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Kimchi: Not Magically Protective Against Weight Gain
How much of societal diet-related scientific illiteracy can be blamed on the publication decisions of medical journals around food studies?
That was the question I pondered when reading “Association between kimchi consumption and obesity based on BMI and abdominal obesity in Korean adults: a cross-sectional analysis of the Health Examinees study,” recently published in BMJ Open. Although I will get to the study particulars momentarily, that it’s 2024 and journals are still publishing cross-sectional studies of the impact of a single food’s subjectively reported consumption on health outcomes is mind boggling.
You might wonder why I wasn’t mind boggled by the authors rather than the journal — but the authors’ interest in publishing a study on kimchi’s supposed impact on obesity is an easy thing to explain, in that the study was funded by the World Institute of Kimchi, where two of its four authors are employed.
You might also wonder why I wasn’t mind boggled by media running with this story — but the media’s job is to capture eyeballs, and who doesn’t love a good magic food story, doubly so for one involving obesity and one with a study backing it up?
Back to this World Institute of Kimchi project looking at kimchi intake on obesity rates. No doubt if I worked for the World Institute of Kimchi, I would want kimchi to be shown to be somehow magically protective against weight gain. So how might I go about exploring that?
Well, I could look to the data from the Health Examinees (HEXA) Study. The HEXA study was a cross-sectional look at South Koreans; included in their data collection was a 106-item food frequency questionnaire (FFQ).
That questionnaire looked at 106 food items — yep, you guessed it, explicitly including kimchi. Not included in this FFQ, though, were prepared foods, meaning that it was unable to measure seasonings, spices, or cooking oils. Also perhaps problematic is that no doubt most of us consume more than 106 total food items in our diets. Perhaps this is why the validation study of HEXA’s food item–based FFQ found that it had “relatively low validity” when compared against 12-day food diaries and why its creators themselves report it to be in their study’s conclusion only “reasonably acceptable” to apply to a population. But yes, kimchi!
So for the sake of this exercise, though, let’s assume that instead of only a reasonably acceptable FFQ with low validity, the FFQ was fantastic and its data robust. How great then is kimchi at preventing obesity? Certainly, the media report it’s pretty darn good. Here’s a smattering from the literal dozens of headlines of stories covering this paper:
Eating kimchi every day could help stave off weight gain, new study says — NBC News
Eating kimchi every day may prevent weight gain, research suggests — Sky News
Want to avoid piling on the pounds? Try kimchi for breakfast — The Telegraph
But when we turn to the paper itself, suddenly things aren’t so clear.
According to the paper, men who reported eating two to three servings of kimchi per day were found to have lower rates of obesity, whereas men who reported eating three to five servings of kimchi per day were not. But these are overlapping groups! Also found was that men consuming more than five servings of kimchi per day have higher rates of obesity. When taken together, these findings do not demonstrate a statistically significant trend of kimchi intake on obesity in men. Whereas in women, things are worse in that the more kimchi reportedly consumed, the more obesity, in a trend that did (just) reach statistical significance.
So even if we pretend the FFQs were robust enough to make conclusions about a single food’s impact on obesity, and we pretend there was a well-described, plausible mechanistic reason to believe same (there isn’t), and we pretend that this particular FFQ had better than “relatively low validity,” there is no conclusion here to be drawn about kimchi’s impact on obesity.
What we can conclude is that when it comes to publishing papers purporting to find the impact of single foods on obesity, journals will still happily publish them and their publication will lead to hyperbolic headlines and stories, which in turn reinforce the scientifically illiterate notion that the highly complex multifactorial problem of obesity boils down to simple food choices, which in turn keeps weight loss grifters everywhere in business while fueling societal weight bias.
Dr. Freedhoff is Associate Professor, Department of Family Medicine, University of Ottawa; Medical Director, Bariatric Medical Institute, Ottawa, Ontario, Canada. He disclosed ties with Bariatric Medical Institute, Constant Health, and Novo Nordisk.
A version of this article appeared on Medscape.com.
How much of societal diet-related scientific illiteracy can be blamed on the publication decisions of medical journals around food studies?
That was the question I pondered when reading “Association between kimchi consumption and obesity based on BMI and abdominal obesity in Korean adults: a cross-sectional analysis of the Health Examinees study,” recently published in BMJ Open. Although I will get to the study particulars momentarily, that it’s 2024 and journals are still publishing cross-sectional studies of the impact of a single food’s subjectively reported consumption on health outcomes is mind boggling.
You might wonder why I wasn’t mind boggled by the authors rather than the journal — but the authors’ interest in publishing a study on kimchi’s supposed impact on obesity is an easy thing to explain, in that the study was funded by the World Institute of Kimchi, where two of its four authors are employed.
You might also wonder why I wasn’t mind boggled by media running with this story — but the media’s job is to capture eyeballs, and who doesn’t love a good magic food story, doubly so for one involving obesity and one with a study backing it up?
Back to this World Institute of Kimchi project looking at kimchi intake on obesity rates. No doubt if I worked for the World Institute of Kimchi, I would want kimchi to be shown to be somehow magically protective against weight gain. So how might I go about exploring that?
Well, I could look to the data from the Health Examinees (HEXA) Study. The HEXA study was a cross-sectional look at South Koreans; included in their data collection was a 106-item food frequency questionnaire (FFQ).
That questionnaire looked at 106 food items — yep, you guessed it, explicitly including kimchi. Not included in this FFQ, though, were prepared foods, meaning that it was unable to measure seasonings, spices, or cooking oils. Also perhaps problematic is that no doubt most of us consume more than 106 total food items in our diets. Perhaps this is why the validation study of HEXA’s food item–based FFQ found that it had “relatively low validity” when compared against 12-day food diaries and why its creators themselves report it to be in their study’s conclusion only “reasonably acceptable” to apply to a population. But yes, kimchi!
So for the sake of this exercise, though, let’s assume that instead of only a reasonably acceptable FFQ with low validity, the FFQ was fantastic and its data robust. How great then is kimchi at preventing obesity? Certainly, the media report it’s pretty darn good. Here’s a smattering from the literal dozens of headlines of stories covering this paper:
Eating kimchi every day could help stave off weight gain, new study says — NBC News
Eating kimchi every day may prevent weight gain, research suggests — Sky News
Want to avoid piling on the pounds? Try kimchi for breakfast — The Telegraph
But when we turn to the paper itself, suddenly things aren’t so clear.
According to the paper, men who reported eating two to three servings of kimchi per day were found to have lower rates of obesity, whereas men who reported eating three to five servings of kimchi per day were not. But these are overlapping groups! Also found was that men consuming more than five servings of kimchi per day have higher rates of obesity. When taken together, these findings do not demonstrate a statistically significant trend of kimchi intake on obesity in men. Whereas in women, things are worse in that the more kimchi reportedly consumed, the more obesity, in a trend that did (just) reach statistical significance.
So even if we pretend the FFQs were robust enough to make conclusions about a single food’s impact on obesity, and we pretend there was a well-described, plausible mechanistic reason to believe same (there isn’t), and we pretend that this particular FFQ had better than “relatively low validity,” there is no conclusion here to be drawn about kimchi’s impact on obesity.
What we can conclude is that when it comes to publishing papers purporting to find the impact of single foods on obesity, journals will still happily publish them and their publication will lead to hyperbolic headlines and stories, which in turn reinforce the scientifically illiterate notion that the highly complex multifactorial problem of obesity boils down to simple food choices, which in turn keeps weight loss grifters everywhere in business while fueling societal weight bias.
Dr. Freedhoff is Associate Professor, Department of Family Medicine, University of Ottawa; Medical Director, Bariatric Medical Institute, Ottawa, Ontario, Canada. He disclosed ties with Bariatric Medical Institute, Constant Health, and Novo Nordisk.
A version of this article appeared on Medscape.com.
How much of societal diet-related scientific illiteracy can be blamed on the publication decisions of medical journals around food studies?
That was the question I pondered when reading “Association between kimchi consumption and obesity based on BMI and abdominal obesity in Korean adults: a cross-sectional analysis of the Health Examinees study,” recently published in BMJ Open. Although I will get to the study particulars momentarily, that it’s 2024 and journals are still publishing cross-sectional studies of the impact of a single food’s subjectively reported consumption on health outcomes is mind boggling.
You might wonder why I wasn’t mind boggled by the authors rather than the journal — but the authors’ interest in publishing a study on kimchi’s supposed impact on obesity is an easy thing to explain, in that the study was funded by the World Institute of Kimchi, where two of its four authors are employed.
You might also wonder why I wasn’t mind boggled by media running with this story — but the media’s job is to capture eyeballs, and who doesn’t love a good magic food story, doubly so for one involving obesity and one with a study backing it up?
Back to this World Institute of Kimchi project looking at kimchi intake on obesity rates. No doubt if I worked for the World Institute of Kimchi, I would want kimchi to be shown to be somehow magically protective against weight gain. So how might I go about exploring that?
Well, I could look to the data from the Health Examinees (HEXA) Study. The HEXA study was a cross-sectional look at South Koreans; included in their data collection was a 106-item food frequency questionnaire (FFQ).
That questionnaire looked at 106 food items — yep, you guessed it, explicitly including kimchi. Not included in this FFQ, though, were prepared foods, meaning that it was unable to measure seasonings, spices, or cooking oils. Also perhaps problematic is that no doubt most of us consume more than 106 total food items in our diets. Perhaps this is why the validation study of HEXA’s food item–based FFQ found that it had “relatively low validity” when compared against 12-day food diaries and why its creators themselves report it to be in their study’s conclusion only “reasonably acceptable” to apply to a population. But yes, kimchi!
So for the sake of this exercise, though, let’s assume that instead of only a reasonably acceptable FFQ with low validity, the FFQ was fantastic and its data robust. How great then is kimchi at preventing obesity? Certainly, the media report it’s pretty darn good. Here’s a smattering from the literal dozens of headlines of stories covering this paper:
Eating kimchi every day could help stave off weight gain, new study says — NBC News
Eating kimchi every day may prevent weight gain, research suggests — Sky News
Want to avoid piling on the pounds? Try kimchi for breakfast — The Telegraph
But when we turn to the paper itself, suddenly things aren’t so clear.
According to the paper, men who reported eating two to three servings of kimchi per day were found to have lower rates of obesity, whereas men who reported eating three to five servings of kimchi per day were not. But these are overlapping groups! Also found was that men consuming more than five servings of kimchi per day have higher rates of obesity. When taken together, these findings do not demonstrate a statistically significant trend of kimchi intake on obesity in men. Whereas in women, things are worse in that the more kimchi reportedly consumed, the more obesity, in a trend that did (just) reach statistical significance.
So even if we pretend the FFQs were robust enough to make conclusions about a single food’s impact on obesity, and we pretend there was a well-described, plausible mechanistic reason to believe same (there isn’t), and we pretend that this particular FFQ had better than “relatively low validity,” there is no conclusion here to be drawn about kimchi’s impact on obesity.
What we can conclude is that when it comes to publishing papers purporting to find the impact of single foods on obesity, journals will still happily publish them and their publication will lead to hyperbolic headlines and stories, which in turn reinforce the scientifically illiterate notion that the highly complex multifactorial problem of obesity boils down to simple food choices, which in turn keeps weight loss grifters everywhere in business while fueling societal weight bias.
Dr. Freedhoff is Associate Professor, Department of Family Medicine, University of Ottawa; Medical Director, Bariatric Medical Institute, Ottawa, Ontario, Canada. He disclosed ties with Bariatric Medical Institute, Constant Health, and Novo Nordisk.
A version of this article appeared on Medscape.com.
Beware the Letter of Intent
I recently received an email from a distraught physician. Several months previously,
He could continue running his office any way he wished, set his own hours and fees, and keep his employees. All his overhead expenses would disappear. His income would remain the same, maybe even increase. He signed it eagerly.When he received the actual sale and employment contracts, none of the details promised in the LOI were included; but he figured that since they were spelled out in the LOI, which both he and the buyer had signed, he was covered. His attorney — a family friend with no experience in medical practice transactions — approved the documents.
The deal seemed too good to be true, and it was. The day after the sale closed, all his employees received termination notices. The group offered to rehire some of them, but at lower salaries and reduced benefits. (Most declined.) The new staffers he received were inadequately trained and unfamiliar with his standard office procedures. Patients complained that fees had increased substantially. His own compensation was contingent on meeting strict billing and performance goals. Malpractice premiums remained his responsibility. His office hours were lengthened to include evenings and Saturday mornings.
When he complained to the group that none of the things promised in the LOI had been delivered, he was informed that the LOI was not legally binding. In fact, the sale and employment contracts both clearly specified that they “replaced any previous written or oral agreements between the parties.”
There are some valuable lessons to be learned here. First, whether you are a young physician seeking a new job with a hospital or large practice, or an older one looking to sell an established practice, retain an attorney experienced in medical transactions early, before you sign anything, binding or not. Second, recognize that any promises made in an LOI must be spelled out in the employment and/or sale contract as well.
You might ask, if the terms in an LOI are not binding, why bother with one at all? For one thing, you want to make sure that you and your potential employer or buyer are on the same page with respect to major terms before you get down to details in the employment agreement and/or the medical practice sale agreement. For another, in most states certain LOI provisions are legally binding. For example, the document will most likely provide that each party is responsible for its own attorneys’ fees and for maintaining confidentiality during the negotiations, and that you will not negotiate with any other parties for some specified period of time. In most cases, such provisions are binding whether you go on to sign a formal contract or not.
When you receive an LOI, go through it carefully and identify areas of concern. The offering party will likely be in a rush to sign you up; but once you sign, you won’t be able to negotiate with anyone else for a while, which weakens your negotiating position. Regardless of what is said about time being “of the essence,” proceed slowly and with caution.
Bear in mind that employers and buyers never begin with their best offer. Unless you have been through this before, it is unlikely that you will know your value as an employee or the value of your practice, or what exactly you are entitled to ask for. Rather than signing something you don’t completely understand, explain to the offering party that you need time to consider and evaluate their offer.
This is the time to hire a competent medical attorney to do some due diligence on the offering party and review their offer, and to educate yourself about practice value and compensation benchmarks in your area. You and your counsel should assemble a list of things that you want changed in the LOI, then present them to the other side. They should be amenable to negotiation. If they are not (as was the case in the example presented earlier), you should reconsider whether you really want to be associated with that particular buyer or employer.
Once you have signed the LOI, experts say speed then works to your advantage. “Time kills all deals,” as one lawyer put it. “The longer it takes to close the transaction, the more that can go wrong.” The prospective employer or buyer could uncover information about you or your practice that decreases their perception of value, or economic conditions might change.
While speed is now important, and most of the core issues should already have been resolved in the LOI, don’t be afraid to ask for everything you want, whether it’s a better sale price, higher compensation, a favorable call schedule, more vacation time, or anything else. You won’t know what you can get if you don’t ask for it.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
I recently received an email from a distraught physician. Several months previously,
He could continue running his office any way he wished, set his own hours and fees, and keep his employees. All his overhead expenses would disappear. His income would remain the same, maybe even increase. He signed it eagerly.When he received the actual sale and employment contracts, none of the details promised in the LOI were included; but he figured that since they were spelled out in the LOI, which both he and the buyer had signed, he was covered. His attorney — a family friend with no experience in medical practice transactions — approved the documents.
The deal seemed too good to be true, and it was. The day after the sale closed, all his employees received termination notices. The group offered to rehire some of them, but at lower salaries and reduced benefits. (Most declined.) The new staffers he received were inadequately trained and unfamiliar with his standard office procedures. Patients complained that fees had increased substantially. His own compensation was contingent on meeting strict billing and performance goals. Malpractice premiums remained his responsibility. His office hours were lengthened to include evenings and Saturday mornings.
When he complained to the group that none of the things promised in the LOI had been delivered, he was informed that the LOI was not legally binding. In fact, the sale and employment contracts both clearly specified that they “replaced any previous written or oral agreements between the parties.”
There are some valuable lessons to be learned here. First, whether you are a young physician seeking a new job with a hospital or large practice, or an older one looking to sell an established practice, retain an attorney experienced in medical transactions early, before you sign anything, binding or not. Second, recognize that any promises made in an LOI must be spelled out in the employment and/or sale contract as well.
You might ask, if the terms in an LOI are not binding, why bother with one at all? For one thing, you want to make sure that you and your potential employer or buyer are on the same page with respect to major terms before you get down to details in the employment agreement and/or the medical practice sale agreement. For another, in most states certain LOI provisions are legally binding. For example, the document will most likely provide that each party is responsible for its own attorneys’ fees and for maintaining confidentiality during the negotiations, and that you will not negotiate with any other parties for some specified period of time. In most cases, such provisions are binding whether you go on to sign a formal contract or not.
When you receive an LOI, go through it carefully and identify areas of concern. The offering party will likely be in a rush to sign you up; but once you sign, you won’t be able to negotiate with anyone else for a while, which weakens your negotiating position. Regardless of what is said about time being “of the essence,” proceed slowly and with caution.
Bear in mind that employers and buyers never begin with their best offer. Unless you have been through this before, it is unlikely that you will know your value as an employee or the value of your practice, or what exactly you are entitled to ask for. Rather than signing something you don’t completely understand, explain to the offering party that you need time to consider and evaluate their offer.
This is the time to hire a competent medical attorney to do some due diligence on the offering party and review their offer, and to educate yourself about practice value and compensation benchmarks in your area. You and your counsel should assemble a list of things that you want changed in the LOI, then present them to the other side. They should be amenable to negotiation. If they are not (as was the case in the example presented earlier), you should reconsider whether you really want to be associated with that particular buyer or employer.
Once you have signed the LOI, experts say speed then works to your advantage. “Time kills all deals,” as one lawyer put it. “The longer it takes to close the transaction, the more that can go wrong.” The prospective employer or buyer could uncover information about you or your practice that decreases their perception of value, or economic conditions might change.
While speed is now important, and most of the core issues should already have been resolved in the LOI, don’t be afraid to ask for everything you want, whether it’s a better sale price, higher compensation, a favorable call schedule, more vacation time, or anything else. You won’t know what you can get if you don’t ask for it.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
I recently received an email from a distraught physician. Several months previously,
He could continue running his office any way he wished, set his own hours and fees, and keep his employees. All his overhead expenses would disappear. His income would remain the same, maybe even increase. He signed it eagerly.When he received the actual sale and employment contracts, none of the details promised in the LOI were included; but he figured that since they were spelled out in the LOI, which both he and the buyer had signed, he was covered. His attorney — a family friend with no experience in medical practice transactions — approved the documents.
The deal seemed too good to be true, and it was. The day after the sale closed, all his employees received termination notices. The group offered to rehire some of them, but at lower salaries and reduced benefits. (Most declined.) The new staffers he received were inadequately trained and unfamiliar with his standard office procedures. Patients complained that fees had increased substantially. His own compensation was contingent on meeting strict billing and performance goals. Malpractice premiums remained his responsibility. His office hours were lengthened to include evenings and Saturday mornings.
When he complained to the group that none of the things promised in the LOI had been delivered, he was informed that the LOI was not legally binding. In fact, the sale and employment contracts both clearly specified that they “replaced any previous written or oral agreements between the parties.”
There are some valuable lessons to be learned here. First, whether you are a young physician seeking a new job with a hospital or large practice, or an older one looking to sell an established practice, retain an attorney experienced in medical transactions early, before you sign anything, binding or not. Second, recognize that any promises made in an LOI must be spelled out in the employment and/or sale contract as well.
You might ask, if the terms in an LOI are not binding, why bother with one at all? For one thing, you want to make sure that you and your potential employer or buyer are on the same page with respect to major terms before you get down to details in the employment agreement and/or the medical practice sale agreement. For another, in most states certain LOI provisions are legally binding. For example, the document will most likely provide that each party is responsible for its own attorneys’ fees and for maintaining confidentiality during the negotiations, and that you will not negotiate with any other parties for some specified period of time. In most cases, such provisions are binding whether you go on to sign a formal contract or not.
When you receive an LOI, go through it carefully and identify areas of concern. The offering party will likely be in a rush to sign you up; but once you sign, you won’t be able to negotiate with anyone else for a while, which weakens your negotiating position. Regardless of what is said about time being “of the essence,” proceed slowly and with caution.
Bear in mind that employers and buyers never begin with their best offer. Unless you have been through this before, it is unlikely that you will know your value as an employee or the value of your practice, or what exactly you are entitled to ask for. Rather than signing something you don’t completely understand, explain to the offering party that you need time to consider and evaluate their offer.
This is the time to hire a competent medical attorney to do some due diligence on the offering party and review their offer, and to educate yourself about practice value and compensation benchmarks in your area. You and your counsel should assemble a list of things that you want changed in the LOI, then present them to the other side. They should be amenable to negotiation. If they are not (as was the case in the example presented earlier), you should reconsider whether you really want to be associated with that particular buyer or employer.
Once you have signed the LOI, experts say speed then works to your advantage. “Time kills all deals,” as one lawyer put it. “The longer it takes to close the transaction, the more that can go wrong.” The prospective employer or buyer could uncover information about you or your practice that decreases their perception of value, or economic conditions might change.
While speed is now important, and most of the core issues should already have been resolved in the LOI, don’t be afraid to ask for everything you want, whether it’s a better sale price, higher compensation, a favorable call schedule, more vacation time, or anything else. You won’t know what you can get if you don’t ask for it.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
Long-Term Follow-Up Emphasizes HPV Vaccination Importance
This transcript has been edited for clarity.
I want to briefly discuss a critically important topic that cannot be overly emphasized. It is the relevance, the importance, the benefits, and the outcome of HPV vaccination.
The paper I’m referring to was published in Pediatrics in October 2023. It’s titled, “Ten-Year Follow-up of 9-Valent Human Papillomavirus Vaccine: Immunogenicity, Effectiveness, and Safety.”
Let me emphasize that we’re talking about a 10-year follow-up. In this particular paper and analysis, 301 boys — I emphasize boys — were included and 971 girls at 40 different sites in 13 countries, who received the 9-valent vaccine, which includes HPV 16, 18, and seven other types.
Most importantly, there was not a single case. Not one. Let me repeat this: There was not a single case of high-grade intraepithelial neoplasia, or worse, or condyloma in either males or females. There was not a single case in over 1000 individuals with a follow-up of more than 10 years.
It is difficult to overstate the magnitude of the benefit associated with HPV vaccination for our children and young adults on their risk of developing highly relevant, life-changing, potentially deadly cancers.
For those of you who are interested in this topic — which should include almost all of you, if not all of you — I encourage you to read this very important follow-up paper, again, demonstrating the simple, overwhelming magnitude of the benefit of HPV vaccination. I thank you for your attention.
Dr. Markman is a professor in the department of medical oncology and therapeutics research, City of Hope, Duarte, California, and president of medicine and science, City of Hope Atlanta, Chicago, and Phoenix. He disclosed ties with GlaxoSmithKline; AstraZeneca.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
I want to briefly discuss a critically important topic that cannot be overly emphasized. It is the relevance, the importance, the benefits, and the outcome of HPV vaccination.
The paper I’m referring to was published in Pediatrics in October 2023. It’s titled, “Ten-Year Follow-up of 9-Valent Human Papillomavirus Vaccine: Immunogenicity, Effectiveness, and Safety.”
Let me emphasize that we’re talking about a 10-year follow-up. In this particular paper and analysis, 301 boys — I emphasize boys — were included and 971 girls at 40 different sites in 13 countries, who received the 9-valent vaccine, which includes HPV 16, 18, and seven other types.
Most importantly, there was not a single case. Not one. Let me repeat this: There was not a single case of high-grade intraepithelial neoplasia, or worse, or condyloma in either males or females. There was not a single case in over 1000 individuals with a follow-up of more than 10 years.
It is difficult to overstate the magnitude of the benefit associated with HPV vaccination for our children and young adults on their risk of developing highly relevant, life-changing, potentially deadly cancers.
For those of you who are interested in this topic — which should include almost all of you, if not all of you — I encourage you to read this very important follow-up paper, again, demonstrating the simple, overwhelming magnitude of the benefit of HPV vaccination. I thank you for your attention.
Dr. Markman is a professor in the department of medical oncology and therapeutics research, City of Hope, Duarte, California, and president of medicine and science, City of Hope Atlanta, Chicago, and Phoenix. He disclosed ties with GlaxoSmithKline; AstraZeneca.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
I want to briefly discuss a critically important topic that cannot be overly emphasized. It is the relevance, the importance, the benefits, and the outcome of HPV vaccination.
The paper I’m referring to was published in Pediatrics in October 2023. It’s titled, “Ten-Year Follow-up of 9-Valent Human Papillomavirus Vaccine: Immunogenicity, Effectiveness, and Safety.”
Let me emphasize that we’re talking about a 10-year follow-up. In this particular paper and analysis, 301 boys — I emphasize boys — were included and 971 girls at 40 different sites in 13 countries, who received the 9-valent vaccine, which includes HPV 16, 18, and seven other types.
Most importantly, there was not a single case. Not one. Let me repeat this: There was not a single case of high-grade intraepithelial neoplasia, or worse, or condyloma in either males or females. There was not a single case in over 1000 individuals with a follow-up of more than 10 years.
It is difficult to overstate the magnitude of the benefit associated with HPV vaccination for our children and young adults on their risk of developing highly relevant, life-changing, potentially deadly cancers.
For those of you who are interested in this topic — which should include almost all of you, if not all of you — I encourage you to read this very important follow-up paper, again, demonstrating the simple, overwhelming magnitude of the benefit of HPV vaccination. I thank you for your attention.
Dr. Markman is a professor in the department of medical oncology and therapeutics research, City of Hope, Duarte, California, and president of medicine and science, City of Hope Atlanta, Chicago, and Phoenix. He disclosed ties with GlaxoSmithKline; AstraZeneca.
A version of this article appeared on Medscape.com.
Healing From Trauma
“You’ll never walk alone.” — Nettie Fowler, Carousel
A few winters ago, a young man and his fiancée were driving on the 91 freeway in southern California during a torrential downpour when their Honda Civic hydroplaned, slamming into the jersey barrier. They were both unhurt. Unsure what to do next, they made the catastrophic decision to exit the vehicle. As the man walked around the back of the car he was nearly hit by a black sedan sliding out of control trying to avoid them. When he came around the car, his fiancé was nowhere to be found. She had been struck at highway speed and lay crushed under the sedan hundreds of feet away.
I know this poor man because he was referred to me. Not as a dermatologist, but as a fellow human healing from trauma. On January 1, 2019, at about 9:30 PM, while we were home together, my beloved wife of 24 years took her own life. Even 5 years on it is difficult to believe that she isn’t proofing this paragraph like she had done for every one of my Derm News columns for years. We had been together since teenagers and had lived a joy-filled life. There isn’t any medical reason to share. But that day I joined the community of those who have carried unbearable heaviness of grief and survived. Sometimes others seek me out for help.
At first, my instinct was to guide them, to give advice, to tell them what to do and where to go. But I’ve learned that people in this dark valley don’t need a guide. They need someone to accompany them. To walk with them for a few minutes on their lonely journey. I recently read David Brooks’s new book, How to Know a Person. I’ve been a fan of his since he joined the New York Times in 2003 and have read almost everything he’s written. I sometimes even imagine how he might approach a column whenever I’m stuck (thank you, David). His The Road to Character book is in my canon of literature for self-growth. This latest book is an interesting digression from that central theme. He argues that our society is in acute need of forming better connections and that an important way we can be moral is to learn, and to practice, how to know each other. He shares an emotional experience of losing a close friend to suicide and writes a poignant explanation of what it means to accompany someone in need. It particularly resonated with me. We are doctors and are wired to find the source of a problem, like quickly rotating through the 4X, 10X, 40X on a microscope. Once identified, we spend most of our time creating and explaining treatments. I see how this makes me a great dermatologist but just an average human.
Brooks tells the story of a woman with a brain tumor who often finds herself on the ground surrounded by well-meaning people trying to help. She explains later that what she really needs in those moments is just for someone to get on the ground and lie with her. To accompany her.
Having crossed the midpoint of life, I see with the benefit of perspective how suffering has afforded me wisdom: I am more sensitive and attuned to others. It also gave me credibility: I know how it feels to walk life’s loneliest journey. I’ve also learned to make myself vulnerable for someone to share their story with me. I won’t be afraid to hear the details. I won’t judge them for weeping too little or for sobbing too much. I don’t answer whys. I won’t say what they should do next. But for a few minutes I can walk beside them as a person who cares.
I do not try to remember the hours and days after Susan’s death, but one moment stands out and makes my eyes well when I think of it. That following day my dear brother flew across the country on the next flight out. I was sitting in a psychiatry waiting room when he came down the hall with his luggage in tow. He hugged me as only a brother could, then looked me in my eyes, which were bloodshot from tears just as his were, and he said, “We’re going to be OK.” And with that he walked with me into the office.
We physicians are blessed to have so many intimate human interactions. This book reminded me that sometimes my most important job is not to be the optimized doctor, but just a good human walking alongside.
I have no conflict of interest and purchased these books.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on X. Write to him at [email protected].
“You’ll never walk alone.” — Nettie Fowler, Carousel
A few winters ago, a young man and his fiancée were driving on the 91 freeway in southern California during a torrential downpour when their Honda Civic hydroplaned, slamming into the jersey barrier. They were both unhurt. Unsure what to do next, they made the catastrophic decision to exit the vehicle. As the man walked around the back of the car he was nearly hit by a black sedan sliding out of control trying to avoid them. When he came around the car, his fiancé was nowhere to be found. She had been struck at highway speed and lay crushed under the sedan hundreds of feet away.
I know this poor man because he was referred to me. Not as a dermatologist, but as a fellow human healing from trauma. On January 1, 2019, at about 9:30 PM, while we were home together, my beloved wife of 24 years took her own life. Even 5 years on it is difficult to believe that she isn’t proofing this paragraph like she had done for every one of my Derm News columns for years. We had been together since teenagers and had lived a joy-filled life. There isn’t any medical reason to share. But that day I joined the community of those who have carried unbearable heaviness of grief and survived. Sometimes others seek me out for help.
At first, my instinct was to guide them, to give advice, to tell them what to do and where to go. But I’ve learned that people in this dark valley don’t need a guide. They need someone to accompany them. To walk with them for a few minutes on their lonely journey. I recently read David Brooks’s new book, How to Know a Person. I’ve been a fan of his since he joined the New York Times in 2003 and have read almost everything he’s written. I sometimes even imagine how he might approach a column whenever I’m stuck (thank you, David). His The Road to Character book is in my canon of literature for self-growth. This latest book is an interesting digression from that central theme. He argues that our society is in acute need of forming better connections and that an important way we can be moral is to learn, and to practice, how to know each other. He shares an emotional experience of losing a close friend to suicide and writes a poignant explanation of what it means to accompany someone in need. It particularly resonated with me. We are doctors and are wired to find the source of a problem, like quickly rotating through the 4X, 10X, 40X on a microscope. Once identified, we spend most of our time creating and explaining treatments. I see how this makes me a great dermatologist but just an average human.
Brooks tells the story of a woman with a brain tumor who often finds herself on the ground surrounded by well-meaning people trying to help. She explains later that what she really needs in those moments is just for someone to get on the ground and lie with her. To accompany her.
Having crossed the midpoint of life, I see with the benefit of perspective how suffering has afforded me wisdom: I am more sensitive and attuned to others. It also gave me credibility: I know how it feels to walk life’s loneliest journey. I’ve also learned to make myself vulnerable for someone to share their story with me. I won’t be afraid to hear the details. I won’t judge them for weeping too little or for sobbing too much. I don’t answer whys. I won’t say what they should do next. But for a few minutes I can walk beside them as a person who cares.
I do not try to remember the hours and days after Susan’s death, but one moment stands out and makes my eyes well when I think of it. That following day my dear brother flew across the country on the next flight out. I was sitting in a psychiatry waiting room when he came down the hall with his luggage in tow. He hugged me as only a brother could, then looked me in my eyes, which were bloodshot from tears just as his were, and he said, “We’re going to be OK.” And with that he walked with me into the office.
We physicians are blessed to have so many intimate human interactions. This book reminded me that sometimes my most important job is not to be the optimized doctor, but just a good human walking alongside.
I have no conflict of interest and purchased these books.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on X. Write to him at [email protected].
“You’ll never walk alone.” — Nettie Fowler, Carousel
A few winters ago, a young man and his fiancée were driving on the 91 freeway in southern California during a torrential downpour when their Honda Civic hydroplaned, slamming into the jersey barrier. They were both unhurt. Unsure what to do next, they made the catastrophic decision to exit the vehicle. As the man walked around the back of the car he was nearly hit by a black sedan sliding out of control trying to avoid them. When he came around the car, his fiancé was nowhere to be found. She had been struck at highway speed and lay crushed under the sedan hundreds of feet away.
I know this poor man because he was referred to me. Not as a dermatologist, but as a fellow human healing from trauma. On January 1, 2019, at about 9:30 PM, while we were home together, my beloved wife of 24 years took her own life. Even 5 years on it is difficult to believe that she isn’t proofing this paragraph like she had done for every one of my Derm News columns for years. We had been together since teenagers and had lived a joy-filled life. There isn’t any medical reason to share. But that day I joined the community of those who have carried unbearable heaviness of grief and survived. Sometimes others seek me out for help.
At first, my instinct was to guide them, to give advice, to tell them what to do and where to go. But I’ve learned that people in this dark valley don’t need a guide. They need someone to accompany them. To walk with them for a few minutes on their lonely journey. I recently read David Brooks’s new book, How to Know a Person. I’ve been a fan of his since he joined the New York Times in 2003 and have read almost everything he’s written. I sometimes even imagine how he might approach a column whenever I’m stuck (thank you, David). His The Road to Character book is in my canon of literature for self-growth. This latest book is an interesting digression from that central theme. He argues that our society is in acute need of forming better connections and that an important way we can be moral is to learn, and to practice, how to know each other. He shares an emotional experience of losing a close friend to suicide and writes a poignant explanation of what it means to accompany someone in need. It particularly resonated with me. We are doctors and are wired to find the source of a problem, like quickly rotating through the 4X, 10X, 40X on a microscope. Once identified, we spend most of our time creating and explaining treatments. I see how this makes me a great dermatologist but just an average human.
Brooks tells the story of a woman with a brain tumor who often finds herself on the ground surrounded by well-meaning people trying to help. She explains later that what she really needs in those moments is just for someone to get on the ground and lie with her. To accompany her.
Having crossed the midpoint of life, I see with the benefit of perspective how suffering has afforded me wisdom: I am more sensitive and attuned to others. It also gave me credibility: I know how it feels to walk life’s loneliest journey. I’ve also learned to make myself vulnerable for someone to share their story with me. I won’t be afraid to hear the details. I won’t judge them for weeping too little or for sobbing too much. I don’t answer whys. I won’t say what they should do next. But for a few minutes I can walk beside them as a person who cares.
I do not try to remember the hours and days after Susan’s death, but one moment stands out and makes my eyes well when I think of it. That following day my dear brother flew across the country on the next flight out. I was sitting in a psychiatry waiting room when he came down the hall with his luggage in tow. He hugged me as only a brother could, then looked me in my eyes, which were bloodshot from tears just as his were, and he said, “We’re going to be OK.” And with that he walked with me into the office.
We physicians are blessed to have so many intimate human interactions. This book reminded me that sometimes my most important job is not to be the optimized doctor, but just a good human walking alongside.
I have no conflict of interest and purchased these books.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on X. Write to him at [email protected].
Bivalent Vaccines Protect Even Children Who’ve Had COVID
This transcript has been edited for clarity.
It was only 3 years ago when we called the pathogen we now refer to as the coronavirus “nCOV-19.” It was, in many ways, more descriptive than what we have today. The little “n” there stood for “novel” — and it was really that little “n” that caused us all the trouble.
You see, coronaviruses themselves were not really new to us. Understudied, perhaps, but with four strains running around the globe at any time giving rise to the common cold, these were viruses our bodies understood.
But Instead of acting like a cold, it acted like nothing we had seen before, at least in our lifetime. The story of the pandemic is very much a bildungsroman of our immune systems — a story of how our immunity grew up.
The difference between the start of 2020 and now, when infections with the coronavirus remain common but not as deadly, can be measured in terms of immune education. Some of our immune systems were educated by infection, some by vaccination, and many by both.
When the first vaccines emerged in December 2020, the opportunity to educate our immune systems was still huge. Though, at the time, an estimated 20 million had been infected in the US and 350,000 had died, there was a large population that remained immunologically naive. I was one of them.
If 2020 into early 2021 was the era of immune education, the postvaccine period was the era of the variant. From one COVID strain to two, to five, to innumerable, our immune memory — trained on a specific version of the virus or its spike protein — became imperfect again. Not naive; these variants were not “novel” in the way COVID-19 was novel, but they were different. And different enough to cause infection.
Following the playbook of another virus that loves to come dressed up in different outfits, the flu virus, we find ourselves in the booster era — a world where yearly doses of a vaccine, ideally matched to the variants circulating when the vaccine is given, are the recommendation if not the norm.
But questions remain about the vaccination program, particularly around who should get it. And two populations with big question marks over their heads are (1) people who have already been infected and (2) kids, because their risk for bad outcomes is so much lower.
This week, we finally have some evidence that can shed light on these questions. The study under the spotlight is this one, appearing in JAMA, which tries to analyze the ability of the bivalent vaccine — that’s the second one to come out, around September 2022 — to protect kids from COVID-19.
Now, right off the bat, this was not a randomized trial. The studies that established the viability of the mRNA vaccine platform were; they happened before the vaccine was authorized. But trials of the bivalent vaccine were mostly limited to proving immune response, not protection from disease.
Nevertheless, with some good observational methods and some statistics, we can try to tease out whether bivalent vaccines in kids worked.
The study combines three prospective cohort studies. The details are in the paper, but what you need to know is that the special sauce of these studies was that the kids were tested for COVID-19 on a weekly basis, whether they had symptoms or not. This is critical because asymptomatic infections can transmit COVID-19.
Let’s do the variables of interest. First and foremost, the bivalent vaccine. Some of these kids got the bivalent vaccine, some didn’t. Other key variables include prior vaccination with the monovalent vaccine. Some had been vaccinated with the monovalent vaccine before, some hadn’t. And, of course, prior infection. Some had been infected before (based on either nasal swabs or blood tests).
Let’s focus first on the primary exposure of interest: getting that bivalent vaccine. Again, this was not randomly assigned; kids who got the bivalent vaccine were different from those who did not. In general, they lived in smaller households, they were more likely to be White, less likely to have had a prior COVID infection, and quite a bit more likely to have at least one chronic condition.
To me, this constellation of factors describes a slightly higher-risk group; it makes sense that they were more likely to get the second vaccine.
Given those factors, what were the rates of COVID infection? After nearly a year of follow-up, around 15% of the kids who hadn’t received the bivalent vaccine got infected compared with 5% of the vaccinated kids. Symptomatic infections represented roughly half of all infections in both groups.
After adjustment for factors that differed between the groups, this difference translated into a vaccine efficacy of about 50% in this population. That’s our first data point. Yes, the bivalent vaccine worked. Not amazingly, of course. But it worked.
What about the kids who had had a prior COVID infection? Somewhat surprisingly, the vaccine was just as effective in this population, despite the fact that their immune systems already had some knowledge of COVID. Ten percent of unvaccinated kids got infected, even though they had been infected before. Just 2.5% of kids who received the bivalent vaccine got infected, suggesting some synergy between prior infection and vaccination.
These data suggest that the bivalent vaccine did reduce the risk for COVID infection in kids. All good. But the piece still missing is how severe these infections were. It doesn’t appear that any of the 426 infections documented in this study resulted in hospitalization or death, fortunately. And no data are presented on the incidence of multisystem inflammatory syndrome of children, though given the rarity, I’d be surprised if any of these kids have this either.
So where are we? Well, it seems that the narrative out there that says “the vaccines don’t work” or “the vaccines don’t work if you’ve already been infected” is probably not true. They do work. This study and others in adults show that. If they work to reduce infections, as this study shows, they will also work to reduce deaths. It’s just that death is fortunately so rare in children that the number needed to vaccinate to prevent one death is very large. In that situation, the decision to vaccinate comes down to the risks associated with vaccination. So far, those risk seem very minimal.
Perhaps falling into a flu-like yearly vaccination schedule is not simply the result of old habits dying hard. Maybe it’s actually not a bad idea.
Dr. F. Perry Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
It was only 3 years ago when we called the pathogen we now refer to as the coronavirus “nCOV-19.” It was, in many ways, more descriptive than what we have today. The little “n” there stood for “novel” — and it was really that little “n” that caused us all the trouble.
You see, coronaviruses themselves were not really new to us. Understudied, perhaps, but with four strains running around the globe at any time giving rise to the common cold, these were viruses our bodies understood.
But Instead of acting like a cold, it acted like nothing we had seen before, at least in our lifetime. The story of the pandemic is very much a bildungsroman of our immune systems — a story of how our immunity grew up.
The difference between the start of 2020 and now, when infections with the coronavirus remain common but not as deadly, can be measured in terms of immune education. Some of our immune systems were educated by infection, some by vaccination, and many by both.
When the first vaccines emerged in December 2020, the opportunity to educate our immune systems was still huge. Though, at the time, an estimated 20 million had been infected in the US and 350,000 had died, there was a large population that remained immunologically naive. I was one of them.
If 2020 into early 2021 was the era of immune education, the postvaccine period was the era of the variant. From one COVID strain to two, to five, to innumerable, our immune memory — trained on a specific version of the virus or its spike protein — became imperfect again. Not naive; these variants were not “novel” in the way COVID-19 was novel, but they were different. And different enough to cause infection.
Following the playbook of another virus that loves to come dressed up in different outfits, the flu virus, we find ourselves in the booster era — a world where yearly doses of a vaccine, ideally matched to the variants circulating when the vaccine is given, are the recommendation if not the norm.
But questions remain about the vaccination program, particularly around who should get it. And two populations with big question marks over their heads are (1) people who have already been infected and (2) kids, because their risk for bad outcomes is so much lower.
This week, we finally have some evidence that can shed light on these questions. The study under the spotlight is this one, appearing in JAMA, which tries to analyze the ability of the bivalent vaccine — that’s the second one to come out, around September 2022 — to protect kids from COVID-19.
Now, right off the bat, this was not a randomized trial. The studies that established the viability of the mRNA vaccine platform were; they happened before the vaccine was authorized. But trials of the bivalent vaccine were mostly limited to proving immune response, not protection from disease.
Nevertheless, with some good observational methods and some statistics, we can try to tease out whether bivalent vaccines in kids worked.
The study combines three prospective cohort studies. The details are in the paper, but what you need to know is that the special sauce of these studies was that the kids were tested for COVID-19 on a weekly basis, whether they had symptoms or not. This is critical because asymptomatic infections can transmit COVID-19.
Let’s do the variables of interest. First and foremost, the bivalent vaccine. Some of these kids got the bivalent vaccine, some didn’t. Other key variables include prior vaccination with the monovalent vaccine. Some had been vaccinated with the monovalent vaccine before, some hadn’t. And, of course, prior infection. Some had been infected before (based on either nasal swabs or blood tests).
Let’s focus first on the primary exposure of interest: getting that bivalent vaccine. Again, this was not randomly assigned; kids who got the bivalent vaccine were different from those who did not. In general, they lived in smaller households, they were more likely to be White, less likely to have had a prior COVID infection, and quite a bit more likely to have at least one chronic condition.
To me, this constellation of factors describes a slightly higher-risk group; it makes sense that they were more likely to get the second vaccine.
Given those factors, what were the rates of COVID infection? After nearly a year of follow-up, around 15% of the kids who hadn’t received the bivalent vaccine got infected compared with 5% of the vaccinated kids. Symptomatic infections represented roughly half of all infections in both groups.
After adjustment for factors that differed between the groups, this difference translated into a vaccine efficacy of about 50% in this population. That’s our first data point. Yes, the bivalent vaccine worked. Not amazingly, of course. But it worked.
What about the kids who had had a prior COVID infection? Somewhat surprisingly, the vaccine was just as effective in this population, despite the fact that their immune systems already had some knowledge of COVID. Ten percent of unvaccinated kids got infected, even though they had been infected before. Just 2.5% of kids who received the bivalent vaccine got infected, suggesting some synergy between prior infection and vaccination.
These data suggest that the bivalent vaccine did reduce the risk for COVID infection in kids. All good. But the piece still missing is how severe these infections were. It doesn’t appear that any of the 426 infections documented in this study resulted in hospitalization or death, fortunately. And no data are presented on the incidence of multisystem inflammatory syndrome of children, though given the rarity, I’d be surprised if any of these kids have this either.
So where are we? Well, it seems that the narrative out there that says “the vaccines don’t work” or “the vaccines don’t work if you’ve already been infected” is probably not true. They do work. This study and others in adults show that. If they work to reduce infections, as this study shows, they will also work to reduce deaths. It’s just that death is fortunately so rare in children that the number needed to vaccinate to prevent one death is very large. In that situation, the decision to vaccinate comes down to the risks associated with vaccination. So far, those risk seem very minimal.
Perhaps falling into a flu-like yearly vaccination schedule is not simply the result of old habits dying hard. Maybe it’s actually not a bad idea.
Dr. F. Perry Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
It was only 3 years ago when we called the pathogen we now refer to as the coronavirus “nCOV-19.” It was, in many ways, more descriptive than what we have today. The little “n” there stood for “novel” — and it was really that little “n” that caused us all the trouble.
You see, coronaviruses themselves were not really new to us. Understudied, perhaps, but with four strains running around the globe at any time giving rise to the common cold, these were viruses our bodies understood.
But Instead of acting like a cold, it acted like nothing we had seen before, at least in our lifetime. The story of the pandemic is very much a bildungsroman of our immune systems — a story of how our immunity grew up.
The difference between the start of 2020 and now, when infections with the coronavirus remain common but not as deadly, can be measured in terms of immune education. Some of our immune systems were educated by infection, some by vaccination, and many by both.
When the first vaccines emerged in December 2020, the opportunity to educate our immune systems was still huge. Though, at the time, an estimated 20 million had been infected in the US and 350,000 had died, there was a large population that remained immunologically naive. I was one of them.
If 2020 into early 2021 was the era of immune education, the postvaccine period was the era of the variant. From one COVID strain to two, to five, to innumerable, our immune memory — trained on a specific version of the virus or its spike protein — became imperfect again. Not naive; these variants were not “novel” in the way COVID-19 was novel, but they were different. And different enough to cause infection.
Following the playbook of another virus that loves to come dressed up in different outfits, the flu virus, we find ourselves in the booster era — a world where yearly doses of a vaccine, ideally matched to the variants circulating when the vaccine is given, are the recommendation if not the norm.
But questions remain about the vaccination program, particularly around who should get it. And two populations with big question marks over their heads are (1) people who have already been infected and (2) kids, because their risk for bad outcomes is so much lower.
This week, we finally have some evidence that can shed light on these questions. The study under the spotlight is this one, appearing in JAMA, which tries to analyze the ability of the bivalent vaccine — that’s the second one to come out, around September 2022 — to protect kids from COVID-19.
Now, right off the bat, this was not a randomized trial. The studies that established the viability of the mRNA vaccine platform were; they happened before the vaccine was authorized. But trials of the bivalent vaccine were mostly limited to proving immune response, not protection from disease.
Nevertheless, with some good observational methods and some statistics, we can try to tease out whether bivalent vaccines in kids worked.
The study combines three prospective cohort studies. The details are in the paper, but what you need to know is that the special sauce of these studies was that the kids were tested for COVID-19 on a weekly basis, whether they had symptoms or not. This is critical because asymptomatic infections can transmit COVID-19.
Let’s do the variables of interest. First and foremost, the bivalent vaccine. Some of these kids got the bivalent vaccine, some didn’t. Other key variables include prior vaccination with the monovalent vaccine. Some had been vaccinated with the monovalent vaccine before, some hadn’t. And, of course, prior infection. Some had been infected before (based on either nasal swabs or blood tests).
Let’s focus first on the primary exposure of interest: getting that bivalent vaccine. Again, this was not randomly assigned; kids who got the bivalent vaccine were different from those who did not. In general, they lived in smaller households, they were more likely to be White, less likely to have had a prior COVID infection, and quite a bit more likely to have at least one chronic condition.
To me, this constellation of factors describes a slightly higher-risk group; it makes sense that they were more likely to get the second vaccine.
Given those factors, what were the rates of COVID infection? After nearly a year of follow-up, around 15% of the kids who hadn’t received the bivalent vaccine got infected compared with 5% of the vaccinated kids. Symptomatic infections represented roughly half of all infections in both groups.
After adjustment for factors that differed between the groups, this difference translated into a vaccine efficacy of about 50% in this population. That’s our first data point. Yes, the bivalent vaccine worked. Not amazingly, of course. But it worked.
What about the kids who had had a prior COVID infection? Somewhat surprisingly, the vaccine was just as effective in this population, despite the fact that their immune systems already had some knowledge of COVID. Ten percent of unvaccinated kids got infected, even though they had been infected before. Just 2.5% of kids who received the bivalent vaccine got infected, suggesting some synergy between prior infection and vaccination.
These data suggest that the bivalent vaccine did reduce the risk for COVID infection in kids. All good. But the piece still missing is how severe these infections were. It doesn’t appear that any of the 426 infections documented in this study resulted in hospitalization or death, fortunately. And no data are presented on the incidence of multisystem inflammatory syndrome of children, though given the rarity, I’d be surprised if any of these kids have this either.
So where are we? Well, it seems that the narrative out there that says “the vaccines don’t work” or “the vaccines don’t work if you’ve already been infected” is probably not true. They do work. This study and others in adults show that. If they work to reduce infections, as this study shows, they will also work to reduce deaths. It’s just that death is fortunately so rare in children that the number needed to vaccinate to prevent one death is very large. In that situation, the decision to vaccinate comes down to the risks associated with vaccination. So far, those risk seem very minimal.
Perhaps falling into a flu-like yearly vaccination schedule is not simply the result of old habits dying hard. Maybe it’s actually not a bad idea.
Dr. F. Perry Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
Hospital Marriage Proposals: The Good, the Bad, the Helipad
Picture your marriage proposal fantasy. Do you see a beautiful beach at sunset? The place where you first met your partner? Maybe a dream vacation — Paris, anyone? And perhaps most popular of all ... the ER?
Why not? For some couples who share medical careers, the hospital is home, and they turn the moment into something just as romantic as any Eiffel Tower backdrop. (And admittedly, sometimes they don’t.)
We spoke with three couples whose medical-themed proposals ended in the word “yes!”
Heaven on the Helipad
When emergency medicine physician Anna Darby, MD, heard a trauma patient was arriving and urgently needed to be intubated, she raced up to the rooftop helipad. As soon as the elevator doors opened, she was met with quite a different scene than expected. There were rose petals ... lots and lots of rose petals.
With her best friends and colleagues lining a red carpet, the roof had been turned into a scene from The Bachelor. Each person gave her a rose. A friend even touched up her makeup and handed over her favorite hoop earrings, transforming her from busy doctor to soon-to-be fiancée. Her boyfriend, cardiologist Merije Chukumerije, MD, stood waiting. You can guess what happened next.
Dr. Chukumerije later wrote in an Instagram post, “We met at this hospital. So, it was only right that I bring her to its highest place as we’ve reached the peak of our union.” The couple actually met in the hospital cafeteria “like all the clichés,” Dr. Darby jokes. For them, the helipad experience was just as Insta-worthy as any braggable, grandiose proposal at a fancy restaurant or on a mountaintop.
“Seeing that scene was totally not what I expected,” Dr. Darby says. “I can’t even describe it. It’s like the second biggest hormonal shift, [second only to] having a baby.” She and Dr. Chukumerije now have two babies of their own, aged 2 months and 2 years old.
Good Morning, Doctor
It was February 2021, the height of the pandemic, and Raaga Vemula, MD, now in her palliative care/hospice care fellowship, was “selected” for a local news interview on COVID-19. Except the interview was really with Good Morning America. And the topic was really a proposal.
Dr. Vemula met Steven Bean, MD, now doing a sleep medicine fellowship, in 2015. “I first saw her, and thought she was one of the prettiest women I’d ever seen. ... We ended up being in the same study group,” he says. “Let’s be honest, I applied to every med school she applied to.”
Six years later, Dr. Bean connected with GMA through The Knot, a wedding planning website and registry. The made-up interview request for Dr. Vemula came from the residency program director, who was in on the surprise. Dr. Vemula’s family also knew what was up when she called with the “news.”
The live broadcast took place at the hospital. Dr. Bean had an earpiece for the producers to give him directions. But “I was so nervous, I walked out immediately,” he says. He ended up standing behind Dr. Vemula. The mistake worked well for viewers though, building anticipation while she answered a COVID-19 question. “We got everybody excited,” says Dr. Bean. “So, when they said ’Raaga, turn around’ it worked out perfectly. She was confused as hell.”
Luckily, Dr. Vemula loves a good surprise. “He knows me very well,” she says.
For her, the proposal was even more meaningful given their background together. “Medicine means so much to both of us and was such a big part of our lives,” she says. “That’s what shaped us to do this. ... I think in our hearts it was meant to be this way.”
Who Says Masks Don’t Work?
Masks conjure up feelings for anyone living through the pandemic, especially medical personnel. But for Rhett Franklin and wife Lauren Gray, they will always symbolize of one of the biggest days of their lives.
Mr. Franklin worked in registration, often following Ms. Gray, an emergency room nurse, around with a wheeled computer station to gather patient information (what’s known as a “creeper,” which isn’t as creepy as it sounds). Eventually, she offered to grab a coffee with him, and when he suggested another coffee, she said it was time for him to buy her a drink.
Mr. Franklin, now a manager of business operations for nursing administration, originally planned to propose to Ms. Gray on a trip to England. But the pandemic prevented their vacation with its potential castle backdrop.
Mr. Franklin often picked up shifts making masks for frontline workers, and an alternate proposal idea started brewing. He schemed to have two very special masks made. “Mine was a black tuxedo that said, ‘Will you marry me?’ and hers resembled a white dress that said, ‘I said yes!’ ” Mr. Franklin says.
But a text almost ruined the surprise. When Mr. Franklin messaged family members about his proposal plan the day before, one relative responded in a group chat that included Ms. Gray. This was when the busy ER came to the rescue — no time to read texts. Family members also started calling Ms. Gray on the hospital’s phoneline as a distraction. Unfazed, Mr. Franklin simply moved up the proposal to that night.
At their favorite dog beach, as the sunset gleamed on the water, Mr. Franklin pulled his mask out and took a knee. He can’t recall what he said behind that mask. “It was kind of one of those blackout moments.” But Ms. Gray remembers for him — “You said ‘Let’s do this.’ ”
Warning Label
Everyone has different tastes. Some healthcare professionals have taken the medical theme further than these couples — maybe too far. A few have even faked life-threatening emergencies, showing up in the ER on a gurney with a made-up peanut allergy reaction or a severe injury and then pulling out a ring.
But who’s to judge? For some, thinking your partner is “dying” and then learning you’ve been tricked might not conjure up the warmest feelings. For others, apparently, it’s a virtual bouquet of roses.
A Few Proposal Pointers
If you’re planning to pop the question, this group says, “go for the medical setting!” But according to them, there are other must-haves to get that “yes” and the lifetime of wedded bliss, of course:
- Make it a hospital-wide morale-booster. “Everyone loves surprises,” Dr. Bean maintains. So, why not bring your colleagues in on the conspiracy? “Involving coworkers will strengthen relationships with their work family by leaving lasting memories for everyone,” he says. “In a busy medical setting, it’s usually unexpected, so it makes it extra special.”
- Have a backup plan. As healthcare professionals, you know that schedules get in the way of everything. So, practice that flexibility you will need as a marriage skill. When Mr. Franklin’s first two engagement locations fell though, he says, it was important to adapt and not panic when things went awry.
- Seize the moment. Think you can’t get engaged during residency? “Planning a proposal during intern year of residency is totally manageable,” Dr. Vemula says. “That way as residency progresses and you have more time, there is more time to focus on the wedding planning.” But she cautions that, “wedding planning during the intern year would be quite difficult.”
A version of this article appeared on Medscape.com.
Picture your marriage proposal fantasy. Do you see a beautiful beach at sunset? The place where you first met your partner? Maybe a dream vacation — Paris, anyone? And perhaps most popular of all ... the ER?
Why not? For some couples who share medical careers, the hospital is home, and they turn the moment into something just as romantic as any Eiffel Tower backdrop. (And admittedly, sometimes they don’t.)
We spoke with three couples whose medical-themed proposals ended in the word “yes!”
Heaven on the Helipad
When emergency medicine physician Anna Darby, MD, heard a trauma patient was arriving and urgently needed to be intubated, she raced up to the rooftop helipad. As soon as the elevator doors opened, she was met with quite a different scene than expected. There were rose petals ... lots and lots of rose petals.
With her best friends and colleagues lining a red carpet, the roof had been turned into a scene from The Bachelor. Each person gave her a rose. A friend even touched up her makeup and handed over her favorite hoop earrings, transforming her from busy doctor to soon-to-be fiancée. Her boyfriend, cardiologist Merije Chukumerije, MD, stood waiting. You can guess what happened next.
Dr. Chukumerije later wrote in an Instagram post, “We met at this hospital. So, it was only right that I bring her to its highest place as we’ve reached the peak of our union.” The couple actually met in the hospital cafeteria “like all the clichés,” Dr. Darby jokes. For them, the helipad experience was just as Insta-worthy as any braggable, grandiose proposal at a fancy restaurant or on a mountaintop.
“Seeing that scene was totally not what I expected,” Dr. Darby says. “I can’t even describe it. It’s like the second biggest hormonal shift, [second only to] having a baby.” She and Dr. Chukumerije now have two babies of their own, aged 2 months and 2 years old.
Good Morning, Doctor
It was February 2021, the height of the pandemic, and Raaga Vemula, MD, now in her palliative care/hospice care fellowship, was “selected” for a local news interview on COVID-19. Except the interview was really with Good Morning America. And the topic was really a proposal.
Dr. Vemula met Steven Bean, MD, now doing a sleep medicine fellowship, in 2015. “I first saw her, and thought she was one of the prettiest women I’d ever seen. ... We ended up being in the same study group,” he says. “Let’s be honest, I applied to every med school she applied to.”
Six years later, Dr. Bean connected with GMA through The Knot, a wedding planning website and registry. The made-up interview request for Dr. Vemula came from the residency program director, who was in on the surprise. Dr. Vemula’s family also knew what was up when she called with the “news.”
The live broadcast took place at the hospital. Dr. Bean had an earpiece for the producers to give him directions. But “I was so nervous, I walked out immediately,” he says. He ended up standing behind Dr. Vemula. The mistake worked well for viewers though, building anticipation while she answered a COVID-19 question. “We got everybody excited,” says Dr. Bean. “So, when they said ’Raaga, turn around’ it worked out perfectly. She was confused as hell.”
Luckily, Dr. Vemula loves a good surprise. “He knows me very well,” she says.
For her, the proposal was even more meaningful given their background together. “Medicine means so much to both of us and was such a big part of our lives,” she says. “That’s what shaped us to do this. ... I think in our hearts it was meant to be this way.”
Who Says Masks Don’t Work?
Masks conjure up feelings for anyone living through the pandemic, especially medical personnel. But for Rhett Franklin and wife Lauren Gray, they will always symbolize of one of the biggest days of their lives.
Mr. Franklin worked in registration, often following Ms. Gray, an emergency room nurse, around with a wheeled computer station to gather patient information (what’s known as a “creeper,” which isn’t as creepy as it sounds). Eventually, she offered to grab a coffee with him, and when he suggested another coffee, she said it was time for him to buy her a drink.
Mr. Franklin, now a manager of business operations for nursing administration, originally planned to propose to Ms. Gray on a trip to England. But the pandemic prevented their vacation with its potential castle backdrop.
Mr. Franklin often picked up shifts making masks for frontline workers, and an alternate proposal idea started brewing. He schemed to have two very special masks made. “Mine was a black tuxedo that said, ‘Will you marry me?’ and hers resembled a white dress that said, ‘I said yes!’ ” Mr. Franklin says.
But a text almost ruined the surprise. When Mr. Franklin messaged family members about his proposal plan the day before, one relative responded in a group chat that included Ms. Gray. This was when the busy ER came to the rescue — no time to read texts. Family members also started calling Ms. Gray on the hospital’s phoneline as a distraction. Unfazed, Mr. Franklin simply moved up the proposal to that night.
At their favorite dog beach, as the sunset gleamed on the water, Mr. Franklin pulled his mask out and took a knee. He can’t recall what he said behind that mask. “It was kind of one of those blackout moments.” But Ms. Gray remembers for him — “You said ‘Let’s do this.’ ”
Warning Label
Everyone has different tastes. Some healthcare professionals have taken the medical theme further than these couples — maybe too far. A few have even faked life-threatening emergencies, showing up in the ER on a gurney with a made-up peanut allergy reaction or a severe injury and then pulling out a ring.
But who’s to judge? For some, thinking your partner is “dying” and then learning you’ve been tricked might not conjure up the warmest feelings. For others, apparently, it’s a virtual bouquet of roses.
A Few Proposal Pointers
If you’re planning to pop the question, this group says, “go for the medical setting!” But according to them, there are other must-haves to get that “yes” and the lifetime of wedded bliss, of course:
- Make it a hospital-wide morale-booster. “Everyone loves surprises,” Dr. Bean maintains. So, why not bring your colleagues in on the conspiracy? “Involving coworkers will strengthen relationships with their work family by leaving lasting memories for everyone,” he says. “In a busy medical setting, it’s usually unexpected, so it makes it extra special.”
- Have a backup plan. As healthcare professionals, you know that schedules get in the way of everything. So, practice that flexibility you will need as a marriage skill. When Mr. Franklin’s first two engagement locations fell though, he says, it was important to adapt and not panic when things went awry.
- Seize the moment. Think you can’t get engaged during residency? “Planning a proposal during intern year of residency is totally manageable,” Dr. Vemula says. “That way as residency progresses and you have more time, there is more time to focus on the wedding planning.” But she cautions that, “wedding planning during the intern year would be quite difficult.”
A version of this article appeared on Medscape.com.
Picture your marriage proposal fantasy. Do you see a beautiful beach at sunset? The place where you first met your partner? Maybe a dream vacation — Paris, anyone? And perhaps most popular of all ... the ER?
Why not? For some couples who share medical careers, the hospital is home, and they turn the moment into something just as romantic as any Eiffel Tower backdrop. (And admittedly, sometimes they don’t.)
We spoke with three couples whose medical-themed proposals ended in the word “yes!”
Heaven on the Helipad
When emergency medicine physician Anna Darby, MD, heard a trauma patient was arriving and urgently needed to be intubated, she raced up to the rooftop helipad. As soon as the elevator doors opened, she was met with quite a different scene than expected. There were rose petals ... lots and lots of rose petals.
With her best friends and colleagues lining a red carpet, the roof had been turned into a scene from The Bachelor. Each person gave her a rose. A friend even touched up her makeup and handed over her favorite hoop earrings, transforming her from busy doctor to soon-to-be fiancée. Her boyfriend, cardiologist Merije Chukumerije, MD, stood waiting. You can guess what happened next.
Dr. Chukumerije later wrote in an Instagram post, “We met at this hospital. So, it was only right that I bring her to its highest place as we’ve reached the peak of our union.” The couple actually met in the hospital cafeteria “like all the clichés,” Dr. Darby jokes. For them, the helipad experience was just as Insta-worthy as any braggable, grandiose proposal at a fancy restaurant or on a mountaintop.
“Seeing that scene was totally not what I expected,” Dr. Darby says. “I can’t even describe it. It’s like the second biggest hormonal shift, [second only to] having a baby.” She and Dr. Chukumerije now have two babies of their own, aged 2 months and 2 years old.
Good Morning, Doctor
It was February 2021, the height of the pandemic, and Raaga Vemula, MD, now in her palliative care/hospice care fellowship, was “selected” for a local news interview on COVID-19. Except the interview was really with Good Morning America. And the topic was really a proposal.
Dr. Vemula met Steven Bean, MD, now doing a sleep medicine fellowship, in 2015. “I first saw her, and thought she was one of the prettiest women I’d ever seen. ... We ended up being in the same study group,” he says. “Let’s be honest, I applied to every med school she applied to.”
Six years later, Dr. Bean connected with GMA through The Knot, a wedding planning website and registry. The made-up interview request for Dr. Vemula came from the residency program director, who was in on the surprise. Dr. Vemula’s family also knew what was up when she called with the “news.”
The live broadcast took place at the hospital. Dr. Bean had an earpiece for the producers to give him directions. But “I was so nervous, I walked out immediately,” he says. He ended up standing behind Dr. Vemula. The mistake worked well for viewers though, building anticipation while she answered a COVID-19 question. “We got everybody excited,” says Dr. Bean. “So, when they said ’Raaga, turn around’ it worked out perfectly. She was confused as hell.”
Luckily, Dr. Vemula loves a good surprise. “He knows me very well,” she says.
For her, the proposal was even more meaningful given their background together. “Medicine means so much to both of us and was such a big part of our lives,” she says. “That’s what shaped us to do this. ... I think in our hearts it was meant to be this way.”
Who Says Masks Don’t Work?
Masks conjure up feelings for anyone living through the pandemic, especially medical personnel. But for Rhett Franklin and wife Lauren Gray, they will always symbolize of one of the biggest days of their lives.
Mr. Franklin worked in registration, often following Ms. Gray, an emergency room nurse, around with a wheeled computer station to gather patient information (what’s known as a “creeper,” which isn’t as creepy as it sounds). Eventually, she offered to grab a coffee with him, and when he suggested another coffee, she said it was time for him to buy her a drink.
Mr. Franklin, now a manager of business operations for nursing administration, originally planned to propose to Ms. Gray on a trip to England. But the pandemic prevented their vacation with its potential castle backdrop.
Mr. Franklin often picked up shifts making masks for frontline workers, and an alternate proposal idea started brewing. He schemed to have two very special masks made. “Mine was a black tuxedo that said, ‘Will you marry me?’ and hers resembled a white dress that said, ‘I said yes!’ ” Mr. Franklin says.
But a text almost ruined the surprise. When Mr. Franklin messaged family members about his proposal plan the day before, one relative responded in a group chat that included Ms. Gray. This was when the busy ER came to the rescue — no time to read texts. Family members also started calling Ms. Gray on the hospital’s phoneline as a distraction. Unfazed, Mr. Franklin simply moved up the proposal to that night.
At their favorite dog beach, as the sunset gleamed on the water, Mr. Franklin pulled his mask out and took a knee. He can’t recall what he said behind that mask. “It was kind of one of those blackout moments.” But Ms. Gray remembers for him — “You said ‘Let’s do this.’ ”
Warning Label
Everyone has different tastes. Some healthcare professionals have taken the medical theme further than these couples — maybe too far. A few have even faked life-threatening emergencies, showing up in the ER on a gurney with a made-up peanut allergy reaction or a severe injury and then pulling out a ring.
But who’s to judge? For some, thinking your partner is “dying” and then learning you’ve been tricked might not conjure up the warmest feelings. For others, apparently, it’s a virtual bouquet of roses.
A Few Proposal Pointers
If you’re planning to pop the question, this group says, “go for the medical setting!” But according to them, there are other must-haves to get that “yes” and the lifetime of wedded bliss, of course:
- Make it a hospital-wide morale-booster. “Everyone loves surprises,” Dr. Bean maintains. So, why not bring your colleagues in on the conspiracy? “Involving coworkers will strengthen relationships with their work family by leaving lasting memories for everyone,” he says. “In a busy medical setting, it’s usually unexpected, so it makes it extra special.”
- Have a backup plan. As healthcare professionals, you know that schedules get in the way of everything. So, practice that flexibility you will need as a marriage skill. When Mr. Franklin’s first two engagement locations fell though, he says, it was important to adapt and not panic when things went awry.
- Seize the moment. Think you can’t get engaged during residency? “Planning a proposal during intern year of residency is totally manageable,” Dr. Vemula says. “That way as residency progresses and you have more time, there is more time to focus on the wedding planning.” But she cautions that, “wedding planning during the intern year would be quite difficult.”
A version of this article appeared on Medscape.com.
An Ethical Analysis of Treatment of an Active-Duty Service Member With Limited Follow-up
For active-duty service members, dermatologic conditions are among the most common presenting concerns, comprising 15% to 75% of wartime outpatient visits.1 In general, there are unique considerations when caring for active-duty service members, including meeting designated active-duty retention and hierarchical standards.2 We present a hypothetical case: An active-duty military patient presents to a new dermatologist for cosmetic enhancement of facial skin dyspigmentation. The patient will be leaving soon for deployment and will not be able to follow up for 9 months. How should the dermatologist treat a patient who cannot follow up for so long?
The therapeutic modalities offered can be impacted by forthcoming deployments3 that may result in delayed time to administer repeat treatments or follow-up. The patient may have high expectations for a single appointment for a condition that requires prolonged treatment courses. Because there often is no reliable mechanism for patients to obtain refills during deployment, any medications prescribed would need to be provided in advance for the entire deployment duration, which often is 6 to 9 months. Additionally, treatment monitoring or modifications are severely limited, especially in the context of treatment nonresponse or adverse reactions. Considering the unique limitations of this patient population, both military and civilian physicians are faced with a need to maximize beneficence and autonomy while balancing nonmaleficence and justice.
One possible option is to decline to treat until the patient can follow up after returning from deployment. However, denying a request for an active treatable indication for which the patient desires treatment compromises patient autonomy and beneficence. Further, treatment should be provided to patients equitably to maintain justice. Although there may be a role for discussing active monitoring with nonintervention with the patient, denying treatment can negatively impact their physical and mental health and may be harmful. However, the patient should know and fully understand the risks and benefits of nonintervention with limited follow-up, including suboptimal outcomes or adverse events.
Another possibility for the management of this case may be conducting a one-time laser or light-based therapy or a one-time superficial- to medium-depth chemical peel before the patient leaves on deployment. Often, a series of laser- or light-based treatments is required to maximize outcomes for dyspigmentation. Without follow-up and with possible deployment to an environment with high UV exposure, the patient may experience disease exacerbation or other adverse effects. Treatment of those adverse effects may be delayed, as further intervention is not possible during deployment. Lower initial laser settings may be safer but may not be highly effective initially. More rigorous treatment upon return from deployment may be considered. Similar to laser therapies, chemical peels usually require several treatments for optimal outcomes. Without follow-up and with potential deployment to remote environments, there is a risk for adverse events that outweighs the minimal benefit of a single treatment. Therefore, either intervention may violate the principle of nonmaleficence.
A more reasonable approach may be initiating topical therapy and following up via telemedicine evaluation. Topical therapy often is the least-invasive approach and carries a reduced risk for adverse effects. Triple-combination therapy with topical retinoids, hydroquinone, and topical steroids is a common first-line approach.4 Because this approach is patient dependent, therapy can be more easily modulated or halted in the context of undesired results. Additionally, if internet connectivity is available, an asynchronous telemedicine approach could be utilized during deployment to monitor and advise changes as necessary, provided the regulatory framework allows for it.5
Although there is no uniformly correct approach in a scenario of limited patient follow-up, the last solution may be most ethically favorable: to begin therapy with milder and safer therapies (topical) and defer higher-intensity regimens until the patient returns from deployment. This allows some treatment initiation to preserve justice, beneficence, and patient autonomy. Associated virtual follow-up via telemedicine also allows avoidance of nonmaleficence in this context.
- Hwang J, Kakimoto C. Teledermatology in the US military: a historic foundation for current and future applications. Cutis. 2018;101:335;337;345.
- Dodd JG, Grant-Kels JM. Ethical concerns in caring for active duty service members who may be seeking dermatologic care outside the military soon. Int J Womens Dermatol. 2020;6:445-447. doi:10.1016/j.ijwd.2020.07.001
- Burke KR, Larrymore DC, Cho S. Treatment consideration for US military members with skin disease. Cutis. 2019;103:329-332.
- Desai SR. Hyperpigmentation therapy: a review. J Clin Aesthet Dermatol. 2014;7:13-17.
- Hwang JS, Lappan CM, Sperling LC, et al. Utilization of telemedicine in the U.S. military in a deployed setting. Mil Med. 2014;179:1347-1353. doi:10.7205/MILMED-D-14-00115
For active-duty service members, dermatologic conditions are among the most common presenting concerns, comprising 15% to 75% of wartime outpatient visits.1 In general, there are unique considerations when caring for active-duty service members, including meeting designated active-duty retention and hierarchical standards.2 We present a hypothetical case: An active-duty military patient presents to a new dermatologist for cosmetic enhancement of facial skin dyspigmentation. The patient will be leaving soon for deployment and will not be able to follow up for 9 months. How should the dermatologist treat a patient who cannot follow up for so long?
The therapeutic modalities offered can be impacted by forthcoming deployments3 that may result in delayed time to administer repeat treatments or follow-up. The patient may have high expectations for a single appointment for a condition that requires prolonged treatment courses. Because there often is no reliable mechanism for patients to obtain refills during deployment, any medications prescribed would need to be provided in advance for the entire deployment duration, which often is 6 to 9 months. Additionally, treatment monitoring or modifications are severely limited, especially in the context of treatment nonresponse or adverse reactions. Considering the unique limitations of this patient population, both military and civilian physicians are faced with a need to maximize beneficence and autonomy while balancing nonmaleficence and justice.
One possible option is to decline to treat until the patient can follow up after returning from deployment. However, denying a request for an active treatable indication for which the patient desires treatment compromises patient autonomy and beneficence. Further, treatment should be provided to patients equitably to maintain justice. Although there may be a role for discussing active monitoring with nonintervention with the patient, denying treatment can negatively impact their physical and mental health and may be harmful. However, the patient should know and fully understand the risks and benefits of nonintervention with limited follow-up, including suboptimal outcomes or adverse events.
Another possibility for the management of this case may be conducting a one-time laser or light-based therapy or a one-time superficial- to medium-depth chemical peel before the patient leaves on deployment. Often, a series of laser- or light-based treatments is required to maximize outcomes for dyspigmentation. Without follow-up and with possible deployment to an environment with high UV exposure, the patient may experience disease exacerbation or other adverse effects. Treatment of those adverse effects may be delayed, as further intervention is not possible during deployment. Lower initial laser settings may be safer but may not be highly effective initially. More rigorous treatment upon return from deployment may be considered. Similar to laser therapies, chemical peels usually require several treatments for optimal outcomes. Without follow-up and with potential deployment to remote environments, there is a risk for adverse events that outweighs the minimal benefit of a single treatment. Therefore, either intervention may violate the principle of nonmaleficence.
A more reasonable approach may be initiating topical therapy and following up via telemedicine evaluation. Topical therapy often is the least-invasive approach and carries a reduced risk for adverse effects. Triple-combination therapy with topical retinoids, hydroquinone, and topical steroids is a common first-line approach.4 Because this approach is patient dependent, therapy can be more easily modulated or halted in the context of undesired results. Additionally, if internet connectivity is available, an asynchronous telemedicine approach could be utilized during deployment to monitor and advise changes as necessary, provided the regulatory framework allows for it.5
Although there is no uniformly correct approach in a scenario of limited patient follow-up, the last solution may be most ethically favorable: to begin therapy with milder and safer therapies (topical) and defer higher-intensity regimens until the patient returns from deployment. This allows some treatment initiation to preserve justice, beneficence, and patient autonomy. Associated virtual follow-up via telemedicine also allows avoidance of nonmaleficence in this context.
For active-duty service members, dermatologic conditions are among the most common presenting concerns, comprising 15% to 75% of wartime outpatient visits.1 In general, there are unique considerations when caring for active-duty service members, including meeting designated active-duty retention and hierarchical standards.2 We present a hypothetical case: An active-duty military patient presents to a new dermatologist for cosmetic enhancement of facial skin dyspigmentation. The patient will be leaving soon for deployment and will not be able to follow up for 9 months. How should the dermatologist treat a patient who cannot follow up for so long?
The therapeutic modalities offered can be impacted by forthcoming deployments3 that may result in delayed time to administer repeat treatments or follow-up. The patient may have high expectations for a single appointment for a condition that requires prolonged treatment courses. Because there often is no reliable mechanism for patients to obtain refills during deployment, any medications prescribed would need to be provided in advance for the entire deployment duration, which often is 6 to 9 months. Additionally, treatment monitoring or modifications are severely limited, especially in the context of treatment nonresponse or adverse reactions. Considering the unique limitations of this patient population, both military and civilian physicians are faced with a need to maximize beneficence and autonomy while balancing nonmaleficence and justice.
One possible option is to decline to treat until the patient can follow up after returning from deployment. However, denying a request for an active treatable indication for which the patient desires treatment compromises patient autonomy and beneficence. Further, treatment should be provided to patients equitably to maintain justice. Although there may be a role for discussing active monitoring with nonintervention with the patient, denying treatment can negatively impact their physical and mental health and may be harmful. However, the patient should know and fully understand the risks and benefits of nonintervention with limited follow-up, including suboptimal outcomes or adverse events.
Another possibility for the management of this case may be conducting a one-time laser or light-based therapy or a one-time superficial- to medium-depth chemical peel before the patient leaves on deployment. Often, a series of laser- or light-based treatments is required to maximize outcomes for dyspigmentation. Without follow-up and with possible deployment to an environment with high UV exposure, the patient may experience disease exacerbation or other adverse effects. Treatment of those adverse effects may be delayed, as further intervention is not possible during deployment. Lower initial laser settings may be safer but may not be highly effective initially. More rigorous treatment upon return from deployment may be considered. Similar to laser therapies, chemical peels usually require several treatments for optimal outcomes. Without follow-up and with potential deployment to remote environments, there is a risk for adverse events that outweighs the minimal benefit of a single treatment. Therefore, either intervention may violate the principle of nonmaleficence.
A more reasonable approach may be initiating topical therapy and following up via telemedicine evaluation. Topical therapy often is the least-invasive approach and carries a reduced risk for adverse effects. Triple-combination therapy with topical retinoids, hydroquinone, and topical steroids is a common first-line approach.4 Because this approach is patient dependent, therapy can be more easily modulated or halted in the context of undesired results. Additionally, if internet connectivity is available, an asynchronous telemedicine approach could be utilized during deployment to monitor and advise changes as necessary, provided the regulatory framework allows for it.5
Although there is no uniformly correct approach in a scenario of limited patient follow-up, the last solution may be most ethically favorable: to begin therapy with milder and safer therapies (topical) and defer higher-intensity regimens until the patient returns from deployment. This allows some treatment initiation to preserve justice, beneficence, and patient autonomy. Associated virtual follow-up via telemedicine also allows avoidance of nonmaleficence in this context.
- Hwang J, Kakimoto C. Teledermatology in the US military: a historic foundation for current and future applications. Cutis. 2018;101:335;337;345.
- Dodd JG, Grant-Kels JM. Ethical concerns in caring for active duty service members who may be seeking dermatologic care outside the military soon. Int J Womens Dermatol. 2020;6:445-447. doi:10.1016/j.ijwd.2020.07.001
- Burke KR, Larrymore DC, Cho S. Treatment consideration for US military members with skin disease. Cutis. 2019;103:329-332.
- Desai SR. Hyperpigmentation therapy: a review. J Clin Aesthet Dermatol. 2014;7:13-17.
- Hwang JS, Lappan CM, Sperling LC, et al. Utilization of telemedicine in the U.S. military in a deployed setting. Mil Med. 2014;179:1347-1353. doi:10.7205/MILMED-D-14-00115
- Hwang J, Kakimoto C. Teledermatology in the US military: a historic foundation for current and future applications. Cutis. 2018;101:335;337;345.
- Dodd JG, Grant-Kels JM. Ethical concerns in caring for active duty service members who may be seeking dermatologic care outside the military soon. Int J Womens Dermatol. 2020;6:445-447. doi:10.1016/j.ijwd.2020.07.001
- Burke KR, Larrymore DC, Cho S. Treatment consideration for US military members with skin disease. Cutis. 2019;103:329-332.
- Desai SR. Hyperpigmentation therapy: a review. J Clin Aesthet Dermatol. 2014;7:13-17.
- Hwang JS, Lappan CM, Sperling LC, et al. Utilization of telemedicine in the U.S. military in a deployed setting. Mil Med. 2014;179:1347-1353. doi:10.7205/MILMED-D-14-00115
PRACTICE POINTS
- Dermatologic conditions are among the most common concerns reported by active-duty service members.
- The unique considerations of deployments are important for dermatologists to consider in the treatment of skin disease.
A 74-year-old White male presented with a 1-year history of depigmented patches on the hands, arms, and face, as well as white eyelashes and eyebrows
This patient showed no evidence of recurrence in the scar where the melanoma was excised, and had no enlarged lymph nodes on palpation. His complete blood count and liver function tests were normal. A positron emission tomography (PET) scan was ordered by Dr. Nasser that revealed hypermetabolic right paratracheal, right hilar, and subcarinal lymph nodes, highly suspicious for malignant lymph nodes. The patient was referred to oncology for metastatic melanoma treatment and has been doing well on ipilimumab and nivolumab.
Vitiligo is an autoimmune condition characterized by the progressive destruction of melanocytes resulting in hypopigmentation or depigmentation of the skin. Vitiligo has been associated with cutaneous melanoma.
Melanoma, like vitiligo, is considered highly immunogenic, and cytotoxic T lymphocytes (CTLs) can recognize antigens in melanoma. Furthermore, studies have shown a vitiligo-like halo around melanoma tumors, likely caused by T-cell recruitment, and this may lead to tumor destruction, but rarely total clearance. It seems that the CTL infiltrate in both diseases is similar, but regulatory T cells are decreased in vitiligo, whereas they are present in melanomas and may contribute to the immunosuppressive tumor microenvironment found at the margin of these lesions.
Leukoderma is also associated with melanoma immunotherapy which may be described as drug-induced leukoderma. Additionally, the frequency of recognition of melanoma cells by CTLs leading to hypopigmentation appears to be higher in those with metastatic disease. High immune infiltrate with CTLs and interferon-gamma (IFN-gamma) expression by type 1 T helper cells is associated with favorable prognosis. Immunotherapy with checkpoint inhibitors has shown promise in treatment augmentation for melanoma, but not all patients fully respond to therapy. Nonetheless, development of leukoderma with these treatments has been significantly associated with good therapeutic response. Depigmentation of hair and retinal epithelium has also been reported. However, drug-induced leukoderma and vitiligo seem to have clinical and biological differences, including family history of disease and serum chemokine levels. Vaccines are in production to aid in the treatment of melanoma, but researchers must first identify the appropriate antigen(s) to include.
Conversely, vitiligo-like depigmentation has been reported as a harbinger of metastatic melanoma. Patients with previous excision of primary melanoma have presented months or years later with depigmentation and, upon further evaluation, have been diagnosed with metastatic melanoma. The prevalence of depigmentation in melanoma patients is about 3%-6%, and is estimated to be 7-10 times more common in those with melanoma than in the general population. In most cases, hypopigmentation follows the diagnosis of melanoma, with an average of 4.8 years after the initial diagnosis and 1-2 years after lymph node or distant metastases. It is unclear whether hypopigmentation occurs before or after the growth of metastatic lesions, but this clinical finding in a patient with previous melanoma may serve as an important clue to conduct further investigation for metastasis.
This case and the photos were submitted by Lucas Shapiro, BS, of Nova Southeastern University College of Osteopathic Medicine, Fort Lauderdale, Florida, and Natalie Y. Nasser, MD, Kaiser Permanente Riverside Medical Center; Riverside, California. The column was edited by Donna Bilu Martin, MD.
Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Florida More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].
References
Cerci FB et al. Cutis. 2017 Jun;99(6):E1-E2. PMID: 28686764.
Cho EA et al. Ann Dermatol. 2009 May;21(2):178-181.
Failla CM et al. Int J Mol Sci. 2019 Nov 15;20(22):5731.
This patient showed no evidence of recurrence in the scar where the melanoma was excised, and had no enlarged lymph nodes on palpation. His complete blood count and liver function tests were normal. A positron emission tomography (PET) scan was ordered by Dr. Nasser that revealed hypermetabolic right paratracheal, right hilar, and subcarinal lymph nodes, highly suspicious for malignant lymph nodes. The patient was referred to oncology for metastatic melanoma treatment and has been doing well on ipilimumab and nivolumab.
Vitiligo is an autoimmune condition characterized by the progressive destruction of melanocytes resulting in hypopigmentation or depigmentation of the skin. Vitiligo has been associated with cutaneous melanoma.
Melanoma, like vitiligo, is considered highly immunogenic, and cytotoxic T lymphocytes (CTLs) can recognize antigens in melanoma. Furthermore, studies have shown a vitiligo-like halo around melanoma tumors, likely caused by T-cell recruitment, and this may lead to tumor destruction, but rarely total clearance. It seems that the CTL infiltrate in both diseases is similar, but regulatory T cells are decreased in vitiligo, whereas they are present in melanomas and may contribute to the immunosuppressive tumor microenvironment found at the margin of these lesions.
Leukoderma is also associated with melanoma immunotherapy which may be described as drug-induced leukoderma. Additionally, the frequency of recognition of melanoma cells by CTLs leading to hypopigmentation appears to be higher in those with metastatic disease. High immune infiltrate with CTLs and interferon-gamma (IFN-gamma) expression by type 1 T helper cells is associated with favorable prognosis. Immunotherapy with checkpoint inhibitors has shown promise in treatment augmentation for melanoma, but not all patients fully respond to therapy. Nonetheless, development of leukoderma with these treatments has been significantly associated with good therapeutic response. Depigmentation of hair and retinal epithelium has also been reported. However, drug-induced leukoderma and vitiligo seem to have clinical and biological differences, including family history of disease and serum chemokine levels. Vaccines are in production to aid in the treatment of melanoma, but researchers must first identify the appropriate antigen(s) to include.
Conversely, vitiligo-like depigmentation has been reported as a harbinger of metastatic melanoma. Patients with previous excision of primary melanoma have presented months or years later with depigmentation and, upon further evaluation, have been diagnosed with metastatic melanoma. The prevalence of depigmentation in melanoma patients is about 3%-6%, and is estimated to be 7-10 times more common in those with melanoma than in the general population. In most cases, hypopigmentation follows the diagnosis of melanoma, with an average of 4.8 years after the initial diagnosis and 1-2 years after lymph node or distant metastases. It is unclear whether hypopigmentation occurs before or after the growth of metastatic lesions, but this clinical finding in a patient with previous melanoma may serve as an important clue to conduct further investigation for metastasis.
This case and the photos were submitted by Lucas Shapiro, BS, of Nova Southeastern University College of Osteopathic Medicine, Fort Lauderdale, Florida, and Natalie Y. Nasser, MD, Kaiser Permanente Riverside Medical Center; Riverside, California. The column was edited by Donna Bilu Martin, MD.
Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Florida More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].
References
Cerci FB et al. Cutis. 2017 Jun;99(6):E1-E2. PMID: 28686764.
Cho EA et al. Ann Dermatol. 2009 May;21(2):178-181.
Failla CM et al. Int J Mol Sci. 2019 Nov 15;20(22):5731.
This patient showed no evidence of recurrence in the scar where the melanoma was excised, and had no enlarged lymph nodes on palpation. His complete blood count and liver function tests were normal. A positron emission tomography (PET) scan was ordered by Dr. Nasser that revealed hypermetabolic right paratracheal, right hilar, and subcarinal lymph nodes, highly suspicious for malignant lymph nodes. The patient was referred to oncology for metastatic melanoma treatment and has been doing well on ipilimumab and nivolumab.
Vitiligo is an autoimmune condition characterized by the progressive destruction of melanocytes resulting in hypopigmentation or depigmentation of the skin. Vitiligo has been associated with cutaneous melanoma.
Melanoma, like vitiligo, is considered highly immunogenic, and cytotoxic T lymphocytes (CTLs) can recognize antigens in melanoma. Furthermore, studies have shown a vitiligo-like halo around melanoma tumors, likely caused by T-cell recruitment, and this may lead to tumor destruction, but rarely total clearance. It seems that the CTL infiltrate in both diseases is similar, but regulatory T cells are decreased in vitiligo, whereas they are present in melanomas and may contribute to the immunosuppressive tumor microenvironment found at the margin of these lesions.
Leukoderma is also associated with melanoma immunotherapy which may be described as drug-induced leukoderma. Additionally, the frequency of recognition of melanoma cells by CTLs leading to hypopigmentation appears to be higher in those with metastatic disease. High immune infiltrate with CTLs and interferon-gamma (IFN-gamma) expression by type 1 T helper cells is associated with favorable prognosis. Immunotherapy with checkpoint inhibitors has shown promise in treatment augmentation for melanoma, but not all patients fully respond to therapy. Nonetheless, development of leukoderma with these treatments has been significantly associated with good therapeutic response. Depigmentation of hair and retinal epithelium has also been reported. However, drug-induced leukoderma and vitiligo seem to have clinical and biological differences, including family history of disease and serum chemokine levels. Vaccines are in production to aid in the treatment of melanoma, but researchers must first identify the appropriate antigen(s) to include.
Conversely, vitiligo-like depigmentation has been reported as a harbinger of metastatic melanoma. Patients with previous excision of primary melanoma have presented months or years later with depigmentation and, upon further evaluation, have been diagnosed with metastatic melanoma. The prevalence of depigmentation in melanoma patients is about 3%-6%, and is estimated to be 7-10 times more common in those with melanoma than in the general population. In most cases, hypopigmentation follows the diagnosis of melanoma, with an average of 4.8 years after the initial diagnosis and 1-2 years after lymph node or distant metastases. It is unclear whether hypopigmentation occurs before or after the growth of metastatic lesions, but this clinical finding in a patient with previous melanoma may serve as an important clue to conduct further investigation for metastasis.
This case and the photos were submitted by Lucas Shapiro, BS, of Nova Southeastern University College of Osteopathic Medicine, Fort Lauderdale, Florida, and Natalie Y. Nasser, MD, Kaiser Permanente Riverside Medical Center; Riverside, California. The column was edited by Donna Bilu Martin, MD.
Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Florida More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].
References
Cerci FB et al. Cutis. 2017 Jun;99(6):E1-E2. PMID: 28686764.
Cho EA et al. Ann Dermatol. 2009 May;21(2):178-181.
Failla CM et al. Int J Mol Sci. 2019 Nov 15;20(22):5731.
When Babies ‘Stop Breathing,’ Who Needs Admission and a Workup?
Many infants have experienced an episode of apnea, defined as a pause in respiration of 20 seconds or more. Most episodes remain unexplained, and no underlying cause can be found. Historically, these were referred to as “near-miss SIDS,” episodes, but that label suggested that all of these events would have ended in death had someone not intervened. New descriptive terminology was needed.
In the mid-1980s, the term “apparent life-threatening event” (ALTE) was adopted. But that term, too, was an overstatement, because although scary for parents, these brief apnea episodes were not, in most cases, truly life-threatening.
In 2013, authors of a systematic review coined the term “brief resolved unexplained event” (BRUE). This review also addressed the history and physical exam features associated with risk for a subsequent episode. It was felt that hospitalization and testing might be warranted if certain infants could be identified as high risk for recurrence.
What Is Considered a BRUE?
In the current working definition of BRUE, the child must be < 1 year old. The episode must be a sudden, brief, and resolved, with one or more of these characteristics:
- Cyanosis or pallor (but not turning red)
- A change in breathing (absent, decreased, or irregular)
- A change in tone (hypertonia or hypotonia)
- A change in responsiveness.
Furthermore, to qualify as a BRUE, no explanation can be found for the event based on the history and physical examination but before any laboratory testing is done. The definition also excludes children with known potential explanatory diagnoses (such as gastroesophageal reflux or bronchiolitis) and those who are otherwise symptomatically ill at the time of the event.
Decision to Admit and Recurrence Risk
An apnea event in an otherwise healthy infant, regardless of what it’s called, puts providers and parents in a difficult position. Should the infant be hospitalized for further monitoring and potentially more invasive testing to determine the cause of the episode? And what are the chances that the episode will be repeated?
A clinical practice guideline (CPG) for BRUE, widely adopted in 2016, resulted in significant reductions in healthcare utilization. The CPG attempted to identify low-risk infants who could safely be discharged from the emergency department. Although the CPG improved outcomes, experts acknowledged that an underlying problem was not likely to be identified even among infants deemed high risk, and these infants would be hospitalized unnecessarily.
Available data were simply insufficient to support this decision. So, with the goal of identifying factors that could help predict recurrent BRUE risk, a 15-hospital collaborative study was undertaken, followed by the development and validation of a clinical decision rule for predicting the risk for a serious underlying diagnosis or event recurrence among infants presenting with BRUE.
Here’s what we learned from more than 3000 cases of BRUE.
First, it turns out that it’s not easy to determine whether an infant is at low or high risk for recurrence of BRUE. Initially, 91.5% of patients enrolled in the study would have been labeled high risk.
Furthermore, a BRUE recurred in 14.3% of the cohort, and 4.8% of high-risk infants were found to have a serious undiagnosed condition. Seizures, airway anomalies, and gastroesophageal reflux were the top three causes of BRUE, but the spectrum of underlying pathology was quite considerable.
The problem was that 4.6% of the entire cohort were found to have a serious underlying condition, nearly identical to the proportion of high-risk infants with these conditions. This prompted the question of whether simply labeling infants “high risk” was really appropriate any longer.
Revised BRUE Management
Although it hasn’t been possible to group infants neatly in low and high-risk categories, the data from that large cohort led to the development of the BRUE 2.0 criteria, which enabled more focused risk assessment of an infant who experienced a BRUE. With an app on MDCalc, these criteria allow providers to ascertain, and show families, a visual representation of their infant’s individualized risk for a subsequent BRUE and of having a serious underlying condition.
The cohort study also identified red flags from the history or physical exam of infants who experienced a BRUE: weight loss, failure to thrive, or a history of feeding problems. Exam findings such as a bulging fontanelle, forceful or bilious emesis, and evidence of gastrointestinal (GI) bleeding suggest a medical diagnosis rather than a BRUE. If GI-related causes are high on the differential, a feeding evaluation can be helpful. A feeding evaluation can be done in the outpatient setting and does not require hospitalization.
For suspicion of an underlying neurological condition (such as seizures), experts recommend obtaining a short EEG, which is highly sensitive for detecting infantile spasms and encephalopathy. They recommend reserving MRI for infants with abnormalities on EEG or physical exam. Metabolic or genetic testing should be done only if the infant looks ill, because most patients with genetic or inborn errors of metabolism will continue to have symptoms as they become older.
The approach to BRUE has moved into the realm of shared decision-making with families. The likelihood of identifying a serious diagnosis is low for most of these children. And unfortunately, no single test can diagnose the full spectrum of potential explanatory diagnoses. For example, data from 2023 demonstrate that only 1.1% of lab tests following a BRUE contributed to a diagnosis, and most of the time that was a positive viral test. Similarly, imaging was helpful in only 1.5% of cases. So, explaining the evidence and deciding along with parents what is reasonable to do (or not do) is the current state of affairs.
My Take
As I reflect back on two and a half decades of caring for these patients, I believe that recent data have helped us a great deal. We do less testing and admit fewer infants to the hospital than we did 20 years ago, and that’s a good thing. Nevertheless, looking for a few red flags, having a high index of suspicion when the clinical exam is abnormal, and engaging in shared decision-making with families can help make the caring for these challenging patients more bearable and lead to better outcomes for all involved.
Dr. Basco is Professor, Department of Pediatrics, Medical University of South Carolina (MUSC); Director, Division of General Pediatrics, Department of Pediatrics, MUSC Children’s Hospital, Charleston, South Carolina. He has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Many infants have experienced an episode of apnea, defined as a pause in respiration of 20 seconds or more. Most episodes remain unexplained, and no underlying cause can be found. Historically, these were referred to as “near-miss SIDS,” episodes, but that label suggested that all of these events would have ended in death had someone not intervened. New descriptive terminology was needed.
In the mid-1980s, the term “apparent life-threatening event” (ALTE) was adopted. But that term, too, was an overstatement, because although scary for parents, these brief apnea episodes were not, in most cases, truly life-threatening.
In 2013, authors of a systematic review coined the term “brief resolved unexplained event” (BRUE). This review also addressed the history and physical exam features associated with risk for a subsequent episode. It was felt that hospitalization and testing might be warranted if certain infants could be identified as high risk for recurrence.
What Is Considered a BRUE?
In the current working definition of BRUE, the child must be < 1 year old. The episode must be a sudden, brief, and resolved, with one or more of these characteristics:
- Cyanosis or pallor (but not turning red)
- A change in breathing (absent, decreased, or irregular)
- A change in tone (hypertonia or hypotonia)
- A change in responsiveness.
Furthermore, to qualify as a BRUE, no explanation can be found for the event based on the history and physical examination but before any laboratory testing is done. The definition also excludes children with known potential explanatory diagnoses (such as gastroesophageal reflux or bronchiolitis) and those who are otherwise symptomatically ill at the time of the event.
Decision to Admit and Recurrence Risk
An apnea event in an otherwise healthy infant, regardless of what it’s called, puts providers and parents in a difficult position. Should the infant be hospitalized for further monitoring and potentially more invasive testing to determine the cause of the episode? And what are the chances that the episode will be repeated?
A clinical practice guideline (CPG) for BRUE, widely adopted in 2016, resulted in significant reductions in healthcare utilization. The CPG attempted to identify low-risk infants who could safely be discharged from the emergency department. Although the CPG improved outcomes, experts acknowledged that an underlying problem was not likely to be identified even among infants deemed high risk, and these infants would be hospitalized unnecessarily.
Available data were simply insufficient to support this decision. So, with the goal of identifying factors that could help predict recurrent BRUE risk, a 15-hospital collaborative study was undertaken, followed by the development and validation of a clinical decision rule for predicting the risk for a serious underlying diagnosis or event recurrence among infants presenting with BRUE.
Here’s what we learned from more than 3000 cases of BRUE.
First, it turns out that it’s not easy to determine whether an infant is at low or high risk for recurrence of BRUE. Initially, 91.5% of patients enrolled in the study would have been labeled high risk.
Furthermore, a BRUE recurred in 14.3% of the cohort, and 4.8% of high-risk infants were found to have a serious undiagnosed condition. Seizures, airway anomalies, and gastroesophageal reflux were the top three causes of BRUE, but the spectrum of underlying pathology was quite considerable.
The problem was that 4.6% of the entire cohort were found to have a serious underlying condition, nearly identical to the proportion of high-risk infants with these conditions. This prompted the question of whether simply labeling infants “high risk” was really appropriate any longer.
Revised BRUE Management
Although it hasn’t been possible to group infants neatly in low and high-risk categories, the data from that large cohort led to the development of the BRUE 2.0 criteria, which enabled more focused risk assessment of an infant who experienced a BRUE. With an app on MDCalc, these criteria allow providers to ascertain, and show families, a visual representation of their infant’s individualized risk for a subsequent BRUE and of having a serious underlying condition.
The cohort study also identified red flags from the history or physical exam of infants who experienced a BRUE: weight loss, failure to thrive, or a history of feeding problems. Exam findings such as a bulging fontanelle, forceful or bilious emesis, and evidence of gastrointestinal (GI) bleeding suggest a medical diagnosis rather than a BRUE. If GI-related causes are high on the differential, a feeding evaluation can be helpful. A feeding evaluation can be done in the outpatient setting and does not require hospitalization.
For suspicion of an underlying neurological condition (such as seizures), experts recommend obtaining a short EEG, which is highly sensitive for detecting infantile spasms and encephalopathy. They recommend reserving MRI for infants with abnormalities on EEG or physical exam. Metabolic or genetic testing should be done only if the infant looks ill, because most patients with genetic or inborn errors of metabolism will continue to have symptoms as they become older.
The approach to BRUE has moved into the realm of shared decision-making with families. The likelihood of identifying a serious diagnosis is low for most of these children. And unfortunately, no single test can diagnose the full spectrum of potential explanatory diagnoses. For example, data from 2023 demonstrate that only 1.1% of lab tests following a BRUE contributed to a diagnosis, and most of the time that was a positive viral test. Similarly, imaging was helpful in only 1.5% of cases. So, explaining the evidence and deciding along with parents what is reasonable to do (or not do) is the current state of affairs.
My Take
As I reflect back on two and a half decades of caring for these patients, I believe that recent data have helped us a great deal. We do less testing and admit fewer infants to the hospital than we did 20 years ago, and that’s a good thing. Nevertheless, looking for a few red flags, having a high index of suspicion when the clinical exam is abnormal, and engaging in shared decision-making with families can help make the caring for these challenging patients more bearable and lead to better outcomes for all involved.
Dr. Basco is Professor, Department of Pediatrics, Medical University of South Carolina (MUSC); Director, Division of General Pediatrics, Department of Pediatrics, MUSC Children’s Hospital, Charleston, South Carolina. He has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Many infants have experienced an episode of apnea, defined as a pause in respiration of 20 seconds or more. Most episodes remain unexplained, and no underlying cause can be found. Historically, these were referred to as “near-miss SIDS,” episodes, but that label suggested that all of these events would have ended in death had someone not intervened. New descriptive terminology was needed.
In the mid-1980s, the term “apparent life-threatening event” (ALTE) was adopted. But that term, too, was an overstatement, because although scary for parents, these brief apnea episodes were not, in most cases, truly life-threatening.
In 2013, authors of a systematic review coined the term “brief resolved unexplained event” (BRUE). This review also addressed the history and physical exam features associated with risk for a subsequent episode. It was felt that hospitalization and testing might be warranted if certain infants could be identified as high risk for recurrence.
What Is Considered a BRUE?
In the current working definition of BRUE, the child must be < 1 year old. The episode must be a sudden, brief, and resolved, with one or more of these characteristics:
- Cyanosis or pallor (but not turning red)
- A change in breathing (absent, decreased, or irregular)
- A change in tone (hypertonia or hypotonia)
- A change in responsiveness.
Furthermore, to qualify as a BRUE, no explanation can be found for the event based on the history and physical examination but before any laboratory testing is done. The definition also excludes children with known potential explanatory diagnoses (such as gastroesophageal reflux or bronchiolitis) and those who are otherwise symptomatically ill at the time of the event.
Decision to Admit and Recurrence Risk
An apnea event in an otherwise healthy infant, regardless of what it’s called, puts providers and parents in a difficult position. Should the infant be hospitalized for further monitoring and potentially more invasive testing to determine the cause of the episode? And what are the chances that the episode will be repeated?
A clinical practice guideline (CPG) for BRUE, widely adopted in 2016, resulted in significant reductions in healthcare utilization. The CPG attempted to identify low-risk infants who could safely be discharged from the emergency department. Although the CPG improved outcomes, experts acknowledged that an underlying problem was not likely to be identified even among infants deemed high risk, and these infants would be hospitalized unnecessarily.
Available data were simply insufficient to support this decision. So, with the goal of identifying factors that could help predict recurrent BRUE risk, a 15-hospital collaborative study was undertaken, followed by the development and validation of a clinical decision rule for predicting the risk for a serious underlying diagnosis or event recurrence among infants presenting with BRUE.
Here’s what we learned from more than 3000 cases of BRUE.
First, it turns out that it’s not easy to determine whether an infant is at low or high risk for recurrence of BRUE. Initially, 91.5% of patients enrolled in the study would have been labeled high risk.
Furthermore, a BRUE recurred in 14.3% of the cohort, and 4.8% of high-risk infants were found to have a serious undiagnosed condition. Seizures, airway anomalies, and gastroesophageal reflux were the top three causes of BRUE, but the spectrum of underlying pathology was quite considerable.
The problem was that 4.6% of the entire cohort were found to have a serious underlying condition, nearly identical to the proportion of high-risk infants with these conditions. This prompted the question of whether simply labeling infants “high risk” was really appropriate any longer.
Revised BRUE Management
Although it hasn’t been possible to group infants neatly in low and high-risk categories, the data from that large cohort led to the development of the BRUE 2.0 criteria, which enabled more focused risk assessment of an infant who experienced a BRUE. With an app on MDCalc, these criteria allow providers to ascertain, and show families, a visual representation of their infant’s individualized risk for a subsequent BRUE and of having a serious underlying condition.
The cohort study also identified red flags from the history or physical exam of infants who experienced a BRUE: weight loss, failure to thrive, or a history of feeding problems. Exam findings such as a bulging fontanelle, forceful or bilious emesis, and evidence of gastrointestinal (GI) bleeding suggest a medical diagnosis rather than a BRUE. If GI-related causes are high on the differential, a feeding evaluation can be helpful. A feeding evaluation can be done in the outpatient setting and does not require hospitalization.
For suspicion of an underlying neurological condition (such as seizures), experts recommend obtaining a short EEG, which is highly sensitive for detecting infantile spasms and encephalopathy. They recommend reserving MRI for infants with abnormalities on EEG or physical exam. Metabolic or genetic testing should be done only if the infant looks ill, because most patients with genetic or inborn errors of metabolism will continue to have symptoms as they become older.
The approach to BRUE has moved into the realm of shared decision-making with families. The likelihood of identifying a serious diagnosis is low for most of these children. And unfortunately, no single test can diagnose the full spectrum of potential explanatory diagnoses. For example, data from 2023 demonstrate that only 1.1% of lab tests following a BRUE contributed to a diagnosis, and most of the time that was a positive viral test. Similarly, imaging was helpful in only 1.5% of cases. So, explaining the evidence and deciding along with parents what is reasonable to do (or not do) is the current state of affairs.
My Take
As I reflect back on two and a half decades of caring for these patients, I believe that recent data have helped us a great deal. We do less testing and admit fewer infants to the hospital than we did 20 years ago, and that’s a good thing. Nevertheless, looking for a few red flags, having a high index of suspicion when the clinical exam is abnormal, and engaging in shared decision-making with families can help make the caring for these challenging patients more bearable and lead to better outcomes for all involved.
Dr. Basco is Professor, Department of Pediatrics, Medical University of South Carolina (MUSC); Director, Division of General Pediatrics, Department of Pediatrics, MUSC Children’s Hospital, Charleston, South Carolina. He has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
New Guidelines: Brain Death Is Equal to Heart Death, Says Ethicist
This transcript has been edited for clarity.
Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at the New York University Grossman School of Medicine in New York City.
I think we had a breakthrough on a very controversial subject over the past month. Over and over again, debates have been breaking out, cases have been going to court, and fights have been coming to ethics committees about brain death. How do we know what brain death is, how do we diagnose it, and what rights do families have with respect to the diagnosis?
The American Academy of Neurology decided to form a task force, and they just issued guidelines on the definition, tests to use it, and the rights of families. They did a wonderful job, in my view. They›ve achieved clarity.
First, they tried to handle both adults and children. Children are, if you will, more difficult — and that’s been known — to test for brain death. Their brains are smaller. You get more interference and false signals coming from muscle or nerve activity that might be going on elsewhere in their bodies.
The guidelines say we’re going to try to see whether a person can breathe without support. If it’s an adult, one test over a 24-hour period would be sufficient. If you had them off the ventilator and they can’t breathe and show no signs of being able to do that, that’s a very fundamental test for brain death. For children, you’re going to have to do it twice. The guidelines are saying to be cautious.
Second, they say it’s very important to know the cause of the suspected brain death condition. If someone has a massive head injury, that’s different from a situation in which someone overdoses from drugs or drowns. Those conditions can be a little deceptive. In the case of drowning, sometimes the brain has protective mechanisms to protect circulation to the brain naturally for a little bit of time. I’m talking about minutes, not hours.
You want to be careful to make sure that you know the cause of the massive brain injury or insult that makes someone believe that the patient is brain-dead, whether it’s a stroke, an embolism, a bleed, a gunshot wound, or trauma to the head. Those factors really drive the certainty with which brain death should be pronounced. I think that’s very, very important.
They also said that brain death means the permanent loss of brain function. You may get a few cells still firing or you may be in a situation, because the life support is still there, where the body looks pink and perhaps might appear to still be alive to someone. When you know that the damage to the brain is so severe that there’s nothing that can be done to bring back the support of heart function, breathing, and most likely any ability to sense or feel anything, that is death.
I believe it’s very important, when talking to families, to say there are two ways that we pronounce people dead, and they’re equal: One is to say their heart has stopped, their breathing has stopped, and there’s nothing we can do to resuscitate them, which is cardiac death. The other is to say their brain has permanently ceased to function in any kind of integrated way. That means no heartbeat, no breathing, and no mental sensations. That is death.
In approaching families, it is critical that doctors and nurses don’t say, “Your relative is brain-dead.” That gives the family a sense that maybe they’re only “partially dead” or maybe there’s one key organ that has stopped working but maybe you can bring it back. Death is death. The law recognizes both cardiac death and brain death as death.
When you approach a family, if you believe that death has occurred, you say, “I’m very sorry. With regret, I have to tell you, your loved one is dead.” If they ask how you know, you can say, “We’ve determined it through brain death or through cardiac death.” You don’t give them a sense that people could be kind of dead, sort of dead, or nearly dead. Those states are comas or permanent vegetative states; they’re not the same as death.
What if the family says, “I don’t want you to do any testing. I don’t want to find out whether my relative is dead”? The American Academy of Neurology looked at this carefully and said that any test for death can be done without the permission or consent of the family. They said that because doctors need to know what steps to take to treat someone.
If a person is dead, then treatment is going to stop. It may not stop immediately. There may be issues about organ donation. There may be issues about gathering the family to come to the bedside to say goodbye, because many people think that’s more humane than saying goodbye at the morgue or in another setting.
This is all well and good, but patients cannot protect against bad news when it comes to death. We don’t want to be doing things to the dead that cost money or are futile because of death and using resources that might go to others.
We’ve got much more clarity than we have ever had with respect to the issue of brain death and how it works in any hospital. We have certain tests, including being off the ventilator and some other tests, that the guidelines supply. We know we have to be more careful with children. We want to know the etiology of the cause of the brain trauma, the devastating brain injury, to be sure that this is something that really is permanent cessation of integrated brain function.
We know that if you believe the person has died, you don’t need the consent of the family in order to do a brain-death test. You have to do it because there is no point in continuing treatment in expensive ICU settings and denying resources to others who might want to use those resources. The family can’t hold the medical team hostage.
We do know that when we approach someone with the determination, whatever it is, we should lead by saying that the person has died and then explain how that was determined, whether it be by cardiac death pronouncement — where you tried to resuscitate and the heart’s not beating — or brain-death analysis.
I’m Art Caplan at the Division of Medical Ethics at the NYU Grossman School of Medicine. Thanks for watching.
Dr. Caplan has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for: Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position); serves as a contributing author and adviser for this news organization.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at the New York University Grossman School of Medicine in New York City.
I think we had a breakthrough on a very controversial subject over the past month. Over and over again, debates have been breaking out, cases have been going to court, and fights have been coming to ethics committees about brain death. How do we know what brain death is, how do we diagnose it, and what rights do families have with respect to the diagnosis?
The American Academy of Neurology decided to form a task force, and they just issued guidelines on the definition, tests to use it, and the rights of families. They did a wonderful job, in my view. They›ve achieved clarity.
First, they tried to handle both adults and children. Children are, if you will, more difficult — and that’s been known — to test for brain death. Their brains are smaller. You get more interference and false signals coming from muscle or nerve activity that might be going on elsewhere in their bodies.
The guidelines say we’re going to try to see whether a person can breathe without support. If it’s an adult, one test over a 24-hour period would be sufficient. If you had them off the ventilator and they can’t breathe and show no signs of being able to do that, that’s a very fundamental test for brain death. For children, you’re going to have to do it twice. The guidelines are saying to be cautious.
Second, they say it’s very important to know the cause of the suspected brain death condition. If someone has a massive head injury, that’s different from a situation in which someone overdoses from drugs or drowns. Those conditions can be a little deceptive. In the case of drowning, sometimes the brain has protective mechanisms to protect circulation to the brain naturally for a little bit of time. I’m talking about minutes, not hours.
You want to be careful to make sure that you know the cause of the massive brain injury or insult that makes someone believe that the patient is brain-dead, whether it’s a stroke, an embolism, a bleed, a gunshot wound, or trauma to the head. Those factors really drive the certainty with which brain death should be pronounced. I think that’s very, very important.
They also said that brain death means the permanent loss of brain function. You may get a few cells still firing or you may be in a situation, because the life support is still there, where the body looks pink and perhaps might appear to still be alive to someone. When you know that the damage to the brain is so severe that there’s nothing that can be done to bring back the support of heart function, breathing, and most likely any ability to sense or feel anything, that is death.
I believe it’s very important, when talking to families, to say there are two ways that we pronounce people dead, and they’re equal: One is to say their heart has stopped, their breathing has stopped, and there’s nothing we can do to resuscitate them, which is cardiac death. The other is to say their brain has permanently ceased to function in any kind of integrated way. That means no heartbeat, no breathing, and no mental sensations. That is death.
In approaching families, it is critical that doctors and nurses don’t say, “Your relative is brain-dead.” That gives the family a sense that maybe they’re only “partially dead” or maybe there’s one key organ that has stopped working but maybe you can bring it back. Death is death. The law recognizes both cardiac death and brain death as death.
When you approach a family, if you believe that death has occurred, you say, “I’m very sorry. With regret, I have to tell you, your loved one is dead.” If they ask how you know, you can say, “We’ve determined it through brain death or through cardiac death.” You don’t give them a sense that people could be kind of dead, sort of dead, or nearly dead. Those states are comas or permanent vegetative states; they’re not the same as death.
What if the family says, “I don’t want you to do any testing. I don’t want to find out whether my relative is dead”? The American Academy of Neurology looked at this carefully and said that any test for death can be done without the permission or consent of the family. They said that because doctors need to know what steps to take to treat someone.
If a person is dead, then treatment is going to stop. It may not stop immediately. There may be issues about organ donation. There may be issues about gathering the family to come to the bedside to say goodbye, because many people think that’s more humane than saying goodbye at the morgue or in another setting.
This is all well and good, but patients cannot protect against bad news when it comes to death. We don’t want to be doing things to the dead that cost money or are futile because of death and using resources that might go to others.
We’ve got much more clarity than we have ever had with respect to the issue of brain death and how it works in any hospital. We have certain tests, including being off the ventilator and some other tests, that the guidelines supply. We know we have to be more careful with children. We want to know the etiology of the cause of the brain trauma, the devastating brain injury, to be sure that this is something that really is permanent cessation of integrated brain function.
We know that if you believe the person has died, you don’t need the consent of the family in order to do a brain-death test. You have to do it because there is no point in continuing treatment in expensive ICU settings and denying resources to others who might want to use those resources. The family can’t hold the medical team hostage.
We do know that when we approach someone with the determination, whatever it is, we should lead by saying that the person has died and then explain how that was determined, whether it be by cardiac death pronouncement — where you tried to resuscitate and the heart’s not beating — or brain-death analysis.
I’m Art Caplan at the Division of Medical Ethics at the NYU Grossman School of Medicine. Thanks for watching.
Dr. Caplan has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for: Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position); serves as a contributing author and adviser for this news organization.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at the New York University Grossman School of Medicine in New York City.
I think we had a breakthrough on a very controversial subject over the past month. Over and over again, debates have been breaking out, cases have been going to court, and fights have been coming to ethics committees about brain death. How do we know what brain death is, how do we diagnose it, and what rights do families have with respect to the diagnosis?
The American Academy of Neurology decided to form a task force, and they just issued guidelines on the definition, tests to use it, and the rights of families. They did a wonderful job, in my view. They›ve achieved clarity.
First, they tried to handle both adults and children. Children are, if you will, more difficult — and that’s been known — to test for brain death. Their brains are smaller. You get more interference and false signals coming from muscle or nerve activity that might be going on elsewhere in their bodies.
The guidelines say we’re going to try to see whether a person can breathe without support. If it’s an adult, one test over a 24-hour period would be sufficient. If you had them off the ventilator and they can’t breathe and show no signs of being able to do that, that’s a very fundamental test for brain death. For children, you’re going to have to do it twice. The guidelines are saying to be cautious.
Second, they say it’s very important to know the cause of the suspected brain death condition. If someone has a massive head injury, that’s different from a situation in which someone overdoses from drugs or drowns. Those conditions can be a little deceptive. In the case of drowning, sometimes the brain has protective mechanisms to protect circulation to the brain naturally for a little bit of time. I’m talking about minutes, not hours.
You want to be careful to make sure that you know the cause of the massive brain injury or insult that makes someone believe that the patient is brain-dead, whether it’s a stroke, an embolism, a bleed, a gunshot wound, or trauma to the head. Those factors really drive the certainty with which brain death should be pronounced. I think that’s very, very important.
They also said that brain death means the permanent loss of brain function. You may get a few cells still firing or you may be in a situation, because the life support is still there, where the body looks pink and perhaps might appear to still be alive to someone. When you know that the damage to the brain is so severe that there’s nothing that can be done to bring back the support of heart function, breathing, and most likely any ability to sense or feel anything, that is death.
I believe it’s very important, when talking to families, to say there are two ways that we pronounce people dead, and they’re equal: One is to say their heart has stopped, their breathing has stopped, and there’s nothing we can do to resuscitate them, which is cardiac death. The other is to say their brain has permanently ceased to function in any kind of integrated way. That means no heartbeat, no breathing, and no mental sensations. That is death.
In approaching families, it is critical that doctors and nurses don’t say, “Your relative is brain-dead.” That gives the family a sense that maybe they’re only “partially dead” or maybe there’s one key organ that has stopped working but maybe you can bring it back. Death is death. The law recognizes both cardiac death and brain death as death.
When you approach a family, if you believe that death has occurred, you say, “I’m very sorry. With regret, I have to tell you, your loved one is dead.” If they ask how you know, you can say, “We’ve determined it through brain death or through cardiac death.” You don’t give them a sense that people could be kind of dead, sort of dead, or nearly dead. Those states are comas or permanent vegetative states; they’re not the same as death.
What if the family says, “I don’t want you to do any testing. I don’t want to find out whether my relative is dead”? The American Academy of Neurology looked at this carefully and said that any test for death can be done without the permission or consent of the family. They said that because doctors need to know what steps to take to treat someone.
If a person is dead, then treatment is going to stop. It may not stop immediately. There may be issues about organ donation. There may be issues about gathering the family to come to the bedside to say goodbye, because many people think that’s more humane than saying goodbye at the morgue or in another setting.
This is all well and good, but patients cannot protect against bad news when it comes to death. We don’t want to be doing things to the dead that cost money or are futile because of death and using resources that might go to others.
We’ve got much more clarity than we have ever had with respect to the issue of brain death and how it works in any hospital. We have certain tests, including being off the ventilator and some other tests, that the guidelines supply. We know we have to be more careful with children. We want to know the etiology of the cause of the brain trauma, the devastating brain injury, to be sure that this is something that really is permanent cessation of integrated brain function.
We know that if you believe the person has died, you don’t need the consent of the family in order to do a brain-death test. You have to do it because there is no point in continuing treatment in expensive ICU settings and denying resources to others who might want to use those resources. The family can’t hold the medical team hostage.
We do know that when we approach someone with the determination, whatever it is, we should lead by saying that the person has died and then explain how that was determined, whether it be by cardiac death pronouncement — where you tried to resuscitate and the heart’s not beating — or brain-death analysis.
I’m Art Caplan at the Division of Medical Ethics at the NYU Grossman School of Medicine. Thanks for watching.
Dr. Caplan has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for: Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position); serves as a contributing author and adviser for this news organization.
A version of this article appeared on Medscape.com.