Commentary

This discussion was recorded on July 12, 2024. This transcript has been edited for clarity. 

Robert D. Glatter, MD: Hi and welcome. I’m Dr. Robert Glatter, medical advisor for Medscape Emergency Medicine. I recently met an innovative young woman named Hannah Herbst while attending the annual Eagles EMS Conference in Fort Lauderdale, Florida. 

Hannah Herbst is a graduate of Florida Atlantic University, selected for Forbes 30 Under 30, and founder of a company called Golden Hour Medical. She has a background in IT and developed an automated pneumatic tourniquet known as AutoTQ, which we’re going to discuss at length here. 

Also joining us is Dr. Peter Antevy, a pediatric emergency physician and medical director for Davie Fire Rescue as well as Coral Springs Parkland Fire Rescue. Peter is a member of EMS Eagles Global Alliance and is highly involved in high-quality research in prehospital emergency care and is quite well known in Florida and nationally. 

Welcome to both of you. 

Hannah Herbst: Thank you very much. Very grateful to be here.

Dr. Glatter: Hannah, I’ll let you start by explaining what AutoTQ is and then compare that to a standard Combat Application Tourniquet (CAT).

Ms. Herbst: Thank you. Unfortunately, blood loss is a leading cause of preventable death and trauma. When there’s blood loss occurring from an arm or a leg, the easiest way to stop it is by applying a tourniquet, which is this compression type of device that you place above the site of bleeding, and it then applies a high amount of pressure to stop blood flow through the limb. 

Currently, tourniquets on the market have failure rates as high as 84%. This became very real to me back in 2018, when I became aware of mass casualty incidents when I was a student. I became interested in how we can reimagine the conventional tourniquet and try to make it something that’s very user-friendly, much like an automated external defibrillator (AED). 

My team and I developed AutoTQ, which is an automated tourniquet. You press one button to wake it up and one button to inflate it. It guides you through the process of placing it above the site of bleeding on a limb, which is a leading cause of tourniquet failure and being able to effectively administer treatment to a patient that may bleed out. 
 

Tourniquet Failure Rates

Dr. Glatter: In terms of tourniquet failure, how often do standard tourniquets fail, like the CAT combat-type tourniquet? 

Ms. Herbst: Unfortunately, they fail very frequently. There are several studies that have been conducted to evaluate this. Many of them occur immediately after training. They found failure rates between 80% and 90% for the current conventional CAT tourniquet immediately after training, which is very concerning. 

Dr. Glatter: In terms of failure, was it the windlass aspect of the tourniquet that failed? Or was it something related to the actual strap? Was that in any way detailed? 

Ms. Herbst: There are usually a few different failure points that have been found in the literature. One is placement. Many times, when you’re panicked, you don’t remember exactly how to place it. It should be placed high and tight above the bleed and not over a joint. 

The second problem is inadequate tightness. For a CAT tourniquet to be effective, you have to get it extremely tight on that first pull before the windlass is activated, and many times people don’t remember that in the stress of the moment. 

Dr. Glatter: Peter, in terms of tourniquet application by your medics in the field, certainly the CAT-type device has been in existence for quite a while. Hannah’s proposing a new iteration of how to do this, which is automated and simple. What is your take on such a device? And how did you learn about Hannah’s device? 

Peter M. Antevy, MD: We’ve been training on tourniquets ever since the military data showed that there was an extreme benefit in using them. We’ve been doing training for many years, including our police officers. What we’ve noticed is that every time we gather everyone together to show them how to place a tourniquet — and we have to do one-on-one sessions with them — it’s not a device that they can easily put on. These are police officers who had the training last year. 

Like Hannah said, most of the time they have a problem unraveling it and understanding how to actually place it. It’s easier on the arm than it is on the leg. You can imagine it would be harder to place it on your own leg, especially if you had an injury. Then, they don’t tighten it well enough, as Hannah just mentioned. In order for a tourniquet to really be placed properly, it’s going to hurt that person. Many people have that tendency not to want to tighten it as much as they can. 

Having said that, how I got into all of this is because I’m the medical director for Coral Springs and Parkland, and unfortunately, we had the 2018 Valentine’s Day murders that happened where we lost 17 adults and kids. However, 17 people were saved that day, and the credit goes to our police officers who had tourniquets or chest seals on before those patients were brought out to EMS. Many lives were saved by the tourniquet. 

If you look at the Boston Marathon massacre and many other events that have happened, I believe — and I’ve always believed — that tourniquets should be in the glove box of every citizen. It should be in every school room. They should be in buildings along with the AED. 

In my town of Davie, we were the first in the country to add an ordinance that required a Stop the Bleed kit in the AED cabinet, and those were required by buildings of certain sizes. In order to get this lifesaving device everywhere, I think it has to be put into local ordinance and supported by states and by the national folks, which they are doing. 
 

Trials Are Underway

Dr. Glatter: In terms of adoption of such a device, it certainly has to go through rigorous testing and maybe some trials. Hannah, where are you at with vetting this in terms of any type of trial? Has it been compared head to head with standard tourniquets? 

Ms. Herbst: Yes, we’re currently doing large amounts of field testing. We’re doing testing on emergency vehicles and in the surgical setting with different customers. In addition, we’re running pilot studies at different universities and with different organizations, including the military, to make sure that this device is effective. We’re evaluating cognitive offloading of people. We’re hoping to start that study later this year. We’re excited to be doing this in a variety of settings. 

We’re also testing the quality of it in different environmental conditions and under different atmospheric pressure. We’re doing everything we can to ensure the device is safe and effective. We’re excited to scale and fill our preorders and be able to develop this and deliver it to many people. 

Dr. Glatter: I was wondering if you could describe the actual device. There’s a brain part of it and then, obviously, the strap aspect of it. I was curious about contamination and reusability issues. 

Ms. Herbst: That’s a great question. One of the limitations of conventional tourniquets on the market is that they are single use, and often, it requires two tourniquets to stop a bleed, both of which have to be disposed of. 

With AutoTQ, we have a reusable component and a disposable component. I actually have one here that I can show you. We have a cover on it that says: Stop bleed, slide up and power on. You just pull this cover off and then you have a few simple commands. You have powering the device on. I’ll just click this button: Tighten strap above bleeding, then press inflate. It delivers audible instructions telling you exactly how to use the device. Then, you tighten it above your bleed on the limb, and you press the inflate button. Then it administers air into the cuff and stops the patient’s bleed. 
 

Tourniquet Conversion and Limb Salvage

Dr. Glatter: In terms of ischemia time, how can a device like this make it easier for us to know when to let the tourniquet down and allow some blood flow? Certainly, limb salvage is important, and we don’t want to have necrosis and so forth. 

Dr. Antevy: That’s a great question. The limb salvage rate when tourniquets have been used is 85%. When used correctly, you can really improve the outcomes for many patients. 

On the flip side of that, there’s something called tourniquet conversion. That’s exactly what you mentioned. It’s making sure that the tourniquet doesn’t stay on for too long of a time. If you can imagine a patient going to an outlying hospital where there’s no trauma center, and then that patient then has to be moved a couple hours to the trauma center, could you potentially have a tourniquet on for too long that then ends up causing the patient a bad outcome? The answer is yes.

I just had someone on my webinar recently describing the appropriate conversion techniques of tourniquets. You don’t find too much of that in the literature, but you really have to ensure that as you’re taking the tourniquet down, the bleeding is actually stopped. It’s not really recommended to take a tourniquet down if the patient was just acutely bleeding. 

However, imagine a situation where a tourniquet was put on incorrectly. Let’s say a patient got nervous and they just put it on a patient who didn’t really need it. You really have to understand how to evaluate that wound to be sure that, as you’re taking the tourniquet down slowly, the patient doesn’t rebleed again. 

There are two sides of the question, Rob. One is making sure it’s not on inappropriately. The second one is making sure it’s not on for too long, which ends up causing ischemia to that limb. 

Dr. Glatter: Hannah, does your device collect data on the number of hours or minutes that the tourniquet has been up and then automatically deflate it in some sense to allow for that improvement in limb salvage?

Ms. Herbst: That’s a great question, and I really appreciate your answer as well, Dr Antevy. Ischemia time is a very important and critical component of tourniquet use. This is something, when we were designing AutoTQ, that we took into high consideration. 

We found, when we evaluated AutoTQ vs a CAT tourniquet in a mannequin model, that AutoTQ can achieve cessation of hemorrhage at around 400 mm Hg of mercury, whereas CAT requires 700-800 mm Hg. Already our ischemia time is slightly extended just based on existing literature with pneumatic tourniquets because it can stop the bleed at a lower pressure, which causes less complications with the patient’s limb. 

There are different features that we build out for different customers, so depending on what people want, it is possible to deflate the tourniquet. However, typically, you’re at the hospital within 30 minutes. It’s quick to get them there, and then the physician can treat and take that tourniquet down in a supervised and controlled setting. 

Dr. Glatter: In terms of patients with obesity, do you have adjustable straps that will accommodate for that aspect? 

Ms. Herbst: Yes, we have different cuff sizes to accommodate different limbs.
 

Will AutoTQ Be Available to the Public?

Dr. Glatter: Peter, in terms of usability in the prehospital setting, where do you think this is going in the next 3-5 years? 

Dr. Antevy: I’ll start with the public safety sector of the United States, which is the one that is actually first on scene. Whether you’re talking about police officers or EMS, it would behoove us to have tourniquets everywhere. On all of my ambulances, across all of my agencies that I manage, we have quite a number of tourniquets. 

Obviously, cost is a factor, and I know that Hannah has done a great job of making that brain reusable. All we have to do is purchase the straps, which are effectively the same cost, I understand, as a typical tourniquet you would purchase. 

Moving forward though, however, I think that this has wide scalability to the public market, whether it be schools, office buildings, the glove box, and so on. It’s really impossible to teach somebody how to do this the right way, if you have to teach them how to put the strap on, tighten it correctly, and so on. If there was an easy way, like Hannah developed, of just putting it on and pushing a button, then I think that the outcomes and the scalability are much further beyond what we can do in EMS. I think there’s great value in both markets. 
 

The ‘AED of Bleeding’: Rechargeable and Reusable

Dr. Glatter: This is the AED of bleeding. You have a device here that has wide-scale interest, certainly from the public and private sector. 

Hannah, in terms of battery decay, how would that work out if it was in someone’s garage? Let’s just say someone purchased it and they hadn’t used it in 3 or 4 months. What type of decay are we looking at and can they rely on it? 

Ms. Herbst: AutoTQ is rechargeable by a USB-C port, and our battery lasts for a year. Once a year, you’ll get an email reminder that says: “Hey, please charge your AutoTQ and make sure it’s up to the battery level.” We do everything in our power to make sure that our consumers are checking their batteries and that they’re ready to go. 

Dr. Glatter: Is it heat and fire resistant? What, in terms of durability, does your device have? 

Ms. Herbst: Just like any other medical device, we come with manufacturer recommendations for the upper and lower bounds of temperature and different storage recommendations. All of that is in our instructions for use. 

Dr. Glatter: Peter, getting back to logistics. In terms of adoption, do you feel that, in the long term, this device will be something that we’re going to be seeing widely adopted just going forward? 

Dr. Antevy: I do, and I’ll tell you why. When you look at AED use in this country, the odds of someone actually getting an AED and using it correctly are still very low. Part of that is because it’s complicated for many people to do. Getting tourniquets everywhere is step No. 1, and I think the federal government and the Stop the Bleed program is really making that happen. 

We talked about ordinances, but ease of use, I think, is really the key. You have people who oftentimes have their child in cardiac arrest in front of them, and they won’t put two hands on their chest because they just are afraid of doing it. 

When you have a device that’s a tourniquet, that’s a single-button turn on and single-button inflate, I think that would make it much more likely that a person will use that device when they’re passing the scene of an accident, as an example. 

We’ve had many non–mass casualty incident events that have had tourniquets. We’ve had some media stories on them, where they’re just happening because someone got into a motor vehicle accident. It doesn’t have to be a school shooting. I think the tourniquets should be everywhere and should be easily used by everybody. 
 

Managing Pain 

Dr. Glatter: Regarding sedation, is there a need because of the pain involved with the application? How would you sedate a patient, pediatric or adult, who needs a tourniquet? 

Dr. Antevy: We always evaluate people’s pain. If the patient is an extremist, we’re just going to be managing and trying to get them back to life. Once somebody is stabilized and is exhibiting pain of any sort, even, for example, after we intubate somebody, we have to sedate them and provide them pain control because they have a piece of plastic in their trachea. 

It’s the same thing here for a tourniquet. These are painful, and we do have the appropriate medications on our vehicles to address that pain. Again, just simply the trauma itself is very painful. Yes, we do address that in EMS, and I would say most public agencies across this country would address pain appropriately. 
 

Training on Tourniquet Use

Dr. Glatter: Hannah, can you talk a little bit about public training types of approaches? How would you train a consumer who purchases this type of device?

Ms. Herbst: A huge part of our mission is making blood loss prevention and control training accessible to a wide variety of people. One way that we’re able to do that is through our online training platform. When you purchase an AutoTQ kit, you plug it into your computer, and it walks you through the process of using it. It lets you practice on your own limb and on your buddy’s limb, just to be able to effectively apply it. We think this will have huge impacts in making sure that people are prepared and ready to stop the bleed with AutoTQ. 

Dr. Glatter: Do you recommend people training once a month, in general, just to keep their skills up to use this? In the throes of a trauma and very chaotic situation, people sometimes lose their ability to think clearly and straightly. 

Ms. Herbst: One of the studies we’re conducting is a learning curve study to try to figure out how quickly these skills degrade over time. We know that with the windlass tourniquet, it degrades within moments of training. With AutoTQ, we think the learning curve will last much longer. That’s something we’re evaluating, but we recommend people train as often as they can. 

Dr. Antevy: Rob, if I can mention that there is a concept of just-in-time training. I think that with having the expectation that people are going to be training frequently, unfortunately, as many of us know, even with the AED as a perfect example, people don’t do that. 

Yes. I would agree that you have to train at least once a year, is what I would say. At my office, we have a 2-hour training that goes over all these different items once a year. 

The device itself should have the ability to allow you to figure out how to use it just in time, whether via video, or like Hannah’s device, by audio. I think that having both those things would make it more likely that the device be used when needed. 

People panic, and if they have a device that can talk to them or walk them through it, they will be much more likely to use it at that time.

 

Final Takeaways

Dr. Glatter: Any other final thoughts or a few pearls for listeners to take away? Hannah, I’ll start with you. 

Ms. Herbst: I’m very grateful for your time, and I’m very excited about the potential for AutoTQ. To me, it’s so exciting to see people preordering the device now. We’ve had people from school bus companies and small sports teams. I think, just like Dr Antevy said, tourniquets aren’t limited to mass casualty situations. Blood loss can happen anywhere and to anyone. 

Being able to equip people and serve them to better prepare them for this happening to themselves, their friends, or their family is just the honor of a lifetime. Thank you very much for covering the device and for having me today. 

Dr. Glatter: Of course, my pleasure. Peter? 

Dr. Antevy: The citizens of this country, and everyone who lives across the world, has started to understand that there are things that we expect from our people, from the community. We expect them to do CPR for cardiac arrest. We expect them to know how to use an EpiPen. We expect them to know how to use an AED, and we also expect them to know how to stop bleeding with a tourniquet. 

The American public has gotten to understand that these devices are very important. Having a device that’s easily used, that I can teach you in 10 seconds, that speaks to you — these are all things that make this product have great potential. I do look forward to the studies, not just the cadaver studies, but the real human studies. 

I know Hannah is really a phenom and has been doing all these things so that this product can be on the shelves of Walmart and CVS one day. I commend you, Hannah, for everything you’re doing and wishing you the best of luck. We’re here for you. 

Dr. Glatter: Same here. Congratulations on your innovative capability and what you’ve done to change the outcomes of bleeding related to penetrating trauma. Thank you so much.

Robert D. Glatter, MD, is an assistant professor of emergency medicine at Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York. He is a medical advisor for Medscape and hosts the Hot Topics in EM series. Hannah D. Herbst, BS, is a graduate of Florida Atlantic University, was selected for Forbes 30 Under 30, and is the founder/CEO of Golden Hour Medical. Peter M. Antevy, MD, is a pediatric emergency medicine physician and medical director for Davie Fire Rescue and Coral Springs–Parkland Fire Department in Florida. He is also a member of the EMS Eagles Global Alliance.



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

This discussion was recorded on July 12, 2024. This transcript has been edited for clarity. 

Robert D. Glatter, MD: Hi and welcome. I’m Dr. Robert Glatter, medical advisor for Medscape Emergency Medicine. I recently met an innovative young woman named Hannah Herbst while attending the annual Eagles EMS Conference in Fort Lauderdale, Florida. 

Hannah Herbst is a graduate of Florida Atlantic University, selected for Forbes 30 Under 30, and founder of a company called Golden Hour Medical. She has a background in IT and developed an automated pneumatic tourniquet known as AutoTQ, which we’re going to discuss at length here. 

Also joining us is Dr. Peter Antevy, a pediatric emergency physician and medical director for Davie Fire Rescue as well as Coral Springs Parkland Fire Rescue. Peter is a member of EMS Eagles Global Alliance and is highly involved in high-quality research in prehospital emergency care and is quite well known in Florida and nationally. 

Welcome to both of you. 

Hannah Herbst: Thank you very much. Very grateful to be here.

Dr. Glatter: Hannah, I’ll let you start by explaining what AutoTQ is and then compare that to a standard Combat Application Tourniquet (CAT).

Ms. Herbst: Thank you. Unfortunately, blood loss is a leading cause of preventable death and trauma. When there’s blood loss occurring from an arm or a leg, the easiest way to stop it is by applying a tourniquet, which is this compression type of device that you place above the site of bleeding, and it then applies a high amount of pressure to stop blood flow through the limb. 

Currently, tourniquets on the market have failure rates as high as 84%. This became very real to me back in 2018, when I became aware of mass casualty incidents when I was a student. I became interested in how we can reimagine the conventional tourniquet and try to make it something that’s very user-friendly, much like an automated external defibrillator (AED). 

My team and I developed AutoTQ, which is an automated tourniquet. You press one button to wake it up and one button to inflate it. It guides you through the process of placing it above the site of bleeding on a limb, which is a leading cause of tourniquet failure and being able to effectively administer treatment to a patient that may bleed out. 
 

Tourniquet Failure Rates

Dr. Glatter: In terms of tourniquet failure, how often do standard tourniquets fail, like the CAT combat-type tourniquet? 

Ms. Herbst: Unfortunately, they fail very frequently. There are several studies that have been conducted to evaluate this. Many of them occur immediately after training. They found failure rates between 80% and 90% for the current conventional CAT tourniquet immediately after training, which is very concerning. 

Dr. Glatter: In terms of failure, was it the windlass aspect of the tourniquet that failed? Or was it something related to the actual strap? Was that in any way detailed? 

Ms. Herbst: There are usually a few different failure points that have been found in the literature. One is placement. Many times, when you’re panicked, you don’t remember exactly how to place it. It should be placed high and tight above the bleed and not over a joint. 

The second problem is inadequate tightness. For a CAT tourniquet to be effective, you have to get it extremely tight on that first pull before the windlass is activated, and many times people don’t remember that in the stress of the moment. 

Dr. Glatter: Peter, in terms of tourniquet application by your medics in the field, certainly the CAT-type device has been in existence for quite a while. Hannah’s proposing a new iteration of how to do this, which is automated and simple. What is your take on such a device? And how did you learn about Hannah’s device? 

Peter M. Antevy, MD: We’ve been training on tourniquets ever since the military data showed that there was an extreme benefit in using them. We’ve been doing training for many years, including our police officers. What we’ve noticed is that every time we gather everyone together to show them how to place a tourniquet — and we have to do one-on-one sessions with them — it’s not a device that they can easily put on. These are police officers who had the training last year. 

Like Hannah said, most of the time they have a problem unraveling it and understanding how to actually place it. It’s easier on the arm than it is on the leg. You can imagine it would be harder to place it on your own leg, especially if you had an injury. Then, they don’t tighten it well enough, as Hannah just mentioned. In order for a tourniquet to really be placed properly, it’s going to hurt that person. Many people have that tendency not to want to tighten it as much as they can. 

Having said that, how I got into all of this is because I’m the medical director for Coral Springs and Parkland, and unfortunately, we had the 2018 Valentine’s Day murders that happened where we lost 17 adults and kids. However, 17 people were saved that day, and the credit goes to our police officers who had tourniquets or chest seals on before those patients were brought out to EMS. Many lives were saved by the tourniquet. 

If you look at the Boston Marathon massacre and many other events that have happened, I believe — and I’ve always believed — that tourniquets should be in the glove box of every citizen. It should be in every school room. They should be in buildings along with the AED. 

In my town of Davie, we were the first in the country to add an ordinance that required a Stop the Bleed kit in the AED cabinet, and those were required by buildings of certain sizes. In order to get this lifesaving device everywhere, I think it has to be put into local ordinance and supported by states and by the national folks, which they are doing. 
 

Trials Are Underway

Dr. Glatter: In terms of adoption of such a device, it certainly has to go through rigorous testing and maybe some trials. Hannah, where are you at with vetting this in terms of any type of trial? Has it been compared head to head with standard tourniquets? 

Ms. Herbst: Yes, we’re currently doing large amounts of field testing. We’re doing testing on emergency vehicles and in the surgical setting with different customers. In addition, we’re running pilot studies at different universities and with different organizations, including the military, to make sure that this device is effective. We’re evaluating cognitive offloading of people. We’re hoping to start that study later this year. We’re excited to be doing this in a variety of settings. 

We’re also testing the quality of it in different environmental conditions and under different atmospheric pressure. We’re doing everything we can to ensure the device is safe and effective. We’re excited to scale and fill our preorders and be able to develop this and deliver it to many people. 

Dr. Glatter: I was wondering if you could describe the actual device. There’s a brain part of it and then, obviously, the strap aspect of it. I was curious about contamination and reusability issues. 

Ms. Herbst: That’s a great question. One of the limitations of conventional tourniquets on the market is that they are single use, and often, it requires two tourniquets to stop a bleed, both of which have to be disposed of. 

With AutoTQ, we have a reusable component and a disposable component. I actually have one here that I can show you. We have a cover on it that says: Stop bleed, slide up and power on. You just pull this cover off and then you have a few simple commands. You have powering the device on. I’ll just click this button: Tighten strap above bleeding, then press inflate. It delivers audible instructions telling you exactly how to use the device. Then, you tighten it above your bleed on the limb, and you press the inflate button. Then it administers air into the cuff and stops the patient’s bleed. 
 

Tourniquet Conversion and Limb Salvage

Dr. Glatter: In terms of ischemia time, how can a device like this make it easier for us to know when to let the tourniquet down and allow some blood flow? Certainly, limb salvage is important, and we don’t want to have necrosis and so forth. 

Dr. Antevy: That’s a great question. The limb salvage rate when tourniquets have been used is 85%. When used correctly, you can really improve the outcomes for many patients. 

On the flip side of that, there’s something called tourniquet conversion. That’s exactly what you mentioned. It’s making sure that the tourniquet doesn’t stay on for too long of a time. If you can imagine a patient going to an outlying hospital where there’s no trauma center, and then that patient then has to be moved a couple hours to the trauma center, could you potentially have a tourniquet on for too long that then ends up causing the patient a bad outcome? The answer is yes.

I just had someone on my webinar recently describing the appropriate conversion techniques of tourniquets. You don’t find too much of that in the literature, but you really have to ensure that as you’re taking the tourniquet down, the bleeding is actually stopped. It’s not really recommended to take a tourniquet down if the patient was just acutely bleeding. 

However, imagine a situation where a tourniquet was put on incorrectly. Let’s say a patient got nervous and they just put it on a patient who didn’t really need it. You really have to understand how to evaluate that wound to be sure that, as you’re taking the tourniquet down slowly, the patient doesn’t rebleed again. 

There are two sides of the question, Rob. One is making sure it’s not on inappropriately. The second one is making sure it’s not on for too long, which ends up causing ischemia to that limb. 

Dr. Glatter: Hannah, does your device collect data on the number of hours or minutes that the tourniquet has been up and then automatically deflate it in some sense to allow for that improvement in limb salvage?

Ms. Herbst: That’s a great question, and I really appreciate your answer as well, Dr Antevy. Ischemia time is a very important and critical component of tourniquet use. This is something, when we were designing AutoTQ, that we took into high consideration. 

We found, when we evaluated AutoTQ vs a CAT tourniquet in a mannequin model, that AutoTQ can achieve cessation of hemorrhage at around 400 mm Hg of mercury, whereas CAT requires 700-800 mm Hg. Already our ischemia time is slightly extended just based on existing literature with pneumatic tourniquets because it can stop the bleed at a lower pressure, which causes less complications with the patient’s limb. 

There are different features that we build out for different customers, so depending on what people want, it is possible to deflate the tourniquet. However, typically, you’re at the hospital within 30 minutes. It’s quick to get them there, and then the physician can treat and take that tourniquet down in a supervised and controlled setting. 

Dr. Glatter: In terms of patients with obesity, do you have adjustable straps that will accommodate for that aspect? 

Ms. Herbst: Yes, we have different cuff sizes to accommodate different limbs.
 

Will AutoTQ Be Available to the Public?

Dr. Glatter: Peter, in terms of usability in the prehospital setting, where do you think this is going in the next 3-5 years? 

Dr. Antevy: I’ll start with the public safety sector of the United States, which is the one that is actually first on scene. Whether you’re talking about police officers or EMS, it would behoove us to have tourniquets everywhere. On all of my ambulances, across all of my agencies that I manage, we have quite a number of tourniquets. 

Obviously, cost is a factor, and I know that Hannah has done a great job of making that brain reusable. All we have to do is purchase the straps, which are effectively the same cost, I understand, as a typical tourniquet you would purchase. 

Moving forward though, however, I think that this has wide scalability to the public market, whether it be schools, office buildings, the glove box, and so on. It’s really impossible to teach somebody how to do this the right way, if you have to teach them how to put the strap on, tighten it correctly, and so on. If there was an easy way, like Hannah developed, of just putting it on and pushing a button, then I think that the outcomes and the scalability are much further beyond what we can do in EMS. I think there’s great value in both markets. 
 

The ‘AED of Bleeding’: Rechargeable and Reusable

Dr. Glatter: This is the AED of bleeding. You have a device here that has wide-scale interest, certainly from the public and private sector. 

Hannah, in terms of battery decay, how would that work out if it was in someone’s garage? Let’s just say someone purchased it and they hadn’t used it in 3 or 4 months. What type of decay are we looking at and can they rely on it? 

Ms. Herbst: AutoTQ is rechargeable by a USB-C port, and our battery lasts for a year. Once a year, you’ll get an email reminder that says: “Hey, please charge your AutoTQ and make sure it’s up to the battery level.” We do everything in our power to make sure that our consumers are checking their batteries and that they’re ready to go. 

Dr. Glatter: Is it heat and fire resistant? What, in terms of durability, does your device have? 

Ms. Herbst: Just like any other medical device, we come with manufacturer recommendations for the upper and lower bounds of temperature and different storage recommendations. All of that is in our instructions for use. 

Dr. Glatter: Peter, getting back to logistics. In terms of adoption, do you feel that, in the long term, this device will be something that we’re going to be seeing widely adopted just going forward? 

Dr. Antevy: I do, and I’ll tell you why. When you look at AED use in this country, the odds of someone actually getting an AED and using it correctly are still very low. Part of that is because it’s complicated for many people to do. Getting tourniquets everywhere is step No. 1, and I think the federal government and the Stop the Bleed program is really making that happen. 

We talked about ordinances, but ease of use, I think, is really the key. You have people who oftentimes have their child in cardiac arrest in front of them, and they won’t put two hands on their chest because they just are afraid of doing it. 

When you have a device that’s a tourniquet, that’s a single-button turn on and single-button inflate, I think that would make it much more likely that a person will use that device when they’re passing the scene of an accident, as an example. 

We’ve had many non–mass casualty incident events that have had tourniquets. We’ve had some media stories on them, where they’re just happening because someone got into a motor vehicle accident. It doesn’t have to be a school shooting. I think the tourniquets should be everywhere and should be easily used by everybody. 
 

Managing Pain 

Dr. Glatter: Regarding sedation, is there a need because of the pain involved with the application? How would you sedate a patient, pediatric or adult, who needs a tourniquet? 

Dr. Antevy: We always evaluate people’s pain. If the patient is an extremist, we’re just going to be managing and trying to get them back to life. Once somebody is stabilized and is exhibiting pain of any sort, even, for example, after we intubate somebody, we have to sedate them and provide them pain control because they have a piece of plastic in their trachea. 

It’s the same thing here for a tourniquet. These are painful, and we do have the appropriate medications on our vehicles to address that pain. Again, just simply the trauma itself is very painful. Yes, we do address that in EMS, and I would say most public agencies across this country would address pain appropriately. 
 

Training on Tourniquet Use

Dr. Glatter: Hannah, can you talk a little bit about public training types of approaches? How would you train a consumer who purchases this type of device?

Ms. Herbst: A huge part of our mission is making blood loss prevention and control training accessible to a wide variety of people. One way that we’re able to do that is through our online training platform. When you purchase an AutoTQ kit, you plug it into your computer, and it walks you through the process of using it. It lets you practice on your own limb and on your buddy’s limb, just to be able to effectively apply it. We think this will have huge impacts in making sure that people are prepared and ready to stop the bleed with AutoTQ. 

Dr. Glatter: Do you recommend people training once a month, in general, just to keep their skills up to use this? In the throes of a trauma and very chaotic situation, people sometimes lose their ability to think clearly and straightly. 

Ms. Herbst: One of the studies we’re conducting is a learning curve study to try to figure out how quickly these skills degrade over time. We know that with the windlass tourniquet, it degrades within moments of training. With AutoTQ, we think the learning curve will last much longer. That’s something we’re evaluating, but we recommend people train as often as they can. 

Dr. Antevy: Rob, if I can mention that there is a concept of just-in-time training. I think that with having the expectation that people are going to be training frequently, unfortunately, as many of us know, even with the AED as a perfect example, people don’t do that. 

Yes. I would agree that you have to train at least once a year, is what I would say. At my office, we have a 2-hour training that goes over all these different items once a year. 

The device itself should have the ability to allow you to figure out how to use it just in time, whether via video, or like Hannah’s device, by audio. I think that having both those things would make it more likely that the device be used when needed. 

People panic, and if they have a device that can talk to them or walk them through it, they will be much more likely to use it at that time.

 

Final Takeaways

Dr. Glatter: Any other final thoughts or a few pearls for listeners to take away? Hannah, I’ll start with you. 

Ms. Herbst: I’m very grateful for your time, and I’m very excited about the potential for AutoTQ. To me, it’s so exciting to see people preordering the device now. We’ve had people from school bus companies and small sports teams. I think, just like Dr Antevy said, tourniquets aren’t limited to mass casualty situations. Blood loss can happen anywhere and to anyone. 

Being able to equip people and serve them to better prepare them for this happening to themselves, their friends, or their family is just the honor of a lifetime. Thank you very much for covering the device and for having me today. 

Dr. Glatter: Of course, my pleasure. Peter? 

Dr. Antevy: The citizens of this country, and everyone who lives across the world, has started to understand that there are things that we expect from our people, from the community. We expect them to do CPR for cardiac arrest. We expect them to know how to use an EpiPen. We expect them to know how to use an AED, and we also expect them to know how to stop bleeding with a tourniquet. 

The American public has gotten to understand that these devices are very important. Having a device that’s easily used, that I can teach you in 10 seconds, that speaks to you — these are all things that make this product have great potential. I do look forward to the studies, not just the cadaver studies, but the real human studies. 

I know Hannah is really a phenom and has been doing all these things so that this product can be on the shelves of Walmart and CVS one day. I commend you, Hannah, for everything you’re doing and wishing you the best of luck. We’re here for you. 

Dr. Glatter: Same here. Congratulations on your innovative capability and what you’ve done to change the outcomes of bleeding related to penetrating trauma. Thank you so much.

Robert D. Glatter, MD, is an assistant professor of emergency medicine at Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York. He is a medical advisor for Medscape and hosts the Hot Topics in EM series. Hannah D. Herbst, BS, is a graduate of Florida Atlantic University, was selected for Forbes 30 Under 30, and is the founder/CEO of Golden Hour Medical. Peter M. Antevy, MD, is a pediatric emergency medicine physician and medical director for Davie Fire Rescue and Coral Springs–Parkland Fire Department in Florida. He is also a member of the EMS Eagles Global Alliance.



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

This discussion was recorded on July 12, 2024. This transcript has been edited for clarity. 

Robert D. Glatter, MD: Hi and welcome. I’m Dr. Robert Glatter, medical advisor for Medscape Emergency Medicine. I recently met an innovative young woman named Hannah Herbst while attending the annual Eagles EMS Conference in Fort Lauderdale, Florida. 

Hannah Herbst is a graduate of Florida Atlantic University, selected for Forbes 30 Under 30, and founder of a company called Golden Hour Medical. She has a background in IT and developed an automated pneumatic tourniquet known as AutoTQ, which we’re going to discuss at length here. 

Also joining us is Dr. Peter Antevy, a pediatric emergency physician and medical director for Davie Fire Rescue as well as Coral Springs Parkland Fire Rescue. Peter is a member of EMS Eagles Global Alliance and is highly involved in high-quality research in prehospital emergency care and is quite well known in Florida and nationally. 

Welcome to both of you. 

Hannah Herbst: Thank you very much. Very grateful to be here.

Dr. Glatter: Hannah, I’ll let you start by explaining what AutoTQ is and then compare that to a standard Combat Application Tourniquet (CAT).

Ms. Herbst: Thank you. Unfortunately, blood loss is a leading cause of preventable death and trauma. When there’s blood loss occurring from an arm or a leg, the easiest way to stop it is by applying a tourniquet, which is this compression type of device that you place above the site of bleeding, and it then applies a high amount of pressure to stop blood flow through the limb. 

Currently, tourniquets on the market have failure rates as high as 84%. This became very real to me back in 2018, when I became aware of mass casualty incidents when I was a student. I became interested in how we can reimagine the conventional tourniquet and try to make it something that’s very user-friendly, much like an automated external defibrillator (AED). 

My team and I developed AutoTQ, which is an automated tourniquet. You press one button to wake it up and one button to inflate it. It guides you through the process of placing it above the site of bleeding on a limb, which is a leading cause of tourniquet failure and being able to effectively administer treatment to a patient that may bleed out. 
 

Tourniquet Failure Rates

Dr. Glatter: In terms of tourniquet failure, how often do standard tourniquets fail, like the CAT combat-type tourniquet? 

Ms. Herbst: Unfortunately, they fail very frequently. There are several studies that have been conducted to evaluate this. Many of them occur immediately after training. They found failure rates between 80% and 90% for the current conventional CAT tourniquet immediately after training, which is very concerning. 

Dr. Glatter: In terms of failure, was it the windlass aspect of the tourniquet that failed? Or was it something related to the actual strap? Was that in any way detailed? 

Ms. Herbst: There are usually a few different failure points that have been found in the literature. One is placement. Many times, when you’re panicked, you don’t remember exactly how to place it. It should be placed high and tight above the bleed and not over a joint. 

The second problem is inadequate tightness. For a CAT tourniquet to be effective, you have to get it extremely tight on that first pull before the windlass is activated, and many times people don’t remember that in the stress of the moment. 

Dr. Glatter: Peter, in terms of tourniquet application by your medics in the field, certainly the CAT-type device has been in existence for quite a while. Hannah’s proposing a new iteration of how to do this, which is automated and simple. What is your take on such a device? And how did you learn about Hannah’s device? 

Peter M. Antevy, MD: We’ve been training on tourniquets ever since the military data showed that there was an extreme benefit in using them. We’ve been doing training for many years, including our police officers. What we’ve noticed is that every time we gather everyone together to show them how to place a tourniquet — and we have to do one-on-one sessions with them — it’s not a device that they can easily put on. These are police officers who had the training last year. 

Like Hannah said, most of the time they have a problem unraveling it and understanding how to actually place it. It’s easier on the arm than it is on the leg. You can imagine it would be harder to place it on your own leg, especially if you had an injury. Then, they don’t tighten it well enough, as Hannah just mentioned. In order for a tourniquet to really be placed properly, it’s going to hurt that person. Many people have that tendency not to want to tighten it as much as they can. 

Having said that, how I got into all of this is because I’m the medical director for Coral Springs and Parkland, and unfortunately, we had the 2018 Valentine’s Day murders that happened where we lost 17 adults and kids. However, 17 people were saved that day, and the credit goes to our police officers who had tourniquets or chest seals on before those patients were brought out to EMS. Many lives were saved by the tourniquet. 

If you look at the Boston Marathon massacre and many other events that have happened, I believe — and I’ve always believed — that tourniquets should be in the glove box of every citizen. It should be in every school room. They should be in buildings along with the AED. 

In my town of Davie, we were the first in the country to add an ordinance that required a Stop the Bleed kit in the AED cabinet, and those were required by buildings of certain sizes. In order to get this lifesaving device everywhere, I think it has to be put into local ordinance and supported by states and by the national folks, which they are doing. 
 

Trials Are Underway

Dr. Glatter: In terms of adoption of such a device, it certainly has to go through rigorous testing and maybe some trials. Hannah, where are you at with vetting this in terms of any type of trial? Has it been compared head to head with standard tourniquets? 

Ms. Herbst: Yes, we’re currently doing large amounts of field testing. We’re doing testing on emergency vehicles and in the surgical setting with different customers. In addition, we’re running pilot studies at different universities and with different organizations, including the military, to make sure that this device is effective. We’re evaluating cognitive offloading of people. We’re hoping to start that study later this year. We’re excited to be doing this in a variety of settings. 

We’re also testing the quality of it in different environmental conditions and under different atmospheric pressure. We’re doing everything we can to ensure the device is safe and effective. We’re excited to scale and fill our preorders and be able to develop this and deliver it to many people. 

Dr. Glatter: I was wondering if you could describe the actual device. There’s a brain part of it and then, obviously, the strap aspect of it. I was curious about contamination and reusability issues. 

Ms. Herbst: That’s a great question. One of the limitations of conventional tourniquets on the market is that they are single use, and often, it requires two tourniquets to stop a bleed, both of which have to be disposed of. 

With AutoTQ, we have a reusable component and a disposable component. I actually have one here that I can show you. We have a cover on it that says: Stop bleed, slide up and power on. You just pull this cover off and then you have a few simple commands. You have powering the device on. I’ll just click this button: Tighten strap above bleeding, then press inflate. It delivers audible instructions telling you exactly how to use the device. Then, you tighten it above your bleed on the limb, and you press the inflate button. Then it administers air into the cuff and stops the patient’s bleed. 
 

Tourniquet Conversion and Limb Salvage

Dr. Glatter: In terms of ischemia time, how can a device like this make it easier for us to know when to let the tourniquet down and allow some blood flow? Certainly, limb salvage is important, and we don’t want to have necrosis and so forth. 

Dr. Antevy: That’s a great question. The limb salvage rate when tourniquets have been used is 85%. When used correctly, you can really improve the outcomes for many patients. 

On the flip side of that, there’s something called tourniquet conversion. That’s exactly what you mentioned. It’s making sure that the tourniquet doesn’t stay on for too long of a time. If you can imagine a patient going to an outlying hospital where there’s no trauma center, and then that patient then has to be moved a couple hours to the trauma center, could you potentially have a tourniquet on for too long that then ends up causing the patient a bad outcome? The answer is yes.

I just had someone on my webinar recently describing the appropriate conversion techniques of tourniquets. You don’t find too much of that in the literature, but you really have to ensure that as you’re taking the tourniquet down, the bleeding is actually stopped. It’s not really recommended to take a tourniquet down if the patient was just acutely bleeding. 

However, imagine a situation where a tourniquet was put on incorrectly. Let’s say a patient got nervous and they just put it on a patient who didn’t really need it. You really have to understand how to evaluate that wound to be sure that, as you’re taking the tourniquet down slowly, the patient doesn’t rebleed again. 

There are two sides of the question, Rob. One is making sure it’s not on inappropriately. The second one is making sure it’s not on for too long, which ends up causing ischemia to that limb. 

Dr. Glatter: Hannah, does your device collect data on the number of hours or minutes that the tourniquet has been up and then automatically deflate it in some sense to allow for that improvement in limb salvage?

Ms. Herbst: That’s a great question, and I really appreciate your answer as well, Dr Antevy. Ischemia time is a very important and critical component of tourniquet use. This is something, when we were designing AutoTQ, that we took into high consideration. 

We found, when we evaluated AutoTQ vs a CAT tourniquet in a mannequin model, that AutoTQ can achieve cessation of hemorrhage at around 400 mm Hg of mercury, whereas CAT requires 700-800 mm Hg. Already our ischemia time is slightly extended just based on existing literature with pneumatic tourniquets because it can stop the bleed at a lower pressure, which causes less complications with the patient’s limb. 

There are different features that we build out for different customers, so depending on what people want, it is possible to deflate the tourniquet. However, typically, you’re at the hospital within 30 minutes. It’s quick to get them there, and then the physician can treat and take that tourniquet down in a supervised and controlled setting. 

Dr. Glatter: In terms of patients with obesity, do you have adjustable straps that will accommodate for that aspect? 

Ms. Herbst: Yes, we have different cuff sizes to accommodate different limbs.
 

Will AutoTQ Be Available to the Public?

Dr. Glatter: Peter, in terms of usability in the prehospital setting, where do you think this is going in the next 3-5 years? 

Dr. Antevy: I’ll start with the public safety sector of the United States, which is the one that is actually first on scene. Whether you’re talking about police officers or EMS, it would behoove us to have tourniquets everywhere. On all of my ambulances, across all of my agencies that I manage, we have quite a number of tourniquets. 

Obviously, cost is a factor, and I know that Hannah has done a great job of making that brain reusable. All we have to do is purchase the straps, which are effectively the same cost, I understand, as a typical tourniquet you would purchase. 

Moving forward though, however, I think that this has wide scalability to the public market, whether it be schools, office buildings, the glove box, and so on. It’s really impossible to teach somebody how to do this the right way, if you have to teach them how to put the strap on, tighten it correctly, and so on. If there was an easy way, like Hannah developed, of just putting it on and pushing a button, then I think that the outcomes and the scalability are much further beyond what we can do in EMS. I think there’s great value in both markets. 
 

The ‘AED of Bleeding’: Rechargeable and Reusable

Dr. Glatter: This is the AED of bleeding. You have a device here that has wide-scale interest, certainly from the public and private sector. 

Hannah, in terms of battery decay, how would that work out if it was in someone’s garage? Let’s just say someone purchased it and they hadn’t used it in 3 or 4 months. What type of decay are we looking at and can they rely on it? 

Ms. Herbst: AutoTQ is rechargeable by a USB-C port, and our battery lasts for a year. Once a year, you’ll get an email reminder that says: “Hey, please charge your AutoTQ and make sure it’s up to the battery level.” We do everything in our power to make sure that our consumers are checking their batteries and that they’re ready to go. 

Dr. Glatter: Is it heat and fire resistant? What, in terms of durability, does your device have? 

Ms. Herbst: Just like any other medical device, we come with manufacturer recommendations for the upper and lower bounds of temperature and different storage recommendations. All of that is in our instructions for use. 

Dr. Glatter: Peter, getting back to logistics. In terms of adoption, do you feel that, in the long term, this device will be something that we’re going to be seeing widely adopted just going forward? 

Dr. Antevy: I do, and I’ll tell you why. When you look at AED use in this country, the odds of someone actually getting an AED and using it correctly are still very low. Part of that is because it’s complicated for many people to do. Getting tourniquets everywhere is step No. 1, and I think the federal government and the Stop the Bleed program is really making that happen. 

We talked about ordinances, but ease of use, I think, is really the key. You have people who oftentimes have their child in cardiac arrest in front of them, and they won’t put two hands on their chest because they just are afraid of doing it. 

When you have a device that’s a tourniquet, that’s a single-button turn on and single-button inflate, I think that would make it much more likely that a person will use that device when they’re passing the scene of an accident, as an example. 

We’ve had many non–mass casualty incident events that have had tourniquets. We’ve had some media stories on them, where they’re just happening because someone got into a motor vehicle accident. It doesn’t have to be a school shooting. I think the tourniquets should be everywhere and should be easily used by everybody. 
 

Managing Pain 

Dr. Glatter: Regarding sedation, is there a need because of the pain involved with the application? How would you sedate a patient, pediatric or adult, who needs a tourniquet? 

Dr. Antevy: We always evaluate people’s pain. If the patient is an extremist, we’re just going to be managing and trying to get them back to life. Once somebody is stabilized and is exhibiting pain of any sort, even, for example, after we intubate somebody, we have to sedate them and provide them pain control because they have a piece of plastic in their trachea. 

It’s the same thing here for a tourniquet. These are painful, and we do have the appropriate medications on our vehicles to address that pain. Again, just simply the trauma itself is very painful. Yes, we do address that in EMS, and I would say most public agencies across this country would address pain appropriately. 
 

Training on Tourniquet Use

Dr. Glatter: Hannah, can you talk a little bit about public training types of approaches? How would you train a consumer who purchases this type of device?

Ms. Herbst: A huge part of our mission is making blood loss prevention and control training accessible to a wide variety of people. One way that we’re able to do that is through our online training platform. When you purchase an AutoTQ kit, you plug it into your computer, and it walks you through the process of using it. It lets you practice on your own limb and on your buddy’s limb, just to be able to effectively apply it. We think this will have huge impacts in making sure that people are prepared and ready to stop the bleed with AutoTQ. 

Dr. Glatter: Do you recommend people training once a month, in general, just to keep their skills up to use this? In the throes of a trauma and very chaotic situation, people sometimes lose their ability to think clearly and straightly. 

Ms. Herbst: One of the studies we’re conducting is a learning curve study to try to figure out how quickly these skills degrade over time. We know that with the windlass tourniquet, it degrades within moments of training. With AutoTQ, we think the learning curve will last much longer. That’s something we’re evaluating, but we recommend people train as often as they can. 

Dr. Antevy: Rob, if I can mention that there is a concept of just-in-time training. I think that with having the expectation that people are going to be training frequently, unfortunately, as many of us know, even with the AED as a perfect example, people don’t do that. 

Yes. I would agree that you have to train at least once a year, is what I would say. At my office, we have a 2-hour training that goes over all these different items once a year. 

The device itself should have the ability to allow you to figure out how to use it just in time, whether via video, or like Hannah’s device, by audio. I think that having both those things would make it more likely that the device be used when needed. 

People panic, and if they have a device that can talk to them or walk them through it, they will be much more likely to use it at that time.

 

Final Takeaways

Dr. Glatter: Any other final thoughts or a few pearls for listeners to take away? Hannah, I’ll start with you. 

Ms. Herbst: I’m very grateful for your time, and I’m very excited about the potential for AutoTQ. To me, it’s so exciting to see people preordering the device now. We’ve had people from school bus companies and small sports teams. I think, just like Dr Antevy said, tourniquets aren’t limited to mass casualty situations. Blood loss can happen anywhere and to anyone. 

Being able to equip people and serve them to better prepare them for this happening to themselves, their friends, or their family is just the honor of a lifetime. Thank you very much for covering the device and for having me today. 

Dr. Glatter: Of course, my pleasure. Peter? 

Dr. Antevy: The citizens of this country, and everyone who lives across the world, has started to understand that there are things that we expect from our people, from the community. We expect them to do CPR for cardiac arrest. We expect them to know how to use an EpiPen. We expect them to know how to use an AED, and we also expect them to know how to stop bleeding with a tourniquet. 

The American public has gotten to understand that these devices are very important. Having a device that’s easily used, that I can teach you in 10 seconds, that speaks to you — these are all things that make this product have great potential. I do look forward to the studies, not just the cadaver studies, but the real human studies. 

I know Hannah is really a phenom and has been doing all these things so that this product can be on the shelves of Walmart and CVS one day. I commend you, Hannah, for everything you’re doing and wishing you the best of luck. We’re here for you. 

Dr. Glatter: Same here. Congratulations on your innovative capability and what you’ve done to change the outcomes of bleeding related to penetrating trauma. Thank you so much.

Robert D. Glatter, MD, is an assistant professor of emergency medicine at Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York. He is a medical advisor for Medscape and hosts the Hot Topics in EM series. Hannah D. Herbst, BS, is a graduate of Florida Atlantic University, was selected for Forbes 30 Under 30, and is the founder/CEO of Golden Hour Medical. Peter M. Antevy, MD, is a pediatric emergency medicine physician and medical director for Davie Fire Rescue and Coral Springs–Parkland Fire Department in Florida. He is also a member of the EMS Eagles Global Alliance.



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

A new report on the preventability of dementia is both exciting and paradigm-shifting. The new study, published in The Lancet by the Lancet Commission on Dementia, estimates that close to 50% of cases of dementia worldwide can be prevented or delayed by improving 14 modifiable risk factors. 

This is paradigm-shifting because dementia is often perceived as an inevitable consequence of the aging process, with a major genetic component. But this study suggests that modifying these risk factors can benefit everyone, irrespective of genetic risk, and that it’s important to have a life-course approach. It’s never too early or too late to start to modify these factors. 

We’ve known for a long time that many chronic diseases are highly preventable and modifiable. Some that come to mind are type 2 diabetes, coronary heart disease, and even certain forms of cancer. Modifiable risk factors include cigarette smoking, diet, physical activity, and maintaining a healthy weight. This study suggests that many of the same risk factors and more are relevant to reducing risk for dementia. 

Let’s go through the risk factors, many of which are behavioral. These risk factors include lifestyle factors such as lack of physical activity, cigarette smoking, excessive alcohol consumption, and obesity. The cardiovascular or vascular-specific risk factors include not only those behavioral factors but also hypertension, high LDL cholesterol, and diabetes. Cognitive engagement–specific risk factors include social isolation, which is a major risk factor for dementia, as well as untreated hearing or vision loss, which can exacerbate social isolation and depression, and low educational attainment, which can be related to less cognitive engagement.

They also mention traumatic brain injury from an accident or contact sports without head protection as a risk factor, and the environmental risk factor of air pollution or poor air quality. 

Two of these risk factors are new since the previous report in 2020: elevated LDL cholesterol and untreated vision loss, both of which are quite treatable. Overall, these findings suggest that a lot can be done to lower dementia risk, but it requires individual behavior modifications as well as a comprehensive approach with involvement of the healthcare system for improved screening, access, and public policy to reduce air pollution.

Some of these risk factors are more relevant to women, especially the social isolation that is so common later in life in women. In the United States, close to two out of three patients with dementia are women.

So, informing our patients about these risk factors and what can be done in terms of behavior modification, increased screening, and treatment for these conditions can go a long way in helping our patients reduce their risk for dementia.
 

Dr. Manson is professor of medicine and the Michael and Lee Bell Professor of Women’s Health, Harvard Medical School, chief, Division of Preventive Medicine, Brigham and Women’s Hospital, Boston, and past president, North American Menopause Society, 2011-2012. She disclosed receiving study pill donation and infrastructure support from Mars Symbioscience (for the COSMOS trial).

A version of this article appeared on Medscape.com.

A new report on the preventability of dementia is both exciting and paradigm-shifting. The new study, published in The Lancet by the Lancet Commission on Dementia, estimates that close to 50% of cases of dementia worldwide can be prevented or delayed by improving 14 modifiable risk factors. 

This is paradigm-shifting because dementia is often perceived as an inevitable consequence of the aging process, with a major genetic component. But this study suggests that modifying these risk factors can benefit everyone, irrespective of genetic risk, and that it’s important to have a life-course approach. It’s never too early or too late to start to modify these factors. 

We’ve known for a long time that many chronic diseases are highly preventable and modifiable. Some that come to mind are type 2 diabetes, coronary heart disease, and even certain forms of cancer. Modifiable risk factors include cigarette smoking, diet, physical activity, and maintaining a healthy weight. This study suggests that many of the same risk factors and more are relevant to reducing risk for dementia. 

Let’s go through the risk factors, many of which are behavioral. These risk factors include lifestyle factors such as lack of physical activity, cigarette smoking, excessive alcohol consumption, and obesity. The cardiovascular or vascular-specific risk factors include not only those behavioral factors but also hypertension, high LDL cholesterol, and diabetes. Cognitive engagement–specific risk factors include social isolation, which is a major risk factor for dementia, as well as untreated hearing or vision loss, which can exacerbate social isolation and depression, and low educational attainment, which can be related to less cognitive engagement.

They also mention traumatic brain injury from an accident or contact sports without head protection as a risk factor, and the environmental risk factor of air pollution or poor air quality. 

Two of these risk factors are new since the previous report in 2020: elevated LDL cholesterol and untreated vision loss, both of which are quite treatable. Overall, these findings suggest that a lot can be done to lower dementia risk, but it requires individual behavior modifications as well as a comprehensive approach with involvement of the healthcare system for improved screening, access, and public policy to reduce air pollution.

Some of these risk factors are more relevant to women, especially the social isolation that is so common later in life in women. In the United States, close to two out of three patients with dementia are women.

So, informing our patients about these risk factors and what can be done in terms of behavior modification, increased screening, and treatment for these conditions can go a long way in helping our patients reduce their risk for dementia.
 

Dr. Manson is professor of medicine and the Michael and Lee Bell Professor of Women’s Health, Harvard Medical School, chief, Division of Preventive Medicine, Brigham and Women’s Hospital, Boston, and past president, North American Menopause Society, 2011-2012. She disclosed receiving study pill donation and infrastructure support from Mars Symbioscience (for the COSMOS trial).

A version of this article appeared on Medscape.com.

A new report on the preventability of dementia is both exciting and paradigm-shifting. The new study, published in The Lancet by the Lancet Commission on Dementia, estimates that close to 50% of cases of dementia worldwide can be prevented or delayed by improving 14 modifiable risk factors. 

This is paradigm-shifting because dementia is often perceived as an inevitable consequence of the aging process, with a major genetic component. But this study suggests that modifying these risk factors can benefit everyone, irrespective of genetic risk, and that it’s important to have a life-course approach. It’s never too early or too late to start to modify these factors. 

We’ve known for a long time that many chronic diseases are highly preventable and modifiable. Some that come to mind are type 2 diabetes, coronary heart disease, and even certain forms of cancer. Modifiable risk factors include cigarette smoking, diet, physical activity, and maintaining a healthy weight. This study suggests that many of the same risk factors and more are relevant to reducing risk for dementia. 

Let’s go through the risk factors, many of which are behavioral. These risk factors include lifestyle factors such as lack of physical activity, cigarette smoking, excessive alcohol consumption, and obesity. The cardiovascular or vascular-specific risk factors include not only those behavioral factors but also hypertension, high LDL cholesterol, and diabetes. Cognitive engagement–specific risk factors include social isolation, which is a major risk factor for dementia, as well as untreated hearing or vision loss, which can exacerbate social isolation and depression, and low educational attainment, which can be related to less cognitive engagement.

They also mention traumatic brain injury from an accident or contact sports without head protection as a risk factor, and the environmental risk factor of air pollution or poor air quality. 

Two of these risk factors are new since the previous report in 2020: elevated LDL cholesterol and untreated vision loss, both of which are quite treatable. Overall, these findings suggest that a lot can be done to lower dementia risk, but it requires individual behavior modifications as well as a comprehensive approach with involvement of the healthcare system for improved screening, access, and public policy to reduce air pollution.

Some of these risk factors are more relevant to women, especially the social isolation that is so common later in life in women. In the United States, close to two out of three patients with dementia are women.

So, informing our patients about these risk factors and what can be done in terms of behavior modification, increased screening, and treatment for these conditions can go a long way in helping our patients reduce their risk for dementia.
 

Dr. Manson is professor of medicine and the Michael and Lee Bell Professor of Women’s Health, Harvard Medical School, chief, Division of Preventive Medicine, Brigham and Women’s Hospital, Boston, and past president, North American Menopause Society, 2011-2012. She disclosed receiving study pill donation and infrastructure support from Mars Symbioscience (for the COSMOS trial).

A version of this article appeared on Medscape.com.

Consider this: If you’re taking your children to the beach, how do you protect them from drowning? You don’t tell them, “Don’t go into the ocean.” You teach them how to swim; you give them floaties; and you accompany them in the water and go in only when a lifeguard is present. In other words, you give them all the tools to protect themselves because you know they will go into the ocean anyway. 

Patients are diving into the ocean. Patients with obesity, who know that a treatment for their disease exists but is inaccessible, are diving into the ocean. Unfortunately, they are diving in without floaties or a lifeguard, and well-meaning bystanders are simply telling them to not go. 

Compounded peptides are an ocean of alternative therapies. Even though compounding pharmacists need specialized training, facilities and equipment need to be properly certified, and final dosage forms need extensive testing, pharmacies are not equal when it comes to sterile compounding. Regulatory agencies such as the US Food and Drug Administration (FDA) have expressed caution around compounded semaglutide. Professional societies such as the Obesity Medicine Association (OMA) advise against compounded peptides because they lack clinical trials that prove their safety and efficacy. Ask any individual doctor and you are likely to receive a range of opinions. 

As an endocrinologist specializing in obesity, I practice evidence-based medicine as much as possible. However, I also recognize how today’s dysfunctional medical system compels patients to dive into that ocean in search of an alternative solution. 

Doctors can’t be lifeguards, but we can at least empower patients who want to decide for themselves whether the risk of compounded peptides is worth it. 

With the help of pharmacists, compounding pharmacists, researchers, and clinicians, here is a checklist for patients who seek compounded semaglutide or tirzepatide: 

• Check the state licensing board website to see if there have been any complaints or disciplinary actions made against the pharmacy facility. These government-maintained websites vary in searchability and user-friendliness, but you are specifically looking for whether the FDA ever issued a 483 form.
• Ask for the pharmacy’s state board inspection report. There should be at least one of these reports, issued at the pharmacy’s founding, and there may be more depending on individual state regulations on frequencies of inspections.
• Ask if the compounding pharmacy is accredited by the Pharmacy Compounding Accreditation Board (PCAB). Accreditation is an extra optional step that some compounding pharmacies take to be legitimized by a third party.
• Ask if the pharmacy follows Current Good Manufacturing Practice (CGMP). CGMP is not required of 503a pharmacies, which are pharmacies that provide semaglutide or tirzepatide directly to patients, but following CGMP means an extra level of quality assurance. The bare minimum for anyone doing sterile compounding in the United States is to meet the standards found in the US Pharmacopeia, chapter <797>, Sterile Compounding.
• Ask your compounding pharmacy where they source the medication’s active pharmaceutical ingredient (API).
• Find out if this supplier is registered with the FDA by searching here or here.
• Confirm that semaglutide base, not semaglutide salt, is used in the compounding process.
• Request a certificate of analysis (COA) of the active pharmaceutical ingredient, which should be semaglutide base. This shows you whether the medication has impurities or byproducts due to its manufacturing process.
• Ask if they have third-party confirmation of potency, stability, and sterility testing of the final product.

In generating this guidance, I’m not endorsing compounded peptides, and in fact, I recognize that there is nothing keeping small-time compounding pharmacies from skirting some of these quality measures, falsifying records, and flying under the radar. However, I hope this checklist serves as a starting point for education and risk mitigation. If a compounder is unwilling or unable to answer these questions, consider it a red flag and look elsewhere. 

In an ideal world, the state regulators or the FDA would proactively supervise instead of reactively monitor; trusted compounding pharmacies would be systematically activated to ease medication shortages; and patients with obesity would have access to safe and efficacious treatments for their disease. Until then, we as providers can acknowledge the disappointments of our healthcare system while still developing realistic and individualized solutions that prioritize patient care and safety. 
 

Dr. Tchang is assistant professor, Clinical Medicine, Division of Endocrinology, Diabetes, and Metabolism, Weill Cornell Medicine, and a physician, Department of Medicine, Iris Cantor Women’s Health Center, Comprehensive Weight Control Center, New York. She is an adviser for Novo Nordisk, which manufactures Wegovy, and an adviser for Ro, a telehealth company that offers compounded semaglutide, and serves or has served as a director, officer, partner, employee, advisor, consultant, or trustee for Gelesis and Novo Nordisk.

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

Consider this: If you’re taking your children to the beach, how do you protect them from drowning? You don’t tell them, “Don’t go into the ocean.” You teach them how to swim; you give them floaties; and you accompany them in the water and go in only when a lifeguard is present. In other words, you give them all the tools to protect themselves because you know they will go into the ocean anyway. 

Patients are diving into the ocean. Patients with obesity, who know that a treatment for their disease exists but is inaccessible, are diving into the ocean. Unfortunately, they are diving in without floaties or a lifeguard, and well-meaning bystanders are simply telling them to not go. 

Compounded peptides are an ocean of alternative therapies. Even though compounding pharmacists need specialized training, facilities and equipment need to be properly certified, and final dosage forms need extensive testing, pharmacies are not equal when it comes to sterile compounding. Regulatory agencies such as the US Food and Drug Administration (FDA) have expressed caution around compounded semaglutide. Professional societies such as the Obesity Medicine Association (OMA) advise against compounded peptides because they lack clinical trials that prove their safety and efficacy. Ask any individual doctor and you are likely to receive a range of opinions. 

As an endocrinologist specializing in obesity, I practice evidence-based medicine as much as possible. However, I also recognize how today’s dysfunctional medical system compels patients to dive into that ocean in search of an alternative solution. 

Doctors can’t be lifeguards, but we can at least empower patients who want to decide for themselves whether the risk of compounded peptides is worth it. 

With the help of pharmacists, compounding pharmacists, researchers, and clinicians, here is a checklist for patients who seek compounded semaglutide or tirzepatide: 

• Check the state licensing board website to see if there have been any complaints or disciplinary actions made against the pharmacy facility. These government-maintained websites vary in searchability and user-friendliness, but you are specifically looking for whether the FDA ever issued a 483 form.
• Ask for the pharmacy’s state board inspection report. There should be at least one of these reports, issued at the pharmacy’s founding, and there may be more depending on individual state regulations on frequencies of inspections.
• Ask if the compounding pharmacy is accredited by the Pharmacy Compounding Accreditation Board (PCAB). Accreditation is an extra optional step that some compounding pharmacies take to be legitimized by a third party.
• Ask if the pharmacy follows Current Good Manufacturing Practice (CGMP). CGMP is not required of 503a pharmacies, which are pharmacies that provide semaglutide or tirzepatide directly to patients, but following CGMP means an extra level of quality assurance. The bare minimum for anyone doing sterile compounding in the United States is to meet the standards found in the US Pharmacopeia, chapter <797>, Sterile Compounding.
• Ask your compounding pharmacy where they source the medication’s active pharmaceutical ingredient (API).
• Find out if this supplier is registered with the FDA by searching here or here.
• Confirm that semaglutide base, not semaglutide salt, is used in the compounding process.
• Request a certificate of analysis (COA) of the active pharmaceutical ingredient, which should be semaglutide base. This shows you whether the medication has impurities or byproducts due to its manufacturing process.
• Ask if they have third-party confirmation of potency, stability, and sterility testing of the final product.

In generating this guidance, I’m not endorsing compounded peptides, and in fact, I recognize that there is nothing keeping small-time compounding pharmacies from skirting some of these quality measures, falsifying records, and flying under the radar. However, I hope this checklist serves as a starting point for education and risk mitigation. If a compounder is unwilling or unable to answer these questions, consider it a red flag and look elsewhere. 

In an ideal world, the state regulators or the FDA would proactively supervise instead of reactively monitor; trusted compounding pharmacies would be systematically activated to ease medication shortages; and patients with obesity would have access to safe and efficacious treatments for their disease. Until then, we as providers can acknowledge the disappointments of our healthcare system while still developing realistic and individualized solutions that prioritize patient care and safety. 
 

Dr. Tchang is assistant professor, Clinical Medicine, Division of Endocrinology, Diabetes, and Metabolism, Weill Cornell Medicine, and a physician, Department of Medicine, Iris Cantor Women’s Health Center, Comprehensive Weight Control Center, New York. She is an adviser for Novo Nordisk, which manufactures Wegovy, and an adviser for Ro, a telehealth company that offers compounded semaglutide, and serves or has served as a director, officer, partner, employee, advisor, consultant, or trustee for Gelesis and Novo Nordisk.

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

Consider this: If you’re taking your children to the beach, how do you protect them from drowning? You don’t tell them, “Don’t go into the ocean.” You teach them how to swim; you give them floaties; and you accompany them in the water and go in only when a lifeguard is present. In other words, you give them all the tools to protect themselves because you know they will go into the ocean anyway. 

Patients are diving into the ocean. Patients with obesity, who know that a treatment for their disease exists but is inaccessible, are diving into the ocean. Unfortunately, they are diving in without floaties or a lifeguard, and well-meaning bystanders are simply telling them to not go. 

Compounded peptides are an ocean of alternative therapies. Even though compounding pharmacists need specialized training, facilities and equipment need to be properly certified, and final dosage forms need extensive testing, pharmacies are not equal when it comes to sterile compounding. Regulatory agencies such as the US Food and Drug Administration (FDA) have expressed caution around compounded semaglutide. Professional societies such as the Obesity Medicine Association (OMA) advise against compounded peptides because they lack clinical trials that prove their safety and efficacy. Ask any individual doctor and you are likely to receive a range of opinions. 

As an endocrinologist specializing in obesity, I practice evidence-based medicine as much as possible. However, I also recognize how today’s dysfunctional medical system compels patients to dive into that ocean in search of an alternative solution. 

Doctors can’t be lifeguards, but we can at least empower patients who want to decide for themselves whether the risk of compounded peptides is worth it. 

With the help of pharmacists, compounding pharmacists, researchers, and clinicians, here is a checklist for patients who seek compounded semaglutide or tirzepatide: 

• Check the state licensing board website to see if there have been any complaints or disciplinary actions made against the pharmacy facility. These government-maintained websites vary in searchability and user-friendliness, but you are specifically looking for whether the FDA ever issued a 483 form.
• Ask for the pharmacy’s state board inspection report. There should be at least one of these reports, issued at the pharmacy’s founding, and there may be more depending on individual state regulations on frequencies of inspections.
• Ask if the compounding pharmacy is accredited by the Pharmacy Compounding Accreditation Board (PCAB). Accreditation is an extra optional step that some compounding pharmacies take to be legitimized by a third party.
• Ask if the pharmacy follows Current Good Manufacturing Practice (CGMP). CGMP is not required of 503a pharmacies, which are pharmacies that provide semaglutide or tirzepatide directly to patients, but following CGMP means an extra level of quality assurance. The bare minimum for anyone doing sterile compounding in the United States is to meet the standards found in the US Pharmacopeia, chapter <797>, Sterile Compounding.
• Ask your compounding pharmacy where they source the medication’s active pharmaceutical ingredient (API).
• Find out if this supplier is registered with the FDA by searching here or here.
• Confirm that semaglutide base, not semaglutide salt, is used in the compounding process.
• Request a certificate of analysis (COA) of the active pharmaceutical ingredient, which should be semaglutide base. This shows you whether the medication has impurities or byproducts due to its manufacturing process.
• Ask if they have third-party confirmation of potency, stability, and sterility testing of the final product.

In generating this guidance, I’m not endorsing compounded peptides, and in fact, I recognize that there is nothing keeping small-time compounding pharmacies from skirting some of these quality measures, falsifying records, and flying under the radar. However, I hope this checklist serves as a starting point for education and risk mitigation. If a compounder is unwilling or unable to answer these questions, consider it a red flag and look elsewhere. 

In an ideal world, the state regulators or the FDA would proactively supervise instead of reactively monitor; trusted compounding pharmacies would be systematically activated to ease medication shortages; and patients with obesity would have access to safe and efficacious treatments for their disease. Until then, we as providers can acknowledge the disappointments of our healthcare system while still developing realistic and individualized solutions that prioritize patient care and safety. 
 

Dr. Tchang is assistant professor, Clinical Medicine, Division of Endocrinology, Diabetes, and Metabolism, Weill Cornell Medicine, and a physician, Department of Medicine, Iris Cantor Women’s Health Center, Comprehensive Weight Control Center, New York. She is an adviser for Novo Nordisk, which manufactures Wegovy, and an adviser for Ro, a telehealth company that offers compounded semaglutide, and serves or has served as a director, officer, partner, employee, advisor, consultant, or trustee for Gelesis and Novo Nordisk.

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

The European Centre for Disease Prevention and Control (ECDC) has issued a warning to travelers in areas in South and Central America and the Caribbean affected by a current outbreak of Oropouche virus (OROV) disease. The ECDC said that there had been more than 8000 cases reported in these areas since January, with 19 imported cases reported in Europe for the first time in June and July. Of these, 12 were in Spain, five were in Italy, and two were in Germany. 

The ECDC’s Threat Assessment Brief of Aug. 9 said that one of those affected had traveled to Brazil and the other 18 to Cuba; however, outbreaks have also been reported this year in Bolivia, Colombia, and Peru. Though the overall risk for infection to European travelers to OROV-epidemic countries was assessed as moderate, it was higher in the more affected municipalities of the northern states of Brazil and/or the Amazon region, and/or if personal protection measures are not taken.

An editorial published Aug. 8 in The Lancet Infectious Diseases described OROV as a “mysterious threat,” which there is limited knowledge about despite some half a million cases recorded since it was first detected in Trinidad and Tobago in 1955. 

OROV is transmitted primarily through bites from infected midges (Culicoides paraensis). However, some mosquitoes species can also spread the virus, which causes symptoms very similar to other arbovirus diseases from the same regions, such as dengue, chikungunya, and Zika virus infection. 

Most cases are mild, but meningitis and encephalitis can occur as well as possible fetal death and deformities after infection in pregnancy. Last month, the first fatal cases were reported in two young Brazilian women who, concerningly, had no comorbidities.

This news organization asked Jan Felix Drexler, MD, of the Institute of Virology at Charité – Universitätsmedizin in Berlin, Germany, who has studied the emergence of Oropouche fever in Latin America, what clinicians should know about OROV disease.

What are the main symptoms of OROV disease for which clinicians should be alert?

The main symptoms are not different from other arboviral infections, ie, fever, maybe joint and muscle pain, maybe rash. The problem is that we do not know how often severe disease may occur because we do not know whether the severe cases that have been postulated, including death in apparently healthy people and congenital infection, are due to increased testing; an altered virus; or an altered, more intense circulation (so that many more infections simply lead to rare severe cases appearing). Be alert and ask for testing in your patients. 

What is the differential diagnosis if a recent traveler to affected regions presents with symptoms? Are there any clues to suggest whether the disease is Oropouche as opposed to Zika, etc.?

The main message is: Do not assume a particular infection based on clinical symptoms. If your patient is returning from or living in an endemic area, consider OROV disease in the differential diagnosis.

What personal protective measures should clinicians advise travelers in affected areas to take? Do these differ from normal mosquito precautions?

Repellents are extremely important as usual. However, there are differences. Mosquito nets’ hole sizes need to be smaller than those used against the vectors of malaria or dengue; in other words, they need to have a higher mesh. The problem is that nets with high mesh are complicated in very hot and humid conditions because they also limit ventilation. Travelers should discuss with local suppliers about the best trade-off.

The risk for midge bites is likely highest at dawn and dusk in still and humid conditions. So on the one hand, one could recommend avoiding those areas and being outside during those times of the day. On the other hand, specific recommendations cannot be made robustly because we cannot exclude other invertebrate vectors at current knowledge. Some studies have implicated that mosquitoes may also transmit the virus. If that holds true, then we are back to reducing any bite.

Should pregnant women be advised to avoid travel to affected regions?

Not immediately, but caution must be taken. We simply do not have sufficient data to gauge the risk for potential congenital infection. Much more epidemiologic data and controlled infection experiments will be required to make evidence-based recommendations.

All the cases reported in Europe so far were imported from Cuba and Brazil. Is there any risk for local transmission, eg, via midges/mosquitoes that might hitch a ride on an aircraft, as in cases of airport malaria?

Not immediately, but it cannot be excluded. We know very little about the infection intensity in the vectors. Controlled infection experiments, including robustness of vectors against commonly used insecticides in airplanes, need to be done.

What is the risk for an animal reservoir emerging in Europe?

We do not know, but there is also no reason for ringing the alarm bells. Controlled infection experiments and surveillance will be required.

Is treatment purely supportive or are there any specific agents worth trying in case of severe symptoms/neurologic involvement?

No specific treatment can be recommended as is. However, severe dengue illustrates the relevance of supportive treatment, which is hugely effective in reducing mortality.

The Lancet paper states: “Several laboratory tests have been developed but robust commercial tests are hardly available.” How likely is it that laboratories in Europe will have the capability to test for the Oropouche organism? 

European laboratory networks have already taken action, and testing is now available at least in the major and reference laboratories. If a clinician asks for OROV testing, they will probably get a robust answer in a reasonable timespan. Of course, that can be improved once we have more cases and more laboratories will be equipped for testing.

Is there anything else you think clinicians should be aware of?

The most important is to think beyond the textbooks we know from medical school. Things change rapidly in a connected world under altered climate conditions.

Dr. Drexler has no conflicts of interest to declare.
 

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

The European Centre for Disease Prevention and Control (ECDC) has issued a warning to travelers in areas in South and Central America and the Caribbean affected by a current outbreak of Oropouche virus (OROV) disease. The ECDC said that there had been more than 8000 cases reported in these areas since January, with 19 imported cases reported in Europe for the first time in June and July. Of these, 12 were in Spain, five were in Italy, and two were in Germany. 

The ECDC’s Threat Assessment Brief of Aug. 9 said that one of those affected had traveled to Brazil and the other 18 to Cuba; however, outbreaks have also been reported this year in Bolivia, Colombia, and Peru. Though the overall risk for infection to European travelers to OROV-epidemic countries was assessed as moderate, it was higher in the more affected municipalities of the northern states of Brazil and/or the Amazon region, and/or if personal protection measures are not taken.

An editorial published Aug. 8 in The Lancet Infectious Diseases described OROV as a “mysterious threat,” which there is limited knowledge about despite some half a million cases recorded since it was first detected in Trinidad and Tobago in 1955. 

OROV is transmitted primarily through bites from infected midges (Culicoides paraensis). However, some mosquitoes species can also spread the virus, which causes symptoms very similar to other arbovirus diseases from the same regions, such as dengue, chikungunya, and Zika virus infection. 

Most cases are mild, but meningitis and encephalitis can occur as well as possible fetal death and deformities after infection in pregnancy. Last month, the first fatal cases were reported in two young Brazilian women who, concerningly, had no comorbidities.

This news organization asked Jan Felix Drexler, MD, of the Institute of Virology at Charité – Universitätsmedizin in Berlin, Germany, who has studied the emergence of Oropouche fever in Latin America, what clinicians should know about OROV disease.

What are the main symptoms of OROV disease for which clinicians should be alert?

The main symptoms are not different from other arboviral infections, ie, fever, maybe joint and muscle pain, maybe rash. The problem is that we do not know how often severe disease may occur because we do not know whether the severe cases that have been postulated, including death in apparently healthy people and congenital infection, are due to increased testing; an altered virus; or an altered, more intense circulation (so that many more infections simply lead to rare severe cases appearing). Be alert and ask for testing in your patients. 

What is the differential diagnosis if a recent traveler to affected regions presents with symptoms? Are there any clues to suggest whether the disease is Oropouche as opposed to Zika, etc.?

The main message is: Do not assume a particular infection based on clinical symptoms. If your patient is returning from or living in an endemic area, consider OROV disease in the differential diagnosis.

What personal protective measures should clinicians advise travelers in affected areas to take? Do these differ from normal mosquito precautions?

Repellents are extremely important as usual. However, there are differences. Mosquito nets’ hole sizes need to be smaller than those used against the vectors of malaria or dengue; in other words, they need to have a higher mesh. The problem is that nets with high mesh are complicated in very hot and humid conditions because they also limit ventilation. Travelers should discuss with local suppliers about the best trade-off.

The risk for midge bites is likely highest at dawn and dusk in still and humid conditions. So on the one hand, one could recommend avoiding those areas and being outside during those times of the day. On the other hand, specific recommendations cannot be made robustly because we cannot exclude other invertebrate vectors at current knowledge. Some studies have implicated that mosquitoes may also transmit the virus. If that holds true, then we are back to reducing any bite.

Should pregnant women be advised to avoid travel to affected regions?

Not immediately, but caution must be taken. We simply do not have sufficient data to gauge the risk for potential congenital infection. Much more epidemiologic data and controlled infection experiments will be required to make evidence-based recommendations.

All the cases reported in Europe so far were imported from Cuba and Brazil. Is there any risk for local transmission, eg, via midges/mosquitoes that might hitch a ride on an aircraft, as in cases of airport malaria?

Not immediately, but it cannot be excluded. We know very little about the infection intensity in the vectors. Controlled infection experiments, including robustness of vectors against commonly used insecticides in airplanes, need to be done.

What is the risk for an animal reservoir emerging in Europe?

We do not know, but there is also no reason for ringing the alarm bells. Controlled infection experiments and surveillance will be required.

Is treatment purely supportive or are there any specific agents worth trying in case of severe symptoms/neurologic involvement?

No specific treatment can be recommended as is. However, severe dengue illustrates the relevance of supportive treatment, which is hugely effective in reducing mortality.

The Lancet paper states: “Several laboratory tests have been developed but robust commercial tests are hardly available.” How likely is it that laboratories in Europe will have the capability to test for the Oropouche organism? 

European laboratory networks have already taken action, and testing is now available at least in the major and reference laboratories. If a clinician asks for OROV testing, they will probably get a robust answer in a reasonable timespan. Of course, that can be improved once we have more cases and more laboratories will be equipped for testing.

Is there anything else you think clinicians should be aware of?

The most important is to think beyond the textbooks we know from medical school. Things change rapidly in a connected world under altered climate conditions.

Dr. Drexler has no conflicts of interest to declare.
 

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

The European Centre for Disease Prevention and Control (ECDC) has issued a warning to travelers in areas in South and Central America and the Caribbean affected by a current outbreak of Oropouche virus (OROV) disease. The ECDC said that there had been more than 8000 cases reported in these areas since January, with 19 imported cases reported in Europe for the first time in June and July. Of these, 12 were in Spain, five were in Italy, and two were in Germany. 

The ECDC’s Threat Assessment Brief of Aug. 9 said that one of those affected had traveled to Brazil and the other 18 to Cuba; however, outbreaks have also been reported this year in Bolivia, Colombia, and Peru. Though the overall risk for infection to European travelers to OROV-epidemic countries was assessed as moderate, it was higher in the more affected municipalities of the northern states of Brazil and/or the Amazon region, and/or if personal protection measures are not taken.

An editorial published Aug. 8 in The Lancet Infectious Diseases described OROV as a “mysterious threat,” which there is limited knowledge about despite some half a million cases recorded since it was first detected in Trinidad and Tobago in 1955. 

OROV is transmitted primarily through bites from infected midges (Culicoides paraensis). However, some mosquitoes species can also spread the virus, which causes symptoms very similar to other arbovirus diseases from the same regions, such as dengue, chikungunya, and Zika virus infection. 

Most cases are mild, but meningitis and encephalitis can occur as well as possible fetal death and deformities after infection in pregnancy. Last month, the first fatal cases were reported in two young Brazilian women who, concerningly, had no comorbidities.

This news organization asked Jan Felix Drexler, MD, of the Institute of Virology at Charité – Universitätsmedizin in Berlin, Germany, who has studied the emergence of Oropouche fever in Latin America, what clinicians should know about OROV disease.

What are the main symptoms of OROV disease for which clinicians should be alert?

The main symptoms are not different from other arboviral infections, ie, fever, maybe joint and muscle pain, maybe rash. The problem is that we do not know how often severe disease may occur because we do not know whether the severe cases that have been postulated, including death in apparently healthy people and congenital infection, are due to increased testing; an altered virus; or an altered, more intense circulation (so that many more infections simply lead to rare severe cases appearing). Be alert and ask for testing in your patients. 

What is the differential diagnosis if a recent traveler to affected regions presents with symptoms? Are there any clues to suggest whether the disease is Oropouche as opposed to Zika, etc.?

The main message is: Do not assume a particular infection based on clinical symptoms. If your patient is returning from or living in an endemic area, consider OROV disease in the differential diagnosis.

What personal protective measures should clinicians advise travelers in affected areas to take? Do these differ from normal mosquito precautions?

Repellents are extremely important as usual. However, there are differences. Mosquito nets’ hole sizes need to be smaller than those used against the vectors of malaria or dengue; in other words, they need to have a higher mesh. The problem is that nets with high mesh are complicated in very hot and humid conditions because they also limit ventilation. Travelers should discuss with local suppliers about the best trade-off.

The risk for midge bites is likely highest at dawn and dusk in still and humid conditions. So on the one hand, one could recommend avoiding those areas and being outside during those times of the day. On the other hand, specific recommendations cannot be made robustly because we cannot exclude other invertebrate vectors at current knowledge. Some studies have implicated that mosquitoes may also transmit the virus. If that holds true, then we are back to reducing any bite.

Should pregnant women be advised to avoid travel to affected regions?

Not immediately, but caution must be taken. We simply do not have sufficient data to gauge the risk for potential congenital infection. Much more epidemiologic data and controlled infection experiments will be required to make evidence-based recommendations.

All the cases reported in Europe so far were imported from Cuba and Brazil. Is there any risk for local transmission, eg, via midges/mosquitoes that might hitch a ride on an aircraft, as in cases of airport malaria?

Not immediately, but it cannot be excluded. We know very little about the infection intensity in the vectors. Controlled infection experiments, including robustness of vectors against commonly used insecticides in airplanes, need to be done.

What is the risk for an animal reservoir emerging in Europe?

We do not know, but there is also no reason for ringing the alarm bells. Controlled infection experiments and surveillance will be required.

Is treatment purely supportive or are there any specific agents worth trying in case of severe symptoms/neurologic involvement?

No specific treatment can be recommended as is. However, severe dengue illustrates the relevance of supportive treatment, which is hugely effective in reducing mortality.

The Lancet paper states: “Several laboratory tests have been developed but robust commercial tests are hardly available.” How likely is it that laboratories in Europe will have the capability to test for the Oropouche organism? 

European laboratory networks have already taken action, and testing is now available at least in the major and reference laboratories. If a clinician asks for OROV testing, they will probably get a robust answer in a reasonable timespan. Of course, that can be improved once we have more cases and more laboratories will be equipped for testing.

Is there anything else you think clinicians should be aware of?

The most important is to think beyond the textbooks we know from medical school. Things change rapidly in a connected world under altered climate conditions.

Dr. Drexler has no conflicts of interest to declare.
 

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

The Heritage Foundation sponsored and developed Project 2025 for the explicit, stated purpose of building a conservative victory through policy, personnel, and training with a 180-day game plan after a sympathetic new President of the United States takes office. To date, Project 2025 has not been formally endorsed by any presidential campaign.

More than 100 conservative organizations are said to be participating. More than 400 conservative scholars and experts have collaborated in authorship of the mandate’s 40 chapters. Chapter 14 of the “Mandate for Leadership” is an exhaustive proposed overhaul of the Department of Health and Human Services (HHS), one of the major existing arms of the executive branch of the US government. 

The mandate’s sweeping recommendations, if implemented, would impact the lives of all Americans and all healthcare workers, as outlined in the following excerpts. 
 

Healthcare-Related Excerpts From Project 2025

• “From the moment of conception, every human being possesses inherent dignity and worth, and our humanity does not depend on our age, stage of development, race, or abilities. The Secretary must ensure that all HHS programs and activities are rooted in a deep respect for innocent human life from day one until natural death: Abortion and euthanasia are not health care.”
• “Unfortunately, family policies and programs under President Biden’s HHS are fraught with agenda items focusing on ‘LGBTQ+ equity,’ subsidizing single motherhood, disincentivizing work, and penalizing marriage. These policies should be repealed and replaced by policies that support the formation of stable, married, nuclear families.”
• “The next Administration should guard against the regulatory capture of our public health agencies by pharmaceutical companies, insurers, hospital conglomerates, and related economic interests that these agencies are meant to regulate. We must erect robust firewalls to mitigate these obvious financial conflicts of interest.”
• “All National Institutes of Health, Centers for Disease Control and Prevention, and Food and Drug Administration regulators should be entirely free from private biopharmaceutical funding. In this realm, ‘public–private partnerships’ is a euphemism for agency capture, a thin veneer for corporatism. Funding for agencies and individual government researchers must come directly from the government with robust congressional oversight.”
• “The CDC [Centers for Disease Control and Prevention] operates several programs related to vaccine safety including the Vaccine Adverse Event Reporting System (VAERS); Vaccine Safety Datalink (VSD); and Clinical Immunization Safety Assessment (CISA) Project. Those functions and their associated funding should be transferred to the FDA [Food and Drug Administration], which is responsible for post-market surveillance and evaluation of all other drugs and biological products.”
• “Because liberal states have now become sanctuaries for abortion tourism, HHS should use every available tool, including the cutting of funds, to ensure that every state reports exactly how many abortions take place within its borders, at what gestational age of the child, for what reason, the mother’s state of residence, and by what method. It should also ensure that statistics are separated by category: spontaneous miscarriage; treatments that incidentally result in the death of a child (such as chemotherapy); stillbirths; and induced abortion. In addition, CDC should require monitoring and reporting for complications due to abortion and every instance of children being born alive after an abortion.”
• “The CDC should immediately end its collection of data on gender identity, which legitimizes the unscientific notion that men can become women (and vice versa) and encourages the phenomenon of ever-multiplying subjective identities.”
• “A test developed by a lab in accordance with the protocols developed by another lab (non-commercial sharing) currently constitutes a ‘new’ laboratory-developed test because the lab in which it will be used is different from the initial developing lab. To encourage interlaboratory collaboration and discourage duplicative test creation (and associated regulatory and logistical burdens), the FDA should introduce mechanisms through which laboratory-developed tests can easily be shared with other laboratories without the current regulatory burdens.”
• “[FDA should] Reverse its approval of chemical abortion drugs because the politicized approval process was illegal from the start. The FDA failed to abide by its legal obligations to protect the health, safety, and welfare of girls and women.”
• “[FDA should] Stop promoting or approving mail-order abortions in violation of long-standing federal laws that prohibit the mailing and interstate carriage of abortion drugs.”
• “[HHS should] Promptly restore the ethics advisory committee to oversee abortion-derived fetal tissue research, and Congress should prohibit such research altogether.”
• “[HHS should] End intramural research projects using tissue from aborted children within the NIH, which should end its human embryonic stem cell registry.”
• “Under Francis Collins, NIH became so focused on the #MeToo movement that it refused to sponsor scientific conferences unless there were a certain number of women panelists, which violates federal civil rights law against sex discrimination. This quota practice should be ended, and the NIH Office of Equity, Diversity, and Inclusion, which pushes such unlawful actions, should be abolished.”
• “Make Medicare Advantage [MA] the default enrollment option.”
• “[Legislation reforming legacy (non-MA) Medicare should] Repeal harmful health policies enacted under the Obama and Biden Administrations such as the Medicare Shared Savings Program and Inflation Reduction Act.”
• “…the next Administration should] Add work requirements and match Medicaid benefits to beneficiary needs. Because Medicaid serves a broad and diverse group of individuals, it should be flexible enough to accommodate different designs for different groups.”
• “The No Surprises Act should scrap the dispute resolution process in favor of a truth-in-advertising approach that will protect consumers and free doctors, insurers, and arbiters from confused and conflicting standards for resolving disputes that the disputing parties can best resolve themselves.”
• “Prohibit abortion travel funding. Providing funding for abortions increases the number of abortions and violates the conscience and religious freedom rights of Americans who object to subsidizing the taking of life.”
• “Prohibit Planned Parenthood from receiving Medicaid funds. During the 2020–2021 reporting period, Planned Parenthood performed more than 383,000 abortions.”
• “Protect faith-based grant recipients from religious liberty violations and maintain a biblically based, social science–reinforced definition of marriage and family. Social science reports that assess the objective outcomes for children raised in homes aside from a heterosexual, intact marriage are clear.”
• “Allocate funding to strategy programs promoting father involvement or terminate parental rights quickly.”
• “Eliminate the Head Start program.”
• “Support palliative care. Physician-assisted suicide (PAS) is legal in 10 states and the District of Columbia. Legalizing PAS is a grave mistake that endangers the weak and vulnerable, corrupts the practice of medicine and the doctor–patient relationship, compromises the family and intergenerational commitments, and betrays human dignity and equality before the law.”
• “Eliminate men’s preventive services from the women’s preventive services mandate. In December 2021, HRSA [Health Resources and Services Administration] updated its women’s preventive services guidelines to include male condoms.”
• “Prioritize funding for home-based childcare, not universal day care.”
• “ The Office of the Secretary should eliminate the HHS Reproductive Healthcare Access Task Force and install a pro-life task force to ensure that all of the department’s divisions seek to use their authority to promote the life and health of women and their unborn children.”
• “The ASH [Assistant Secretary for Health] and SG [Surgeon General] positions should be combined into one four-star position with the rank, responsibilities, and authority of the ASH retained but with the title of Surgeon General.”
• “OCR [Office for Civil Rights] should withdraw its Health Insurance Portability and Accountability Act (HIPAA) guidance on abortion.”

Dr. Lundberg is Editor in Chief, Cancer Commons, and has disclosed no relevant financial relationships.

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

The Heritage Foundation sponsored and developed Project 2025 for the explicit, stated purpose of building a conservative victory through policy, personnel, and training with a 180-day game plan after a sympathetic new President of the United States takes office. To date, Project 2025 has not been formally endorsed by any presidential campaign.

More than 100 conservative organizations are said to be participating. More than 400 conservative scholars and experts have collaborated in authorship of the mandate’s 40 chapters. Chapter 14 of the “Mandate for Leadership” is an exhaustive proposed overhaul of the Department of Health and Human Services (HHS), one of the major existing arms of the executive branch of the US government. 

The mandate’s sweeping recommendations, if implemented, would impact the lives of all Americans and all healthcare workers, as outlined in the following excerpts. 
 

Healthcare-Related Excerpts From Project 2025

• “From the moment of conception, every human being possesses inherent dignity and worth, and our humanity does not depend on our age, stage of development, race, or abilities. The Secretary must ensure that all HHS programs and activities are rooted in a deep respect for innocent human life from day one until natural death: Abortion and euthanasia are not health care.”
• “Unfortunately, family policies and programs under President Biden’s HHS are fraught with agenda items focusing on ‘LGBTQ+ equity,’ subsidizing single motherhood, disincentivizing work, and penalizing marriage. These policies should be repealed and replaced by policies that support the formation of stable, married, nuclear families.”
• “The next Administration should guard against the regulatory capture of our public health agencies by pharmaceutical companies, insurers, hospital conglomerates, and related economic interests that these agencies are meant to regulate. We must erect robust firewalls to mitigate these obvious financial conflicts of interest.”
• “All National Institutes of Health, Centers for Disease Control and Prevention, and Food and Drug Administration regulators should be entirely free from private biopharmaceutical funding. In this realm, ‘public–private partnerships’ is a euphemism for agency capture, a thin veneer for corporatism. Funding for agencies and individual government researchers must come directly from the government with robust congressional oversight.”
• “The CDC [Centers for Disease Control and Prevention] operates several programs related to vaccine safety including the Vaccine Adverse Event Reporting System (VAERS); Vaccine Safety Datalink (VSD); and Clinical Immunization Safety Assessment (CISA) Project. Those functions and their associated funding should be transferred to the FDA [Food and Drug Administration], which is responsible for post-market surveillance and evaluation of all other drugs and biological products.”
• “Because liberal states have now become sanctuaries for abortion tourism, HHS should use every available tool, including the cutting of funds, to ensure that every state reports exactly how many abortions take place within its borders, at what gestational age of the child, for what reason, the mother’s state of residence, and by what method. It should also ensure that statistics are separated by category: spontaneous miscarriage; treatments that incidentally result in the death of a child (such as chemotherapy); stillbirths; and induced abortion. In addition, CDC should require monitoring and reporting for complications due to abortion and every instance of children being born alive after an abortion.”
• “The CDC should immediately end its collection of data on gender identity, which legitimizes the unscientific notion that men can become women (and vice versa) and encourages the phenomenon of ever-multiplying subjective identities.”
• “A test developed by a lab in accordance with the protocols developed by another lab (non-commercial sharing) currently constitutes a ‘new’ laboratory-developed test because the lab in which it will be used is different from the initial developing lab. To encourage interlaboratory collaboration and discourage duplicative test creation (and associated regulatory and logistical burdens), the FDA should introduce mechanisms through which laboratory-developed tests can easily be shared with other laboratories without the current regulatory burdens.”
• “[FDA should] Reverse its approval of chemical abortion drugs because the politicized approval process was illegal from the start. The FDA failed to abide by its legal obligations to protect the health, safety, and welfare of girls and women.”
• “[FDA should] Stop promoting or approving mail-order abortions in violation of long-standing federal laws that prohibit the mailing and interstate carriage of abortion drugs.”
• “[HHS should] Promptly restore the ethics advisory committee to oversee abortion-derived fetal tissue research, and Congress should prohibit such research altogether.”
• “[HHS should] End intramural research projects using tissue from aborted children within the NIH, which should end its human embryonic stem cell registry.”
• “Under Francis Collins, NIH became so focused on the #MeToo movement that it refused to sponsor scientific conferences unless there were a certain number of women panelists, which violates federal civil rights law against sex discrimination. This quota practice should be ended, and the NIH Office of Equity, Diversity, and Inclusion, which pushes such unlawful actions, should be abolished.”
• “Make Medicare Advantage [MA] the default enrollment option.”
• “[Legislation reforming legacy (non-MA) Medicare should] Repeal harmful health policies enacted under the Obama and Biden Administrations such as the Medicare Shared Savings Program and Inflation Reduction Act.”
• “…the next Administration should] Add work requirements and match Medicaid benefits to beneficiary needs. Because Medicaid serves a broad and diverse group of individuals, it should be flexible enough to accommodate different designs for different groups.”
• “The No Surprises Act should scrap the dispute resolution process in favor of a truth-in-advertising approach that will protect consumers and free doctors, insurers, and arbiters from confused and conflicting standards for resolving disputes that the disputing parties can best resolve themselves.”
• “Prohibit abortion travel funding. Providing funding for abortions increases the number of abortions and violates the conscience and religious freedom rights of Americans who object to subsidizing the taking of life.”
• “Prohibit Planned Parenthood from receiving Medicaid funds. During the 2020–2021 reporting period, Planned Parenthood performed more than 383,000 abortions.”
• “Protect faith-based grant recipients from religious liberty violations and maintain a biblically based, social science–reinforced definition of marriage and family. Social science reports that assess the objective outcomes for children raised in homes aside from a heterosexual, intact marriage are clear.”
• “Allocate funding to strategy programs promoting father involvement or terminate parental rights quickly.”
• “Eliminate the Head Start program.”
• “Support palliative care. Physician-assisted suicide (PAS) is legal in 10 states and the District of Columbia. Legalizing PAS is a grave mistake that endangers the weak and vulnerable, corrupts the practice of medicine and the doctor–patient relationship, compromises the family and intergenerational commitments, and betrays human dignity and equality before the law.”
• “Eliminate men’s preventive services from the women’s preventive services mandate. In December 2021, HRSA [Health Resources and Services Administration] updated its women’s preventive services guidelines to include male condoms.”
• “Prioritize funding for home-based childcare, not universal day care.”
• “ The Office of the Secretary should eliminate the HHS Reproductive Healthcare Access Task Force and install a pro-life task force to ensure that all of the department’s divisions seek to use their authority to promote the life and health of women and their unborn children.”
• “The ASH [Assistant Secretary for Health] and SG [Surgeon General] positions should be combined into one four-star position with the rank, responsibilities, and authority of the ASH retained but with the title of Surgeon General.”
• “OCR [Office for Civil Rights] should withdraw its Health Insurance Portability and Accountability Act (HIPAA) guidance on abortion.”

Dr. Lundberg is Editor in Chief, Cancer Commons, and has disclosed no relevant financial relationships.

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

The Heritage Foundation sponsored and developed Project 2025 for the explicit, stated purpose of building a conservative victory through policy, personnel, and training with a 180-day game plan after a sympathetic new President of the United States takes office. To date, Project 2025 has not been formally endorsed by any presidential campaign.

More than 100 conservative organizations are said to be participating. More than 400 conservative scholars and experts have collaborated in authorship of the mandate’s 40 chapters. Chapter 14 of the “Mandate for Leadership” is an exhaustive proposed overhaul of the Department of Health and Human Services (HHS), one of the major existing arms of the executive branch of the US government. 

The mandate’s sweeping recommendations, if implemented, would impact the lives of all Americans and all healthcare workers, as outlined in the following excerpts. 
 

Healthcare-Related Excerpts From Project 2025

• “From the moment of conception, every human being possesses inherent dignity and worth, and our humanity does not depend on our age, stage of development, race, or abilities. The Secretary must ensure that all HHS programs and activities are rooted in a deep respect for innocent human life from day one until natural death: Abortion and euthanasia are not health care.”
• “Unfortunately, family policies and programs under President Biden’s HHS are fraught with agenda items focusing on ‘LGBTQ+ equity,’ subsidizing single motherhood, disincentivizing work, and penalizing marriage. These policies should be repealed and replaced by policies that support the formation of stable, married, nuclear families.”
• “The next Administration should guard against the regulatory capture of our public health agencies by pharmaceutical companies, insurers, hospital conglomerates, and related economic interests that these agencies are meant to regulate. We must erect robust firewalls to mitigate these obvious financial conflicts of interest.”
• “All National Institutes of Health, Centers for Disease Control and Prevention, and Food and Drug Administration regulators should be entirely free from private biopharmaceutical funding. In this realm, ‘public–private partnerships’ is a euphemism for agency capture, a thin veneer for corporatism. Funding for agencies and individual government researchers must come directly from the government with robust congressional oversight.”
• “The CDC [Centers for Disease Control and Prevention] operates several programs related to vaccine safety including the Vaccine Adverse Event Reporting System (VAERS); Vaccine Safety Datalink (VSD); and Clinical Immunization Safety Assessment (CISA) Project. Those functions and their associated funding should be transferred to the FDA [Food and Drug Administration], which is responsible for post-market surveillance and evaluation of all other drugs and biological products.”
• “Because liberal states have now become sanctuaries for abortion tourism, HHS should use every available tool, including the cutting of funds, to ensure that every state reports exactly how many abortions take place within its borders, at what gestational age of the child, for what reason, the mother’s state of residence, and by what method. It should also ensure that statistics are separated by category: spontaneous miscarriage; treatments that incidentally result in the death of a child (such as chemotherapy); stillbirths; and induced abortion. In addition, CDC should require monitoring and reporting for complications due to abortion and every instance of children being born alive after an abortion.”
• “The CDC should immediately end its collection of data on gender identity, which legitimizes the unscientific notion that men can become women (and vice versa) and encourages the phenomenon of ever-multiplying subjective identities.”
• “A test developed by a lab in accordance with the protocols developed by another lab (non-commercial sharing) currently constitutes a ‘new’ laboratory-developed test because the lab in which it will be used is different from the initial developing lab. To encourage interlaboratory collaboration and discourage duplicative test creation (and associated regulatory and logistical burdens), the FDA should introduce mechanisms through which laboratory-developed tests can easily be shared with other laboratories without the current regulatory burdens.”
• “[FDA should] Reverse its approval of chemical abortion drugs because the politicized approval process was illegal from the start. The FDA failed to abide by its legal obligations to protect the health, safety, and welfare of girls and women.”
• “[FDA should] Stop promoting or approving mail-order abortions in violation of long-standing federal laws that prohibit the mailing and interstate carriage of abortion drugs.”
• “[HHS should] Promptly restore the ethics advisory committee to oversee abortion-derived fetal tissue research, and Congress should prohibit such research altogether.”
• “[HHS should] End intramural research projects using tissue from aborted children within the NIH, which should end its human embryonic stem cell registry.”
• “Under Francis Collins, NIH became so focused on the #MeToo movement that it refused to sponsor scientific conferences unless there were a certain number of women panelists, which violates federal civil rights law against sex discrimination. This quota practice should be ended, and the NIH Office of Equity, Diversity, and Inclusion, which pushes such unlawful actions, should be abolished.”
• “Make Medicare Advantage [MA] the default enrollment option.”
• “[Legislation reforming legacy (non-MA) Medicare should] Repeal harmful health policies enacted under the Obama and Biden Administrations such as the Medicare Shared Savings Program and Inflation Reduction Act.”
• “…the next Administration should] Add work requirements and match Medicaid benefits to beneficiary needs. Because Medicaid serves a broad and diverse group of individuals, it should be flexible enough to accommodate different designs for different groups.”
• “The No Surprises Act should scrap the dispute resolution process in favor of a truth-in-advertising approach that will protect consumers and free doctors, insurers, and arbiters from confused and conflicting standards for resolving disputes that the disputing parties can best resolve themselves.”
• “Prohibit abortion travel funding. Providing funding for abortions increases the number of abortions and violates the conscience and religious freedom rights of Americans who object to subsidizing the taking of life.”
• “Prohibit Planned Parenthood from receiving Medicaid funds. During the 2020–2021 reporting period, Planned Parenthood performed more than 383,000 abortions.”
• “Protect faith-based grant recipients from religious liberty violations and maintain a biblically based, social science–reinforced definition of marriage and family. Social science reports that assess the objective outcomes for children raised in homes aside from a heterosexual, intact marriage are clear.”
• “Allocate funding to strategy programs promoting father involvement or terminate parental rights quickly.”
• “Eliminate the Head Start program.”
• “Support palliative care. Physician-assisted suicide (PAS) is legal in 10 states and the District of Columbia. Legalizing PAS is a grave mistake that endangers the weak and vulnerable, corrupts the practice of medicine and the doctor–patient relationship, compromises the family and intergenerational commitments, and betrays human dignity and equality before the law.”
• “Eliminate men’s preventive services from the women’s preventive services mandate. In December 2021, HRSA [Health Resources and Services Administration] updated its women’s preventive services guidelines to include male condoms.”
• “Prioritize funding for home-based childcare, not universal day care.”
• “ The Office of the Secretary should eliminate the HHS Reproductive Healthcare Access Task Force and install a pro-life task force to ensure that all of the department’s divisions seek to use their authority to promote the life and health of women and their unborn children.”
• “The ASH [Assistant Secretary for Health] and SG [Surgeon General] positions should be combined into one four-star position with the rank, responsibilities, and authority of the ASH retained but with the title of Surgeon General.”
• “OCR [Office for Civil Rights] should withdraw its Health Insurance Portability and Accountability Act (HIPAA) guidance on abortion.”

Dr. Lundberg is Editor in Chief, Cancer Commons, and has disclosed no relevant financial relationships.

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

My husband Scott and I were flying back to Washington state with our two kids, who were about 1 and 4. We had been in Florida for a family vacation, and we were near the end of the flight, with both kids passed out on top of me.

Suddenly, there was some scuffling and a lot of movement from the flight attendants. The announcement came: “Are there any healthcare providers on board?” My husband and I are both nurses. We looked at each other, and we looked at our sleeping kids. Should we say anything?

One of the stewardesses walked by looking very flustered. My husband was in the aisle seat, so he leaned out and told her that we were nurses. Her eyes got all big, and she said: “Oh yeah, come on up.”

She was looking at both of us. I said, “I think he’s got it.” I assumed it wasn’t that big of a deal. Plus — kids sleeping on top of me.

Scott went up to the front of the plane. But a few minutes later, the stewardess came back and said: “You need to help.” I was holding my 1-year-old son, so I handed her my kid. She sat down with him, and I boogied up to the front of the plane.

I got to the first-class stewards’ area where the restrooms are and the cabinets with all the food and drinks. I could see an older man on the ground on his back. He was unconscious and bleeding profusely from his scalp.

When I saw the bleeding, my first reaction was we need to apply pressure. I asked for a towel. There were no towels. A blanket? Anything to help absorb the blood? Nope. They had nothing. I was given a pair of gloves that were much too big and a fistful of cocktail napkins.

It was such a small space there wasn’t any way to be next to the man. So, I kind of squatted over the top of him to reach behind his head. I got a stack of napkins on there and held pressure as hard as I could with the tips of my fingers on one hand.

I’m a postanesthesia care unit nurse, so my next thought was to check his pupils and make sure he had a good airway by doing a jaw thrust and a chin lift. I noticed there was blood in his mouth. His breathing was in short gusts. I was trying to do all that with my free hand without crushing him with my body.

Scott had made some ice packs, so I applied those as well, which helped to constrict the bleeding. Then he checked the plane’s medical kit to try to get an intravenous (IV) started. It wasn’t easy. The IV start kit was very different from what you would normally use. And at the same time, the plane had started to descend for landing, so we were on an angle. But he tried.

We asked about what had happened. The steward team said the man had fallen and hit his head on one of the stainless steel cabinets. He seemed to be in his 70s or 80s, a tall, solid guy.

His wife was sitting nearby — pretty calm and stoic given the circumstances. We asked her about his medical history, trying to get a feel for why he might be unconscious. He was still totally out. She told us he had diabetes. He was on a blood pressure medication and also a blood thinner.

The plane kept going down. I was in a really awkward position, squatting and holding myself up against the cabinets. I just kept talking to the man, trying to get him to wake up. “Can you hear me? Everything’s okay. You hit your head.”

Someone brought us an oxygen tank. I looked for the mask. And realized it wasn’t a mask. It was a plastic bag. I set it on the patient’s face, and it felt like I was suffocating him. So, I tried to do it blowby to just increase the oxygen in the air near his face.

At one point, his breathing was agonal for a few minutes, which really concerned me. My fear was that he was going to stop breathing. I rubbed his chest and kind of said: “Hey, let’s not do that!”

I would have felt a lot better about resuscitating him with an actual oxygen mask rather than a plastic bag.

The amount of blood definitely looked alarming. I couldn’t tell how much he was actively bleeding. But it was a lot. He wasn’t turning gray though, so that was a good sign.

Finally, he started coming to and opening his eyes. I introduced myself and asked him: “Do you know where you are? Do you know what’s going on?” Trying to see if he was oriented at all.

Eventually, he was able to talk to me, so I kept asking questions: “Are you guys on vacation? Where are you headed? Where are you staying?”

He told me they were going to visit his granddaughter, and he was able to talk about that. He didn’t try to get up, which I was glad about, because that would’ve been really challenging to navigate.

I could tell he was embarrassed about what had happened. I’ve helped a lot of older gentlemen after falling down, and their egos are often bruised. They don’t want to be in a position of needing help.

Finally, the plane landed. There was blood absolutely everywhere. The ice packs had melted, and the water had mixed with the pool of blood. It was such a mess.

The pilots had called the airport ahead to let them know we needed medical services. So, the first responding team came on right away. They stabilized the man with a board, put the neck brace on him, and did all the stuff you do for a patient after a fall.

I gave them a report — that’s just my style. But it didn’t seem like they needed a lot of information at that point.

I was finally able to talk to the man’s wife who was clearly terrified. I gave her a hug and told her he would be all right. She thanked us.

The emergency team didn’t seem to have anything to help staunch the bleeding either because the rolling gurney left puddles of blood all down the gangway, causing a significant biohazard problem.

They let one person leave who had a connecting flight, but everyone else had to get off from the rear of the plane and walk across the tarmac.

When we finally got back to our seats, the stewardess was still sitting with our kids. They were both totally chill, watching some show, apparently very well behaved. Our daughter asked us what was going on, and I said: “Oh, somebody got hurt at the front of the plane.” She’s so used to hearing that we work with sick people that it didn’t faze her at all.

As we left, we got a lot of thank-yous from people who had been sitting up front and saw what happened.

When we got home, there was still blood on my shoes. I remember looking at them and thinking: Disinfect or throw away? I disinfected them. They were still a good pair of shoes.

A few days later, we got an email from the airline with a voucher, expressing their gratitude for our help. That was nice and unexpected.

I responded with a suggestion: How about having some protocols for medical events on airplanes? Pilots go through checklists for almost everything they do. Why wouldn’t they have something like that for medical responses?

I also asked how the man and his wife were doing. But they couldn’t disclose that information.

It was certainly strange being out of my element, helping a patient in that tiny little space; I’m used to working in a recovery room where you have literally everything you need within arm’s reach — the Ambu bag, suction, and bandages. And with airway management, there’s usually more than one person in the room to assist. If there’s a problem, a whole bunch of people show up around the bed so fast.

I’m definitely thinking about field medicine a lot more. Wondering what I would do in certain situations. While debriefing with my mom (an advanced registered nurse practitioner), she pointed out that we should have asked passengers for sanitary pads or diapers to stabilize the bleeding instead of the cocktail napkins. Brilliant idea! I didn’t think of it in the moment. But I’m keeping that little tip tucked in my back pocket for any future bleeding-in-the-wild scenarios.

Audra Podruzny, MSN, RN, CPAN, lives in Washington state and is currently attending the Washington State University Doctor of Nursing Practice Family Nurse Practitioner program.

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

My husband Scott and I were flying back to Washington state with our two kids, who were about 1 and 4. We had been in Florida for a family vacation, and we were near the end of the flight, with both kids passed out on top of me.

Suddenly, there was some scuffling and a lot of movement from the flight attendants. The announcement came: “Are there any healthcare providers on board?” My husband and I are both nurses. We looked at each other, and we looked at our sleeping kids. Should we say anything?

One of the stewardesses walked by looking very flustered. My husband was in the aisle seat, so he leaned out and told her that we were nurses. Her eyes got all big, and she said: “Oh yeah, come on up.”

She was looking at both of us. I said, “I think he’s got it.” I assumed it wasn’t that big of a deal. Plus — kids sleeping on top of me.

Scott went up to the front of the plane. But a few minutes later, the stewardess came back and said: “You need to help.” I was holding my 1-year-old son, so I handed her my kid. She sat down with him, and I boogied up to the front of the plane.

I got to the first-class stewards’ area where the restrooms are and the cabinets with all the food and drinks. I could see an older man on the ground on his back. He was unconscious and bleeding profusely from his scalp.

When I saw the bleeding, my first reaction was we need to apply pressure. I asked for a towel. There were no towels. A blanket? Anything to help absorb the blood? Nope. They had nothing. I was given a pair of gloves that were much too big and a fistful of cocktail napkins.

It was such a small space there wasn’t any way to be next to the man. So, I kind of squatted over the top of him to reach behind his head. I got a stack of napkins on there and held pressure as hard as I could with the tips of my fingers on one hand.

I’m a postanesthesia care unit nurse, so my next thought was to check his pupils and make sure he had a good airway by doing a jaw thrust and a chin lift. I noticed there was blood in his mouth. His breathing was in short gusts. I was trying to do all that with my free hand without crushing him with my body.

Scott had made some ice packs, so I applied those as well, which helped to constrict the bleeding. Then he checked the plane’s medical kit to try to get an intravenous (IV) started. It wasn’t easy. The IV start kit was very different from what you would normally use. And at the same time, the plane had started to descend for landing, so we were on an angle. But he tried.

We asked about what had happened. The steward team said the man had fallen and hit his head on one of the stainless steel cabinets. He seemed to be in his 70s or 80s, a tall, solid guy.

His wife was sitting nearby — pretty calm and stoic given the circumstances. We asked her about his medical history, trying to get a feel for why he might be unconscious. He was still totally out. She told us he had diabetes. He was on a blood pressure medication and also a blood thinner.

The plane kept going down. I was in a really awkward position, squatting and holding myself up against the cabinets. I just kept talking to the man, trying to get him to wake up. “Can you hear me? Everything’s okay. You hit your head.”

Someone brought us an oxygen tank. I looked for the mask. And realized it wasn’t a mask. It was a plastic bag. I set it on the patient’s face, and it felt like I was suffocating him. So, I tried to do it blowby to just increase the oxygen in the air near his face.

At one point, his breathing was agonal for a few minutes, which really concerned me. My fear was that he was going to stop breathing. I rubbed his chest and kind of said: “Hey, let’s not do that!”

I would have felt a lot better about resuscitating him with an actual oxygen mask rather than a plastic bag.

The amount of blood definitely looked alarming. I couldn’t tell how much he was actively bleeding. But it was a lot. He wasn’t turning gray though, so that was a good sign.

Finally, he started coming to and opening his eyes. I introduced myself and asked him: “Do you know where you are? Do you know what’s going on?” Trying to see if he was oriented at all.

Eventually, he was able to talk to me, so I kept asking questions: “Are you guys on vacation? Where are you headed? Where are you staying?”

He told me they were going to visit his granddaughter, and he was able to talk about that. He didn’t try to get up, which I was glad about, because that would’ve been really challenging to navigate.

I could tell he was embarrassed about what had happened. I’ve helped a lot of older gentlemen after falling down, and their egos are often bruised. They don’t want to be in a position of needing help.

Finally, the plane landed. There was blood absolutely everywhere. The ice packs had melted, and the water had mixed with the pool of blood. It was such a mess.

The pilots had called the airport ahead to let them know we needed medical services. So, the first responding team came on right away. They stabilized the man with a board, put the neck brace on him, and did all the stuff you do for a patient after a fall.

I gave them a report — that’s just my style. But it didn’t seem like they needed a lot of information at that point.

I was finally able to talk to the man’s wife who was clearly terrified. I gave her a hug and told her he would be all right. She thanked us.

The emergency team didn’t seem to have anything to help staunch the bleeding either because the rolling gurney left puddles of blood all down the gangway, causing a significant biohazard problem.

They let one person leave who had a connecting flight, but everyone else had to get off from the rear of the plane and walk across the tarmac.

When we finally got back to our seats, the stewardess was still sitting with our kids. They were both totally chill, watching some show, apparently very well behaved. Our daughter asked us what was going on, and I said: “Oh, somebody got hurt at the front of the plane.” She’s so used to hearing that we work with sick people that it didn’t faze her at all.

As we left, we got a lot of thank-yous from people who had been sitting up front and saw what happened.

When we got home, there was still blood on my shoes. I remember looking at them and thinking: Disinfect or throw away? I disinfected them. They were still a good pair of shoes.

A few days later, we got an email from the airline with a voucher, expressing their gratitude for our help. That was nice and unexpected.

I responded with a suggestion: How about having some protocols for medical events on airplanes? Pilots go through checklists for almost everything they do. Why wouldn’t they have something like that for medical responses?

I also asked how the man and his wife were doing. But they couldn’t disclose that information.

It was certainly strange being out of my element, helping a patient in that tiny little space; I’m used to working in a recovery room where you have literally everything you need within arm’s reach — the Ambu bag, suction, and bandages. And with airway management, there’s usually more than one person in the room to assist. If there’s a problem, a whole bunch of people show up around the bed so fast.

I’m definitely thinking about field medicine a lot more. Wondering what I would do in certain situations. While debriefing with my mom (an advanced registered nurse practitioner), she pointed out that we should have asked passengers for sanitary pads or diapers to stabilize the bleeding instead of the cocktail napkins. Brilliant idea! I didn’t think of it in the moment. But I’m keeping that little tip tucked in my back pocket for any future bleeding-in-the-wild scenarios.

Audra Podruzny, MSN, RN, CPAN, lives in Washington state and is currently attending the Washington State University Doctor of Nursing Practice Family Nurse Practitioner program.

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

My husband Scott and I were flying back to Washington state with our two kids, who were about 1 and 4. We had been in Florida for a family vacation, and we were near the end of the flight, with both kids passed out on top of me.

Suddenly, there was some scuffling and a lot of movement from the flight attendants. The announcement came: “Are there any healthcare providers on board?” My husband and I are both nurses. We looked at each other, and we looked at our sleeping kids. Should we say anything?

One of the stewardesses walked by looking very flustered. My husband was in the aisle seat, so he leaned out and told her that we were nurses. Her eyes got all big, and she said: “Oh yeah, come on up.”

She was looking at both of us. I said, “I think he’s got it.” I assumed it wasn’t that big of a deal. Plus — kids sleeping on top of me.

Scott went up to the front of the plane. But a few minutes later, the stewardess came back and said: “You need to help.” I was holding my 1-year-old son, so I handed her my kid. She sat down with him, and I boogied up to the front of the plane.

I got to the first-class stewards’ area where the restrooms are and the cabinets with all the food and drinks. I could see an older man on the ground on his back. He was unconscious and bleeding profusely from his scalp.

When I saw the bleeding, my first reaction was we need to apply pressure. I asked for a towel. There were no towels. A blanket? Anything to help absorb the blood? Nope. They had nothing. I was given a pair of gloves that were much too big and a fistful of cocktail napkins.

It was such a small space there wasn’t any way to be next to the man. So, I kind of squatted over the top of him to reach behind his head. I got a stack of napkins on there and held pressure as hard as I could with the tips of my fingers on one hand.

I’m a postanesthesia care unit nurse, so my next thought was to check his pupils and make sure he had a good airway by doing a jaw thrust and a chin lift. I noticed there was blood in his mouth. His breathing was in short gusts. I was trying to do all that with my free hand without crushing him with my body.

Scott had made some ice packs, so I applied those as well, which helped to constrict the bleeding. Then he checked the plane’s medical kit to try to get an intravenous (IV) started. It wasn’t easy. The IV start kit was very different from what you would normally use. And at the same time, the plane had started to descend for landing, so we were on an angle. But he tried.

We asked about what had happened. The steward team said the man had fallen and hit his head on one of the stainless steel cabinets. He seemed to be in his 70s or 80s, a tall, solid guy.

His wife was sitting nearby — pretty calm and stoic given the circumstances. We asked her about his medical history, trying to get a feel for why he might be unconscious. He was still totally out. She told us he had diabetes. He was on a blood pressure medication and also a blood thinner.

The plane kept going down. I was in a really awkward position, squatting and holding myself up against the cabinets. I just kept talking to the man, trying to get him to wake up. “Can you hear me? Everything’s okay. You hit your head.”

Someone brought us an oxygen tank. I looked for the mask. And realized it wasn’t a mask. It was a plastic bag. I set it on the patient’s face, and it felt like I was suffocating him. So, I tried to do it blowby to just increase the oxygen in the air near his face.

At one point, his breathing was agonal for a few minutes, which really concerned me. My fear was that he was going to stop breathing. I rubbed his chest and kind of said: “Hey, let’s not do that!”

I would have felt a lot better about resuscitating him with an actual oxygen mask rather than a plastic bag.

The amount of blood definitely looked alarming. I couldn’t tell how much he was actively bleeding. But it was a lot. He wasn’t turning gray though, so that was a good sign.

Finally, he started coming to and opening his eyes. I introduced myself and asked him: “Do you know where you are? Do you know what’s going on?” Trying to see if he was oriented at all.

Eventually, he was able to talk to me, so I kept asking questions: “Are you guys on vacation? Where are you headed? Where are you staying?”

He told me they were going to visit his granddaughter, and he was able to talk about that. He didn’t try to get up, which I was glad about, because that would’ve been really challenging to navigate.

I could tell he was embarrassed about what had happened. I’ve helped a lot of older gentlemen after falling down, and their egos are often bruised. They don’t want to be in a position of needing help.

Finally, the plane landed. There was blood absolutely everywhere. The ice packs had melted, and the water had mixed with the pool of blood. It was such a mess.

The pilots had called the airport ahead to let them know we needed medical services. So, the first responding team came on right away. They stabilized the man with a board, put the neck brace on him, and did all the stuff you do for a patient after a fall.

I gave them a report — that’s just my style. But it didn’t seem like they needed a lot of information at that point.

I was finally able to talk to the man’s wife who was clearly terrified. I gave her a hug and told her he would be all right. She thanked us.

The emergency team didn’t seem to have anything to help staunch the bleeding either because the rolling gurney left puddles of blood all down the gangway, causing a significant biohazard problem.

They let one person leave who had a connecting flight, but everyone else had to get off from the rear of the plane and walk across the tarmac.

When we finally got back to our seats, the stewardess was still sitting with our kids. They were both totally chill, watching some show, apparently very well behaved. Our daughter asked us what was going on, and I said: “Oh, somebody got hurt at the front of the plane.” She’s so used to hearing that we work with sick people that it didn’t faze her at all.

As we left, we got a lot of thank-yous from people who had been sitting up front and saw what happened.

When we got home, there was still blood on my shoes. I remember looking at them and thinking: Disinfect or throw away? I disinfected them. They were still a good pair of shoes.

A few days later, we got an email from the airline with a voucher, expressing their gratitude for our help. That was nice and unexpected.

I responded with a suggestion: How about having some protocols for medical events on airplanes? Pilots go through checklists for almost everything they do. Why wouldn’t they have something like that for medical responses?

I also asked how the man and his wife were doing. But they couldn’t disclose that information.

It was certainly strange being out of my element, helping a patient in that tiny little space; I’m used to working in a recovery room where you have literally everything you need within arm’s reach — the Ambu bag, suction, and bandages. And with airway management, there’s usually more than one person in the room to assist. If there’s a problem, a whole bunch of people show up around the bed so fast.

I’m definitely thinking about field medicine a lot more. Wondering what I would do in certain situations. While debriefing with my mom (an advanced registered nurse practitioner), she pointed out that we should have asked passengers for sanitary pads or diapers to stabilize the bleeding instead of the cocktail napkins. Brilliant idea! I didn’t think of it in the moment. But I’m keeping that little tip tucked in my back pocket for any future bleeding-in-the-wild scenarios.

Audra Podruzny, MSN, RN, CPAN, lives in Washington state and is currently attending the Washington State University Doctor of Nursing Practice Family Nurse Practitioner program.

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

We are quickly approaching the typical cold and flu season. But can we call anything typical since 2020? Since 2020, there have been different recommendations for prevention, testing, return to work, and treatment since our world was rocked by the pandemic. Now that we are in the “post-pandemic” era, family physicians and other primary care professionals are the front line for discussions on prevention, evaluation, and treatment of the typical upper-respiratory infections, influenza, and COVID-19.

Let’s start with prevention. We have all heard the old adage, an ounce of prevention is worth a pound of cure. In primary care, we need to focus on prevention. Vaccination is often one of our best tools against the myriad of infections we are hoping to help patients prevent during cold and flu season. Most recently, we have fall vaccinations aimed to prevent COVID-19, influenza, and respiratory syncytial virus (RSV).

The number and timing of each of these vaccinations has different recommendations based on a variety of factors including age, pregnancy status, and whether or not the patient is immunocompromised. For the 2024-2025 season, the Centers for Disease Control and Prevention has recommended updated vaccines for both influenza and COVID-19.¹

They have also updated the RSV vaccine recommendations to “People 75 or older, or between 60-74 with certain chronic health conditions or living in a nursing home should get one dose of the RSV vaccine to provide an extra layer of protection.”²

In addition to vaccines as prevention, there is also hygiene, staying home when sick and away from others who are sick, following guidelines for where and when to wear a face mask, and the general tools of eating well, and getting sufficient sleep and exercise to help maintain the healthiest immune system.

Despite the best of intentions, there will still be many who experience viral infections in this upcoming season. The CDC is currently recommending persons to stay away from others for at least 24 hours after their symptoms improve and they are fever-free without antipyretics. In addition to isolation while sick, general symptom management is something that we can recommend for all of these illnesses.

There is more to consider, though, as our patients face these illnesses. The first question is how to determine the diagnosis — and if that diagnosis is even necessary. Unfortunately, many of these viral illnesses can look the same. They can all cause fevers, chills, and other upper respiratory symptoms. They are all fairly contagious. All of these viruses can cause serious illness associated with additional complications. It is not truly possible to determine which virus someone has by symptoms alone, our patients can have multiple viruses at the same time and diagnosis of one does not preclude having another.³

Instead, we truly do need a test for diagnosis. In-office testing is available for RSV, influenza, and COVID-19. Additionally, despite not being as freely available as they were during the pandemic, patients are able to do home COVID tests and then call in with their results. At the time of writing this, at-home rapid influenza tests have also been approved by the FDA but are not yet readily available to the public. These tests are important for determining if the patient is eligible for treatment. Both influenza and COVID-19 have antiviral treatments available to help decrease the severity of the illness and potentially the length of illness and time contagious. According to the CDC, both treatments are underutilized.

This could be because of a lack of testing and diagnosis. It may also be because of a lack of familiarity with the available treatments.^4,5

Influenza treatment is recommended as soon as possible for those with suspected or confirmed diagnosis, immediately for anyone hospitalized, anyone with severe, complicated, or progressing illness, and for those at high risk of severe illness including but not limited to those under 2 years old, those over 65, those who are pregnant, and those with many chronic conditions.

Treatment can also be used for those who are not high risk when diagnosed within 48 hours. In the United States, four antivirals are recommended to treat influenza: oseltamivir phosphate, zanamivir, peramivir, and baloxavir marboxil. For COVID-19, treatments are also available for mild or moderate disease in those at risk for severe disease. Both remdesivir and nimatrelvir with ritonavir are treatment options that can be used for COVID-19 infection. Unfortunately, no specific antiviral is available for the other viral illnesses we see often during this season.

In primary care, we have some important roles to play. We need to continue to discuss all methods of prevention. Not only do vaccine recommendations change at least annually, our patients’ situations change and we have to reassess them. Additionally, people often need to hear things more than once before committing — so it never hurts to continue having those conversations. Combining the conversation about vaccines with other prevention measures is also important so that it does not seem like we are only recommending one thing. We should also start talking about treatment options before our patients are sick. We can communicate what is available as long as they let us know they are sick early. We can also be there to help our patients determine when they are at risk for severe illness and when they should consider a higher level of care.

The availability of home testing gives us the opportunity to provide these treatments via telehealth and even potentially in times when these illnesses are everywhere — with standing orders with our clinical teams. Although it is a busy time for us in the clinic, “cold and flu” season is definitely one of those times when our primary care relationship can truly help our patients.
 

References

1. CDC Recommends Updated 2024-2025 COVID-19 and Flu Vaccines for Fall/Winter Virus Season. https://www.cdc.gov/media/releases/2024/s-t0627-vaccine-recommendations.html. Accessed August 8, 2024. Source: Centers for Disease Control and Prevention.

2. CDC Updates RSV Vaccination Recommendation for Adults. https://www.cdc.gov/media/releases/2024/s-0626-vaccination-adults.html. Accessed August 8, 2024. Source: Centers for Disease Control and Prevention.

3. Similarities and Differences between Flu and COVID-19. https://www.cdc.gov/flu/symptoms/flu-vs-covid19.htm. Accessed August 8, 2024. Source: Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases.

4. Respiratory Virus Guidance. https://www.cdc.gov/respiratory-viruses/guidance/index.html. Accessed August 9, 2024. Source: National Center for Immunization and Respiratory Diseases.

5. Provider Toolkit: Preparing Patients for the Fall and Winter Virus Season. https://www.cdc.gov/respiratory-viruses/hcp/tools-resources/index.html. Accessed August 9, 2024. Source: Centers for Disease Control and Prevention.

We are quickly approaching the typical cold and flu season. But can we call anything typical since 2020? Since 2020, there have been different recommendations for prevention, testing, return to work, and treatment since our world was rocked by the pandemic. Now that we are in the “post-pandemic” era, family physicians and other primary care professionals are the front line for discussions on prevention, evaluation, and treatment of the typical upper-respiratory infections, influenza, and COVID-19.

Let’s start with prevention. We have all heard the old adage, an ounce of prevention is worth a pound of cure. In primary care, we need to focus on prevention. Vaccination is often one of our best tools against the myriad of infections we are hoping to help patients prevent during cold and flu season. Most recently, we have fall vaccinations aimed to prevent COVID-19, influenza, and respiratory syncytial virus (RSV).

The number and timing of each of these vaccinations has different recommendations based on a variety of factors including age, pregnancy status, and whether or not the patient is immunocompromised. For the 2024-2025 season, the Centers for Disease Control and Prevention has recommended updated vaccines for both influenza and COVID-19.¹

They have also updated the RSV vaccine recommendations to “People 75 or older, or between 60-74 with certain chronic health conditions or living in a nursing home should get one dose of the RSV vaccine to provide an extra layer of protection.”²

In addition to vaccines as prevention, there is also hygiene, staying home when sick and away from others who are sick, following guidelines for where and when to wear a face mask, and the general tools of eating well, and getting sufficient sleep and exercise to help maintain the healthiest immune system.

Despite the best of intentions, there will still be many who experience viral infections in this upcoming season. The CDC is currently recommending persons to stay away from others for at least 24 hours after their symptoms improve and they are fever-free without antipyretics. In addition to isolation while sick, general symptom management is something that we can recommend for all of these illnesses.

There is more to consider, though, as our patients face these illnesses. The first question is how to determine the diagnosis — and if that diagnosis is even necessary. Unfortunately, many of these viral illnesses can look the same. They can all cause fevers, chills, and other upper respiratory symptoms. They are all fairly contagious. All of these viruses can cause serious illness associated with additional complications. It is not truly possible to determine which virus someone has by symptoms alone, our patients can have multiple viruses at the same time and diagnosis of one does not preclude having another.³

Instead, we truly do need a test for diagnosis. In-office testing is available for RSV, influenza, and COVID-19. Additionally, despite not being as freely available as they were during the pandemic, patients are able to do home COVID tests and then call in with their results. At the time of writing this, at-home rapid influenza tests have also been approved by the FDA but are not yet readily available to the public. These tests are important for determining if the patient is eligible for treatment. Both influenza and COVID-19 have antiviral treatments available to help decrease the severity of the illness and potentially the length of illness and time contagious. According to the CDC, both treatments are underutilized.

This could be because of a lack of testing and diagnosis. It may also be because of a lack of familiarity with the available treatments.^4,5

Influenza treatment is recommended as soon as possible for those with suspected or confirmed diagnosis, immediately for anyone hospitalized, anyone with severe, complicated, or progressing illness, and for those at high risk of severe illness including but not limited to those under 2 years old, those over 65, those who are pregnant, and those with many chronic conditions.

Treatment can also be used for those who are not high risk when diagnosed within 48 hours. In the United States, four antivirals are recommended to treat influenza: oseltamivir phosphate, zanamivir, peramivir, and baloxavir marboxil. For COVID-19, treatments are also available for mild or moderate disease in those at risk for severe disease. Both remdesivir and nimatrelvir with ritonavir are treatment options that can be used for COVID-19 infection. Unfortunately, no specific antiviral is available for the other viral illnesses we see often during this season.

In primary care, we have some important roles to play. We need to continue to discuss all methods of prevention. Not only do vaccine recommendations change at least annually, our patients’ situations change and we have to reassess them. Additionally, people often need to hear things more than once before committing — so it never hurts to continue having those conversations. Combining the conversation about vaccines with other prevention measures is also important so that it does not seem like we are only recommending one thing. We should also start talking about treatment options before our patients are sick. We can communicate what is available as long as they let us know they are sick early. We can also be there to help our patients determine when they are at risk for severe illness and when they should consider a higher level of care.

The availability of home testing gives us the opportunity to provide these treatments via telehealth and even potentially in times when these illnesses are everywhere — with standing orders with our clinical teams. Although it is a busy time for us in the clinic, “cold and flu” season is definitely one of those times when our primary care relationship can truly help our patients.
 

References

1. CDC Recommends Updated 2024-2025 COVID-19 and Flu Vaccines for Fall/Winter Virus Season. https://www.cdc.gov/media/releases/2024/s-t0627-vaccine-recommendations.html. Accessed August 8, 2024. Source: Centers for Disease Control and Prevention.

2. CDC Updates RSV Vaccination Recommendation for Adults. https://www.cdc.gov/media/releases/2024/s-0626-vaccination-adults.html. Accessed August 8, 2024. Source: Centers for Disease Control and Prevention.

3. Similarities and Differences between Flu and COVID-19. https://www.cdc.gov/flu/symptoms/flu-vs-covid19.htm. Accessed August 8, 2024. Source: Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases.

4. Respiratory Virus Guidance. https://www.cdc.gov/respiratory-viruses/guidance/index.html. Accessed August 9, 2024. Source: National Center for Immunization and Respiratory Diseases.

5. Provider Toolkit: Preparing Patients for the Fall and Winter Virus Season. https://www.cdc.gov/respiratory-viruses/hcp/tools-resources/index.html. Accessed August 9, 2024. Source: Centers for Disease Control and Prevention.

We are quickly approaching the typical cold and flu season. But can we call anything typical since 2020? Since 2020, there have been different recommendations for prevention, testing, return to work, and treatment since our world was rocked by the pandemic. Now that we are in the “post-pandemic” era, family physicians and other primary care professionals are the front line for discussions on prevention, evaluation, and treatment of the typical upper-respiratory infections, influenza, and COVID-19.

Let’s start with prevention. We have all heard the old adage, an ounce of prevention is worth a pound of cure. In primary care, we need to focus on prevention. Vaccination is often one of our best tools against the myriad of infections we are hoping to help patients prevent during cold and flu season. Most recently, we have fall vaccinations aimed to prevent COVID-19, influenza, and respiratory syncytial virus (RSV).

The number and timing of each of these vaccinations has different recommendations based on a variety of factors including age, pregnancy status, and whether or not the patient is immunocompromised. For the 2024-2025 season, the Centers for Disease Control and Prevention has recommended updated vaccines for both influenza and COVID-19.¹

They have also updated the RSV vaccine recommendations to “People 75 or older, or between 60-74 with certain chronic health conditions or living in a nursing home should get one dose of the RSV vaccine to provide an extra layer of protection.”²

In addition to vaccines as prevention, there is also hygiene, staying home when sick and away from others who are sick, following guidelines for where and when to wear a face mask, and the general tools of eating well, and getting sufficient sleep and exercise to help maintain the healthiest immune system.

Despite the best of intentions, there will still be many who experience viral infections in this upcoming season. The CDC is currently recommending persons to stay away from others for at least 24 hours after their symptoms improve and they are fever-free without antipyretics. In addition to isolation while sick, general symptom management is something that we can recommend for all of these illnesses.

There is more to consider, though, as our patients face these illnesses. The first question is how to determine the diagnosis — and if that diagnosis is even necessary. Unfortunately, many of these viral illnesses can look the same. They can all cause fevers, chills, and other upper respiratory symptoms. They are all fairly contagious. All of these viruses can cause serious illness associated with additional complications. It is not truly possible to determine which virus someone has by symptoms alone, our patients can have multiple viruses at the same time and diagnosis of one does not preclude having another.³

Instead, we truly do need a test for diagnosis. In-office testing is available for RSV, influenza, and COVID-19. Additionally, despite not being as freely available as they were during the pandemic, patients are able to do home COVID tests and then call in with their results. At the time of writing this, at-home rapid influenza tests have also been approved by the FDA but are not yet readily available to the public. These tests are important for determining if the patient is eligible for treatment. Both influenza and COVID-19 have antiviral treatments available to help decrease the severity of the illness and potentially the length of illness and time contagious. According to the CDC, both treatments are underutilized.

This could be because of a lack of testing and diagnosis. It may also be because of a lack of familiarity with the available treatments.^4,5

Influenza treatment is recommended as soon as possible for those with suspected or confirmed diagnosis, immediately for anyone hospitalized, anyone with severe, complicated, or progressing illness, and for those at high risk of severe illness including but not limited to those under 2 years old, those over 65, those who are pregnant, and those with many chronic conditions.

Treatment can also be used for those who are not high risk when diagnosed within 48 hours. In the United States, four antivirals are recommended to treat influenza: oseltamivir phosphate, zanamivir, peramivir, and baloxavir marboxil. For COVID-19, treatments are also available for mild or moderate disease in those at risk for severe disease. Both remdesivir and nimatrelvir with ritonavir are treatment options that can be used for COVID-19 infection. Unfortunately, no specific antiviral is available for the other viral illnesses we see often during this season.

In primary care, we have some important roles to play. We need to continue to discuss all methods of prevention. Not only do vaccine recommendations change at least annually, our patients’ situations change and we have to reassess them. Additionally, people often need to hear things more than once before committing — so it never hurts to continue having those conversations. Combining the conversation about vaccines with other prevention measures is also important so that it does not seem like we are only recommending one thing. We should also start talking about treatment options before our patients are sick. We can communicate what is available as long as they let us know they are sick early. We can also be there to help our patients determine when they are at risk for severe illness and when they should consider a higher level of care.

The availability of home testing gives us the opportunity to provide these treatments via telehealth and even potentially in times when these illnesses are everywhere — with standing orders with our clinical teams. Although it is a busy time for us in the clinic, “cold and flu” season is definitely one of those times when our primary care relationship can truly help our patients.
 

References

1. CDC Recommends Updated 2024-2025 COVID-19 and Flu Vaccines for Fall/Winter Virus Season. https://www.cdc.gov/media/releases/2024/s-t0627-vaccine-recommendations.html. Accessed August 8, 2024. Source: Centers for Disease Control and Prevention.

2. CDC Updates RSV Vaccination Recommendation for Adults. https://www.cdc.gov/media/releases/2024/s-0626-vaccination-adults.html. Accessed August 8, 2024. Source: Centers for Disease Control and Prevention.

3. Similarities and Differences between Flu and COVID-19. https://www.cdc.gov/flu/symptoms/flu-vs-covid19.htm. Accessed August 8, 2024. Source: Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases.

4. Respiratory Virus Guidance. https://www.cdc.gov/respiratory-viruses/guidance/index.html. Accessed August 9, 2024. Source: National Center for Immunization and Respiratory Diseases.

5. Provider Toolkit: Preparing Patients for the Fall and Winter Virus Season. https://www.cdc.gov/respiratory-viruses/hcp/tools-resources/index.html. Accessed August 9, 2024. Source: Centers for Disease Control and Prevention.

To the Editor:

We read with interest the case report from Abdelkader et al¹ (Cutis. 2024;113:E22-E24) of a 32-year-old man who received the Sinopharm BBIBP COVID-19 vaccine (BBIBP-CorV) and experienced acute-onset erythroderma and severe itching. The patient did not disclose any recent medication intake and had no noteworthy medical history. Physical examination revealed palmoplantar keratoderma, keratotic follicular papules on the legs and feet, and typical orange-red erythroderma. The laboratory workup was normal, including a negative test result for HIV infection.

The absence of details regarding the patient’s history of allergic reactions or sensitivities is one possible shortcoming in this case report and may have given important information about the possible reason for the erythroderma that occurred following vaccination. Furthermore, more research into the precise Sinopharm BBIBP vaccine ingredients that may have caused the skin reaction would have been helpful in deciphering the underlying mechanisms.

Larger-scale studies examining the frequency of cutaneous reactions following COVID-19 vaccination with various vaccine formulations may be the focus of future research efforts and could assist in determining the risk factors for experiencing such reactions, which would enable health care providers to offer advice on vaccination alternatives or preventative measures for those who are more vulnerable. Furthermore, collaboration among dermatologists and allergists could improve patient outcomes and improve management.

By highlighting an uncommon but noteworthy dermatologic manifestation following COVID-19 immunization, this case report emphasizes how crucial it is to keep an eye out for and report any possible side effects linked to vaccinations to protect patient safety. Subsequent investigations should concentrate on enhancing comprehension of the pathophysiology of cutaneous reactions following immunization and devising tactics to alleviate these hazards. Working together, researchers and health care professionals can effectively tackle the issues raised by these newly discovered vaccine-related skin responses.

To the Editor:

We read with interest the case report from Abdelkader et al¹ (Cutis. 2024;113:E22-E24) of a 32-year-old man who received the Sinopharm BBIBP COVID-19 vaccine (BBIBP-CorV) and experienced acute-onset erythroderma and severe itching. The patient did not disclose any recent medication intake and had no noteworthy medical history. Physical examination revealed palmoplantar keratoderma, keratotic follicular papules on the legs and feet, and typical orange-red erythroderma. The laboratory workup was normal, including a negative test result for HIV infection.

The absence of details regarding the patient’s history of allergic reactions or sensitivities is one possible shortcoming in this case report and may have given important information about the possible reason for the erythroderma that occurred following vaccination. Furthermore, more research into the precise Sinopharm BBIBP vaccine ingredients that may have caused the skin reaction would have been helpful in deciphering the underlying mechanisms.

Larger-scale studies examining the frequency of cutaneous reactions following COVID-19 vaccination with various vaccine formulations may be the focus of future research efforts and could assist in determining the risk factors for experiencing such reactions, which would enable health care providers to offer advice on vaccination alternatives or preventative measures for those who are more vulnerable. Furthermore, collaboration among dermatologists and allergists could improve patient outcomes and improve management.

By highlighting an uncommon but noteworthy dermatologic manifestation following COVID-19 immunization, this case report emphasizes how crucial it is to keep an eye out for and report any possible side effects linked to vaccinations to protect patient safety. Subsequent investigations should concentrate on enhancing comprehension of the pathophysiology of cutaneous reactions following immunization and devising tactics to alleviate these hazards. Working together, researchers and health care professionals can effectively tackle the issues raised by these newly discovered vaccine-related skin responses.

To the Editor:

We read with interest the case report from Abdelkader et al¹ (Cutis. 2024;113:E22-E24) of a 32-year-old man who received the Sinopharm BBIBP COVID-19 vaccine (BBIBP-CorV) and experienced acute-onset erythroderma and severe itching. The patient did not disclose any recent medication intake and had no noteworthy medical history. Physical examination revealed palmoplantar keratoderma, keratotic follicular papules on the legs and feet, and typical orange-red erythroderma. The laboratory workup was normal, including a negative test result for HIV infection.

The absence of details regarding the patient’s history of allergic reactions or sensitivities is one possible shortcoming in this case report and may have given important information about the possible reason for the erythroderma that occurred following vaccination. Furthermore, more research into the precise Sinopharm BBIBP vaccine ingredients that may have caused the skin reaction would have been helpful in deciphering the underlying mechanisms.

Larger-scale studies examining the frequency of cutaneous reactions following COVID-19 vaccination with various vaccine formulations may be the focus of future research efforts and could assist in determining the risk factors for experiencing such reactions, which would enable health care providers to offer advice on vaccination alternatives or preventative measures for those who are more vulnerable. Furthermore, collaboration among dermatologists and allergists could improve patient outcomes and improve management.

By highlighting an uncommon but noteworthy dermatologic manifestation following COVID-19 immunization, this case report emphasizes how crucial it is to keep an eye out for and report any possible side effects linked to vaccinations to protect patient safety. Subsequent investigations should concentrate on enhancing comprehension of the pathophysiology of cutaneous reactions following immunization and devising tactics to alleviate these hazards. Working together, researchers and health care professionals can effectively tackle the issues raised by these newly discovered vaccine-related skin responses.

Vulvar dermatoses continue to be an overlooked aspect of medical care, highlighting the necessity for enhanced diagnosis and management of these conditions. Here, we address recent advancements in understanding vulvar inflammatory dermatoses other than lichen sclerosus (LS), which was discussed in a prior Guest Editorial¹—specifically vulvovaginal lichen planus (VLP), plasma cell vulvitis (PCV), and vulvar lichen simplex chronicus (LSC).

Vulvar Inflammatory Skin Disease and Quality of Life

There is an increased awareness of the impact vulvar skin disease has on quality of life and its association with anxiety and depression.^2-5 Evaluating the burden of vulvar dermatoses remains an active area of research due to its significance in monitoring disease progression and assessing therapeutic effectiveness. Despite the existence of various dermatology quality-of-life assessment tools, many fail to adequately capture the unique impacts of vulvovaginal diseases, such as sexual or urinary dysfunction. The vulvar quality of life index, which was developed and validated by Saunderson et al⁶ in 2020, consists of a 15-item questionnaire spanning 4 domains: symptoms, anxiety, activities of daily living, and sexuality. This tool has been utilized to gauge treatment response in vulvar conditions and to compare disease burden of various vulvar dermatoses.^7,8 Moving forward, integrating this tool into clinical studies on vulvar skin disease holds promise for enhancing our understanding and management of these conditions.

Vulvovaginal Lichen Planus

Vulvovaginal lichen planus is unique among several prevalent vulvar inflammatory skin disorders encountered by dermatologists—primarily due to its erosive form, which can extend to the vagina, resulting in noninfectious vaginitis and potential vaginal stenosis.^9,10 Managing VLP poses a notable challenge, even when it is confined to the vulva, as it often proves resistant to topical therapies.¹¹

Evaluation for Vaginal Mucosal Disease—In contrast to LS, which typically spares the vaginal mucosa, VLP can involve mucosal sites.^9,12,13 Therefore, it is imperative that all patients with a diagnosis of vulvar VLP undergo evaluation for potential vaginal involvement through speculum examination, wet mount, or vaginal biopsy. Strategies to manage vaginal involvement include use of dilators and pelvic floor physical therapy, lysis of adhesions (if present), topical estrogen, and intravaginal corticosteroids—all tailored to the severity of the disease.^9,11,14

Management of VLP—Approximately 20% to 40% of patients with VLP may require systemic therapy for disease management, including those who are younger, those of non-White ethnicity, and those presenting with vulvar pruritus.¹¹ Various systemic immunosuppressants have been used for VLP, with a recent retrospective study revealing similar response rates for both methotrexate and mycophenolate mofetil in the treatment of VLP.¹⁵ Another retrospective study found hydroxychloroquine to be safe and effective for VLP but noted a slow onset of action, with approximately 70% responding at 9 months following initiation of therapy.¹⁶

Recent attention has shifted to use of targeted therapies for VLP. For instance, apremilast has shown efficacy in a single-center, nonrandomized, open-label pilot study.¹⁷ Tildrakizumab, an IL-23 inhibitor, demonstrated efficacy in a case series involving 24 patients with VLP.¹⁸ Moreover, recent case reports and series have highlighted the potential of oral Janus kinase (JAK) ­inhibitors, such as tofacitinib, in VLP treatment.¹⁹ Clinical trials are ongoing to evaluate the safety and efficacy of topical ruxolitinib and deucravacitinib (a tyrosine kinase 2 inhibitor) in VLP.^20-22 Systemic therapies for VLP currently are used off label, emphasizing the need for future randomized controlled trials to ascertain the optimal therapies for patients affected by erosive and nonerosive forms of this disease.

Plasma Cell Vulvitis

Plasma cell vulvitis is a chronic inflammatory disorder with an unknown etiology that some consider to be a variant of VLP.²³ Others have observed an overlap with desquamative inflammatory vaginitis, categorizing PCV as a hemorrhagic vestibulovaginitis.²⁴ Although its classification as a distinct entity remains under scrutiny, studies indicate a predilection for the nonkeratinized or partially keratinized vulva. A systematic review outlining common clinical findings reported that the most common anatomic sites included the vulvar vestibule, periurethral area, and labia minora.²³ Additionally, reports have emphasized the association between PCV and other inflammatory vulvar skin conditions, including LS.²⁵

Clinical Variants of PCV—A retrospective review proposed 2 clinical phenotypes for PCV: (1) primary non–lichen-associated PCV and (2) secondary lichen-associated PCV, which is linked to LS.²⁶ The primary form is reported to be restricted to the vestibule, and the authors considered this a vulvar counterpart of atrophic vaginitis due to estrogen deficiency (now known as postmenopausal genitourinary syndrome). The secondary phenotype more commonly involved the vestibular and extravestibular epithelium.²⁶

Management of PCV—Recognizing PCV in the context of LS may be important for identifying comorbid conditions and guiding treatment. However, evidence-based guidelines for PCV treatment are lacking. Commonly reported treatment modalities include clobetasol ointment 0.05% and tacrolimus ointment 0.1%.²³ Successful treatment with hydrocortisone suppositories alternating with estradiol vaginal cream was reported in a recent case series.²⁷ Crisaborole also has been reported as a treatment in 1 case of PCV.²⁸ A recent case report found abrocitinib to be effective for the treatment of plasma cell balanitis in the setting of male genital LS,²⁹ but there are limited data on the use of JAK inhibitors for PCV. Further research is necessary to ascertain the incidence, prevalence, clinical subtypes, and optimal management strategies for PCV to effectively treat patients with this condition.

Vulvar LSC

Similar to extragenital LSC, the evaluation of vulvar LSC should prioritize identification of underlying ­etiologies that contribute to the itch-scratch cycle, which may include psoriasis, atopic dermatitis, neurologic conditions, and allergic or irritant contact dermatitis.^30,31 Although treatment strategies may vary based on underlying ­conditions, we will concentrate on updates in managing vulvar LSC and pruritus associated with an atopic ­diathesis or resulting from chronic contact dermatitis, which is prevalent in vulvar skin areas. Finally, we highlight some emerging vulvar allergens for consideration in clinical practice.

Management of Vulvar LSC—The advent of targeted therapies, including biologics and small-molecule inhibitors, for atopic dermatitis and prurigo nodularis in recent years presents potential options for treatment of individuals with vulvar LSC. However, studies on the use of these therapies specifically for vulvar LSC are limited, necessitating thorough discussions with patients. Given the debilitating nature of vulvar pruritus that may be seen in vulvar LSC and the potential inadequacy of topical steroids as monotherapy, systemic therapies may serve as alternative options for patients with refractory disease.³⁰

Dupilumab, a dual inhibitor of IL-4 and IL-13 signaling, has shown rapid and sustained disease improvement in patients with atopic dermatitis, prurigo nodularis, and pruritus.^32,33 Although data on its role in managing vulvar LSC are scarce, a recent case series reported improvement of vulvar pruritus with dupilumab.³⁴ Similarly, tralokinumab, an IL-13 inhibitor approved by the US Food and Drug Administration (FDA) for atopic dermatitis, has shown efficacy in prurigo nodularis³⁵ and may benefit patients with vulvar LSC, though studies on cutaneous outcomes in those with genital involvement specifically are lacking. Oral JAK inhibitors such as upadacitinib and abrocitinib—both FDA approved for atopic dermatitis—have demonstrated efficacy in treating LSC and itch, potentially serving as management options for vulvar LSC in cases resistant to topical steroids or in which steroid atrophy or other steroid adverse effects may preclude continued use of such agents.^36,37 Finally, IL-31 inhibitors such as nemolizumab, which reduced the signs and symptoms of prurigo nodularis in a recent phase 3 clinical trial, may hold utility in addressing vulvar LSC and associated pruritus.³⁸

The topical JAK inhibitor ruxolitinib, which is FDA approved for atopic dermatitis and vitiligo, holds promise for managing LSC on vulvar skin while mitigating the risk for steroid-induced atrophy.³⁹ Additionally, nonsteroidal topicals including roflumilast cream 0.3% and tapinarof cream 1%, both FDA approved for psoriasis, are being evaluated in studies for their safety and efficacy in atopic dermatitis.^40,41 These agents may have the potential to improve signs and symptoms of vulvar LSC, but further studies are necessary.

Vulvar Allergens and LSC—When assessing patients with vulvar LSC, it is crucial to recognize that allergic contact dermatitis is a common primary vulvar dermatosis but can coexist with other vulvar dermatoses such as LS.^13,30 The vulvar skin’s susceptibly to allergic contact dermatitis is attributed to factors such as a higher ratio of antigen-presenting cells in the vulvar skin, the nonkeratinized nature of certain sites, and frequent contact with potential allergens.^42,43 Therefore, incorporating patch testing into the diagnostic process should be considered when evaluating patients with vulvar skin conditions.⁴³

A systemic review identified multiple vulvar allergens, including metals, topical medicaments, fragrances, preservatives, cosmetic constituents, and rubber components that led to contact dermatitis.⁴⁴ Moreover, a recent analysis of topical preparations recommended by women with LS on social media found a high prevalence of known vulvar allergens in these agents, including botanical extracts/spices.⁴⁵ Personal-care wipes marketed for vulvar care and hygiene are known to contain a variety of allergens, with a recent study finding numerous allergens in commercially available wipes including fragrances, scented botanicals in the form of essences, oils, fruit juices, and vitamin E.⁴⁶ These findings underscore the importance of considering potential allergens when caring for patients with vulvar LSC and counseling patients about the potential allergens in many commercially available products that may be recommended on social media sites or by other sources.

Final Thoughts

Vulvar inflammatory dermatoses are becoming increasingly recognized, and there is a need to develop more effective diagnostic and treatment approaches. Recent literature has shed light on some of the challenges in the management of VLP, particularly its resistance to topical therapies and the importance of assessing and managing both cutaneous and vaginal involvement. Efforts have been made to refine the classification of PCV, with studies suggesting a variant that coexists with LS. Although evidence for vulvar-specific treatment of LSC is limited, the emergence of biologics and small-molecule inhibitors that are FDA approved for atopic dermatitis and prurigo nodularis offer promise for certain cases of vulvar LSC and vulvar pruritus. Moreover, recent developments in steroid-sparing topical agents warrant further investigation for their potential efficacy in treating vulvar LSC and possibly other vulvar inflammatory conditions in the future.

Vulvar dermatoses continue to be an overlooked aspect of medical care, highlighting the necessity for enhanced diagnosis and management of these conditions. Here, we address recent advancements in understanding vulvar inflammatory dermatoses other than lichen sclerosus (LS), which was discussed in a prior Guest Editorial¹—specifically vulvovaginal lichen planus (VLP), plasma cell vulvitis (PCV), and vulvar lichen simplex chronicus (LSC).

Vulvar Inflammatory Skin Disease and Quality of Life

There is an increased awareness of the impact vulvar skin disease has on quality of life and its association with anxiety and depression.^2-5 Evaluating the burden of vulvar dermatoses remains an active area of research due to its significance in monitoring disease progression and assessing therapeutic effectiveness. Despite the existence of various dermatology quality-of-life assessment tools, many fail to adequately capture the unique impacts of vulvovaginal diseases, such as sexual or urinary dysfunction. The vulvar quality of life index, which was developed and validated by Saunderson et al⁶ in 2020, consists of a 15-item questionnaire spanning 4 domains: symptoms, anxiety, activities of daily living, and sexuality. This tool has been utilized to gauge treatment response in vulvar conditions and to compare disease burden of various vulvar dermatoses.^7,8 Moving forward, integrating this tool into clinical studies on vulvar skin disease holds promise for enhancing our understanding and management of these conditions.

Vulvovaginal Lichen Planus

Vulvovaginal lichen planus is unique among several prevalent vulvar inflammatory skin disorders encountered by dermatologists—primarily due to its erosive form, which can extend to the vagina, resulting in noninfectious vaginitis and potential vaginal stenosis.^9,10 Managing VLP poses a notable challenge, even when it is confined to the vulva, as it often proves resistant to topical therapies.¹¹

Evaluation for Vaginal Mucosal Disease—In contrast to LS, which typically spares the vaginal mucosa, VLP can involve mucosal sites.^9,12,13 Therefore, it is imperative that all patients with a diagnosis of vulvar VLP undergo evaluation for potential vaginal involvement through speculum examination, wet mount, or vaginal biopsy. Strategies to manage vaginal involvement include use of dilators and pelvic floor physical therapy, lysis of adhesions (if present), topical estrogen, and intravaginal corticosteroids—all tailored to the severity of the disease.^9,11,14

Management of VLP—Approximately 20% to 40% of patients with VLP may require systemic therapy for disease management, including those who are younger, those of non-White ethnicity, and those presenting with vulvar pruritus.¹¹ Various systemic immunosuppressants have been used for VLP, with a recent retrospective study revealing similar response rates for both methotrexate and mycophenolate mofetil in the treatment of VLP.¹⁵ Another retrospective study found hydroxychloroquine to be safe and effective for VLP but noted a slow onset of action, with approximately 70% responding at 9 months following initiation of therapy.¹⁶

Recent attention has shifted to use of targeted therapies for VLP. For instance, apremilast has shown efficacy in a single-center, nonrandomized, open-label pilot study.¹⁷ Tildrakizumab, an IL-23 inhibitor, demonstrated efficacy in a case series involving 24 patients with VLP.¹⁸ Moreover, recent case reports and series have highlighted the potential of oral Janus kinase (JAK) ­inhibitors, such as tofacitinib, in VLP treatment.¹⁹ Clinical trials are ongoing to evaluate the safety and efficacy of topical ruxolitinib and deucravacitinib (a tyrosine kinase 2 inhibitor) in VLP.^20-22 Systemic therapies for VLP currently are used off label, emphasizing the need for future randomized controlled trials to ascertain the optimal therapies for patients affected by erosive and nonerosive forms of this disease.

Plasma Cell Vulvitis

Plasma cell vulvitis is a chronic inflammatory disorder with an unknown etiology that some consider to be a variant of VLP.²³ Others have observed an overlap with desquamative inflammatory vaginitis, categorizing PCV as a hemorrhagic vestibulovaginitis.²⁴ Although its classification as a distinct entity remains under scrutiny, studies indicate a predilection for the nonkeratinized or partially keratinized vulva. A systematic review outlining common clinical findings reported that the most common anatomic sites included the vulvar vestibule, periurethral area, and labia minora.²³ Additionally, reports have emphasized the association between PCV and other inflammatory vulvar skin conditions, including LS.²⁵

Clinical Variants of PCV—A retrospective review proposed 2 clinical phenotypes for PCV: (1) primary non–lichen-associated PCV and (2) secondary lichen-associated PCV, which is linked to LS.²⁶ The primary form is reported to be restricted to the vestibule, and the authors considered this a vulvar counterpart of atrophic vaginitis due to estrogen deficiency (now known as postmenopausal genitourinary syndrome). The secondary phenotype more commonly involved the vestibular and extravestibular epithelium.²⁶

Management of PCV—Recognizing PCV in the context of LS may be important for identifying comorbid conditions and guiding treatment. However, evidence-based guidelines for PCV treatment are lacking. Commonly reported treatment modalities include clobetasol ointment 0.05% and tacrolimus ointment 0.1%.²³ Successful treatment with hydrocortisone suppositories alternating with estradiol vaginal cream was reported in a recent case series.²⁷ Crisaborole also has been reported as a treatment in 1 case of PCV.²⁸ A recent case report found abrocitinib to be effective for the treatment of plasma cell balanitis in the setting of male genital LS,²⁹ but there are limited data on the use of JAK inhibitors for PCV. Further research is necessary to ascertain the incidence, prevalence, clinical subtypes, and optimal management strategies for PCV to effectively treat patients with this condition.

Vulvar LSC

Similar to extragenital LSC, the evaluation of vulvar LSC should prioritize identification of underlying ­etiologies that contribute to the itch-scratch cycle, which may include psoriasis, atopic dermatitis, neurologic conditions, and allergic or irritant contact dermatitis.^30,31 Although treatment strategies may vary based on underlying ­conditions, we will concentrate on updates in managing vulvar LSC and pruritus associated with an atopic ­diathesis or resulting from chronic contact dermatitis, which is prevalent in vulvar skin areas. Finally, we highlight some emerging vulvar allergens for consideration in clinical practice.

Management of Vulvar LSC—The advent of targeted therapies, including biologics and small-molecule inhibitors, for atopic dermatitis and prurigo nodularis in recent years presents potential options for treatment of individuals with vulvar LSC. However, studies on the use of these therapies specifically for vulvar LSC are limited, necessitating thorough discussions with patients. Given the debilitating nature of vulvar pruritus that may be seen in vulvar LSC and the potential inadequacy of topical steroids as monotherapy, systemic therapies may serve as alternative options for patients with refractory disease.³⁰

Dupilumab, a dual inhibitor of IL-4 and IL-13 signaling, has shown rapid and sustained disease improvement in patients with atopic dermatitis, prurigo nodularis, and pruritus.^32,33 Although data on its role in managing vulvar LSC are scarce, a recent case series reported improvement of vulvar pruritus with dupilumab.³⁴ Similarly, tralokinumab, an IL-13 inhibitor approved by the US Food and Drug Administration (FDA) for atopic dermatitis, has shown efficacy in prurigo nodularis³⁵ and may benefit patients with vulvar LSC, though studies on cutaneous outcomes in those with genital involvement specifically are lacking. Oral JAK inhibitors such as upadacitinib and abrocitinib—both FDA approved for atopic dermatitis—have demonstrated efficacy in treating LSC and itch, potentially serving as management options for vulvar LSC in cases resistant to topical steroids or in which steroid atrophy or other steroid adverse effects may preclude continued use of such agents.^36,37 Finally, IL-31 inhibitors such as nemolizumab, which reduced the signs and symptoms of prurigo nodularis in a recent phase 3 clinical trial, may hold utility in addressing vulvar LSC and associated pruritus.³⁸

The topical JAK inhibitor ruxolitinib, which is FDA approved for atopic dermatitis and vitiligo, holds promise for managing LSC on vulvar skin while mitigating the risk for steroid-induced atrophy.³⁹ Additionally, nonsteroidal topicals including roflumilast cream 0.3% and tapinarof cream 1%, both FDA approved for psoriasis, are being evaluated in studies for their safety and efficacy in atopic dermatitis.^40,41 These agents may have the potential to improve signs and symptoms of vulvar LSC, but further studies are necessary.

Vulvar Allergens and LSC—When assessing patients with vulvar LSC, it is crucial to recognize that allergic contact dermatitis is a common primary vulvar dermatosis but can coexist with other vulvar dermatoses such as LS.^13,30 The vulvar skin’s susceptibly to allergic contact dermatitis is attributed to factors such as a higher ratio of antigen-presenting cells in the vulvar skin, the nonkeratinized nature of certain sites, and frequent contact with potential allergens.^42,43 Therefore, incorporating patch testing into the diagnostic process should be considered when evaluating patients with vulvar skin conditions.⁴³

A systemic review identified multiple vulvar allergens, including metals, topical medicaments, fragrances, preservatives, cosmetic constituents, and rubber components that led to contact dermatitis.⁴⁴ Moreover, a recent analysis of topical preparations recommended by women with LS on social media found a high prevalence of known vulvar allergens in these agents, including botanical extracts/spices.⁴⁵ Personal-care wipes marketed for vulvar care and hygiene are known to contain a variety of allergens, with a recent study finding numerous allergens in commercially available wipes including fragrances, scented botanicals in the form of essences, oils, fruit juices, and vitamin E.⁴⁶ These findings underscore the importance of considering potential allergens when caring for patients with vulvar LSC and counseling patients about the potential allergens in many commercially available products that may be recommended on social media sites or by other sources.

Final Thoughts

Vulvar inflammatory dermatoses are becoming increasingly recognized, and there is a need to develop more effective diagnostic and treatment approaches. Recent literature has shed light on some of the challenges in the management of VLP, particularly its resistance to topical therapies and the importance of assessing and managing both cutaneous and vaginal involvement. Efforts have been made to refine the classification of PCV, with studies suggesting a variant that coexists with LS. Although evidence for vulvar-specific treatment of LSC is limited, the emergence of biologics and small-molecule inhibitors that are FDA approved for atopic dermatitis and prurigo nodularis offer promise for certain cases of vulvar LSC and vulvar pruritus. Moreover, recent developments in steroid-sparing topical agents warrant further investigation for their potential efficacy in treating vulvar LSC and possibly other vulvar inflammatory conditions in the future.

Vulvar dermatoses continue to be an overlooked aspect of medical care, highlighting the necessity for enhanced diagnosis and management of these conditions. Here, we address recent advancements in understanding vulvar inflammatory dermatoses other than lichen sclerosus (LS), which was discussed in a prior Guest Editorial¹—specifically vulvovaginal lichen planus (VLP), plasma cell vulvitis (PCV), and vulvar lichen simplex chronicus (LSC).

Vulvar Inflammatory Skin Disease and Quality of Life

There is an increased awareness of the impact vulvar skin disease has on quality of life and its association with anxiety and depression.^2-5 Evaluating the burden of vulvar dermatoses remains an active area of research due to its significance in monitoring disease progression and assessing therapeutic effectiveness. Despite the existence of various dermatology quality-of-life assessment tools, many fail to adequately capture the unique impacts of vulvovaginal diseases, such as sexual or urinary dysfunction. The vulvar quality of life index, which was developed and validated by Saunderson et al⁶ in 2020, consists of a 15-item questionnaire spanning 4 domains: symptoms, anxiety, activities of daily living, and sexuality. This tool has been utilized to gauge treatment response in vulvar conditions and to compare disease burden of various vulvar dermatoses.^7,8 Moving forward, integrating this tool into clinical studies on vulvar skin disease holds promise for enhancing our understanding and management of these conditions.

Vulvovaginal Lichen Planus

Vulvovaginal lichen planus is unique among several prevalent vulvar inflammatory skin disorders encountered by dermatologists—primarily due to its erosive form, which can extend to the vagina, resulting in noninfectious vaginitis and potential vaginal stenosis.^9,10 Managing VLP poses a notable challenge, even when it is confined to the vulva, as it often proves resistant to topical therapies.¹¹

Evaluation for Vaginal Mucosal Disease—In contrast to LS, which typically spares the vaginal mucosa, VLP can involve mucosal sites.^9,12,13 Therefore, it is imperative that all patients with a diagnosis of vulvar VLP undergo evaluation for potential vaginal involvement through speculum examination, wet mount, or vaginal biopsy. Strategies to manage vaginal involvement include use of dilators and pelvic floor physical therapy, lysis of adhesions (if present), topical estrogen, and intravaginal corticosteroids—all tailored to the severity of the disease.^9,11,14

Management of VLP—Approximately 20% to 40% of patients with VLP may require systemic therapy for disease management, including those who are younger, those of non-White ethnicity, and those presenting with vulvar pruritus.¹¹ Various systemic immunosuppressants have been used for VLP, with a recent retrospective study revealing similar response rates for both methotrexate and mycophenolate mofetil in the treatment of VLP.¹⁵ Another retrospective study found hydroxychloroquine to be safe and effective for VLP but noted a slow onset of action, with approximately 70% responding at 9 months following initiation of therapy.¹⁶

Recent attention has shifted to use of targeted therapies for VLP. For instance, apremilast has shown efficacy in a single-center, nonrandomized, open-label pilot study.¹⁷ Tildrakizumab, an IL-23 inhibitor, demonstrated efficacy in a case series involving 24 patients with VLP.¹⁸ Moreover, recent case reports and series have highlighted the potential of oral Janus kinase (JAK) ­inhibitors, such as tofacitinib, in VLP treatment.¹⁹ Clinical trials are ongoing to evaluate the safety and efficacy of topical ruxolitinib and deucravacitinib (a tyrosine kinase 2 inhibitor) in VLP.^20-22 Systemic therapies for VLP currently are used off label, emphasizing the need for future randomized controlled trials to ascertain the optimal therapies for patients affected by erosive and nonerosive forms of this disease.

Plasma Cell Vulvitis

Plasma cell vulvitis is a chronic inflammatory disorder with an unknown etiology that some consider to be a variant of VLP.²³ Others have observed an overlap with desquamative inflammatory vaginitis, categorizing PCV as a hemorrhagic vestibulovaginitis.²⁴ Although its classification as a distinct entity remains under scrutiny, studies indicate a predilection for the nonkeratinized or partially keratinized vulva. A systematic review outlining common clinical findings reported that the most common anatomic sites included the vulvar vestibule, periurethral area, and labia minora.²³ Additionally, reports have emphasized the association between PCV and other inflammatory vulvar skin conditions, including LS.²⁵

Clinical Variants of PCV—A retrospective review proposed 2 clinical phenotypes for PCV: (1) primary non–lichen-associated PCV and (2) secondary lichen-associated PCV, which is linked to LS.²⁶ The primary form is reported to be restricted to the vestibule, and the authors considered this a vulvar counterpart of atrophic vaginitis due to estrogen deficiency (now known as postmenopausal genitourinary syndrome). The secondary phenotype more commonly involved the vestibular and extravestibular epithelium.²⁶

Management of PCV—Recognizing PCV in the context of LS may be important for identifying comorbid conditions and guiding treatment. However, evidence-based guidelines for PCV treatment are lacking. Commonly reported treatment modalities include clobetasol ointment 0.05% and tacrolimus ointment 0.1%.²³ Successful treatment with hydrocortisone suppositories alternating with estradiol vaginal cream was reported in a recent case series.²⁷ Crisaborole also has been reported as a treatment in 1 case of PCV.²⁸ A recent case report found abrocitinib to be effective for the treatment of plasma cell balanitis in the setting of male genital LS,²⁹ but there are limited data on the use of JAK inhibitors for PCV. Further research is necessary to ascertain the incidence, prevalence, clinical subtypes, and optimal management strategies for PCV to effectively treat patients with this condition.

Vulvar LSC

Similar to extragenital LSC, the evaluation of vulvar LSC should prioritize identification of underlying ­etiologies that contribute to the itch-scratch cycle, which may include psoriasis, atopic dermatitis, neurologic conditions, and allergic or irritant contact dermatitis.^30,31 Although treatment strategies may vary based on underlying ­conditions, we will concentrate on updates in managing vulvar LSC and pruritus associated with an atopic ­diathesis or resulting from chronic contact dermatitis, which is prevalent in vulvar skin areas. Finally, we highlight some emerging vulvar allergens for consideration in clinical practice.

Management of Vulvar LSC—The advent of targeted therapies, including biologics and small-molecule inhibitors, for atopic dermatitis and prurigo nodularis in recent years presents potential options for treatment of individuals with vulvar LSC. However, studies on the use of these therapies specifically for vulvar LSC are limited, necessitating thorough discussions with patients. Given the debilitating nature of vulvar pruritus that may be seen in vulvar LSC and the potential inadequacy of topical steroids as monotherapy, systemic therapies may serve as alternative options for patients with refractory disease.³⁰

Dupilumab, a dual inhibitor of IL-4 and IL-13 signaling, has shown rapid and sustained disease improvement in patients with atopic dermatitis, prurigo nodularis, and pruritus.^32,33 Although data on its role in managing vulvar LSC are scarce, a recent case series reported improvement of vulvar pruritus with dupilumab.³⁴ Similarly, tralokinumab, an IL-13 inhibitor approved by the US Food and Drug Administration (FDA) for atopic dermatitis, has shown efficacy in prurigo nodularis³⁵ and may benefit patients with vulvar LSC, though studies on cutaneous outcomes in those with genital involvement specifically are lacking. Oral JAK inhibitors such as upadacitinib and abrocitinib—both FDA approved for atopic dermatitis—have demonstrated efficacy in treating LSC and itch, potentially serving as management options for vulvar LSC in cases resistant to topical steroids or in which steroid atrophy or other steroid adverse effects may preclude continued use of such agents.^36,37 Finally, IL-31 inhibitors such as nemolizumab, which reduced the signs and symptoms of prurigo nodularis in a recent phase 3 clinical trial, may hold utility in addressing vulvar LSC and associated pruritus.³⁸

The topical JAK inhibitor ruxolitinib, which is FDA approved for atopic dermatitis and vitiligo, holds promise for managing LSC on vulvar skin while mitigating the risk for steroid-induced atrophy.³⁹ Additionally, nonsteroidal topicals including roflumilast cream 0.3% and tapinarof cream 1%, both FDA approved for psoriasis, are being evaluated in studies for their safety and efficacy in atopic dermatitis.^40,41 These agents may have the potential to improve signs and symptoms of vulvar LSC, but further studies are necessary.

Vulvar Allergens and LSC—When assessing patients with vulvar LSC, it is crucial to recognize that allergic contact dermatitis is a common primary vulvar dermatosis but can coexist with other vulvar dermatoses such as LS.^13,30 The vulvar skin’s susceptibly to allergic contact dermatitis is attributed to factors such as a higher ratio of antigen-presenting cells in the vulvar skin, the nonkeratinized nature of certain sites, and frequent contact with potential allergens.^42,43 Therefore, incorporating patch testing into the diagnostic process should be considered when evaluating patients with vulvar skin conditions.⁴³

A systemic review identified multiple vulvar allergens, including metals, topical medicaments, fragrances, preservatives, cosmetic constituents, and rubber components that led to contact dermatitis.⁴⁴ Moreover, a recent analysis of topical preparations recommended by women with LS on social media found a high prevalence of known vulvar allergens in these agents, including botanical extracts/spices.⁴⁵ Personal-care wipes marketed for vulvar care and hygiene are known to contain a variety of allergens, with a recent study finding numerous allergens in commercially available wipes including fragrances, scented botanicals in the form of essences, oils, fruit juices, and vitamin E.⁴⁶ These findings underscore the importance of considering potential allergens when caring for patients with vulvar LSC and counseling patients about the potential allergens in many commercially available products that may be recommended on social media sites or by other sources.

Final Thoughts

Vulvar inflammatory dermatoses are becoming increasingly recognized, and there is a need to develop more effective diagnostic and treatment approaches. Recent literature has shed light on some of the challenges in the management of VLP, particularly its resistance to topical therapies and the importance of assessing and managing both cutaneous and vaginal involvement. Efforts have been made to refine the classification of PCV, with studies suggesting a variant that coexists with LS. Although evidence for vulvar-specific treatment of LSC is limited, the emergence of biologics and small-molecule inhibitors that are FDA approved for atopic dermatitis and prurigo nodularis offer promise for certain cases of vulvar LSC and vulvar pruritus. Moreover, recent developments in steroid-sparing topical agents warrant further investigation for their potential efficacy in treating vulvar LSC and possibly other vulvar inflammatory conditions in the future.

The new American Heart Association Predicting Risk of cardiovascular disease EVENTs (PREVENT) equation outperforms the standard pooled cohort equation (PCE). But there is a problem. A big one, actually. 

The new score incorporates kidney function and social situation, and it eliminates race from the estimate. It was derived from larger, more modern datasets and can be applied to younger adults. 

Two luminaries in preventive cardiology recently called the PREVENT calculator a “substantial improvement over the PCE in terms of accuracy and precision of risk estimates over the entire population and within demographic subgroups.”
 

Now to the Problem of PREVENT vs PCE

A recent study comparing PREVENT and PCE found that the PREVENT equation would assign lower 10-year risks to millions of US adults. 

The authors estimated that the more accurate calculator would result in an estimated 14 million adults no longer reaching the statin eligibility risk threshold of 7.5% over 10 years. Nearly 3 million adults would also not reach the threshold for blood pressure therapy. 

Because statins and blood pressure drugs reduce cardiac events, the authors further estimated that more than 100,000 excess myocardial infarctions (MIs) would occur if the PREVENT equation was used along with the current risk thresholds for statin eligibility.

The change in eligibility induced by PREVENT would affect more men than women and a greater proportion of Black adults than White adults. 
 

The Tension of Arbitrary Thresholds

Modern cardiac therapeutics are amazing, but it’s still better to prevent an event than to treat it. 

Statin drugs reduce cardiac risk by about 20%-25% at all absolute risks. American experts chose a 10-year risk of 7.5% as the threshold where statin benefit exceed risk. The USPSTF chose 10%. But the thresholds are arbitrary and derived only by opinion. 

If your frame is population health, the more patients who take statins, the fewer cardiac events there will be. Anything that reduces statin use increases cardiac events. 

The tension occurs because a more accurate equation decreases the number of people who meet eligibility for primary prevention therapy and therefore increases the number of cardiac events. 

I write from the perspective of both a clinician and a possible patient. As a clinician, patients often ask me whether they should take a statin. (Sadly, most have not had a risk-based discussion with their clinician. But that is another column.) 

The incidence of MI or stroke in a population has no effect on either of these scenarios. I see three broad categories of patients: minimizers, maximizers, and those in between. 

I am a minimizer. I don’t worry much about heart disease. First, I won’t ignore symptoms, and I know that we have great treatments. Second, my wife, Staci, practiced hospice and palliative care medicine, and this taught me that worrying about one specific disease is folly. In the next decade, I, like anyone my age, could have many other bad things happen: cancer, trauma, infection, etc. Given these competing risks for serious disease, a PREVENT-calculated risk of 4% or a PCE-calculated risk of 8% makes no difference. I don’t like pills, and, with risks in this range, I decline statin drugs. 

Then there are the maximizers. This person wants to avoid heart disease. Maybe they have family or friends who had terrible cardiac events. This person will maximize everything to avoid heart disease. The calculated 10-year risk makes little difference to a maximizer. Whether it is 4% or 8% matters not. They will take a statin or blood pressure drugs to reduce risk to as low as possible. 

There are people between minimizers and maximizers. I am not sure that there are that many truly undecided people, but I challenge you to translate a difference of a few percent over a decade to them. I feel comfortable with numbers but struggle to sort out these small absolute differences over such a long time frame. 
 

Other Issues With Risk-Based Decisions 

Venk Murthy, MD, PhD, from the University of Michigan, wrote on X about two other issues with a risk-based decision. One is that it does not consider life-years lost. If a 50-year-old person has a fatal MI, that counts as one event. But in life-years lost, that one event is much worse than a fatal MI in a 79-year-old. Cardiac prevention, therefore, may have a greater effect in lower-risk younger people. 

Another point Dr. Murthy made is that risk and benefit are driven by many different preferences and rare events. Minimizers and maximizers come to the decision with widely disparate preferences. Risk-based decisions treat patients as if they were automatons who make decisions based simply on calculated probabilities. Clinicians know how untrue that is. 
 

Conclusion

If you carry forward the logic of being disturbed by the estimate of more MIs using the PREVENT score, then you could justify putting statins in the water — because that would reduce population estimates of MIs. 

I am not disturbed by the PREVENT score. Clinicians treat individuals, not populations. Individuals want a more accurate score. They don’t need expert-based thresholds. Clinician and patient can discuss the evidence and come up with an agreeable decision, one that is concordant with a person’s goals. The next patient may have a different decision despite seeing the same evidence. 

The tension created by this comparative study exposes the gap between population health and basic clinical care. I don’t think clinicians need to worry about populations. 
 

Dr. Mandrola, a clinical electrophysiologist at Baptist Medical Associates, Louisville, Kentucky, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

The new American Heart Association Predicting Risk of cardiovascular disease EVENTs (PREVENT) equation outperforms the standard pooled cohort equation (PCE). But there is a problem. A big one, actually. 

The new score incorporates kidney function and social situation, and it eliminates race from the estimate. It was derived from larger, more modern datasets and can be applied to younger adults. 

Two luminaries in preventive cardiology recently called the PREVENT calculator a “substantial improvement over the PCE in terms of accuracy and precision of risk estimates over the entire population and within demographic subgroups.”
 

Now to the Problem of PREVENT vs PCE

A recent study comparing PREVENT and PCE found that the PREVENT equation would assign lower 10-year risks to millions of US adults. 

The authors estimated that the more accurate calculator would result in an estimated 14 million adults no longer reaching the statin eligibility risk threshold of 7.5% over 10 years. Nearly 3 million adults would also not reach the threshold for blood pressure therapy. 

Because statins and blood pressure drugs reduce cardiac events, the authors further estimated that more than 100,000 excess myocardial infarctions (MIs) would occur if the PREVENT equation was used along with the current risk thresholds for statin eligibility.

The change in eligibility induced by PREVENT would affect more men than women and a greater proportion of Black adults than White adults. 
 

The Tension of Arbitrary Thresholds

Modern cardiac therapeutics are amazing, but it’s still better to prevent an event than to treat it. 

Statin drugs reduce cardiac risk by about 20%-25% at all absolute risks. American experts chose a 10-year risk of 7.5% as the threshold where statin benefit exceed risk. The USPSTF chose 10%. But the thresholds are arbitrary and derived only by opinion. 

If your frame is population health, the more patients who take statins, the fewer cardiac events there will be. Anything that reduces statin use increases cardiac events. 

The tension occurs because a more accurate equation decreases the number of people who meet eligibility for primary prevention therapy and therefore increases the number of cardiac events. 

I write from the perspective of both a clinician and a possible patient. As a clinician, patients often ask me whether they should take a statin. (Sadly, most have not had a risk-based discussion with their clinician. But that is another column.) 

The incidence of MI or stroke in a population has no effect on either of these scenarios. I see three broad categories of patients: minimizers, maximizers, and those in between. 

I am a minimizer. I don’t worry much about heart disease. First, I won’t ignore symptoms, and I know that we have great treatments. Second, my wife, Staci, practiced hospice and palliative care medicine, and this taught me that worrying about one specific disease is folly. In the next decade, I, like anyone my age, could have many other bad things happen: cancer, trauma, infection, etc. Given these competing risks for serious disease, a PREVENT-calculated risk of 4% or a PCE-calculated risk of 8% makes no difference. I don’t like pills, and, with risks in this range, I decline statin drugs. 

Then there are the maximizers. This person wants to avoid heart disease. Maybe they have family or friends who had terrible cardiac events. This person will maximize everything to avoid heart disease. The calculated 10-year risk makes little difference to a maximizer. Whether it is 4% or 8% matters not. They will take a statin or blood pressure drugs to reduce risk to as low as possible. 

There are people between minimizers and maximizers. I am not sure that there are that many truly undecided people, but I challenge you to translate a difference of a few percent over a decade to them. I feel comfortable with numbers but struggle to sort out these small absolute differences over such a long time frame. 
 

Other Issues With Risk-Based Decisions 

Venk Murthy, MD, PhD, from the University of Michigan, wrote on X about two other issues with a risk-based decision. One is that it does not consider life-years lost. If a 50-year-old person has a fatal MI, that counts as one event. But in life-years lost, that one event is much worse than a fatal MI in a 79-year-old. Cardiac prevention, therefore, may have a greater effect in lower-risk younger people. 

Another point Dr. Murthy made is that risk and benefit are driven by many different preferences and rare events. Minimizers and maximizers come to the decision with widely disparate preferences. Risk-based decisions treat patients as if they were automatons who make decisions based simply on calculated probabilities. Clinicians know how untrue that is. 
 

Conclusion

If you carry forward the logic of being disturbed by the estimate of more MIs using the PREVENT score, then you could justify putting statins in the water — because that would reduce population estimates of MIs. 

I am not disturbed by the PREVENT score. Clinicians treat individuals, not populations. Individuals want a more accurate score. They don’t need expert-based thresholds. Clinician and patient can discuss the evidence and come up with an agreeable decision, one that is concordant with a person’s goals. The next patient may have a different decision despite seeing the same evidence. 

The tension created by this comparative study exposes the gap between population health and basic clinical care. I don’t think clinicians need to worry about populations. 
 

Dr. Mandrola, a clinical electrophysiologist at Baptist Medical Associates, Louisville, Kentucky, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

The new American Heart Association Predicting Risk of cardiovascular disease EVENTs (PREVENT) equation outperforms the standard pooled cohort equation (PCE). But there is a problem. A big one, actually. 

The new score incorporates kidney function and social situation, and it eliminates race from the estimate. It was derived from larger, more modern datasets and can be applied to younger adults. 

Two luminaries in preventive cardiology recently called the PREVENT calculator a “substantial improvement over the PCE in terms of accuracy and precision of risk estimates over the entire population and within demographic subgroups.”
 

Now to the Problem of PREVENT vs PCE

A recent study comparing PREVENT and PCE found that the PREVENT equation would assign lower 10-year risks to millions of US adults. 

The authors estimated that the more accurate calculator would result in an estimated 14 million adults no longer reaching the statin eligibility risk threshold of 7.5% over 10 years. Nearly 3 million adults would also not reach the threshold for blood pressure therapy. 

Because statins and blood pressure drugs reduce cardiac events, the authors further estimated that more than 100,000 excess myocardial infarctions (MIs) would occur if the PREVENT equation was used along with the current risk thresholds for statin eligibility.

The change in eligibility induced by PREVENT would affect more men than women and a greater proportion of Black adults than White adults. 
 

The Tension of Arbitrary Thresholds

Modern cardiac therapeutics are amazing, but it’s still better to prevent an event than to treat it. 

Statin drugs reduce cardiac risk by about 20%-25% at all absolute risks. American experts chose a 10-year risk of 7.5% as the threshold where statin benefit exceed risk. The USPSTF chose 10%. But the thresholds are arbitrary and derived only by opinion. 

If your frame is population health, the more patients who take statins, the fewer cardiac events there will be. Anything that reduces statin use increases cardiac events. 

The tension occurs because a more accurate equation decreases the number of people who meet eligibility for primary prevention therapy and therefore increases the number of cardiac events. 

I write from the perspective of both a clinician and a possible patient. As a clinician, patients often ask me whether they should take a statin. (Sadly, most have not had a risk-based discussion with their clinician. But that is another column.) 

The incidence of MI or stroke in a population has no effect on either of these scenarios. I see three broad categories of patients: minimizers, maximizers, and those in between. 

I am a minimizer. I don’t worry much about heart disease. First, I won’t ignore symptoms, and I know that we have great treatments. Second, my wife, Staci, practiced hospice and palliative care medicine, and this taught me that worrying about one specific disease is folly. In the next decade, I, like anyone my age, could have many other bad things happen: cancer, trauma, infection, etc. Given these competing risks for serious disease, a PREVENT-calculated risk of 4% or a PCE-calculated risk of 8% makes no difference. I don’t like pills, and, with risks in this range, I decline statin drugs. 

Then there are the maximizers. This person wants to avoid heart disease. Maybe they have family or friends who had terrible cardiac events. This person will maximize everything to avoid heart disease. The calculated 10-year risk makes little difference to a maximizer. Whether it is 4% or 8% matters not. They will take a statin or blood pressure drugs to reduce risk to as low as possible. 

There are people between minimizers and maximizers. I am not sure that there are that many truly undecided people, but I challenge you to translate a difference of a few percent over a decade to them. I feel comfortable with numbers but struggle to sort out these small absolute differences over such a long time frame. 
 

Other Issues With Risk-Based Decisions 

Venk Murthy, MD, PhD, from the University of Michigan, wrote on X about two other issues with a risk-based decision. One is that it does not consider life-years lost. If a 50-year-old person has a fatal MI, that counts as one event. But in life-years lost, that one event is much worse than a fatal MI in a 79-year-old. Cardiac prevention, therefore, may have a greater effect in lower-risk younger people. 

Another point Dr. Murthy made is that risk and benefit are driven by many different preferences and rare events. Minimizers and maximizers come to the decision with widely disparate preferences. Risk-based decisions treat patients as if they were automatons who make decisions based simply on calculated probabilities. Clinicians know how untrue that is. 
 

Conclusion

If you carry forward the logic of being disturbed by the estimate of more MIs using the PREVENT score, then you could justify putting statins in the water — because that would reduce population estimates of MIs. 

I am not disturbed by the PREVENT score. Clinicians treat individuals, not populations. Individuals want a more accurate score. They don’t need expert-based thresholds. Clinician and patient can discuss the evidence and come up with an agreeable decision, one that is concordant with a person’s goals. The next patient may have a different decision despite seeing the same evidence. 

The tension created by this comparative study exposes the gap between population health and basic clinical care. I don’t think clinicians need to worry about populations. 
 

Dr. Mandrola, a clinical electrophysiologist at Baptist Medical Associates, Louisville, Kentucky, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.