduced serum contraceptive steroid levels.

Because there is uncertainty regarding the degree to which the use of topiramate reduces serum levels of etonogestrel (the progestin released by the implant), investigators performed a prospective study to assess the pharmacokinetic impact of topiramate in women with the implant.

Ongoing users of contraceptive implants who agreed to use additional nonhormonal contraception were recruited to a 6-week study, during which they took topiramate and periodically had blood drawn.

Overall, use of topiramate was found to lower serum etonogestrel levels from baseline on a dose-related basis. At study completion, almost one-third of study participants were found to have serum progestin levels lower than the threshold associated with predictable ovulation suppression.

The results of this carefully conducted study support guidance from the Centers for Disease Control and Prevention that women seeking contraception and using topiramate or other enzyme-inducing AEDs should be encouraged to use intrauterine devices or injectable contraception. The contraceptive efficacy of these latter methods is not diminished by concomitant use of enzyme inducers.

I am Andrew Kaunitz. Please take care of yourself and each other.

Any views expressed above are the author’s own and do not necessarily reflect the views of WebMD or Medscape.

Andrew M. Kaunitz is a professor and Associate Chairman, department of obstetrics and gynecology, University of Florida, Jacksonville.

A version of this article first appeared on Medscape.com.

Topiramate, introduced as an antiepileptic drug (AED), is currently most widely used for prevention of migraine headaches.

Because reproductive-aged women represent a population in which migraines are prevalent, clinicians need guidance to help women taking topiramate make sound contraceptive choices.

Several issues are relevant here. First, women who have migraines with aura should avoid estrogen-containing contraceptive pills, patches, and rings. Instead, progestin-only methods, including the contraceptive implant, may be recommended to patients with migraines.

Second, because topiramate, as with a number of other AEDs, is a teratogen, women using this medication need highly effective contraception. This consideration may also lead clinicians to recommend use of the implant in women with migraines.

Finally, topiramate, along with other AEDs (phenytoin, carbamazepine, barbiturates, primidone, and oxcarbazepine) induces hepatic enzymes, which results in reduced serum contraceptive steroid levels.

Because there is uncertainty regarding the degree to which the use of topiramate reduces serum levels of etonogestrel (the progestin released by the implant), investigators performed a prospective study to assess the pharmacokinetic impact of topiramate in women with the implant.

Ongoing users of contraceptive implants who agreed to use additional nonhormonal contraception were recruited to a 6-week study, during which they took topiramate and periodically had blood drawn.

Overall, use of topiramate was found to lower serum etonogestrel levels from baseline on a dose-related basis. At study completion, almost one-third of study participants were found to have serum progestin levels lower than the threshold associated with predictable ovulation suppression.

The results of this carefully conducted study support guidance from the Centers for Disease Control and Prevention that women seeking contraception and using topiramate or other enzyme-inducing AEDs should be encouraged to use intrauterine devices or injectable contraception. The contraceptive efficacy of these latter methods is not diminished by concomitant use of enzyme inducers.

I am Andrew Kaunitz. Please take care of yourself and each other.

Any views expressed above are the author’s own and do not necessarily reflect the views of WebMD or Medscape.

Andrew M. Kaunitz is a professor and Associate Chairman, department of obstetrics and gynecology, University of Florida, Jacksonville.

A version of this article first appeared on Medscape.com.

In 2014, the Task Force for Mass Critical Care (TFMCC) published a CHEST consensus statement on disaster preparedness principles in caring for the critically ill during disasters and pandemics (Christian et al. CHEST. 2014;146[4_suppl]:8s-34s). This publication attempted to guide preparedness for both single-event disasters and more prolonged events, including a feared influenza pandemic.

Despite the foundation of planning and support this guidance provided, the COVID-19 pandemic response revealed substantial gaps in our understanding and preparedness for these more prolonged and widespread events.

In New York City, as the first COVID-19 wave began in March and April of 2020, area hospitals responded with surge plans that prioritized what was felt to be most important (Griffin et al. Am J Respir Crit Care Med. 2020 Jun 1;201[11]:1337-44). Tiered, creative staffing structures were rapidly created with intensivists supervising non-ICU physicians and APPs. Procedure teams were created for intubation, proning, and central line placement. ICU space was created with adaptations to ORs and PACUs, and rooms on med-surg floors and step-down units underwent emergency renovations to allow creation of new “pop-up” ICUs. Triage protocols were altered: patients on high levels of supplemental oxygen, who would under normal circumstances have been admitted to an ICU, were triaged to floors and stepdown units. Equipment was reused, modified, and substituted creatively to optimize care for the maximum number of patients.

In the face of all of these struggles, many around the country and the world felt the efforts, though heroic, resulted in less than standard of care. Two subsequent publications validated this concern (Kadri et al. Ann Int Med. 2021,174;9:1240-51; Bravata DM et al. JAMA Open Network. 2021;4[1]:e2034266), demonstrating during severe surge, COVID-19 patients’ mortality increased significantly beyond that seen in non-surging or less-severe surging times, demonstrating a mortality effect of surge itself. Though these studies observed COVID-19 patients only, there is every reason to believe the findings applied to all critically ill patients cared for during these surges.

These experiences led the TFMCC to report updated strategies for remaining in contingency care levels and avoiding crisis care (Dichter JR et al. CHEST. 2022;161[2]:429-47). Contingency is equivalent to routine care though may require adaptations and employment of otherwise non-traditional resources. The ultimate goal of mass critical care in a public health emergency is to avoid crisis-operating conditions, crisis standards of care, and their associated challenging triage decisions regarding allocation of scarce resources.

The 10 suggestions included in the most recent TFMCC publication include staffing strategies and suggestions based on COVID-19 experiences for graded staff-to-patient ratios, and support processes to preserve the existing health care work force. Strategies also include reduction of redundant documentation, limiting overtime, and most importantly, approaches for improving teamwork and supporting psychological well-being and resilience. Examples include daily unit huddles to update care and share experiences, genuine intra-team recognition and appreciation, and embedding emotional health experts within teams to provide ongoing support.

Consistent communication between incident command and frontline clinicians was also a suggested priority, perhaps with a newly proposed position of physician clinical support supervisor. This would be a formal role within hospital incident command, a liaison between the two groups.

Surge strategies should include empowerment of bedside clinicians and leaders with both planning and real-time assessment of the clinical situation, as being at the front line of care enables the situational awareness to assess ICU strain most effectively. Further, ICU clinicians must recognize when progression deeper into contingency operations occurs and they become perilously close to crisis mode. At this point, decisions are made and scarce resources are modified beyond routine standards of care to preserve life. TFMCC designates this gray area between contingency and crisis as the Critical Clinical Prioritization level (Figure).

Courtesy ACCP

At this point, more resources must be provided, or patients must be transferred to other resourced hospitals.

Critical Clinical Prioritization is an illustration of necessity being the mother of invention, as these are adaptations clinicians devised under duress. Some particularly poignant examples are the spreading of 24 hours of continuous renal replacement therapy (CRRT) resource between two and sometimes three patients to provide life sustainment to all; and when ventilators were in short supply, determining which patients required full ICU ventilator support vs those who could manage with lower functioning ventilators, and trading them between patients when demands changed.

These adaptations can only be done by experienced clinicians proactively managing bedside critical care under duress, further underscoring the importance of our suggestion that Critical Clinical Prioritization and ICU strain be managed by bedside clinicians and leaders.

The response of early transfer of patients – load-balancing - should be considered as soon as any hospital enters contingency conditions. This strategy is commonly implemented within larger health systems, ideally before reaching Critical Clinical Prioritization. Formal, organized state or regional load-balancing coordination, now referred to as medical operations command centers (MOCCs), were highly effective and proved lifesaving for those states that implemented them (including Arizona, Washington, California, Minnesota, and others). Support for establishment of MOCC’s is crucial in prolonging contingency operations and further helps support and protect disadvantaged populations (White et al. N Engl J Med. 2021;385[24]:2211-4).

Establishment of MOCCs has met resistance due to challenges that include interhospital/intersystem competition, logistics of moving critically ill patients sometimes across significant physical distance, and the costs of assuming care of uninsured or underinsured patients. Nevertheless, the benefits to the population as a whole necessitate working through these obstacles as successful MOCCs have done, usually with government and hospital association support.

In their final suggestion of the 2022 updated strategies, TFMCC suggests that hospitals use telemedicine technology both to expand specialists’ ability to provide care and facilitate families virtually visiting their critically ill loved one when safety precludes in-person visits.

These suggestions are pivotal in planning for future public health emergencies that include mass critical care, even during events that are limited in scope and duration.

Lastly, intensivists struggled with legal and ethical concerns when mired in crisis care circumstances and decisions of allocation, and potential reallocation, of scarce resources. These issues were not well addressed during the COVID-19 pandemic, further emphasizing the importance of maintaining contingency level care and requiring further involvement from legal and medical ethics professionals for future planning.

The guiding principle of disaster preparedness is that we must do all the planning we can to ensure that we never need crisis standards of care (National Academies of Sciences, Engineering, and Medicine. 2020 Mar 28. Rapid Expert Consultation on Crisis Standards of Care for the COVID-19 Pandemic. Washington, DC: The National Academies Press.).

We must be prepared. Guidelines and suggestions laid out through decades of experience gained a real-world test in the COVID-19 pandemic. Now we must all reorganize and create new plans or augment old ones with the information we have gained. The time is now. The work must continue.
 

Dr. Griffin is Assistant Professor of Medicine, New York Presbyterian Hospital – Weill Cornell Medicine. Dr. Dichter is Associate Professor of Medicine, University of Minnesota.

In 2014, the Task Force for Mass Critical Care (TFMCC) published a CHEST consensus statement on disaster preparedness principles in caring for the critically ill during disasters and pandemics (Christian et al. CHEST. 2014;146[4_suppl]:8s-34s). This publication attempted to guide preparedness for both single-event disasters and more prolonged events, including a feared influenza pandemic.

Despite the foundation of planning and support this guidance provided, the COVID-19 pandemic response revealed substantial gaps in our understanding and preparedness for these more prolonged and widespread events.

In New York City, as the first COVID-19 wave began in March and April of 2020, area hospitals responded with surge plans that prioritized what was felt to be most important (Griffin et al. Am J Respir Crit Care Med. 2020 Jun 1;201[11]:1337-44). Tiered, creative staffing structures were rapidly created with intensivists supervising non-ICU physicians and APPs. Procedure teams were created for intubation, proning, and central line placement. ICU space was created with adaptations to ORs and PACUs, and rooms on med-surg floors and step-down units underwent emergency renovations to allow creation of new “pop-up” ICUs. Triage protocols were altered: patients on high levels of supplemental oxygen, who would under normal circumstances have been admitted to an ICU, were triaged to floors and stepdown units. Equipment was reused, modified, and substituted creatively to optimize care for the maximum number of patients.

In the face of all of these struggles, many around the country and the world felt the efforts, though heroic, resulted in less than standard of care. Two subsequent publications validated this concern (Kadri et al. Ann Int Med. 2021,174;9:1240-51; Bravata DM et al. JAMA Open Network. 2021;4[1]:e2034266), demonstrating during severe surge, COVID-19 patients’ mortality increased significantly beyond that seen in non-surging or less-severe surging times, demonstrating a mortality effect of surge itself. Though these studies observed COVID-19 patients only, there is every reason to believe the findings applied to all critically ill patients cared for during these surges.

These experiences led the TFMCC to report updated strategies for remaining in contingency care levels and avoiding crisis care (Dichter JR et al. CHEST. 2022;161[2]:429-47). Contingency is equivalent to routine care though may require adaptations and employment of otherwise non-traditional resources. The ultimate goal of mass critical care in a public health emergency is to avoid crisis-operating conditions, crisis standards of care, and their associated challenging triage decisions regarding allocation of scarce resources.

The 10 suggestions included in the most recent TFMCC publication include staffing strategies and suggestions based on COVID-19 experiences for graded staff-to-patient ratios, and support processes to preserve the existing health care work force. Strategies also include reduction of redundant documentation, limiting overtime, and most importantly, approaches for improving teamwork and supporting psychological well-being and resilience. Examples include daily unit huddles to update care and share experiences, genuine intra-team recognition and appreciation, and embedding emotional health experts within teams to provide ongoing support.

Consistent communication between incident command and frontline clinicians was also a suggested priority, perhaps with a newly proposed position of physician clinical support supervisor. This would be a formal role within hospital incident command, a liaison between the two groups.

Surge strategies should include empowerment of bedside clinicians and leaders with both planning and real-time assessment of the clinical situation, as being at the front line of care enables the situational awareness to assess ICU strain most effectively. Further, ICU clinicians must recognize when progression deeper into contingency operations occurs and they become perilously close to crisis mode. At this point, decisions are made and scarce resources are modified beyond routine standards of care to preserve life. TFMCC designates this gray area between contingency and crisis as the Critical Clinical Prioritization level (Figure).

Courtesy ACCP

At this point, more resources must be provided, or patients must be transferred to other resourced hospitals.

Critical Clinical Prioritization is an illustration of necessity being the mother of invention, as these are adaptations clinicians devised under duress. Some particularly poignant examples are the spreading of 24 hours of continuous renal replacement therapy (CRRT) resource between two and sometimes three patients to provide life sustainment to all; and when ventilators were in short supply, determining which patients required full ICU ventilator support vs those who could manage with lower functioning ventilators, and trading them between patients when demands changed.

These adaptations can only be done by experienced clinicians proactively managing bedside critical care under duress, further underscoring the importance of our suggestion that Critical Clinical Prioritization and ICU strain be managed by bedside clinicians and leaders.

The response of early transfer of patients – load-balancing - should be considered as soon as any hospital enters contingency conditions. This strategy is commonly implemented within larger health systems, ideally before reaching Critical Clinical Prioritization. Formal, organized state or regional load-balancing coordination, now referred to as medical operations command centers (MOCCs), were highly effective and proved lifesaving for those states that implemented them (including Arizona, Washington, California, Minnesota, and others). Support for establishment of MOCC’s is crucial in prolonging contingency operations and further helps support and protect disadvantaged populations (White et al. N Engl J Med. 2021;385[24]:2211-4).

Establishment of MOCCs has met resistance due to challenges that include interhospital/intersystem competition, logistics of moving critically ill patients sometimes across significant physical distance, and the costs of assuming care of uninsured or underinsured patients. Nevertheless, the benefits to the population as a whole necessitate working through these obstacles as successful MOCCs have done, usually with government and hospital association support.

In their final suggestion of the 2022 updated strategies, TFMCC suggests that hospitals use telemedicine technology both to expand specialists’ ability to provide care and facilitate families virtually visiting their critically ill loved one when safety precludes in-person visits.

These suggestions are pivotal in planning for future public health emergencies that include mass critical care, even during events that are limited in scope and duration.

Lastly, intensivists struggled with legal and ethical concerns when mired in crisis care circumstances and decisions of allocation, and potential reallocation, of scarce resources. These issues were not well addressed during the COVID-19 pandemic, further emphasizing the importance of maintaining contingency level care and requiring further involvement from legal and medical ethics professionals for future planning.

The guiding principle of disaster preparedness is that we must do all the planning we can to ensure that we never need crisis standards of care (National Academies of Sciences, Engineering, and Medicine. 2020 Mar 28. Rapid Expert Consultation on Crisis Standards of Care for the COVID-19 Pandemic. Washington, DC: The National Academies Press.).

We must be prepared. Guidelines and suggestions laid out through decades of experience gained a real-world test in the COVID-19 pandemic. Now we must all reorganize and create new plans or augment old ones with the information we have gained. The time is now. The work must continue.
 

Dr. Griffin is Assistant Professor of Medicine, New York Presbyterian Hospital – Weill Cornell Medicine. Dr. Dichter is Associate Professor of Medicine, University of Minnesota.

In 2014, the Task Force for Mass Critical Care (TFMCC) published a CHEST consensus statement on disaster preparedness principles in caring for the critically ill during disasters and pandemics (Christian et al. CHEST. 2014;146[4_suppl]:8s-34s). This publication attempted to guide preparedness for both single-event disasters and more prolonged events, including a feared influenza pandemic.

Despite the foundation of planning and support this guidance provided, the COVID-19 pandemic response revealed substantial gaps in our understanding and preparedness for these more prolonged and widespread events.

In New York City, as the first COVID-19 wave began in March and April of 2020, area hospitals responded with surge plans that prioritized what was felt to be most important (Griffin et al. Am J Respir Crit Care Med. 2020 Jun 1;201[11]:1337-44). Tiered, creative staffing structures were rapidly created with intensivists supervising non-ICU physicians and APPs. Procedure teams were created for intubation, proning, and central line placement. ICU space was created with adaptations to ORs and PACUs, and rooms on med-surg floors and step-down units underwent emergency renovations to allow creation of new “pop-up” ICUs. Triage protocols were altered: patients on high levels of supplemental oxygen, who would under normal circumstances have been admitted to an ICU, were triaged to floors and stepdown units. Equipment was reused, modified, and substituted creatively to optimize care for the maximum number of patients.

In the face of all of these struggles, many around the country and the world felt the efforts, though heroic, resulted in less than standard of care. Two subsequent publications validated this concern (Kadri et al. Ann Int Med. 2021,174;9:1240-51; Bravata DM et al. JAMA Open Network. 2021;4[1]:e2034266), demonstrating during severe surge, COVID-19 patients’ mortality increased significantly beyond that seen in non-surging or less-severe surging times, demonstrating a mortality effect of surge itself. Though these studies observed COVID-19 patients only, there is every reason to believe the findings applied to all critically ill patients cared for during these surges.

These experiences led the TFMCC to report updated strategies for remaining in contingency care levels and avoiding crisis care (Dichter JR et al. CHEST. 2022;161[2]:429-47). Contingency is equivalent to routine care though may require adaptations and employment of otherwise non-traditional resources. The ultimate goal of mass critical care in a public health emergency is to avoid crisis-operating conditions, crisis standards of care, and their associated challenging triage decisions regarding allocation of scarce resources.

The 10 suggestions included in the most recent TFMCC publication include staffing strategies and suggestions based on COVID-19 experiences for graded staff-to-patient ratios, and support processes to preserve the existing health care work force. Strategies also include reduction of redundant documentation, limiting overtime, and most importantly, approaches for improving teamwork and supporting psychological well-being and resilience. Examples include daily unit huddles to update care and share experiences, genuine intra-team recognition and appreciation, and embedding emotional health experts within teams to provide ongoing support.

Consistent communication between incident command and frontline clinicians was also a suggested priority, perhaps with a newly proposed position of physician clinical support supervisor. This would be a formal role within hospital incident command, a liaison between the two groups.

Surge strategies should include empowerment of bedside clinicians and leaders with both planning and real-time assessment of the clinical situation, as being at the front line of care enables the situational awareness to assess ICU strain most effectively. Further, ICU clinicians must recognize when progression deeper into contingency operations occurs and they become perilously close to crisis mode. At this point, decisions are made and scarce resources are modified beyond routine standards of care to preserve life. TFMCC designates this gray area between contingency and crisis as the Critical Clinical Prioritization level (Figure).

Courtesy ACCP

At this point, more resources must be provided, or patients must be transferred to other resourced hospitals.

Critical Clinical Prioritization is an illustration of necessity being the mother of invention, as these are adaptations clinicians devised under duress. Some particularly poignant examples are the spreading of 24 hours of continuous renal replacement therapy (CRRT) resource between two and sometimes three patients to provide life sustainment to all; and when ventilators were in short supply, determining which patients required full ICU ventilator support vs those who could manage with lower functioning ventilators, and trading them between patients when demands changed.

These adaptations can only be done by experienced clinicians proactively managing bedside critical care under duress, further underscoring the importance of our suggestion that Critical Clinical Prioritization and ICU strain be managed by bedside clinicians and leaders.

The response of early transfer of patients – load-balancing - should be considered as soon as any hospital enters contingency conditions. This strategy is commonly implemented within larger health systems, ideally before reaching Critical Clinical Prioritization. Formal, organized state or regional load-balancing coordination, now referred to as medical operations command centers (MOCCs), were highly effective and proved lifesaving for those states that implemented them (including Arizona, Washington, California, Minnesota, and others). Support for establishment of MOCC’s is crucial in prolonging contingency operations and further helps support and protect disadvantaged populations (White et al. N Engl J Med. 2021;385[24]:2211-4).

Establishment of MOCCs has met resistance due to challenges that include interhospital/intersystem competition, logistics of moving critically ill patients sometimes across significant physical distance, and the costs of assuming care of uninsured or underinsured patients. Nevertheless, the benefits to the population as a whole necessitate working through these obstacles as successful MOCCs have done, usually with government and hospital association support.

In their final suggestion of the 2022 updated strategies, TFMCC suggests that hospitals use telemedicine technology both to expand specialists’ ability to provide care and facilitate families virtually visiting their critically ill loved one when safety precludes in-person visits.

These suggestions are pivotal in planning for future public health emergencies that include mass critical care, even during events that are limited in scope and duration.

Lastly, intensivists struggled with legal and ethical concerns when mired in crisis care circumstances and decisions of allocation, and potential reallocation, of scarce resources. These issues were not well addressed during the COVID-19 pandemic, further emphasizing the importance of maintaining contingency level care and requiring further involvement from legal and medical ethics professionals for future planning.

The guiding principle of disaster preparedness is that we must do all the planning we can to ensure that we never need crisis standards of care (National Academies of Sciences, Engineering, and Medicine. 2020 Mar 28. Rapid Expert Consultation on Crisis Standards of Care for the COVID-19 Pandemic. Washington, DC: The National Academies Press.).

We must be prepared. Guidelines and suggestions laid out through decades of experience gained a real-world test in the COVID-19 pandemic. Now we must all reorganize and create new plans or augment old ones with the information we have gained. The time is now. The work must continue.
 

Dr. Griffin is Assistant Professor of Medicine, New York Presbyterian Hospital – Weill Cornell Medicine. Dr. Dichter is Associate Professor of Medicine, University of Minnesota.

Since its inception, the CMS Sep-1 Core Quality Measure has been unpopular in some circles. It is now under official attack by the American College of Emergency Physicians (ACEP) and the Infectious Diseases Society of America (IDSA), along with a handful of smaller professional societies. These societies appealed the National Quality Forum’s (NQF) 2021 recommendation that the measure be renewed. The NQF is the multidisciplinary and broadly representative group of evaluators who evaluate proposals for CMS-sponsored quality improvement on behalf of the American people and of the Centers for Medicare & Medicaid Services (CMS). Readers of CHEST Physician are likely familiar with core measures, in general, and with Sep-1, in particular. CMS requires hospitals to publicly report their compliance with several Core Quality Measures, and the failure to do so results in across the board reductions in Medicare payments. As of now, no penalties are levied for the degree of compliance but only for failure to report the degree of compliance.

The measure asks, in the main, for hospitals to perform what most physicians can agree should be standard care for patients with sepsis. Depending on whether shock is present, the measure requires:

1. Blood cultures before antibiotics

2. Antibiotics within 3 hours of recognition of sepsis

3. Serum lactate measurement in the first 3 hours and, if increased, a repeat measurement by 6 hours

4. If the patient is hypotensive, 30 mL/kg IV crystalloid within 3 hours, or documentation of why that is not appropriate for the patient

5. If hypotension persists, vasopressors within 6 hours

6. Repeat cardiovascular assessment within 6 hours for patients with shock

If I evaluate these criteria as a patient who has been hospitalized for a serious infection, which I am, they do not seem particularly stringent. In fact, as a patient, I would want my doctors and nurses to act substantially faster than this if I had sepsis or septic shock. If my doctor did not come back in less than 6 hours to check on my shock status, I would be disappointed, to say the least. Nevertheless, some physicians and professional societies see no reason why these should be standards and state that the data underlying them are of low quality. Meanwhile, according to CMS’ own careful evaluation, national compliance with the measures is less than 50%, while being compliant with the measures reduces absolute overall mortality by approximately 4%, from 26.3% to 22.2% (Townsend SR et al. Chest. 2022;161[2]:392-406). This would translate to between 14,000 and 15,000 fewer patients dying from sepsis per year, if all patients received bundled, measure-compliant care. These are patients I don’t care to ignore.

ACEP and IDSA point specifically to the new Surviving Sepsis Campaign Guidelines (SSC) recommendations as evidence that the antibiotic measure is based on low quality evidence (Evans L et al. Crit Care Med. 2021;49[11]:1974-82). In this regard, they are technically correct; the system of evidence review that the SSC panel uses, Grading of Assessment, Recommendations, and Evaluation (GRADE), considers that retrospective analyses, which nearly all of these studies are, can be graded no higher than low quality. Clearly, retrospective studies will never achieve the level of certainty that we achieve with randomized controlled trials, but the NQF, itself, typically views that when a number of well-performed retrospective studies point in the same direction, the level of evidence is at least moderate. After all, just as it would be inappropriate to randomize participants to decades of smoking vs nonsmoking in order prove that smoking causes lung cancer, it is not appropriate to randomize patients with sepsis to receive delayed antibiotics before we accept that such delays are harmful to them.

ACEP and IDSA also assert that the association of early antibiotics with survival is “stronger” for septic shock than for sepsis. In fact, the association is quite strong for both severities of illness. Until it progresses to septic shock, the expected mortality of sepsis is lower, and the percent reduction in mortality is less than for septic shock. However, the opportunity for lives preserved is quite large, because the number of patients with sepsis at presentation is approximately 10 times higher than the number with septic shock at presentation. Antibiotic delays are also associated with progression from infection or sepsis to septic shock (Whiles BB et al. Crit Care Med. 2017;45[4]:623-29; Bisarya R et al. Chest. 2022;161[1]:112-20). Importantly, SSC gave a strong recommendation for all patients with suspected sepsis to receive antibiotics within 3 hours of suspecting sepsis and within 1 hour of suspecting septic shock, a recommendation even stronger than that of Sep-1.

Critics opine that CMS should stop looking at the process measures and focus only on the outcomes of sepsis care. There is a certain attractiveness to this proposition. One could say that it does not matter so much how a hospital achieves lower mortality as long as they do achieve it. However, the question would then become – how low should the mortality rate be? I have a notion that whatever the number, the Sep-1 critics would find it unbearable.

There is a core principle embedded in the Sep-1 process measures, in SSC guidelines, and in the concept of early goal-directed therapy that preceded them: success is not dependent only on what we do but on when we do it. All of you have experienced this. Each of you has attended a professional school, whether medical, nursing, respiratory therapy, etc. None of you showed up unannounced on opening day of the semester and was admitted to that school. All of you garnered the grades, solicited the letters of recommendation, took the entrance exams, and submitted an application. Some of you went to an interview. All of these things were done in a timely fashion; professional schools do not accept incomplete applications or late applications. Doing the right things at the wrong time would have left us all pursuing different careers.

Very early in my career as an attending physician in the ICU, I found myself exasperated by the circumstances of many patients who we received in the ICU with sepsis. I would peruse their medical records and find that they had been septic, ie, had met criteria for severe sepsis, 1 to 2 days before their deterioration to septic shock, yet they had not been diagnosed with sepsis until shock developed. In the ICU, we began resuscitative fluids, ensured appropriate antibiotics, and started vasopressors, but it was often to no avail. The treatments we gave made no difference for many patients, because they were given too late. For me, this was career altering; much of my career since that time has focused on teaching medical personnel how to recognize sepsis, how to give timely and appropriate treatments, and how to keep the data to show when they have done that and when they have not.

Before Sep-1 many, if not most, of the hospitals in the United States had no particular strategy in place to recognize and treat patients with sepsis, even though it was and is the most common cause of death and the costliest condition in American hospitals. Now, most hospitals do have such strategies. Assertions by professional societies that it is difficult to collect the data for Sep-1 reporting are likely true. However, keeping patients safe and alive is a hospital’s primary reason for existing. As long as hospitals are tracking each antibiotic and every liter of fluid so that they can bill for them, my own ears are deaf to hearing that it is too difficult to make sure that we are doing our job. Modifying or eliminating Sep-1 for any reason except data that show we can clearly further improve the outcome for all patients with sepsis is the wrong move to make. So far, other professional societies want to remove elements of Sep-1 without evidence that it would improve our care for patients with sepsis or their outcomes. Thankfully, from the time we proposed the first criteria for diagnosing sepsis, CHEST has promoted what is best for patients, whether it is difficult or not.
 

Dr. Simpson is a pulmonologist and intensivist with an extensive background in sepsis and in critical care quality improvement, including by serving as a senior adviser to the Solving Sepsis initiative of the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services and an author of the 2016 and 2020 updates of the Surviving Sepsis Campaign Guidelines. Dr. Simpson is the senior medical adviser for Sepsis Alliance, a nationwide patient information and advocacy organization. He is the immediate past president of CHEST.

Since its inception, the CMS Sep-1 Core Quality Measure has been unpopular in some circles. It is now under official attack by the American College of Emergency Physicians (ACEP) and the Infectious Diseases Society of America (IDSA), along with a handful of smaller professional societies. These societies appealed the National Quality Forum’s (NQF) 2021 recommendation that the measure be renewed. The NQF is the multidisciplinary and broadly representative group of evaluators who evaluate proposals for CMS-sponsored quality improvement on behalf of the American people and of the Centers for Medicare & Medicaid Services (CMS). Readers of CHEST Physician are likely familiar with core measures, in general, and with Sep-1, in particular. CMS requires hospitals to publicly report their compliance with several Core Quality Measures, and the failure to do so results in across the board reductions in Medicare payments. As of now, no penalties are levied for the degree of compliance but only for failure to report the degree of compliance.

The measure asks, in the main, for hospitals to perform what most physicians can agree should be standard care for patients with sepsis. Depending on whether shock is present, the measure requires:

1. Blood cultures before antibiotics

2. Antibiotics within 3 hours of recognition of sepsis

3. Serum lactate measurement in the first 3 hours and, if increased, a repeat measurement by 6 hours

4. If the patient is hypotensive, 30 mL/kg IV crystalloid within 3 hours, or documentation of why that is not appropriate for the patient

5. If hypotension persists, vasopressors within 6 hours

6. Repeat cardiovascular assessment within 6 hours for patients with shock

If I evaluate these criteria as a patient who has been hospitalized for a serious infection, which I am, they do not seem particularly stringent. In fact, as a patient, I would want my doctors and nurses to act substantially faster than this if I had sepsis or septic shock. If my doctor did not come back in less than 6 hours to check on my shock status, I would be disappointed, to say the least. Nevertheless, some physicians and professional societies see no reason why these should be standards and state that the data underlying them are of low quality. Meanwhile, according to CMS’ own careful evaluation, national compliance with the measures is less than 50%, while being compliant with the measures reduces absolute overall mortality by approximately 4%, from 26.3% to 22.2% (Townsend SR et al. Chest. 2022;161[2]:392-406). This would translate to between 14,000 and 15,000 fewer patients dying from sepsis per year, if all patients received bundled, measure-compliant care. These are patients I don’t care to ignore.

ACEP and IDSA point specifically to the new Surviving Sepsis Campaign Guidelines (SSC) recommendations as evidence that the antibiotic measure is based on low quality evidence (Evans L et al. Crit Care Med. 2021;49[11]:1974-82). In this regard, they are technically correct; the system of evidence review that the SSC panel uses, Grading of Assessment, Recommendations, and Evaluation (GRADE), considers that retrospective analyses, which nearly all of these studies are, can be graded no higher than low quality. Clearly, retrospective studies will never achieve the level of certainty that we achieve with randomized controlled trials, but the NQF, itself, typically views that when a number of well-performed retrospective studies point in the same direction, the level of evidence is at least moderate. After all, just as it would be inappropriate to randomize participants to decades of smoking vs nonsmoking in order prove that smoking causes lung cancer, it is not appropriate to randomize patients with sepsis to receive delayed antibiotics before we accept that such delays are harmful to them.

ACEP and IDSA also assert that the association of early antibiotics with survival is “stronger” for septic shock than for sepsis. In fact, the association is quite strong for both severities of illness. Until it progresses to septic shock, the expected mortality of sepsis is lower, and the percent reduction in mortality is less than for septic shock. However, the opportunity for lives preserved is quite large, because the number of patients with sepsis at presentation is approximately 10 times higher than the number with septic shock at presentation. Antibiotic delays are also associated with progression from infection or sepsis to septic shock (Whiles BB et al. Crit Care Med. 2017;45[4]:623-29; Bisarya R et al. Chest. 2022;161[1]:112-20). Importantly, SSC gave a strong recommendation for all patients with suspected sepsis to receive antibiotics within 3 hours of suspecting sepsis and within 1 hour of suspecting septic shock, a recommendation even stronger than that of Sep-1.

Critics opine that CMS should stop looking at the process measures and focus only on the outcomes of sepsis care. There is a certain attractiveness to this proposition. One could say that it does not matter so much how a hospital achieves lower mortality as long as they do achieve it. However, the question would then become – how low should the mortality rate be? I have a notion that whatever the number, the Sep-1 critics would find it unbearable.

There is a core principle embedded in the Sep-1 process measures, in SSC guidelines, and in the concept of early goal-directed therapy that preceded them: success is not dependent only on what we do but on when we do it. All of you have experienced this. Each of you has attended a professional school, whether medical, nursing, respiratory therapy, etc. None of you showed up unannounced on opening day of the semester and was admitted to that school. All of you garnered the grades, solicited the letters of recommendation, took the entrance exams, and submitted an application. Some of you went to an interview. All of these things were done in a timely fashion; professional schools do not accept incomplete applications or late applications. Doing the right things at the wrong time would have left us all pursuing different careers.

Very early in my career as an attending physician in the ICU, I found myself exasperated by the circumstances of many patients who we received in the ICU with sepsis. I would peruse their medical records and find that they had been septic, ie, had met criteria for severe sepsis, 1 to 2 days before their deterioration to septic shock, yet they had not been diagnosed with sepsis until shock developed. In the ICU, we began resuscitative fluids, ensured appropriate antibiotics, and started vasopressors, but it was often to no avail. The treatments we gave made no difference for many patients, because they were given too late. For me, this was career altering; much of my career since that time has focused on teaching medical personnel how to recognize sepsis, how to give timely and appropriate treatments, and how to keep the data to show when they have done that and when they have not.

Before Sep-1 many, if not most, of the hospitals in the United States had no particular strategy in place to recognize and treat patients with sepsis, even though it was and is the most common cause of death and the costliest condition in American hospitals. Now, most hospitals do have such strategies. Assertions by professional societies that it is difficult to collect the data for Sep-1 reporting are likely true. However, keeping patients safe and alive is a hospital’s primary reason for existing. As long as hospitals are tracking each antibiotic and every liter of fluid so that they can bill for them, my own ears are deaf to hearing that it is too difficult to make sure that we are doing our job. Modifying or eliminating Sep-1 for any reason except data that show we can clearly further improve the outcome for all patients with sepsis is the wrong move to make. So far, other professional societies want to remove elements of Sep-1 without evidence that it would improve our care for patients with sepsis or their outcomes. Thankfully, from the time we proposed the first criteria for diagnosing sepsis, CHEST has promoted what is best for patients, whether it is difficult or not.
 

Dr. Simpson is a pulmonologist and intensivist with an extensive background in sepsis and in critical care quality improvement, including by serving as a senior adviser to the Solving Sepsis initiative of the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services and an author of the 2016 and 2020 updates of the Surviving Sepsis Campaign Guidelines. Dr. Simpson is the senior medical adviser for Sepsis Alliance, a nationwide patient information and advocacy organization. He is the immediate past president of CHEST.

Since its inception, the CMS Sep-1 Core Quality Measure has been unpopular in some circles. It is now under official attack by the American College of Emergency Physicians (ACEP) and the Infectious Diseases Society of America (IDSA), along with a handful of smaller professional societies. These societies appealed the National Quality Forum’s (NQF) 2021 recommendation that the measure be renewed. The NQF is the multidisciplinary and broadly representative group of evaluators who evaluate proposals for CMS-sponsored quality improvement on behalf of the American people and of the Centers for Medicare & Medicaid Services (CMS). Readers of CHEST Physician are likely familiar with core measures, in general, and with Sep-1, in particular. CMS requires hospitals to publicly report their compliance with several Core Quality Measures, and the failure to do so results in across the board reductions in Medicare payments. As of now, no penalties are levied for the degree of compliance but only for failure to report the degree of compliance.

The measure asks, in the main, for hospitals to perform what most physicians can agree should be standard care for patients with sepsis. Depending on whether shock is present, the measure requires:

1. Blood cultures before antibiotics

2. Antibiotics within 3 hours of recognition of sepsis

3. Serum lactate measurement in the first 3 hours and, if increased, a repeat measurement by 6 hours

4. If the patient is hypotensive, 30 mL/kg IV crystalloid within 3 hours, or documentation of why that is not appropriate for the patient

5. If hypotension persists, vasopressors within 6 hours

6. Repeat cardiovascular assessment within 6 hours for patients with shock

If I evaluate these criteria as a patient who has been hospitalized for a serious infection, which I am, they do not seem particularly stringent. In fact, as a patient, I would want my doctors and nurses to act substantially faster than this if I had sepsis or septic shock. If my doctor did not come back in less than 6 hours to check on my shock status, I would be disappointed, to say the least. Nevertheless, some physicians and professional societies see no reason why these should be standards and state that the data underlying them are of low quality. Meanwhile, according to CMS’ own careful evaluation, national compliance with the measures is less than 50%, while being compliant with the measures reduces absolute overall mortality by approximately 4%, from 26.3% to 22.2% (Townsend SR et al. Chest. 2022;161[2]:392-406). This would translate to between 14,000 and 15,000 fewer patients dying from sepsis per year, if all patients received bundled, measure-compliant care. These are patients I don’t care to ignore.

ACEP and IDSA point specifically to the new Surviving Sepsis Campaign Guidelines (SSC) recommendations as evidence that the antibiotic measure is based on low quality evidence (Evans L et al. Crit Care Med. 2021;49[11]:1974-82). In this regard, they are technically correct; the system of evidence review that the SSC panel uses, Grading of Assessment, Recommendations, and Evaluation (GRADE), considers that retrospective analyses, which nearly all of these studies are, can be graded no higher than low quality. Clearly, retrospective studies will never achieve the level of certainty that we achieve with randomized controlled trials, but the NQF, itself, typically views that when a number of well-performed retrospective studies point in the same direction, the level of evidence is at least moderate. After all, just as it would be inappropriate to randomize participants to decades of smoking vs nonsmoking in order prove that smoking causes lung cancer, it is not appropriate to randomize patients with sepsis to receive delayed antibiotics before we accept that such delays are harmful to them.

ACEP and IDSA also assert that the association of early antibiotics with survival is “stronger” for septic shock than for sepsis. In fact, the association is quite strong for both severities of illness. Until it progresses to septic shock, the expected mortality of sepsis is lower, and the percent reduction in mortality is less than for septic shock. However, the opportunity for lives preserved is quite large, because the number of patients with sepsis at presentation is approximately 10 times higher than the number with septic shock at presentation. Antibiotic delays are also associated with progression from infection or sepsis to septic shock (Whiles BB et al. Crit Care Med. 2017;45[4]:623-29; Bisarya R et al. Chest. 2022;161[1]:112-20). Importantly, SSC gave a strong recommendation for all patients with suspected sepsis to receive antibiotics within 3 hours of suspecting sepsis and within 1 hour of suspecting septic shock, a recommendation even stronger than that of Sep-1.

Critics opine that CMS should stop looking at the process measures and focus only on the outcomes of sepsis care. There is a certain attractiveness to this proposition. One could say that it does not matter so much how a hospital achieves lower mortality as long as they do achieve it. However, the question would then become – how low should the mortality rate be? I have a notion that whatever the number, the Sep-1 critics would find it unbearable.

There is a core principle embedded in the Sep-1 process measures, in SSC guidelines, and in the concept of early goal-directed therapy that preceded them: success is not dependent only on what we do but on when we do it. All of you have experienced this. Each of you has attended a professional school, whether medical, nursing, respiratory therapy, etc. None of you showed up unannounced on opening day of the semester and was admitted to that school. All of you garnered the grades, solicited the letters of recommendation, took the entrance exams, and submitted an application. Some of you went to an interview. All of these things were done in a timely fashion; professional schools do not accept incomplete applications or late applications. Doing the right things at the wrong time would have left us all pursuing different careers.

Very early in my career as an attending physician in the ICU, I found myself exasperated by the circumstances of many patients who we received in the ICU with sepsis. I would peruse their medical records and find that they had been septic, ie, had met criteria for severe sepsis, 1 to 2 days before their deterioration to septic shock, yet they had not been diagnosed with sepsis until shock developed. In the ICU, we began resuscitative fluids, ensured appropriate antibiotics, and started vasopressors, but it was often to no avail. The treatments we gave made no difference for many patients, because they were given too late. For me, this was career altering; much of my career since that time has focused on teaching medical personnel how to recognize sepsis, how to give timely and appropriate treatments, and how to keep the data to show when they have done that and when they have not.

Before Sep-1 many, if not most, of the hospitals in the United States had no particular strategy in place to recognize and treat patients with sepsis, even though it was and is the most common cause of death and the costliest condition in American hospitals. Now, most hospitals do have such strategies. Assertions by professional societies that it is difficult to collect the data for Sep-1 reporting are likely true. However, keeping patients safe and alive is a hospital’s primary reason for existing. As long as hospitals are tracking each antibiotic and every liter of fluid so that they can bill for them, my own ears are deaf to hearing that it is too difficult to make sure that we are doing our job. Modifying or eliminating Sep-1 for any reason except data that show we can clearly further improve the outcome for all patients with sepsis is the wrong move to make. So far, other professional societies want to remove elements of Sep-1 without evidence that it would improve our care for patients with sepsis or their outcomes. Thankfully, from the time we proposed the first criteria for diagnosing sepsis, CHEST has promoted what is best for patients, whether it is difficult or not.
 

Dr. Simpson is a pulmonologist and intensivist with an extensive background in sepsis and in critical care quality improvement, including by serving as a senior adviser to the Solving Sepsis initiative of the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services and an author of the 2016 and 2020 updates of the Surviving Sepsis Campaign Guidelines. Dr. Simpson is the senior medical adviser for Sepsis Alliance, a nationwide patient information and advocacy organization. He is the immediate past president of CHEST.

Despite current guidelines permitting opt-out STI screening and the ability in most states to treat adolescents 13 years old and older for STIs without parental notification, STI testing rates remain low. The articles about the 2019 survey raise several concerns.

Screening was more common with certain known risky behaviors, so risk-based screening seems prevalent. Of note, one recently reported factor increasing risky behaviors, but not noted above, is homelessness, suggesting it also be a trigger for STI screening (Child Youth Services Rev. 2022;139. doi: 10.1016/j.childyouth.2022.106538). But won’t risk-based screening inevitably lead to undertesting/treating? Are adolescents comfortable/willing to answer even the most carefully crafted, gentle, and simple questions about risky behaviors? 

Because STIs are so frequent in adolescents (many asymptomatic), is risk-based screening/testing adequate for common STIs? Could urine-based screening for gonorrhea and chlamydia be useful in any adolescent who has been sexually active or uses the ED for routine care? Syphilis seems different. Screening requires a blood draw and is more difficult to implement, so risk-based testing seems okay. Also, the CDC recommends risk-based screening for syphilis.

Chief complaints at adolescent visits are usually not STI-related, unless symptomatic or visible, e.g., genital warts or herpes. So STI screening (even opt-out) will lengthen visits, perhaps a lot, over what was scheduled – even if only to explain negative results. Multiple visits with screening in the same morning could wreck patient flow. Maybe this doesn’t influence decisions to screen/test, but reexamining our approach can maximize appropriate STI screening/testing. 

STIs run in packs, so if you detect one, expand testing to include the others. 

Christopher J. Harrison, MD, is professor, University of Missouri Kansas City School of Medicine, department of medicine, infectious diseases section, Kansas City. He has no financial conflicts of interest.
 

Despite current guidelines permitting opt-out STI screening and the ability in most states to treat adolescents 13 years old and older for STIs without parental notification, STI testing rates remain low. The articles about the 2019 survey raise several concerns.

Screening was more common with certain known risky behaviors, so risk-based screening seems prevalent. Of note, one recently reported factor increasing risky behaviors, but not noted above, is homelessness, suggesting it also be a trigger for STI screening (Child Youth Services Rev. 2022;139. doi: 10.1016/j.childyouth.2022.106538). But won’t risk-based screening inevitably lead to undertesting/treating? Are adolescents comfortable/willing to answer even the most carefully crafted, gentle, and simple questions about risky behaviors? 

Because STIs are so frequent in adolescents (many asymptomatic), is risk-based screening/testing adequate for common STIs? Could urine-based screening for gonorrhea and chlamydia be useful in any adolescent who has been sexually active or uses the ED for routine care? Syphilis seems different. Screening requires a blood draw and is more difficult to implement, so risk-based testing seems okay. Also, the CDC recommends risk-based screening for syphilis.

Chief complaints at adolescent visits are usually not STI-related, unless symptomatic or visible, e.g., genital warts or herpes. So STI screening (even opt-out) will lengthen visits, perhaps a lot, over what was scheduled – even if only to explain negative results. Multiple visits with screening in the same morning could wreck patient flow. Maybe this doesn’t influence decisions to screen/test, but reexamining our approach can maximize appropriate STI screening/testing. 

STIs run in packs, so if you detect one, expand testing to include the others. 

Christopher J. Harrison, MD, is professor, University of Missouri Kansas City School of Medicine, department of medicine, infectious diseases section, Kansas City. He has no financial conflicts of interest.
 

Despite current guidelines permitting opt-out STI screening and the ability in most states to treat adolescents 13 years old and older for STIs without parental notification, STI testing rates remain low. The articles about the 2019 survey raise several concerns.

Screening was more common with certain known risky behaviors, so risk-based screening seems prevalent. Of note, one recently reported factor increasing risky behaviors, but not noted above, is homelessness, suggesting it also be a trigger for STI screening (Child Youth Services Rev. 2022;139. doi: 10.1016/j.childyouth.2022.106538). But won’t risk-based screening inevitably lead to undertesting/treating? Are adolescents comfortable/willing to answer even the most carefully crafted, gentle, and simple questions about risky behaviors? 

Because STIs are so frequent in adolescents (many asymptomatic), is risk-based screening/testing adequate for common STIs? Could urine-based screening for gonorrhea and chlamydia be useful in any adolescent who has been sexually active or uses the ED for routine care? Syphilis seems different. Screening requires a blood draw and is more difficult to implement, so risk-based testing seems okay. Also, the CDC recommends risk-based screening for syphilis.

Chief complaints at adolescent visits are usually not STI-related, unless symptomatic or visible, e.g., genital warts or herpes. So STI screening (even opt-out) will lengthen visits, perhaps a lot, over what was scheduled – even if only to explain negative results. Multiple visits with screening in the same morning could wreck patient flow. Maybe this doesn’t influence decisions to screen/test, but reexamining our approach can maximize appropriate STI screening/testing. 

STIs run in packs, so if you detect one, expand testing to include the others. 

Christopher J. Harrison, MD, is professor, University of Missouri Kansas City School of Medicine, department of medicine, infectious diseases section, Kansas City. He has no financial conflicts of interest.
 

The American Academy of Pediatrics, with funding from the Centers for Disease Control and Prevention, studied the CDC’s “Learn the Signs. Act Early” developmental surveillance milestones for children 0-5 years to update the milestones based on published studies. The goal was to improve this tool for developmental surveillance and use by the public. Developmental surveillance is not just observing a child at a check-up but rather “is a longitudinal process that involves eliciting concerns, taking a developmental history based on milestone attainment, observing milestones and other behaviors, examining the child, and applying clinical judgment during health supervision visits (HSVs).”¹

While the milestones we were trained on were a good start and highlighted the developmental progression central to pediatrics, they were not based on norms or cut scores indicating significant developmental risk unless taught from a validated tool. The CDC was concerned that their public handouts and apps were based on median ages (middle number of the entire range) of attainment not the mode (most common) or even average ages. That means that about half of all typically developing children would “not have attained” that skill at the age noted, potentially evoking unnecessary concern for parents and a “wait-and-see” message from a knowledgeable provider who realized the statistical meaning and the broad range of normal. Another potential problem with using milestones set at the median age is that parents, especially those with several children or experienced friends, may see the provider as an alarmist when they have seen great variation in children who later were normal. This reaction can dampen provider willingness to discuss development or even to screen with validated tools. We have learned the hard way from COVID-19 that it is difficult to convey concepts of risk effectively both balancing fear and stimulating action.

The AAP experts reviewed the English literature for data-based milestones, finding 34 articles, 10 of which had an opinion for at least one milestone. If this sounds like a very small number, you are correct. You may not realize that almost all screening and diagnostic tools have been based on data collected by Gesell in 1928!² While most of health care has changed since then, which milestones are measured in infants has not.

The biggest change from this review was deciding to use as milestones skills reported for 75% of children at each age of typical HSVs, adding ones for 15 and 30 months. The implication is that children not attaining these milestones are all at risk and deserving of more careful history, examination, and administration of a validated screening tool; not true when based on median data. Of the 94 existing CDC milestones retained after the review, one-third were moved to a different age with 21 of 31 assigned to an older age. Domains of functioning for the milestones were consolidated into social emotional, cognitive, language/communication, and motor, to help parents learn to distinguish these areas, and, although many milestones reflect several domains, each was included only once to reduce confusion.

Psychosocial assessment is recommended by the AAP and Bright Futures at every HSV but the fewest milestones with normative data were identified for this domain, often self-help rather than social engagement or emotion regulation skills. The cross-cultural study cited for many of the new milestones was reassuring overall in that the median ages for 67%-88% of milestones in most domains were equivalent across the four countries sampled, but only 22% of self-help skills were equivalent.³ This should remind us that parenting has more influence over psychosocial skills than other domains. Psychosocial and behavioral functioning, especially emotional regulation, also deserve “surveillance” as they have enormous impact on life outcomes but need to be measured and supported differently. Routine use of validated tools such as the Early Childhood Screening Assessment or the Ages & Stages Questionnaires: Social-Emotional for these domains are also needed.

Normal variations in temperament and patterns of attachment can affect many milestones including courage for walking, exploration, social engagement, and prosocial behaviors or self-control for social situations, attention, range of affect, and cooperation. All of these skills are among the 42 total (14 new) social-emotional milestones for 0- to 5-year-olds. Variations in these functions are at the root of the most common “challenging behaviors” in our studies in primary care. They are also the most vulnerable to suboptimal parent-child relationships, adverse childhood experiences, and social determinants of health.

As primary care providers, we not only need to detect children at risk for developmental problems but also promote and celebrate developmental progress. I hope that changing the threshold for concern to 75% will allow for a more positive review with the family (as fewer will be flagged as at risk) and chance to congratulate parents on all that is going well. But I also hope the change will not make us overlook parenting challenges, often from the psychosocial milestones most amenable to our guidance and support.

Early identification is mainly important to obtain the early intervention shown to improve outcomes. However, less than 25% of children with delays or disabilities receive early intervention before age 3 and most with emotional, behavioral, and developmental conditions, other than autism spectrum disorder, not before age 5. Since early intervention services are freely available in all states, we also need to do better at getting children to this care.

Let’s reconsider the process of developmental surveillance in this light of delayed referral: “Eliciting concerns” is key as parents have been shown to be usually correct in their worries. Listening to how they express the concerns can help you connect their specific issues when discussing reasons for referral. While most parent “recall of past milestones” is not accurate, current milestones reported are; thus, the need to have the new more accurate norms for all ages for comparison. When we make observations of a child’s abilities and behaviors ourselves we may not only pick up on issues missed by the parent, but will be more convincing in conveying the need for referral when indicated. When we “examine” the child we can use our professional skills to determine the very important risk factor of the quality of how a skill is performed, not just that it is. The recommended “use of validated screening tools” when the new milestones are not met give us an objective tool to share with parents, more confidence in when referral is warranted, which we will convey to parents (and perhaps skeptical relatives), and baseline documentation from which we can “track” referrals, progress, and, hopefully, better outcomes.

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. Email her at [email protected].

References

1. Zubler JM et al. Pediatrics. 2022;149(3):e2021052138.

2. Gessell A et al. Macmillan: New York, 1928.

3. Ertem IO et al. Lancet Glob Health. 2018 Mar;6(3):e279-91.

The American Academy of Pediatrics, with funding from the Centers for Disease Control and Prevention, studied the CDC’s “Learn the Signs. Act Early” developmental surveillance milestones for children 0-5 years to update the milestones based on published studies. The goal was to improve this tool for developmental surveillance and use by the public. Developmental surveillance is not just observing a child at a check-up but rather “is a longitudinal process that involves eliciting concerns, taking a developmental history based on milestone attainment, observing milestones and other behaviors, examining the child, and applying clinical judgment during health supervision visits (HSVs).”¹

While the milestones we were trained on were a good start and highlighted the developmental progression central to pediatrics, they were not based on norms or cut scores indicating significant developmental risk unless taught from a validated tool. The CDC was concerned that their public handouts and apps were based on median ages (middle number of the entire range) of attainment not the mode (most common) or even average ages. That means that about half of all typically developing children would “not have attained” that skill at the age noted, potentially evoking unnecessary concern for parents and a “wait-and-see” message from a knowledgeable provider who realized the statistical meaning and the broad range of normal. Another potential problem with using milestones set at the median age is that parents, especially those with several children or experienced friends, may see the provider as an alarmist when they have seen great variation in children who later were normal. This reaction can dampen provider willingness to discuss development or even to screen with validated tools. We have learned the hard way from COVID-19 that it is difficult to convey concepts of risk effectively both balancing fear and stimulating action.

The AAP experts reviewed the English literature for data-based milestones, finding 34 articles, 10 of which had an opinion for at least one milestone. If this sounds like a very small number, you are correct. You may not realize that almost all screening and diagnostic tools have been based on data collected by Gesell in 1928!² While most of health care has changed since then, which milestones are measured in infants has not.

The biggest change from this review was deciding to use as milestones skills reported for 75% of children at each age of typical HSVs, adding ones for 15 and 30 months. The implication is that children not attaining these milestones are all at risk and deserving of more careful history, examination, and administration of a validated screening tool; not true when based on median data. Of the 94 existing CDC milestones retained after the review, one-third were moved to a different age with 21 of 31 assigned to an older age. Domains of functioning for the milestones were consolidated into social emotional, cognitive, language/communication, and motor, to help parents learn to distinguish these areas, and, although many milestones reflect several domains, each was included only once to reduce confusion.

Psychosocial assessment is recommended by the AAP and Bright Futures at every HSV but the fewest milestones with normative data were identified for this domain, often self-help rather than social engagement or emotion regulation skills. The cross-cultural study cited for many of the new milestones was reassuring overall in that the median ages for 67%-88% of milestones in most domains were equivalent across the four countries sampled, but only 22% of self-help skills were equivalent.³ This should remind us that parenting has more influence over psychosocial skills than other domains. Psychosocial and behavioral functioning, especially emotional regulation, also deserve “surveillance” as they have enormous impact on life outcomes but need to be measured and supported differently. Routine use of validated tools such as the Early Childhood Screening Assessment or the Ages & Stages Questionnaires: Social-Emotional for these domains are also needed.

Normal variations in temperament and patterns of attachment can affect many milestones including courage for walking, exploration, social engagement, and prosocial behaviors or self-control for social situations, attention, range of affect, and cooperation. All of these skills are among the 42 total (14 new) social-emotional milestones for 0- to 5-year-olds. Variations in these functions are at the root of the most common “challenging behaviors” in our studies in primary care. They are also the most vulnerable to suboptimal parent-child relationships, adverse childhood experiences, and social determinants of health.

As primary care providers, we not only need to detect children at risk for developmental problems but also promote and celebrate developmental progress. I hope that changing the threshold for concern to 75% will allow for a more positive review with the family (as fewer will be flagged as at risk) and chance to congratulate parents on all that is going well. But I also hope the change will not make us overlook parenting challenges, often from the psychosocial milestones most amenable to our guidance and support.

Early identification is mainly important to obtain the early intervention shown to improve outcomes. However, less than 25% of children with delays or disabilities receive early intervention before age 3 and most with emotional, behavioral, and developmental conditions, other than autism spectrum disorder, not before age 5. Since early intervention services are freely available in all states, we also need to do better at getting children to this care.

Let’s reconsider the process of developmental surveillance in this light of delayed referral: “Eliciting concerns” is key as parents have been shown to be usually correct in their worries. Listening to how they express the concerns can help you connect their specific issues when discussing reasons for referral. While most parent “recall of past milestones” is not accurate, current milestones reported are; thus, the need to have the new more accurate norms for all ages for comparison. When we make observations of a child’s abilities and behaviors ourselves we may not only pick up on issues missed by the parent, but will be more convincing in conveying the need for referral when indicated. When we “examine” the child we can use our professional skills to determine the very important risk factor of the quality of how a skill is performed, not just that it is. The recommended “use of validated screening tools” when the new milestones are not met give us an objective tool to share with parents, more confidence in when referral is warranted, which we will convey to parents (and perhaps skeptical relatives), and baseline documentation from which we can “track” referrals, progress, and, hopefully, better outcomes.

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. Email her at [email protected].

References

1. Zubler JM et al. Pediatrics. 2022;149(3):e2021052138.

2. Gessell A et al. Macmillan: New York, 1928.

3. Ertem IO et al. Lancet Glob Health. 2018 Mar;6(3):e279-91.

The American Academy of Pediatrics, with funding from the Centers for Disease Control and Prevention, studied the CDC’s “Learn the Signs. Act Early” developmental surveillance milestones for children 0-5 years to update the milestones based on published studies. The goal was to improve this tool for developmental surveillance and use by the public. Developmental surveillance is not just observing a child at a check-up but rather “is a longitudinal process that involves eliciting concerns, taking a developmental history based on milestone attainment, observing milestones and other behaviors, examining the child, and applying clinical judgment during health supervision visits (HSVs).”¹

While the milestones we were trained on were a good start and highlighted the developmental progression central to pediatrics, they were not based on norms or cut scores indicating significant developmental risk unless taught from a validated tool. The CDC was concerned that their public handouts and apps were based on median ages (middle number of the entire range) of attainment not the mode (most common) or even average ages. That means that about half of all typically developing children would “not have attained” that skill at the age noted, potentially evoking unnecessary concern for parents and a “wait-and-see” message from a knowledgeable provider who realized the statistical meaning and the broad range of normal. Another potential problem with using milestones set at the median age is that parents, especially those with several children or experienced friends, may see the provider as an alarmist when they have seen great variation in children who later were normal. This reaction can dampen provider willingness to discuss development or even to screen with validated tools. We have learned the hard way from COVID-19 that it is difficult to convey concepts of risk effectively both balancing fear and stimulating action.

The AAP experts reviewed the English literature for data-based milestones, finding 34 articles, 10 of which had an opinion for at least one milestone. If this sounds like a very small number, you are correct. You may not realize that almost all screening and diagnostic tools have been based on data collected by Gesell in 1928!² While most of health care has changed since then, which milestones are measured in infants has not.

The biggest change from this review was deciding to use as milestones skills reported for 75% of children at each age of typical HSVs, adding ones for 15 and 30 months. The implication is that children not attaining these milestones are all at risk and deserving of more careful history, examination, and administration of a validated screening tool; not true when based on median data. Of the 94 existing CDC milestones retained after the review, one-third were moved to a different age with 21 of 31 assigned to an older age. Domains of functioning for the milestones were consolidated into social emotional, cognitive, language/communication, and motor, to help parents learn to distinguish these areas, and, although many milestones reflect several domains, each was included only once to reduce confusion.

Psychosocial assessment is recommended by the AAP and Bright Futures at every HSV but the fewest milestones with normative data were identified for this domain, often self-help rather than social engagement or emotion regulation skills. The cross-cultural study cited for many of the new milestones was reassuring overall in that the median ages for 67%-88% of milestones in most domains were equivalent across the four countries sampled, but only 22% of self-help skills were equivalent.³ This should remind us that parenting has more influence over psychosocial skills than other domains. Psychosocial and behavioral functioning, especially emotional regulation, also deserve “surveillance” as they have enormous impact on life outcomes but need to be measured and supported differently. Routine use of validated tools such as the Early Childhood Screening Assessment or the Ages & Stages Questionnaires: Social-Emotional for these domains are also needed.

Normal variations in temperament and patterns of attachment can affect many milestones including courage for walking, exploration, social engagement, and prosocial behaviors or self-control for social situations, attention, range of affect, and cooperation. All of these skills are among the 42 total (14 new) social-emotional milestones for 0- to 5-year-olds. Variations in these functions are at the root of the most common “challenging behaviors” in our studies in primary care. They are also the most vulnerable to suboptimal parent-child relationships, adverse childhood experiences, and social determinants of health.

As primary care providers, we not only need to detect children at risk for developmental problems but also promote and celebrate developmental progress. I hope that changing the threshold for concern to 75% will allow for a more positive review with the family (as fewer will be flagged as at risk) and chance to congratulate parents on all that is going well. But I also hope the change will not make us overlook parenting challenges, often from the psychosocial milestones most amenable to our guidance and support.

Early identification is mainly important to obtain the early intervention shown to improve outcomes. However, less than 25% of children with delays or disabilities receive early intervention before age 3 and most with emotional, behavioral, and developmental conditions, other than autism spectrum disorder, not before age 5. Since early intervention services are freely available in all states, we also need to do better at getting children to this care.

Let’s reconsider the process of developmental surveillance in this light of delayed referral: “Eliciting concerns” is key as parents have been shown to be usually correct in their worries. Listening to how they express the concerns can help you connect their specific issues when discussing reasons for referral. While most parent “recall of past milestones” is not accurate, current milestones reported are; thus, the need to have the new more accurate norms for all ages for comparison. When we make observations of a child’s abilities and behaviors ourselves we may not only pick up on issues missed by the parent, but will be more convincing in conveying the need for referral when indicated. When we “examine” the child we can use our professional skills to determine the very important risk factor of the quality of how a skill is performed, not just that it is. The recommended “use of validated screening tools” when the new milestones are not met give us an objective tool to share with parents, more confidence in when referral is warranted, which we will convey to parents (and perhaps skeptical relatives), and baseline documentation from which we can “track” referrals, progress, and, hopefully, better outcomes.

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. Email her at [email protected].

References

1. Zubler JM et al. Pediatrics. 2022;149(3):e2021052138.

2. Gessell A et al. Macmillan: New York, 1928.

3. Ertem IO et al. Lancet Glob Health. 2018 Mar;6(3):e279-91.

The medical news is full of articles about the coming epidemic of dementia. How many people will have it in 10 years, 20 years, etc. It’s a very legitimate concern, and I am not going to make light of it, or disagree with the predictions.

In my everyday practice, though, I find there’s an epidemic of overdiagnosed dementia, in those who aren’t even close.

This occurs in a few ways:

Aricept is pretty inexpensive these days. Long off patent, insurance companies don’t bother to question its use anymore. So anyone older than 60 who complains of losing their car keys gets put on it. Why? Because patients want their doctors to DO SOMETHING. Even if the doctor knows that there’s really nothing of alarm going on, sometimes it’s easier to go with the placebo effect than argue. I think we’ve all done that before.

There are also a lot of nonneurologists in practice who still, after almost 30 years on the market, think Aricept improves memory, when in fact that’s far from the truth. The best it can claim to do is slow down the rate at which patients get worse, but nobody wants to hear that.

I’ve also seen Aricept used for pseudodementia due to depression. Actually, I’ve seen it used for depression, too. Sometimes it’s used to counteract the side effects dof drugs that can impair cognition, such as Topamax, even in patients who aren’t even remotely demented.

None of the above are a major issue on their own. Where the trouble really happens, as with so many other things, is when they collide with an EMR, or someone too rushed to take a history, or both.

Let’s say Mrs. Jones is on Aricept because she went into a room, then forgot why she did.

Then she gets admitted to the hospital for pneumonia. Or she changes doctors and, like many practices these days, her medications are put in the computer by an MA or secretary.

A lot of times just the mention of Aricept will automatically bring the assumption that the person is demented, so that gets punched in as a diagnosis and the patient is now believed to be unable to provide a reliable history. Or the person entering the info looks up its indication and enters “Alzheimer’s disease.”

Even worse is that I’ve seen EMRs where, in an effort to save time, the computer automatically enters diagnoses as you type medications in, and it’s up to the doctor to review them for accuracy. How that saves time I have no idea. But, as above, in these cases it’s going to lead to an entry of dementia where there isn’t any.

That, in particular, is pretty scary. As I wrote here in January of this year, what happens in the EMR stays in the EMR (kind of like Las Vegas).

I’m not knocking off-label use of medications. I don’t know a doctor who doesn’t use some that way, including myself.

But when doing so leads to the wrong assumptions and diagnoses it creates a lot of problems.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

The medical news is full of articles about the coming epidemic of dementia. How many people will have it in 10 years, 20 years, etc. It’s a very legitimate concern, and I am not going to make light of it, or disagree with the predictions.

In my everyday practice, though, I find there’s an epidemic of overdiagnosed dementia, in those who aren’t even close.

This occurs in a few ways:

Aricept is pretty inexpensive these days. Long off patent, insurance companies don’t bother to question its use anymore. So anyone older than 60 who complains of losing their car keys gets put on it. Why? Because patients want their doctors to DO SOMETHING. Even if the doctor knows that there’s really nothing of alarm going on, sometimes it’s easier to go with the placebo effect than argue. I think we’ve all done that before.

There are also a lot of nonneurologists in practice who still, after almost 30 years on the market, think Aricept improves memory, when in fact that’s far from the truth. The best it can claim to do is slow down the rate at which patients get worse, but nobody wants to hear that.

I’ve also seen Aricept used for pseudodementia due to depression. Actually, I’ve seen it used for depression, too. Sometimes it’s used to counteract the side effects dof drugs that can impair cognition, such as Topamax, even in patients who aren’t even remotely demented.

None of the above are a major issue on their own. Where the trouble really happens, as with so many other things, is when they collide with an EMR, or someone too rushed to take a history, or both.

Let’s say Mrs. Jones is on Aricept because she went into a room, then forgot why she did.

Then she gets admitted to the hospital for pneumonia. Or she changes doctors and, like many practices these days, her medications are put in the computer by an MA or secretary.

A lot of times just the mention of Aricept will automatically bring the assumption that the person is demented, so that gets punched in as a diagnosis and the patient is now believed to be unable to provide a reliable history. Or the person entering the info looks up its indication and enters “Alzheimer’s disease.”

Even worse is that I’ve seen EMRs where, in an effort to save time, the computer automatically enters diagnoses as you type medications in, and it’s up to the doctor to review them for accuracy. How that saves time I have no idea. But, as above, in these cases it’s going to lead to an entry of dementia where there isn’t any.

That, in particular, is pretty scary. As I wrote here in January of this year, what happens in the EMR stays in the EMR (kind of like Las Vegas).

I’m not knocking off-label use of medications. I don’t know a doctor who doesn’t use some that way, including myself.

But when doing so leads to the wrong assumptions and diagnoses it creates a lot of problems.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

The medical news is full of articles about the coming epidemic of dementia. How many people will have it in 10 years, 20 years, etc. It’s a very legitimate concern, and I am not going to make light of it, or disagree with the predictions.

In my everyday practice, though, I find there’s an epidemic of overdiagnosed dementia, in those who aren’t even close.

This occurs in a few ways:

Aricept is pretty inexpensive these days. Long off patent, insurance companies don’t bother to question its use anymore. So anyone older than 60 who complains of losing their car keys gets put on it. Why? Because patients want their doctors to DO SOMETHING. Even if the doctor knows that there’s really nothing of alarm going on, sometimes it’s easier to go with the placebo effect than argue. I think we’ve all done that before.

There are also a lot of nonneurologists in practice who still, after almost 30 years on the market, think Aricept improves memory, when in fact that’s far from the truth. The best it can claim to do is slow down the rate at which patients get worse, but nobody wants to hear that.

I’ve also seen Aricept used for pseudodementia due to depression. Actually, I’ve seen it used for depression, too. Sometimes it’s used to counteract the side effects dof drugs that can impair cognition, such as Topamax, even in patients who aren’t even remotely demented.

None of the above are a major issue on their own. Where the trouble really happens, as with so many other things, is when they collide with an EMR, or someone too rushed to take a history, or both.

Let’s say Mrs. Jones is on Aricept because she went into a room, then forgot why she did.

Then she gets admitted to the hospital for pneumonia. Or she changes doctors and, like many practices these days, her medications are put in the computer by an MA or secretary.

A lot of times just the mention of Aricept will automatically bring the assumption that the person is demented, so that gets punched in as a diagnosis and the patient is now believed to be unable to provide a reliable history. Or the person entering the info looks up its indication and enters “Alzheimer’s disease.”

Even worse is that I’ve seen EMRs where, in an effort to save time, the computer automatically enters diagnoses as you type medications in, and it’s up to the doctor to review them for accuracy. How that saves time I have no idea. But, as above, in these cases it’s going to lead to an entry of dementia where there isn’t any.

That, in particular, is pretty scary. As I wrote here in January of this year, what happens in the EMR stays in the EMR (kind of like Las Vegas).

I’m not knocking off-label use of medications. I don’t know a doctor who doesn’t use some that way, including myself.

But when doing so leads to the wrong assumptions and diagnoses it creates a lot of problems.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.