I am grateful for the opportunity to clarify and correct my recent commentary.¹ I wrote that the word provider was first used to refer to health care professionals during the 1930s in Nazi Germany, when Jewish physicians were termed Behandler. The cited manuscript stated that Behandler was “freely translated” as “provider.”² However, after reading social media comments that claimed this was a mistranslation, I sought to verify the translation.

Online German-English dictionaries yielded perplexing results. The dictionary Reverso translates Behandler as “dentist,” “practitioner,” or “therapist.”³ The Past Tenses Dictionary translates Behandler as “handlers.”⁴ Although a distasteful way to refer to a clinician-patient relationship, it still doesn’t translate as “provider.” The Collins and Cambridge dictionaries do not include Behandler, and the Langenscheidt dictionary does not provide a translation, instead noting that the translation “is missing” and that they are “verifying the word in question.”^5-7 Conversely, Anbieter appears to be the commonly provided German translation for provider.

The author of the original manuscript acknowledged that although Behandler is not listed as a translation for provider, it “comes close.”² He added that Behandler is not used anymore in German medicine because of the Nazi past (Saenger P, personal communication, February 9, 2022). A native German and Professor of German Studies at the University of Kentucky shared that “My best guess is that the term Behandler was used as a short form of Krankenbehandler, the designation for Jewish doctors in Nazi Germany who were still allowed to treat Jewish patients after withdrawal of their medical license. The best translations would be (health) practitioner or health care provider.” (Hobusch H, personal communication, 2022). However, Krankenbehandler has also been translated as “practitioner of the sick.”⁸

Given this ambiguity, it is ultimately unclear whether or to what extent Behandler can be translated as provider. Despite this uncertainty, my original argument remains unchanged. It is best to refer to all health care professionals (eg, psychotherapists, physicians, nurses, phlebotomists, pharmacists, physician assistants, social workers, physical therapists, dentists, optometrists) by their credentials. Overarching terms such as clinicians, practitioners, or health care professionals also are reasonable. This ensures accurate terminology, respects individuals’ unique training and degrees, and avoids confusion within multidisciplinary health care settings.

I thank Paul Saenger, MD, and Harald Höbusch, PhD, for their helpful insights, and those individuals who raised this concern on social media.

I am grateful for the opportunity to clarify and correct my recent commentary.¹ I wrote that the word provider was first used to refer to health care professionals during the 1930s in Nazi Germany, when Jewish physicians were termed Behandler. The cited manuscript stated that Behandler was “freely translated” as “provider.”² However, after reading social media comments that claimed this was a mistranslation, I sought to verify the translation.

Online German-English dictionaries yielded perplexing results. The dictionary Reverso translates Behandler as “dentist,” “practitioner,” or “therapist.”³ The Past Tenses Dictionary translates Behandler as “handlers.”⁴ Although a distasteful way to refer to a clinician-patient relationship, it still doesn’t translate as “provider.” The Collins and Cambridge dictionaries do not include Behandler, and the Langenscheidt dictionary does not provide a translation, instead noting that the translation “is missing” and that they are “verifying the word in question.”^5-7 Conversely, Anbieter appears to be the commonly provided German translation for provider.

The author of the original manuscript acknowledged that although Behandler is not listed as a translation for provider, it “comes close.”² He added that Behandler is not used anymore in German medicine because of the Nazi past (Saenger P, personal communication, February 9, 2022). A native German and Professor of German Studies at the University of Kentucky shared that “My best guess is that the term Behandler was used as a short form of Krankenbehandler, the designation for Jewish doctors in Nazi Germany who were still allowed to treat Jewish patients after withdrawal of their medical license. The best translations would be (health) practitioner or health care provider.” (Hobusch H, personal communication, 2022). However, Krankenbehandler has also been translated as “practitioner of the sick.”⁸

Given this ambiguity, it is ultimately unclear whether or to what extent Behandler can be translated as provider. Despite this uncertainty, my original argument remains unchanged. It is best to refer to all health care professionals (eg, psychotherapists, physicians, nurses, phlebotomists, pharmacists, physician assistants, social workers, physical therapists, dentists, optometrists) by their credentials. Overarching terms such as clinicians, practitioners, or health care professionals also are reasonable. This ensures accurate terminology, respects individuals’ unique training and degrees, and avoids confusion within multidisciplinary health care settings.

I thank Paul Saenger, MD, and Harald Höbusch, PhD, for their helpful insights, and those individuals who raised this concern on social media.

I am grateful for the opportunity to clarify and correct my recent commentary.¹ I wrote that the word provider was first used to refer to health care professionals during the 1930s in Nazi Germany, when Jewish physicians were termed Behandler. The cited manuscript stated that Behandler was “freely translated” as “provider.”² However, after reading social media comments that claimed this was a mistranslation, I sought to verify the translation.

Online German-English dictionaries yielded perplexing results. The dictionary Reverso translates Behandler as “dentist,” “practitioner,” or “therapist.”³ The Past Tenses Dictionary translates Behandler as “handlers.”⁴ Although a distasteful way to refer to a clinician-patient relationship, it still doesn’t translate as “provider.” The Collins and Cambridge dictionaries do not include Behandler, and the Langenscheidt dictionary does not provide a translation, instead noting that the translation “is missing” and that they are “verifying the word in question.”^5-7 Conversely, Anbieter appears to be the commonly provided German translation for provider.

The author of the original manuscript acknowledged that although Behandler is not listed as a translation for provider, it “comes close.”² He added that Behandler is not used anymore in German medicine because of the Nazi past (Saenger P, personal communication, February 9, 2022). A native German and Professor of German Studies at the University of Kentucky shared that “My best guess is that the term Behandler was used as a short form of Krankenbehandler, the designation for Jewish doctors in Nazi Germany who were still allowed to treat Jewish patients after withdrawal of their medical license. The best translations would be (health) practitioner or health care provider.” (Hobusch H, personal communication, 2022). However, Krankenbehandler has also been translated as “practitioner of the sick.”⁸

Given this ambiguity, it is ultimately unclear whether or to what extent Behandler can be translated as provider. Despite this uncertainty, my original argument remains unchanged. It is best to refer to all health care professionals (eg, psychotherapists, physicians, nurses, phlebotomists, pharmacists, physician assistants, social workers, physical therapists, dentists, optometrists) by their credentials. Overarching terms such as clinicians, practitioners, or health care professionals also are reasonable. This ensures accurate terminology, respects individuals’ unique training and degrees, and avoids confusion within multidisciplinary health care settings.

I thank Paul Saenger, MD, and Harald Höbusch, PhD, for their helpful insights, and those individuals who raised this concern on social media.

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.

Driving from his home in Asheville, N.C., to his new job at the tiny Cane Creek clinic, Benjamin Gilmer, MD, was eager to start his new life and pay off his medical school debts.

The rural clinic had been forced to close after his predecessor, family physician Vince Gilmer, MD, (no relation) had been convicted of first-degree murder 4 years earlier. He was serving a life sentence in a West Virginia prison without the possibility of parole. He is still behind bars and could not comment on this story.

As the months flew by, Benjamin Gilmer’s patients shared stories about the other Dr. Gilmer that surprised him. They described Vince Gilmer as a caring, generous person who went out of his way to help them. He made house calls, and if a patient couldn’t afford to pay him, he would accept a bushel of corn instead.

Yet there was no doubt about the gruesome murder. Vince Gilmer was convicted of strangling his frail 60-year-old father with a rope in his Toyota truck. He then cut off all his father’s fingers and dumped his father’s body by the side of the road.

“Four years later, his patients were still shocked about what happened and couldn’t reconcile the person they knew with the event that happened,” says Benjamin Gilmer.

Yet, Vince Gilmer had admitted to the killing, and the prosecution had presented evidence at the trial that it was premeditated and that he tried to cover up the crime. The detectives found the “murder” weapons in Vince’s truck: the ropes he strangled his father with and the garden shears that he cut off his fingers with. They also had evidence that he drove to Virginia to dump the body, returned to see patients for several days as if nothing had happened, and then ran away when a detective came to arrest him.

But something kept gnawing away at Benjamin Gilmer. Could there be a medical explanation for his sudden change in personality and behavior?

Little did he know that he would embark on a journey to solve a medical mystery, and then even fight to get the convicted killer out of prison.
 

Solving a medical mystery

Benjamin Gilmer decided to investigate what might have happened to Vince in the months leading up to the murder. He talked to his friends and found several clues about Vince’s medical history. They recalled that he suffered a concussion in a car accident 6 months before the murder, which suggested he could have had a traumatic brain injury.

Benjamin Gilmer also discovered that Vince’s father was diagnosed with schizophrenia and had been in a residential psychiatric facility in Virginia until he was released that fateful night to Vince’s custody.

Vince had written to friends that “something is wrong with my brain and help me.” He mentioned SSRI discontinuation syndrome because he abruptly stopped taking his medication the week of the murder (which can cause electric shock sensations and mood swings among other symptoms).

Vince had mentioned the SSRI discontinuation syndrome at his trial and that his father had sexually molested him for years and that he tried to molest him again during the ride in his truck. However, the court dismissed that information because Vince represented himself, dismissed his court-appointed attorneys, and lacked expert testimony about his mental state.

The prosecutor portrayed Vince as a lying sociopath who had planned his father’s murder down to the last detail. The judge agreed. Two psychiatrists and a psychologist who later evaluated him in prison concluded that he was faking his symptoms and denied his requests for an SSRI.

Meanwhile, Benjamin Gilmer became increasingly preoccupied with what happened to Vince. “It was hard to erase a memory that had so tainted that community,” he said.

When Sarah Koenig, a journalist and former producer of the radio program This American Life, called Benjamin Gilmer to interview him about the coincidence of taking over Vince Gilmer’s practice and sharing the same last name, he refused. “I was scared and didn’t want to be on his radar, I was afraid of how he might react.”

In spring 2012, he called Koenig and agreed to collaborate on an episode about Vince’s case. Benjamin Gilmer wrote to Vince Gilmer in prison, asking for a meeting. To his surprise, Vince wanted to meet them.

When Vince shuffled into the waiting area at the Wallens Ridge State Prison in West Virginia, Benjamin Gilmer was shocked by his appearance. “He looked like a caged animal, it was very hard for him to string together ideas and express himself, and he was twitching and shaking dramatically. He looked 20 years older than his actual age of 50 and like someone you would imagine in the movie One Flew Over the Cuckoo’s Nest,” said Benjamin Gilmer.

He felt that “there was something clearly wrong with him.” They agreed to a second meeting, and this time Benjamin Gilmer invited a psychiatrist, Steve Buie, MD, to observe Vince. As the visit ended and Vince turned to leave, Dr. Buie watched his shuffling gait. They suspected he may have Huntington’s disease, “which explained why he had delusions and his mind was unraveling,” says Benjamin Gilmer. But they had no way of testing him in prison.

Unexpectedly, an event happened that turned the whole case on its head. Vince was moved to a psychiatric hospital in southern Virginia because he had threatened to commit suicide. The chief psychiatrist, Colin Angliker, MD, was willing to order a genetic test, and the results confirmed the diagnosis: Vince Gilmer had a terminal degenerative brain disease.

Benjamin Gilmer worried how Vince would take the news. To his surprise, Vince was grateful and relieved. He finally knew what was wrong with him.

Vince also improved with the SSRI that Dr. Angliker prescribed — he was less anxious and more mentally alert. “He expressed joy for the first time, despite the death sentence of a diagnosis.”

Still, he was going to spend the rest of his life in prison for the crime he committed.

After the This American Life episode aired in 2013, Benjamin Gilmer felt that he couldn’t just abandon Vince to the prison system, where thousands of inmates with mental illness languish without adequate treatment.

Benjamin Gilmer decided he had a new — although controversial — mission — to get Vince out.
 

Confronting the politics of a pardon

After nearly a decade of trying, Benjamin Gilmer now admits that he was naive to think he could get him released quickly.

After the episode aired, offers of legal help started to arrive, and a team was assembled who agreed to work on the case pro bono. They wanted justice for Vince but also to prevent anyone else with mental illness from experiencing a similar tragedy.

The goal was to get Vince transferred to a secure hospital, a psychiatric facility dedicated to Huntington’s patients, or a nursing home with a dementia unit.

However, after realizing that Vince may not survive a potentially lengthy court battle, the legal team decided to ask the governor of Virginia to grant a clemency pardon.

They gathered the evidence for Vince’s case and presented their petition to Gov. Terry McAuliffe (D). He rejected it at the end of his term in 2017.

The team tried again with his successor, Gov. Ralph Northam (D), a neurologist. He dashed their hopes when he rejected their petition in late 2021.

That was a huge setback. The team had spent $1 million and had exhausted every contact they could make with the governor’s office, says Gilmer. “We were totally demoralized.”

He dreaded having to tell Vince that yet another governor had rejected their clemency petition. “I went to prison and could see the hopelessness and despair in his reaction. I lost it emotionally,” says Benjamin Gilmer.

Vince surprised him by hugging and comforting him and thanking him for all his efforts. They had developed a strong bond over a decade of visits and calls. Benjamin Gilmer had even brought his wife and children along on special occasions.

“I thought of him as a friend, as a patient, and someone who was really suffering, all those things helped our relationship evolve and kept me engaged with him all these years and continued to inspire me to fight for him. I also liked him because I knew what he was like before the murder from the stories I was hearing from his friends and patients.”

But his continuous advocacy came at a personal cost. “This battle pushed me to my limits emotionally and intellectually. I was busy building my career, trying to be a good doctor, teacher, husband, and father to two young children. I became so distracted that my wife confronted me several times about not being more emotionally present,” says Benjamin Gilmer.

But he knows that without Vince in his life, he would not have written his first book (released earlier this year) about the case and their unlikely friendship.
 

A pardon is finally granted

He had also given Gov. Northam’s staff advance copies of the book. In a highly unusual move, the governor reversed his previous rejection and granted Vince Gilmer his long-awaited pardon on January 12.

Benjamin Gilmer isn’t ready to celebrate yet. “Despite being a free man, Vince is still living behind bars because we haven’t been able to find him an available bed in a secure treatment facility. There has been a shortage of beds due to COVID.”

He says Vince is looking forward to being safe and being surrounded by people who are committed to caring for him and not punishing him. He can’t wait to be around his family and to give and receive hugs.

“After a while, it was hard not to believe that I was supposed to be in his path and this was just part of my destiny,” says Benjamin Gilmer.

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

Driving from his home in Asheville, N.C., to his new job at the tiny Cane Creek clinic, Benjamin Gilmer, MD, was eager to start his new life and pay off his medical school debts.

The rural clinic had been forced to close after his predecessor, family physician Vince Gilmer, MD, (no relation) had been convicted of first-degree murder 4 years earlier. He was serving a life sentence in a West Virginia prison without the possibility of parole. He is still behind bars and could not comment on this story.

As the months flew by, Benjamin Gilmer’s patients shared stories about the other Dr. Gilmer that surprised him. They described Vince Gilmer as a caring, generous person who went out of his way to help them. He made house calls, and if a patient couldn’t afford to pay him, he would accept a bushel of corn instead.

Yet there was no doubt about the gruesome murder. Vince Gilmer was convicted of strangling his frail 60-year-old father with a rope in his Toyota truck. He then cut off all his father’s fingers and dumped his father’s body by the side of the road.

“Four years later, his patients were still shocked about what happened and couldn’t reconcile the person they knew with the event that happened,” says Benjamin Gilmer.

Yet, Vince Gilmer had admitted to the killing, and the prosecution had presented evidence at the trial that it was premeditated and that he tried to cover up the crime. The detectives found the “murder” weapons in Vince’s truck: the ropes he strangled his father with and the garden shears that he cut off his fingers with. They also had evidence that he drove to Virginia to dump the body, returned to see patients for several days as if nothing had happened, and then ran away when a detective came to arrest him.

But something kept gnawing away at Benjamin Gilmer. Could there be a medical explanation for his sudden change in personality and behavior?

Little did he know that he would embark on a journey to solve a medical mystery, and then even fight to get the convicted killer out of prison.
 

Solving a medical mystery

Benjamin Gilmer decided to investigate what might have happened to Vince in the months leading up to the murder. He talked to his friends and found several clues about Vince’s medical history. They recalled that he suffered a concussion in a car accident 6 months before the murder, which suggested he could have had a traumatic brain injury.

Benjamin Gilmer also discovered that Vince’s father was diagnosed with schizophrenia and had been in a residential psychiatric facility in Virginia until he was released that fateful night to Vince’s custody.

Vince had written to friends that “something is wrong with my brain and help me.” He mentioned SSRI discontinuation syndrome because he abruptly stopped taking his medication the week of the murder (which can cause electric shock sensations and mood swings among other symptoms).

Vince had mentioned the SSRI discontinuation syndrome at his trial and that his father had sexually molested him for years and that he tried to molest him again during the ride in his truck. However, the court dismissed that information because Vince represented himself, dismissed his court-appointed attorneys, and lacked expert testimony about his mental state.

The prosecutor portrayed Vince as a lying sociopath who had planned his father’s murder down to the last detail. The judge agreed. Two psychiatrists and a psychologist who later evaluated him in prison concluded that he was faking his symptoms and denied his requests for an SSRI.

Meanwhile, Benjamin Gilmer became increasingly preoccupied with what happened to Vince. “It was hard to erase a memory that had so tainted that community,” he said.

When Sarah Koenig, a journalist and former producer of the radio program This American Life, called Benjamin Gilmer to interview him about the coincidence of taking over Vince Gilmer’s practice and sharing the same last name, he refused. “I was scared and didn’t want to be on his radar, I was afraid of how he might react.”

In spring 2012, he called Koenig and agreed to collaborate on an episode about Vince’s case. Benjamin Gilmer wrote to Vince Gilmer in prison, asking for a meeting. To his surprise, Vince wanted to meet them.

When Vince shuffled into the waiting area at the Wallens Ridge State Prison in West Virginia, Benjamin Gilmer was shocked by his appearance. “He looked like a caged animal, it was very hard for him to string together ideas and express himself, and he was twitching and shaking dramatically. He looked 20 years older than his actual age of 50 and like someone you would imagine in the movie One Flew Over the Cuckoo’s Nest,” said Benjamin Gilmer.

He felt that “there was something clearly wrong with him.” They agreed to a second meeting, and this time Benjamin Gilmer invited a psychiatrist, Steve Buie, MD, to observe Vince. As the visit ended and Vince turned to leave, Dr. Buie watched his shuffling gait. They suspected he may have Huntington’s disease, “which explained why he had delusions and his mind was unraveling,” says Benjamin Gilmer. But they had no way of testing him in prison.

Unexpectedly, an event happened that turned the whole case on its head. Vince was moved to a psychiatric hospital in southern Virginia because he had threatened to commit suicide. The chief psychiatrist, Colin Angliker, MD, was willing to order a genetic test, and the results confirmed the diagnosis: Vince Gilmer had a terminal degenerative brain disease.

Benjamin Gilmer worried how Vince would take the news. To his surprise, Vince was grateful and relieved. He finally knew what was wrong with him.

Vince also improved with the SSRI that Dr. Angliker prescribed — he was less anxious and more mentally alert. “He expressed joy for the first time, despite the death sentence of a diagnosis.”

Still, he was going to spend the rest of his life in prison for the crime he committed.

After the This American Life episode aired in 2013, Benjamin Gilmer felt that he couldn’t just abandon Vince to the prison system, where thousands of inmates with mental illness languish without adequate treatment.

Benjamin Gilmer decided he had a new — although controversial — mission — to get Vince out.
 

Confronting the politics of a pardon

After nearly a decade of trying, Benjamin Gilmer now admits that he was naive to think he could get him released quickly.

After the episode aired, offers of legal help started to arrive, and a team was assembled who agreed to work on the case pro bono. They wanted justice for Vince but also to prevent anyone else with mental illness from experiencing a similar tragedy.

The goal was to get Vince transferred to a secure hospital, a psychiatric facility dedicated to Huntington’s patients, or a nursing home with a dementia unit.

However, after realizing that Vince may not survive a potentially lengthy court battle, the legal team decided to ask the governor of Virginia to grant a clemency pardon.

They gathered the evidence for Vince’s case and presented their petition to Gov. Terry McAuliffe (D). He rejected it at the end of his term in 2017.

The team tried again with his successor, Gov. Ralph Northam (D), a neurologist. He dashed their hopes when he rejected their petition in late 2021.

That was a huge setback. The team had spent $1 million and had exhausted every contact they could make with the governor’s office, says Gilmer. “We were totally demoralized.”

He dreaded having to tell Vince that yet another governor had rejected their clemency petition. “I went to prison and could see the hopelessness and despair in his reaction. I lost it emotionally,” says Benjamin Gilmer.

Vince surprised him by hugging and comforting him and thanking him for all his efforts. They had developed a strong bond over a decade of visits and calls. Benjamin Gilmer had even brought his wife and children along on special occasions.

“I thought of him as a friend, as a patient, and someone who was really suffering, all those things helped our relationship evolve and kept me engaged with him all these years and continued to inspire me to fight for him. I also liked him because I knew what he was like before the murder from the stories I was hearing from his friends and patients.”

But his continuous advocacy came at a personal cost. “This battle pushed me to my limits emotionally and intellectually. I was busy building my career, trying to be a good doctor, teacher, husband, and father to two young children. I became so distracted that my wife confronted me several times about not being more emotionally present,” says Benjamin Gilmer.

But he knows that without Vince in his life, he would not have written his first book (released earlier this year) about the case and their unlikely friendship.
 

A pardon is finally granted

He had also given Gov. Northam’s staff advance copies of the book. In a highly unusual move, the governor reversed his previous rejection and granted Vince Gilmer his long-awaited pardon on January 12.

Benjamin Gilmer isn’t ready to celebrate yet. “Despite being a free man, Vince is still living behind bars because we haven’t been able to find him an available bed in a secure treatment facility. There has been a shortage of beds due to COVID.”

He says Vince is looking forward to being safe and being surrounded by people who are committed to caring for him and not punishing him. He can’t wait to be around his family and to give and receive hugs.

“After a while, it was hard not to believe that I was supposed to be in his path and this was just part of my destiny,” says Benjamin Gilmer.

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

Driving from his home in Asheville, N.C., to his new job at the tiny Cane Creek clinic, Benjamin Gilmer, MD, was eager to start his new life and pay off his medical school debts.

The rural clinic had been forced to close after his predecessor, family physician Vince Gilmer, MD, (no relation) had been convicted of first-degree murder 4 years earlier. He was serving a life sentence in a West Virginia prison without the possibility of parole. He is still behind bars and could not comment on this story.

As the months flew by, Benjamin Gilmer’s patients shared stories about the other Dr. Gilmer that surprised him. They described Vince Gilmer as a caring, generous person who went out of his way to help them. He made house calls, and if a patient couldn’t afford to pay him, he would accept a bushel of corn instead.

Yet there was no doubt about the gruesome murder. Vince Gilmer was convicted of strangling his frail 60-year-old father with a rope in his Toyota truck. He then cut off all his father’s fingers and dumped his father’s body by the side of the road.

“Four years later, his patients were still shocked about what happened and couldn’t reconcile the person they knew with the event that happened,” says Benjamin Gilmer.

Yet, Vince Gilmer had admitted to the killing, and the prosecution had presented evidence at the trial that it was premeditated and that he tried to cover up the crime. The detectives found the “murder” weapons in Vince’s truck: the ropes he strangled his father with and the garden shears that he cut off his fingers with. They also had evidence that he drove to Virginia to dump the body, returned to see patients for several days as if nothing had happened, and then ran away when a detective came to arrest him.

But something kept gnawing away at Benjamin Gilmer. Could there be a medical explanation for his sudden change in personality and behavior?

Little did he know that he would embark on a journey to solve a medical mystery, and then even fight to get the convicted killer out of prison.
 

Solving a medical mystery

Benjamin Gilmer decided to investigate what might have happened to Vince in the months leading up to the murder. He talked to his friends and found several clues about Vince’s medical history. They recalled that he suffered a concussion in a car accident 6 months before the murder, which suggested he could have had a traumatic brain injury.

Benjamin Gilmer also discovered that Vince’s father was diagnosed with schizophrenia and had been in a residential psychiatric facility in Virginia until he was released that fateful night to Vince’s custody.

Vince had written to friends that “something is wrong with my brain and help me.” He mentioned SSRI discontinuation syndrome because he abruptly stopped taking his medication the week of the murder (which can cause electric shock sensations and mood swings among other symptoms).

Vince had mentioned the SSRI discontinuation syndrome at his trial and that his father had sexually molested him for years and that he tried to molest him again during the ride in his truck. However, the court dismissed that information because Vince represented himself, dismissed his court-appointed attorneys, and lacked expert testimony about his mental state.

The prosecutor portrayed Vince as a lying sociopath who had planned his father’s murder down to the last detail. The judge agreed. Two psychiatrists and a psychologist who later evaluated him in prison concluded that he was faking his symptoms and denied his requests for an SSRI.

Meanwhile, Benjamin Gilmer became increasingly preoccupied with what happened to Vince. “It was hard to erase a memory that had so tainted that community,” he said.

When Sarah Koenig, a journalist and former producer of the radio program This American Life, called Benjamin Gilmer to interview him about the coincidence of taking over Vince Gilmer’s practice and sharing the same last name, he refused. “I was scared and didn’t want to be on his radar, I was afraid of how he might react.”

In spring 2012, he called Koenig and agreed to collaborate on an episode about Vince’s case. Benjamin Gilmer wrote to Vince Gilmer in prison, asking for a meeting. To his surprise, Vince wanted to meet them.

When Vince shuffled into the waiting area at the Wallens Ridge State Prison in West Virginia, Benjamin Gilmer was shocked by his appearance. “He looked like a caged animal, it was very hard for him to string together ideas and express himself, and he was twitching and shaking dramatically. He looked 20 years older than his actual age of 50 and like someone you would imagine in the movie One Flew Over the Cuckoo’s Nest,” said Benjamin Gilmer.

He felt that “there was something clearly wrong with him.” They agreed to a second meeting, and this time Benjamin Gilmer invited a psychiatrist, Steve Buie, MD, to observe Vince. As the visit ended and Vince turned to leave, Dr. Buie watched his shuffling gait. They suspected he may have Huntington’s disease, “which explained why he had delusions and his mind was unraveling,” says Benjamin Gilmer. But they had no way of testing him in prison.

Unexpectedly, an event happened that turned the whole case on its head. Vince was moved to a psychiatric hospital in southern Virginia because he had threatened to commit suicide. The chief psychiatrist, Colin Angliker, MD, was willing to order a genetic test, and the results confirmed the diagnosis: Vince Gilmer had a terminal degenerative brain disease.

Benjamin Gilmer worried how Vince would take the news. To his surprise, Vince was grateful and relieved. He finally knew what was wrong with him.

Vince also improved with the SSRI that Dr. Angliker prescribed — he was less anxious and more mentally alert. “He expressed joy for the first time, despite the death sentence of a diagnosis.”

Still, he was going to spend the rest of his life in prison for the crime he committed.

After the This American Life episode aired in 2013, Benjamin Gilmer felt that he couldn’t just abandon Vince to the prison system, where thousands of inmates with mental illness languish without adequate treatment.

Benjamin Gilmer decided he had a new — although controversial — mission — to get Vince out.
 

Confronting the politics of a pardon

After nearly a decade of trying, Benjamin Gilmer now admits that he was naive to think he could get him released quickly.

After the episode aired, offers of legal help started to arrive, and a team was assembled who agreed to work on the case pro bono. They wanted justice for Vince but also to prevent anyone else with mental illness from experiencing a similar tragedy.

The goal was to get Vince transferred to a secure hospital, a psychiatric facility dedicated to Huntington’s patients, or a nursing home with a dementia unit.

However, after realizing that Vince may not survive a potentially lengthy court battle, the legal team decided to ask the governor of Virginia to grant a clemency pardon.

They gathered the evidence for Vince’s case and presented their petition to Gov. Terry McAuliffe (D). He rejected it at the end of his term in 2017.

The team tried again with his successor, Gov. Ralph Northam (D), a neurologist. He dashed their hopes when he rejected their petition in late 2021.

That was a huge setback. The team had spent $1 million and had exhausted every contact they could make with the governor’s office, says Gilmer. “We were totally demoralized.”

He dreaded having to tell Vince that yet another governor had rejected their clemency petition. “I went to prison and could see the hopelessness and despair in his reaction. I lost it emotionally,” says Benjamin Gilmer.

Vince surprised him by hugging and comforting him and thanking him for all his efforts. They had developed a strong bond over a decade of visits and calls. Benjamin Gilmer had even brought his wife and children along on special occasions.

“I thought of him as a friend, as a patient, and someone who was really suffering, all those things helped our relationship evolve and kept me engaged with him all these years and continued to inspire me to fight for him. I also liked him because I knew what he was like before the murder from the stories I was hearing from his friends and patients.”

But his continuous advocacy came at a personal cost. “This battle pushed me to my limits emotionally and intellectually. I was busy building my career, trying to be a good doctor, teacher, husband, and father to two young children. I became so distracted that my wife confronted me several times about not being more emotionally present,” says Benjamin Gilmer.

But he knows that without Vince in his life, he would not have written his first book (released earlier this year) about the case and their unlikely friendship.
 

A pardon is finally granted

He had also given Gov. Northam’s staff advance copies of the book. In a highly unusual move, the governor reversed his previous rejection and granted Vince Gilmer his long-awaited pardon on January 12.

Benjamin Gilmer isn’t ready to celebrate yet. “Despite being a free man, Vince is still living behind bars because we haven’t been able to find him an available bed in a secure treatment facility. There has been a shortage of beds due to COVID.”

He says Vince is looking forward to being safe and being surrounded by people who are committed to caring for him and not punishing him. He can’t wait to be around his family and to give and receive hugs.

“After a while, it was hard not to believe that I was supposed to be in his path and this was just part of my destiny,” says Benjamin Gilmer.

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

Dr. Taylor: Endometriosis is a very common disease. Unfortunately, it's still widely under-recognized. It's estimated that perhaps up to 10% of reproductive age women have endometriosis, yet many are never diagnosed or diagnosed late. The average time that it takes for someone to be diagnosed is about 10 years; that is from the time they have classic symptoms of endometriosis until the time they get a definitive diagnosis and treatment.

I think it's very important that we recognize the clinical features of endometriosis. It's absolutely crucial if we want to shorten the time tom diagnosis. Often patients see multiple physicians before they get an accurate diagnosis. They're often dismissed by their early caregivers who are not very familiar with the disease.

For me, the most important feature is the pelvic pain. To identify endometriosis, I look specifically at the cyclic nature of the pelvic pain, and the progressive nature of the pelvic pain. Endometriosis is by far the most common reason that women have pelvic pain and initially it tends to be cyclic. It often starts as dysmenorrhea (painful periods), however it can progress to the point where pain occurs at times outside of menses. In fact, it can progress to the point where it's painful all the time. However, it almost always starts as dysmennorhea, and progresses.

Pelvic pain that someone had from their first menses on, i.e., from menarche, is less likely to be endometriosis than the pain that progresses and becomes worse or spreads to other times of the menstrual cycle. Endometriosis is a progressive disease, and that's one of the key distinctions in making me think somebody has endometriosis.

Most women with cyclic pelvic pain that gets worse over time, cyclic progressive pelvic pain, will have endometriosis. Those are the key features I look for.

It is also very important to recognize that endometriosis can have effects outside of the reproductive tract, can cause systemic inflammation, and impact other organ systems.  Bowel and bladder dysfunction are very common. If that is cyclic and coincides with the pelvic pain, it’s very likely to be secondary to endometriosis. It's important not to get distracted or mislead into making other diagnoses.

What are some of the common symptoms and how does that impact your diagnosis evaluation?

Dr. Taylor: The most common symptom we see is that cyclic pelvic pain I just discussed. Pain, often starting as dysmenorrhea, can go on to include pain outside of the time of menses and become more than just dysmenorrhea- pain in other areas.  The other common symptom is infertility. Many women with endometriosis do not have severe pain or may not have pain at all, but first present when they have trouble conceiving.

Endometriosis may be the cause of infertility. Sometimes we recognize that it's endometriosis when we do a physical exam or an ultrasound and find an endometrioma.  Cyclic pelvic pain is the classic symptom we look for, and infertility is another key symptom that we shouldn't forget.

Can you talk a little bit about empiric treatment, primarily what that means and how prevalent it is in your current practice?

Dr. Taylor: I think one of the problems we have today with the treatment of endometriosis is that it doesn't get recognized and doesn't get treated right away. When we talk about emperic treatment, it's usually ruling out other potential etiologies of pain. We must ensure no one has  have an infection, a tumor or other etiologies that are the cause of the pain, and not simply  presume that any cyclic progressive pelvic pain is endometriosis – however most of the time it will be due to endometriosis.

Usually with a good history, physical exam, and sometimes with addition of a transvaginal ultrasound, you can rule out other etiologies of pain, and have a very good idea that this pain is related to endometriosis. Based on clinical presentation, and without needing surgery, we can make a clinical diagnosis of endometriosis.

Clinical diagnosis allows patients to have this disease recognized earlier. It allows them to get into treatment sooner and reverses this trend that we've seen of delayed recognition.  This delay is especially difficult in  younger women in formative years in their life, when they're in school, when they're in an early stage of their career. If they're held back because of this debilitating pain, these are critical times and opportunities they really can't completely make up.

It's very important that we recognize endometriosis early. If we require a laparoscopy to make the diagnosis, the threshold becomes very high and we don't make the diagnosis. We miss a lot of women with endometriosis and don't treat them early.

There was time when our medical options were limited, and we wanted to be sure of our diagnosis. But these days, I think we can make a clinical diagnosis knowing that we have several treatment options that are relatively easy and safe for patients. Our first line therapy-- the first thing I use when I make the clinical diagnosis of endometriosis-- the first emperic treatment I would use is an oral contraceptive.

I prefer giving the oral contraceptive in a continuous fashion, rather than in a cyclic fashion. If someone has dysmenorrhea, why have menses at all? Retrograde menstruation is the etiology of most endometriosis. If we can eliminate menstruation, potentially it may be reducing endometriosis in the long run.

A lot of women with endometriosis will not respond to progestins—a phenomenon called progestin resistance—therefore, not everyone who has endometriosis will respond to an oral contraceptive. Probably about a third of patients either will not initially respond or will develop a resistance to a progestin and fail to respond in the long-term. Still others have side effects due to progestin therapy-- breast tenderness, mood changes, or a feeling of bloating are very common progestin related side effects.

We now have agents like oral GnRH antagonists that we can use as a second line treatment for those that either don't respond to progestins or those who have side effects from a progestin, including a progestin based oral contraceptive.  Additionally, in those with severe pain you may want to use something a little more aggressive.

GnRH antagonists are easy to use oral medications, with an immediate onset of action and are easily reversed.   We have come a long way from when we had to use an injectable GnRH agonist as the second line therapy. We have much simpler, easy, second line medications that we can turn to that makes empiric treatment a lot easier.

In the past, when we made a surgical diagnosis it was often because we were afraid of committing them to a long course of Depo GnRH agonist treatment;  we didn't use a lot of add back therapy and they had tremendous side effects and the risk of bone loss. Patients and their physicians were reluctant to use GnRH agonists.

Things have gotten a lot easier with oral contraceptives, that can be followed by GnRH antagonists, which are easy to use, simple medications that are very patient-friendly. I think we can make that clinical diagnosis. We can move to an empiric treatment, either first or second line with an oral contraceptive or a GnRH antagonist and easily treat these women without significant side effects. It is important that we advocate for women with cyclic pain, and recognize it more readily, clinically diagnosed it, and begin that empiric treatment.  That paradigm really has a huge impact on women's lives.

What recent advancements have been made in diagnosing and treating endometriosis?

Dr. Taylor: I think one of the biggest things that I see improving is recognition. Hopefully, we're narrowing that long delay by closing that time gap from initial symptoms to recognition. As we see public awareness grow, patients are recognizing and looking for answers, and thinking to themselves that they may have endometriosis.

Years ago, people were embarrassed to talk about menstruation, painful menstruation, pain with intercourse, pain with bowel movements. Thankfully, we're a more open society now and we can talk about these things. Women are starting to realize that they may have a problem where it was just dismissed before or perhaps, they were embarrassed to talk about it. I think we have seen a huge advancement. Physicians, as well, are recognizing endometriosis even more than before.

I think we're also much more accepting of this clinical diagnosis paradigm and empiric treatment. A lot of that, as we just said, comes from having better, easier to use drugs available that are much more patient-friendly. The GnRH antagonist elagolix is currently available for treatment of endometriosis in the United States. There are two more GnRH antagonists in the pipeline-- relugolix, which we expect to be approved shortly, and linzagolix which is undergoing phase three clinical trials now. Hopefully, we will have several of these second line drugs,  drugs which we can even use first line for severe endometriosis. Their availability is another huge advance.

I also think it is essential, that we don't put someone through surgery to recognize endometriosis. We must be better at taking a good history, doing an exam, and ultrasound when needed. You don't need a surgery to diagnose endometriosis. 

However,  we do still sometimes need surgery to treat endometriosis. Often, endometriosis will cause adhesions or scarring. These long-term sequelae of endometriosis can still require surgery. The medications we have available today are very good at stopping active disease. But the damage done from long-term endometriosis if we don’t treat may still require surgery. I'm hoping that the earlier we start treating people, the less damage will be done, and the less therapeutic surgeries needed. I think these changes are coming and are all very promising.

It would also be great if we had a non-invasive definitive diagnostic test. There are several of those under development, but nothing available yet. I suspect that we'll see those become available very shortly.

The other thing that we still need in the field is a treatment we can use for those women trying to get pregnant.  We use in vitro fertilization, which works very well in the endometriosis population. But a medical therapy that can suppress endometriosis and allow people to try to conceive without needing IVF is something I hope for in the future. A specific endometriosis therapy that is not hormonal, that targets the specific pathophysiology of endometriosis, is something that I'd like to see developed and many of us are currently working on.

I think there is a lot coming, but we've already moved the needle a long way. The GnRH antagonists have given us much more confidence in moving forward with clinical diagnosis and empiric treatment of this disease. It's a huge boon for women's health, allowing early recognition and preventing long-term complications of endometriosis.

Dr. Taylor: Endometriosis is a very common disease. Unfortunately, it's still widely under-recognized. It's estimated that perhaps up to 10% of reproductive age women have endometriosis, yet many are never diagnosed or diagnosed late. The average time that it takes for someone to be diagnosed is about 10 years; that is from the time they have classic symptoms of endometriosis until the time they get a definitive diagnosis and treatment.

I think it's very important that we recognize the clinical features of endometriosis. It's absolutely crucial if we want to shorten the time tom diagnosis. Often patients see multiple physicians before they get an accurate diagnosis. They're often dismissed by their early caregivers who are not very familiar with the disease.

For me, the most important feature is the pelvic pain. To identify endometriosis, I look specifically at the cyclic nature of the pelvic pain, and the progressive nature of the pelvic pain. Endometriosis is by far the most common reason that women have pelvic pain and initially it tends to be cyclic. It often starts as dysmenorrhea (painful periods), however it can progress to the point where pain occurs at times outside of menses. In fact, it can progress to the point where it's painful all the time. However, it almost always starts as dysmennorhea, and progresses.

Pelvic pain that someone had from their first menses on, i.e., from menarche, is less likely to be endometriosis than the pain that progresses and becomes worse or spreads to other times of the menstrual cycle. Endometriosis is a progressive disease, and that's one of the key distinctions in making me think somebody has endometriosis.

Most women with cyclic pelvic pain that gets worse over time, cyclic progressive pelvic pain, will have endometriosis. Those are the key features I look for.

It is also very important to recognize that endometriosis can have effects outside of the reproductive tract, can cause systemic inflammation, and impact other organ systems.  Bowel and bladder dysfunction are very common. If that is cyclic and coincides with the pelvic pain, it’s very likely to be secondary to endometriosis. It's important not to get distracted or mislead into making other diagnoses.

What are some of the common symptoms and how does that impact your diagnosis evaluation?

Dr. Taylor: The most common symptom we see is that cyclic pelvic pain I just discussed. Pain, often starting as dysmenorrhea, can go on to include pain outside of the time of menses and become more than just dysmenorrhea- pain in other areas.  The other common symptom is infertility. Many women with endometriosis do not have severe pain or may not have pain at all, but first present when they have trouble conceiving.

Endometriosis may be the cause of infertility. Sometimes we recognize that it's endometriosis when we do a physical exam or an ultrasound and find an endometrioma.  Cyclic pelvic pain is the classic symptom we look for, and infertility is another key symptom that we shouldn't forget.

Can you talk a little bit about empiric treatment, primarily what that means and how prevalent it is in your current practice?

Dr. Taylor: I think one of the problems we have today with the treatment of endometriosis is that it doesn't get recognized and doesn't get treated right away. When we talk about emperic treatment, it's usually ruling out other potential etiologies of pain. We must ensure no one has  have an infection, a tumor or other etiologies that are the cause of the pain, and not simply  presume that any cyclic progressive pelvic pain is endometriosis – however most of the time it will be due to endometriosis.

Usually with a good history, physical exam, and sometimes with addition of a transvaginal ultrasound, you can rule out other etiologies of pain, and have a very good idea that this pain is related to endometriosis. Based on clinical presentation, and without needing surgery, we can make a clinical diagnosis of endometriosis.

Clinical diagnosis allows patients to have this disease recognized earlier. It allows them to get into treatment sooner and reverses this trend that we've seen of delayed recognition.  This delay is especially difficult in  younger women in formative years in their life, when they're in school, when they're in an early stage of their career. If they're held back because of this debilitating pain, these are critical times and opportunities they really can't completely make up.

It's very important that we recognize endometriosis early. If we require a laparoscopy to make the diagnosis, the threshold becomes very high and we don't make the diagnosis. We miss a lot of women with endometriosis and don't treat them early.

There was time when our medical options were limited, and we wanted to be sure of our diagnosis. But these days, I think we can make a clinical diagnosis knowing that we have several treatment options that are relatively easy and safe for patients. Our first line therapy-- the first thing I use when I make the clinical diagnosis of endometriosis-- the first emperic treatment I would use is an oral contraceptive.

I prefer giving the oral contraceptive in a continuous fashion, rather than in a cyclic fashion. If someone has dysmenorrhea, why have menses at all? Retrograde menstruation is the etiology of most endometriosis. If we can eliminate menstruation, potentially it may be reducing endometriosis in the long run.

A lot of women with endometriosis will not respond to progestins—a phenomenon called progestin resistance—therefore, not everyone who has endometriosis will respond to an oral contraceptive. Probably about a third of patients either will not initially respond or will develop a resistance to a progestin and fail to respond in the long-term. Still others have side effects due to progestin therapy-- breast tenderness, mood changes, or a feeling of bloating are very common progestin related side effects.

We now have agents like oral GnRH antagonists that we can use as a second line treatment for those that either don't respond to progestins or those who have side effects from a progestin, including a progestin based oral contraceptive.  Additionally, in those with severe pain you may want to use something a little more aggressive.

GnRH antagonists are easy to use oral medications, with an immediate onset of action and are easily reversed.   We have come a long way from when we had to use an injectable GnRH agonist as the second line therapy. We have much simpler, easy, second line medications that we can turn to that makes empiric treatment a lot easier.

In the past, when we made a surgical diagnosis it was often because we were afraid of committing them to a long course of Depo GnRH agonist treatment;  we didn't use a lot of add back therapy and they had tremendous side effects and the risk of bone loss. Patients and their physicians were reluctant to use GnRH agonists.

Things have gotten a lot easier with oral contraceptives, that can be followed by GnRH antagonists, which are easy to use, simple medications that are very patient-friendly. I think we can make that clinical diagnosis. We can move to an empiric treatment, either first or second line with an oral contraceptive or a GnRH antagonist and easily treat these women without significant side effects. It is important that we advocate for women with cyclic pain, and recognize it more readily, clinically diagnosed it, and begin that empiric treatment.  That paradigm really has a huge impact on women's lives.

What recent advancements have been made in diagnosing and treating endometriosis?

Dr. Taylor: I think one of the biggest things that I see improving is recognition. Hopefully, we're narrowing that long delay by closing that time gap from initial symptoms to recognition. As we see public awareness grow, patients are recognizing and looking for answers, and thinking to themselves that they may have endometriosis.

Years ago, people were embarrassed to talk about menstruation, painful menstruation, pain with intercourse, pain with bowel movements. Thankfully, we're a more open society now and we can talk about these things. Women are starting to realize that they may have a problem where it was just dismissed before or perhaps, they were embarrassed to talk about it. I think we have seen a huge advancement. Physicians, as well, are recognizing endometriosis even more than before.

I think we're also much more accepting of this clinical diagnosis paradigm and empiric treatment. A lot of that, as we just said, comes from having better, easier to use drugs available that are much more patient-friendly. The GnRH antagonist elagolix is currently available for treatment of endometriosis in the United States. There are two more GnRH antagonists in the pipeline-- relugolix, which we expect to be approved shortly, and linzagolix which is undergoing phase three clinical trials now. Hopefully, we will have several of these second line drugs,  drugs which we can even use first line for severe endometriosis. Their availability is another huge advance.

I also think it is essential, that we don't put someone through surgery to recognize endometriosis. We must be better at taking a good history, doing an exam, and ultrasound when needed. You don't need a surgery to diagnose endometriosis. 

However,  we do still sometimes need surgery to treat endometriosis. Often, endometriosis will cause adhesions or scarring. These long-term sequelae of endometriosis can still require surgery. The medications we have available today are very good at stopping active disease. But the damage done from long-term endometriosis if we don’t treat may still require surgery. I'm hoping that the earlier we start treating people, the less damage will be done, and the less therapeutic surgeries needed. I think these changes are coming and are all very promising.

It would also be great if we had a non-invasive definitive diagnostic test. There are several of those under development, but nothing available yet. I suspect that we'll see those become available very shortly.

The other thing that we still need in the field is a treatment we can use for those women trying to get pregnant.  We use in vitro fertilization, which works very well in the endometriosis population. But a medical therapy that can suppress endometriosis and allow people to try to conceive without needing IVF is something I hope for in the future. A specific endometriosis therapy that is not hormonal, that targets the specific pathophysiology of endometriosis, is something that I'd like to see developed and many of us are currently working on.

I think there is a lot coming, but we've already moved the needle a long way. The GnRH antagonists have given us much more confidence in moving forward with clinical diagnosis and empiric treatment of this disease. It's a huge boon for women's health, allowing early recognition and preventing long-term complications of endometriosis.

Dr. Taylor: Endometriosis is a very common disease. Unfortunately, it's still widely under-recognized. It's estimated that perhaps up to 10% of reproductive age women have endometriosis, yet many are never diagnosed or diagnosed late. The average time that it takes for someone to be diagnosed is about 10 years; that is from the time they have classic symptoms of endometriosis until the time they get a definitive diagnosis and treatment.

I think it's very important that we recognize the clinical features of endometriosis. It's absolutely crucial if we want to shorten the time tom diagnosis. Often patients see multiple physicians before they get an accurate diagnosis. They're often dismissed by their early caregivers who are not very familiar with the disease.

For me, the most important feature is the pelvic pain. To identify endometriosis, I look specifically at the cyclic nature of the pelvic pain, and the progressive nature of the pelvic pain. Endometriosis is by far the most common reason that women have pelvic pain and initially it tends to be cyclic. It often starts as dysmenorrhea (painful periods), however it can progress to the point where pain occurs at times outside of menses. In fact, it can progress to the point where it's painful all the time. However, it almost always starts as dysmennorhea, and progresses.

Pelvic pain that someone had from their first menses on, i.e., from menarche, is less likely to be endometriosis than the pain that progresses and becomes worse or spreads to other times of the menstrual cycle. Endometriosis is a progressive disease, and that's one of the key distinctions in making me think somebody has endometriosis.

Most women with cyclic pelvic pain that gets worse over time, cyclic progressive pelvic pain, will have endometriosis. Those are the key features I look for.

It is also very important to recognize that endometriosis can have effects outside of the reproductive tract, can cause systemic inflammation, and impact other organ systems.  Bowel and bladder dysfunction are very common. If that is cyclic and coincides with the pelvic pain, it’s very likely to be secondary to endometriosis. It's important not to get distracted or mislead into making other diagnoses.

What are some of the common symptoms and how does that impact your diagnosis evaluation?

Dr. Taylor: The most common symptom we see is that cyclic pelvic pain I just discussed. Pain, often starting as dysmenorrhea, can go on to include pain outside of the time of menses and become more than just dysmenorrhea- pain in other areas.  The other common symptom is infertility. Many women with endometriosis do not have severe pain or may not have pain at all, but first present when they have trouble conceiving.

Endometriosis may be the cause of infertility. Sometimes we recognize that it's endometriosis when we do a physical exam or an ultrasound and find an endometrioma.  Cyclic pelvic pain is the classic symptom we look for, and infertility is another key symptom that we shouldn't forget.

Can you talk a little bit about empiric treatment, primarily what that means and how prevalent it is in your current practice?

Dr. Taylor: I think one of the problems we have today with the treatment of endometriosis is that it doesn't get recognized and doesn't get treated right away. When we talk about emperic treatment, it's usually ruling out other potential etiologies of pain. We must ensure no one has  have an infection, a tumor or other etiologies that are the cause of the pain, and not simply  presume that any cyclic progressive pelvic pain is endometriosis – however most of the time it will be due to endometriosis.

Usually with a good history, physical exam, and sometimes with addition of a transvaginal ultrasound, you can rule out other etiologies of pain, and have a very good idea that this pain is related to endometriosis. Based on clinical presentation, and without needing surgery, we can make a clinical diagnosis of endometriosis.

Clinical diagnosis allows patients to have this disease recognized earlier. It allows them to get into treatment sooner and reverses this trend that we've seen of delayed recognition.  This delay is especially difficult in  younger women in formative years in their life, when they're in school, when they're in an early stage of their career. If they're held back because of this debilitating pain, these are critical times and opportunities they really can't completely make up.

It's very important that we recognize endometriosis early. If we require a laparoscopy to make the diagnosis, the threshold becomes very high and we don't make the diagnosis. We miss a lot of women with endometriosis and don't treat them early.

There was time when our medical options were limited, and we wanted to be sure of our diagnosis. But these days, I think we can make a clinical diagnosis knowing that we have several treatment options that are relatively easy and safe for patients. Our first line therapy-- the first thing I use when I make the clinical diagnosis of endometriosis-- the first emperic treatment I would use is an oral contraceptive.

I prefer giving the oral contraceptive in a continuous fashion, rather than in a cyclic fashion. If someone has dysmenorrhea, why have menses at all? Retrograde menstruation is the etiology of most endometriosis. If we can eliminate menstruation, potentially it may be reducing endometriosis in the long run.

A lot of women with endometriosis will not respond to progestins—a phenomenon called progestin resistance—therefore, not everyone who has endometriosis will respond to an oral contraceptive. Probably about a third of patients either will not initially respond or will develop a resistance to a progestin and fail to respond in the long-term. Still others have side effects due to progestin therapy-- breast tenderness, mood changes, or a feeling of bloating are very common progestin related side effects.

We now have agents like oral GnRH antagonists that we can use as a second line treatment for those that either don't respond to progestins or those who have side effects from a progestin, including a progestin based oral contraceptive.  Additionally, in those with severe pain you may want to use something a little more aggressive.

GnRH antagonists are easy to use oral medications, with an immediate onset of action and are easily reversed.   We have come a long way from when we had to use an injectable GnRH agonist as the second line therapy. We have much simpler, easy, second line medications that we can turn to that makes empiric treatment a lot easier.

In the past, when we made a surgical diagnosis it was often because we were afraid of committing them to a long course of Depo GnRH agonist treatment;  we didn't use a lot of add back therapy and they had tremendous side effects and the risk of bone loss. Patients and their physicians were reluctant to use GnRH agonists.

Things have gotten a lot easier with oral contraceptives, that can be followed by GnRH antagonists, which are easy to use, simple medications that are very patient-friendly. I think we can make that clinical diagnosis. We can move to an empiric treatment, either first or second line with an oral contraceptive or a GnRH antagonist and easily treat these women without significant side effects. It is important that we advocate for women with cyclic pain, and recognize it more readily, clinically diagnosed it, and begin that empiric treatment.  That paradigm really has a huge impact on women's lives.

What recent advancements have been made in diagnosing and treating endometriosis?

Dr. Taylor: I think one of the biggest things that I see improving is recognition. Hopefully, we're narrowing that long delay by closing that time gap from initial symptoms to recognition. As we see public awareness grow, patients are recognizing and looking for answers, and thinking to themselves that they may have endometriosis.

Years ago, people were embarrassed to talk about menstruation, painful menstruation, pain with intercourse, pain with bowel movements. Thankfully, we're a more open society now and we can talk about these things. Women are starting to realize that they may have a problem where it was just dismissed before or perhaps, they were embarrassed to talk about it. I think we have seen a huge advancement. Physicians, as well, are recognizing endometriosis even more than before.

I think we're also much more accepting of this clinical diagnosis paradigm and empiric treatment. A lot of that, as we just said, comes from having better, easier to use drugs available that are much more patient-friendly. The GnRH antagonist elagolix is currently available for treatment of endometriosis in the United States. There are two more GnRH antagonists in the pipeline-- relugolix, which we expect to be approved shortly, and linzagolix which is undergoing phase three clinical trials now. Hopefully, we will have several of these second line drugs,  drugs which we can even use first line for severe endometriosis. Their availability is another huge advance.

I also think it is essential, that we don't put someone through surgery to recognize endometriosis. We must be better at taking a good history, doing an exam, and ultrasound when needed. You don't need a surgery to diagnose endometriosis. 

However,  we do still sometimes need surgery to treat endometriosis. Often, endometriosis will cause adhesions or scarring. These long-term sequelae of endometriosis can still require surgery. The medications we have available today are very good at stopping active disease. But the damage done from long-term endometriosis if we don’t treat may still require surgery. I'm hoping that the earlier we start treating people, the less damage will be done, and the less therapeutic surgeries needed. I think these changes are coming and are all very promising.

It would also be great if we had a non-invasive definitive diagnostic test. There are several of those under development, but nothing available yet. I suspect that we'll see those become available very shortly.

The other thing that we still need in the field is a treatment we can use for those women trying to get pregnant.  We use in vitro fertilization, which works very well in the endometriosis population. But a medical therapy that can suppress endometriosis and allow people to try to conceive without needing IVF is something I hope for in the future. A specific endometriosis therapy that is not hormonal, that targets the specific pathophysiology of endometriosis, is something that I'd like to see developed and many of us are currently working on.

I think there is a lot coming, but we've already moved the needle a long way. The GnRH antagonists have given us much more confidence in moving forward with clinical diagnosis and empiric treatment of this disease. It's a huge boon for women's health, allowing early recognition and preventing long-term complications of endometriosis.

Between 2014 and 2020, the frequency of adverse pregnancy outcomes in the United States increased among women with gestational diabetes, with persisting differences in adverse outcomes by race and ethnicity, according to a report in JAMA

“[Previous] population-based studies on racial and ethnic disparities in gestational diabetes have focused on differences in the rate of diagnosis, rather than adverse pregnancy outcomes,” lead author Kartik K. Venkatesh, MD, PhD, of Ohio State University, Columbus, and colleagues explained.

The researchers conducted a cross-sectional, descriptive study to evaluate whether the frequency of adverse pregnancy outcomes with gestational diabetes changed over time and whether the risk of these outcomes differed by maternal race and ethnicity.

The data were obtained from the Centers for Disease Control and Prevention’s National Center for Health Statistics Natality Files. Exposures of interest were year of delivery, as well as race and ethnicity.
 

Results

The study cohort included 1,560,822 pregnant women with gestational diabetes aged 15-44 years. Among the study participants the mean age was 31 years (standard deviation, 5.5 years) and the majority were White (48%), followed by Hispanic/Latina (27%), Asian/Pacific Islander (13%), and Black (12%).

There was a significant increase in the overall frequency of transfusion (8.0%; 95% confidence interval, 3.8%-12.4%), preeclampsia or gestational hypertension (4.2%; 95% CI, 3.3%-5.2%), NICU admission (1.0%; 95% CI, 0.3%-1.7%), and preterm birth at less than 37 weeks (0.9%; 95% CI, 0.3%-1.5%) from 2014 to 2020 for these women and their infants.

In addition, there was a significant decrease in the following outcomes: macrosomia (–4.7%; 95% CI, –5.3% to –4.0%), cesarean delivery (–1.4%; 95% CI, –1.7% to –1.1%), primary cesarean delivery (–1.2%; 95% CI, –1.5% to –0.9%), and large for gestational age (–2.3%; 95% CI, –2.8% to –1.8%), but there was no significant differences in maternal ICU admission and small-for-gestational-age infants.

From 2014 through 2020, differences in adverse outcomes by race and ethnicity persisted; in comparison with Whites, Black participants were at significantly higher risk of all evaluated outcomes, except for macrosomia and large for gestational age.

Hispanic/Latina and Asian/Pacific Islander individuals were also at significantly higher risk of preterm birth, NICU admission, maternal ICU admission, and small for gestational age. Furthermore, American Indian participants were at significantly higher risk of all evaluated outcomes, except for cesarean delivery and small for gestational age.
 

Results in context

Health policy researcher Felicia Hill-Briggs, PhD, at the Feinstein Institutes for Medical Research in Manhasset, N.Y. commented: “Two alarming trends highlighted by this study: 1) Racial and ethnic inequities in adverse gestational diabetes outcomes; and 2) the rising rates of gestational diabetes overall – both must and can be halted.”

“Optimizing medical management of gestational diabetes, whether through improved access to diabetes care in pregnancy, behavioral interventions, and pharmacotherapy can decrease the risk of adverse pregnancy outcomes,” Dr. Venkatesh commented. “It is possible that the equitable delivery of these interventions to address glycemic control could decrease racial and ethnic disparities in adverse pregnancy outcomes among individuals with gestational diabetes.”

Dr. Venkatesh and his colleagues acknowledged that a key limitation of the study was the use of administrative data; thus, inferences on maternal care improvements could not be determined.

“Further research could focus on greater understanding of racial and ethnic differences in the management of gestational diabetes,” the researchers concluded.

This study was supported by the Care Innovation and Community Improvement Program at Ohio State University. One author reported receiving grants from the National Institutes of Health outside of this study. The other authors reported no relevant disclosures. Dr. Hill-Briggs had no relevant disclosures.

Between 2014 and 2020, the frequency of adverse pregnancy outcomes in the United States increased among women with gestational diabetes, with persisting differences in adverse outcomes by race and ethnicity, according to a report in JAMA

“[Previous] population-based studies on racial and ethnic disparities in gestational diabetes have focused on differences in the rate of diagnosis, rather than adverse pregnancy outcomes,” lead author Kartik K. Venkatesh, MD, PhD, of Ohio State University, Columbus, and colleagues explained.

The researchers conducted a cross-sectional, descriptive study to evaluate whether the frequency of adverse pregnancy outcomes with gestational diabetes changed over time and whether the risk of these outcomes differed by maternal race and ethnicity.

The data were obtained from the Centers for Disease Control and Prevention’s National Center for Health Statistics Natality Files. Exposures of interest were year of delivery, as well as race and ethnicity.
 

Results

The study cohort included 1,560,822 pregnant women with gestational diabetes aged 15-44 years. Among the study participants the mean age was 31 years (standard deviation, 5.5 years) and the majority were White (48%), followed by Hispanic/Latina (27%), Asian/Pacific Islander (13%), and Black (12%).

There was a significant increase in the overall frequency of transfusion (8.0%; 95% confidence interval, 3.8%-12.4%), preeclampsia or gestational hypertension (4.2%; 95% CI, 3.3%-5.2%), NICU admission (1.0%; 95% CI, 0.3%-1.7%), and preterm birth at less than 37 weeks (0.9%; 95% CI, 0.3%-1.5%) from 2014 to 2020 for these women and their infants.

In addition, there was a significant decrease in the following outcomes: macrosomia (–4.7%; 95% CI, –5.3% to –4.0%), cesarean delivery (–1.4%; 95% CI, –1.7% to –1.1%), primary cesarean delivery (–1.2%; 95% CI, –1.5% to –0.9%), and large for gestational age (–2.3%; 95% CI, –2.8% to –1.8%), but there was no significant differences in maternal ICU admission and small-for-gestational-age infants.

From 2014 through 2020, differences in adverse outcomes by race and ethnicity persisted; in comparison with Whites, Black participants were at significantly higher risk of all evaluated outcomes, except for macrosomia and large for gestational age.

Hispanic/Latina and Asian/Pacific Islander individuals were also at significantly higher risk of preterm birth, NICU admission, maternal ICU admission, and small for gestational age. Furthermore, American Indian participants were at significantly higher risk of all evaluated outcomes, except for cesarean delivery and small for gestational age.
 

Results in context

Health policy researcher Felicia Hill-Briggs, PhD, at the Feinstein Institutes for Medical Research in Manhasset, N.Y. commented: “Two alarming trends highlighted by this study: 1) Racial and ethnic inequities in adverse gestational diabetes outcomes; and 2) the rising rates of gestational diabetes overall – both must and can be halted.”

“Optimizing medical management of gestational diabetes, whether through improved access to diabetes care in pregnancy, behavioral interventions, and pharmacotherapy can decrease the risk of adverse pregnancy outcomes,” Dr. Venkatesh commented. “It is possible that the equitable delivery of these interventions to address glycemic control could decrease racial and ethnic disparities in adverse pregnancy outcomes among individuals with gestational diabetes.”

Dr. Venkatesh and his colleagues acknowledged that a key limitation of the study was the use of administrative data; thus, inferences on maternal care improvements could not be determined.

“Further research could focus on greater understanding of racial and ethnic differences in the management of gestational diabetes,” the researchers concluded.

This study was supported by the Care Innovation and Community Improvement Program at Ohio State University. One author reported receiving grants from the National Institutes of Health outside of this study. The other authors reported no relevant disclosures. Dr. Hill-Briggs had no relevant disclosures.

Between 2014 and 2020, the frequency of adverse pregnancy outcomes in the United States increased among women with gestational diabetes, with persisting differences in adverse outcomes by race and ethnicity, according to a report in JAMA

“[Previous] population-based studies on racial and ethnic disparities in gestational diabetes have focused on differences in the rate of diagnosis, rather than adverse pregnancy outcomes,” lead author Kartik K. Venkatesh, MD, PhD, of Ohio State University, Columbus, and colleagues explained.

The researchers conducted a cross-sectional, descriptive study to evaluate whether the frequency of adverse pregnancy outcomes with gestational diabetes changed over time and whether the risk of these outcomes differed by maternal race and ethnicity.

The data were obtained from the Centers for Disease Control and Prevention’s National Center for Health Statistics Natality Files. Exposures of interest were year of delivery, as well as race and ethnicity.
 

Results

The study cohort included 1,560,822 pregnant women with gestational diabetes aged 15-44 years. Among the study participants the mean age was 31 years (standard deviation, 5.5 years) and the majority were White (48%), followed by Hispanic/Latina (27%), Asian/Pacific Islander (13%), and Black (12%).

There was a significant increase in the overall frequency of transfusion (8.0%; 95% confidence interval, 3.8%-12.4%), preeclampsia or gestational hypertension (4.2%; 95% CI, 3.3%-5.2%), NICU admission (1.0%; 95% CI, 0.3%-1.7%), and preterm birth at less than 37 weeks (0.9%; 95% CI, 0.3%-1.5%) from 2014 to 2020 for these women and their infants.

In addition, there was a significant decrease in the following outcomes: macrosomia (–4.7%; 95% CI, –5.3% to –4.0%), cesarean delivery (–1.4%; 95% CI, –1.7% to –1.1%), primary cesarean delivery (–1.2%; 95% CI, –1.5% to –0.9%), and large for gestational age (–2.3%; 95% CI, –2.8% to –1.8%), but there was no significant differences in maternal ICU admission and small-for-gestational-age infants.

From 2014 through 2020, differences in adverse outcomes by race and ethnicity persisted; in comparison with Whites, Black participants were at significantly higher risk of all evaluated outcomes, except for macrosomia and large for gestational age.

Hispanic/Latina and Asian/Pacific Islander individuals were also at significantly higher risk of preterm birth, NICU admission, maternal ICU admission, and small for gestational age. Furthermore, American Indian participants were at significantly higher risk of all evaluated outcomes, except for cesarean delivery and small for gestational age.
 

Results in context

Health policy researcher Felicia Hill-Briggs, PhD, at the Feinstein Institutes for Medical Research in Manhasset, N.Y. commented: “Two alarming trends highlighted by this study: 1) Racial and ethnic inequities in adverse gestational diabetes outcomes; and 2) the rising rates of gestational diabetes overall – both must and can be halted.”

“Optimizing medical management of gestational diabetes, whether through improved access to diabetes care in pregnancy, behavioral interventions, and pharmacotherapy can decrease the risk of adverse pregnancy outcomes,” Dr. Venkatesh commented. “It is possible that the equitable delivery of these interventions to address glycemic control could decrease racial and ethnic disparities in adverse pregnancy outcomes among individuals with gestational diabetes.”

Dr. Venkatesh and his colleagues acknowledged that a key limitation of the study was the use of administrative data; thus, inferences on maternal care improvements could not be determined.

“Further research could focus on greater understanding of racial and ethnic differences in the management of gestational diabetes,” the researchers concluded.

This study was supported by the Care Innovation and Community Improvement Program at Ohio State University. One author reported receiving grants from the National Institutes of Health outside of this study. The other authors reported no relevant disclosures. Dr. Hill-Briggs had no relevant disclosures.

Compared with White people, Black people are less likely to develop cirrhosis from nonalcoholic steatohepatitis (NASH) but are more likely to die when hospitalized with this condition, researchers say.

The finding highlights the importance of addressing hepatic complications and nonhepatic comorbidities with a comprehensive and interdisciplinary approach that includes social determinants of health, said Emad Qayed, MD, MPH, an associate professor of medicine at Emory University School of Medicine, Atlanta.

“Clinicians should realize that in Black patients with NASH and NASH cirrhosis, mortality can be high despite a low rate of hepatic complications,” he told this news organization.

The study by Dr. Qayed and colleagues was published in the Journal of Clinical Gastroenterology.
 

A nationwide analysis

Previous studies have indicated that Black people are less likely than White people to develop nonalcoholic fatty liver disease (NAFLD), despite the fact that prevalence is increasing. Furthermore, when Black people do develop NAFLD, the disease is less likely to progress to NASH. In cases in which NASH does develop, the evidence has been mixed as to the effect of race on hospital outcomes.

To shed new light on that question, Dr. Qayed and colleagues analyzed data from 2016 to 2018 from the National Inpatient Sample, which is produced by the Healthcare Cost and Utilization Project and is sponsored by the Agency of Healthcare Research and Quality.

They identified 43,409 hospitalizations for NASH, with 41,143 White patients and 2,266 Black patients. The mean age of the Black patients was less than that of the White patients (56.4 years vs. 63.0 years), and Black patients were more likely to be women (69.9% vs. 61.6%).

More of the Black patients had hypertension, obesity, chronic kidney disease, and congestive heart failure, while more of the White patients had diabetes, dyslipidemia, and ischemic heart disease.

Among the Black patients, 33.6% had cirrhosis, compared with 56.4% of the White patients. Likewise, among the Black patients, there were fewer manifestations of decompensated cirrhosis, compared with the White patients. Black patients were also less likely to have had to undergo upper endoscopy and paracentesis.

The Black patients died in the hospital at a rate of 3.9%, which was not significantly higher than the 3.7% rate for the White patients (unadjusted odds ratio = 1.06; 95% confidence interval: 0.84-1.32; P = .6). But, when the researchers adjusted for age, sex, cirrhosis, risk of mortality (based on the overall number and severity of diseases), and insurance status, there were significantly higher odds of mortality among the Black patients (adjusted OR, 1.34; 95% CI: 1.05-1.71; P = .018).

They did not find any association between hospital size, location, or region with mortality.

They also found no difference in mortality between Black patients and White patients among those those with and those without cirrhosis. However, they found that Black patients were more likely to have acute kidney injury, chronic kidney disease, and congestive heart failure.

Regarding the reasons for hospitalization, the researchers found liver-related illnesses, such as hepatic failure and noninfectious hepatitis, to be most common among the White patients. Circulatory disorders, such as heart failure, and endocrine disorders, such as diabetes mellitus with complications, were found to be most common among the Black patients.

The length of time in the hospital was longer for the Black patients than the White patients (6.3 days vs. 5.6 days; P < .0001). The cost of hospitalization was higher for Black patients as well ($18,603 vs. $17,467). This suggests that Black patients were sicker overall, despite their lower rates of liver complications.

“Some of these differences are likely related to socioeconomic factors and clinical comorbidities, such as cardiac and renal disease,” Dr. Qayed said. “However, the underlying etiologies for such disparities in NASH and cirrhosis remain unclear. Further research is warranted to clarify these etiologies.”
 

NASH as part of the metabolic syndrome

“Clinicians should consider NASH as part of the metabolic syndrome,” Paul Martin, MD, chief of digestive health and liver diseases at the University of Miami, told this news organization. He was not involved in the study.

“Typically, these patients have a number of risk factors for fatty liver, including obesity and often hyperlipidemia, hypertension, and sleep apnea,” he said. “Clinicians should screen their patients for such comorbidities and then treat them.”

Genetic factors could also play a role in the difference in susceptibility to fatty liver disease found between Black and White patients, he added.

Dr. Martin noted a prevalence of fatty liver in many Hispanic populations and that it is found in Asia but sometimes in the absence of the risk factors associated with it in the United States.

Dr. Qayed and Dr. Martin reported no relevant financial relationships.

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

Compared with White people, Black people are less likely to develop cirrhosis from nonalcoholic steatohepatitis (NASH) but are more likely to die when hospitalized with this condition, researchers say.

The finding highlights the importance of addressing hepatic complications and nonhepatic comorbidities with a comprehensive and interdisciplinary approach that includes social determinants of health, said Emad Qayed, MD, MPH, an associate professor of medicine at Emory University School of Medicine, Atlanta.

“Clinicians should realize that in Black patients with NASH and NASH cirrhosis, mortality can be high despite a low rate of hepatic complications,” he told this news organization.

The study by Dr. Qayed and colleagues was published in the Journal of Clinical Gastroenterology.
 

A nationwide analysis

Previous studies have indicated that Black people are less likely than White people to develop nonalcoholic fatty liver disease (NAFLD), despite the fact that prevalence is increasing. Furthermore, when Black people do develop NAFLD, the disease is less likely to progress to NASH. In cases in which NASH does develop, the evidence has been mixed as to the effect of race on hospital outcomes.

To shed new light on that question, Dr. Qayed and colleagues analyzed data from 2016 to 2018 from the National Inpatient Sample, which is produced by the Healthcare Cost and Utilization Project and is sponsored by the Agency of Healthcare Research and Quality.

They identified 43,409 hospitalizations for NASH, with 41,143 White patients and 2,266 Black patients. The mean age of the Black patients was less than that of the White patients (56.4 years vs. 63.0 years), and Black patients were more likely to be women (69.9% vs. 61.6%).

More of the Black patients had hypertension, obesity, chronic kidney disease, and congestive heart failure, while more of the White patients had diabetes, dyslipidemia, and ischemic heart disease.

Among the Black patients, 33.6% had cirrhosis, compared with 56.4% of the White patients. Likewise, among the Black patients, there were fewer manifestations of decompensated cirrhosis, compared with the White patients. Black patients were also less likely to have had to undergo upper endoscopy and paracentesis.

The Black patients died in the hospital at a rate of 3.9%, which was not significantly higher than the 3.7% rate for the White patients (unadjusted odds ratio = 1.06; 95% confidence interval: 0.84-1.32; P = .6). But, when the researchers adjusted for age, sex, cirrhosis, risk of mortality (based on the overall number and severity of diseases), and insurance status, there were significantly higher odds of mortality among the Black patients (adjusted OR, 1.34; 95% CI: 1.05-1.71; P = .018).

They did not find any association between hospital size, location, or region with mortality.

They also found no difference in mortality between Black patients and White patients among those those with and those without cirrhosis. However, they found that Black patients were more likely to have acute kidney injury, chronic kidney disease, and congestive heart failure.

Regarding the reasons for hospitalization, the researchers found liver-related illnesses, such as hepatic failure and noninfectious hepatitis, to be most common among the White patients. Circulatory disorders, such as heart failure, and endocrine disorders, such as diabetes mellitus with complications, were found to be most common among the Black patients.

The length of time in the hospital was longer for the Black patients than the White patients (6.3 days vs. 5.6 days; P < .0001). The cost of hospitalization was higher for Black patients as well ($18,603 vs. $17,467). This suggests that Black patients were sicker overall, despite their lower rates of liver complications.

“Some of these differences are likely related to socioeconomic factors and clinical comorbidities, such as cardiac and renal disease,” Dr. Qayed said. “However, the underlying etiologies for such disparities in NASH and cirrhosis remain unclear. Further research is warranted to clarify these etiologies.”
 

NASH as part of the metabolic syndrome

“Clinicians should consider NASH as part of the metabolic syndrome,” Paul Martin, MD, chief of digestive health and liver diseases at the University of Miami, told this news organization. He was not involved in the study.

“Typically, these patients have a number of risk factors for fatty liver, including obesity and often hyperlipidemia, hypertension, and sleep apnea,” he said. “Clinicians should screen their patients for such comorbidities and then treat them.”

Genetic factors could also play a role in the difference in susceptibility to fatty liver disease found between Black and White patients, he added.

Dr. Martin noted a prevalence of fatty liver in many Hispanic populations and that it is found in Asia but sometimes in the absence of the risk factors associated with it in the United States.

Dr. Qayed and Dr. Martin reported no relevant financial relationships.

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

Compared with White people, Black people are less likely to develop cirrhosis from nonalcoholic steatohepatitis (NASH) but are more likely to die when hospitalized with this condition, researchers say.

The finding highlights the importance of addressing hepatic complications and nonhepatic comorbidities with a comprehensive and interdisciplinary approach that includes social determinants of health, said Emad Qayed, MD, MPH, an associate professor of medicine at Emory University School of Medicine, Atlanta.

“Clinicians should realize that in Black patients with NASH and NASH cirrhosis, mortality can be high despite a low rate of hepatic complications,” he told this news organization.

The study by Dr. Qayed and colleagues was published in the Journal of Clinical Gastroenterology.
 

A nationwide analysis

Previous studies have indicated that Black people are less likely than White people to develop nonalcoholic fatty liver disease (NAFLD), despite the fact that prevalence is increasing. Furthermore, when Black people do develop NAFLD, the disease is less likely to progress to NASH. In cases in which NASH does develop, the evidence has been mixed as to the effect of race on hospital outcomes.

To shed new light on that question, Dr. Qayed and colleagues analyzed data from 2016 to 2018 from the National Inpatient Sample, which is produced by the Healthcare Cost and Utilization Project and is sponsored by the Agency of Healthcare Research and Quality.

They identified 43,409 hospitalizations for NASH, with 41,143 White patients and 2,266 Black patients. The mean age of the Black patients was less than that of the White patients (56.4 years vs. 63.0 years), and Black patients were more likely to be women (69.9% vs. 61.6%).

More of the Black patients had hypertension, obesity, chronic kidney disease, and congestive heart failure, while more of the White patients had diabetes, dyslipidemia, and ischemic heart disease.

Among the Black patients, 33.6% had cirrhosis, compared with 56.4% of the White patients. Likewise, among the Black patients, there were fewer manifestations of decompensated cirrhosis, compared with the White patients. Black patients were also less likely to have had to undergo upper endoscopy and paracentesis.

The Black patients died in the hospital at a rate of 3.9%, which was not significantly higher than the 3.7% rate for the White patients (unadjusted odds ratio = 1.06; 95% confidence interval: 0.84-1.32; P = .6). But, when the researchers adjusted for age, sex, cirrhosis, risk of mortality (based on the overall number and severity of diseases), and insurance status, there were significantly higher odds of mortality among the Black patients (adjusted OR, 1.34; 95% CI: 1.05-1.71; P = .018).

They did not find any association between hospital size, location, or region with mortality.

They also found no difference in mortality between Black patients and White patients among those those with and those without cirrhosis. However, they found that Black patients were more likely to have acute kidney injury, chronic kidney disease, and congestive heart failure.

Regarding the reasons for hospitalization, the researchers found liver-related illnesses, such as hepatic failure and noninfectious hepatitis, to be most common among the White patients. Circulatory disorders, such as heart failure, and endocrine disorders, such as diabetes mellitus with complications, were found to be most common among the Black patients.

The length of time in the hospital was longer for the Black patients than the White patients (6.3 days vs. 5.6 days; P < .0001). The cost of hospitalization was higher for Black patients as well ($18,603 vs. $17,467). This suggests that Black patients were sicker overall, despite their lower rates of liver complications.

“Some of these differences are likely related to socioeconomic factors and clinical comorbidities, such as cardiac and renal disease,” Dr. Qayed said. “However, the underlying etiologies for such disparities in NASH and cirrhosis remain unclear. Further research is warranted to clarify these etiologies.”
 

NASH as part of the metabolic syndrome

“Clinicians should consider NASH as part of the metabolic syndrome,” Paul Martin, MD, chief of digestive health and liver diseases at the University of Miami, told this news organization. He was not involved in the study.

“Typically, these patients have a number of risk factors for fatty liver, including obesity and often hyperlipidemia, hypertension, and sleep apnea,” he said. “Clinicians should screen their patients for such comorbidities and then treat them.”

Genetic factors could also play a role in the difference in susceptibility to fatty liver disease found between Black and White patients, he added.

Dr. Martin noted a prevalence of fatty liver in many Hispanic populations and that it is found in Asia but sometimes in the absence of the risk factors associated with it in the United States.

Dr. Qayed and Dr. Martin reported no relevant financial relationships.

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

A fecal immunochemical test (FIT) conducted 2 years apart could form the basis for population-based colorectal cancer screening if this approach goes on to show a mortality benefit, according to a preliminary analysis.

Researchers are investigating the effect of this time frame of FIT screening as well as a single colonoscopy on colorectal cancer incidence and mortality as the primary endpoints of a randomized controlled trial called SCREESCO. Both were compared to a control of no intervention.

“The rationale is to have the FIT test for a 2-year interval and then no more [colorectal cancer screening] after that,” Anna Forsberg, MD, PhD, lead author and a researcher at the Karolinska Institute in Stockholm, told this news organization.

In addition to the spacing of the FIT screening, the cutoff value in the stool sample of 10 micrograms of hemoglobin per gram is also unique to SCREESCO.

“In most other studies, the cutoff is either 20 micrograms or 40 micrograms,” Dr. Forsberg said. “With this very low cutoff, we hope that we find cancer, including advanced adenomas that are precancerous and can be removed.”

The preliminary analysis reporting the trial’s baseline findings was published online  in The Lancet Gastroenterology & Hepatology.
 

Comparing two interventions

Between 2014 and 2020, the study included 278,280 individuals, with 31,140 assigned to the colonoscopy group, 60,300 to the FIT group, and 186,840 to the control group. Both colonoscopy and FIT screening occurred at age 60 years.

Of the individuals in the colonoscopy group, 35.1% had a colonoscopy, compared with 55.5% in the FIT group who participated in at least one round of testing; 41.4% completed both rounds of FIT screening.

In the FIT group, 6.3% of the test results were positive, and 90.8% of individuals with a positive FIT test underwent a follow-up colonoscopy.

Polyps were found in 45.2% of colonoscopies in the colonoscopy group and in 58.2% in the FIT group. The median adenoma detection rate was 20% in the colonoscopy group and 34% in the FIT group.

The intention-to-treat analysis found a colorectal cancer detection rate of 0.16% in the colonoscopy group and 0.20% in the FIT group, but it was not statistically significant. Advanced adenomas were detected more often in the colonoscopy group than in the FIT group (2.05% vs. 1.61%; relative risk, 1.27; 95% confidence interval, 1.15-1.41).

The number of colonoscopies needed to detect one cancer was 218 in the colonoscopy group and 49 in the FIT group; to detect a single advanced adenoma, 17 and 6 colonoscopies had to be done, respectively.
 

Too early to change screening strategies

When asked to comment on the study, David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, said that the results should be understood as preliminary.

“This is only a description of what they have to date and not of what they proposed for their endpoints,” said Dr. Johnson, who wasn’t associated with the research. “A recommendation for changing screening strategies based on these findings would be very inappropriate at this point.”

Dr. Johnson raised concerns about the quality of the colonoscopies, noting that the procedures were carried out by a mix of gastroenterologists and surgeons. He said that several measures, including the surprisingly low yields for the colonoscopy group and even more so for the FIT-positive group, were concerning.

“They are much lower than even the minimum standard that we would use as benchmark quality indicators in the United States,” he said. “That raises a considerable flag to me that the quality of the colonoscopy confirmation [after a positive FIT test] and screening were both low.”

Dr. Johnson said the ultimate goal of colorectal cancer screening is to detect and remove polyps, a strategy that has been shown to reduce mortality. But FIT tests are not well suited to detecting adenomatous polyps and are of little value in detecting sessile serrated lesions.

“FIT is a detection for cancer, not a detection for polyps. The true value of screening is not just detection but prevention by identification and removal of precancerous polyps,” he said.

Still, Dr. Forsberg emphasized the importance of maximizing uptake of colorectal cancer screening.

“When we pooled the results from the two interventions, the participation in the FIT arm was 56%, which is good. If you look at international figures, that is also high for participation in colonoscopy screening,” Dr. Forsberg said.

“Participation is the main thing. You can have the most fantastic test, but if people don’t participate, then it’s not worth much.”

SCREESCO is one of several ongoing studies comparing screening strategies that employ colonoscopy or FIT. Other studies of colon cancer surveillance methods include the COLONPREV and CONFIRM trials comparing colonoscopy to FIT, and the NordICC trial comparing colonoscopy to no intervention. None of these trials have yet published their final results on colorectal cancer mortality.

Dr. Forsberg and Dr. Johnson have disclosed no relevant financial disclosures. The study was funded by Swedish regions, County Council, Regional Cancer Center Mellansverige, Swedish Cancer Society, Aleris Research and Development Fund, and Eiken Chemical.

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

A fecal immunochemical test (FIT) conducted 2 years apart could form the basis for population-based colorectal cancer screening if this approach goes on to show a mortality benefit, according to a preliminary analysis.

Researchers are investigating the effect of this time frame of FIT screening as well as a single colonoscopy on colorectal cancer incidence and mortality as the primary endpoints of a randomized controlled trial called SCREESCO. Both were compared to a control of no intervention.

“The rationale is to have the FIT test for a 2-year interval and then no more [colorectal cancer screening] after that,” Anna Forsberg, MD, PhD, lead author and a researcher at the Karolinska Institute in Stockholm, told this news organization.

In addition to the spacing of the FIT screening, the cutoff value in the stool sample of 10 micrograms of hemoglobin per gram is also unique to SCREESCO.

“In most other studies, the cutoff is either 20 micrograms or 40 micrograms,” Dr. Forsberg said. “With this very low cutoff, we hope that we find cancer, including advanced adenomas that are precancerous and can be removed.”

The preliminary analysis reporting the trial’s baseline findings was published online  in The Lancet Gastroenterology & Hepatology.
 

Comparing two interventions

Between 2014 and 2020, the study included 278,280 individuals, with 31,140 assigned to the colonoscopy group, 60,300 to the FIT group, and 186,840 to the control group. Both colonoscopy and FIT screening occurred at age 60 years.

Of the individuals in the colonoscopy group, 35.1% had a colonoscopy, compared with 55.5% in the FIT group who participated in at least one round of testing; 41.4% completed both rounds of FIT screening.

In the FIT group, 6.3% of the test results were positive, and 90.8% of individuals with a positive FIT test underwent a follow-up colonoscopy.

Polyps were found in 45.2% of colonoscopies in the colonoscopy group and in 58.2% in the FIT group. The median adenoma detection rate was 20% in the colonoscopy group and 34% in the FIT group.

The intention-to-treat analysis found a colorectal cancer detection rate of 0.16% in the colonoscopy group and 0.20% in the FIT group, but it was not statistically significant. Advanced adenomas were detected more often in the colonoscopy group than in the FIT group (2.05% vs. 1.61%; relative risk, 1.27; 95% confidence interval, 1.15-1.41).

The number of colonoscopies needed to detect one cancer was 218 in the colonoscopy group and 49 in the FIT group; to detect a single advanced adenoma, 17 and 6 colonoscopies had to be done, respectively.
 

Too early to change screening strategies

When asked to comment on the study, David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, said that the results should be understood as preliminary.

“This is only a description of what they have to date and not of what they proposed for their endpoints,” said Dr. Johnson, who wasn’t associated with the research. “A recommendation for changing screening strategies based on these findings would be very inappropriate at this point.”

Dr. Johnson raised concerns about the quality of the colonoscopies, noting that the procedures were carried out by a mix of gastroenterologists and surgeons. He said that several measures, including the surprisingly low yields for the colonoscopy group and even more so for the FIT-positive group, were concerning.

“They are much lower than even the minimum standard that we would use as benchmark quality indicators in the United States,” he said. “That raises a considerable flag to me that the quality of the colonoscopy confirmation [after a positive FIT test] and screening were both low.”

Dr. Johnson said the ultimate goal of colorectal cancer screening is to detect and remove polyps, a strategy that has been shown to reduce mortality. But FIT tests are not well suited to detecting adenomatous polyps and are of little value in detecting sessile serrated lesions.

“FIT is a detection for cancer, not a detection for polyps. The true value of screening is not just detection but prevention by identification and removal of precancerous polyps,” he said.

Still, Dr. Forsberg emphasized the importance of maximizing uptake of colorectal cancer screening.

“When we pooled the results from the two interventions, the participation in the FIT arm was 56%, which is good. If you look at international figures, that is also high for participation in colonoscopy screening,” Dr. Forsberg said.

“Participation is the main thing. You can have the most fantastic test, but if people don’t participate, then it’s not worth much.”

SCREESCO is one of several ongoing studies comparing screening strategies that employ colonoscopy or FIT. Other studies of colon cancer surveillance methods include the COLONPREV and CONFIRM trials comparing colonoscopy to FIT, and the NordICC trial comparing colonoscopy to no intervention. None of these trials have yet published their final results on colorectal cancer mortality.

Dr. Forsberg and Dr. Johnson have disclosed no relevant financial disclosures. The study was funded by Swedish regions, County Council, Regional Cancer Center Mellansverige, Swedish Cancer Society, Aleris Research and Development Fund, and Eiken Chemical.

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

A fecal immunochemical test (FIT) conducted 2 years apart could form the basis for population-based colorectal cancer screening if this approach goes on to show a mortality benefit, according to a preliminary analysis.

Researchers are investigating the effect of this time frame of FIT screening as well as a single colonoscopy on colorectal cancer incidence and mortality as the primary endpoints of a randomized controlled trial called SCREESCO. Both were compared to a control of no intervention.

“The rationale is to have the FIT test for a 2-year interval and then no more [colorectal cancer screening] after that,” Anna Forsberg, MD, PhD, lead author and a researcher at the Karolinska Institute in Stockholm, told this news organization.

In addition to the spacing of the FIT screening, the cutoff value in the stool sample of 10 micrograms of hemoglobin per gram is also unique to SCREESCO.

“In most other studies, the cutoff is either 20 micrograms or 40 micrograms,” Dr. Forsberg said. “With this very low cutoff, we hope that we find cancer, including advanced adenomas that are precancerous and can be removed.”

The preliminary analysis reporting the trial’s baseline findings was published online  in The Lancet Gastroenterology & Hepatology.
 

Comparing two interventions

Between 2014 and 2020, the study included 278,280 individuals, with 31,140 assigned to the colonoscopy group, 60,300 to the FIT group, and 186,840 to the control group. Both colonoscopy and FIT screening occurred at age 60 years.

Of the individuals in the colonoscopy group, 35.1% had a colonoscopy, compared with 55.5% in the FIT group who participated in at least one round of testing; 41.4% completed both rounds of FIT screening.

In the FIT group, 6.3% of the test results were positive, and 90.8% of individuals with a positive FIT test underwent a follow-up colonoscopy.

Polyps were found in 45.2% of colonoscopies in the colonoscopy group and in 58.2% in the FIT group. The median adenoma detection rate was 20% in the colonoscopy group and 34% in the FIT group.

The intention-to-treat analysis found a colorectal cancer detection rate of 0.16% in the colonoscopy group and 0.20% in the FIT group, but it was not statistically significant. Advanced adenomas were detected more often in the colonoscopy group than in the FIT group (2.05% vs. 1.61%; relative risk, 1.27; 95% confidence interval, 1.15-1.41).

The number of colonoscopies needed to detect one cancer was 218 in the colonoscopy group and 49 in the FIT group; to detect a single advanced adenoma, 17 and 6 colonoscopies had to be done, respectively.
 

Too early to change screening strategies

When asked to comment on the study, David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, said that the results should be understood as preliminary.

“This is only a description of what they have to date and not of what they proposed for their endpoints,” said Dr. Johnson, who wasn’t associated with the research. “A recommendation for changing screening strategies based on these findings would be very inappropriate at this point.”

Dr. Johnson raised concerns about the quality of the colonoscopies, noting that the procedures were carried out by a mix of gastroenterologists and surgeons. He said that several measures, including the surprisingly low yields for the colonoscopy group and even more so for the FIT-positive group, were concerning.

“They are much lower than even the minimum standard that we would use as benchmark quality indicators in the United States,” he said. “That raises a considerable flag to me that the quality of the colonoscopy confirmation [after a positive FIT test] and screening were both low.”

Dr. Johnson said the ultimate goal of colorectal cancer screening is to detect and remove polyps, a strategy that has been shown to reduce mortality. But FIT tests are not well suited to detecting adenomatous polyps and are of little value in detecting sessile serrated lesions.

“FIT is a detection for cancer, not a detection for polyps. The true value of screening is not just detection but prevention by identification and removal of precancerous polyps,” he said.

Still, Dr. Forsberg emphasized the importance of maximizing uptake of colorectal cancer screening.

“When we pooled the results from the two interventions, the participation in the FIT arm was 56%, which is good. If you look at international figures, that is also high for participation in colonoscopy screening,” Dr. Forsberg said.

“Participation is the main thing. You can have the most fantastic test, but if people don’t participate, then it’s not worth much.”

SCREESCO is one of several ongoing studies comparing screening strategies that employ colonoscopy or FIT. Other studies of colon cancer surveillance methods include the COLONPREV and CONFIRM trials comparing colonoscopy to FIT, and the NordICC trial comparing colonoscopy to no intervention. None of these trials have yet published their final results on colorectal cancer mortality.

Dr. Forsberg and Dr. Johnson have disclosed no relevant financial disclosures. The study was funded by Swedish regions, County Council, Regional Cancer Center Mellansverige, Swedish Cancer Society, Aleris Research and Development Fund, and Eiken Chemical.

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

A vibrating wearable device helped people with gastroesophageal reflux disease (GERD) stay positioned on their left side while sleeping, alleviating night time reflux symptoms, compared with sham treatment, a small, randomized study suggests.

People often report having more reflux symptoms when sleeping on their right side, and experimental studies suggest that sleeping on the right side is associated with higher esophageal acid exposure time and slower esophageal acid clearance, compared with sleeping on the left side, the authors wrote.

They cite a possible cause as the stomach being above the esophagus when a person is sleeping on their right side, resulting in more reflux.

“There are two very exciting new things that can be learned,” Arjan Bredenoord, MD, PhD, a principal investigator of the study and professor of neurogastroenterology and motility at the Academic Medical Center in Amsterdam, told this news organization. “First, we show that a device that trains people to sleep on the left side really helps to relieve nocturnal reflux symptoms. Second, the study was performed completely remotely, with the patients being at home.”

“The devices were shipped to the patients. All contact was via video calling, and questionnaires were done via links in emails that were linked to secure databases to store the patients’ symptom responses,” he added.

The findings were published online in Clinical Gastroenterology and Hepatology.
 

A study in sleep positional therapy

Researchers performed a double-blind, randomized, sham-controlled trial in 100 patients with night time GERD symptoms who wore a programmed device (about 1.5 inches square) on their chest, midsternum.

Patients were advised to sleep on their left side and randomly assigned (1:1) either to a group whose device produced a gentle vibration when they flipped onto their right side throughout sleep or to the group whose device vibrated when they flipped to the right side but only for the first 20 minutes of use (the sham intervention).

The primary outcome for success was at least a 50% reduction in the Nocturnal Gastroesophageal Reflux Disease Symptom Severity and Impact Questionnaire (N-GSSIQ) score. Secondary outcomes included change in sleep position and reflux symptoms.

In the intention-to-treat analysis, the rate of treatment success was 44% in the intervention group versus 24% in the sham group. The risk difference was 20% (95% confidence interval, 1.8% to 38.2%; P = .03).

Treatment led to a significant avoidance of sleeping on the right side (intervention 2.2% vs. sham 23.5%; P ≤ .0001) and an increased time of sleeping on the left side (intervention 60.9% vs. sham 38.5%; P ≤ .0001).

Patients in the intervention group also had more reflux-free nights (9 nights vs. 6 nights for the sham group).

After 2 weeks of treatment, the average total N-GSSIQ scores were lower in the active device group (18.8 vs. 23.7 in the sham group; P = .04).
 

Most with GERD have night time symptoms

The authors pointed out that up to 80% of patients with GERD experience symptoms during the night, such as heartburn and regurgitation, which can significantly impair sleep quality and daytime functioning.

Solutions are of high interest because current measures have shortcomings.

Raising the head-end of the bed and lengthening the time between dinner and bedtime have limited effect, the authors explained. And while proton pump inhibitors are very effective for daytime symptoms, they have limited efficacy for night time reflux symptoms.

Antireflux pillows, which are designed to keep patients on their left side through the night, have been found to result in less recumbent acid exposure and less self-reported night time reflux symptoms, but they do not allow for spontaneous body movements and can be uncomfortable, they explained.

The lightweight vibration device, made by Side Sleep Technologies BV, registers the sleep position of a subject at 30-second intervals. It categorizes sleep position as supine, right, left, prone, or upright.

Michiel Allessie, CEO of Side Sleep Technologies, told this news organization that the wearable V1.0 is sold as a consumer electronic device rather than a medical device in the United Kingdom for £99. He said the company expects to sell the V1.0 in the United States starting in June, with a target price of $99.
 

Promising but device still needs real-world testing

When asked to comment, Philip Katz, MD, a gastroenterologist at Weill Cornell Medicine, New York, said it was a fantastic study scientifically and academically incredibly interesting, but the device is not a panacea.

Dr. Katz said he will remain skeptical until the device is tested in real life and added that it’s important to remember this is one study with 100 people.

He also wondered whether there might be an even better solution in a well-designed wedge, for example, and whether the buzzing of this product might affect sleep quality. If so, would that be worth the tradeoff?

Dr. Katz noted that busy physicians may not have the time to determine whether patients truly have nocturnal GERD or just similar symptoms. This study included people who were carefully screened by the researchers for nocturnal reflux symptoms, he pointed out.

Based on this study, Dr. Katz said he would tell patients, “You have a 50% chance to be helped because their primary outcome was met by 44%.”

He said the decision is up to the patients and comes down to this: “It’s better than nothing for sure. Is it worth $100? You tell me.”

Dr. Bredenoord said the next step is a study using pH-impedance monitoring of the esophagus to show that there is also an effect on reflux episodes.

The investigational medical devices were provided free of charge and without restrictions by Side Sleep Technologies BV. Dr. Bredenoord disclosed research funding from Nutricia, Norgine, SST, Thelial, and Bayer; speaker and/or consulting fees from Laborie, EsoCap, Medtronic, Dr. Falk Pharma, Calypso Biotech, Alimentiv, Reckett Benkiser, Regeneron, and AstraZeneca; and previously owned shares in Side Sleep Technologies BV. Another coauthor received research funding from Boston Scientific and speaker and/or consulting fees from Cook and Olympus. The remaining authors have disclosed no relevant financial relationships. Dr. Katz reported being a consultant for Phathom Pharmaceuticals and Sebela.

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

A vibrating wearable device helped people with gastroesophageal reflux disease (GERD) stay positioned on their left side while sleeping, alleviating night time reflux symptoms, compared with sham treatment, a small, randomized study suggests.

People often report having more reflux symptoms when sleeping on their right side, and experimental studies suggest that sleeping on the right side is associated with higher esophageal acid exposure time and slower esophageal acid clearance, compared with sleeping on the left side, the authors wrote.

They cite a possible cause as the stomach being above the esophagus when a person is sleeping on their right side, resulting in more reflux.

“There are two very exciting new things that can be learned,” Arjan Bredenoord, MD, PhD, a principal investigator of the study and professor of neurogastroenterology and motility at the Academic Medical Center in Amsterdam, told this news organization. “First, we show that a device that trains people to sleep on the left side really helps to relieve nocturnal reflux symptoms. Second, the study was performed completely remotely, with the patients being at home.”

“The devices were shipped to the patients. All contact was via video calling, and questionnaires were done via links in emails that were linked to secure databases to store the patients’ symptom responses,” he added.

The findings were published online in Clinical Gastroenterology and Hepatology.
 

A study in sleep positional therapy

Researchers performed a double-blind, randomized, sham-controlled trial in 100 patients with night time GERD symptoms who wore a programmed device (about 1.5 inches square) on their chest, midsternum.

Patients were advised to sleep on their left side and randomly assigned (1:1) either to a group whose device produced a gentle vibration when they flipped onto their right side throughout sleep or to the group whose device vibrated when they flipped to the right side but only for the first 20 minutes of use (the sham intervention).

The primary outcome for success was at least a 50% reduction in the Nocturnal Gastroesophageal Reflux Disease Symptom Severity and Impact Questionnaire (N-GSSIQ) score. Secondary outcomes included change in sleep position and reflux symptoms.

In the intention-to-treat analysis, the rate of treatment success was 44% in the intervention group versus 24% in the sham group. The risk difference was 20% (95% confidence interval, 1.8% to 38.2%; P = .03).

Treatment led to a significant avoidance of sleeping on the right side (intervention 2.2% vs. sham 23.5%; P ≤ .0001) and an increased time of sleeping on the left side (intervention 60.9% vs. sham 38.5%; P ≤ .0001).

Patients in the intervention group also had more reflux-free nights (9 nights vs. 6 nights for the sham group).

After 2 weeks of treatment, the average total N-GSSIQ scores were lower in the active device group (18.8 vs. 23.7 in the sham group; P = .04).
 

Most with GERD have night time symptoms

The authors pointed out that up to 80% of patients with GERD experience symptoms during the night, such as heartburn and regurgitation, which can significantly impair sleep quality and daytime functioning.

Solutions are of high interest because current measures have shortcomings.

Raising the head-end of the bed and lengthening the time between dinner and bedtime have limited effect, the authors explained. And while proton pump inhibitors are very effective for daytime symptoms, they have limited efficacy for night time reflux symptoms.

Antireflux pillows, which are designed to keep patients on their left side through the night, have been found to result in less recumbent acid exposure and less self-reported night time reflux symptoms, but they do not allow for spontaneous body movements and can be uncomfortable, they explained.

The lightweight vibration device, made by Side Sleep Technologies BV, registers the sleep position of a subject at 30-second intervals. It categorizes sleep position as supine, right, left, prone, or upright.

Michiel Allessie, CEO of Side Sleep Technologies, told this news organization that the wearable V1.0 is sold as a consumer electronic device rather than a medical device in the United Kingdom for £99. He said the company expects to sell the V1.0 in the United States starting in June, with a target price of $99.
 

Promising but device still needs real-world testing

When asked to comment, Philip Katz, MD, a gastroenterologist at Weill Cornell Medicine, New York, said it was a fantastic study scientifically and academically incredibly interesting, but the device is not a panacea.

Dr. Katz said he will remain skeptical until the device is tested in real life and added that it’s important to remember this is one study with 100 people.

He also wondered whether there might be an even better solution in a well-designed wedge, for example, and whether the buzzing of this product might affect sleep quality. If so, would that be worth the tradeoff?

Dr. Katz noted that busy physicians may not have the time to determine whether patients truly have nocturnal GERD or just similar symptoms. This study included people who were carefully screened by the researchers for nocturnal reflux symptoms, he pointed out.

Based on this study, Dr. Katz said he would tell patients, “You have a 50% chance to be helped because their primary outcome was met by 44%.”

He said the decision is up to the patients and comes down to this: “It’s better than nothing for sure. Is it worth $100? You tell me.”

Dr. Bredenoord said the next step is a study using pH-impedance monitoring of the esophagus to show that there is also an effect on reflux episodes.

The investigational medical devices were provided free of charge and without restrictions by Side Sleep Technologies BV. Dr. Bredenoord disclosed research funding from Nutricia, Norgine, SST, Thelial, and Bayer; speaker and/or consulting fees from Laborie, EsoCap, Medtronic, Dr. Falk Pharma, Calypso Biotech, Alimentiv, Reckett Benkiser, Regeneron, and AstraZeneca; and previously owned shares in Side Sleep Technologies BV. Another coauthor received research funding from Boston Scientific and speaker and/or consulting fees from Cook and Olympus. The remaining authors have disclosed no relevant financial relationships. Dr. Katz reported being a consultant for Phathom Pharmaceuticals and Sebela.

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

A vibrating wearable device helped people with gastroesophageal reflux disease (GERD) stay positioned on their left side while sleeping, alleviating night time reflux symptoms, compared with sham treatment, a small, randomized study suggests.

People often report having more reflux symptoms when sleeping on their right side, and experimental studies suggest that sleeping on the right side is associated with higher esophageal acid exposure time and slower esophageal acid clearance, compared with sleeping on the left side, the authors wrote.

They cite a possible cause as the stomach being above the esophagus when a person is sleeping on their right side, resulting in more reflux.

“There are two very exciting new things that can be learned,” Arjan Bredenoord, MD, PhD, a principal investigator of the study and professor of neurogastroenterology and motility at the Academic Medical Center in Amsterdam, told this news organization. “First, we show that a device that trains people to sleep on the left side really helps to relieve nocturnal reflux symptoms. Second, the study was performed completely remotely, with the patients being at home.”

“The devices were shipped to the patients. All contact was via video calling, and questionnaires were done via links in emails that were linked to secure databases to store the patients’ symptom responses,” he added.

The findings were published online in Clinical Gastroenterology and Hepatology.
 

A study in sleep positional therapy

Researchers performed a double-blind, randomized, sham-controlled trial in 100 patients with night time GERD symptoms who wore a programmed device (about 1.5 inches square) on their chest, midsternum.

Patients were advised to sleep on their left side and randomly assigned (1:1) either to a group whose device produced a gentle vibration when they flipped onto their right side throughout sleep or to the group whose device vibrated when they flipped to the right side but only for the first 20 minutes of use (the sham intervention).

The primary outcome for success was at least a 50% reduction in the Nocturnal Gastroesophageal Reflux Disease Symptom Severity and Impact Questionnaire (N-GSSIQ) score. Secondary outcomes included change in sleep position and reflux symptoms.

In the intention-to-treat analysis, the rate of treatment success was 44% in the intervention group versus 24% in the sham group. The risk difference was 20% (95% confidence interval, 1.8% to 38.2%; P = .03).

Treatment led to a significant avoidance of sleeping on the right side (intervention 2.2% vs. sham 23.5%; P ≤ .0001) and an increased time of sleeping on the left side (intervention 60.9% vs. sham 38.5%; P ≤ .0001).

Patients in the intervention group also had more reflux-free nights (9 nights vs. 6 nights for the sham group).

After 2 weeks of treatment, the average total N-GSSIQ scores were lower in the active device group (18.8 vs. 23.7 in the sham group; P = .04).
 

Most with GERD have night time symptoms

The authors pointed out that up to 80% of patients with GERD experience symptoms during the night, such as heartburn and regurgitation, which can significantly impair sleep quality and daytime functioning.

Solutions are of high interest because current measures have shortcomings.

Raising the head-end of the bed and lengthening the time between dinner and bedtime have limited effect, the authors explained. And while proton pump inhibitors are very effective for daytime symptoms, they have limited efficacy for night time reflux symptoms.

Antireflux pillows, which are designed to keep patients on their left side through the night, have been found to result in less recumbent acid exposure and less self-reported night time reflux symptoms, but they do not allow for spontaneous body movements and can be uncomfortable, they explained.

The lightweight vibration device, made by Side Sleep Technologies BV, registers the sleep position of a subject at 30-second intervals. It categorizes sleep position as supine, right, left, prone, or upright.

Michiel Allessie, CEO of Side Sleep Technologies, told this news organization that the wearable V1.0 is sold as a consumer electronic device rather than a medical device in the United Kingdom for £99. He said the company expects to sell the V1.0 in the United States starting in June, with a target price of $99.
 

Promising but device still needs real-world testing

When asked to comment, Philip Katz, MD, a gastroenterologist at Weill Cornell Medicine, New York, said it was a fantastic study scientifically and academically incredibly interesting, but the device is not a panacea.

Dr. Katz said he will remain skeptical until the device is tested in real life and added that it’s important to remember this is one study with 100 people.

He also wondered whether there might be an even better solution in a well-designed wedge, for example, and whether the buzzing of this product might affect sleep quality. If so, would that be worth the tradeoff?

Dr. Katz noted that busy physicians may not have the time to determine whether patients truly have nocturnal GERD or just similar symptoms. This study included people who were carefully screened by the researchers for nocturnal reflux symptoms, he pointed out.

Based on this study, Dr. Katz said he would tell patients, “You have a 50% chance to be helped because their primary outcome was met by 44%.”

He said the decision is up to the patients and comes down to this: “It’s better than nothing for sure. Is it worth $100? You tell me.”

Dr. Bredenoord said the next step is a study using pH-impedance monitoring of the esophagus to show that there is also an effect on reflux episodes.

The investigational medical devices were provided free of charge and without restrictions by Side Sleep Technologies BV. Dr. Bredenoord disclosed research funding from Nutricia, Norgine, SST, Thelial, and Bayer; speaker and/or consulting fees from Laborie, EsoCap, Medtronic, Dr. Falk Pharma, Calypso Biotech, Alimentiv, Reckett Benkiser, Regeneron, and AstraZeneca; and previously owned shares in Side Sleep Technologies BV. Another coauthor received research funding from Boston Scientific and speaker and/or consulting fees from Cook and Olympus. The remaining authors have disclosed no relevant financial relationships. Dr. Katz reported being a consultant for Phathom Pharmaceuticals and Sebela.

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

Jo Ward’s twin boys have been to the emergency department for respiratory problems about as many times as the dozen years they’ve been alive. Both have asthma and bronchopulmonary dysplasia, a form of chronic airway damage that can occur in children born premature, as the twins were. But each time Ms. Ward took them in for treatment during an acute bout of breathing distress, the staff told her to schedule a follow-up visit for the children with their physician only if they didn’t get better, not regardless of the outcome – as medical guidelines recommend.

“They asked questions, they did the exams, but they really didn’t give you a lot of information to help you at home,” Ms. Ward told this news organization. If they had, she doesn’t think she’d have needed to take them in for emergency care so often.

A new study, published in Academic Pediatrics, suggests she’s right.

Current clinical guidelines for asthma recommend that patients who visit the ED for an asthma-related problem should have a follow-up appointment within a month after the visit, independent of how well they have recovered once home, according to Naomi S. Bardach, MD, a professor of pediatrics and health policy at the University of California, San Francisco, who led the new study.

Her research found that children who have a follow-up appointment within 2 weeks of such a visit are less likely to come back again the next year. Yet the study also found that only about one in five youth had a follow-up visit within that 2-week window.

“The emergency department visit is probably a sign that they need some additional attention for their asthma,” Dr. Bardach said. “We know we can prevent emergency department visits if they get the right kind of medication or if they figure out how to avoid the things that are going to cause an asthma exacerbation or flare.”

For the study, Dr. Bardach and colleagues analyzed data from California, Vermont, and Massachusetts for all asthma-related emergency visits for patients aged 3-21 years between 2013 and 2016.

Out of the 90,267 such visits they identified, 22.6% of patients had a follow-up within 2 weeks, more often by patients who were younger, had commercial insurance, had evidence of prior asthma, or had complex chronic conditions.

Whereas 5.7% of patients who had follow-up visits returned to the ED within 60 days, 6.4% of those who didn’t came back – a 12% difference (P < .001). The gap was larger a year out, with 25% of those with follow-ups returning to the ED, compared with 28.3% of those without follow-ups returning (P < .001), according to the researchers.

Overall, Dr. Bardach’s group estimates that for every 30 children who have follow-up visits with a physician, one would avoid a return trip to the emergency department for asthma within a year.

But given the sheer number of asthma-related trips to the ED each year – 164,145 for kids age 1-17 years in the United States in 2016 alone – that translates into big numbers of kids not going back to the hospital: approximately 72,000 such trips avoided at a savings to the health care system of at least $8.6 million annually.
 

Missed opportunities

Had Ms. Ward’s boys been among the one in five to receive follow-up care earlier in their lives, she might have saved a significant amount of time, money, anxiety, and heartache. When the twins were 9 years old, she took them to a new pediatric pulmonologist. That changed everything. In that first visit, “they gave me way more information than I ever had in the first 9 years,” she said.

The doctor told Ms. Ward to keep steroids on hand, gave her a prescription for extra doses of the powerful medication, and explained that they needed to be used within 24 hours of the first sign of a breathing problem.

“She said if you give them the steroids right away, it keeps them out of the emergency room, and that’s actually worked,” Ms. Ward said. “She made sure we had care plans every visit and asked me each time if I still had it or we needed to rewrite it. They gave me signs to look for, for when to go to hospital visits. I think that when you go to the doctor, they should be telling you stuff like that.”

Dr. Bardach said visits with a primary care doctor or asthma specialist offer families a chance to receive information to keep the condition from becoming critical.

“Going to that follow-up visit, they can get access to education from the provider about how to avoid things that trigger asthma, and there’s medication that kids can take that keeps the lungs calm and less likely to have a big asthma reaction, so getting access to that medication can be really helpful,” she said.

That was the case for Amy Davenport, of Chapel Hill, N.C., whose 6-year-old son has been to the ED twice for his asthma.

The first time, when he was 3, he was having trouble breathing with a respiratory tract infection and received nebulizer treatment – although he received it in the ED since no beds were available in the ICU. The staff did tell Ms. Davenport to follow up with her primary care provider, but her son’s pediatrician was reluctant to diagnose him with asthma at such a young age and didn’t prescribe any maintenance medications.

A few months later, Ms. Davenport and her son found themselves back in the hospital, and an ICU bed was open this time. The critical care staff referred Davenport to a pediatric pulmonary specialist, and they haven’t been back to the hospital since. Ms. Davenport said she believes if they’d received a maintenance medication after the first visit, it likely would have prevented the second one.

“I’ve definitely seen now that, after the second admission, we got an asthma action plan and it said exactly what to do,” she said. “I felt like we had really good follow-up. We had that action plan on our refrigerator for a long time, and it helped us as parents with three small children to manage.”

Of course, follow-up care takes time – time away from work and school that not all families can spare, the researchers acknowledged. Telehealth may be an option, especially after its use expanded during the COVID-19 pandemic.

“We know that health systems have a hard time being flexible enough to actually have a kid be able to make an appointment within a short period of time, and we also know it’s hard for families sometimes to go back into a clinical setting within a certain period of time,” Dr. Bardach said. The urgency for the appointment may wane for those whose children seem to be doing better.

When the researchers adjusted their calculations for socioeconomic status, the results didn’t change much. But the study did find that patients with private insurance were about twice as likely to have follow-up visits as those on Medicaid (43.7% vs. 21.7%). And “the content and conduct” of the follow-up visit makes a difference as well.

Ms. Ward, whose boys are insured through Medicaid, recalled several visits to the ED where she had to push the staff to get the care her children needed. In one case, when one of her boys was a year old and struggling to breathe, the emergency doctor handed her a prescription and recommended she fill it at a neighborhood drugstore that would be cheaper than the hospital’s pharmacy. Then a nurse came in to begin the discharge process.

“I said no, ‘we’re not ready yet. Look at him,’” Ms. Ward said. The nurse took a pulse oximeter reading that showed the boy’s oxygen levels were at 84%, dangerously low. “If I wasn’t so knowledgeable and paid attention when they were born, since they were preemies, if it would have been somebody else, they probably would’ve went home and he’d have died.”

With the pediatric pulmonologist the boys have now, Ms. Ward said she feels more capable of managing their asthma and knowing how to reduce the likelihood that they’ll need to visit the ED.

“Part of what we’re seeing here is that having an existing and trusting relationship with a clinician can be helpful to kids with asthma,” Dr. Bardach said. “If we help establish and maintain those connections, and explain how important that connection can be, that can also help somebody with asthma overall.”

The research was funded by the Agency for Healthcare Research and Quality. The authors disclosed no relevant financial relationships.

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

Jo Ward’s twin boys have been to the emergency department for respiratory problems about as many times as the dozen years they’ve been alive. Both have asthma and bronchopulmonary dysplasia, a form of chronic airway damage that can occur in children born premature, as the twins were. But each time Ms. Ward took them in for treatment during an acute bout of breathing distress, the staff told her to schedule a follow-up visit for the children with their physician only if they didn’t get better, not regardless of the outcome – as medical guidelines recommend.

“They asked questions, they did the exams, but they really didn’t give you a lot of information to help you at home,” Ms. Ward told this news organization. If they had, she doesn’t think she’d have needed to take them in for emergency care so often.

A new study, published in Academic Pediatrics, suggests she’s right.

Current clinical guidelines for asthma recommend that patients who visit the ED for an asthma-related problem should have a follow-up appointment within a month after the visit, independent of how well they have recovered once home, according to Naomi S. Bardach, MD, a professor of pediatrics and health policy at the University of California, San Francisco, who led the new study.

Her research found that children who have a follow-up appointment within 2 weeks of such a visit are less likely to come back again the next year. Yet the study also found that only about one in five youth had a follow-up visit within that 2-week window.

“The emergency department visit is probably a sign that they need some additional attention for their asthma,” Dr. Bardach said. “We know we can prevent emergency department visits if they get the right kind of medication or if they figure out how to avoid the things that are going to cause an asthma exacerbation or flare.”

For the study, Dr. Bardach and colleagues analyzed data from California, Vermont, and Massachusetts for all asthma-related emergency visits for patients aged 3-21 years between 2013 and 2016.

Out of the 90,267 such visits they identified, 22.6% of patients had a follow-up within 2 weeks, more often by patients who were younger, had commercial insurance, had evidence of prior asthma, or had complex chronic conditions.

Whereas 5.7% of patients who had follow-up visits returned to the ED within 60 days, 6.4% of those who didn’t came back – a 12% difference (P < .001). The gap was larger a year out, with 25% of those with follow-ups returning to the ED, compared with 28.3% of those without follow-ups returning (P < .001), according to the researchers.

Overall, Dr. Bardach’s group estimates that for every 30 children who have follow-up visits with a physician, one would avoid a return trip to the emergency department for asthma within a year.

But given the sheer number of asthma-related trips to the ED each year – 164,145 for kids age 1-17 years in the United States in 2016 alone – that translates into big numbers of kids not going back to the hospital: approximately 72,000 such trips avoided at a savings to the health care system of at least $8.6 million annually.
 

Missed opportunities

Had Ms. Ward’s boys been among the one in five to receive follow-up care earlier in their lives, she might have saved a significant amount of time, money, anxiety, and heartache. When the twins were 9 years old, she took them to a new pediatric pulmonologist. That changed everything. In that first visit, “they gave me way more information than I ever had in the first 9 years,” she said.

The doctor told Ms. Ward to keep steroids on hand, gave her a prescription for extra doses of the powerful medication, and explained that they needed to be used within 24 hours of the first sign of a breathing problem.

“She said if you give them the steroids right away, it keeps them out of the emergency room, and that’s actually worked,” Ms. Ward said. “She made sure we had care plans every visit and asked me each time if I still had it or we needed to rewrite it. They gave me signs to look for, for when to go to hospital visits. I think that when you go to the doctor, they should be telling you stuff like that.”

Dr. Bardach said visits with a primary care doctor or asthma specialist offer families a chance to receive information to keep the condition from becoming critical.

“Going to that follow-up visit, they can get access to education from the provider about how to avoid things that trigger asthma, and there’s medication that kids can take that keeps the lungs calm and less likely to have a big asthma reaction, so getting access to that medication can be really helpful,” she said.

That was the case for Amy Davenport, of Chapel Hill, N.C., whose 6-year-old son has been to the ED twice for his asthma.

The first time, when he was 3, he was having trouble breathing with a respiratory tract infection and received nebulizer treatment – although he received it in the ED since no beds were available in the ICU. The staff did tell Ms. Davenport to follow up with her primary care provider, but her son’s pediatrician was reluctant to diagnose him with asthma at such a young age and didn’t prescribe any maintenance medications.

A few months later, Ms. Davenport and her son found themselves back in the hospital, and an ICU bed was open this time. The critical care staff referred Davenport to a pediatric pulmonary specialist, and they haven’t been back to the hospital since. Ms. Davenport said she believes if they’d received a maintenance medication after the first visit, it likely would have prevented the second one.

“I’ve definitely seen now that, after the second admission, we got an asthma action plan and it said exactly what to do,” she said. “I felt like we had really good follow-up. We had that action plan on our refrigerator for a long time, and it helped us as parents with three small children to manage.”

Of course, follow-up care takes time – time away from work and school that not all families can spare, the researchers acknowledged. Telehealth may be an option, especially after its use expanded during the COVID-19 pandemic.

“We know that health systems have a hard time being flexible enough to actually have a kid be able to make an appointment within a short period of time, and we also know it’s hard for families sometimes to go back into a clinical setting within a certain period of time,” Dr. Bardach said. The urgency for the appointment may wane for those whose children seem to be doing better.

When the researchers adjusted their calculations for socioeconomic status, the results didn’t change much. But the study did find that patients with private insurance were about twice as likely to have follow-up visits as those on Medicaid (43.7% vs. 21.7%). And “the content and conduct” of the follow-up visit makes a difference as well.

Ms. Ward, whose boys are insured through Medicaid, recalled several visits to the ED where she had to push the staff to get the care her children needed. In one case, when one of her boys was a year old and struggling to breathe, the emergency doctor handed her a prescription and recommended she fill it at a neighborhood drugstore that would be cheaper than the hospital’s pharmacy. Then a nurse came in to begin the discharge process.

“I said no, ‘we’re not ready yet. Look at him,’” Ms. Ward said. The nurse took a pulse oximeter reading that showed the boy’s oxygen levels were at 84%, dangerously low. “If I wasn’t so knowledgeable and paid attention when they were born, since they were preemies, if it would have been somebody else, they probably would’ve went home and he’d have died.”

With the pediatric pulmonologist the boys have now, Ms. Ward said she feels more capable of managing their asthma and knowing how to reduce the likelihood that they’ll need to visit the ED.

“Part of what we’re seeing here is that having an existing and trusting relationship with a clinician can be helpful to kids with asthma,” Dr. Bardach said. “If we help establish and maintain those connections, and explain how important that connection can be, that can also help somebody with asthma overall.”

The research was funded by the Agency for Healthcare Research and Quality. The authors disclosed no relevant financial relationships.

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

Jo Ward’s twin boys have been to the emergency department for respiratory problems about as many times as the dozen years they’ve been alive. Both have asthma and bronchopulmonary dysplasia, a form of chronic airway damage that can occur in children born premature, as the twins were. But each time Ms. Ward took them in for treatment during an acute bout of breathing distress, the staff told her to schedule a follow-up visit for the children with their physician only if they didn’t get better, not regardless of the outcome – as medical guidelines recommend.

“They asked questions, they did the exams, but they really didn’t give you a lot of information to help you at home,” Ms. Ward told this news organization. If they had, she doesn’t think she’d have needed to take them in for emergency care so often.

A new study, published in Academic Pediatrics, suggests she’s right.

Current clinical guidelines for asthma recommend that patients who visit the ED for an asthma-related problem should have a follow-up appointment within a month after the visit, independent of how well they have recovered once home, according to Naomi S. Bardach, MD, a professor of pediatrics and health policy at the University of California, San Francisco, who led the new study.

Her research found that children who have a follow-up appointment within 2 weeks of such a visit are less likely to come back again the next year. Yet the study also found that only about one in five youth had a follow-up visit within that 2-week window.

“The emergency department visit is probably a sign that they need some additional attention for their asthma,” Dr. Bardach said. “We know we can prevent emergency department visits if they get the right kind of medication or if they figure out how to avoid the things that are going to cause an asthma exacerbation or flare.”

For the study, Dr. Bardach and colleagues analyzed data from California, Vermont, and Massachusetts for all asthma-related emergency visits for patients aged 3-21 years between 2013 and 2016.

Out of the 90,267 such visits they identified, 22.6% of patients had a follow-up within 2 weeks, more often by patients who were younger, had commercial insurance, had evidence of prior asthma, or had complex chronic conditions.

Whereas 5.7% of patients who had follow-up visits returned to the ED within 60 days, 6.4% of those who didn’t came back – a 12% difference (P < .001). The gap was larger a year out, with 25% of those with follow-ups returning to the ED, compared with 28.3% of those without follow-ups returning (P < .001), according to the researchers.

Overall, Dr. Bardach’s group estimates that for every 30 children who have follow-up visits with a physician, one would avoid a return trip to the emergency department for asthma within a year.

But given the sheer number of asthma-related trips to the ED each year – 164,145 for kids age 1-17 years in the United States in 2016 alone – that translates into big numbers of kids not going back to the hospital: approximately 72,000 such trips avoided at a savings to the health care system of at least $8.6 million annually.
 

Missed opportunities

Had Ms. Ward’s boys been among the one in five to receive follow-up care earlier in their lives, she might have saved a significant amount of time, money, anxiety, and heartache. When the twins were 9 years old, she took them to a new pediatric pulmonologist. That changed everything. In that first visit, “they gave me way more information than I ever had in the first 9 years,” she said.

The doctor told Ms. Ward to keep steroids on hand, gave her a prescription for extra doses of the powerful medication, and explained that they needed to be used within 24 hours of the first sign of a breathing problem.

“She said if you give them the steroids right away, it keeps them out of the emergency room, and that’s actually worked,” Ms. Ward said. “She made sure we had care plans every visit and asked me each time if I still had it or we needed to rewrite it. They gave me signs to look for, for when to go to hospital visits. I think that when you go to the doctor, they should be telling you stuff like that.”

Dr. Bardach said visits with a primary care doctor or asthma specialist offer families a chance to receive information to keep the condition from becoming critical.

“Going to that follow-up visit, they can get access to education from the provider about how to avoid things that trigger asthma, and there’s medication that kids can take that keeps the lungs calm and less likely to have a big asthma reaction, so getting access to that medication can be really helpful,” she said.

That was the case for Amy Davenport, of Chapel Hill, N.C., whose 6-year-old son has been to the ED twice for his asthma.

The first time, when he was 3, he was having trouble breathing with a respiratory tract infection and received nebulizer treatment – although he received it in the ED since no beds were available in the ICU. The staff did tell Ms. Davenport to follow up with her primary care provider, but her son’s pediatrician was reluctant to diagnose him with asthma at such a young age and didn’t prescribe any maintenance medications.

A few months later, Ms. Davenport and her son found themselves back in the hospital, and an ICU bed was open this time. The critical care staff referred Davenport to a pediatric pulmonary specialist, and they haven’t been back to the hospital since. Ms. Davenport said she believes if they’d received a maintenance medication after the first visit, it likely would have prevented the second one.

“I’ve definitely seen now that, after the second admission, we got an asthma action plan and it said exactly what to do,” she said. “I felt like we had really good follow-up. We had that action plan on our refrigerator for a long time, and it helped us as parents with three small children to manage.”

Of course, follow-up care takes time – time away from work and school that not all families can spare, the researchers acknowledged. Telehealth may be an option, especially after its use expanded during the COVID-19 pandemic.

“We know that health systems have a hard time being flexible enough to actually have a kid be able to make an appointment within a short period of time, and we also know it’s hard for families sometimes to go back into a clinical setting within a certain period of time,” Dr. Bardach said. The urgency for the appointment may wane for those whose children seem to be doing better.

When the researchers adjusted their calculations for socioeconomic status, the results didn’t change much. But the study did find that patients with private insurance were about twice as likely to have follow-up visits as those on Medicaid (43.7% vs. 21.7%). And “the content and conduct” of the follow-up visit makes a difference as well.

Ms. Ward, whose boys are insured through Medicaid, recalled several visits to the ED where she had to push the staff to get the care her children needed. In one case, when one of her boys was a year old and struggling to breathe, the emergency doctor handed her a prescription and recommended she fill it at a neighborhood drugstore that would be cheaper than the hospital’s pharmacy. Then a nurse came in to begin the discharge process.

“I said no, ‘we’re not ready yet. Look at him,’” Ms. Ward said. The nurse took a pulse oximeter reading that showed the boy’s oxygen levels were at 84%, dangerously low. “If I wasn’t so knowledgeable and paid attention when they were born, since they were preemies, if it would have been somebody else, they probably would’ve went home and he’d have died.”

With the pediatric pulmonologist the boys have now, Ms. Ward said she feels more capable of managing their asthma and knowing how to reduce the likelihood that they’ll need to visit the ED.

“Part of what we’re seeing here is that having an existing and trusting relationship with a clinician can be helpful to kids with asthma,” Dr. Bardach said. “If we help establish and maintain those connections, and explain how important that connection can be, that can also help somebody with asthma overall.”

The research was funded by the Agency for Healthcare Research and Quality. The authors disclosed no relevant financial relationships.

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

A swallowable, capsule-sponge device used to sample biomarkers offers a reliable, noninvasive alternative to endoscopy for diagnosing Barrett’s esophagus, according to a new guideline from the American College of Gastroenterology.

In addition, the guideline recommends that patients with Barrett’s esophagus with segments of less than 3 cm be screened every 5 years, but if their Barrett’s esophagus segments are 5 cm or greater, they should be screened every 3 years.

“We don’t want to scope everyone for the lowest risk of cancer,” lead author Nicholas J. Shaheen, MD, MPH, chief of gastroenterology and hepatology at the University of North Carolina School of Medicine, Chapel Hill, told this news organization.

“The traditional way to diagnose Barrett’s esophagus is by upper endoscopy, but it’s expensive and not available everywhere,” he said. “One big change since the last iteration of this guideline is that there’s been a development of nonendoscopic screening modalities.”

The guideline was published in The American Journal of Gastroenterology.
 

Progress with swallowable devices

Solid evidence supports the Cytosponge, a capsule containing a compressed spherical polyurethane sponge attached to a string. The sponge expands to a sphere when the capsule dissolves after being swallowed, Dr. Shaheen said.

When withdrawn, the sponge contains esophageal cytology samples that can be used to identify biomarkers for Barrett’s esophagus, either the protein trefoil factor 3 expressed in intestinal metaplasia or methylated DNA markers associated with Barrett’s esophagus mucosa.

More than 90% of participants in trials have been able to swallow the device. Some mild gagging or throat discomfort has been reported.

In one trial, patients with chronic reflux were randomly assigned to either swallow the Cytosponge or be screened by endoscopy based on the practitioner’s usual care. Any diagnosis with the Cytosponge was confirmed with endoscopy. Barrett’s esophagus was found in 2% of patients who had undergone the Cytosponge procedure, versus less than 1% of those screened in the usual way. Of the 6,834 patients in the Cytosponge group, nine were diagnosed with dysplastic Barrett’s esophagus or stage I esophagogastric cancer, versus none of the 6,388 participants in the usual-care group.

“At least for now, we’re using the same guidance that we used for endoscopy to decide who might be best served by these devices,” Dr. Shaheen said. “There are not good data to make a recommendation yet, but you could easily imagine how you could broaden screening guidelines by having a cheaper, more available test.”

Screening for esophageal cancer may one day be as common as screening for colon cancer, said Herbert C. Wolfsen, MD, a consultant in gastroenterology at the Mayo Clinic in Jacksonville, Florida, and professor of medicine at the Mayo Clinic College of Medicine, Rochester, Minn. He was not involved in writing the new guideline.

“We’ve known for years that at least half of patients with esophageal cancer have little, if any, reflux symptoms,” he told this news organization. “This is an area where the guidelines have been consistent, but I think we’re going to see them start to change.”
 

Additional recommendations

The expert panel of the new guideline held off on recommending the use of biomarkers more generally, deeming the evidence insufficient.

The new guideline also endorses endoscopic treatment for dysplastic Barrett’s esophagus but not for Barrett’s esophagus with no dysplasia.

For the first time, it recommends that patients undergo surveillance after successful ablation.

Dr. Wolfsen took note of the guideline’s recommendation that clinicians benchmark their practices against published standards.

The guideline mentions “documentation of landmarks and extent of [Barrett’s esophagus], not obtaining biopsies in the setting of a normal-appearing squamocolumnar junction, sampling using the Seattle biopsy protocol, and performing surveillance endoscopy in patients with [nondysplastic Barrett’s esophagus] no sooner than 3-5 years.”

“The acceptance and implementation of these quality metrics is important,” Dr. Wolfsen said.

However, the guideline underscores the need for considerably more research, he added.

“This group did a fabulous job,” Dr. Wolfsen said. “But when it comes to getting a consensus and people on board, all headed in the same direction, it’s hard when you’re not working with very good data.”

Dr. Shaheen reports financial relationships with Medtronic, Steris, Pentax, CDx Diagnostics, Interpace Diagnostics, Lucid Medical, Cernostics, Phathom Pharmaceuticals, Exact Sciences, Aqua Medical, and Cook Medical. Dr. Wolfsen reports no relevant financial relationships.

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

A swallowable, capsule-sponge device used to sample biomarkers offers a reliable, noninvasive alternative to endoscopy for diagnosing Barrett’s esophagus, according to a new guideline from the American College of Gastroenterology.

In addition, the guideline recommends that patients with Barrett’s esophagus with segments of less than 3 cm be screened every 5 years, but if their Barrett’s esophagus segments are 5 cm or greater, they should be screened every 3 years.

“We don’t want to scope everyone for the lowest risk of cancer,” lead author Nicholas J. Shaheen, MD, MPH, chief of gastroenterology and hepatology at the University of North Carolina School of Medicine, Chapel Hill, told this news organization.

“The traditional way to diagnose Barrett’s esophagus is by upper endoscopy, but it’s expensive and not available everywhere,” he said. “One big change since the last iteration of this guideline is that there’s been a development of nonendoscopic screening modalities.”

The guideline was published in The American Journal of Gastroenterology.
 

Progress with swallowable devices

Solid evidence supports the Cytosponge, a capsule containing a compressed spherical polyurethane sponge attached to a string. The sponge expands to a sphere when the capsule dissolves after being swallowed, Dr. Shaheen said.

When withdrawn, the sponge contains esophageal cytology samples that can be used to identify biomarkers for Barrett’s esophagus, either the protein trefoil factor 3 expressed in intestinal metaplasia or methylated DNA markers associated with Barrett’s esophagus mucosa.

More than 90% of participants in trials have been able to swallow the device. Some mild gagging or throat discomfort has been reported.

In one trial, patients with chronic reflux were randomly assigned to either swallow the Cytosponge or be screened by endoscopy based on the practitioner’s usual care. Any diagnosis with the Cytosponge was confirmed with endoscopy. Barrett’s esophagus was found in 2% of patients who had undergone the Cytosponge procedure, versus less than 1% of those screened in the usual way. Of the 6,834 patients in the Cytosponge group, nine were diagnosed with dysplastic Barrett’s esophagus or stage I esophagogastric cancer, versus none of the 6,388 participants in the usual-care group.

“At least for now, we’re using the same guidance that we used for endoscopy to decide who might be best served by these devices,” Dr. Shaheen said. “There are not good data to make a recommendation yet, but you could easily imagine how you could broaden screening guidelines by having a cheaper, more available test.”

Screening for esophageal cancer may one day be as common as screening for colon cancer, said Herbert C. Wolfsen, MD, a consultant in gastroenterology at the Mayo Clinic in Jacksonville, Florida, and professor of medicine at the Mayo Clinic College of Medicine, Rochester, Minn. He was not involved in writing the new guideline.

“We’ve known for years that at least half of patients with esophageal cancer have little, if any, reflux symptoms,” he told this news organization. “This is an area where the guidelines have been consistent, but I think we’re going to see them start to change.”
 

Additional recommendations

The expert panel of the new guideline held off on recommending the use of biomarkers more generally, deeming the evidence insufficient.

The new guideline also endorses endoscopic treatment for dysplastic Barrett’s esophagus but not for Barrett’s esophagus with no dysplasia.

For the first time, it recommends that patients undergo surveillance after successful ablation.

Dr. Wolfsen took note of the guideline’s recommendation that clinicians benchmark their practices against published standards.

The guideline mentions “documentation of landmarks and extent of [Barrett’s esophagus], not obtaining biopsies in the setting of a normal-appearing squamocolumnar junction, sampling using the Seattle biopsy protocol, and performing surveillance endoscopy in patients with [nondysplastic Barrett’s esophagus] no sooner than 3-5 years.”

“The acceptance and implementation of these quality metrics is important,” Dr. Wolfsen said.

However, the guideline underscores the need for considerably more research, he added.

“This group did a fabulous job,” Dr. Wolfsen said. “But when it comes to getting a consensus and people on board, all headed in the same direction, it’s hard when you’re not working with very good data.”

Dr. Shaheen reports financial relationships with Medtronic, Steris, Pentax, CDx Diagnostics, Interpace Diagnostics, Lucid Medical, Cernostics, Phathom Pharmaceuticals, Exact Sciences, Aqua Medical, and Cook Medical. Dr. Wolfsen reports no relevant financial relationships.

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

A swallowable, capsule-sponge device used to sample biomarkers offers a reliable, noninvasive alternative to endoscopy for diagnosing Barrett’s esophagus, according to a new guideline from the American College of Gastroenterology.

In addition, the guideline recommends that patients with Barrett’s esophagus with segments of less than 3 cm be screened every 5 years, but if their Barrett’s esophagus segments are 5 cm or greater, they should be screened every 3 years.

“We don’t want to scope everyone for the lowest risk of cancer,” lead author Nicholas J. Shaheen, MD, MPH, chief of gastroenterology and hepatology at the University of North Carolina School of Medicine, Chapel Hill, told this news organization.

“The traditional way to diagnose Barrett’s esophagus is by upper endoscopy, but it’s expensive and not available everywhere,” he said. “One big change since the last iteration of this guideline is that there’s been a development of nonendoscopic screening modalities.”

The guideline was published in The American Journal of Gastroenterology.
 

Progress with swallowable devices

Solid evidence supports the Cytosponge, a capsule containing a compressed spherical polyurethane sponge attached to a string. The sponge expands to a sphere when the capsule dissolves after being swallowed, Dr. Shaheen said.

When withdrawn, the sponge contains esophageal cytology samples that can be used to identify biomarkers for Barrett’s esophagus, either the protein trefoil factor 3 expressed in intestinal metaplasia or methylated DNA markers associated with Barrett’s esophagus mucosa.

More than 90% of participants in trials have been able to swallow the device. Some mild gagging or throat discomfort has been reported.

In one trial, patients with chronic reflux were randomly assigned to either swallow the Cytosponge or be screened by endoscopy based on the practitioner’s usual care. Any diagnosis with the Cytosponge was confirmed with endoscopy. Barrett’s esophagus was found in 2% of patients who had undergone the Cytosponge procedure, versus less than 1% of those screened in the usual way. Of the 6,834 patients in the Cytosponge group, nine were diagnosed with dysplastic Barrett’s esophagus or stage I esophagogastric cancer, versus none of the 6,388 participants in the usual-care group.

“At least for now, we’re using the same guidance that we used for endoscopy to decide who might be best served by these devices,” Dr. Shaheen said. “There are not good data to make a recommendation yet, but you could easily imagine how you could broaden screening guidelines by having a cheaper, more available test.”

Screening for esophageal cancer may one day be as common as screening for colon cancer, said Herbert C. Wolfsen, MD, a consultant in gastroenterology at the Mayo Clinic in Jacksonville, Florida, and professor of medicine at the Mayo Clinic College of Medicine, Rochester, Minn. He was not involved in writing the new guideline.

“We’ve known for years that at least half of patients with esophageal cancer have little, if any, reflux symptoms,” he told this news organization. “This is an area where the guidelines have been consistent, but I think we’re going to see them start to change.”
 

Additional recommendations

The expert panel of the new guideline held off on recommending the use of biomarkers more generally, deeming the evidence insufficient.

The new guideline also endorses endoscopic treatment for dysplastic Barrett’s esophagus but not for Barrett’s esophagus with no dysplasia.

For the first time, it recommends that patients undergo surveillance after successful ablation.

Dr. Wolfsen took note of the guideline’s recommendation that clinicians benchmark their practices against published standards.

The guideline mentions “documentation of landmarks and extent of [Barrett’s esophagus], not obtaining biopsies in the setting of a normal-appearing squamocolumnar junction, sampling using the Seattle biopsy protocol, and performing surveillance endoscopy in patients with [nondysplastic Barrett’s esophagus] no sooner than 3-5 years.”

“The acceptance and implementation of these quality metrics is important,” Dr. Wolfsen said.

However, the guideline underscores the need for considerably more research, he added.

“This group did a fabulous job,” Dr. Wolfsen said. “But when it comes to getting a consensus and people on board, all headed in the same direction, it’s hard when you’re not working with very good data.”

Dr. Shaheen reports financial relationships with Medtronic, Steris, Pentax, CDx Diagnostics, Interpace Diagnostics, Lucid Medical, Cernostics, Phathom Pharmaceuticals, Exact Sciences, Aqua Medical, and Cook Medical. Dr. Wolfsen reports no relevant financial relationships.

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