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The new normal in body temperature
This transcript has been edited for clarity.
Every branch of science has its constants. Physics has the speed of light, the gravitational constant, the Planck constant. Chemistry gives us Avogadro’s number, Faraday’s constant, the charge of an electron. Medicine isn’t quite as reliable as physics when it comes to these things, but insofar as there are any constants in medicine, might I suggest normal body temperature: 37° Celsius, 98.6° Fahrenheit.
Sure, serum sodium may be less variable and lactate concentration more clinically relevant, but even my 7-year-old knows that normal body temperature is 98.6°.
Except, as it turns out, 98.6° isn’t normal at all.
How did we arrive at 37.0° C for normal body temperature? We got it from this guy – German physician Carl Reinhold August Wunderlich, who, in addition to looking eerily like Luciano Pavarotti, was the first to realize that fever was not itself a disease but a symptom of one.
In 1851, Dr. Wunderlich released his measurements of more than 1 million body temperatures taken from 25,000 Germans – a painstaking process at the time, which employed a foot-long thermometer and took 20 minutes to obtain a measurement.
The average temperature measured, of course, was 37° C.
We’re more than 150 years post-Wunderlich right now, and the average person in the United States might be quite a bit different from the average German in 1850. Moreover, we can do a lot better than just measuring a ton of people and taking the average, because we have statistics. The problem with measuring a bunch of people and taking the average temperature as normal is that you can’t be sure that the people you are measuring are normal. There are obvious causes of elevated temperature that you could exclude. Let’s not take people with a respiratory infection or who are taking Tylenol, for example. But as highlighted in this paper in JAMA Internal Medicine, we can do a lot better than that.
The study leverages the fact that body temperature is typically measured during all medical office visits and recorded in the ever-present electronic medical record.
Researchers from Stanford identified 724,199 patient encounters with outpatient temperature data. They excluded extreme temperatures – less than 34° C or greater than 40° C – excluded patients under 20 or above 80 years, and excluded those with extremes of height, weight, or body mass index.
You end up with a distribution like this. Note that the peak is clearly lower than 37° C.
But we’re still not at “normal.” Some people would be seeing their doctor for conditions that affect body temperature, such as infection. You could use diagnosis codes to flag these individuals and drop them, but that feels a bit arbitrary.
I really love how the researchers used data to fix this problem. They used a technique called LIMIT (Laboratory Information Mining for Individualized Thresholds). It works like this:
Take all the temperature measurements and then identify the outliers – the very tails of the distribution.
Look at all the diagnosis codes in those distributions. Determine which diagnosis codes are overrepresented in those distributions. Now you have a data-driven way to say that yes, these diagnoses are associated with weird temperatures. Next, eliminate everyone with those diagnoses from the dataset. What you are left with is a normal population, or at least a population that doesn’t have a condition that seems to meaningfully affect temperature.
So, who was dropped? Well, a lot of people, actually. It turned out that diabetes was way overrepresented in the outlier group. Although 9.2% of the population had diabetes, 26% of people with very low temperatures did, so everyone with diabetes is removed from the dataset. While 5% of the population had a cough at their encounter, 7% of the people with very high temperature and 7% of the people with very low temperature had a cough, so everyone with cough gets thrown out.
The algorithm excluded people on antibiotics or who had sinusitis, urinary tract infections, pneumonia, and, yes, a diagnosis of “fever.” The list makes sense, which is always nice when you have a purely algorithmic classification system.
What do we have left? What is the real normal temperature? Ready?
It’s 36.64° C, or about 98.0° F.
Of course, normal temperature varied depending on the time of day it was measured – higher in the afternoon.
The normal temperature in women tended to be higher than in men. The normal temperature declined with age as well.
In fact, the researchers built a nice online calculator where you can enter your own, or your patient’s, parameters and calculate a normal body temperature for them. Here’s mine. My normal temperature at around 2 p.m. should be 36.7° C.
So, we’re all more cold-blooded than we thought. Is this just because of better methods? Maybe. But studies have actually shown that body temperature may be decreasing over time in humans, possibly because of the lower levels of inflammation we face in modern life (thanks to improvements in hygiene and antibiotics).
Of course, I’m sure some of you are asking yourselves whether any of this really matters. Is 37° C close enough?
Sure, this may be sort of puttering around the edges of physical diagnosis, but I think the methodology is really interesting and can obviously be applied to other broadly collected data points. But these data show us that thin, older individuals really do run cooler, and that we may need to pay more attention to a low-grade fever in that population than we otherwise would.
In any case, it’s time for a little re-education. If someone asks you what normal body temperature is, just say 36.6° C, 98.0° F. For his work in this area, I suggest we call it Wunderlich’s constant.
Dr. Wilson is associate professor of medicine and public health at Yale University, New Haven, Conn., and director of Yale’s Clinical and Translational Research Accelerator. He has no disclosures.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
Every branch of science has its constants. Physics has the speed of light, the gravitational constant, the Planck constant. Chemistry gives us Avogadro’s number, Faraday’s constant, the charge of an electron. Medicine isn’t quite as reliable as physics when it comes to these things, but insofar as there are any constants in medicine, might I suggest normal body temperature: 37° Celsius, 98.6° Fahrenheit.
Sure, serum sodium may be less variable and lactate concentration more clinically relevant, but even my 7-year-old knows that normal body temperature is 98.6°.
Except, as it turns out, 98.6° isn’t normal at all.
How did we arrive at 37.0° C for normal body temperature? We got it from this guy – German physician Carl Reinhold August Wunderlich, who, in addition to looking eerily like Luciano Pavarotti, was the first to realize that fever was not itself a disease but a symptom of one.
In 1851, Dr. Wunderlich released his measurements of more than 1 million body temperatures taken from 25,000 Germans – a painstaking process at the time, which employed a foot-long thermometer and took 20 minutes to obtain a measurement.
The average temperature measured, of course, was 37° C.
We’re more than 150 years post-Wunderlich right now, and the average person in the United States might be quite a bit different from the average German in 1850. Moreover, we can do a lot better than just measuring a ton of people and taking the average, because we have statistics. The problem with measuring a bunch of people and taking the average temperature as normal is that you can’t be sure that the people you are measuring are normal. There are obvious causes of elevated temperature that you could exclude. Let’s not take people with a respiratory infection or who are taking Tylenol, for example. But as highlighted in this paper in JAMA Internal Medicine, we can do a lot better than that.
The study leverages the fact that body temperature is typically measured during all medical office visits and recorded in the ever-present electronic medical record.
Researchers from Stanford identified 724,199 patient encounters with outpatient temperature data. They excluded extreme temperatures – less than 34° C or greater than 40° C – excluded patients under 20 or above 80 years, and excluded those with extremes of height, weight, or body mass index.
You end up with a distribution like this. Note that the peak is clearly lower than 37° C.
But we’re still not at “normal.” Some people would be seeing their doctor for conditions that affect body temperature, such as infection. You could use diagnosis codes to flag these individuals and drop them, but that feels a bit arbitrary.
I really love how the researchers used data to fix this problem. They used a technique called LIMIT (Laboratory Information Mining for Individualized Thresholds). It works like this:
Take all the temperature measurements and then identify the outliers – the very tails of the distribution.
Look at all the diagnosis codes in those distributions. Determine which diagnosis codes are overrepresented in those distributions. Now you have a data-driven way to say that yes, these diagnoses are associated with weird temperatures. Next, eliminate everyone with those diagnoses from the dataset. What you are left with is a normal population, or at least a population that doesn’t have a condition that seems to meaningfully affect temperature.
So, who was dropped? Well, a lot of people, actually. It turned out that diabetes was way overrepresented in the outlier group. Although 9.2% of the population had diabetes, 26% of people with very low temperatures did, so everyone with diabetes is removed from the dataset. While 5% of the population had a cough at their encounter, 7% of the people with very high temperature and 7% of the people with very low temperature had a cough, so everyone with cough gets thrown out.
The algorithm excluded people on antibiotics or who had sinusitis, urinary tract infections, pneumonia, and, yes, a diagnosis of “fever.” The list makes sense, which is always nice when you have a purely algorithmic classification system.
What do we have left? What is the real normal temperature? Ready?
It’s 36.64° C, or about 98.0° F.
Of course, normal temperature varied depending on the time of day it was measured – higher in the afternoon.
The normal temperature in women tended to be higher than in men. The normal temperature declined with age as well.
In fact, the researchers built a nice online calculator where you can enter your own, or your patient’s, parameters and calculate a normal body temperature for them. Here’s mine. My normal temperature at around 2 p.m. should be 36.7° C.
So, we’re all more cold-blooded than we thought. Is this just because of better methods? Maybe. But studies have actually shown that body temperature may be decreasing over time in humans, possibly because of the lower levels of inflammation we face in modern life (thanks to improvements in hygiene and antibiotics).
Of course, I’m sure some of you are asking yourselves whether any of this really matters. Is 37° C close enough?
Sure, this may be sort of puttering around the edges of physical diagnosis, but I think the methodology is really interesting and can obviously be applied to other broadly collected data points. But these data show us that thin, older individuals really do run cooler, and that we may need to pay more attention to a low-grade fever in that population than we otherwise would.
In any case, it’s time for a little re-education. If someone asks you what normal body temperature is, just say 36.6° C, 98.0° F. For his work in this area, I suggest we call it Wunderlich’s constant.
Dr. Wilson is associate professor of medicine and public health at Yale University, New Haven, Conn., and director of Yale’s Clinical and Translational Research Accelerator. He has no disclosures.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
Every branch of science has its constants. Physics has the speed of light, the gravitational constant, the Planck constant. Chemistry gives us Avogadro’s number, Faraday’s constant, the charge of an electron. Medicine isn’t quite as reliable as physics when it comes to these things, but insofar as there are any constants in medicine, might I suggest normal body temperature: 37° Celsius, 98.6° Fahrenheit.
Sure, serum sodium may be less variable and lactate concentration more clinically relevant, but even my 7-year-old knows that normal body temperature is 98.6°.
Except, as it turns out, 98.6° isn’t normal at all.
How did we arrive at 37.0° C for normal body temperature? We got it from this guy – German physician Carl Reinhold August Wunderlich, who, in addition to looking eerily like Luciano Pavarotti, was the first to realize that fever was not itself a disease but a symptom of one.
In 1851, Dr. Wunderlich released his measurements of more than 1 million body temperatures taken from 25,000 Germans – a painstaking process at the time, which employed a foot-long thermometer and took 20 minutes to obtain a measurement.
The average temperature measured, of course, was 37° C.
We’re more than 150 years post-Wunderlich right now, and the average person in the United States might be quite a bit different from the average German in 1850. Moreover, we can do a lot better than just measuring a ton of people and taking the average, because we have statistics. The problem with measuring a bunch of people and taking the average temperature as normal is that you can’t be sure that the people you are measuring are normal. There are obvious causes of elevated temperature that you could exclude. Let’s not take people with a respiratory infection or who are taking Tylenol, for example. But as highlighted in this paper in JAMA Internal Medicine, we can do a lot better than that.
The study leverages the fact that body temperature is typically measured during all medical office visits and recorded in the ever-present electronic medical record.
Researchers from Stanford identified 724,199 patient encounters with outpatient temperature data. They excluded extreme temperatures – less than 34° C or greater than 40° C – excluded patients under 20 or above 80 years, and excluded those with extremes of height, weight, or body mass index.
You end up with a distribution like this. Note that the peak is clearly lower than 37° C.
But we’re still not at “normal.” Some people would be seeing their doctor for conditions that affect body temperature, such as infection. You could use diagnosis codes to flag these individuals and drop them, but that feels a bit arbitrary.
I really love how the researchers used data to fix this problem. They used a technique called LIMIT (Laboratory Information Mining for Individualized Thresholds). It works like this:
Take all the temperature measurements and then identify the outliers – the very tails of the distribution.
Look at all the diagnosis codes in those distributions. Determine which diagnosis codes are overrepresented in those distributions. Now you have a data-driven way to say that yes, these diagnoses are associated with weird temperatures. Next, eliminate everyone with those diagnoses from the dataset. What you are left with is a normal population, or at least a population that doesn’t have a condition that seems to meaningfully affect temperature.
So, who was dropped? Well, a lot of people, actually. It turned out that diabetes was way overrepresented in the outlier group. Although 9.2% of the population had diabetes, 26% of people with very low temperatures did, so everyone with diabetes is removed from the dataset. While 5% of the population had a cough at their encounter, 7% of the people with very high temperature and 7% of the people with very low temperature had a cough, so everyone with cough gets thrown out.
The algorithm excluded people on antibiotics or who had sinusitis, urinary tract infections, pneumonia, and, yes, a diagnosis of “fever.” The list makes sense, which is always nice when you have a purely algorithmic classification system.
What do we have left? What is the real normal temperature? Ready?
It’s 36.64° C, or about 98.0° F.
Of course, normal temperature varied depending on the time of day it was measured – higher in the afternoon.
The normal temperature in women tended to be higher than in men. The normal temperature declined with age as well.
In fact, the researchers built a nice online calculator where you can enter your own, or your patient’s, parameters and calculate a normal body temperature for them. Here’s mine. My normal temperature at around 2 p.m. should be 36.7° C.
So, we’re all more cold-blooded than we thought. Is this just because of better methods? Maybe. But studies have actually shown that body temperature may be decreasing over time in humans, possibly because of the lower levels of inflammation we face in modern life (thanks to improvements in hygiene and antibiotics).
Of course, I’m sure some of you are asking yourselves whether any of this really matters. Is 37° C close enough?
Sure, this may be sort of puttering around the edges of physical diagnosis, but I think the methodology is really interesting and can obviously be applied to other broadly collected data points. But these data show us that thin, older individuals really do run cooler, and that we may need to pay more attention to a low-grade fever in that population than we otherwise would.
In any case, it’s time for a little re-education. If someone asks you what normal body temperature is, just say 36.6° C, 98.0° F. For his work in this area, I suggest we call it Wunderlich’s constant.
Dr. Wilson is associate professor of medicine and public health at Yale University, New Haven, Conn., and director of Yale’s Clinical and Translational Research Accelerator. He has no disclosures.
A version of this article appeared on Medscape.com.
New AI-enhanced bandages poised to transform wound treatment
You cut yourself. You put on a bandage. In a week or so, your wound heals.
Most people take this routine for granted. But for the more than 8.2 million Americans who have chronic wounds, it’s not so simple.
Traumatic injuries, post-surgical complications, advanced age, and chronic illnesses like diabetes and vascular disease can all disrupt the delicate healing process, leading to wounds that last months or years.
Left untreated, about 30% led to amputation. And recent studies show the risk of dying from a chronic wound complication within 5 years rivals that of most cancers.
Yet until recently, medical technology had not kept up with what experts say is a snowballing threat to public health.
“Wound care – even with all of the billions of products that are sold – still exists on kind of a medieval level,” said Geoffrey Gurtner, MD, chair of the department of surgery and professor of biomedical engineering at the University of Arizona College of Medicine. “We’re still putting on poultices and salves ... and when it comes to diagnosing infection, it’s really an art. I think we can do better.”
Old-school bandage meets AI
Dr. Gurtner is among dozens of clinicians and researchers reimagining the humble bandage, combining cutting-edge materials science with artificial intelligence and patient data to develop “smart bandages” that do far more than shield a wound.
Someday soon, these paper-thin bandages embedded with miniaturized electronics could monitor the healing process in real time, alerting the patient – or a doctor – when things go wrong. With the press of a smartphone button, that bandage could deliver medicine to fight an infection or an electrical pulse to stimulate healing.
Some “closed-loop” designs need no prompting, instead monitoring the wound and automatically giving it what it needs.
Others in development could halt a battlefield wound from hemorrhaging or kick-start healing in a blast wound, preventing longer-term disability.
The same technologies could – if the price is right – speed up healing and reduce scarring in minor cuts and scrapes, too, said Dr. Gurtner.
And unlike many cutting-edge medical innovations, these next-generation bandages could be made relatively cheaply and benefit some of the most vulnerable populations, including older adults, people with low incomes, and those in developing countries.
They could also save the health care system money, as the U.S. spends more than $28 billion annually treating chronic wounds.
“This is a condition that many patients find shameful and embarrassing, so there hasn’t been a lot of advocacy,” said Dr. Gurtner, outgoing board president of the Wound Healing Society. “It’s a relatively ignored problem afflicting an underserved population that has a huge cost. It’s a perfect storm.”
How wounds heal, or don’t
Wound healing is one of the most complex processes of the human body.
First platelets rush to the injury, prompting blood to clot. Then immune cells emit compounds called inflammatory cytokines, helping to fight off pathogens and keep infection at bay. Other compounds, including nitric oxide, spark the growth of new blood vessels and collagen to rebuild skin and connective tissue. As inflammation slows and stops, the flesh continues to reform.
But some conditions can stall the process, often in the inflammatory stage.
In people with diabetes, high glucose levels and poor circulation tend to sabotage the process. And people with nerve damage from spinal cord injuries, diabetes, or other ailments may not be able to feel it when a wound is getting worse or reinjured.
“We end up with patients going months with open wounds that are festering and infected,” said Roslyn Rivkah Isseroff, MD, professor of dermatology at the University of California Davis and head of the VA Northern California Health Care System’s wound healing clinic. “The patients are upset with the smell. These open ulcers put the patient at risk for systemic infection, like sepsis.” It can impact mental health, draining the patient’s ability to care for their wound.
“We see them once a week and send them home and say change your dressing every day, and they say, ‘I can barely move. I can’t do this,’ ” said Dr. Isseroff.
Checking for infection means removing bandages and culturing the wound. That can be painful, and results take time.
A lot can happen to a wound in a week.
“Sometimes, they come back and it’s a disaster, and they have to be admitted to the ER or even get an amputation,” Dr. Gurtner said.
People who are housing insecure or lack access to health care are even more vulnerable to complications.
“If you had the ability to say ‘there is something bad happening,’ you could do a lot to prevent this cascade and downward spiral.”
Bandages 2.0
In 2019, the Defense Advanced Research Projects Agency, the research arm of the Department of Defense, launched the Bioelectronics for Tissue Regeneration program to encourage scientists to develop a “closed-loop” bandage capable of both monitoring and hastening healing.
Tens of millions in funding has kick-started a flood of innovation since.
“It’s kind of a race to the finish,” said Marco Rolandi, PhD, associate professor of electrical and computer engineering at the University of California Santa Cruz and the principal investigator for a team including engineers, medical doctors, and computer scientists from UC Santa Cruz, UC Davis, and Tufts. “I’ve been amazed and impressed at all the work coming out.”
His team’s goal is to cut healing time in half by using (a) real-time monitoring of how a wound is healing – using indicators like temperature, pH level, oxygen, moisture, glucose, electrical activity, and certain proteins, and (b) appropriate stimulation.
“Every wound is different, so there is no one solution,” said Dr. Isseroff, the team’s clinical lead. “The idea is that it will be able to sense different parameters unique to the wound, use AI to figure out what stage it is in, and provide the right stimulus to kick it out of that stalled stage.”
The team has developed a proof-of-concept prototype: a bandage embedded with a tiny camera that takes pictures and transmits them to a computer algorithm to assess the wound’s progress. Miniaturized battery-powered actuators, or motors, automatically deliver medication.
Phase I trials in rodents went well, Dr. Rolandi said. The team is now testing the bandage on pigs.
Across the globe, other promising developments are underway.
In a scientific paper published in May, researchers at the University of Glasgow described a new “low-cost, environmentally friendly” bandage embedded with light-emitting diodes that use ultraviolet light to kill bacteria – no antibiotics needed. The fabric is stitched with a slim, flexible coil that powers the lights without a battery using wireless power transfer. In lab studies, it eradicated gram-negative bacteria (some of the nastiest bugs) in 6 hours.
Also in May, in the journal Bioactive Materials, a Penn State team detailed a bandage with medicine-injecting microneedles that can halt bleeding immediately after injury. In lab and animal tests, it reduced clotting time from 11.5 minutes to 1.3 minutes and bleeding by 90%.
“With hemorrhaging injuries, it is often the loss of blood – not the injury itself – that causes death,” said study author Amir Sheikhi, PhD, assistant professor of chemical and biomedical engineering at Penn State. “Those 10 minutes could be the difference between life and death.”
Another smart bandage, developed at Northwestern University, Chicago, harmlessly dissolves – electrodes and all – into the body after it is no longer needed, eliminating what can be a painful removal.
Guillermo Ameer, DSc, a study author reporting on the technology in Science Advances, hopes it could be made cheaply and used in developing countries.
“We’d like to create something that you could use in your home, even in a very remote village,” said Dr. Ameer, professor of biomedical engineering at Northwestern.
Timeline for clinical use
These are early days for the smart bandage, scientists say. Most studies have been in rodents and more work is needed to develop human-scale bandages, reduce cost, solve long-term data storage, and ensure material adheres well without irritating the skin.
But Dr. Gurtner is hopeful that some iteration could be used in clinical practice within a few years.
In May, he and colleagues at Stanford (Calif.) University published a paper in Nature Biotechnology describing their smart bandage. It includes a microcontroller unit, a radio antenna, biosensors, and an electrical stimulator all affixed to a rubbery, skin-like polymer (or hydrogel) about the thickness of a single coat of latex paint.
The bandage senses changes in temperature and electrical conductivity as the wound heals, and it gives electrical stimulation to accelerate that healing.
Animals treated with the bandage healed 25% faster, with 50% less scarring.
Electrical currents are already used for wound healing in clinical practice, Dr. Gurtner said. Because the stimulus is already approved and the cost to make the bandage could be low (as little as $10 to $50), he believes it could be ushered through the approval processes relatively quickly.
“Is this the ultimate embodiment of all the bells and whistles that are possible in a smart bandage? No. Not yet,” he said. “But we think it will help people. And right now, that’s good enough.”
A version of this article appeared on WebMD.com.
You cut yourself. You put on a bandage. In a week or so, your wound heals.
Most people take this routine for granted. But for the more than 8.2 million Americans who have chronic wounds, it’s not so simple.
Traumatic injuries, post-surgical complications, advanced age, and chronic illnesses like diabetes and vascular disease can all disrupt the delicate healing process, leading to wounds that last months or years.
Left untreated, about 30% led to amputation. And recent studies show the risk of dying from a chronic wound complication within 5 years rivals that of most cancers.
Yet until recently, medical technology had not kept up with what experts say is a snowballing threat to public health.
“Wound care – even with all of the billions of products that are sold – still exists on kind of a medieval level,” said Geoffrey Gurtner, MD, chair of the department of surgery and professor of biomedical engineering at the University of Arizona College of Medicine. “We’re still putting on poultices and salves ... and when it comes to diagnosing infection, it’s really an art. I think we can do better.”
Old-school bandage meets AI
Dr. Gurtner is among dozens of clinicians and researchers reimagining the humble bandage, combining cutting-edge materials science with artificial intelligence and patient data to develop “smart bandages” that do far more than shield a wound.
Someday soon, these paper-thin bandages embedded with miniaturized electronics could monitor the healing process in real time, alerting the patient – or a doctor – when things go wrong. With the press of a smartphone button, that bandage could deliver medicine to fight an infection or an electrical pulse to stimulate healing.
Some “closed-loop” designs need no prompting, instead monitoring the wound and automatically giving it what it needs.
Others in development could halt a battlefield wound from hemorrhaging or kick-start healing in a blast wound, preventing longer-term disability.
The same technologies could – if the price is right – speed up healing and reduce scarring in minor cuts and scrapes, too, said Dr. Gurtner.
And unlike many cutting-edge medical innovations, these next-generation bandages could be made relatively cheaply and benefit some of the most vulnerable populations, including older adults, people with low incomes, and those in developing countries.
They could also save the health care system money, as the U.S. spends more than $28 billion annually treating chronic wounds.
“This is a condition that many patients find shameful and embarrassing, so there hasn’t been a lot of advocacy,” said Dr. Gurtner, outgoing board president of the Wound Healing Society. “It’s a relatively ignored problem afflicting an underserved population that has a huge cost. It’s a perfect storm.”
How wounds heal, or don’t
Wound healing is one of the most complex processes of the human body.
First platelets rush to the injury, prompting blood to clot. Then immune cells emit compounds called inflammatory cytokines, helping to fight off pathogens and keep infection at bay. Other compounds, including nitric oxide, spark the growth of new blood vessels and collagen to rebuild skin and connective tissue. As inflammation slows and stops, the flesh continues to reform.
But some conditions can stall the process, often in the inflammatory stage.
In people with diabetes, high glucose levels and poor circulation tend to sabotage the process. And people with nerve damage from spinal cord injuries, diabetes, or other ailments may not be able to feel it when a wound is getting worse or reinjured.
“We end up with patients going months with open wounds that are festering and infected,” said Roslyn Rivkah Isseroff, MD, professor of dermatology at the University of California Davis and head of the VA Northern California Health Care System’s wound healing clinic. “The patients are upset with the smell. These open ulcers put the patient at risk for systemic infection, like sepsis.” It can impact mental health, draining the patient’s ability to care for their wound.
“We see them once a week and send them home and say change your dressing every day, and they say, ‘I can barely move. I can’t do this,’ ” said Dr. Isseroff.
Checking for infection means removing bandages and culturing the wound. That can be painful, and results take time.
A lot can happen to a wound in a week.
“Sometimes, they come back and it’s a disaster, and they have to be admitted to the ER or even get an amputation,” Dr. Gurtner said.
People who are housing insecure or lack access to health care are even more vulnerable to complications.
“If you had the ability to say ‘there is something bad happening,’ you could do a lot to prevent this cascade and downward spiral.”
Bandages 2.0
In 2019, the Defense Advanced Research Projects Agency, the research arm of the Department of Defense, launched the Bioelectronics for Tissue Regeneration program to encourage scientists to develop a “closed-loop” bandage capable of both monitoring and hastening healing.
Tens of millions in funding has kick-started a flood of innovation since.
“It’s kind of a race to the finish,” said Marco Rolandi, PhD, associate professor of electrical and computer engineering at the University of California Santa Cruz and the principal investigator for a team including engineers, medical doctors, and computer scientists from UC Santa Cruz, UC Davis, and Tufts. “I’ve been amazed and impressed at all the work coming out.”
His team’s goal is to cut healing time in half by using (a) real-time monitoring of how a wound is healing – using indicators like temperature, pH level, oxygen, moisture, glucose, electrical activity, and certain proteins, and (b) appropriate stimulation.
“Every wound is different, so there is no one solution,” said Dr. Isseroff, the team’s clinical lead. “The idea is that it will be able to sense different parameters unique to the wound, use AI to figure out what stage it is in, and provide the right stimulus to kick it out of that stalled stage.”
The team has developed a proof-of-concept prototype: a bandage embedded with a tiny camera that takes pictures and transmits them to a computer algorithm to assess the wound’s progress. Miniaturized battery-powered actuators, or motors, automatically deliver medication.
Phase I trials in rodents went well, Dr. Rolandi said. The team is now testing the bandage on pigs.
Across the globe, other promising developments are underway.
In a scientific paper published in May, researchers at the University of Glasgow described a new “low-cost, environmentally friendly” bandage embedded with light-emitting diodes that use ultraviolet light to kill bacteria – no antibiotics needed. The fabric is stitched with a slim, flexible coil that powers the lights without a battery using wireless power transfer. In lab studies, it eradicated gram-negative bacteria (some of the nastiest bugs) in 6 hours.
Also in May, in the journal Bioactive Materials, a Penn State team detailed a bandage with medicine-injecting microneedles that can halt bleeding immediately after injury. In lab and animal tests, it reduced clotting time from 11.5 minutes to 1.3 minutes and bleeding by 90%.
“With hemorrhaging injuries, it is often the loss of blood – not the injury itself – that causes death,” said study author Amir Sheikhi, PhD, assistant professor of chemical and biomedical engineering at Penn State. “Those 10 minutes could be the difference between life and death.”
Another smart bandage, developed at Northwestern University, Chicago, harmlessly dissolves – electrodes and all – into the body after it is no longer needed, eliminating what can be a painful removal.
Guillermo Ameer, DSc, a study author reporting on the technology in Science Advances, hopes it could be made cheaply and used in developing countries.
“We’d like to create something that you could use in your home, even in a very remote village,” said Dr. Ameer, professor of biomedical engineering at Northwestern.
Timeline for clinical use
These are early days for the smart bandage, scientists say. Most studies have been in rodents and more work is needed to develop human-scale bandages, reduce cost, solve long-term data storage, and ensure material adheres well without irritating the skin.
But Dr. Gurtner is hopeful that some iteration could be used in clinical practice within a few years.
In May, he and colleagues at Stanford (Calif.) University published a paper in Nature Biotechnology describing their smart bandage. It includes a microcontroller unit, a radio antenna, biosensors, and an electrical stimulator all affixed to a rubbery, skin-like polymer (or hydrogel) about the thickness of a single coat of latex paint.
The bandage senses changes in temperature and electrical conductivity as the wound heals, and it gives electrical stimulation to accelerate that healing.
Animals treated with the bandage healed 25% faster, with 50% less scarring.
Electrical currents are already used for wound healing in clinical practice, Dr. Gurtner said. Because the stimulus is already approved and the cost to make the bandage could be low (as little as $10 to $50), he believes it could be ushered through the approval processes relatively quickly.
“Is this the ultimate embodiment of all the bells and whistles that are possible in a smart bandage? No. Not yet,” he said. “But we think it will help people. And right now, that’s good enough.”
A version of this article appeared on WebMD.com.
You cut yourself. You put on a bandage. In a week or so, your wound heals.
Most people take this routine for granted. But for the more than 8.2 million Americans who have chronic wounds, it’s not so simple.
Traumatic injuries, post-surgical complications, advanced age, and chronic illnesses like diabetes and vascular disease can all disrupt the delicate healing process, leading to wounds that last months or years.
Left untreated, about 30% led to amputation. And recent studies show the risk of dying from a chronic wound complication within 5 years rivals that of most cancers.
Yet until recently, medical technology had not kept up with what experts say is a snowballing threat to public health.
“Wound care – even with all of the billions of products that are sold – still exists on kind of a medieval level,” said Geoffrey Gurtner, MD, chair of the department of surgery and professor of biomedical engineering at the University of Arizona College of Medicine. “We’re still putting on poultices and salves ... and when it comes to diagnosing infection, it’s really an art. I think we can do better.”
Old-school bandage meets AI
Dr. Gurtner is among dozens of clinicians and researchers reimagining the humble bandage, combining cutting-edge materials science with artificial intelligence and patient data to develop “smart bandages” that do far more than shield a wound.
Someday soon, these paper-thin bandages embedded with miniaturized electronics could monitor the healing process in real time, alerting the patient – or a doctor – when things go wrong. With the press of a smartphone button, that bandage could deliver medicine to fight an infection or an electrical pulse to stimulate healing.
Some “closed-loop” designs need no prompting, instead monitoring the wound and automatically giving it what it needs.
Others in development could halt a battlefield wound from hemorrhaging or kick-start healing in a blast wound, preventing longer-term disability.
The same technologies could – if the price is right – speed up healing and reduce scarring in minor cuts and scrapes, too, said Dr. Gurtner.
And unlike many cutting-edge medical innovations, these next-generation bandages could be made relatively cheaply and benefit some of the most vulnerable populations, including older adults, people with low incomes, and those in developing countries.
They could also save the health care system money, as the U.S. spends more than $28 billion annually treating chronic wounds.
“This is a condition that many patients find shameful and embarrassing, so there hasn’t been a lot of advocacy,” said Dr. Gurtner, outgoing board president of the Wound Healing Society. “It’s a relatively ignored problem afflicting an underserved population that has a huge cost. It’s a perfect storm.”
How wounds heal, or don’t
Wound healing is one of the most complex processes of the human body.
First platelets rush to the injury, prompting blood to clot. Then immune cells emit compounds called inflammatory cytokines, helping to fight off pathogens and keep infection at bay. Other compounds, including nitric oxide, spark the growth of new blood vessels and collagen to rebuild skin and connective tissue. As inflammation slows and stops, the flesh continues to reform.
But some conditions can stall the process, often in the inflammatory stage.
In people with diabetes, high glucose levels and poor circulation tend to sabotage the process. And people with nerve damage from spinal cord injuries, diabetes, or other ailments may not be able to feel it when a wound is getting worse or reinjured.
“We end up with patients going months with open wounds that are festering and infected,” said Roslyn Rivkah Isseroff, MD, professor of dermatology at the University of California Davis and head of the VA Northern California Health Care System’s wound healing clinic. “The patients are upset with the smell. These open ulcers put the patient at risk for systemic infection, like sepsis.” It can impact mental health, draining the patient’s ability to care for their wound.
“We see them once a week and send them home and say change your dressing every day, and they say, ‘I can barely move. I can’t do this,’ ” said Dr. Isseroff.
Checking for infection means removing bandages and culturing the wound. That can be painful, and results take time.
A lot can happen to a wound in a week.
“Sometimes, they come back and it’s a disaster, and they have to be admitted to the ER or even get an amputation,” Dr. Gurtner said.
People who are housing insecure or lack access to health care are even more vulnerable to complications.
“If you had the ability to say ‘there is something bad happening,’ you could do a lot to prevent this cascade and downward spiral.”
Bandages 2.0
In 2019, the Defense Advanced Research Projects Agency, the research arm of the Department of Defense, launched the Bioelectronics for Tissue Regeneration program to encourage scientists to develop a “closed-loop” bandage capable of both monitoring and hastening healing.
Tens of millions in funding has kick-started a flood of innovation since.
“It’s kind of a race to the finish,” said Marco Rolandi, PhD, associate professor of electrical and computer engineering at the University of California Santa Cruz and the principal investigator for a team including engineers, medical doctors, and computer scientists from UC Santa Cruz, UC Davis, and Tufts. “I’ve been amazed and impressed at all the work coming out.”
His team’s goal is to cut healing time in half by using (a) real-time monitoring of how a wound is healing – using indicators like temperature, pH level, oxygen, moisture, glucose, electrical activity, and certain proteins, and (b) appropriate stimulation.
“Every wound is different, so there is no one solution,” said Dr. Isseroff, the team’s clinical lead. “The idea is that it will be able to sense different parameters unique to the wound, use AI to figure out what stage it is in, and provide the right stimulus to kick it out of that stalled stage.”
The team has developed a proof-of-concept prototype: a bandage embedded with a tiny camera that takes pictures and transmits them to a computer algorithm to assess the wound’s progress. Miniaturized battery-powered actuators, or motors, automatically deliver medication.
Phase I trials in rodents went well, Dr. Rolandi said. The team is now testing the bandage on pigs.
Across the globe, other promising developments are underway.
In a scientific paper published in May, researchers at the University of Glasgow described a new “low-cost, environmentally friendly” bandage embedded with light-emitting diodes that use ultraviolet light to kill bacteria – no antibiotics needed. The fabric is stitched with a slim, flexible coil that powers the lights without a battery using wireless power transfer. In lab studies, it eradicated gram-negative bacteria (some of the nastiest bugs) in 6 hours.
Also in May, in the journal Bioactive Materials, a Penn State team detailed a bandage with medicine-injecting microneedles that can halt bleeding immediately after injury. In lab and animal tests, it reduced clotting time from 11.5 minutes to 1.3 minutes and bleeding by 90%.
“With hemorrhaging injuries, it is often the loss of blood – not the injury itself – that causes death,” said study author Amir Sheikhi, PhD, assistant professor of chemical and biomedical engineering at Penn State. “Those 10 minutes could be the difference between life and death.”
Another smart bandage, developed at Northwestern University, Chicago, harmlessly dissolves – electrodes and all – into the body after it is no longer needed, eliminating what can be a painful removal.
Guillermo Ameer, DSc, a study author reporting on the technology in Science Advances, hopes it could be made cheaply and used in developing countries.
“We’d like to create something that you could use in your home, even in a very remote village,” said Dr. Ameer, professor of biomedical engineering at Northwestern.
Timeline for clinical use
These are early days for the smart bandage, scientists say. Most studies have been in rodents and more work is needed to develop human-scale bandages, reduce cost, solve long-term data storage, and ensure material adheres well without irritating the skin.
But Dr. Gurtner is hopeful that some iteration could be used in clinical practice within a few years.
In May, he and colleagues at Stanford (Calif.) University published a paper in Nature Biotechnology describing their smart bandage. It includes a microcontroller unit, a radio antenna, biosensors, and an electrical stimulator all affixed to a rubbery, skin-like polymer (or hydrogel) about the thickness of a single coat of latex paint.
The bandage senses changes in temperature and electrical conductivity as the wound heals, and it gives electrical stimulation to accelerate that healing.
Animals treated with the bandage healed 25% faster, with 50% less scarring.
Electrical currents are already used for wound healing in clinical practice, Dr. Gurtner said. Because the stimulus is already approved and the cost to make the bandage could be low (as little as $10 to $50), he believes it could be ushered through the approval processes relatively quickly.
“Is this the ultimate embodiment of all the bells and whistles that are possible in a smart bandage? No. Not yet,” he said. “But we think it will help people. And right now, that’s good enough.”
A version of this article appeared on WebMD.com.
‘Missed opportunities’ for accurate diagnosing of women with vaginitis
Although the standard of care of diagnosing vaginitis is clinical evaluation, many practices do not perform accurate and comprehensive clinical examinations for a variety for reasons, and the Centers for Disease Control and Prevention currently recommends molecular testing, wrote Casey N. Pinto, PhD, of Penn State University, Hershey, and colleagues. The CDC also recommends testing women with vaginitis for Chlamydia trachomatis (CT) and Neissaria gonorrhoeae (NG) given the high rate of coinfections between vaginitis and these sexually transmitted infections, but data on cotesting in clinical practice are limited, they said.
In a study published in Sexually Transmitted Diseases, the researchers reviewed data from a commercial administrative claims database for 1,359,289 women aged 18-50 years who were diagnosed with vaginitis between 2012 and 2017.
The women were categorized into groups based on type of vaginitis diagnosis: nucleic amplification test (NAAT), DNA probe test, traditional lab test, and those diagnosed clinically at an index visit but with no CPT code for further testing.
Overall, nearly half of the women (49.2%) had no CPT code for further vaginitis testing beyond clinical diagnosis. Of those with CPT codes for testing, 50.9% underwent traditional point-of-care testing, wet mount, or culture, 23.5% had a DNA probe, and 20.6% had NAAT testing.
Approximately one-third (34%) of women were cotested for CT/NG. Testing rates varied widely across the type of vaginitis test, from 70.8% of women who received NAAT to 22.8% of women with no CPT code. In multivariate analysis including age, region, and the Charlson Comorbidity Index (CCI), those tested with NAAT were eight times more likely to be cotested for CT/NG than those with no CPT code (odds ratio, 8.77; P < .0001).
Women who received a traditional test or DNA probe test for vaginitis also were more likely to have CT/NG testing than women with no CPT code, but only 1.8-2.5 times as likely.
“Our data suggest that most clinicians are not engaging the standard of care for testing and diagnosing vaginitis, or not engaging in comprehensive care by cotesting for vaginitis and CT/NG when patients may be at risk, resulting in missed opportunities for accurate diagnosis and potential associated coinfections,” the researchers wrote in their discussion. The higher rates for CT/NG testing among women receiving either NAAT or DNA probe vaginitis testing could be attributed to bundled testing, they noted, and the lower rate of CT/NG testing for patients with no CPT code could stem from limited access to microscopy or clinician preference for clinical diagnosis only, they said.
The findings were limited by several factors, including the lack of data on testing and diagnoses prior to the study period and not billed to insurance, and by the inability to account for variables including race, ethnicity, and socioeconomic status, the researchers noted.
However, the results highlight the need for more comprehensive care in vaginitis testing to take advantage of opportunities to identify CT or NG in women diagnosed with vaginitis, they concluded.
The study was supported by Becton, Dickinson and Company. Lead author Dr. Pinto disclosed consulting for Becton, Dickinson and Company, and receiving an honorarium from Roche.
Although the standard of care of diagnosing vaginitis is clinical evaluation, many practices do not perform accurate and comprehensive clinical examinations for a variety for reasons, and the Centers for Disease Control and Prevention currently recommends molecular testing, wrote Casey N. Pinto, PhD, of Penn State University, Hershey, and colleagues. The CDC also recommends testing women with vaginitis for Chlamydia trachomatis (CT) and Neissaria gonorrhoeae (NG) given the high rate of coinfections between vaginitis and these sexually transmitted infections, but data on cotesting in clinical practice are limited, they said.
In a study published in Sexually Transmitted Diseases, the researchers reviewed data from a commercial administrative claims database for 1,359,289 women aged 18-50 years who were diagnosed with vaginitis between 2012 and 2017.
The women were categorized into groups based on type of vaginitis diagnosis: nucleic amplification test (NAAT), DNA probe test, traditional lab test, and those diagnosed clinically at an index visit but with no CPT code for further testing.
Overall, nearly half of the women (49.2%) had no CPT code for further vaginitis testing beyond clinical diagnosis. Of those with CPT codes for testing, 50.9% underwent traditional point-of-care testing, wet mount, or culture, 23.5% had a DNA probe, and 20.6% had NAAT testing.
Approximately one-third (34%) of women were cotested for CT/NG. Testing rates varied widely across the type of vaginitis test, from 70.8% of women who received NAAT to 22.8% of women with no CPT code. In multivariate analysis including age, region, and the Charlson Comorbidity Index (CCI), those tested with NAAT were eight times more likely to be cotested for CT/NG than those with no CPT code (odds ratio, 8.77; P < .0001).
Women who received a traditional test or DNA probe test for vaginitis also were more likely to have CT/NG testing than women with no CPT code, but only 1.8-2.5 times as likely.
“Our data suggest that most clinicians are not engaging the standard of care for testing and diagnosing vaginitis, or not engaging in comprehensive care by cotesting for vaginitis and CT/NG when patients may be at risk, resulting in missed opportunities for accurate diagnosis and potential associated coinfections,” the researchers wrote in their discussion. The higher rates for CT/NG testing among women receiving either NAAT or DNA probe vaginitis testing could be attributed to bundled testing, they noted, and the lower rate of CT/NG testing for patients with no CPT code could stem from limited access to microscopy or clinician preference for clinical diagnosis only, they said.
The findings were limited by several factors, including the lack of data on testing and diagnoses prior to the study period and not billed to insurance, and by the inability to account for variables including race, ethnicity, and socioeconomic status, the researchers noted.
However, the results highlight the need for more comprehensive care in vaginitis testing to take advantage of opportunities to identify CT or NG in women diagnosed with vaginitis, they concluded.
The study was supported by Becton, Dickinson and Company. Lead author Dr. Pinto disclosed consulting for Becton, Dickinson and Company, and receiving an honorarium from Roche.
Although the standard of care of diagnosing vaginitis is clinical evaluation, many practices do not perform accurate and comprehensive clinical examinations for a variety for reasons, and the Centers for Disease Control and Prevention currently recommends molecular testing, wrote Casey N. Pinto, PhD, of Penn State University, Hershey, and colleagues. The CDC also recommends testing women with vaginitis for Chlamydia trachomatis (CT) and Neissaria gonorrhoeae (NG) given the high rate of coinfections between vaginitis and these sexually transmitted infections, but data on cotesting in clinical practice are limited, they said.
In a study published in Sexually Transmitted Diseases, the researchers reviewed data from a commercial administrative claims database for 1,359,289 women aged 18-50 years who were diagnosed with vaginitis between 2012 and 2017.
The women were categorized into groups based on type of vaginitis diagnosis: nucleic amplification test (NAAT), DNA probe test, traditional lab test, and those diagnosed clinically at an index visit but with no CPT code for further testing.
Overall, nearly half of the women (49.2%) had no CPT code for further vaginitis testing beyond clinical diagnosis. Of those with CPT codes for testing, 50.9% underwent traditional point-of-care testing, wet mount, or culture, 23.5% had a DNA probe, and 20.6% had NAAT testing.
Approximately one-third (34%) of women were cotested for CT/NG. Testing rates varied widely across the type of vaginitis test, from 70.8% of women who received NAAT to 22.8% of women with no CPT code. In multivariate analysis including age, region, and the Charlson Comorbidity Index (CCI), those tested with NAAT were eight times more likely to be cotested for CT/NG than those with no CPT code (odds ratio, 8.77; P < .0001).
Women who received a traditional test or DNA probe test for vaginitis also were more likely to have CT/NG testing than women with no CPT code, but only 1.8-2.5 times as likely.
“Our data suggest that most clinicians are not engaging the standard of care for testing and diagnosing vaginitis, or not engaging in comprehensive care by cotesting for vaginitis and CT/NG when patients may be at risk, resulting in missed opportunities for accurate diagnosis and potential associated coinfections,” the researchers wrote in their discussion. The higher rates for CT/NG testing among women receiving either NAAT or DNA probe vaginitis testing could be attributed to bundled testing, they noted, and the lower rate of CT/NG testing for patients with no CPT code could stem from limited access to microscopy or clinician preference for clinical diagnosis only, they said.
The findings were limited by several factors, including the lack of data on testing and diagnoses prior to the study period and not billed to insurance, and by the inability to account for variables including race, ethnicity, and socioeconomic status, the researchers noted.
However, the results highlight the need for more comprehensive care in vaginitis testing to take advantage of opportunities to identify CT or NG in women diagnosed with vaginitis, they concluded.
The study was supported by Becton, Dickinson and Company. Lead author Dr. Pinto disclosed consulting for Becton, Dickinson and Company, and receiving an honorarium from Roche.
FROM SEXUALLY TRANSMITTED DISEASES
Are you ready for RSV season? There’s a new preventive option
There is now an additional option for the prevention of respiratory syncytial virus (RSV), the most common cause of hospitalization among infants and children in the United States. In July, the US Food and Drug Administration (FDA) approved nirsevimab, an RSV preventive monoclonal antibody, for use in neonates and infants born during or entering their first RSV season and in children up to 24 months of age who remain vulnerable to RSV during their second season.1 The Advisory Committee on Immunization Practices (ACIP) subsequently made 2 recommendations regarding use of nirsevimab, which I’ll detail in a moment.2
First, a word about RSV. The Centers for Disease Control and Prevention estimates that each year in children younger than 5 years, RSV is responsible for 1.5 million outpatient clinic visits, 520,000 emergency department visits, 58,000 to 80,000 hospitalizations, and 100 to 200 deaths.2 The risk for hospitalization from RSV is highest in the second and third months of life and decreases with increasing age.
There are some racial disparities in RSV severity, likely reflecting social drivers of health: ICU admission rates are 1.2 to 1.6 times higher among non-Hispanic Black infants younger than 6 months than among non-Hispanic White infants, and hospitalization rates are up to 5 times higher in American Indian and Alaska Native populations.2
What nirsevimab adds to the toolbox. Until recently, there was only 1 RSV preventive agent available: palivizumab, also a monoclonal antibody. The American Academy of Pediatrics has recommended palivizumab be used only for infants at high risk for RSV infection, due to its high cost and the need for monthly injections for the duration of an RSV season. In addition, the Academy has noted that palivizumab has limited effect on RSV hospitalizations on a population basis and does not appear to affect mortality.3
Nirsevimab has a longer half-life than palivizumab, and only 1 injection is needed for the RSV season. Early studies on nirsevimab demonstrate 79% effectiveness in preventing medical-attended lower respiratory tract infection, 80.6% effectiveness in preventing hospitalization, and 90% effectiveness in preventing ICU admission. The number needed to immunize with nirsevimab to prevent an outpatient visit is estimated to be 17; to prevent an ED visit, 48; and to prevent an inpatient admission, 128. Due to the low RSV death rate, the studies were not able to demonstrate reduced mortality.2
What the ACIP recommends. At a special meeting in July, the ACIP recommended 1 dose of nirsevimab for2:
- all infants younger than 8 months who are born during or entering their first RSV season
- children ages 8 to 19 months who are at increased risk for severe RSV disease and entering their second RSV season.
Those at risk include children with chronic lung disease of prematurity who required medical support any time during the 6-month period before the start of their second RSV season; those with severe immunocompromise; those with cystic fibrosis who have manifestations of severe lung disease or weight-for-length < 10th percentile; and American Indian and Alaska Native children.2
How to administer nirsevimab. The dose of nirsevimab is 50 mg IM for those weighing < 5 kg, 100 mg for those weighing ≥ 5 kg, and 200 mg for high-risk children entering their second RSV season.2 Nirsevimab can be co-administered with other recommended vaccines; however, both nirsevimab and palivizumab should not be used in the same child in the same RSV season.
Nirsevimab should be administered in the first week of life for infants born shortly before or during RSV season, and shortly before the season for infants younger than 8 months and those ages 8 to 19 months who are at high risk.4 The months of highest RSV transmission in most locations are December through February, but this can vary. Local epidemiology and advice from state and local health departments are the best source of information about when RSV season starts and ends in your area.
On the horizon. Nirsevimab will be included in the Vaccines for Children program and covered by commercial health plans with no cost sharing.5 A maternal vaccine to prevent RSV in newborns is likely to be approved by the FDA in the near future.
1. FDA. FDA approves new drug to prevent RSV in babies and toddlers [press release]. Published July 17, 2023. Accessed August 29, 2023. www.fda.gov/news-events/press-announcements/fda-approves-new-drug-prevent-rsv-babies-and-toddlers
2. Jones J. Evidence to recommendation framework: nirsevimab updates. Presented to the ACIP on August 3, 2023. Accessed August 23, 2023. https://stacks.cdc.gov/view/cdc/131586
3. American Academy of Pediatrics Committee on Infectious Diseases; American Academy of Pediatrics Bronchiolitis Guidelines Committee. Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics. 2014;134:e620–e638. doi: 10.1542/peds.2014-1666
4. Jones J. Proposed clinical consideration updates for nirsevimab. Presented to the ACIP on August 3, 2023. Accessed August 23, 2023. www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-08-3/04-rsv-jones-508.pdf
5. Peacock G. Nirsevimab: implementation considerations. Presented to the ACIP on August 3, 2023. Accessed August 23, 2023. https://stacks.cdc.gov/view/cdc/131587
There is now an additional option for the prevention of respiratory syncytial virus (RSV), the most common cause of hospitalization among infants and children in the United States. In July, the US Food and Drug Administration (FDA) approved nirsevimab, an RSV preventive monoclonal antibody, for use in neonates and infants born during or entering their first RSV season and in children up to 24 months of age who remain vulnerable to RSV during their second season.1 The Advisory Committee on Immunization Practices (ACIP) subsequently made 2 recommendations regarding use of nirsevimab, which I’ll detail in a moment.2
First, a word about RSV. The Centers for Disease Control and Prevention estimates that each year in children younger than 5 years, RSV is responsible for 1.5 million outpatient clinic visits, 520,000 emergency department visits, 58,000 to 80,000 hospitalizations, and 100 to 200 deaths.2 The risk for hospitalization from RSV is highest in the second and third months of life and decreases with increasing age.
There are some racial disparities in RSV severity, likely reflecting social drivers of health: ICU admission rates are 1.2 to 1.6 times higher among non-Hispanic Black infants younger than 6 months than among non-Hispanic White infants, and hospitalization rates are up to 5 times higher in American Indian and Alaska Native populations.2
What nirsevimab adds to the toolbox. Until recently, there was only 1 RSV preventive agent available: palivizumab, also a monoclonal antibody. The American Academy of Pediatrics has recommended palivizumab be used only for infants at high risk for RSV infection, due to its high cost and the need for monthly injections for the duration of an RSV season. In addition, the Academy has noted that palivizumab has limited effect on RSV hospitalizations on a population basis and does not appear to affect mortality.3
Nirsevimab has a longer half-life than palivizumab, and only 1 injection is needed for the RSV season. Early studies on nirsevimab demonstrate 79% effectiveness in preventing medical-attended lower respiratory tract infection, 80.6% effectiveness in preventing hospitalization, and 90% effectiveness in preventing ICU admission. The number needed to immunize with nirsevimab to prevent an outpatient visit is estimated to be 17; to prevent an ED visit, 48; and to prevent an inpatient admission, 128. Due to the low RSV death rate, the studies were not able to demonstrate reduced mortality.2
What the ACIP recommends. At a special meeting in July, the ACIP recommended 1 dose of nirsevimab for2:
- all infants younger than 8 months who are born during or entering their first RSV season
- children ages 8 to 19 months who are at increased risk for severe RSV disease and entering their second RSV season.
Those at risk include children with chronic lung disease of prematurity who required medical support any time during the 6-month period before the start of their second RSV season; those with severe immunocompromise; those with cystic fibrosis who have manifestations of severe lung disease or weight-for-length < 10th percentile; and American Indian and Alaska Native children.2
How to administer nirsevimab. The dose of nirsevimab is 50 mg IM for those weighing < 5 kg, 100 mg for those weighing ≥ 5 kg, and 200 mg for high-risk children entering their second RSV season.2 Nirsevimab can be co-administered with other recommended vaccines; however, both nirsevimab and palivizumab should not be used in the same child in the same RSV season.
Nirsevimab should be administered in the first week of life for infants born shortly before or during RSV season, and shortly before the season for infants younger than 8 months and those ages 8 to 19 months who are at high risk.4 The months of highest RSV transmission in most locations are December through February, but this can vary. Local epidemiology and advice from state and local health departments are the best source of information about when RSV season starts and ends in your area.
On the horizon. Nirsevimab will be included in the Vaccines for Children program and covered by commercial health plans with no cost sharing.5 A maternal vaccine to prevent RSV in newborns is likely to be approved by the FDA in the near future.
There is now an additional option for the prevention of respiratory syncytial virus (RSV), the most common cause of hospitalization among infants and children in the United States. In July, the US Food and Drug Administration (FDA) approved nirsevimab, an RSV preventive monoclonal antibody, for use in neonates and infants born during or entering their first RSV season and in children up to 24 months of age who remain vulnerable to RSV during their second season.1 The Advisory Committee on Immunization Practices (ACIP) subsequently made 2 recommendations regarding use of nirsevimab, which I’ll detail in a moment.2
First, a word about RSV. The Centers for Disease Control and Prevention estimates that each year in children younger than 5 years, RSV is responsible for 1.5 million outpatient clinic visits, 520,000 emergency department visits, 58,000 to 80,000 hospitalizations, and 100 to 200 deaths.2 The risk for hospitalization from RSV is highest in the second and third months of life and decreases with increasing age.
There are some racial disparities in RSV severity, likely reflecting social drivers of health: ICU admission rates are 1.2 to 1.6 times higher among non-Hispanic Black infants younger than 6 months than among non-Hispanic White infants, and hospitalization rates are up to 5 times higher in American Indian and Alaska Native populations.2
What nirsevimab adds to the toolbox. Until recently, there was only 1 RSV preventive agent available: palivizumab, also a monoclonal antibody. The American Academy of Pediatrics has recommended palivizumab be used only for infants at high risk for RSV infection, due to its high cost and the need for monthly injections for the duration of an RSV season. In addition, the Academy has noted that palivizumab has limited effect on RSV hospitalizations on a population basis and does not appear to affect mortality.3
Nirsevimab has a longer half-life than palivizumab, and only 1 injection is needed for the RSV season. Early studies on nirsevimab demonstrate 79% effectiveness in preventing medical-attended lower respiratory tract infection, 80.6% effectiveness in preventing hospitalization, and 90% effectiveness in preventing ICU admission. The number needed to immunize with nirsevimab to prevent an outpatient visit is estimated to be 17; to prevent an ED visit, 48; and to prevent an inpatient admission, 128. Due to the low RSV death rate, the studies were not able to demonstrate reduced mortality.2
What the ACIP recommends. At a special meeting in July, the ACIP recommended 1 dose of nirsevimab for2:
- all infants younger than 8 months who are born during or entering their first RSV season
- children ages 8 to 19 months who are at increased risk for severe RSV disease and entering their second RSV season.
Those at risk include children with chronic lung disease of prematurity who required medical support any time during the 6-month period before the start of their second RSV season; those with severe immunocompromise; those with cystic fibrosis who have manifestations of severe lung disease or weight-for-length < 10th percentile; and American Indian and Alaska Native children.2
How to administer nirsevimab. The dose of nirsevimab is 50 mg IM for those weighing < 5 kg, 100 mg for those weighing ≥ 5 kg, and 200 mg for high-risk children entering their second RSV season.2 Nirsevimab can be co-administered with other recommended vaccines; however, both nirsevimab and palivizumab should not be used in the same child in the same RSV season.
Nirsevimab should be administered in the first week of life for infants born shortly before or during RSV season, and shortly before the season for infants younger than 8 months and those ages 8 to 19 months who are at high risk.4 The months of highest RSV transmission in most locations are December through February, but this can vary. Local epidemiology and advice from state and local health departments are the best source of information about when RSV season starts and ends in your area.
On the horizon. Nirsevimab will be included in the Vaccines for Children program and covered by commercial health plans with no cost sharing.5 A maternal vaccine to prevent RSV in newborns is likely to be approved by the FDA in the near future.
1. FDA. FDA approves new drug to prevent RSV in babies and toddlers [press release]. Published July 17, 2023. Accessed August 29, 2023. www.fda.gov/news-events/press-announcements/fda-approves-new-drug-prevent-rsv-babies-and-toddlers
2. Jones J. Evidence to recommendation framework: nirsevimab updates. Presented to the ACIP on August 3, 2023. Accessed August 23, 2023. https://stacks.cdc.gov/view/cdc/131586
3. American Academy of Pediatrics Committee on Infectious Diseases; American Academy of Pediatrics Bronchiolitis Guidelines Committee. Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics. 2014;134:e620–e638. doi: 10.1542/peds.2014-1666
4. Jones J. Proposed clinical consideration updates for nirsevimab. Presented to the ACIP on August 3, 2023. Accessed August 23, 2023. www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-08-3/04-rsv-jones-508.pdf
5. Peacock G. Nirsevimab: implementation considerations. Presented to the ACIP on August 3, 2023. Accessed August 23, 2023. https://stacks.cdc.gov/view/cdc/131587
1. FDA. FDA approves new drug to prevent RSV in babies and toddlers [press release]. Published July 17, 2023. Accessed August 29, 2023. www.fda.gov/news-events/press-announcements/fda-approves-new-drug-prevent-rsv-babies-and-toddlers
2. Jones J. Evidence to recommendation framework: nirsevimab updates. Presented to the ACIP on August 3, 2023. Accessed August 23, 2023. https://stacks.cdc.gov/view/cdc/131586
3. American Academy of Pediatrics Committee on Infectious Diseases; American Academy of Pediatrics Bronchiolitis Guidelines Committee. Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics. 2014;134:e620–e638. doi: 10.1542/peds.2014-1666
4. Jones J. Proposed clinical consideration updates for nirsevimab. Presented to the ACIP on August 3, 2023. Accessed August 23, 2023. www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-08-3/04-rsv-jones-508.pdf
5. Peacock G. Nirsevimab: implementation considerations. Presented to the ACIP on August 3, 2023. Accessed August 23, 2023. https://stacks.cdc.gov/view/cdc/131587
Sepsis too often neglected in hospitals
according to a recent survey by the Centers for Disease Control and Prevention.
For the hospitals that do have sepsis teams, only 55% of them report that their team leaders get dedicated time to manage their sepsis programs.
“One in three people who dies in a hospital has sepsis during that hospitalization,” CDC Director Mandy Cohen, MD, MPH, noted in a statement. “That’s why CDC is calling on all U.S. hospitals to have a sepsis program and raise the bar on sepsis care by incorporating seven core elements.”
The sepsis seven
- Leadership: Dedicating the necessary human, financial, and information technology resources.
- Accountability: Appointing a leader responsible for program outcomes and setting concrete goals.
- Multiprofessional: Engaging key partners throughout the organization.
- Action: Implementing structures and processes to improve the identification, management, and recovery from sepsis.
- Tracking: Measuring sepsis epidemiology, outcomes, and progress toward program goals and the impact of sepsis initiatives.
- Reporting: Providing usable information on sepsis treatment and outcomes to relevant partners.
- Education: Providing sepsis education to health care professionals during onboarding and annually.
Craig Weinert, MD, MPH, a pulmonologist and critical care physician and professor of medicine at the University of Minnesota, Minneapolis, says the point the CDC is making with the announcement is that when these sepsis programs have been implemented at hospitals, they have been successful at reducing mortality. And now, the agency is urging all hospitals to implement them and support them properly.
“It’s not asking hospitals to develop new, innovative kinds of sepsis programs. This is not about new drugs or new antibiotics or new devices,” Dr. Weinert says. “This is about having hospitals dedicate organizational resources to implementing sepsis programs.”
The CDC’s announcement is aimed toward hospital administrators, Dr. Weinert adds. The agency is making the case that sepsis needs more funding in hospitals that either don’t have the programs or aren’t supporting them with dedicated resources.
There’s another message as well, Dr. Weinert says.
“COVID basically obliterated sepsis programs for two and a half years,” he says. Now the CDC is saying it’s time to divert staff back to sepsis care.
Stepping up sepsis care
Raymund Dantes, MD, assistant professor of medicine at Emory University, Atlanta, one of the developers of the core elements, says this is like a recipe for sepsis care.
Dr. Dantes compares the instructions for hospitals with getting a good restaurant up and running. And in the restaurant business, “you need more than the recipes. You need a leader or manager to ensure you have the right people working together, with the right supplies, getting the right feedback on their work to continuously improve,” he explains.
Dr. Dantes, who is also the physician lead for the Emory Healthcare Sepsis Program, says the approach is meant to be flexible to the size of the hospital, population served, and available resources.
He points out that a well-run sepsis program at a 25-bed rural hospital will look very different from the program at a 1,000-bed tertiary care hospital.
Some hospitals, Dr. Dantes says, will be starting from scratch when getting a sepsis program, and for those hospitals, the developers included a “Getting Started” section as part of the detailed, 29-page full report.
In September, Sepsis Awareness Month, the CDC will provide educational information to health care professionals, patients, families, and caregivers about preventing infections that can lead to sepsis through its ongoing Get Ahead of Sepsis campaign.
A version of this article first appeared on Medscape.com.
according to a recent survey by the Centers for Disease Control and Prevention.
For the hospitals that do have sepsis teams, only 55% of them report that their team leaders get dedicated time to manage their sepsis programs.
“One in three people who dies in a hospital has sepsis during that hospitalization,” CDC Director Mandy Cohen, MD, MPH, noted in a statement. “That’s why CDC is calling on all U.S. hospitals to have a sepsis program and raise the bar on sepsis care by incorporating seven core elements.”
The sepsis seven
- Leadership: Dedicating the necessary human, financial, and information technology resources.
- Accountability: Appointing a leader responsible for program outcomes and setting concrete goals.
- Multiprofessional: Engaging key partners throughout the organization.
- Action: Implementing structures and processes to improve the identification, management, and recovery from sepsis.
- Tracking: Measuring sepsis epidemiology, outcomes, and progress toward program goals and the impact of sepsis initiatives.
- Reporting: Providing usable information on sepsis treatment and outcomes to relevant partners.
- Education: Providing sepsis education to health care professionals during onboarding and annually.
Craig Weinert, MD, MPH, a pulmonologist and critical care physician and professor of medicine at the University of Minnesota, Minneapolis, says the point the CDC is making with the announcement is that when these sepsis programs have been implemented at hospitals, they have been successful at reducing mortality. And now, the agency is urging all hospitals to implement them and support them properly.
“It’s not asking hospitals to develop new, innovative kinds of sepsis programs. This is not about new drugs or new antibiotics or new devices,” Dr. Weinert says. “This is about having hospitals dedicate organizational resources to implementing sepsis programs.”
The CDC’s announcement is aimed toward hospital administrators, Dr. Weinert adds. The agency is making the case that sepsis needs more funding in hospitals that either don’t have the programs or aren’t supporting them with dedicated resources.
There’s another message as well, Dr. Weinert says.
“COVID basically obliterated sepsis programs for two and a half years,” he says. Now the CDC is saying it’s time to divert staff back to sepsis care.
Stepping up sepsis care
Raymund Dantes, MD, assistant professor of medicine at Emory University, Atlanta, one of the developers of the core elements, says this is like a recipe for sepsis care.
Dr. Dantes compares the instructions for hospitals with getting a good restaurant up and running. And in the restaurant business, “you need more than the recipes. You need a leader or manager to ensure you have the right people working together, with the right supplies, getting the right feedback on their work to continuously improve,” he explains.
Dr. Dantes, who is also the physician lead for the Emory Healthcare Sepsis Program, says the approach is meant to be flexible to the size of the hospital, population served, and available resources.
He points out that a well-run sepsis program at a 25-bed rural hospital will look very different from the program at a 1,000-bed tertiary care hospital.
Some hospitals, Dr. Dantes says, will be starting from scratch when getting a sepsis program, and for those hospitals, the developers included a “Getting Started” section as part of the detailed, 29-page full report.
In September, Sepsis Awareness Month, the CDC will provide educational information to health care professionals, patients, families, and caregivers about preventing infections that can lead to sepsis through its ongoing Get Ahead of Sepsis campaign.
A version of this article first appeared on Medscape.com.
according to a recent survey by the Centers for Disease Control and Prevention.
For the hospitals that do have sepsis teams, only 55% of them report that their team leaders get dedicated time to manage their sepsis programs.
“One in three people who dies in a hospital has sepsis during that hospitalization,” CDC Director Mandy Cohen, MD, MPH, noted in a statement. “That’s why CDC is calling on all U.S. hospitals to have a sepsis program and raise the bar on sepsis care by incorporating seven core elements.”
The sepsis seven
- Leadership: Dedicating the necessary human, financial, and information technology resources.
- Accountability: Appointing a leader responsible for program outcomes and setting concrete goals.
- Multiprofessional: Engaging key partners throughout the organization.
- Action: Implementing structures and processes to improve the identification, management, and recovery from sepsis.
- Tracking: Measuring sepsis epidemiology, outcomes, and progress toward program goals and the impact of sepsis initiatives.
- Reporting: Providing usable information on sepsis treatment and outcomes to relevant partners.
- Education: Providing sepsis education to health care professionals during onboarding and annually.
Craig Weinert, MD, MPH, a pulmonologist and critical care physician and professor of medicine at the University of Minnesota, Minneapolis, says the point the CDC is making with the announcement is that when these sepsis programs have been implemented at hospitals, they have been successful at reducing mortality. And now, the agency is urging all hospitals to implement them and support them properly.
“It’s not asking hospitals to develop new, innovative kinds of sepsis programs. This is not about new drugs or new antibiotics or new devices,” Dr. Weinert says. “This is about having hospitals dedicate organizational resources to implementing sepsis programs.”
The CDC’s announcement is aimed toward hospital administrators, Dr. Weinert adds. The agency is making the case that sepsis needs more funding in hospitals that either don’t have the programs or aren’t supporting them with dedicated resources.
There’s another message as well, Dr. Weinert says.
“COVID basically obliterated sepsis programs for two and a half years,” he says. Now the CDC is saying it’s time to divert staff back to sepsis care.
Stepping up sepsis care
Raymund Dantes, MD, assistant professor of medicine at Emory University, Atlanta, one of the developers of the core elements, says this is like a recipe for sepsis care.
Dr. Dantes compares the instructions for hospitals with getting a good restaurant up and running. And in the restaurant business, “you need more than the recipes. You need a leader or manager to ensure you have the right people working together, with the right supplies, getting the right feedback on their work to continuously improve,” he explains.
Dr. Dantes, who is also the physician lead for the Emory Healthcare Sepsis Program, says the approach is meant to be flexible to the size of the hospital, population served, and available resources.
He points out that a well-run sepsis program at a 25-bed rural hospital will look very different from the program at a 1,000-bed tertiary care hospital.
Some hospitals, Dr. Dantes says, will be starting from scratch when getting a sepsis program, and for those hospitals, the developers included a “Getting Started” section as part of the detailed, 29-page full report.
In September, Sepsis Awareness Month, the CDC will provide educational information to health care professionals, patients, families, and caregivers about preventing infections that can lead to sepsis through its ongoing Get Ahead of Sepsis campaign.
A version of this article first appeared on Medscape.com.
Complications of Body Piercings: A Systematic Review
The practice of body piercing has been present in cultures around the world for centuries. Piercings may be performed for religious or spiritual reasons or as a form of self-expression. In recent years, body piercings have become increasingly popular in all genders, with the most common sites being the ears, mouth, nose, eyebrows, nipples, navel, and genitals.1 The prevalence of body piercing in the general population is estimated to be as high as 50%.2 With the rising popularity of piercings, there also has been an increase in their associated complications, with one study noting that up to 35% of individuals with pierced ears and 30% of all pierced sites developed a complication.3 Common problems following piercing include infections, keloid formation, allergic contact dermatitis, site deformation, and tooth fractures.4 It is of utmost importance that health care professionals are aware of the potential complications associated with such a common practice. A comprehensive review of complications associated with cutaneous and mucosal piercings is lacking. We conducted a systematic review to summarize the clinical characteristics, complication types and frequency, and treatments reported for cutaneous and mucosal piercings.
METHODS
We conducted a systematic review of the literature adhering to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) reporting guidelines.5
Search Strategy, Study Eligibility Criteria, and Study Selection
A literature search of the Embase, MEDLINE, and PubMed databases was performed on June 20, 2022, using search terms related to body piercing and possible piercing-induced complications (Supplemental Information online). All studies reporting complications following body piercing were included. In vitro and animal studies were excluded. Title and abstract screening were completed by 6 independent researchers (S.C., K.K., M.M-B., K.A., T.S., I.M.M.) using Covidence online systematic review software (www.covidence.org). Six reviewers (S.C., K.K., M.M-B., K.A., T.S., I.M.M.) independently evaluated titles, abstracts, and full texts to identify relevant studies. Conflicts were resolved by the senior reviewer (I.M.M.).
Data Extraction and Synthesis
Five reviewers (S.C., K.K., M.M-B., K.A., T.S.) independently extracted data from eligible studies using a standardized extraction form that included title; authors; year of publication; sample size; and key findings, including mean age, sex, piercing location, complication type, and treatment received.
Treatment type was placed into the following categories: surgical treatments, antimicrobials, medical treatments, direct-target therapy, oral procedures, avoidance, miscellaneous therapies, and no treatment. (Data regarding treatments can be found in the Supplemental Information online.)
RESULTS
The combined search yielded 2679 studies, 617 of which underwent full-text review; 319 studies were included (Figure). Studies were published from 1950 to June 2022 and included both adult and pediatric populations.
Patient Characteristics
In total, our pooled analysis included data on 30,090 complications across 36,803 pierced sites in 30,231 patients (Table 1). Demographic data are available for 55% (n=30,231) of patients. Overall, 74% (22,247/30,231) of the individuals included in our analysis were female. The mean age was 27.8 years (range, 0–76 years).
Piercing Location
Overall, 36,803 pierced sites had a reported complication. The oral cavity, location not otherwise specified, was the most common site associated with a complication, accounting for 67% (n=24,478) of complications (Table 1). Other reported sites included (in decreasing frequency) the ears (21%, n=7551), tongue (5%, n=1669), lip (3%, n=998), navel (2%, n=605), nose (1%, n=540), nipple (1%, n=344), face/body (1%, n=269), genitals/groin (0%, n=183), eyebrow (0%, n=161), hand (0%, n=4), and eyelid (0%, n=1). Piercing complications were more commonly reported among females across all piercing locations except for the eyebrow, which was equal in both sexes.
Complications
Local Infections—Local infections accounted for 36% of reported complication types (n=10,872/30,090): perichondritis (1%, n=85); abscesses (0%, n=25); bacterial colonization (1%, n=106); and local infections, not otherwise specified (98%, n=10,648)(Table 2). The majority of local infections were found to be secondary to piercings of the ear and oral cavity. The nipple was found to be a common site for abscesses (40%, n=10), whereas the tongue was found to be the most common site for bacterial colonization (69%, n=73).
Immune-Mediated Issues—Immune-mediated issues encompassed 5% of the total reported complications (n=1561/30,090). The most commonly reported immune-mediated complications included allergies (31%, n=482), edema and swelling (21%, n=331), dermatitis (18%, n=282), and inflammatory lesions (17%, n=270). The majority were found to occur secondary to ear piercings, with the exception of edema, which mainly occurred secondary to tongue piercings (45%, n=150), and allergy, which primarily was associated with oral piercings (51%, n=245)(Table 2).
Tissue Damage—Tissue damage accounted for 43% of all complications (n=13,036/30,090). The most common forms of tissue damage were trauma (55%, n=7182), dysesthesia (22%, n=2883), bleeding and bruising (18%, n=2376), and pain (3%, n=370)(Table 2). Trauma was mainly found to be a complication in the context of oral piercings (99%, n=7121). Similarly, 94% (n=2242) of bleeding and bruising occurred secondary to oral piercings. Embedded piercings (92%, n=127), deformity (91%, n=29), and necrosis (75%, n=3) mostly occurred following ear piercings. Lip piercings were found to be the most common cause of damage to surrounding structures (98%, n=50).
Oral—Overall, 3193 intraoral complications were reported, constituting 11% of the total complications (Table 2). Oral complications included dental damage (86%, n=2732), gum recession (14%, n=459), and gingivitis (0%, n=2). Dental damage was mostly reported following oral piercings (90%, n=2453), whereas gum recession was mostly reported following lip piercings (59%, n=272).
Proliferations—Proliferations accounted for 795 (3%) of reported piercing complications. The majority (97%, n=772) were keloids, 2% (n=16) were other benign growths, and 1% (n=7) were malignancies. These complications mostly occurred secondary to ear piercings, which resulted in 741 (96%) keloids, 6 (38%) benign growths, and 4 (57%) malignancies.
Systemic—Overall, 2% (n=633) of the total complications were classified as systemic issues, including functional impairment (45%, n=282), secondary organ involvement (24%, n=150), cardiac issues (3%, n=21), and aspiration/inhalation (1%, n=8). Nonlocalized infections such as hepatitis or an increased risk thereof (17%, n=107), tetanus (8%, n=52), chlamydia (1%, n=9), HIV (0%, n=1), herpes simplex virus (0%, n=1), gonorrhea (0%, n=1), and bacterial vaginosis (0%, n=1) also were included in this category. The tongue, ear, and genitals were the locations most involved in these complications (Table 2). Secondary organ involvement mostly occurred after ear (36%, n=54) and genital piercings (27%, n=41). A total of 8 cases of piercing aspiration and/or inhalation were reported in association with piercings of the head and neck (Table 2).
COMMENT
Piercing Complications
Overall, the ear, tongue, and oral cavity were found to be the sites with the most associated complications recorded in the literature, and local infection and tissue damage were found to be the most prevalent types of complications. A plethora of treatments were used to manage piercing-induced complications, including surgical or medical treatments and avoidance (Supplemental Information). Reports by Metts6 and Escudero-Castaño et al7 provide detailed protocols and photographs of piercings.
Infections
Our review found that local infections were commonly reported complications associated with body piercings, which is consistent with other studies.1 The initial trauma inherent in the piercing process followed by the presence of an ongoing foreign body lends itself to an increased risk for developing these complications. Wound healing after piercing also varies based on the piercing location.
The rate and severity of the infection are influenced by the anatomic location of the piercing, hygiene, method of piercing, types of materials used, and aftercare.8 Piercing cartilage sites, such as the helix, concha, or nose, increases susceptibility to infections and permanent deformities. Cartilage is particularly at risk because of its avascular nature.9 Other studies have reported similar incidences of superficial localized infections; infectious complications were seen in 10% to 30% of body piercings in one study,3 while 45% of American and Australian college students reported infection at a piercing site in a second study.10
Systemic Issues
Systemic issues are potentially the most dangerous piercing-induced complications, though they were rarer in our analysis. Some serious complications included septic emboli, fatal staphylococcal toxic shock syndrome, and death. Although some systemic issues, such as staphylococcal toxic shock syndrome and septic sacroiliitis, required extensive hospital stays and complex treatment, others had lifelong repercussions, such as hepatitis and HIV. One report showed an increased incidence of endocarditis associated with body piercing, including staphylococcal endocarditis following nasal piercings, Neisseria endocarditis following tongue piercings, and Staphylococcus epidermidis endocarditis following nipple piercings.11 Moreover, Mariano et al12—who noted a case of endocarditis and meningitis associated with a nape piercing in a young female in 2015—reinforced the notion that information pertaining to the risks associated with body piercing must be better disseminated, given the potential for morbid or fatal outcomes. Finally, nonsterile piercing techniques and poor hygiene were found to contribute substantially to the increased risk for infection, so it is of utmost importance to reinforce proper practices in piercing salons.4
Immune-Mediated Issues
Because piercings are foreign bodies, they are susceptible to both acute and chronic immune responses. Our study found that allergies and dermatitis made up almost half of the immune-mediated piercing complications. It is especially important to emphasize that costume jewelry exposes our skin to a variety of contact allergens, most prominently nickel, heightening the risk for developing allergic contact dermatitis.13 Moreover, a study conducted by Brandão et al14 found that patients with pierced ears were significantly more likely to react to nickel than those without pierced ears (P=.031). Although other studies have found that allergy to metals ranges from 8.3% to 20% in the general population,15 we were not able to quantify the incidence in our study due to a lack of reporting of common benign complications, such as contact dermatitis.
Tissue Damage and Local Problems
Our review found that tissue and oral damage also were commonly reported piercing complications, with the most common pathologies being trauma, dysesthesia, bleeding/bruising, and dental damage. Laumann and Derick16 reported that bleeding, tissue trauma, and local problems were common physical health problems associated with body piercing. Severe complications, such as abscesses, toxic shock syndrome, and endocarditis, also have been reported in association with intraoral piercings.17 Moreover, other studies have shown that oral piercings are associated with several adverse oral and systemic conditions. A meta-analysis of individuals with oral piercings found a similar prevalence of dental fracture, gingival recession, and tooth wear (34%), as well as unspecified dental damage (27%) and tooth chipping (22%). Additionally, this meta-analysis reported a 3-fold increased risk for dental fracture and 7-fold increased risk for gingival recession with oral piercings.18 Another meta-analysis of oral piercing complications found a similar prevalence of dental fracture (34%), tooth wear (34%), gingival recession (33%), unspecified dental damage (27%), and tooth chipping (22%).19 Considering the extensive amount of cumulative damage, wearers of oral jewelry require periodic periodontal evaluations to monitor for dental damage and gingival recession.20 There are limited data on treatments for complications of oral piercings, and further research in this area is warranted.
Proliferations and Scars
Although proliferations and scarring were among the least common complications reported in the literature, they are some of the most cosmetically disfiguring for patients. Keloids, the most common type of growth associated with piercings, do not naturally regress and thus require some form of intervention. Given the multimodal approach used to treat keloids, as described by the evidence-based algorithm by Ogawa,21 it is not surprising that keloids also represented the complication most treated with medical therapies, such as steroids, and also with direct-target therapy, such as liquid nitrogen therapy (Supplemental Information).
Other proliferations reported in the literature include benign pyogenic granulomas22 and much less commonly malignant neoplasms such as basal cell carcinoma23 and squamous cell carcinoma.24 Although rare, treatment of piercing-associated malignancies include surgical removal, chemotherapy, and radiation therapy (Supplemental Information).
Limitations
There are several limitations to our systematic review. First, heterogeneity in study designs, patient populations, treatment interventions, and outcome measures of included studies may have affected the quality and generalizability of our results. Moreover, because the studies included in this systematic review focused on specific complications, we could not compare our results to the literature that analyzes incidence rates of piercing complications. Furthermore, not all studies included the data that we hoped to extract, and thus only available data were reported in these instances. Finally, the articles we reviewed may have included publication bias, with positive findings being more frequently published, potentially inflating certain types and sites of complications and treatment choices. Despite these limitations, our review provides essential information that must be interpreted in a clinical context.
CONCLUSION
Given that cutaneous and mucosal piercing has become more prevalent in recent years, along with an increase in the variety of piercing-induced complications, it is of utmost importance that piercing salons have proper hygiene practices in place and that patients are aware of the multitude of potential complications that can arise—whether common and benign or rare but life-threatening.
- Preslar D, Borger J. Body piercing infections. In: StatPearls. StatPearls Publishing; 2022.
- Antoszewski B, Jedrzejczak M, Kruk-Jeromin J. Complications after body piercing in patient suffering from type 1 diabetes mellitus. Int J Dermatol. 2007;46:1250-1252.
- Simplot TC, Hoffman HT. Comparison between cartilage and soft tissue ear piercing complications. Am J Otolaryngol. 1998;19:305-310.
- Meltzer DI. Complications of body piercing. Am Fam Physician. 2005;72:2029-2034.
- Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71.
- Metts J. Common complications of body piercing. West J Med. 2002;176:85-86.
- Escudero-Castaño N, Perea-García MA, Campo-Trapero J, et al. Oral and perioral piercing complications. Open Dent J. 2008;2:133-136.
- Tweeten SS, Rickman LS. Infectious complications of body piercing. Clin Infect Dis. 1998;26:735-740.
- Gabriel OT, Anthony OO, Paul EA, et al. Trends and complications of ear piercing among selected Nigerian population. J Family Med Prim Care. 2017;6:517-521.
- Armstrong ML, Koch JR, Saunders JC, et al. The hole picture: risks, decision making, purpose, regulations, and the future of body piercing. Clin Dermatol. 2007;25:398-406.
- Millar BC, Moore JE. Antibiotic prophylaxis, body piercing and infective endocarditis. J Antimicrob Chemother. 2004;53:123-126.
- Mariano A, Pisapia R, Abdeddaim A, et al. Endocarditis and meningitis associated to nape piercing in a young female: a case report. Infez Med. 2015;23:275-279.
- Ivey LA, Limone BA, Jacob SE. Approach to the jewelry aficionado. Pediatr Dermatol. 2018;35:274-275.
- Brandão MH, Gontijo B, Girundi MA, et al. Ear piercing as a risk factor for contact allergy to nickel. J Pediatr (Rio J). 2010;86:149-154.
- Schuttelaar MLA, Ofenloch RF, Bruze M, et al. Prevalence of contact allergy to metals in the European general population with a focus on nickel and piercings: The EDEN Fragrance Study. Contact Dermatitis. 2018;79:1-9.
- Laumann AE, Derick AJ. Tattoos and body piercings in the United States: a national data set. J Am Acad Dermatol. 2006;55:413-421.
- De Moor RJ, De Witte AM, Delmé KI, et al. Dental and oral complications of lip and tongue piercings. Br Dent J. 2005;199:506-509.
- Offen E, Allison JR. Do oral piercings cause problems in the mouth? Evid Based Dent. 2022;23:126-127.
- Passos PF, Pintor AVB, Marañón-Vásquez GA, et al. Oral manifestations arising from oral piercings: A systematic review and meta-analyses. Oral Surg Oral Med Oral Pathol Oral Radiol. 2022;134:327-341.
- Covello F, Salerno C, Giovannini V, et al. Piercing and oral health: a study on the knowledge of risks and complications. Int J Environ Res Public Health. 2020;17:613.
- Ogawa R. The most current algorithms for the treatment and prevention of hypertrophic scars and keloids: a 2020 update of the algorithms published 10 years ago. Plast Reconstr Surg. 2022;149:E79-E94.
- Kumar Ghosh S, Bandyopadhyay D. Granuloma pyogenicum as a complication of decorative nose piercing: report of eight cases from eastern India. J Cutan Med Surg. 2012;16:197-200.
- Dreher K, Kern M, Rush L, et al. Basal cell carcinoma invasion of an ear piercing. Dermatol Online J. 2022;28.
- Stanko P, Poruban D, Mracna J, et al. Squamous cell carcinoma and piercing of the tongue—a case report. J Craniomaxillofac Surg. 2012;40:329-331.
The practice of body piercing has been present in cultures around the world for centuries. Piercings may be performed for religious or spiritual reasons or as a form of self-expression. In recent years, body piercings have become increasingly popular in all genders, with the most common sites being the ears, mouth, nose, eyebrows, nipples, navel, and genitals.1 The prevalence of body piercing in the general population is estimated to be as high as 50%.2 With the rising popularity of piercings, there also has been an increase in their associated complications, with one study noting that up to 35% of individuals with pierced ears and 30% of all pierced sites developed a complication.3 Common problems following piercing include infections, keloid formation, allergic contact dermatitis, site deformation, and tooth fractures.4 It is of utmost importance that health care professionals are aware of the potential complications associated with such a common practice. A comprehensive review of complications associated with cutaneous and mucosal piercings is lacking. We conducted a systematic review to summarize the clinical characteristics, complication types and frequency, and treatments reported for cutaneous and mucosal piercings.
METHODS
We conducted a systematic review of the literature adhering to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) reporting guidelines.5
Search Strategy, Study Eligibility Criteria, and Study Selection
A literature search of the Embase, MEDLINE, and PubMed databases was performed on June 20, 2022, using search terms related to body piercing and possible piercing-induced complications (Supplemental Information online). All studies reporting complications following body piercing were included. In vitro and animal studies were excluded. Title and abstract screening were completed by 6 independent researchers (S.C., K.K., M.M-B., K.A., T.S., I.M.M.) using Covidence online systematic review software (www.covidence.org). Six reviewers (S.C., K.K., M.M-B., K.A., T.S., I.M.M.) independently evaluated titles, abstracts, and full texts to identify relevant studies. Conflicts were resolved by the senior reviewer (I.M.M.).
Data Extraction and Synthesis
Five reviewers (S.C., K.K., M.M-B., K.A., T.S.) independently extracted data from eligible studies using a standardized extraction form that included title; authors; year of publication; sample size; and key findings, including mean age, sex, piercing location, complication type, and treatment received.
Treatment type was placed into the following categories: surgical treatments, antimicrobials, medical treatments, direct-target therapy, oral procedures, avoidance, miscellaneous therapies, and no treatment. (Data regarding treatments can be found in the Supplemental Information online.)
RESULTS
The combined search yielded 2679 studies, 617 of which underwent full-text review; 319 studies were included (Figure). Studies were published from 1950 to June 2022 and included both adult and pediatric populations.
Patient Characteristics
In total, our pooled analysis included data on 30,090 complications across 36,803 pierced sites in 30,231 patients (Table 1). Demographic data are available for 55% (n=30,231) of patients. Overall, 74% (22,247/30,231) of the individuals included in our analysis were female. The mean age was 27.8 years (range, 0–76 years).
Piercing Location
Overall, 36,803 pierced sites had a reported complication. The oral cavity, location not otherwise specified, was the most common site associated with a complication, accounting for 67% (n=24,478) of complications (Table 1). Other reported sites included (in decreasing frequency) the ears (21%, n=7551), tongue (5%, n=1669), lip (3%, n=998), navel (2%, n=605), nose (1%, n=540), nipple (1%, n=344), face/body (1%, n=269), genitals/groin (0%, n=183), eyebrow (0%, n=161), hand (0%, n=4), and eyelid (0%, n=1). Piercing complications were more commonly reported among females across all piercing locations except for the eyebrow, which was equal in both sexes.
Complications
Local Infections—Local infections accounted for 36% of reported complication types (n=10,872/30,090): perichondritis (1%, n=85); abscesses (0%, n=25); bacterial colonization (1%, n=106); and local infections, not otherwise specified (98%, n=10,648)(Table 2). The majority of local infections were found to be secondary to piercings of the ear and oral cavity. The nipple was found to be a common site for abscesses (40%, n=10), whereas the tongue was found to be the most common site for bacterial colonization (69%, n=73).
Immune-Mediated Issues—Immune-mediated issues encompassed 5% of the total reported complications (n=1561/30,090). The most commonly reported immune-mediated complications included allergies (31%, n=482), edema and swelling (21%, n=331), dermatitis (18%, n=282), and inflammatory lesions (17%, n=270). The majority were found to occur secondary to ear piercings, with the exception of edema, which mainly occurred secondary to tongue piercings (45%, n=150), and allergy, which primarily was associated with oral piercings (51%, n=245)(Table 2).
Tissue Damage—Tissue damage accounted for 43% of all complications (n=13,036/30,090). The most common forms of tissue damage were trauma (55%, n=7182), dysesthesia (22%, n=2883), bleeding and bruising (18%, n=2376), and pain (3%, n=370)(Table 2). Trauma was mainly found to be a complication in the context of oral piercings (99%, n=7121). Similarly, 94% (n=2242) of bleeding and bruising occurred secondary to oral piercings. Embedded piercings (92%, n=127), deformity (91%, n=29), and necrosis (75%, n=3) mostly occurred following ear piercings. Lip piercings were found to be the most common cause of damage to surrounding structures (98%, n=50).
Oral—Overall, 3193 intraoral complications were reported, constituting 11% of the total complications (Table 2). Oral complications included dental damage (86%, n=2732), gum recession (14%, n=459), and gingivitis (0%, n=2). Dental damage was mostly reported following oral piercings (90%, n=2453), whereas gum recession was mostly reported following lip piercings (59%, n=272).
Proliferations—Proliferations accounted for 795 (3%) of reported piercing complications. The majority (97%, n=772) were keloids, 2% (n=16) were other benign growths, and 1% (n=7) were malignancies. These complications mostly occurred secondary to ear piercings, which resulted in 741 (96%) keloids, 6 (38%) benign growths, and 4 (57%) malignancies.
Systemic—Overall, 2% (n=633) of the total complications were classified as systemic issues, including functional impairment (45%, n=282), secondary organ involvement (24%, n=150), cardiac issues (3%, n=21), and aspiration/inhalation (1%, n=8). Nonlocalized infections such as hepatitis or an increased risk thereof (17%, n=107), tetanus (8%, n=52), chlamydia (1%, n=9), HIV (0%, n=1), herpes simplex virus (0%, n=1), gonorrhea (0%, n=1), and bacterial vaginosis (0%, n=1) also were included in this category. The tongue, ear, and genitals were the locations most involved in these complications (Table 2). Secondary organ involvement mostly occurred after ear (36%, n=54) and genital piercings (27%, n=41). A total of 8 cases of piercing aspiration and/or inhalation were reported in association with piercings of the head and neck (Table 2).
COMMENT
Piercing Complications
Overall, the ear, tongue, and oral cavity were found to be the sites with the most associated complications recorded in the literature, and local infection and tissue damage were found to be the most prevalent types of complications. A plethora of treatments were used to manage piercing-induced complications, including surgical or medical treatments and avoidance (Supplemental Information). Reports by Metts6 and Escudero-Castaño et al7 provide detailed protocols and photographs of piercings.
Infections
Our review found that local infections were commonly reported complications associated with body piercings, which is consistent with other studies.1 The initial trauma inherent in the piercing process followed by the presence of an ongoing foreign body lends itself to an increased risk for developing these complications. Wound healing after piercing also varies based on the piercing location.
The rate and severity of the infection are influenced by the anatomic location of the piercing, hygiene, method of piercing, types of materials used, and aftercare.8 Piercing cartilage sites, such as the helix, concha, or nose, increases susceptibility to infections and permanent deformities. Cartilage is particularly at risk because of its avascular nature.9 Other studies have reported similar incidences of superficial localized infections; infectious complications were seen in 10% to 30% of body piercings in one study,3 while 45% of American and Australian college students reported infection at a piercing site in a second study.10
Systemic Issues
Systemic issues are potentially the most dangerous piercing-induced complications, though they were rarer in our analysis. Some serious complications included septic emboli, fatal staphylococcal toxic shock syndrome, and death. Although some systemic issues, such as staphylococcal toxic shock syndrome and septic sacroiliitis, required extensive hospital stays and complex treatment, others had lifelong repercussions, such as hepatitis and HIV. One report showed an increased incidence of endocarditis associated with body piercing, including staphylococcal endocarditis following nasal piercings, Neisseria endocarditis following tongue piercings, and Staphylococcus epidermidis endocarditis following nipple piercings.11 Moreover, Mariano et al12—who noted a case of endocarditis and meningitis associated with a nape piercing in a young female in 2015—reinforced the notion that information pertaining to the risks associated with body piercing must be better disseminated, given the potential for morbid or fatal outcomes. Finally, nonsterile piercing techniques and poor hygiene were found to contribute substantially to the increased risk for infection, so it is of utmost importance to reinforce proper practices in piercing salons.4
Immune-Mediated Issues
Because piercings are foreign bodies, they are susceptible to both acute and chronic immune responses. Our study found that allergies and dermatitis made up almost half of the immune-mediated piercing complications. It is especially important to emphasize that costume jewelry exposes our skin to a variety of contact allergens, most prominently nickel, heightening the risk for developing allergic contact dermatitis.13 Moreover, a study conducted by Brandão et al14 found that patients with pierced ears were significantly more likely to react to nickel than those without pierced ears (P=.031). Although other studies have found that allergy to metals ranges from 8.3% to 20% in the general population,15 we were not able to quantify the incidence in our study due to a lack of reporting of common benign complications, such as contact dermatitis.
Tissue Damage and Local Problems
Our review found that tissue and oral damage also were commonly reported piercing complications, with the most common pathologies being trauma, dysesthesia, bleeding/bruising, and dental damage. Laumann and Derick16 reported that bleeding, tissue trauma, and local problems were common physical health problems associated with body piercing. Severe complications, such as abscesses, toxic shock syndrome, and endocarditis, also have been reported in association with intraoral piercings.17 Moreover, other studies have shown that oral piercings are associated with several adverse oral and systemic conditions. A meta-analysis of individuals with oral piercings found a similar prevalence of dental fracture, gingival recession, and tooth wear (34%), as well as unspecified dental damage (27%) and tooth chipping (22%). Additionally, this meta-analysis reported a 3-fold increased risk for dental fracture and 7-fold increased risk for gingival recession with oral piercings.18 Another meta-analysis of oral piercing complications found a similar prevalence of dental fracture (34%), tooth wear (34%), gingival recession (33%), unspecified dental damage (27%), and tooth chipping (22%).19 Considering the extensive amount of cumulative damage, wearers of oral jewelry require periodic periodontal evaluations to monitor for dental damage and gingival recession.20 There are limited data on treatments for complications of oral piercings, and further research in this area is warranted.
Proliferations and Scars
Although proliferations and scarring were among the least common complications reported in the literature, they are some of the most cosmetically disfiguring for patients. Keloids, the most common type of growth associated with piercings, do not naturally regress and thus require some form of intervention. Given the multimodal approach used to treat keloids, as described by the evidence-based algorithm by Ogawa,21 it is not surprising that keloids also represented the complication most treated with medical therapies, such as steroids, and also with direct-target therapy, such as liquid nitrogen therapy (Supplemental Information).
Other proliferations reported in the literature include benign pyogenic granulomas22 and much less commonly malignant neoplasms such as basal cell carcinoma23 and squamous cell carcinoma.24 Although rare, treatment of piercing-associated malignancies include surgical removal, chemotherapy, and radiation therapy (Supplemental Information).
Limitations
There are several limitations to our systematic review. First, heterogeneity in study designs, patient populations, treatment interventions, and outcome measures of included studies may have affected the quality and generalizability of our results. Moreover, because the studies included in this systematic review focused on specific complications, we could not compare our results to the literature that analyzes incidence rates of piercing complications. Furthermore, not all studies included the data that we hoped to extract, and thus only available data were reported in these instances. Finally, the articles we reviewed may have included publication bias, with positive findings being more frequently published, potentially inflating certain types and sites of complications and treatment choices. Despite these limitations, our review provides essential information that must be interpreted in a clinical context.
CONCLUSION
Given that cutaneous and mucosal piercing has become more prevalent in recent years, along with an increase in the variety of piercing-induced complications, it is of utmost importance that piercing salons have proper hygiene practices in place and that patients are aware of the multitude of potential complications that can arise—whether common and benign or rare but life-threatening.
The practice of body piercing has been present in cultures around the world for centuries. Piercings may be performed for religious or spiritual reasons or as a form of self-expression. In recent years, body piercings have become increasingly popular in all genders, with the most common sites being the ears, mouth, nose, eyebrows, nipples, navel, and genitals.1 The prevalence of body piercing in the general population is estimated to be as high as 50%.2 With the rising popularity of piercings, there also has been an increase in their associated complications, with one study noting that up to 35% of individuals with pierced ears and 30% of all pierced sites developed a complication.3 Common problems following piercing include infections, keloid formation, allergic contact dermatitis, site deformation, and tooth fractures.4 It is of utmost importance that health care professionals are aware of the potential complications associated with such a common practice. A comprehensive review of complications associated with cutaneous and mucosal piercings is lacking. We conducted a systematic review to summarize the clinical characteristics, complication types and frequency, and treatments reported for cutaneous and mucosal piercings.
METHODS
We conducted a systematic review of the literature adhering to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) reporting guidelines.5
Search Strategy, Study Eligibility Criteria, and Study Selection
A literature search of the Embase, MEDLINE, and PubMed databases was performed on June 20, 2022, using search terms related to body piercing and possible piercing-induced complications (Supplemental Information online). All studies reporting complications following body piercing were included. In vitro and animal studies were excluded. Title and abstract screening were completed by 6 independent researchers (S.C., K.K., M.M-B., K.A., T.S., I.M.M.) using Covidence online systematic review software (www.covidence.org). Six reviewers (S.C., K.K., M.M-B., K.A., T.S., I.M.M.) independently evaluated titles, abstracts, and full texts to identify relevant studies. Conflicts were resolved by the senior reviewer (I.M.M.).
Data Extraction and Synthesis
Five reviewers (S.C., K.K., M.M-B., K.A., T.S.) independently extracted data from eligible studies using a standardized extraction form that included title; authors; year of publication; sample size; and key findings, including mean age, sex, piercing location, complication type, and treatment received.
Treatment type was placed into the following categories: surgical treatments, antimicrobials, medical treatments, direct-target therapy, oral procedures, avoidance, miscellaneous therapies, and no treatment. (Data regarding treatments can be found in the Supplemental Information online.)
RESULTS
The combined search yielded 2679 studies, 617 of which underwent full-text review; 319 studies were included (Figure). Studies were published from 1950 to June 2022 and included both adult and pediatric populations.
Patient Characteristics
In total, our pooled analysis included data on 30,090 complications across 36,803 pierced sites in 30,231 patients (Table 1). Demographic data are available for 55% (n=30,231) of patients. Overall, 74% (22,247/30,231) of the individuals included in our analysis were female. The mean age was 27.8 years (range, 0–76 years).
Piercing Location
Overall, 36,803 pierced sites had a reported complication. The oral cavity, location not otherwise specified, was the most common site associated with a complication, accounting for 67% (n=24,478) of complications (Table 1). Other reported sites included (in decreasing frequency) the ears (21%, n=7551), tongue (5%, n=1669), lip (3%, n=998), navel (2%, n=605), nose (1%, n=540), nipple (1%, n=344), face/body (1%, n=269), genitals/groin (0%, n=183), eyebrow (0%, n=161), hand (0%, n=4), and eyelid (0%, n=1). Piercing complications were more commonly reported among females across all piercing locations except for the eyebrow, which was equal in both sexes.
Complications
Local Infections—Local infections accounted for 36% of reported complication types (n=10,872/30,090): perichondritis (1%, n=85); abscesses (0%, n=25); bacterial colonization (1%, n=106); and local infections, not otherwise specified (98%, n=10,648)(Table 2). The majority of local infections were found to be secondary to piercings of the ear and oral cavity. The nipple was found to be a common site for abscesses (40%, n=10), whereas the tongue was found to be the most common site for bacterial colonization (69%, n=73).
Immune-Mediated Issues—Immune-mediated issues encompassed 5% of the total reported complications (n=1561/30,090). The most commonly reported immune-mediated complications included allergies (31%, n=482), edema and swelling (21%, n=331), dermatitis (18%, n=282), and inflammatory lesions (17%, n=270). The majority were found to occur secondary to ear piercings, with the exception of edema, which mainly occurred secondary to tongue piercings (45%, n=150), and allergy, which primarily was associated with oral piercings (51%, n=245)(Table 2).
Tissue Damage—Tissue damage accounted for 43% of all complications (n=13,036/30,090). The most common forms of tissue damage were trauma (55%, n=7182), dysesthesia (22%, n=2883), bleeding and bruising (18%, n=2376), and pain (3%, n=370)(Table 2). Trauma was mainly found to be a complication in the context of oral piercings (99%, n=7121). Similarly, 94% (n=2242) of bleeding and bruising occurred secondary to oral piercings. Embedded piercings (92%, n=127), deformity (91%, n=29), and necrosis (75%, n=3) mostly occurred following ear piercings. Lip piercings were found to be the most common cause of damage to surrounding structures (98%, n=50).
Oral—Overall, 3193 intraoral complications were reported, constituting 11% of the total complications (Table 2). Oral complications included dental damage (86%, n=2732), gum recession (14%, n=459), and gingivitis (0%, n=2). Dental damage was mostly reported following oral piercings (90%, n=2453), whereas gum recession was mostly reported following lip piercings (59%, n=272).
Proliferations—Proliferations accounted for 795 (3%) of reported piercing complications. The majority (97%, n=772) were keloids, 2% (n=16) were other benign growths, and 1% (n=7) were malignancies. These complications mostly occurred secondary to ear piercings, which resulted in 741 (96%) keloids, 6 (38%) benign growths, and 4 (57%) malignancies.
Systemic—Overall, 2% (n=633) of the total complications were classified as systemic issues, including functional impairment (45%, n=282), secondary organ involvement (24%, n=150), cardiac issues (3%, n=21), and aspiration/inhalation (1%, n=8). Nonlocalized infections such as hepatitis or an increased risk thereof (17%, n=107), tetanus (8%, n=52), chlamydia (1%, n=9), HIV (0%, n=1), herpes simplex virus (0%, n=1), gonorrhea (0%, n=1), and bacterial vaginosis (0%, n=1) also were included in this category. The tongue, ear, and genitals were the locations most involved in these complications (Table 2). Secondary organ involvement mostly occurred after ear (36%, n=54) and genital piercings (27%, n=41). A total of 8 cases of piercing aspiration and/or inhalation were reported in association with piercings of the head and neck (Table 2).
COMMENT
Piercing Complications
Overall, the ear, tongue, and oral cavity were found to be the sites with the most associated complications recorded in the literature, and local infection and tissue damage were found to be the most prevalent types of complications. A plethora of treatments were used to manage piercing-induced complications, including surgical or medical treatments and avoidance (Supplemental Information). Reports by Metts6 and Escudero-Castaño et al7 provide detailed protocols and photographs of piercings.
Infections
Our review found that local infections were commonly reported complications associated with body piercings, which is consistent with other studies.1 The initial trauma inherent in the piercing process followed by the presence of an ongoing foreign body lends itself to an increased risk for developing these complications. Wound healing after piercing also varies based on the piercing location.
The rate and severity of the infection are influenced by the anatomic location of the piercing, hygiene, method of piercing, types of materials used, and aftercare.8 Piercing cartilage sites, such as the helix, concha, or nose, increases susceptibility to infections and permanent deformities. Cartilage is particularly at risk because of its avascular nature.9 Other studies have reported similar incidences of superficial localized infections; infectious complications were seen in 10% to 30% of body piercings in one study,3 while 45% of American and Australian college students reported infection at a piercing site in a second study.10
Systemic Issues
Systemic issues are potentially the most dangerous piercing-induced complications, though they were rarer in our analysis. Some serious complications included septic emboli, fatal staphylococcal toxic shock syndrome, and death. Although some systemic issues, such as staphylococcal toxic shock syndrome and septic sacroiliitis, required extensive hospital stays and complex treatment, others had lifelong repercussions, such as hepatitis and HIV. One report showed an increased incidence of endocarditis associated with body piercing, including staphylococcal endocarditis following nasal piercings, Neisseria endocarditis following tongue piercings, and Staphylococcus epidermidis endocarditis following nipple piercings.11 Moreover, Mariano et al12—who noted a case of endocarditis and meningitis associated with a nape piercing in a young female in 2015—reinforced the notion that information pertaining to the risks associated with body piercing must be better disseminated, given the potential for morbid or fatal outcomes. Finally, nonsterile piercing techniques and poor hygiene were found to contribute substantially to the increased risk for infection, so it is of utmost importance to reinforce proper practices in piercing salons.4
Immune-Mediated Issues
Because piercings are foreign bodies, they are susceptible to both acute and chronic immune responses. Our study found that allergies and dermatitis made up almost half of the immune-mediated piercing complications. It is especially important to emphasize that costume jewelry exposes our skin to a variety of contact allergens, most prominently nickel, heightening the risk for developing allergic contact dermatitis.13 Moreover, a study conducted by Brandão et al14 found that patients with pierced ears were significantly more likely to react to nickel than those without pierced ears (P=.031). Although other studies have found that allergy to metals ranges from 8.3% to 20% in the general population,15 we were not able to quantify the incidence in our study due to a lack of reporting of common benign complications, such as contact dermatitis.
Tissue Damage and Local Problems
Our review found that tissue and oral damage also were commonly reported piercing complications, with the most common pathologies being trauma, dysesthesia, bleeding/bruising, and dental damage. Laumann and Derick16 reported that bleeding, tissue trauma, and local problems were common physical health problems associated with body piercing. Severe complications, such as abscesses, toxic shock syndrome, and endocarditis, also have been reported in association with intraoral piercings.17 Moreover, other studies have shown that oral piercings are associated with several adverse oral and systemic conditions. A meta-analysis of individuals with oral piercings found a similar prevalence of dental fracture, gingival recession, and tooth wear (34%), as well as unspecified dental damage (27%) and tooth chipping (22%). Additionally, this meta-analysis reported a 3-fold increased risk for dental fracture and 7-fold increased risk for gingival recession with oral piercings.18 Another meta-analysis of oral piercing complications found a similar prevalence of dental fracture (34%), tooth wear (34%), gingival recession (33%), unspecified dental damage (27%), and tooth chipping (22%).19 Considering the extensive amount of cumulative damage, wearers of oral jewelry require periodic periodontal evaluations to monitor for dental damage and gingival recession.20 There are limited data on treatments for complications of oral piercings, and further research in this area is warranted.
Proliferations and Scars
Although proliferations and scarring were among the least common complications reported in the literature, they are some of the most cosmetically disfiguring for patients. Keloids, the most common type of growth associated with piercings, do not naturally regress and thus require some form of intervention. Given the multimodal approach used to treat keloids, as described by the evidence-based algorithm by Ogawa,21 it is not surprising that keloids also represented the complication most treated with medical therapies, such as steroids, and also with direct-target therapy, such as liquid nitrogen therapy (Supplemental Information).
Other proliferations reported in the literature include benign pyogenic granulomas22 and much less commonly malignant neoplasms such as basal cell carcinoma23 and squamous cell carcinoma.24 Although rare, treatment of piercing-associated malignancies include surgical removal, chemotherapy, and radiation therapy (Supplemental Information).
Limitations
There are several limitations to our systematic review. First, heterogeneity in study designs, patient populations, treatment interventions, and outcome measures of included studies may have affected the quality and generalizability of our results. Moreover, because the studies included in this systematic review focused on specific complications, we could not compare our results to the literature that analyzes incidence rates of piercing complications. Furthermore, not all studies included the data that we hoped to extract, and thus only available data were reported in these instances. Finally, the articles we reviewed may have included publication bias, with positive findings being more frequently published, potentially inflating certain types and sites of complications and treatment choices. Despite these limitations, our review provides essential information that must be interpreted in a clinical context.
CONCLUSION
Given that cutaneous and mucosal piercing has become more prevalent in recent years, along with an increase in the variety of piercing-induced complications, it is of utmost importance that piercing salons have proper hygiene practices in place and that patients are aware of the multitude of potential complications that can arise—whether common and benign or rare but life-threatening.
- Preslar D, Borger J. Body piercing infections. In: StatPearls. StatPearls Publishing; 2022.
- Antoszewski B, Jedrzejczak M, Kruk-Jeromin J. Complications after body piercing in patient suffering from type 1 diabetes mellitus. Int J Dermatol. 2007;46:1250-1252.
- Simplot TC, Hoffman HT. Comparison between cartilage and soft tissue ear piercing complications. Am J Otolaryngol. 1998;19:305-310.
- Meltzer DI. Complications of body piercing. Am Fam Physician. 2005;72:2029-2034.
- Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71.
- Metts J. Common complications of body piercing. West J Med. 2002;176:85-86.
- Escudero-Castaño N, Perea-García MA, Campo-Trapero J, et al. Oral and perioral piercing complications. Open Dent J. 2008;2:133-136.
- Tweeten SS, Rickman LS. Infectious complications of body piercing. Clin Infect Dis. 1998;26:735-740.
- Gabriel OT, Anthony OO, Paul EA, et al. Trends and complications of ear piercing among selected Nigerian population. J Family Med Prim Care. 2017;6:517-521.
- Armstrong ML, Koch JR, Saunders JC, et al. The hole picture: risks, decision making, purpose, regulations, and the future of body piercing. Clin Dermatol. 2007;25:398-406.
- Millar BC, Moore JE. Antibiotic prophylaxis, body piercing and infective endocarditis. J Antimicrob Chemother. 2004;53:123-126.
- Mariano A, Pisapia R, Abdeddaim A, et al. Endocarditis and meningitis associated to nape piercing in a young female: a case report. Infez Med. 2015;23:275-279.
- Ivey LA, Limone BA, Jacob SE. Approach to the jewelry aficionado. Pediatr Dermatol. 2018;35:274-275.
- Brandão MH, Gontijo B, Girundi MA, et al. Ear piercing as a risk factor for contact allergy to nickel. J Pediatr (Rio J). 2010;86:149-154.
- Schuttelaar MLA, Ofenloch RF, Bruze M, et al. Prevalence of contact allergy to metals in the European general population with a focus on nickel and piercings: The EDEN Fragrance Study. Contact Dermatitis. 2018;79:1-9.
- Laumann AE, Derick AJ. Tattoos and body piercings in the United States: a national data set. J Am Acad Dermatol. 2006;55:413-421.
- De Moor RJ, De Witte AM, Delmé KI, et al. Dental and oral complications of lip and tongue piercings. Br Dent J. 2005;199:506-509.
- Offen E, Allison JR. Do oral piercings cause problems in the mouth? Evid Based Dent. 2022;23:126-127.
- Passos PF, Pintor AVB, Marañón-Vásquez GA, et al. Oral manifestations arising from oral piercings: A systematic review and meta-analyses. Oral Surg Oral Med Oral Pathol Oral Radiol. 2022;134:327-341.
- Covello F, Salerno C, Giovannini V, et al. Piercing and oral health: a study on the knowledge of risks and complications. Int J Environ Res Public Health. 2020;17:613.
- Ogawa R. The most current algorithms for the treatment and prevention of hypertrophic scars and keloids: a 2020 update of the algorithms published 10 years ago. Plast Reconstr Surg. 2022;149:E79-E94.
- Kumar Ghosh S, Bandyopadhyay D. Granuloma pyogenicum as a complication of decorative nose piercing: report of eight cases from eastern India. J Cutan Med Surg. 2012;16:197-200.
- Dreher K, Kern M, Rush L, et al. Basal cell carcinoma invasion of an ear piercing. Dermatol Online J. 2022;28.
- Stanko P, Poruban D, Mracna J, et al. Squamous cell carcinoma and piercing of the tongue—a case report. J Craniomaxillofac Surg. 2012;40:329-331.
- Preslar D, Borger J. Body piercing infections. In: StatPearls. StatPearls Publishing; 2022.
- Antoszewski B, Jedrzejczak M, Kruk-Jeromin J. Complications after body piercing in patient suffering from type 1 diabetes mellitus. Int J Dermatol. 2007;46:1250-1252.
- Simplot TC, Hoffman HT. Comparison between cartilage and soft tissue ear piercing complications. Am J Otolaryngol. 1998;19:305-310.
- Meltzer DI. Complications of body piercing. Am Fam Physician. 2005;72:2029-2034.
- Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71.
- Metts J. Common complications of body piercing. West J Med. 2002;176:85-86.
- Escudero-Castaño N, Perea-García MA, Campo-Trapero J, et al. Oral and perioral piercing complications. Open Dent J. 2008;2:133-136.
- Tweeten SS, Rickman LS. Infectious complications of body piercing. Clin Infect Dis. 1998;26:735-740.
- Gabriel OT, Anthony OO, Paul EA, et al. Trends and complications of ear piercing among selected Nigerian population. J Family Med Prim Care. 2017;6:517-521.
- Armstrong ML, Koch JR, Saunders JC, et al. The hole picture: risks, decision making, purpose, regulations, and the future of body piercing. Clin Dermatol. 2007;25:398-406.
- Millar BC, Moore JE. Antibiotic prophylaxis, body piercing and infective endocarditis. J Antimicrob Chemother. 2004;53:123-126.
- Mariano A, Pisapia R, Abdeddaim A, et al. Endocarditis and meningitis associated to nape piercing in a young female: a case report. Infez Med. 2015;23:275-279.
- Ivey LA, Limone BA, Jacob SE. Approach to the jewelry aficionado. Pediatr Dermatol. 2018;35:274-275.
- Brandão MH, Gontijo B, Girundi MA, et al. Ear piercing as a risk factor for contact allergy to nickel. J Pediatr (Rio J). 2010;86:149-154.
- Schuttelaar MLA, Ofenloch RF, Bruze M, et al. Prevalence of contact allergy to metals in the European general population with a focus on nickel and piercings: The EDEN Fragrance Study. Contact Dermatitis. 2018;79:1-9.
- Laumann AE, Derick AJ. Tattoos and body piercings in the United States: a national data set. J Am Acad Dermatol. 2006;55:413-421.
- De Moor RJ, De Witte AM, Delmé KI, et al. Dental and oral complications of lip and tongue piercings. Br Dent J. 2005;199:506-509.
- Offen E, Allison JR. Do oral piercings cause problems in the mouth? Evid Based Dent. 2022;23:126-127.
- Passos PF, Pintor AVB, Marañón-Vásquez GA, et al. Oral manifestations arising from oral piercings: A systematic review and meta-analyses. Oral Surg Oral Med Oral Pathol Oral Radiol. 2022;134:327-341.
- Covello F, Salerno C, Giovannini V, et al. Piercing and oral health: a study on the knowledge of risks and complications. Int J Environ Res Public Health. 2020;17:613.
- Ogawa R. The most current algorithms for the treatment and prevention of hypertrophic scars and keloids: a 2020 update of the algorithms published 10 years ago. Plast Reconstr Surg. 2022;149:E79-E94.
- Kumar Ghosh S, Bandyopadhyay D. Granuloma pyogenicum as a complication of decorative nose piercing: report of eight cases from eastern India. J Cutan Med Surg. 2012;16:197-200.
- Dreher K, Kern M, Rush L, et al. Basal cell carcinoma invasion of an ear piercing. Dermatol Online J. 2022;28.
- Stanko P, Poruban D, Mracna J, et al. Squamous cell carcinoma and piercing of the tongue—a case report. J Craniomaxillofac Surg. 2012;40:329-331.
Practice Points
- Intraoral piercings of the tongue, lip, gingiva, or mucosa are associated with the most acute and chronic complications.
- Tissue damage is a common complication associated with cutaneous and mucocutaneous piercings, including trauma, bleeding and bruising, or dysesthesia.
- Given the rapid rise in the popularity of piercings, general practitioners and dermatologists should be aware of the multitude of acute or chronic complications associated with body piercings as well as effective treatment modalities.
PPIs linked to long-term infection in kids
Researchers in France are warning against the overzealous use of acid-suppressing drugs in infants after finding that the medications are associated with an increase in risk of serious infections later in life.
The focus on the use of proton pump inhibitors (PPIs) during infancy comes as use of the drugs in young children is rising in France, New Zealand, Scandinavia, and the United States. Much of this use is not to manage confirmed cases of gastroesophageal reflux but rather to soothe the jangled nerves of parents of babies in discomfort, according to the researchers, who have studied national prescribing patterns. In addition to concerns about infection, inappropriate or prolonged use of the acid suppressants is also associated with an increase in the risk of such conditions as hospital-acquired acute kidney injury and inflammatory bowel diseases in children.
PPIs such as omeprazole are effective at reducing gastric acid in babies with gastroesophageal reflux disease. But the researchers warned against using the drugs to manage normal spitting up and dribbling that would have resolved of itself anyway.
“In this study, increased risk of serious infections was associated with PPI use in young children, overall and for various sites and pathogens. In this population, PPIs should not be used without a clear indication,” epidemiologist Marion Lassalle, PharmD, PhD, of EPI-PHARE in Saint-Denis, France, and colleagues reported in JAMA Pediatrics.
Drawing on data from a national birth registry, Dr. Lassalle and colleagues compared infection rates among more than 1.2 million infants who received a PPI at an average age of 88 days with infection rates among children who received another kind of acid suppressant (a histamine receptor blocker or antacid) at an average age of 82 days. More than 600,000 children made up each group.
Slightly over half of the participants were boys, and the study followed children to a maximum age of 9 years. Among children who used PPIs rather than another acid suppressant, there was an overall higher rate of serious infections that required hospitalization (adjusted hazard ratio, 1.34; 95% confidence interval, 1.32-1.36). There were higher rates of infections in the digestive tract; the ear, nose, and throat; the kidneys or urinary tract; the lower respiratory tract; and the nervous system.
Serious infections first appeared 9.7 (range, 3.9-21.3) months after a child stopped using a PPI – a date that Dr. Lassalle’s group determined on the basis of there being a delay of at least 90 days in filling a PPI prescription.
Possible confounders
“The study shows an association, it does not show causation,” said Rina Sanghavi, MD, a pediatric gastroenterologist at UT Southwestern Medical Center, Dallas. Dr. Sanghavi noted that the children who continued taking PPIs generally were sicker in their first year of life, as shown by the higher rates of respiratory ailments and corticosteroid use. This could mean that the infections they eventually experienced had many causes and not necessarily the PPI.
Similarly, pediatric gastroenterologist Sophia Patel, MD, of the Cleveland Clinic, pointed to the almost 10-month average lag time between stopping a PPI and developing a first serious infection. That interval is long enough that it is possible that the infection was caused by something else, Dr. Patel said.
Despite the limitations of the study, Dr. Sanghavi and Dr. Patel said the findings serve as a good reminder to clinicians to use PPIs only when needed and to limit their use once begun. The overall evidence base for limiting use of PPIs is strong, both physicians noted, even if this study does not show direct causation between PPI use and infection rates.
“Ask: Does this child need a PPI?” Dr. Sanghavi said. If so, she generally prescribes PPIs for a period of 2 weeks to a maximum of 2 months and she never authorizes automatic refills. Through this approach, a parent and child will come back to the clinic frequently, which in most cases allows faster tapering of the drugs.
Dr. Lassalle, Dr. Sanghavi, and Dr. Patel reported no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
Researchers in France are warning against the overzealous use of acid-suppressing drugs in infants after finding that the medications are associated with an increase in risk of serious infections later in life.
The focus on the use of proton pump inhibitors (PPIs) during infancy comes as use of the drugs in young children is rising in France, New Zealand, Scandinavia, and the United States. Much of this use is not to manage confirmed cases of gastroesophageal reflux but rather to soothe the jangled nerves of parents of babies in discomfort, according to the researchers, who have studied national prescribing patterns. In addition to concerns about infection, inappropriate or prolonged use of the acid suppressants is also associated with an increase in the risk of such conditions as hospital-acquired acute kidney injury and inflammatory bowel diseases in children.
PPIs such as omeprazole are effective at reducing gastric acid in babies with gastroesophageal reflux disease. But the researchers warned against using the drugs to manage normal spitting up and dribbling that would have resolved of itself anyway.
“In this study, increased risk of serious infections was associated with PPI use in young children, overall and for various sites and pathogens. In this population, PPIs should not be used without a clear indication,” epidemiologist Marion Lassalle, PharmD, PhD, of EPI-PHARE in Saint-Denis, France, and colleagues reported in JAMA Pediatrics.
Drawing on data from a national birth registry, Dr. Lassalle and colleagues compared infection rates among more than 1.2 million infants who received a PPI at an average age of 88 days with infection rates among children who received another kind of acid suppressant (a histamine receptor blocker or antacid) at an average age of 82 days. More than 600,000 children made up each group.
Slightly over half of the participants were boys, and the study followed children to a maximum age of 9 years. Among children who used PPIs rather than another acid suppressant, there was an overall higher rate of serious infections that required hospitalization (adjusted hazard ratio, 1.34; 95% confidence interval, 1.32-1.36). There were higher rates of infections in the digestive tract; the ear, nose, and throat; the kidneys or urinary tract; the lower respiratory tract; and the nervous system.
Serious infections first appeared 9.7 (range, 3.9-21.3) months after a child stopped using a PPI – a date that Dr. Lassalle’s group determined on the basis of there being a delay of at least 90 days in filling a PPI prescription.
Possible confounders
“The study shows an association, it does not show causation,” said Rina Sanghavi, MD, a pediatric gastroenterologist at UT Southwestern Medical Center, Dallas. Dr. Sanghavi noted that the children who continued taking PPIs generally were sicker in their first year of life, as shown by the higher rates of respiratory ailments and corticosteroid use. This could mean that the infections they eventually experienced had many causes and not necessarily the PPI.
Similarly, pediatric gastroenterologist Sophia Patel, MD, of the Cleveland Clinic, pointed to the almost 10-month average lag time between stopping a PPI and developing a first serious infection. That interval is long enough that it is possible that the infection was caused by something else, Dr. Patel said.
Despite the limitations of the study, Dr. Sanghavi and Dr. Patel said the findings serve as a good reminder to clinicians to use PPIs only when needed and to limit their use once begun. The overall evidence base for limiting use of PPIs is strong, both physicians noted, even if this study does not show direct causation between PPI use and infection rates.
“Ask: Does this child need a PPI?” Dr. Sanghavi said. If so, she generally prescribes PPIs for a period of 2 weeks to a maximum of 2 months and she never authorizes automatic refills. Through this approach, a parent and child will come back to the clinic frequently, which in most cases allows faster tapering of the drugs.
Dr. Lassalle, Dr. Sanghavi, and Dr. Patel reported no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
Researchers in France are warning against the overzealous use of acid-suppressing drugs in infants after finding that the medications are associated with an increase in risk of serious infections later in life.
The focus on the use of proton pump inhibitors (PPIs) during infancy comes as use of the drugs in young children is rising in France, New Zealand, Scandinavia, and the United States. Much of this use is not to manage confirmed cases of gastroesophageal reflux but rather to soothe the jangled nerves of parents of babies in discomfort, according to the researchers, who have studied national prescribing patterns. In addition to concerns about infection, inappropriate or prolonged use of the acid suppressants is also associated with an increase in the risk of such conditions as hospital-acquired acute kidney injury and inflammatory bowel diseases in children.
PPIs such as omeprazole are effective at reducing gastric acid in babies with gastroesophageal reflux disease. But the researchers warned against using the drugs to manage normal spitting up and dribbling that would have resolved of itself anyway.
“In this study, increased risk of serious infections was associated with PPI use in young children, overall and for various sites and pathogens. In this population, PPIs should not be used without a clear indication,” epidemiologist Marion Lassalle, PharmD, PhD, of EPI-PHARE in Saint-Denis, France, and colleagues reported in JAMA Pediatrics.
Drawing on data from a national birth registry, Dr. Lassalle and colleagues compared infection rates among more than 1.2 million infants who received a PPI at an average age of 88 days with infection rates among children who received another kind of acid suppressant (a histamine receptor blocker or antacid) at an average age of 82 days. More than 600,000 children made up each group.
Slightly over half of the participants were boys, and the study followed children to a maximum age of 9 years. Among children who used PPIs rather than another acid suppressant, there was an overall higher rate of serious infections that required hospitalization (adjusted hazard ratio, 1.34; 95% confidence interval, 1.32-1.36). There were higher rates of infections in the digestive tract; the ear, nose, and throat; the kidneys or urinary tract; the lower respiratory tract; and the nervous system.
Serious infections first appeared 9.7 (range, 3.9-21.3) months after a child stopped using a PPI – a date that Dr. Lassalle’s group determined on the basis of there being a delay of at least 90 days in filling a PPI prescription.
Possible confounders
“The study shows an association, it does not show causation,” said Rina Sanghavi, MD, a pediatric gastroenterologist at UT Southwestern Medical Center, Dallas. Dr. Sanghavi noted that the children who continued taking PPIs generally were sicker in their first year of life, as shown by the higher rates of respiratory ailments and corticosteroid use. This could mean that the infections they eventually experienced had many causes and not necessarily the PPI.
Similarly, pediatric gastroenterologist Sophia Patel, MD, of the Cleveland Clinic, pointed to the almost 10-month average lag time between stopping a PPI and developing a first serious infection. That interval is long enough that it is possible that the infection was caused by something else, Dr. Patel said.
Despite the limitations of the study, Dr. Sanghavi and Dr. Patel said the findings serve as a good reminder to clinicians to use PPIs only when needed and to limit their use once begun. The overall evidence base for limiting use of PPIs is strong, both physicians noted, even if this study does not show direct causation between PPI use and infection rates.
“Ask: Does this child need a PPI?” Dr. Sanghavi said. If so, she generally prescribes PPIs for a period of 2 weeks to a maximum of 2 months and she never authorizes automatic refills. Through this approach, a parent and child will come back to the clinic frequently, which in most cases allows faster tapering of the drugs.
Dr. Lassalle, Dr. Sanghavi, and Dr. Patel reported no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM JAMA PEDIATRICS
One in five men carries high-risk HPV in international study
Findings from a meta-analysis of 65 studies conducted in 35 countries indicate that These estimates provide further weight to arguments in favor of vaccinating boys against HPV to prevent certain types of cancer.
“Our results support that sexually active men, regardless of age, are an important reservoir of HPV genital infection,” wrote the authors in The Lancet Global Health . “These estimates emphasize the importance of incorporating men into comprehensive HPV prevention strategies to reduce HPV-related morbidity and mortality in men and ultimately achieve elimination of cervical cancer and other HPV-related diseases.”
Literature review
HPV infection is the most common sexually transmitted viral infection worldwide. More than 200 HPV types can be transmitted sexually, and at least 12 types are oncogenic. Previous studies have shown that most sexually active men and women acquire at least one genital HPV infection during their lifetime.
Although most HPV infections are asymptomatic, they can lead to cancer. Indeed, HPV is involved in the development of cervical, vulval, and vaginal cancers, as well as oropharyngeal and anal cancers, which also affect the male population. More than 25% of cancers caused by HPV occur in men.
Despite these observations, fewer epidemiologic studies have assessed HPV infection in men than in women. To determine the prevalence of HPV infection in the male population, Laia Bruni, MD, MPH, PhD, an epidemiologist at the Catalan Institute of Oncology in Barcelona, and her colleagues collated data from 65 studies conducted in 35 countries pertaining to males older than 15 years.
In this literature review, the researchers selected studies that reported infection rates in males without HPV-related symptoms. Studies conducted exclusively in populations that were considered at increased risk for sexually transmitted infections (STIs) were excluded. Overall, the analysis included close to 45,000 men.
Prevalent HPV genotype
Testing for HPV was conducted on samples collected from the anus and genitals. The results show a global pooled prevalence of HPV infection in males older than 15 years of 31% for any HPV and 21% for HR-HPV. One of these viruses, HPV-16, was the most prevalent HPV genotype (5% prevalence).
HPV prevalence was highest among young adults. It stabilized and decreased from age 50 years. Between ages 25 and 29 years, 35% of men are infected with HPV. It should be noted that prevalence is already high in the youngest group, reaching 28% in males between the ages of 15 and 19 years. The variations are similar for HR-HPV infections.
This age-related change is different from rates in women. Among the female population, HPV prevalence peaks soon after first sexual activity and declines with age, with a slight rebound after ages 50–55 years (i.e., often after or around the time of menopause), wrote the researchers.
The results also show country- and region-based disparities. The pooled prevalence for any HPV was highest in Sub-Saharan Africa (37%), followed by Europe and Northern America (36%). The lowest prevalence was in East and Southeast Asia (15%). Here again, the trends are similar with high-risk HPV.
Preventive measures
“Our study draws attention to the high prevalence, ranging from 20% to 30% for HR-HPV in men across most regions, and the need for strengthening HPV prevention within overall STI control efforts,” wrote the authors.
“Future epidemiological studies are needed to monitor trends in prevalence in men, especially considering the roll-out of HPV vaccination in girls and young women and that many countries are beginning to vaccinate boys.”
In France, the HPV vaccination program was extended in 2021 to include all boys between the ages of 11 and 14 years (two-dose schedule), with a catch-up course in males up to age 19 years (three-dose schedule). This is the same vaccine program as for girls. It is also recommended for men up to age 26 years who have sex with other men.
The 2023 return to school will see the launch of a general vaccination campaign aimed at seventh-grade students, both boys and girls, with parental consent, to increase vaccine coverage. In 2021, vaccine uptake was 43.6% in girls between the ages of 15 and 18 years and scarcely 6% in boys, according to Public Health France.
Two vaccines are in use: the bivalent Cervarix vaccine, which is effective against HPV-16 and HPV-18, and the nonavalent Gardasil 9, which is effective against types 16, 18, 31, 33, 45, 52, and 58. Both provide protection against HPV-16, the type most common in men, which is responsible for more than half of cases of cervical cancer.
This article was translated from the Medscape French Edition. A version appeared on Medscape.com.
Findings from a meta-analysis of 65 studies conducted in 35 countries indicate that These estimates provide further weight to arguments in favor of vaccinating boys against HPV to prevent certain types of cancer.
“Our results support that sexually active men, regardless of age, are an important reservoir of HPV genital infection,” wrote the authors in The Lancet Global Health . “These estimates emphasize the importance of incorporating men into comprehensive HPV prevention strategies to reduce HPV-related morbidity and mortality in men and ultimately achieve elimination of cervical cancer and other HPV-related diseases.”
Literature review
HPV infection is the most common sexually transmitted viral infection worldwide. More than 200 HPV types can be transmitted sexually, and at least 12 types are oncogenic. Previous studies have shown that most sexually active men and women acquire at least one genital HPV infection during their lifetime.
Although most HPV infections are asymptomatic, they can lead to cancer. Indeed, HPV is involved in the development of cervical, vulval, and vaginal cancers, as well as oropharyngeal and anal cancers, which also affect the male population. More than 25% of cancers caused by HPV occur in men.
Despite these observations, fewer epidemiologic studies have assessed HPV infection in men than in women. To determine the prevalence of HPV infection in the male population, Laia Bruni, MD, MPH, PhD, an epidemiologist at the Catalan Institute of Oncology in Barcelona, and her colleagues collated data from 65 studies conducted in 35 countries pertaining to males older than 15 years.
In this literature review, the researchers selected studies that reported infection rates in males without HPV-related symptoms. Studies conducted exclusively in populations that were considered at increased risk for sexually transmitted infections (STIs) were excluded. Overall, the analysis included close to 45,000 men.
Prevalent HPV genotype
Testing for HPV was conducted on samples collected from the anus and genitals. The results show a global pooled prevalence of HPV infection in males older than 15 years of 31% for any HPV and 21% for HR-HPV. One of these viruses, HPV-16, was the most prevalent HPV genotype (5% prevalence).
HPV prevalence was highest among young adults. It stabilized and decreased from age 50 years. Between ages 25 and 29 years, 35% of men are infected with HPV. It should be noted that prevalence is already high in the youngest group, reaching 28% in males between the ages of 15 and 19 years. The variations are similar for HR-HPV infections.
This age-related change is different from rates in women. Among the female population, HPV prevalence peaks soon after first sexual activity and declines with age, with a slight rebound after ages 50–55 years (i.e., often after or around the time of menopause), wrote the researchers.
The results also show country- and region-based disparities. The pooled prevalence for any HPV was highest in Sub-Saharan Africa (37%), followed by Europe and Northern America (36%). The lowest prevalence was in East and Southeast Asia (15%). Here again, the trends are similar with high-risk HPV.
Preventive measures
“Our study draws attention to the high prevalence, ranging from 20% to 30% for HR-HPV in men across most regions, and the need for strengthening HPV prevention within overall STI control efforts,” wrote the authors.
“Future epidemiological studies are needed to monitor trends in prevalence in men, especially considering the roll-out of HPV vaccination in girls and young women and that many countries are beginning to vaccinate boys.”
In France, the HPV vaccination program was extended in 2021 to include all boys between the ages of 11 and 14 years (two-dose schedule), with a catch-up course in males up to age 19 years (three-dose schedule). This is the same vaccine program as for girls. It is also recommended for men up to age 26 years who have sex with other men.
The 2023 return to school will see the launch of a general vaccination campaign aimed at seventh-grade students, both boys and girls, with parental consent, to increase vaccine coverage. In 2021, vaccine uptake was 43.6% in girls between the ages of 15 and 18 years and scarcely 6% in boys, according to Public Health France.
Two vaccines are in use: the bivalent Cervarix vaccine, which is effective against HPV-16 and HPV-18, and the nonavalent Gardasil 9, which is effective against types 16, 18, 31, 33, 45, 52, and 58. Both provide protection against HPV-16, the type most common in men, which is responsible for more than half of cases of cervical cancer.
This article was translated from the Medscape French Edition. A version appeared on Medscape.com.
Findings from a meta-analysis of 65 studies conducted in 35 countries indicate that These estimates provide further weight to arguments in favor of vaccinating boys against HPV to prevent certain types of cancer.
“Our results support that sexually active men, regardless of age, are an important reservoir of HPV genital infection,” wrote the authors in The Lancet Global Health . “These estimates emphasize the importance of incorporating men into comprehensive HPV prevention strategies to reduce HPV-related morbidity and mortality in men and ultimately achieve elimination of cervical cancer and other HPV-related diseases.”
Literature review
HPV infection is the most common sexually transmitted viral infection worldwide. More than 200 HPV types can be transmitted sexually, and at least 12 types are oncogenic. Previous studies have shown that most sexually active men and women acquire at least one genital HPV infection during their lifetime.
Although most HPV infections are asymptomatic, they can lead to cancer. Indeed, HPV is involved in the development of cervical, vulval, and vaginal cancers, as well as oropharyngeal and anal cancers, which also affect the male population. More than 25% of cancers caused by HPV occur in men.
Despite these observations, fewer epidemiologic studies have assessed HPV infection in men than in women. To determine the prevalence of HPV infection in the male population, Laia Bruni, MD, MPH, PhD, an epidemiologist at the Catalan Institute of Oncology in Barcelona, and her colleagues collated data from 65 studies conducted in 35 countries pertaining to males older than 15 years.
In this literature review, the researchers selected studies that reported infection rates in males without HPV-related symptoms. Studies conducted exclusively in populations that were considered at increased risk for sexually transmitted infections (STIs) were excluded. Overall, the analysis included close to 45,000 men.
Prevalent HPV genotype
Testing for HPV was conducted on samples collected from the anus and genitals. The results show a global pooled prevalence of HPV infection in males older than 15 years of 31% for any HPV and 21% for HR-HPV. One of these viruses, HPV-16, was the most prevalent HPV genotype (5% prevalence).
HPV prevalence was highest among young adults. It stabilized and decreased from age 50 years. Between ages 25 and 29 years, 35% of men are infected with HPV. It should be noted that prevalence is already high in the youngest group, reaching 28% in males between the ages of 15 and 19 years. The variations are similar for HR-HPV infections.
This age-related change is different from rates in women. Among the female population, HPV prevalence peaks soon after first sexual activity and declines with age, with a slight rebound after ages 50–55 years (i.e., often after or around the time of menopause), wrote the researchers.
The results also show country- and region-based disparities. The pooled prevalence for any HPV was highest in Sub-Saharan Africa (37%), followed by Europe and Northern America (36%). The lowest prevalence was in East and Southeast Asia (15%). Here again, the trends are similar with high-risk HPV.
Preventive measures
“Our study draws attention to the high prevalence, ranging from 20% to 30% for HR-HPV in men across most regions, and the need for strengthening HPV prevention within overall STI control efforts,” wrote the authors.
“Future epidemiological studies are needed to monitor trends in prevalence in men, especially considering the roll-out of HPV vaccination in girls and young women and that many countries are beginning to vaccinate boys.”
In France, the HPV vaccination program was extended in 2021 to include all boys between the ages of 11 and 14 years (two-dose schedule), with a catch-up course in males up to age 19 years (three-dose schedule). This is the same vaccine program as for girls. It is also recommended for men up to age 26 years who have sex with other men.
The 2023 return to school will see the launch of a general vaccination campaign aimed at seventh-grade students, both boys and girls, with parental consent, to increase vaccine coverage. In 2021, vaccine uptake was 43.6% in girls between the ages of 15 and 18 years and scarcely 6% in boys, according to Public Health France.
Two vaccines are in use: the bivalent Cervarix vaccine, which is effective against HPV-16 and HPV-18, and the nonavalent Gardasil 9, which is effective against types 16, 18, 31, 33, 45, 52, and 58. Both provide protection against HPV-16, the type most common in men, which is responsible for more than half of cases of cervical cancer.
This article was translated from the Medscape French Edition. A version appeared on Medscape.com.
FROM THE LANCET GLOBAL HEALTH
How to optimize in-hospital antimicrobial prescribing?
Variability in antimicrobial prescribing among hospital-based physicians is not associated with patient characteristics or clinical outcomes, data suggest. The lowest level of such prescribing within each hospital could be considered a target for antimicrobial stewardship, according to the researchers.
In a multicenter study of 124 physicians responsible for more than 124,000 hospitalized patients, the difference in mean prescribing between the highest and lowest quartiles of prescription volume was 15.8 days of treatment per 100 patient-days.
Baseline patient characteristics were similar across the quartiles, and there were no differences in patient outcomes, including in-hospital deaths, hospital length of stay, intensive care unit transfer, and hospital readmission.
Although the investigators expected variation in prescribing, “what surprised us most was the limited association with any differences in clinical outcomes, particularly when it came to the amount of antimicrobials used,” study author Mark T. McIntyre, PharmD, pharmacotherapy specialist at the Sinai Health System in Toronto, told this news organization.
“Importantly, this is not a study that defines quality of care,” he said. “We looked at natural variation in practice and association with outcomes. So, I don’t want clinicians to think, ‘Well, I’m high, therefore I’m bad,’ or, ‘I’m low, therefore I’m good.’
“This is an early explanatory analysis that asks whether this is an opportunity to optimize prescribing in ways we hadn’t thought of before,” he said. “Now that we don’t have an association with higher or lower prescribing and outcomes, we can look at what else is driving that antimicrobial prescribing and what we can do about it. Comfort level, risk tolerance, and social, cultural, and contextual factors all likely play a role.”
The study was published online in the Canadian Medical Association Journal.
Antimicrobial reductions possible
The investigators conducted a retrospective cohort study using the General Medicine Inpatient Initiative database to assess physician-level volume and spectrum of antimicrobial prescribing in adult general medical wards. Four academic hospitals in Toronto were evaluated for the period 2010 to 2019.
The investigators stratified physicians into quartiles by hospital site on the basis of volume of antimicrobial prescribing (specifically, days of therapy per 100 patient-days and antimicrobial-free days) and antibacterial spectrum (modified spectrum score, which assigns a value to each antibacterial agent on the basis of its breadth of coverage).
They also examined potential differences between physician quartiles in patient characteristics, such as age, sex, the Laboratory-Based Acute Physiology Score, discharge diagnosis, and the Charlson Comorbidity Index.
Multilevel modeling allowed the investigators to evaluate the association between clinical outcomes and antimicrobial volume and spectrum.
The primary measure was days of therapy per 100 patient-days.
As noted, the cohort included 124 physicians who were responsible for 124,158 hospital admissions. The median physician-level volume of antimicrobial prescribing was 56.1 days of therapy per 100 patient-days. Patient characteristics were balanced across the quartiles of physician prescribing.
The difference in mean prescribing between physician quartile 4 and quartile 1 was 15.8 days of therapy per 100 patient-days, meaning the median physician in quartile 4 prescribed antimicrobials at a volume that was 30% higher than that of the median physician in quartile 1.
No significant differences were noted for any clinical outcome with regard to quartile of days of therapy, antimicrobial-free days, or modified spectrum score after adjustment for patient-level characteristics.
In addition, no significant differences in the case mix between quartile 4 and quartile 1 were found when the cohort was restricted to patients admitted and discharged by the same most responsible person, nor were differences found in an analysis that was restricted to those without a discharge diagnosis code of palliative care.
In-hospital mortality was higher among patients cared for by prescribers with higher modified spectrum scores (odds ratio, 1.13). “We still can’t fully explain this finding,” Dr. McIntyre acknowledged. “We only saw that in our primary analysis. When we did several sensitivity analyses, that finding didn’t appear.”
The authors concluded, “Ultimately, without discernible benefit in outcomes of patients of physicians who prescribe more frequently, less antimicrobial exposure may be possible, leading to lower risk of antimicrobial resistance.”
Decision-making support
Commenting on the study, Lawrence I. Kaplan, MD, section chief of general internal medicine and associate dean for interprofessional education at the Lewis Katz School of Medicine at Temple University in Philadelphia, said, “Trying to get to the lowest quartile would be a goal, and given that physician characteristics are involved, I think there needs to be much better training in clinical management decision-making: how you come about making a decision based on a diagnosis for a particular patient, in or out of the hospital.” Dr. Kaplan was not involved in the research.
“Clinical decision-making tools that can be plugged into the electronic health record can help,” he suggested. “The tools basically ask if a patient meets certain criteria and then might give a prompt that says, for example, ‘These symptoms are not consistent with bacterial sinusitis. The patient should be treated with decongestants, nasal steroids, et cetera, because antibiotics aren’t appropriate.’
“It’s a bit like checkbox medicine, which a lot of physicians bridle at,” he said. “But if it’s really based on evidence, I think that’s an appropriate use of evidence-based medicine.”
Dr. Kaplan said that more research is needed into the best way to get a physician or any provider to step back and say, “Is this the right decision?” or, “I’m doing this but I’m really on shaky ground. What am I missing?’” He noted that the Society for Medical Decision Making publishes research and resources in this area.
“I love the fact that the paper was authored by an interdisciplinary group,” Dr. Kaplan added. “A pharmacist embedded in the team can, for example, help with treatment decision-making and point out potential drug interactions that prescribers might not be aware of.
“We need to stop practicing medicine siloed, which is what we do a lot of ways, both in the hospital and out of the hospital, because it’s the path of least resistance,” Dr. Kaplan added. “But when we can say, ‘Hey, I have a question about this,’ be it to a computer or a colleague, I would argue that we come up with better care.”
No funding was provided for the study. Dr. McIntyre and Dr. Kaplan have disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
Variability in antimicrobial prescribing among hospital-based physicians is not associated with patient characteristics or clinical outcomes, data suggest. The lowest level of such prescribing within each hospital could be considered a target for antimicrobial stewardship, according to the researchers.
In a multicenter study of 124 physicians responsible for more than 124,000 hospitalized patients, the difference in mean prescribing between the highest and lowest quartiles of prescription volume was 15.8 days of treatment per 100 patient-days.
Baseline patient characteristics were similar across the quartiles, and there were no differences in patient outcomes, including in-hospital deaths, hospital length of stay, intensive care unit transfer, and hospital readmission.
Although the investigators expected variation in prescribing, “what surprised us most was the limited association with any differences in clinical outcomes, particularly when it came to the amount of antimicrobials used,” study author Mark T. McIntyre, PharmD, pharmacotherapy specialist at the Sinai Health System in Toronto, told this news organization.
“Importantly, this is not a study that defines quality of care,” he said. “We looked at natural variation in practice and association with outcomes. So, I don’t want clinicians to think, ‘Well, I’m high, therefore I’m bad,’ or, ‘I’m low, therefore I’m good.’
“This is an early explanatory analysis that asks whether this is an opportunity to optimize prescribing in ways we hadn’t thought of before,” he said. “Now that we don’t have an association with higher or lower prescribing and outcomes, we can look at what else is driving that antimicrobial prescribing and what we can do about it. Comfort level, risk tolerance, and social, cultural, and contextual factors all likely play a role.”
The study was published online in the Canadian Medical Association Journal.
Antimicrobial reductions possible
The investigators conducted a retrospective cohort study using the General Medicine Inpatient Initiative database to assess physician-level volume and spectrum of antimicrobial prescribing in adult general medical wards. Four academic hospitals in Toronto were evaluated for the period 2010 to 2019.
The investigators stratified physicians into quartiles by hospital site on the basis of volume of antimicrobial prescribing (specifically, days of therapy per 100 patient-days and antimicrobial-free days) and antibacterial spectrum (modified spectrum score, which assigns a value to each antibacterial agent on the basis of its breadth of coverage).
They also examined potential differences between physician quartiles in patient characteristics, such as age, sex, the Laboratory-Based Acute Physiology Score, discharge diagnosis, and the Charlson Comorbidity Index.
Multilevel modeling allowed the investigators to evaluate the association between clinical outcomes and antimicrobial volume and spectrum.
The primary measure was days of therapy per 100 patient-days.
As noted, the cohort included 124 physicians who were responsible for 124,158 hospital admissions. The median physician-level volume of antimicrobial prescribing was 56.1 days of therapy per 100 patient-days. Patient characteristics were balanced across the quartiles of physician prescribing.
The difference in mean prescribing between physician quartile 4 and quartile 1 was 15.8 days of therapy per 100 patient-days, meaning the median physician in quartile 4 prescribed antimicrobials at a volume that was 30% higher than that of the median physician in quartile 1.
No significant differences were noted for any clinical outcome with regard to quartile of days of therapy, antimicrobial-free days, or modified spectrum score after adjustment for patient-level characteristics.
In addition, no significant differences in the case mix between quartile 4 and quartile 1 were found when the cohort was restricted to patients admitted and discharged by the same most responsible person, nor were differences found in an analysis that was restricted to those without a discharge diagnosis code of palliative care.
In-hospital mortality was higher among patients cared for by prescribers with higher modified spectrum scores (odds ratio, 1.13). “We still can’t fully explain this finding,” Dr. McIntyre acknowledged. “We only saw that in our primary analysis. When we did several sensitivity analyses, that finding didn’t appear.”
The authors concluded, “Ultimately, without discernible benefit in outcomes of patients of physicians who prescribe more frequently, less antimicrobial exposure may be possible, leading to lower risk of antimicrobial resistance.”
Decision-making support
Commenting on the study, Lawrence I. Kaplan, MD, section chief of general internal medicine and associate dean for interprofessional education at the Lewis Katz School of Medicine at Temple University in Philadelphia, said, “Trying to get to the lowest quartile would be a goal, and given that physician characteristics are involved, I think there needs to be much better training in clinical management decision-making: how you come about making a decision based on a diagnosis for a particular patient, in or out of the hospital.” Dr. Kaplan was not involved in the research.
“Clinical decision-making tools that can be plugged into the electronic health record can help,” he suggested. “The tools basically ask if a patient meets certain criteria and then might give a prompt that says, for example, ‘These symptoms are not consistent with bacterial sinusitis. The patient should be treated with decongestants, nasal steroids, et cetera, because antibiotics aren’t appropriate.’
“It’s a bit like checkbox medicine, which a lot of physicians bridle at,” he said. “But if it’s really based on evidence, I think that’s an appropriate use of evidence-based medicine.”
Dr. Kaplan said that more research is needed into the best way to get a physician or any provider to step back and say, “Is this the right decision?” or, “I’m doing this but I’m really on shaky ground. What am I missing?’” He noted that the Society for Medical Decision Making publishes research and resources in this area.
“I love the fact that the paper was authored by an interdisciplinary group,” Dr. Kaplan added. “A pharmacist embedded in the team can, for example, help with treatment decision-making and point out potential drug interactions that prescribers might not be aware of.
“We need to stop practicing medicine siloed, which is what we do a lot of ways, both in the hospital and out of the hospital, because it’s the path of least resistance,” Dr. Kaplan added. “But when we can say, ‘Hey, I have a question about this,’ be it to a computer or a colleague, I would argue that we come up with better care.”
No funding was provided for the study. Dr. McIntyre and Dr. Kaplan have disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
Variability in antimicrobial prescribing among hospital-based physicians is not associated with patient characteristics or clinical outcomes, data suggest. The lowest level of such prescribing within each hospital could be considered a target for antimicrobial stewardship, according to the researchers.
In a multicenter study of 124 physicians responsible for more than 124,000 hospitalized patients, the difference in mean prescribing between the highest and lowest quartiles of prescription volume was 15.8 days of treatment per 100 patient-days.
Baseline patient characteristics were similar across the quartiles, and there were no differences in patient outcomes, including in-hospital deaths, hospital length of stay, intensive care unit transfer, and hospital readmission.
Although the investigators expected variation in prescribing, “what surprised us most was the limited association with any differences in clinical outcomes, particularly when it came to the amount of antimicrobials used,” study author Mark T. McIntyre, PharmD, pharmacotherapy specialist at the Sinai Health System in Toronto, told this news organization.
“Importantly, this is not a study that defines quality of care,” he said. “We looked at natural variation in practice and association with outcomes. So, I don’t want clinicians to think, ‘Well, I’m high, therefore I’m bad,’ or, ‘I’m low, therefore I’m good.’
“This is an early explanatory analysis that asks whether this is an opportunity to optimize prescribing in ways we hadn’t thought of before,” he said. “Now that we don’t have an association with higher or lower prescribing and outcomes, we can look at what else is driving that antimicrobial prescribing and what we can do about it. Comfort level, risk tolerance, and social, cultural, and contextual factors all likely play a role.”
The study was published online in the Canadian Medical Association Journal.
Antimicrobial reductions possible
The investigators conducted a retrospective cohort study using the General Medicine Inpatient Initiative database to assess physician-level volume and spectrum of antimicrobial prescribing in adult general medical wards. Four academic hospitals in Toronto were evaluated for the period 2010 to 2019.
The investigators stratified physicians into quartiles by hospital site on the basis of volume of antimicrobial prescribing (specifically, days of therapy per 100 patient-days and antimicrobial-free days) and antibacterial spectrum (modified spectrum score, which assigns a value to each antibacterial agent on the basis of its breadth of coverage).
They also examined potential differences between physician quartiles in patient characteristics, such as age, sex, the Laboratory-Based Acute Physiology Score, discharge diagnosis, and the Charlson Comorbidity Index.
Multilevel modeling allowed the investigators to evaluate the association between clinical outcomes and antimicrobial volume and spectrum.
The primary measure was days of therapy per 100 patient-days.
As noted, the cohort included 124 physicians who were responsible for 124,158 hospital admissions. The median physician-level volume of antimicrobial prescribing was 56.1 days of therapy per 100 patient-days. Patient characteristics were balanced across the quartiles of physician prescribing.
The difference in mean prescribing between physician quartile 4 and quartile 1 was 15.8 days of therapy per 100 patient-days, meaning the median physician in quartile 4 prescribed antimicrobials at a volume that was 30% higher than that of the median physician in quartile 1.
No significant differences were noted for any clinical outcome with regard to quartile of days of therapy, antimicrobial-free days, or modified spectrum score after adjustment for patient-level characteristics.
In addition, no significant differences in the case mix between quartile 4 and quartile 1 were found when the cohort was restricted to patients admitted and discharged by the same most responsible person, nor were differences found in an analysis that was restricted to those without a discharge diagnosis code of palliative care.
In-hospital mortality was higher among patients cared for by prescribers with higher modified spectrum scores (odds ratio, 1.13). “We still can’t fully explain this finding,” Dr. McIntyre acknowledged. “We only saw that in our primary analysis. When we did several sensitivity analyses, that finding didn’t appear.”
The authors concluded, “Ultimately, without discernible benefit in outcomes of patients of physicians who prescribe more frequently, less antimicrobial exposure may be possible, leading to lower risk of antimicrobial resistance.”
Decision-making support
Commenting on the study, Lawrence I. Kaplan, MD, section chief of general internal medicine and associate dean for interprofessional education at the Lewis Katz School of Medicine at Temple University in Philadelphia, said, “Trying to get to the lowest quartile would be a goal, and given that physician characteristics are involved, I think there needs to be much better training in clinical management decision-making: how you come about making a decision based on a diagnosis for a particular patient, in or out of the hospital.” Dr. Kaplan was not involved in the research.
“Clinical decision-making tools that can be plugged into the electronic health record can help,” he suggested. “The tools basically ask if a patient meets certain criteria and then might give a prompt that says, for example, ‘These symptoms are not consistent with bacterial sinusitis. The patient should be treated with decongestants, nasal steroids, et cetera, because antibiotics aren’t appropriate.’
“It’s a bit like checkbox medicine, which a lot of physicians bridle at,” he said. “But if it’s really based on evidence, I think that’s an appropriate use of evidence-based medicine.”
Dr. Kaplan said that more research is needed into the best way to get a physician or any provider to step back and say, “Is this the right decision?” or, “I’m doing this but I’m really on shaky ground. What am I missing?’” He noted that the Society for Medical Decision Making publishes research and resources in this area.
“I love the fact that the paper was authored by an interdisciplinary group,” Dr. Kaplan added. “A pharmacist embedded in the team can, for example, help with treatment decision-making and point out potential drug interactions that prescribers might not be aware of.
“We need to stop practicing medicine siloed, which is what we do a lot of ways, both in the hospital and out of the hospital, because it’s the path of least resistance,” Dr. Kaplan added. “But when we can say, ‘Hey, I have a question about this,’ be it to a computer or a colleague, I would argue that we come up with better care.”
No funding was provided for the study. Dr. McIntyre and Dr. Kaplan have disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
Making one key connection may increase HPV vax uptake
The understanding that human papillomavirus (HPV) causes oropharyngeal squamous cell carcinoma (OPSCC) has been linked with increased likelihood of adults having been vaccinated for HPV, new research indicates.
In a study published online in JAMA Otolaryngology–Head and Neck Surgery, most of the 288 adults surveyed with validated questions were not aware that HPV causes OPSCC and had not been told of the relationship by their health care provider.
Researchers found that when participants knew about the relationship between HPV infection and OPSCC they were more than three times as likely to be vaccinated (odds ratio, 3.7; 95% confidence interval, 1.8-7.6) as those without the knowledge.
The survey was paired with a novel point-of-care adult vaccination program within an otolaryngology clinic.
“Targeted education aimed at unvaccinated adults establishing the relationship between HPV infection and OPSCC, paired with point-of-care vaccination, may be an innovative strategy for increasing HPV vaccination rates in adults,” write the authors, led by Jacob C. Bloom, MD, with the department of otolaryngology–head and neck surgery at Boston Medical Center.
Current HPV vaccination recommendations include three parts:
- Routine vaccination at age 11 or 12 years
- Catch-up vaccination at ages 13-26 years if not adequately vaccinated
- Shared clinical decision-making in adults aged 27-45 years if the vaccine series has not been completed.
Despite proven efficacy and safety of the HPV vaccine, vaccination rates are low for adults. Although 75% of adolescents aged 13-17 years have initiated the HPV vaccine, recent studies show only 16% of U.S. men aged 18-21 years have received at least 1 dose of the HPV vaccine, the authors write.
Christiana Zhang, MD, with the division of internal medicine at Johns Hopkins University in Baltimore, who was not part of the study, said she was not surprised by the lack of knowledge about the HPV-OPSCC link.
Patients are often counseled on the relationship between HPV and genital warts or anogenital cancers like cervical cancer, she says, but there is less patient education surrounding the relationship between HPV and oropharyngeal cancers.
She says she does counsel patients on the link with OPSCC, but not all providers do and provider knowledge in general surrounding HPV is low.
“Research has shown that knowledge and confidence among health care providers surrounding HPV vaccination is generally low, and this corresponds with a low vaccination recommendation rate,” she says.
She adds, “Patient education on HPV infection and its relationship with OPSCC, paired with point-of-care vaccination for qualifying patients, is a great approach.”
But the education needs to go beyond patients, she says.
“Given the important role that health care providers play in vaccine uptake, I think further efforts are needed to educate providers on HPV vaccination as well,” she says.
The study included patients aged 18-45 years who sought routine outpatient care at the otolaryngology clinic at Boston Medical Center from Sept. 1, 2020, to May 19, 2021.
Limitations of this study include studying a population from a single otolaryngology clinic in an urban, academic medical center. The population was more racially and ethnically diverse than the U.S. population with 60.3% identifying as racial and ethnic minorities. Gender and educational levels were also not reflective of U.S. demographics as half (50.8%) of the participants had a college degree or higher and 58.3% were women.
Dr. Bloom reports grants from the American Head and Neck Cancer Society during the conduct of the study. Coauthor Dr. Faden reports personal fees from Merck, Neotic, Focus, BMS, Chrystalis Biomedical Advisors, and Guidepoint; receiving nonfinancial support from BostonGene and Predicine; and receiving grants from Calico outside the submitted work. Dr. Zhang reports no relevant financial relationships.
The understanding that human papillomavirus (HPV) causes oropharyngeal squamous cell carcinoma (OPSCC) has been linked with increased likelihood of adults having been vaccinated for HPV, new research indicates.
In a study published online in JAMA Otolaryngology–Head and Neck Surgery, most of the 288 adults surveyed with validated questions were not aware that HPV causes OPSCC and had not been told of the relationship by their health care provider.
Researchers found that when participants knew about the relationship between HPV infection and OPSCC they were more than three times as likely to be vaccinated (odds ratio, 3.7; 95% confidence interval, 1.8-7.6) as those without the knowledge.
The survey was paired with a novel point-of-care adult vaccination program within an otolaryngology clinic.
“Targeted education aimed at unvaccinated adults establishing the relationship between HPV infection and OPSCC, paired with point-of-care vaccination, may be an innovative strategy for increasing HPV vaccination rates in adults,” write the authors, led by Jacob C. Bloom, MD, with the department of otolaryngology–head and neck surgery at Boston Medical Center.
Current HPV vaccination recommendations include three parts:
- Routine vaccination at age 11 or 12 years
- Catch-up vaccination at ages 13-26 years if not adequately vaccinated
- Shared clinical decision-making in adults aged 27-45 years if the vaccine series has not been completed.
Despite proven efficacy and safety of the HPV vaccine, vaccination rates are low for adults. Although 75% of adolescents aged 13-17 years have initiated the HPV vaccine, recent studies show only 16% of U.S. men aged 18-21 years have received at least 1 dose of the HPV vaccine, the authors write.
Christiana Zhang, MD, with the division of internal medicine at Johns Hopkins University in Baltimore, who was not part of the study, said she was not surprised by the lack of knowledge about the HPV-OPSCC link.
Patients are often counseled on the relationship between HPV and genital warts or anogenital cancers like cervical cancer, she says, but there is less patient education surrounding the relationship between HPV and oropharyngeal cancers.
She says she does counsel patients on the link with OPSCC, but not all providers do and provider knowledge in general surrounding HPV is low.
“Research has shown that knowledge and confidence among health care providers surrounding HPV vaccination is generally low, and this corresponds with a low vaccination recommendation rate,” she says.
She adds, “Patient education on HPV infection and its relationship with OPSCC, paired with point-of-care vaccination for qualifying patients, is a great approach.”
But the education needs to go beyond patients, she says.
“Given the important role that health care providers play in vaccine uptake, I think further efforts are needed to educate providers on HPV vaccination as well,” she says.
The study included patients aged 18-45 years who sought routine outpatient care at the otolaryngology clinic at Boston Medical Center from Sept. 1, 2020, to May 19, 2021.
Limitations of this study include studying a population from a single otolaryngology clinic in an urban, academic medical center. The population was more racially and ethnically diverse than the U.S. population with 60.3% identifying as racial and ethnic minorities. Gender and educational levels were also not reflective of U.S. demographics as half (50.8%) of the participants had a college degree or higher and 58.3% were women.
Dr. Bloom reports grants from the American Head and Neck Cancer Society during the conduct of the study. Coauthor Dr. Faden reports personal fees from Merck, Neotic, Focus, BMS, Chrystalis Biomedical Advisors, and Guidepoint; receiving nonfinancial support from BostonGene and Predicine; and receiving grants from Calico outside the submitted work. Dr. Zhang reports no relevant financial relationships.
The understanding that human papillomavirus (HPV) causes oropharyngeal squamous cell carcinoma (OPSCC) has been linked with increased likelihood of adults having been vaccinated for HPV, new research indicates.
In a study published online in JAMA Otolaryngology–Head and Neck Surgery, most of the 288 adults surveyed with validated questions were not aware that HPV causes OPSCC and had not been told of the relationship by their health care provider.
Researchers found that when participants knew about the relationship between HPV infection and OPSCC they were more than three times as likely to be vaccinated (odds ratio, 3.7; 95% confidence interval, 1.8-7.6) as those without the knowledge.
The survey was paired with a novel point-of-care adult vaccination program within an otolaryngology clinic.
“Targeted education aimed at unvaccinated adults establishing the relationship between HPV infection and OPSCC, paired with point-of-care vaccination, may be an innovative strategy for increasing HPV vaccination rates in adults,” write the authors, led by Jacob C. Bloom, MD, with the department of otolaryngology–head and neck surgery at Boston Medical Center.
Current HPV vaccination recommendations include three parts:
- Routine vaccination at age 11 or 12 years
- Catch-up vaccination at ages 13-26 years if not adequately vaccinated
- Shared clinical decision-making in adults aged 27-45 years if the vaccine series has not been completed.
Despite proven efficacy and safety of the HPV vaccine, vaccination rates are low for adults. Although 75% of adolescents aged 13-17 years have initiated the HPV vaccine, recent studies show only 16% of U.S. men aged 18-21 years have received at least 1 dose of the HPV vaccine, the authors write.
Christiana Zhang, MD, with the division of internal medicine at Johns Hopkins University in Baltimore, who was not part of the study, said she was not surprised by the lack of knowledge about the HPV-OPSCC link.
Patients are often counseled on the relationship between HPV and genital warts or anogenital cancers like cervical cancer, she says, but there is less patient education surrounding the relationship between HPV and oropharyngeal cancers.
She says she does counsel patients on the link with OPSCC, but not all providers do and provider knowledge in general surrounding HPV is low.
“Research has shown that knowledge and confidence among health care providers surrounding HPV vaccination is generally low, and this corresponds with a low vaccination recommendation rate,” she says.
She adds, “Patient education on HPV infection and its relationship with OPSCC, paired with point-of-care vaccination for qualifying patients, is a great approach.”
But the education needs to go beyond patients, she says.
“Given the important role that health care providers play in vaccine uptake, I think further efforts are needed to educate providers on HPV vaccination as well,” she says.
The study included patients aged 18-45 years who sought routine outpatient care at the otolaryngology clinic at Boston Medical Center from Sept. 1, 2020, to May 19, 2021.
Limitations of this study include studying a population from a single otolaryngology clinic in an urban, academic medical center. The population was more racially and ethnically diverse than the U.S. population with 60.3% identifying as racial and ethnic minorities. Gender and educational levels were also not reflective of U.S. demographics as half (50.8%) of the participants had a college degree or higher and 58.3% were women.
Dr. Bloom reports grants from the American Head and Neck Cancer Society during the conduct of the study. Coauthor Dr. Faden reports personal fees from Merck, Neotic, Focus, BMS, Chrystalis Biomedical Advisors, and Guidepoint; receiving nonfinancial support from BostonGene and Predicine; and receiving grants from Calico outside the submitted work. Dr. Zhang reports no relevant financial relationships.
FROM JAMA OTOLARYNGOLOGY–HEAD AND NECK SURGERY