Mixed Topics

Cryolipolysis accounted for a majority of noninvasive cosmetic procedures associated with adverse events, according to an analysis of data from the Manufacturer and User Facility Device Experience (MAUDE).

The number of noninvasive body-contouring procedures performed in the United States increased by fivefold from 2011 to 2019, attributed in part to a combination of improved technology and new medical devices, as well as a “cosmetically savvy consumer base heavily influenced by social media,” wrote Young Lim, MD, PhD, of the department of dermatology, Massachusetts General Hospital, Boston, and coauthors.

However, premarket evaluations of many new medical devices fail to capture rare or delayed onset complications, and consumers and providers may not be fully aware of potential adverse events, they said. The MAUDE database was created by the Food and Drug Administration in 1991 to collect information on device-related deaths, serious injuries, or malfunctions based on reports from manufacturers, patients, and health care providers.

The researchers used the MAUDE database to identify and highlight adverse events associated with noninvasive body contouring technology in order to improve patient safety and satisfaction.

In their report, published in Lasers in Surgery and Medicine, they analyzed 723 medical device reports (MDRs) reported between 2015 and 2021: 660 for noninvasive body contouring, 55 for cellulite treatments, and 8 for muscle stimulation.

“Notably, of the 723 total MDRs between 2015 and 2021, 515 (71.2%) were reported in 2021, with the next highest reported being 64 in 2019 (8.8%),” the researchers wrote.

Overall, paradoxical hyperplasia (PAH) accounted for the majority of adverse reactions in the noninvasive body-contouring category (73.2%). In PAH, patients develop additional adipose tissue in areas treated with cryolipolysis. In this study, all reports of PAH as well as all 47 reported cases of abdominal hernias were attributed to the CoolSculpting device.

For cellulite treatments, the most common MDRs – 11 of 55 – were scars and keloids (20%). The Cellfina subcision technique accounted for 47% (26 of 55) of the MDRs in this category, including 9 of the scar and keloid cases.

Only eight of the MDRs analyzed were in the muscle stimulation category; of these, burns were the most common adverse event and accounted for three of the reports. The other reported AEs were two cases of pain and one report each of electrical shock, urticaria, and arrhythmia.

Patients are increasingly opting for noninvasive cosmetic procedures, but adverse events may be underreported despite the existence of databases such as MAUDE, the researchers wrote in their discussion.

“PAH, first reported in 2014 as an adverse sequelae of cryolipolysis, remains without known pathophysiology, though it proportionately affects men more than women,” they noted. The incidence of PAH varies widely, and the current treatment of choice is power-assisted liposuction, they said, although surgical abdominoplasty may be needed in severe cases.

The findings were limited by several factors including the reliance of the quality of submissions, the selection biases of the MAUDE database, and the potential for underreporting, the researchers noted.

However, “by cataloging the AEs of the growing noninvasive cosmetics market, the MAUDE can educate providers and inform patients to maximize safety and efficacy,” they said.

The size of the database and volume of reports provides a picture that likely reflects overall trends occurring in clinical practice, but in order to be effective, such databases require diligence on the part of manufacturers and clinicians to provide accurate, up-to-date information, the researchers concluded.

More procedures mean more complications

“As the market for minimally and noninvasive cosmetic procedures continues to expand, clinicians will likely encounter a greater number of patients with complications from these procedures,” said Jacqueline Watchmaker, MD, a general and cosmetic dermatologist in Scottsdale, Ariz., in an interview.

“Now more than ever, it is important for providers to understand potential side effects of procedures so that they can adequately counsel patients and optimize patient safety,” and therefore the current study is important at this time, she commented.

Dr. Watchmaker, who was not involved in the study, said that, overall, she was not surprised by the findings. “The adverse events analyzed from the Manufacturer and User Facility Device Experience parallel what is seen in clinical practice,” she said. “I did find it slightly surprising that an overwhelming majority of the medical device reports (515 of 723) were from 2021.” As the authors discuss, the reasons for this increase may include such factors as more flexible pandemic work schedules, pandemic weight gain, and the rise in MedSpas in recent years, she added.

“Some patients mistakenly think that ‘noninvasive’ or ‘minimally invasive’ procedures are risk free,” said Dr. Watchmaker. “However, as this review clearly demonstrates, complications can and do occur with these procedures. It is our job as clinicians to educate our patients on potential adverse events prior to treatment,” she emphasized. Also, she added, it is important for clinicians to report all adverse events to the MAUDE database so the true risks of noninvasive procedures can be more accurately assessed.

As for additional research, “It would be interesting to repeat the same study but to look at other minimally and noninvasive cosmetic devices such as radiofrequency and ultrasound devices,” Dr. Watchmaker noted.

The study received no outside funding. Dr. Lim and his coauthors, Adam Wulkan, MD, of the Lahey Clinic, Burlington, Mass., and Mathew Avram, MD, JD, of Massachusetts General Hospital, had no financial conflicts to disclose. Dr. Watchmaker had no financial conflicts to disclose.
 

Medical device–related adverse events can be reported to the FDA’s MAUDE database here .

Cryolipolysis accounted for a majority of noninvasive cosmetic procedures associated with adverse events, according to an analysis of data from the Manufacturer and User Facility Device Experience (MAUDE).

The number of noninvasive body-contouring procedures performed in the United States increased by fivefold from 2011 to 2019, attributed in part to a combination of improved technology and new medical devices, as well as a “cosmetically savvy consumer base heavily influenced by social media,” wrote Young Lim, MD, PhD, of the department of dermatology, Massachusetts General Hospital, Boston, and coauthors.

However, premarket evaluations of many new medical devices fail to capture rare or delayed onset complications, and consumers and providers may not be fully aware of potential adverse events, they said. The MAUDE database was created by the Food and Drug Administration in 1991 to collect information on device-related deaths, serious injuries, or malfunctions based on reports from manufacturers, patients, and health care providers.

The researchers used the MAUDE database to identify and highlight adverse events associated with noninvasive body contouring technology in order to improve patient safety and satisfaction.

In their report, published in Lasers in Surgery and Medicine, they analyzed 723 medical device reports (MDRs) reported between 2015 and 2021: 660 for noninvasive body contouring, 55 for cellulite treatments, and 8 for muscle stimulation.

“Notably, of the 723 total MDRs between 2015 and 2021, 515 (71.2%) were reported in 2021, with the next highest reported being 64 in 2019 (8.8%),” the researchers wrote.

Overall, paradoxical hyperplasia (PAH) accounted for the majority of adverse reactions in the noninvasive body-contouring category (73.2%). In PAH, patients develop additional adipose tissue in areas treated with cryolipolysis. In this study, all reports of PAH as well as all 47 reported cases of abdominal hernias were attributed to the CoolSculpting device.

For cellulite treatments, the most common MDRs – 11 of 55 – were scars and keloids (20%). The Cellfina subcision technique accounted for 47% (26 of 55) of the MDRs in this category, including 9 of the scar and keloid cases.

Only eight of the MDRs analyzed were in the muscle stimulation category; of these, burns were the most common adverse event and accounted for three of the reports. The other reported AEs were two cases of pain and one report each of electrical shock, urticaria, and arrhythmia.

Patients are increasingly opting for noninvasive cosmetic procedures, but adverse events may be underreported despite the existence of databases such as MAUDE, the researchers wrote in their discussion.

“PAH, first reported in 2014 as an adverse sequelae of cryolipolysis, remains without known pathophysiology, though it proportionately affects men more than women,” they noted. The incidence of PAH varies widely, and the current treatment of choice is power-assisted liposuction, they said, although surgical abdominoplasty may be needed in severe cases.

The findings were limited by several factors including the reliance of the quality of submissions, the selection biases of the MAUDE database, and the potential for underreporting, the researchers noted.

However, “by cataloging the AEs of the growing noninvasive cosmetics market, the MAUDE can educate providers and inform patients to maximize safety and efficacy,” they said.

The size of the database and volume of reports provides a picture that likely reflects overall trends occurring in clinical practice, but in order to be effective, such databases require diligence on the part of manufacturers and clinicians to provide accurate, up-to-date information, the researchers concluded.

More procedures mean more complications

“As the market for minimally and noninvasive cosmetic procedures continues to expand, clinicians will likely encounter a greater number of patients with complications from these procedures,” said Jacqueline Watchmaker, MD, a general and cosmetic dermatologist in Scottsdale, Ariz., in an interview.

“Now more than ever, it is important for providers to understand potential side effects of procedures so that they can adequately counsel patients and optimize patient safety,” and therefore the current study is important at this time, she commented.

Dr. Watchmaker, who was not involved in the study, said that, overall, she was not surprised by the findings. “The adverse events analyzed from the Manufacturer and User Facility Device Experience parallel what is seen in clinical practice,” she said. “I did find it slightly surprising that an overwhelming majority of the medical device reports (515 of 723) were from 2021.” As the authors discuss, the reasons for this increase may include such factors as more flexible pandemic work schedules, pandemic weight gain, and the rise in MedSpas in recent years, she added.

“Some patients mistakenly think that ‘noninvasive’ or ‘minimally invasive’ procedures are risk free,” said Dr. Watchmaker. “However, as this review clearly demonstrates, complications can and do occur with these procedures. It is our job as clinicians to educate our patients on potential adverse events prior to treatment,” she emphasized. Also, she added, it is important for clinicians to report all adverse events to the MAUDE database so the true risks of noninvasive procedures can be more accurately assessed.

As for additional research, “It would be interesting to repeat the same study but to look at other minimally and noninvasive cosmetic devices such as radiofrequency and ultrasound devices,” Dr. Watchmaker noted.

The study received no outside funding. Dr. Lim and his coauthors, Adam Wulkan, MD, of the Lahey Clinic, Burlington, Mass., and Mathew Avram, MD, JD, of Massachusetts General Hospital, had no financial conflicts to disclose. Dr. Watchmaker had no financial conflicts to disclose.
 

Medical device–related adverse events can be reported to the FDA’s MAUDE database here .

Cryolipolysis accounted for a majority of noninvasive cosmetic procedures associated with adverse events, according to an analysis of data from the Manufacturer and User Facility Device Experience (MAUDE).

The number of noninvasive body-contouring procedures performed in the United States increased by fivefold from 2011 to 2019, attributed in part to a combination of improved technology and new medical devices, as well as a “cosmetically savvy consumer base heavily influenced by social media,” wrote Young Lim, MD, PhD, of the department of dermatology, Massachusetts General Hospital, Boston, and coauthors.

However, premarket evaluations of many new medical devices fail to capture rare or delayed onset complications, and consumers and providers may not be fully aware of potential adverse events, they said. The MAUDE database was created by the Food and Drug Administration in 1991 to collect information on device-related deaths, serious injuries, or malfunctions based on reports from manufacturers, patients, and health care providers.

The researchers used the MAUDE database to identify and highlight adverse events associated with noninvasive body contouring technology in order to improve patient safety and satisfaction.

In their report, published in Lasers in Surgery and Medicine, they analyzed 723 medical device reports (MDRs) reported between 2015 and 2021: 660 for noninvasive body contouring, 55 for cellulite treatments, and 8 for muscle stimulation.

“Notably, of the 723 total MDRs between 2015 and 2021, 515 (71.2%) were reported in 2021, with the next highest reported being 64 in 2019 (8.8%),” the researchers wrote.

Overall, paradoxical hyperplasia (PAH) accounted for the majority of adverse reactions in the noninvasive body-contouring category (73.2%). In PAH, patients develop additional adipose tissue in areas treated with cryolipolysis. In this study, all reports of PAH as well as all 47 reported cases of abdominal hernias were attributed to the CoolSculpting device.

For cellulite treatments, the most common MDRs – 11 of 55 – were scars and keloids (20%). The Cellfina subcision technique accounted for 47% (26 of 55) of the MDRs in this category, including 9 of the scar and keloid cases.

Only eight of the MDRs analyzed were in the muscle stimulation category; of these, burns were the most common adverse event and accounted for three of the reports. The other reported AEs were two cases of pain and one report each of electrical shock, urticaria, and arrhythmia.

Patients are increasingly opting for noninvasive cosmetic procedures, but adverse events may be underreported despite the existence of databases such as MAUDE, the researchers wrote in their discussion.

“PAH, first reported in 2014 as an adverse sequelae of cryolipolysis, remains without known pathophysiology, though it proportionately affects men more than women,” they noted. The incidence of PAH varies widely, and the current treatment of choice is power-assisted liposuction, they said, although surgical abdominoplasty may be needed in severe cases.

The findings were limited by several factors including the reliance of the quality of submissions, the selection biases of the MAUDE database, and the potential for underreporting, the researchers noted.

However, “by cataloging the AEs of the growing noninvasive cosmetics market, the MAUDE can educate providers and inform patients to maximize safety and efficacy,” they said.

The size of the database and volume of reports provides a picture that likely reflects overall trends occurring in clinical practice, but in order to be effective, such databases require diligence on the part of manufacturers and clinicians to provide accurate, up-to-date information, the researchers concluded.

More procedures mean more complications

“As the market for minimally and noninvasive cosmetic procedures continues to expand, clinicians will likely encounter a greater number of patients with complications from these procedures,” said Jacqueline Watchmaker, MD, a general and cosmetic dermatologist in Scottsdale, Ariz., in an interview.

“Now more than ever, it is important for providers to understand potential side effects of procedures so that they can adequately counsel patients and optimize patient safety,” and therefore the current study is important at this time, she commented.

Dr. Watchmaker, who was not involved in the study, said that, overall, she was not surprised by the findings. “The adverse events analyzed from the Manufacturer and User Facility Device Experience parallel what is seen in clinical practice,” she said. “I did find it slightly surprising that an overwhelming majority of the medical device reports (515 of 723) were from 2021.” As the authors discuss, the reasons for this increase may include such factors as more flexible pandemic work schedules, pandemic weight gain, and the rise in MedSpas in recent years, she added.

“Some patients mistakenly think that ‘noninvasive’ or ‘minimally invasive’ procedures are risk free,” said Dr. Watchmaker. “However, as this review clearly demonstrates, complications can and do occur with these procedures. It is our job as clinicians to educate our patients on potential adverse events prior to treatment,” she emphasized. Also, she added, it is important for clinicians to report all adverse events to the MAUDE database so the true risks of noninvasive procedures can be more accurately assessed.

As for additional research, “It would be interesting to repeat the same study but to look at other minimally and noninvasive cosmetic devices such as radiofrequency and ultrasound devices,” Dr. Watchmaker noted.

The study received no outside funding. Dr. Lim and his coauthors, Adam Wulkan, MD, of the Lahey Clinic, Burlington, Mass., and Mathew Avram, MD, JD, of Massachusetts General Hospital, had no financial conflicts to disclose. Dr. Watchmaker had no financial conflicts to disclose.
 

Medical device–related adverse events can be reported to the FDA’s MAUDE database here .

In June, Rebecca A. Shatsky, MD, a medical oncologist, turned to Twitter for advice: “What do you do/say when a patient won’t believe you that they have #CANCER. As an oncologist this comes up every now and then and proves very difficult, looking to hear how others have dealt and what works best to help patients here.”

About a dozen people weighed in, offering various thoughts on how to approach these thorny situations. One oncologist suggested revisiting the conversation a few days later, after the patient has more time to process; others suggested sharing the pathology report or images with their patient.

Another person simply noted that “if a [patient] doesn’t want to believe they have cancer, no amount of evidence will change that.”

Based on the initial responses, “it appears there is a paucity of answers sadly,” wrote Dr. Shatsky, a breast cancer specialist at University of California, San Diego.

But for Dr. Shatsky, these incidents spoke to another alarming trend: a rampant mistrust of the medical community that is “becoming MORE common instead of less.”
 

‘Erosion of trust’

Overall, experts say that situations like the one Dr. Shatsky described – patients who don’t believe their cancer diagnosis – occur infrequently.

But denial comes in many forms, and complete disbelief is probably the most extreme. Patients may also downplay the severity of their disease, shy away from hearing bad news, or refuse standard treatment or their doctor’s advice.

Like Dr. Shatsky, these experts say they are also seeing a troubling increase in patients who don’t believe their physicians or don’t trust their recommendations.

“I think there’s an erosion of trust in expertise, in general,” said Ronald M. Epstein, MD, professor of family medicine and psychiatry & oncology at the University of Rochester (N.Y.). “People distrust science more than they did maybe 20 or 30 years ago, or at least that seems to be the case.”

Denial and distrust in cancer care are not new. These responses – along with wishful thinking, distraction, and minimization – are long-established responses among oncology patients. In 1972, Avery D. Weisman, MD, a psychiatrist at Harvard Medical School, Boston, wrote his book “On Dying and Denying,” and ever since, denial and similar responses have been explored in the oncology literature.

Much of this research has focused on the latter stages of illness, but denial can be present at diagnosis as well. One study of patients with breast cancer, carried out nearly 30 years ago, suggested that denial of diagnosis generally occurs early in a patient’s course of illness and decreases over time, but may arise again in the terminal phase of cancer. Another analysis, evaluating this phenomenon across 13 studies, found that the prevalence of denial at diagnosis ranged from 4% to as high as 47%. 

An oncologist delivers somewhere between 10,000 to 30,000 episodes of bad news over the course of a career, so there’s always a chance that a patient will respond in a way that’s on the “spectrum of disbelief,” said Paul Helft, MD, professor of medicine and recently retired director of the ethics center at Indiana University, Indianapolis.

Diane Meier, MD, said denial and disbelief are natural, protective responses to difficult or frightening news.

When patients exhibit denial, Dr. Meier advises patience and time. Physicians can also ask the patient if there’s a person they trust – a family member or faith leader, for example – who could speak on their behalf about possible next steps.

“The main thing is not to find ourselves in opposition to the patient ... or threaten them with what will happen if they don’t listen to us,” said Dr. Meier, a professor of geriatrics and palliative medicine at the Icahn School of Medicine at Mount Sinai, New York.

And physicians should be careful when they feel themselves wanting to argue with or lecture a patient.

“The minute we feel that urge coming on, that’s a signal to us to stop and realize that something is going on inside the patient that we don’t understand,” she said. “Forcing information on a person who is signaling in every way that they don’t want it and can’t handle it is not a recipe for trust or a high-quality relationship.”
 

Refusing expert advice

Jennifer Lycette, MD, has encountered a growing number of patients who don’t believe their disease should be treated the way she or other oncologists recommend. Some patients remain adamant about sticking with alternative medicine or doing nothing, despite growing sicker.

“I’ve even had situations where the tumor might be visible, like growing through the skin, and people still double down that whatever they’re doing is working,” said Dr. Lycette, a hematologist and medical oncologist at the Providence Seaside Cancer Center in Seaside, Ore.

She encourages these patients to get a second opinion and tries to keep an open mind about alternative approaches. If she’s not familiar with something a patient is considering, she’ll research it with them.

But she makes sure to point out any risks associated with these approaches. While some alternative therapies can support patients through standard treatment, she strongly cautions patients against using these therapies in place of standard treatment.

“The bottom line is to keep the lines of communication open,” she said.

Like Dr. Lycette, Dr. Helft has been encountering more patients with alternative health beliefs who rely on people outside of the medical system for elements of their care.

In the past, he used to tell these patients that science is incomplete, and physicians don’t know everything. But he’s changed his tune.

“I’ve taken to just telling them what I believe, which is that the majority of things that they hear and are being sold are almost certainly ineffective and a waste of money,” he said. “I’ve come to accept that people are adults, and they make their own decisions, and sometimes they make decisions that are not the ones that I would make or want them to make.”
 

Delivering bad news

Dr. Helft often sees patients seeking a second or third opinion on their cancer. These patients may not all be in denial about having cancer, but they typically don’t want to hear bad news, which can make treatment a challenge.

To handle these scenarios, Dr. Helft has developed a system of responses for engaging with patients. He borrows an approach described in 2008 where he acknowledges a patient’s emotional distress and tries to understand why they may not want to know more.

For instance, he might tell a patient: “I have formulated an opinion about your situation, but it sounds as if you have heard many negative descriptions previously. I don’t want to burden you with one more if you don’t feel prepared to talk about it.”

Trying to understand why a patient is resistant to hearing about their condition may also help build trust. “If you could help me understand your thinking about why you would rather not talk about prognosis, it will help me know more about how to discuss other serious issues,” is one approach highlighted in the 2008 guide.

Behind the scenes, Dr. Helft will privately assess how much information about a patient’s prognosis is salient to their decision making, especially if the patient appears to misunderstand their prognosis or if there are various options for treatment over the long-term. 

Dr. Helft will also ask patients how much they want to know. Do they want to discuss no options? A few? All and in detail?

This approach implicitly recognizes that the information is highly stressful but avoids being overly blunt, he notes. It can also help steer patients on the right treatment track and minimize poor decision making.

Samantha Winemaker, MD, a palliative care physician in Hamilton, Ont., finds patients often go through an adjustment period after learning about a new diagnosis. The reaction tends to range from needing time to accept the diagnosis as real to jumping in to understand as much as possible.

Dr. Winemaker, who cohosts “The Waiting Room Revolution” podcast that focuses on helping people deal with a serious illness, encourages physicians to be realistic with patients about their prognosis and deliver news with a dose of gentle truth from the start.

“We should invite patients ‘into the know’ as early as possible, while maintaining hope,” she said.

She calls this approach of balancing hope and reality “walking two roads” and said it extends throughout the illness journey. This way, patients are less likely to be surprised if things make a turn for the worse.

“We should never wait until the 11th hour to give someone bad news,” she said.
 

‘We all want to hope’

Dr. Epstein has listened to hundreds of hours of discussion between doctors and patients as part of his research on communication. He often hears doctors initiate difficult conversations by lecturing a patient.

Many physicians mistakenly believe that, if they say something authoritatively, patients will believe it, he said. But the opposite often happens – patients shut down and instinctively distrust the physician.

Dr. Epstein teaches doctors to establish trust before providing difficult information. Even when a patient expresses outlandish ideas about their illness, treat them with dignity and respect, he advised. “If people don’t feel respected, you don’t have a leg to stand on and there’s no point in trying to convince them.”

Patients and physicians often leave conversations with discordant views of what’s ahead. In one study, two-thirds of patients held wildly different views on their prognosis, compared with their doctors, and most had no idea they were at odds with their physician.

In the past, Dr. Epstein has tried to close the gap between his understanding of a patient’s prognosis and the patient’s. But more recently he has become less convinced of the need to do so.

“What I try to do now is focus more on the uncertainty there,” he said. He uses phrases like: “Given that we don’t know how long you will live, I just need to know what you would want me to do if things took a turn for the worse” or “I’m worried that if you don’t have the surgery, you might experience more pain in the future.”

He urged doctors to pay attention to their word choices. Use care with the phrase “response rate” – patients sometimes mistake this to mean that they are being cured. And, instead of telling patients they “must” do something, he says that he worries about consequences for them if they don’t.

He asks patients what they’re hearing from other people in their lives or online. Sometimes patients say that people close to them are encouraging them to stop medical treatment or pursue alternative therapies. When that happens, Dr. Epstein asks to meet with that person to talk to them about his concerns for their loved one.

He also acknowledges calculated uncertainty often exists in medicine. That, he says, leaves open the potential for exceptional circumstances.

“And we all want to hope,” Dr. Epstein said.

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

In June, Rebecca A. Shatsky, MD, a medical oncologist, turned to Twitter for advice: “What do you do/say when a patient won’t believe you that they have #CANCER. As an oncologist this comes up every now and then and proves very difficult, looking to hear how others have dealt and what works best to help patients here.”

About a dozen people weighed in, offering various thoughts on how to approach these thorny situations. One oncologist suggested revisiting the conversation a few days later, after the patient has more time to process; others suggested sharing the pathology report or images with their patient.

Another person simply noted that “if a [patient] doesn’t want to believe they have cancer, no amount of evidence will change that.”

Based on the initial responses, “it appears there is a paucity of answers sadly,” wrote Dr. Shatsky, a breast cancer specialist at University of California, San Diego.

But for Dr. Shatsky, these incidents spoke to another alarming trend: a rampant mistrust of the medical community that is “becoming MORE common instead of less.”
 

‘Erosion of trust’

Overall, experts say that situations like the one Dr. Shatsky described – patients who don’t believe their cancer diagnosis – occur infrequently.

But denial comes in many forms, and complete disbelief is probably the most extreme. Patients may also downplay the severity of their disease, shy away from hearing bad news, or refuse standard treatment or their doctor’s advice.

Like Dr. Shatsky, these experts say they are also seeing a troubling increase in patients who don’t believe their physicians or don’t trust their recommendations.

“I think there’s an erosion of trust in expertise, in general,” said Ronald M. Epstein, MD, professor of family medicine and psychiatry & oncology at the University of Rochester (N.Y.). “People distrust science more than they did maybe 20 or 30 years ago, or at least that seems to be the case.”

Denial and distrust in cancer care are not new. These responses – along with wishful thinking, distraction, and minimization – are long-established responses among oncology patients. In 1972, Avery D. Weisman, MD, a psychiatrist at Harvard Medical School, Boston, wrote his book “On Dying and Denying,” and ever since, denial and similar responses have been explored in the oncology literature.

Much of this research has focused on the latter stages of illness, but denial can be present at diagnosis as well. One study of patients with breast cancer, carried out nearly 30 years ago, suggested that denial of diagnosis generally occurs early in a patient’s course of illness and decreases over time, but may arise again in the terminal phase of cancer. Another analysis, evaluating this phenomenon across 13 studies, found that the prevalence of denial at diagnosis ranged from 4% to as high as 47%. 

An oncologist delivers somewhere between 10,000 to 30,000 episodes of bad news over the course of a career, so there’s always a chance that a patient will respond in a way that’s on the “spectrum of disbelief,” said Paul Helft, MD, professor of medicine and recently retired director of the ethics center at Indiana University, Indianapolis.

Diane Meier, MD, said denial and disbelief are natural, protective responses to difficult or frightening news.

When patients exhibit denial, Dr. Meier advises patience and time. Physicians can also ask the patient if there’s a person they trust – a family member or faith leader, for example – who could speak on their behalf about possible next steps.

“The main thing is not to find ourselves in opposition to the patient ... or threaten them with what will happen if they don’t listen to us,” said Dr. Meier, a professor of geriatrics and palliative medicine at the Icahn School of Medicine at Mount Sinai, New York.

And physicians should be careful when they feel themselves wanting to argue with or lecture a patient.

“The minute we feel that urge coming on, that’s a signal to us to stop and realize that something is going on inside the patient that we don’t understand,” she said. “Forcing information on a person who is signaling in every way that they don’t want it and can’t handle it is not a recipe for trust or a high-quality relationship.”
 

Refusing expert advice

Jennifer Lycette, MD, has encountered a growing number of patients who don’t believe their disease should be treated the way she or other oncologists recommend. Some patients remain adamant about sticking with alternative medicine or doing nothing, despite growing sicker.

“I’ve even had situations where the tumor might be visible, like growing through the skin, and people still double down that whatever they’re doing is working,” said Dr. Lycette, a hematologist and medical oncologist at the Providence Seaside Cancer Center in Seaside, Ore.

She encourages these patients to get a second opinion and tries to keep an open mind about alternative approaches. If she’s not familiar with something a patient is considering, she’ll research it with them.

But she makes sure to point out any risks associated with these approaches. While some alternative therapies can support patients through standard treatment, she strongly cautions patients against using these therapies in place of standard treatment.

“The bottom line is to keep the lines of communication open,” she said.

Like Dr. Lycette, Dr. Helft has been encountering more patients with alternative health beliefs who rely on people outside of the medical system for elements of their care.

In the past, he used to tell these patients that science is incomplete, and physicians don’t know everything. But he’s changed his tune.

“I’ve taken to just telling them what I believe, which is that the majority of things that they hear and are being sold are almost certainly ineffective and a waste of money,” he said. “I’ve come to accept that people are adults, and they make their own decisions, and sometimes they make decisions that are not the ones that I would make or want them to make.”
 

Delivering bad news

Dr. Helft often sees patients seeking a second or third opinion on their cancer. These patients may not all be in denial about having cancer, but they typically don’t want to hear bad news, which can make treatment a challenge.

To handle these scenarios, Dr. Helft has developed a system of responses for engaging with patients. He borrows an approach described in 2008 where he acknowledges a patient’s emotional distress and tries to understand why they may not want to know more.

For instance, he might tell a patient: “I have formulated an opinion about your situation, but it sounds as if you have heard many negative descriptions previously. I don’t want to burden you with one more if you don’t feel prepared to talk about it.”

Trying to understand why a patient is resistant to hearing about their condition may also help build trust. “If you could help me understand your thinking about why you would rather not talk about prognosis, it will help me know more about how to discuss other serious issues,” is one approach highlighted in the 2008 guide.

Behind the scenes, Dr. Helft will privately assess how much information about a patient’s prognosis is salient to their decision making, especially if the patient appears to misunderstand their prognosis or if there are various options for treatment over the long-term. 

Dr. Helft will also ask patients how much they want to know. Do they want to discuss no options? A few? All and in detail?

This approach implicitly recognizes that the information is highly stressful but avoids being overly blunt, he notes. It can also help steer patients on the right treatment track and minimize poor decision making.

Samantha Winemaker, MD, a palliative care physician in Hamilton, Ont., finds patients often go through an adjustment period after learning about a new diagnosis. The reaction tends to range from needing time to accept the diagnosis as real to jumping in to understand as much as possible.

Dr. Winemaker, who cohosts “The Waiting Room Revolution” podcast that focuses on helping people deal with a serious illness, encourages physicians to be realistic with patients about their prognosis and deliver news with a dose of gentle truth from the start.

“We should invite patients ‘into the know’ as early as possible, while maintaining hope,” she said.

She calls this approach of balancing hope and reality “walking two roads” and said it extends throughout the illness journey. This way, patients are less likely to be surprised if things make a turn for the worse.

“We should never wait until the 11th hour to give someone bad news,” she said.
 

‘We all want to hope’

Dr. Epstein has listened to hundreds of hours of discussion between doctors and patients as part of his research on communication. He often hears doctors initiate difficult conversations by lecturing a patient.

Many physicians mistakenly believe that, if they say something authoritatively, patients will believe it, he said. But the opposite often happens – patients shut down and instinctively distrust the physician.

Dr. Epstein teaches doctors to establish trust before providing difficult information. Even when a patient expresses outlandish ideas about their illness, treat them with dignity and respect, he advised. “If people don’t feel respected, you don’t have a leg to stand on and there’s no point in trying to convince them.”

Patients and physicians often leave conversations with discordant views of what’s ahead. In one study, two-thirds of patients held wildly different views on their prognosis, compared with their doctors, and most had no idea they were at odds with their physician.

In the past, Dr. Epstein has tried to close the gap between his understanding of a patient’s prognosis and the patient’s. But more recently he has become less convinced of the need to do so.

“What I try to do now is focus more on the uncertainty there,” he said. He uses phrases like: “Given that we don’t know how long you will live, I just need to know what you would want me to do if things took a turn for the worse” or “I’m worried that if you don’t have the surgery, you might experience more pain in the future.”

He urged doctors to pay attention to their word choices. Use care with the phrase “response rate” – patients sometimes mistake this to mean that they are being cured. And, instead of telling patients they “must” do something, he says that he worries about consequences for them if they don’t.

He asks patients what they’re hearing from other people in their lives or online. Sometimes patients say that people close to them are encouraging them to stop medical treatment or pursue alternative therapies. When that happens, Dr. Epstein asks to meet with that person to talk to them about his concerns for their loved one.

He also acknowledges calculated uncertainty often exists in medicine. That, he says, leaves open the potential for exceptional circumstances.

“And we all want to hope,” Dr. Epstein said.

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

In June, Rebecca A. Shatsky, MD, a medical oncologist, turned to Twitter for advice: “What do you do/say when a patient won’t believe you that they have #CANCER. As an oncologist this comes up every now and then and proves very difficult, looking to hear how others have dealt and what works best to help patients here.”

About a dozen people weighed in, offering various thoughts on how to approach these thorny situations. One oncologist suggested revisiting the conversation a few days later, after the patient has more time to process; others suggested sharing the pathology report or images with their patient.

Another person simply noted that “if a [patient] doesn’t want to believe they have cancer, no amount of evidence will change that.”

Based on the initial responses, “it appears there is a paucity of answers sadly,” wrote Dr. Shatsky, a breast cancer specialist at University of California, San Diego.

But for Dr. Shatsky, these incidents spoke to another alarming trend: a rampant mistrust of the medical community that is “becoming MORE common instead of less.”
 

‘Erosion of trust’

Overall, experts say that situations like the one Dr. Shatsky described – patients who don’t believe their cancer diagnosis – occur infrequently.

But denial comes in many forms, and complete disbelief is probably the most extreme. Patients may also downplay the severity of their disease, shy away from hearing bad news, or refuse standard treatment or their doctor’s advice.

Like Dr. Shatsky, these experts say they are also seeing a troubling increase in patients who don’t believe their physicians or don’t trust their recommendations.

“I think there’s an erosion of trust in expertise, in general,” said Ronald M. Epstein, MD, professor of family medicine and psychiatry & oncology at the University of Rochester (N.Y.). “People distrust science more than they did maybe 20 or 30 years ago, or at least that seems to be the case.”

Denial and distrust in cancer care are not new. These responses – along with wishful thinking, distraction, and minimization – are long-established responses among oncology patients. In 1972, Avery D. Weisman, MD, a psychiatrist at Harvard Medical School, Boston, wrote his book “On Dying and Denying,” and ever since, denial and similar responses have been explored in the oncology literature.

Much of this research has focused on the latter stages of illness, but denial can be present at diagnosis as well. One study of patients with breast cancer, carried out nearly 30 years ago, suggested that denial of diagnosis generally occurs early in a patient’s course of illness and decreases over time, but may arise again in the terminal phase of cancer. Another analysis, evaluating this phenomenon across 13 studies, found that the prevalence of denial at diagnosis ranged from 4% to as high as 47%. 

An oncologist delivers somewhere between 10,000 to 30,000 episodes of bad news over the course of a career, so there’s always a chance that a patient will respond in a way that’s on the “spectrum of disbelief,” said Paul Helft, MD, professor of medicine and recently retired director of the ethics center at Indiana University, Indianapolis.

Diane Meier, MD, said denial and disbelief are natural, protective responses to difficult or frightening news.

When patients exhibit denial, Dr. Meier advises patience and time. Physicians can also ask the patient if there’s a person they trust – a family member or faith leader, for example – who could speak on their behalf about possible next steps.

“The main thing is not to find ourselves in opposition to the patient ... or threaten them with what will happen if they don’t listen to us,” said Dr. Meier, a professor of geriatrics and palliative medicine at the Icahn School of Medicine at Mount Sinai, New York.

And physicians should be careful when they feel themselves wanting to argue with or lecture a patient.

“The minute we feel that urge coming on, that’s a signal to us to stop and realize that something is going on inside the patient that we don’t understand,” she said. “Forcing information on a person who is signaling in every way that they don’t want it and can’t handle it is not a recipe for trust or a high-quality relationship.”
 

Refusing expert advice

Jennifer Lycette, MD, has encountered a growing number of patients who don’t believe their disease should be treated the way she or other oncologists recommend. Some patients remain adamant about sticking with alternative medicine or doing nothing, despite growing sicker.

“I’ve even had situations where the tumor might be visible, like growing through the skin, and people still double down that whatever they’re doing is working,” said Dr. Lycette, a hematologist and medical oncologist at the Providence Seaside Cancer Center in Seaside, Ore.

She encourages these patients to get a second opinion and tries to keep an open mind about alternative approaches. If she’s not familiar with something a patient is considering, she’ll research it with them.

But she makes sure to point out any risks associated with these approaches. While some alternative therapies can support patients through standard treatment, she strongly cautions patients against using these therapies in place of standard treatment.

“The bottom line is to keep the lines of communication open,” she said.

Like Dr. Lycette, Dr. Helft has been encountering more patients with alternative health beliefs who rely on people outside of the medical system for elements of their care.

In the past, he used to tell these patients that science is incomplete, and physicians don’t know everything. But he’s changed his tune.

“I’ve taken to just telling them what I believe, which is that the majority of things that they hear and are being sold are almost certainly ineffective and a waste of money,” he said. “I’ve come to accept that people are adults, and they make their own decisions, and sometimes they make decisions that are not the ones that I would make or want them to make.”
 

Delivering bad news

Dr. Helft often sees patients seeking a second or third opinion on their cancer. These patients may not all be in denial about having cancer, but they typically don’t want to hear bad news, which can make treatment a challenge.

To handle these scenarios, Dr. Helft has developed a system of responses for engaging with patients. He borrows an approach described in 2008 where he acknowledges a patient’s emotional distress and tries to understand why they may not want to know more.

For instance, he might tell a patient: “I have formulated an opinion about your situation, but it sounds as if you have heard many negative descriptions previously. I don’t want to burden you with one more if you don’t feel prepared to talk about it.”

Trying to understand why a patient is resistant to hearing about their condition may also help build trust. “If you could help me understand your thinking about why you would rather not talk about prognosis, it will help me know more about how to discuss other serious issues,” is one approach highlighted in the 2008 guide.

Behind the scenes, Dr. Helft will privately assess how much information about a patient’s prognosis is salient to their decision making, especially if the patient appears to misunderstand their prognosis or if there are various options for treatment over the long-term. 

Dr. Helft will also ask patients how much they want to know. Do they want to discuss no options? A few? All and in detail?

This approach implicitly recognizes that the information is highly stressful but avoids being overly blunt, he notes. It can also help steer patients on the right treatment track and minimize poor decision making.

Samantha Winemaker, MD, a palliative care physician in Hamilton, Ont., finds patients often go through an adjustment period after learning about a new diagnosis. The reaction tends to range from needing time to accept the diagnosis as real to jumping in to understand as much as possible.

Dr. Winemaker, who cohosts “The Waiting Room Revolution” podcast that focuses on helping people deal with a serious illness, encourages physicians to be realistic with patients about their prognosis and deliver news with a dose of gentle truth from the start.

“We should invite patients ‘into the know’ as early as possible, while maintaining hope,” she said.

She calls this approach of balancing hope and reality “walking two roads” and said it extends throughout the illness journey. This way, patients are less likely to be surprised if things make a turn for the worse.

“We should never wait until the 11th hour to give someone bad news,” she said.
 

‘We all want to hope’

Dr. Epstein has listened to hundreds of hours of discussion between doctors and patients as part of his research on communication. He often hears doctors initiate difficult conversations by lecturing a patient.

Many physicians mistakenly believe that, if they say something authoritatively, patients will believe it, he said. But the opposite often happens – patients shut down and instinctively distrust the physician.

Dr. Epstein teaches doctors to establish trust before providing difficult information. Even when a patient expresses outlandish ideas about their illness, treat them with dignity and respect, he advised. “If people don’t feel respected, you don’t have a leg to stand on and there’s no point in trying to convince them.”

Patients and physicians often leave conversations with discordant views of what’s ahead. In one study, two-thirds of patients held wildly different views on their prognosis, compared with their doctors, and most had no idea they were at odds with their physician.

In the past, Dr. Epstein has tried to close the gap between his understanding of a patient’s prognosis and the patient’s. But more recently he has become less convinced of the need to do so.

“What I try to do now is focus more on the uncertainty there,” he said. He uses phrases like: “Given that we don’t know how long you will live, I just need to know what you would want me to do if things took a turn for the worse” or “I’m worried that if you don’t have the surgery, you might experience more pain in the future.”

He urged doctors to pay attention to their word choices. Use care with the phrase “response rate” – patients sometimes mistake this to mean that they are being cured. And, instead of telling patients they “must” do something, he says that he worries about consequences for them if they don’t.

He asks patients what they’re hearing from other people in their lives or online. Sometimes patients say that people close to them are encouraging them to stop medical treatment or pursue alternative therapies. When that happens, Dr. Epstein asks to meet with that person to talk to them about his concerns for their loved one.

He also acknowledges calculated uncertainty often exists in medicine. That, he says, leaves open the potential for exceptional circumstances.

“And we all want to hope,” Dr. Epstein said.

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

Ibrutinib (Imbruvica) is now available for use in children aged 1-12 years who have chronic graft-versus-host disease (cGVHD), which can develop after stem cell transplantation for treatment of a blood cancer.

Specifically, the indication is for pediatric patients with cGVHD who have already been treated with one or more lines of systemic therapy. The manufacturers have also launched a new oral suspension formulation, in addition to capsules and tablets, which were already available.

Ibrutinib is already approved for use in adults with cGVHD.

The drug is also approved for use in several blood cancers, including chronic lymphocytic leukemia, mantle cell lymphoma, and Waldenström’s macroglobulinemia. All these approvals are for adult patients.

This is the first pediatric indication for the product and is “incredibly meaningful,” said Gauri Sunkersett, DO, associate medical director at AbbVie, which markets the drug together with Jansen. “As a pediatric oncologist, when my patients describe the physical pain they experience from simply hugging their parents, due to their cGVHD, the importance of researching alternative treatment options in this patient population is further validated.”

These children have already been through a lot, having been diagnosed with a leukemia or lymphoma and then undergoing chemotherapy and/or radiotherapy for a stem cell transplant. Just over half (52%-65%) of children who receive allogeneic transplants go on to develop cGVHD, in which the donor bone marrow or stem cells attack the recipient.

“Imagine going through a transplant and then being told you have a moderate to severe chronic disease that can sometimes also be life-threatening,” commented Paul A. Carpenter, MD, attending physician at Seattle Children’s Hospital. “If these children were between 1 and 12 and didn’t respond to steroid treatment, we didn’t have any rigorously studied treatment options – until now.”

The new indication was approved by the U.S. Food and Drug Administration on the basis of results from the iMAGINE trial, for which Dr. Carpenter was a principal investigator.

The phase 1/2 iMAGINE trial was an open-label, multicenter, single-arm trial conducted with 47 patients (mean age, 13 years; range, 1-19 years) with relapsed/refractory cGVHD who had received at least one prior systemic therapy. Ibrutinib was given at a dose of 420 mg orally once daily to patients aged 12 and older and at a dose of 240 mg/m2 orally once daily to patients who were younger than 12 years.

The overall response rate through week 25 was 60% (confidence interval, 95%, 44%-74%). The median duration of response was 5.3 months (95% CI, 2.8-8.8).

The safety profile was consistent with the established profile for ibrutinib. Observed adverse events in pediatric patients were consistent with those observed in adult patients with moderate to severe cGVHD, the companies noted.

The FDA noted that the most common (≥ 20%) adverse reactions, including laboratory abnormalities, were anemia, musculoskeletal pain, pyrexia, diarrhea, pneumonia, abdominal pain, stomatitis, thrombocytopenia, and headache.

Full prescribing information for ibrutinib is available here.

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

Ibrutinib (Imbruvica) is now available for use in children aged 1-12 years who have chronic graft-versus-host disease (cGVHD), which can develop after stem cell transplantation for treatment of a blood cancer.

Specifically, the indication is for pediatric patients with cGVHD who have already been treated with one or more lines of systemic therapy. The manufacturers have also launched a new oral suspension formulation, in addition to capsules and tablets, which were already available.

Ibrutinib is already approved for use in adults with cGVHD.

The drug is also approved for use in several blood cancers, including chronic lymphocytic leukemia, mantle cell lymphoma, and Waldenström’s macroglobulinemia. All these approvals are for adult patients.

This is the first pediatric indication for the product and is “incredibly meaningful,” said Gauri Sunkersett, DO, associate medical director at AbbVie, which markets the drug together with Jansen. “As a pediatric oncologist, when my patients describe the physical pain they experience from simply hugging their parents, due to their cGVHD, the importance of researching alternative treatment options in this patient population is further validated.”

These children have already been through a lot, having been diagnosed with a leukemia or lymphoma and then undergoing chemotherapy and/or radiotherapy for a stem cell transplant. Just over half (52%-65%) of children who receive allogeneic transplants go on to develop cGVHD, in which the donor bone marrow or stem cells attack the recipient.

“Imagine going through a transplant and then being told you have a moderate to severe chronic disease that can sometimes also be life-threatening,” commented Paul A. Carpenter, MD, attending physician at Seattle Children’s Hospital. “If these children were between 1 and 12 and didn’t respond to steroid treatment, we didn’t have any rigorously studied treatment options – until now.”

The new indication was approved by the U.S. Food and Drug Administration on the basis of results from the iMAGINE trial, for which Dr. Carpenter was a principal investigator.

The phase 1/2 iMAGINE trial was an open-label, multicenter, single-arm trial conducted with 47 patients (mean age, 13 years; range, 1-19 years) with relapsed/refractory cGVHD who had received at least one prior systemic therapy. Ibrutinib was given at a dose of 420 mg orally once daily to patients aged 12 and older and at a dose of 240 mg/m2 orally once daily to patients who were younger than 12 years.

The overall response rate through week 25 was 60% (confidence interval, 95%, 44%-74%). The median duration of response was 5.3 months (95% CI, 2.8-8.8).

The safety profile was consistent with the established profile for ibrutinib. Observed adverse events in pediatric patients were consistent with those observed in adult patients with moderate to severe cGVHD, the companies noted.

The FDA noted that the most common (≥ 20%) adverse reactions, including laboratory abnormalities, were anemia, musculoskeletal pain, pyrexia, diarrhea, pneumonia, abdominal pain, stomatitis, thrombocytopenia, and headache.

Full prescribing information for ibrutinib is available here.

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

Ibrutinib (Imbruvica) is now available for use in children aged 1-12 years who have chronic graft-versus-host disease (cGVHD), which can develop after stem cell transplantation for treatment of a blood cancer.

Specifically, the indication is for pediatric patients with cGVHD who have already been treated with one or more lines of systemic therapy. The manufacturers have also launched a new oral suspension formulation, in addition to capsules and tablets, which were already available.

Ibrutinib is already approved for use in adults with cGVHD.

The drug is also approved for use in several blood cancers, including chronic lymphocytic leukemia, mantle cell lymphoma, and Waldenström’s macroglobulinemia. All these approvals are for adult patients.

This is the first pediatric indication for the product and is “incredibly meaningful,” said Gauri Sunkersett, DO, associate medical director at AbbVie, which markets the drug together with Jansen. “As a pediatric oncologist, when my patients describe the physical pain they experience from simply hugging their parents, due to their cGVHD, the importance of researching alternative treatment options in this patient population is further validated.”

These children have already been through a lot, having been diagnosed with a leukemia or lymphoma and then undergoing chemotherapy and/or radiotherapy for a stem cell transplant. Just over half (52%-65%) of children who receive allogeneic transplants go on to develop cGVHD, in which the donor bone marrow or stem cells attack the recipient.

“Imagine going through a transplant and then being told you have a moderate to severe chronic disease that can sometimes also be life-threatening,” commented Paul A. Carpenter, MD, attending physician at Seattle Children’s Hospital. “If these children were between 1 and 12 and didn’t respond to steroid treatment, we didn’t have any rigorously studied treatment options – until now.”

The new indication was approved by the U.S. Food and Drug Administration on the basis of results from the iMAGINE trial, for which Dr. Carpenter was a principal investigator.

The phase 1/2 iMAGINE trial was an open-label, multicenter, single-arm trial conducted with 47 patients (mean age, 13 years; range, 1-19 years) with relapsed/refractory cGVHD who had received at least one prior systemic therapy. Ibrutinib was given at a dose of 420 mg orally once daily to patients aged 12 and older and at a dose of 240 mg/m2 orally once daily to patients who were younger than 12 years.

The overall response rate through week 25 was 60% (confidence interval, 95%, 44%-74%). The median duration of response was 5.3 months (95% CI, 2.8-8.8).

The safety profile was consistent with the established profile for ibrutinib. Observed adverse events in pediatric patients were consistent with those observed in adult patients with moderate to severe cGVHD, the companies noted.

The FDA noted that the most common (≥ 20%) adverse reactions, including laboratory abnormalities, were anemia, musculoskeletal pain, pyrexia, diarrhea, pneumonia, abdominal pain, stomatitis, thrombocytopenia, and headache.

Full prescribing information for ibrutinib is available here.

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

How common is IUD perforation, expulsion, and malposition?

ROBERT L. BARBIERI, MD (APRIL 2022)

The seriousness of IUD embedment

I appreciated Dr. Barbieri’s comprehensive review of clinical problems regarding the intrauterine device (IUD). It is interesting that, in spite of your mention of IUD embedment in the myometrium, other publications regarding this phenomenon are seemingly absent (except for ours).¹ Whether or not there is associated pain (and sometimes there is not), in our experience its removal can result in IUD fracture. As you stated, it is true that 3D transvaginal sonography perfectly enables this visualization, yet it is surprising that others have not experienced what we have. Nonetheless, it is encouraging to see that IUD embedment is seriously mentioned. 

1. Fernandez CM, Levine EM, Cabiya M, et al. Intrauterine device embedment resulting in its fracture: a case series. Arch Obstet Gynecol. 2021;2:1-4.

Elliot Levine, MD

Chicago, Illinois

Dr. Barbieri responds

I thank Dr. Levine for highlighting the important issue of IUD fracture and providing a reference to a case series of IUD fractures. Although such fracture is not common, when it does occur it may require a hysteroscopic procedure to remove all pieces of the IUD. In the cited case series, fracture was more commonly observed with the copper IUD than with the LNG-IUD. With regard to IUD malposition, 4 publications reviewed in my recent editorial describe the problem of an IUD arm embedded in the myometrium.^1-4

References

1. Benacerraf BR, Shipp TD, Bromley B. Three-dimensional ultrasound detection of abnormally located intrauterine contraceptive devices which are a source of pelvic pain and abnormal bleeding. Ultrasound Obstet Gynecol. 2009;34:110-115.
2. Braaten KP, Benson CB, Maurer R, et al. Malpositioned intrauterine contraceptive devices: risk factors, outcomes and future pregnancies. Obstet Gynecol. 2011;118:1014-1020.
3. Gerkowicz SA, Fiorentino DG, Kovacs AP, et al. Uterine structural abnormality and intrauterine device malposition: analysis of ultrasonographic and demographic variables of 517 patients. Am J Obstet Gynecol. 2019;220:183.e1-e8.
4. Connolly CT, Fox NS. Incidence and risk factors for a malpositioned intrauterine device detected on three-dimensional ultrasound within eight weeks of placement. J Ultrasound Med. September 27, 2021.

Will NAAT replace microscopy for the identification of organisms causing vaginitis?

ROBERT L. BARBIERI, MD (MARCH 2022)

Follow-up questions on NAAT testing

The sensitivity of NAAT testing, as outlined in Dr. Barbieri’s editorial, is undoubtedly better than the clinical methods most clinicians are using. I appreciate the frustration we providers often experience in drawing conclusions for patients based on the Amsel criteria for bacterial vaginitis (BV). I am surprised by the low sensitivity of microscopy for yeast vaginitis. My follow-up questions are:

• Have the NAATs referenced been validated in clinical trials and proven to improve patient outcomes?
• Will the proposal to begin empiric therapy for both yeast vaginitis and BV in combination while waiting for NAAT results lead to an increase of resistant strains?
• What is the cost of NAAT for vaginitis, and is this cost effective in routine practice?
• Can NAATs be utilized to detect resistant strains of yeast or Gardnerella sp?

Alan Paul Gehrich, MD (COL, MC ret.)

Bethesda, Maryland

Dr. Barbieri responds

I thank Dr. Gehrich for raising the important issue of what is the optimal endpoint to assess the clinical utility of NAAT testing for vaginitis. Most studies of the use of NAAT to diagnose the cause of vaginitis focus on comparing NAAT results to standard clinical practice (microscopy and pH), and to a “gold standard.” In most studies the gold standards are Nugent scoring with Amsel criteria to resolve intermediate Nugent scores for bacterial vaginosis, culture for Candida, and culture for Trichomonas vaginalis. It is clear from multiple studies that NAAT provides superior sensitivity and specificity compared with standard clinical practice.^1-3 As noted in the editorial, in a study of 466 patients with symptoms of vaginitis, standard office approaches to the diagnosis of vaginitis resulted in the failure to identify the correct infection in a large number of cases.⁴ For the diagnosis of BV, clinicians missed 42% of the cases identified by NAAT. For the diagnosis of Candida, clinicians missed 46% of the cases identified by NAAT. For the diagnosis of T vaginalis, clinicians missed 72% of the cases identified by NAAT. This resulted in clinicians not appropriately treating many infections detected by NAAT.

NAAT does provide information about the presence of Candida glabrata and Candida krusei, organisms which may be resistant to fluconazole. I agree with Dr. Gehrich that the optimal use of NAAT testing in practice is poorly studied with regard to treatment between sample collection and NAAT results. Cost of testing is a complex issue. Standard microscopy is relatively inexpensive, but performs poorly in clinical practice, resulting in misdiagnosis. NAAT testing is expensive but correctly identifies causes of vaginitis.

References 

1. Schwebke JR, Gaydos CA, Hyirjesy P, et al. Diagnostic performance of a molecular test versus clinician assessment of vaginitis. J Clin Microbiol. 2018;56:e00252-18.
2. Broache M, Cammarata CL, Stonebraker E, et al. Performance of vaginal panel assay compared with clinical diagnosis of vaginitis. Obstet Gynecol. 2021;138:853-859.
3. Schwebke JR, Taylor SN, Ackerman N, et al. Clinical validation of the Aptima bacterial vaginosis and Aptima Candida/Trichomonas vaginalis assays: results from a prospective multi-center study. J Clin Microbiol. 2020;58:e01643-19. 4
4. Gaydos CA, Beqaj S, Schwebke JR, et al. Clinical validation of a test for the diagnosis of vaginitis. Obstet Gynecol. 2017;130:181-189.

How common is IUD perforation, expulsion, and malposition?

ROBERT L. BARBIERI, MD (APRIL 2022)

The seriousness of IUD embedment

I appreciated Dr. Barbieri’s comprehensive review of clinical problems regarding the intrauterine device (IUD). It is interesting that, in spite of your mention of IUD embedment in the myometrium, other publications regarding this phenomenon are seemingly absent (except for ours).¹ Whether or not there is associated pain (and sometimes there is not), in our experience its removal can result in IUD fracture. As you stated, it is true that 3D transvaginal sonography perfectly enables this visualization, yet it is surprising that others have not experienced what we have. Nonetheless, it is encouraging to see that IUD embedment is seriously mentioned. 

1. Fernandez CM, Levine EM, Cabiya M, et al. Intrauterine device embedment resulting in its fracture: a case series. Arch Obstet Gynecol. 2021;2:1-4.

Elliot Levine, MD

Chicago, Illinois

Dr. Barbieri responds

I thank Dr. Levine for highlighting the important issue of IUD fracture and providing a reference to a case series of IUD fractures. Although such fracture is not common, when it does occur it may require a hysteroscopic procedure to remove all pieces of the IUD. In the cited case series, fracture was more commonly observed with the copper IUD than with the LNG-IUD. With regard to IUD malposition, 4 publications reviewed in my recent editorial describe the problem of an IUD arm embedded in the myometrium.^1-4

References

1. Benacerraf BR, Shipp TD, Bromley B. Three-dimensional ultrasound detection of abnormally located intrauterine contraceptive devices which are a source of pelvic pain and abnormal bleeding. Ultrasound Obstet Gynecol. 2009;34:110-115.
2. Braaten KP, Benson CB, Maurer R, et al. Malpositioned intrauterine contraceptive devices: risk factors, outcomes and future pregnancies. Obstet Gynecol. 2011;118:1014-1020.
3. Gerkowicz SA, Fiorentino DG, Kovacs AP, et al. Uterine structural abnormality and intrauterine device malposition: analysis of ultrasonographic and demographic variables of 517 patients. Am J Obstet Gynecol. 2019;220:183.e1-e8.
4. Connolly CT, Fox NS. Incidence and risk factors for a malpositioned intrauterine device detected on three-dimensional ultrasound within eight weeks of placement. J Ultrasound Med. September 27, 2021.

Will NAAT replace microscopy for the identification of organisms causing vaginitis?

ROBERT L. BARBIERI, MD (MARCH 2022)

Follow-up questions on NAAT testing

The sensitivity of NAAT testing, as outlined in Dr. Barbieri’s editorial, is undoubtedly better than the clinical methods most clinicians are using. I appreciate the frustration we providers often experience in drawing conclusions for patients based on the Amsel criteria for bacterial vaginitis (BV). I am surprised by the low sensitivity of microscopy for yeast vaginitis. My follow-up questions are:

• Have the NAATs referenced been validated in clinical trials and proven to improve patient outcomes?
• Will the proposal to begin empiric therapy for both yeast vaginitis and BV in combination while waiting for NAAT results lead to an increase of resistant strains?
• What is the cost of NAAT for vaginitis, and is this cost effective in routine practice?
• Can NAATs be utilized to detect resistant strains of yeast or Gardnerella sp?

Alan Paul Gehrich, MD (COL, MC ret.)

Bethesda, Maryland

Dr. Barbieri responds

I thank Dr. Gehrich for raising the important issue of what is the optimal endpoint to assess the clinical utility of NAAT testing for vaginitis. Most studies of the use of NAAT to diagnose the cause of vaginitis focus on comparing NAAT results to standard clinical practice (microscopy and pH), and to a “gold standard.” In most studies the gold standards are Nugent scoring with Amsel criteria to resolve intermediate Nugent scores for bacterial vaginosis, culture for Candida, and culture for Trichomonas vaginalis. It is clear from multiple studies that NAAT provides superior sensitivity and specificity compared with standard clinical practice.^1-3 As noted in the editorial, in a study of 466 patients with symptoms of vaginitis, standard office approaches to the diagnosis of vaginitis resulted in the failure to identify the correct infection in a large number of cases.⁴ For the diagnosis of BV, clinicians missed 42% of the cases identified by NAAT. For the diagnosis of Candida, clinicians missed 46% of the cases identified by NAAT. For the diagnosis of T vaginalis, clinicians missed 72% of the cases identified by NAAT. This resulted in clinicians not appropriately treating many infections detected by NAAT.

NAAT does provide information about the presence of Candida glabrata and Candida krusei, organisms which may be resistant to fluconazole. I agree with Dr. Gehrich that the optimal use of NAAT testing in practice is poorly studied with regard to treatment between sample collection and NAAT results. Cost of testing is a complex issue. Standard microscopy is relatively inexpensive, but performs poorly in clinical practice, resulting in misdiagnosis. NAAT testing is expensive but correctly identifies causes of vaginitis.

References 

1. Schwebke JR, Gaydos CA, Hyirjesy P, et al. Diagnostic performance of a molecular test versus clinician assessment of vaginitis. J Clin Microbiol. 2018;56:e00252-18.
2. Broache M, Cammarata CL, Stonebraker E, et al. Performance of vaginal panel assay compared with clinical diagnosis of vaginitis. Obstet Gynecol. 2021;138:853-859.
3. Schwebke JR, Taylor SN, Ackerman N, et al. Clinical validation of the Aptima bacterial vaginosis and Aptima Candida/Trichomonas vaginalis assays: results from a prospective multi-center study. J Clin Microbiol. 2020;58:e01643-19. 4
4. Gaydos CA, Beqaj S, Schwebke JR, et al. Clinical validation of a test for the diagnosis of vaginitis. Obstet Gynecol. 2017;130:181-189.

How common is IUD perforation, expulsion, and malposition?

ROBERT L. BARBIERI, MD (APRIL 2022)

The seriousness of IUD embedment

I appreciated Dr. Barbieri’s comprehensive review of clinical problems regarding the intrauterine device (IUD). It is interesting that, in spite of your mention of IUD embedment in the myometrium, other publications regarding this phenomenon are seemingly absent (except for ours).¹ Whether or not there is associated pain (and sometimes there is not), in our experience its removal can result in IUD fracture. As you stated, it is true that 3D transvaginal sonography perfectly enables this visualization, yet it is surprising that others have not experienced what we have. Nonetheless, it is encouraging to see that IUD embedment is seriously mentioned. 

1. Fernandez CM, Levine EM, Cabiya M, et al. Intrauterine device embedment resulting in its fracture: a case series. Arch Obstet Gynecol. 2021;2:1-4.

Elliot Levine, MD

Chicago, Illinois

Dr. Barbieri responds

I thank Dr. Levine for highlighting the important issue of IUD fracture and providing a reference to a case series of IUD fractures. Although such fracture is not common, when it does occur it may require a hysteroscopic procedure to remove all pieces of the IUD. In the cited case series, fracture was more commonly observed with the copper IUD than with the LNG-IUD. With regard to IUD malposition, 4 publications reviewed in my recent editorial describe the problem of an IUD arm embedded in the myometrium.^1-4

References

1. Benacerraf BR, Shipp TD, Bromley B. Three-dimensional ultrasound detection of abnormally located intrauterine contraceptive devices which are a source of pelvic pain and abnormal bleeding. Ultrasound Obstet Gynecol. 2009;34:110-115.
2. Braaten KP, Benson CB, Maurer R, et al. Malpositioned intrauterine contraceptive devices: risk factors, outcomes and future pregnancies. Obstet Gynecol. 2011;118:1014-1020.
3. Gerkowicz SA, Fiorentino DG, Kovacs AP, et al. Uterine structural abnormality and intrauterine device malposition: analysis of ultrasonographic and demographic variables of 517 patients. Am J Obstet Gynecol. 2019;220:183.e1-e8.
4. Connolly CT, Fox NS. Incidence and risk factors for a malpositioned intrauterine device detected on three-dimensional ultrasound within eight weeks of placement. J Ultrasound Med. September 27, 2021.

Will NAAT replace microscopy for the identification of organisms causing vaginitis?

ROBERT L. BARBIERI, MD (MARCH 2022)

Follow-up questions on NAAT testing

The sensitivity of NAAT testing, as outlined in Dr. Barbieri’s editorial, is undoubtedly better than the clinical methods most clinicians are using. I appreciate the frustration we providers often experience in drawing conclusions for patients based on the Amsel criteria for bacterial vaginitis (BV). I am surprised by the low sensitivity of microscopy for yeast vaginitis. My follow-up questions are:

• Have the NAATs referenced been validated in clinical trials and proven to improve patient outcomes?
• Will the proposal to begin empiric therapy for both yeast vaginitis and BV in combination while waiting for NAAT results lead to an increase of resistant strains?
• What is the cost of NAAT for vaginitis, and is this cost effective in routine practice?
• Can NAATs be utilized to detect resistant strains of yeast or Gardnerella sp?

Alan Paul Gehrich, MD (COL, MC ret.)

Bethesda, Maryland

Dr. Barbieri responds

I thank Dr. Gehrich for raising the important issue of what is the optimal endpoint to assess the clinical utility of NAAT testing for vaginitis. Most studies of the use of NAAT to diagnose the cause of vaginitis focus on comparing NAAT results to standard clinical practice (microscopy and pH), and to a “gold standard.” In most studies the gold standards are Nugent scoring with Amsel criteria to resolve intermediate Nugent scores for bacterial vaginosis, culture for Candida, and culture for Trichomonas vaginalis. It is clear from multiple studies that NAAT provides superior sensitivity and specificity compared with standard clinical practice.^1-3 As noted in the editorial, in a study of 466 patients with symptoms of vaginitis, standard office approaches to the diagnosis of vaginitis resulted in the failure to identify the correct infection in a large number of cases.⁴ For the diagnosis of BV, clinicians missed 42% of the cases identified by NAAT. For the diagnosis of Candida, clinicians missed 46% of the cases identified by NAAT. For the diagnosis of T vaginalis, clinicians missed 72% of the cases identified by NAAT. This resulted in clinicians not appropriately treating many infections detected by NAAT.

NAAT does provide information about the presence of Candida glabrata and Candida krusei, organisms which may be resistant to fluconazole. I agree with Dr. Gehrich that the optimal use of NAAT testing in practice is poorly studied with regard to treatment between sample collection and NAAT results. Cost of testing is a complex issue. Standard microscopy is relatively inexpensive, but performs poorly in clinical practice, resulting in misdiagnosis. NAAT testing is expensive but correctly identifies causes of vaginitis.

References 

1. Schwebke JR, Gaydos CA, Hyirjesy P, et al. Diagnostic performance of a molecular test versus clinician assessment of vaginitis. J Clin Microbiol. 2018;56:e00252-18.
2. Broache M, Cammarata CL, Stonebraker E, et al. Performance of vaginal panel assay compared with clinical diagnosis of vaginitis. Obstet Gynecol. 2021;138:853-859.
3. Schwebke JR, Taylor SN, Ackerman N, et al. Clinical validation of the Aptima bacterial vaginosis and Aptima Candida/Trichomonas vaginalis assays: results from a prospective multi-center study. J Clin Microbiol. 2020;58:e01643-19. 4
4. Gaydos CA, Beqaj S, Schwebke JR, et al. Clinical validation of a test for the diagnosis of vaginitis. Obstet Gynecol. 2017;130:181-189.

It’s back to school time, and some may be wondering what the current availability of vaccines may mean and the effects of the ever-changing COVID-19 guidelines on their children’s education and day-to-day experiences as students this year.

Unlike last school year, there are now vaccines available for all over the age of 6 months, and home rapid antigen tests are more readily available. Additionally, many have now been exposed either by infection or vaccination to the virus.

The CDC has removed the recommendations for maintaining cohorts in the K-12 population. This changing landscape along with differing levels of personal risk make it challenging to counsel families about what to expect in terms of COVID this year.

The best defense that we currently have against COVID is the vaccine. Although it seems that many are susceptible to the virus despite the vaccine, those who have been vaccinated are less susceptible to serious disease, including young children.

As older children may be heading to college, it is important

to encourage them to isolate when they have symptoms, even when they test negative for COVID as we would all like to avoid being sick in general.

Additionally, they should pay attention to the COVID risk level in their area and wear masks, particularly when indoors, as the levels increase. College students should have a plan for where they can isolate when not feeling well. If anyone does test positive for COVID, they should follow the most recent quarantine guidelines, including wearing a well fitted mask when they do begin returning to activities.
 

Monkeypox

We now have a new health concern for this school year.

Monkeypox has come onto the scene with information changing as rapidly as information previously did for COVID. With this virus, we must particularly counsel those heading away to college to be careful to limit their exposure to this disease.

Dormitories and other congregate settings are high-risk locations for the spread of monkeypox. Particularly, students headed to stay in dormitories should be counseled about avoiding:

• sexual activity with those with lesions consistent with monkeypox;
• sharing eating and drinking utensils; and
• sleeping in the same bed as or sharing bedding or towels with anyone with a diagnosis of or lesions consistent with monkeypox.

Additionally, as with prevention of all infections, it is important to frequently wash hands or use alcohol-based sanitizer before eating, and avoid touching the face after using the restroom.

Guidance for those eligible for vaccines against monkeypox seems to be quickly changing as well.

At the time of this article, CDC guidance recommends the vaccine against monkeypox for:

• those considered to be at high risk for it, including those identified by public health officials as a contact of someone with monkeypox;
• those who are aware that a sexual partner had a diagnosis of monkeypox within the past 2 weeks;
• those with multiple sex partners in the past 2 weeks in an area with known monkeypox; and
• those whose jobs may expose them to monkeypox.

Currently, the CDC recommends the vaccine JYNNEOS, a two-dose vaccine that reaches maximum protection after fourteen days. Ultimately, guidance is likely to continue to quickly change for both COVID-19 and Monkeypox throughout the fall. It is possible that new vaccinations will become available, and families and physicians alike will have many questions.

Primary care offices should ensure that someone is keeping up to date with the latest guidance to share with the office so that physicians may share accurate information with their patients.

Families should be counseled that we anticipate information about monkeypox, particularly related to vaccinations, to continue to change, as it has during all stages of the COVID pandemic.

As always, patients should be reminded to continue regular routine vaccinations, including the annual influenza vaccine.

Dr. Wheat is a family physician at Erie Family Health Center and program director of Northwestern University’s McGaw Family Medicine residency program, both in Chicago. Dr. Wheat serves on the editorial advisory board of Family Practice News. You can contact her at fpnews@mdedge.com.

It’s back to school time, and some may be wondering what the current availability of vaccines may mean and the effects of the ever-changing COVID-19 guidelines on their children’s education and day-to-day experiences as students this year.

Unlike last school year, there are now vaccines available for all over the age of 6 months, and home rapid antigen tests are more readily available. Additionally, many have now been exposed either by infection or vaccination to the virus.

The CDC has removed the recommendations for maintaining cohorts in the K-12 population. This changing landscape along with differing levels of personal risk make it challenging to counsel families about what to expect in terms of COVID this year.

The best defense that we currently have against COVID is the vaccine. Although it seems that many are susceptible to the virus despite the vaccine, those who have been vaccinated are less susceptible to serious disease, including young children.

As older children may be heading to college, it is important

to encourage them to isolate when they have symptoms, even when they test negative for COVID as we would all like to avoid being sick in general.

Additionally, they should pay attention to the COVID risk level in their area and wear masks, particularly when indoors, as the levels increase. College students should have a plan for where they can isolate when not feeling well. If anyone does test positive for COVID, they should follow the most recent quarantine guidelines, including wearing a well fitted mask when they do begin returning to activities.
 

Monkeypox

We now have a new health concern for this school year.

Monkeypox has come onto the scene with information changing as rapidly as information previously did for COVID. With this virus, we must particularly counsel those heading away to college to be careful to limit their exposure to this disease.

Dormitories and other congregate settings are high-risk locations for the spread of monkeypox. Particularly, students headed to stay in dormitories should be counseled about avoiding:

• sexual activity with those with lesions consistent with monkeypox;
• sharing eating and drinking utensils; and
• sleeping in the same bed as or sharing bedding or towels with anyone with a diagnosis of or lesions consistent with monkeypox.

Additionally, as with prevention of all infections, it is important to frequently wash hands or use alcohol-based sanitizer before eating, and avoid touching the face after using the restroom.

Guidance for those eligible for vaccines against monkeypox seems to be quickly changing as well.

At the time of this article, CDC guidance recommends the vaccine against monkeypox for:

• those considered to be at high risk for it, including those identified by public health officials as a contact of someone with monkeypox;
• those who are aware that a sexual partner had a diagnosis of monkeypox within the past 2 weeks;
• those with multiple sex partners in the past 2 weeks in an area with known monkeypox; and
• those whose jobs may expose them to monkeypox.

Currently, the CDC recommends the vaccine JYNNEOS, a two-dose vaccine that reaches maximum protection after fourteen days. Ultimately, guidance is likely to continue to quickly change for both COVID-19 and Monkeypox throughout the fall. It is possible that new vaccinations will become available, and families and physicians alike will have many questions.

Primary care offices should ensure that someone is keeping up to date with the latest guidance to share with the office so that physicians may share accurate information with their patients.

Families should be counseled that we anticipate information about monkeypox, particularly related to vaccinations, to continue to change, as it has during all stages of the COVID pandemic.

As always, patients should be reminded to continue regular routine vaccinations, including the annual influenza vaccine.

Dr. Wheat is a family physician at Erie Family Health Center and program director of Northwestern University’s McGaw Family Medicine residency program, both in Chicago. Dr. Wheat serves on the editorial advisory board of Family Practice News. You can contact her at fpnews@mdedge.com.

It’s back to school time, and some may be wondering what the current availability of vaccines may mean and the effects of the ever-changing COVID-19 guidelines on their children’s education and day-to-day experiences as students this year.

Unlike last school year, there are now vaccines available for all over the age of 6 months, and home rapid antigen tests are more readily available. Additionally, many have now been exposed either by infection or vaccination to the virus.

The CDC has removed the recommendations for maintaining cohorts in the K-12 population. This changing landscape along with differing levels of personal risk make it challenging to counsel families about what to expect in terms of COVID this year.

The best defense that we currently have against COVID is the vaccine. Although it seems that many are susceptible to the virus despite the vaccine, those who have been vaccinated are less susceptible to serious disease, including young children.

As older children may be heading to college, it is important

to encourage them to isolate when they have symptoms, even when they test negative for COVID as we would all like to avoid being sick in general.

Additionally, they should pay attention to the COVID risk level in their area and wear masks, particularly when indoors, as the levels increase. College students should have a plan for where they can isolate when not feeling well. If anyone does test positive for COVID, they should follow the most recent quarantine guidelines, including wearing a well fitted mask when they do begin returning to activities.
 

Monkeypox

We now have a new health concern for this school year.

Monkeypox has come onto the scene with information changing as rapidly as information previously did for COVID. With this virus, we must particularly counsel those heading away to college to be careful to limit their exposure to this disease.

Dormitories and other congregate settings are high-risk locations for the spread of monkeypox. Particularly, students headed to stay in dormitories should be counseled about avoiding:

• sexual activity with those with lesions consistent with monkeypox;
• sharing eating and drinking utensils; and
• sleeping in the same bed as or sharing bedding or towels with anyone with a diagnosis of or lesions consistent with monkeypox.

Additionally, as with prevention of all infections, it is important to frequently wash hands or use alcohol-based sanitizer before eating, and avoid touching the face after using the restroom.

Guidance for those eligible for vaccines against monkeypox seems to be quickly changing as well.

At the time of this article, CDC guidance recommends the vaccine against monkeypox for:

• those considered to be at high risk for it, including those identified by public health officials as a contact of someone with monkeypox;
• those who are aware that a sexual partner had a diagnosis of monkeypox within the past 2 weeks;
• those with multiple sex partners in the past 2 weeks in an area with known monkeypox; and
• those whose jobs may expose them to monkeypox.

Currently, the CDC recommends the vaccine JYNNEOS, a two-dose vaccine that reaches maximum protection after fourteen days. Ultimately, guidance is likely to continue to quickly change for both COVID-19 and Monkeypox throughout the fall. It is possible that new vaccinations will become available, and families and physicians alike will have many questions.

Primary care offices should ensure that someone is keeping up to date with the latest guidance to share with the office so that physicians may share accurate information with their patients.

Families should be counseled that we anticipate information about monkeypox, particularly related to vaccinations, to continue to change, as it has during all stages of the COVID pandemic.

As always, patients should be reminded to continue regular routine vaccinations, including the annual influenza vaccine.

Dr. Wheat is a family physician at Erie Family Health Center and program director of Northwestern University’s McGaw Family Medicine residency program, both in Chicago. Dr. Wheat serves on the editorial advisory board of Family Practice News. You can contact her at fpnews@mdedge.com.

A 53-year-old male patient presented to the emergency department following a primary care office visit with sudden onset right upper quadrant abdominal pain that persisted for 3 weeks, worsening over the last 2 days. The abdominal pain worsened after eating or drinking and mildly improved with omeprazole. Associated symptoms included intermittent fever, night sweats, fatigue, and bloating since onset without vomiting or diarrhea. He reported a “complicated” cholecystectomy at an outside facility 6 months prior and that his “gallbladder was adhered to his duodenum,” though outside records were not available. Additional medical history included diverticulosis with prior flares of diverticulitis but no recent flares or treatments. His home medications included acetaminophen, naproxen, intranasal fluticasone, omeprazole, gabapentin, baclofen, trazodone, and antihistamines. He reported no tobacco or illicit drug use and stated he consumed a 6 pack of beer every 6 weeks.

Initial vital signs in the emergency department demonstrated an afebrile oral temperature with unremarkable blood pressure and pulse. He was alert and oriented and did not appear in significant acute distress. Physical examination of the abdomen demonstrated a nondistended abdomen, normal active bowel sounds in all 4 quadrants, and mild right upper and lower quadrant tenderness to soft and deep palpation with release.

Significant laboratory values included elevated C-reactive protein of 44.1 mg/L and mild leukocytosis of 11.1 K/µL (reference range, 4.00-10.60 K/µL). The basic metabolic panel, liver-associated enzymes, and lipase levels were within normal limits.

• What is your diagnosis?
• How would you treat this patient?
   

   

Our Diagnosis

Based on the clinical history of postprandial abdominal pain with prior cholecystectomy and leukocytosis, the initial differential diagnosis included peptic ulcer disease, gastroesophageal reflux, or delayed sequela of the cholecystectomy 6 months prior. Although suspicion remained for possible delayed postoperative complications from the cholecystectomy, ultrasound and hepatobiliary iminodiacetic acid (HIDA) scan were not pursued based on CT imaging findings. The needle-like hypodensity in the duodenum with surrounding inflammation visualized on CT was concerning for an unidentified penetrating foreign body with a possible retroperitoneal microperforation.

After these imaging findings were relayed from Radiology to the Gastroenterology Service, the patient underwent an upper gastrointestinal (GI) endoscopy to further evaluate the duodenum. Inspection revealed mild gastritis and a linear, clear piece of plastic with both ends firmly lodged within the mucosa from the distal duodenal bulb to the second portion of the duodenum; a significant mucosal defect of the bowel wall was visualized after careful extraction of the foreign body (Figure 2). The patient was diagnosed with a small duodenal perforation, which was sealed endoscopically with 2 endoclips. The extracted piece of plastic was examined and determined to be a broken cocktail pick (Figure 3). During discussion with the patient postprocedure, he stated that he ingested several olive martinis (which were served with cocktail picks) approximately 3 weeks prior to presentation and did not recall ingesting the cocktail pick. A repeat abdominal CT following the endoscopy demonstrated no leak or free air from the site of the repaired duodenal perforation (Figure 4). The patient avoided surgery and was permitted to resume a liquid diet prior to discharge.

Discussion

Foreign body ingestion in adults is most commonly unintentional with fish bones being the most common culprit.¹ In unintentional instances of foreign body ingestion, many patients are not aware of the event, with dentures posing a significant well-known risk factor due to lack of palatal sensory feedback.² Most ingested foreign bodies pass uninhibited through the GI tract without complications. However, less than 1% of ingested foreign bodies cause potentially life-threatening GI perforations.³

The risk of GI perforation due to foreign body ingestion is greatest with elongated, sharp objects, such as needles, bones, toothpicks, and cocktail picks. These objects tend to lodge at areas of narrowing or angulation, such as the appendix, ileocecal region, or as in this case, the duodenum.³ Passage of a foreign body through the duodenum is more likely to be inhibited if the object is longer than 6 cm and with a diameter > 2.5 cm.⁴ Signs of duodenal perforation are often subtle compared with jejunal or ileal perforations. Patients are commonly afebrile with normal white blood cell counts and are more likely to have chronic symptoms for > 3 days before the appropriate diagnosis of foreign body ingestion is made.¹ Duodenal perforations may be more stable clinically compared with distal GI perforations in part due to the retroperitoneal location with relatively fewer bacteria present intraluminally. GI perforations may not occur acutely during passage of the foreign body but can present weeks, months, or even years later.⁵ Delayed onset of symptoms may happen when the foreign body becomes lodged and only partially perforates the bowel wall, resulting in a chronic inflammatory process. Other possible complications include fistulization and abscess formation from migrating linear sharp objects through the bowel wall, which is most observed with toothpicks and cocktail picks, specifically.⁵

Foreign bodies identified on plain radiographs commonly include radiopaque objects, such as glass, metallic objects, most animal bones and some fish bones, and some medications. However, radiolucent objects, such as toothpicks and cocktail picks, wood, plastic, most fish bones, and most medicines, often will not appear on radiographs. The diagnosis of ingested foreign body can therefore easily be delayed or overlooked on plain radiographs due to ingestion of radiolucent objects or lack of adequate patient history. A high index of suspicion is needed in such instances. The modality of choice for identifying GI perforation due to ingested foreign objects is CT.⁵ All of these commonly missed materials on radiographs will be visible on CT with variable densities. As an added benefit, CT also may reveal ingested objects not visualized on radiographs and show ancillary signs of perforation, such as extraluminal free air, localized inflammation, and fluid collections or abscess surrounding a segment of thickened bowel.⁵

Most ingested foreign bodies will pass through the GI system and can be managed with careful observation alone. However, upper endoscopy is emergently indicated in 3 scenarios of foreign body ingestion: (1) complete occlusion of the esophagus with salivary pooling due to risk of aspiration; (2) ingestion of batteries due to toxic substances; and (3) ingestion of sharp or pointed foreign bodies due to risk of perforation.⁴ Overall, endoscopic intervention is required in 20% of cases and surgical intervention remains rare at 1%.⁴ In the case of this patient, an emergent upper endoscopy was needed due to suspected duodenal perforation.

Treatment of duodenal perforations due to foreign bodies may involve conservative, surgical, or endoscopic management. Contained, small perforations in a stable patient may be treated conservatively with IV fluids, antibiotics, and proton pump inhibitors as they self-seal with omentum if the foreign body has passed.⁶ Retained duodenal foreign bodies pose a risk of persistent perforation or fistulization and must be removed. Anterior duodenal perforations pose a risk of peritonitis, whereas posterior duodenal perforations, although retroperitoneal and sparing the peritoneal cavity, may result in localized abscess formation necessitating foreign body removal. Endoscopic clipping is a modernized, less invasive way to close GI perforations. Through-the-scope clips (TTSCs) can close luminal defects < 2 cm in size.⁷ Defects > 1 cm may be repaired with combined TTSCs and endoloop or omental patching. Over-the-scope clips can close full thickness defects up to 2 to 3 cm with the advantage of being able to close leaks and fistulas involving inflamed or indurated tissue.⁷

Conclusions

Intestinal perforations related to foreign body ingestion are a rare complication occurring in < 1% of patients. Although most ingested foreign objects will pass through the GI tract, elongated or sharp objects pose a risk for perforation. In many cases, a history of foreign body ingestion is not obtained, and a high index of suspicion is required. Duodenal perforations due to foreign body ingestion should be included in the differential among the more common diagnoses of peptic ulcers, pancreatitis, and gallbladder disease in the setting of postprandial right upper quadrant abdominal pain. CT is the best modality for identifying foreign bodies, including objects that may be missed on plain radiographs.

A 53-year-old male patient presented to the emergency department following a primary care office visit with sudden onset right upper quadrant abdominal pain that persisted for 3 weeks, worsening over the last 2 days. The abdominal pain worsened after eating or drinking and mildly improved with omeprazole. Associated symptoms included intermittent fever, night sweats, fatigue, and bloating since onset without vomiting or diarrhea. He reported a “complicated” cholecystectomy at an outside facility 6 months prior and that his “gallbladder was adhered to his duodenum,” though outside records were not available. Additional medical history included diverticulosis with prior flares of diverticulitis but no recent flares or treatments. His home medications included acetaminophen, naproxen, intranasal fluticasone, omeprazole, gabapentin, baclofen, trazodone, and antihistamines. He reported no tobacco or illicit drug use and stated he consumed a 6 pack of beer every 6 weeks.

Initial vital signs in the emergency department demonstrated an afebrile oral temperature with unremarkable blood pressure and pulse. He was alert and oriented and did not appear in significant acute distress. Physical examination of the abdomen demonstrated a nondistended abdomen, normal active bowel sounds in all 4 quadrants, and mild right upper and lower quadrant tenderness to soft and deep palpation with release.

Significant laboratory values included elevated C-reactive protein of 44.1 mg/L and mild leukocytosis of 11.1 K/µL (reference range, 4.00-10.60 K/µL). The basic metabolic panel, liver-associated enzymes, and lipase levels were within normal limits.

• What is your diagnosis?
• How would you treat this patient?
   

   

Our Diagnosis

Based on the clinical history of postprandial abdominal pain with prior cholecystectomy and leukocytosis, the initial differential diagnosis included peptic ulcer disease, gastroesophageal reflux, or delayed sequela of the cholecystectomy 6 months prior. Although suspicion remained for possible delayed postoperative complications from the cholecystectomy, ultrasound and hepatobiliary iminodiacetic acid (HIDA) scan were not pursued based on CT imaging findings. The needle-like hypodensity in the duodenum with surrounding inflammation visualized on CT was concerning for an unidentified penetrating foreign body with a possible retroperitoneal microperforation.

After these imaging findings were relayed from Radiology to the Gastroenterology Service, the patient underwent an upper gastrointestinal (GI) endoscopy to further evaluate the duodenum. Inspection revealed mild gastritis and a linear, clear piece of plastic with both ends firmly lodged within the mucosa from the distal duodenal bulb to the second portion of the duodenum; a significant mucosal defect of the bowel wall was visualized after careful extraction of the foreign body (Figure 2). The patient was diagnosed with a small duodenal perforation, which was sealed endoscopically with 2 endoclips. The extracted piece of plastic was examined and determined to be a broken cocktail pick (Figure 3). During discussion with the patient postprocedure, he stated that he ingested several olive martinis (which were served with cocktail picks) approximately 3 weeks prior to presentation and did not recall ingesting the cocktail pick. A repeat abdominal CT following the endoscopy demonstrated no leak or free air from the site of the repaired duodenal perforation (Figure 4). The patient avoided surgery and was permitted to resume a liquid diet prior to discharge.

Discussion

Foreign body ingestion in adults is most commonly unintentional with fish bones being the most common culprit.¹ In unintentional instances of foreign body ingestion, many patients are not aware of the event, with dentures posing a significant well-known risk factor due to lack of palatal sensory feedback.² Most ingested foreign bodies pass uninhibited through the GI tract without complications. However, less than 1% of ingested foreign bodies cause potentially life-threatening GI perforations.³

The risk of GI perforation due to foreign body ingestion is greatest with elongated, sharp objects, such as needles, bones, toothpicks, and cocktail picks. These objects tend to lodge at areas of narrowing or angulation, such as the appendix, ileocecal region, or as in this case, the duodenum.³ Passage of a foreign body through the duodenum is more likely to be inhibited if the object is longer than 6 cm and with a diameter > 2.5 cm.⁴ Signs of duodenal perforation are often subtle compared with jejunal or ileal perforations. Patients are commonly afebrile with normal white blood cell counts and are more likely to have chronic symptoms for > 3 days before the appropriate diagnosis of foreign body ingestion is made.¹ Duodenal perforations may be more stable clinically compared with distal GI perforations in part due to the retroperitoneal location with relatively fewer bacteria present intraluminally. GI perforations may not occur acutely during passage of the foreign body but can present weeks, months, or even years later.⁵ Delayed onset of symptoms may happen when the foreign body becomes lodged and only partially perforates the bowel wall, resulting in a chronic inflammatory process. Other possible complications include fistulization and abscess formation from migrating linear sharp objects through the bowel wall, which is most observed with toothpicks and cocktail picks, specifically.⁵

Foreign bodies identified on plain radiographs commonly include radiopaque objects, such as glass, metallic objects, most animal bones and some fish bones, and some medications. However, radiolucent objects, such as toothpicks and cocktail picks, wood, plastic, most fish bones, and most medicines, often will not appear on radiographs. The diagnosis of ingested foreign body can therefore easily be delayed or overlooked on plain radiographs due to ingestion of radiolucent objects or lack of adequate patient history. A high index of suspicion is needed in such instances. The modality of choice for identifying GI perforation due to ingested foreign objects is CT.⁵ All of these commonly missed materials on radiographs will be visible on CT with variable densities. As an added benefit, CT also may reveal ingested objects not visualized on radiographs and show ancillary signs of perforation, such as extraluminal free air, localized inflammation, and fluid collections or abscess surrounding a segment of thickened bowel.⁵

Most ingested foreign bodies will pass through the GI system and can be managed with careful observation alone. However, upper endoscopy is emergently indicated in 3 scenarios of foreign body ingestion: (1) complete occlusion of the esophagus with salivary pooling due to risk of aspiration; (2) ingestion of batteries due to toxic substances; and (3) ingestion of sharp or pointed foreign bodies due to risk of perforation.⁴ Overall, endoscopic intervention is required in 20% of cases and surgical intervention remains rare at 1%.⁴ In the case of this patient, an emergent upper endoscopy was needed due to suspected duodenal perforation.

Treatment of duodenal perforations due to foreign bodies may involve conservative, surgical, or endoscopic management. Contained, small perforations in a stable patient may be treated conservatively with IV fluids, antibiotics, and proton pump inhibitors as they self-seal with omentum if the foreign body has passed.⁶ Retained duodenal foreign bodies pose a risk of persistent perforation or fistulization and must be removed. Anterior duodenal perforations pose a risk of peritonitis, whereas posterior duodenal perforations, although retroperitoneal and sparing the peritoneal cavity, may result in localized abscess formation necessitating foreign body removal. Endoscopic clipping is a modernized, less invasive way to close GI perforations. Through-the-scope clips (TTSCs) can close luminal defects < 2 cm in size.⁷ Defects > 1 cm may be repaired with combined TTSCs and endoloop or omental patching. Over-the-scope clips can close full thickness defects up to 2 to 3 cm with the advantage of being able to close leaks and fistulas involving inflamed or indurated tissue.⁷

Conclusions

Intestinal perforations related to foreign body ingestion are a rare complication occurring in < 1% of patients. Although most ingested foreign objects will pass through the GI tract, elongated or sharp objects pose a risk for perforation. In many cases, a history of foreign body ingestion is not obtained, and a high index of suspicion is required. Duodenal perforations due to foreign body ingestion should be included in the differential among the more common diagnoses of peptic ulcers, pancreatitis, and gallbladder disease in the setting of postprandial right upper quadrant abdominal pain. CT is the best modality for identifying foreign bodies, including objects that may be missed on plain radiographs.

A 53-year-old male patient presented to the emergency department following a primary care office visit with sudden onset right upper quadrant abdominal pain that persisted for 3 weeks, worsening over the last 2 days. The abdominal pain worsened after eating or drinking and mildly improved with omeprazole. Associated symptoms included intermittent fever, night sweats, fatigue, and bloating since onset without vomiting or diarrhea. He reported a “complicated” cholecystectomy at an outside facility 6 months prior and that his “gallbladder was adhered to his duodenum,” though outside records were not available. Additional medical history included diverticulosis with prior flares of diverticulitis but no recent flares or treatments. His home medications included acetaminophen, naproxen, intranasal fluticasone, omeprazole, gabapentin, baclofen, trazodone, and antihistamines. He reported no tobacco or illicit drug use and stated he consumed a 6 pack of beer every 6 weeks.

Initial vital signs in the emergency department demonstrated an afebrile oral temperature with unremarkable blood pressure and pulse. He was alert and oriented and did not appear in significant acute distress. Physical examination of the abdomen demonstrated a nondistended abdomen, normal active bowel sounds in all 4 quadrants, and mild right upper and lower quadrant tenderness to soft and deep palpation with release.

Significant laboratory values included elevated C-reactive protein of 44.1 mg/L and mild leukocytosis of 11.1 K/µL (reference range, 4.00-10.60 K/µL). The basic metabolic panel, liver-associated enzymes, and lipase levels were within normal limits.

• What is your diagnosis?
• How would you treat this patient?
   

   

Our Diagnosis

Based on the clinical history of postprandial abdominal pain with prior cholecystectomy and leukocytosis, the initial differential diagnosis included peptic ulcer disease, gastroesophageal reflux, or delayed sequela of the cholecystectomy 6 months prior. Although suspicion remained for possible delayed postoperative complications from the cholecystectomy, ultrasound and hepatobiliary iminodiacetic acid (HIDA) scan were not pursued based on CT imaging findings. The needle-like hypodensity in the duodenum with surrounding inflammation visualized on CT was concerning for an unidentified penetrating foreign body with a possible retroperitoneal microperforation.

After these imaging findings were relayed from Radiology to the Gastroenterology Service, the patient underwent an upper gastrointestinal (GI) endoscopy to further evaluate the duodenum. Inspection revealed mild gastritis and a linear, clear piece of plastic with both ends firmly lodged within the mucosa from the distal duodenal bulb to the second portion of the duodenum; a significant mucosal defect of the bowel wall was visualized after careful extraction of the foreign body (Figure 2). The patient was diagnosed with a small duodenal perforation, which was sealed endoscopically with 2 endoclips. The extracted piece of plastic was examined and determined to be a broken cocktail pick (Figure 3). During discussion with the patient postprocedure, he stated that he ingested several olive martinis (which were served with cocktail picks) approximately 3 weeks prior to presentation and did not recall ingesting the cocktail pick. A repeat abdominal CT following the endoscopy demonstrated no leak or free air from the site of the repaired duodenal perforation (Figure 4). The patient avoided surgery and was permitted to resume a liquid diet prior to discharge.

Discussion

Foreign body ingestion in adults is most commonly unintentional with fish bones being the most common culprit.¹ In unintentional instances of foreign body ingestion, many patients are not aware of the event, with dentures posing a significant well-known risk factor due to lack of palatal sensory feedback.² Most ingested foreign bodies pass uninhibited through the GI tract without complications. However, less than 1% of ingested foreign bodies cause potentially life-threatening GI perforations.³

The risk of GI perforation due to foreign body ingestion is greatest with elongated, sharp objects, such as needles, bones, toothpicks, and cocktail picks. These objects tend to lodge at areas of narrowing or angulation, such as the appendix, ileocecal region, or as in this case, the duodenum.³ Passage of a foreign body through the duodenum is more likely to be inhibited if the object is longer than 6 cm and with a diameter > 2.5 cm.⁴ Signs of duodenal perforation are often subtle compared with jejunal or ileal perforations. Patients are commonly afebrile with normal white blood cell counts and are more likely to have chronic symptoms for > 3 days before the appropriate diagnosis of foreign body ingestion is made.¹ Duodenal perforations may be more stable clinically compared with distal GI perforations in part due to the retroperitoneal location with relatively fewer bacteria present intraluminally. GI perforations may not occur acutely during passage of the foreign body but can present weeks, months, or even years later.⁵ Delayed onset of symptoms may happen when the foreign body becomes lodged and only partially perforates the bowel wall, resulting in a chronic inflammatory process. Other possible complications include fistulization and abscess formation from migrating linear sharp objects through the bowel wall, which is most observed with toothpicks and cocktail picks, specifically.⁵

Foreign bodies identified on plain radiographs commonly include radiopaque objects, such as glass, metallic objects, most animal bones and some fish bones, and some medications. However, radiolucent objects, such as toothpicks and cocktail picks, wood, plastic, most fish bones, and most medicines, often will not appear on radiographs. The diagnosis of ingested foreign body can therefore easily be delayed or overlooked on plain radiographs due to ingestion of radiolucent objects or lack of adequate patient history. A high index of suspicion is needed in such instances. The modality of choice for identifying GI perforation due to ingested foreign objects is CT.⁵ All of these commonly missed materials on radiographs will be visible on CT with variable densities. As an added benefit, CT also may reveal ingested objects not visualized on radiographs and show ancillary signs of perforation, such as extraluminal free air, localized inflammation, and fluid collections or abscess surrounding a segment of thickened bowel.⁵

Most ingested foreign bodies will pass through the GI system and can be managed with careful observation alone. However, upper endoscopy is emergently indicated in 3 scenarios of foreign body ingestion: (1) complete occlusion of the esophagus with salivary pooling due to risk of aspiration; (2) ingestion of batteries due to toxic substances; and (3) ingestion of sharp or pointed foreign bodies due to risk of perforation.⁴ Overall, endoscopic intervention is required in 20% of cases and surgical intervention remains rare at 1%.⁴ In the case of this patient, an emergent upper endoscopy was needed due to suspected duodenal perforation.

Treatment of duodenal perforations due to foreign bodies may involve conservative, surgical, or endoscopic management. Contained, small perforations in a stable patient may be treated conservatively with IV fluids, antibiotics, and proton pump inhibitors as they self-seal with omentum if the foreign body has passed.⁶ Retained duodenal foreign bodies pose a risk of persistent perforation or fistulization and must be removed. Anterior duodenal perforations pose a risk of peritonitis, whereas posterior duodenal perforations, although retroperitoneal and sparing the peritoneal cavity, may result in localized abscess formation necessitating foreign body removal. Endoscopic clipping is a modernized, less invasive way to close GI perforations. Through-the-scope clips (TTSCs) can close luminal defects < 2 cm in size.⁷ Defects > 1 cm may be repaired with combined TTSCs and endoloop or omental patching. Over-the-scope clips can close full thickness defects up to 2 to 3 cm with the advantage of being able to close leaks and fistulas involving inflamed or indurated tissue.⁷

Conclusions

Intestinal perforations related to foreign body ingestion are a rare complication occurring in < 1% of patients. Although most ingested foreign objects will pass through the GI tract, elongated or sharp objects pose a risk for perforation. In many cases, a history of foreign body ingestion is not obtained, and a high index of suspicion is required. Duodenal perforations due to foreign body ingestion should be included in the differential among the more common diagnoses of peptic ulcers, pancreatitis, and gallbladder disease in the setting of postprandial right upper quadrant abdominal pain. CT is the best modality for identifying foreign bodies, including objects that may be missed on plain radiographs.

Something about this COVID testing smells fishy

The Chinese have been challenging America’s political and economic hegemony (yes, we did have to look that one up – you’re rude to ask) for some time, but now they’ve gone too far. Are we going to just sit here and let China do something more ridiculous than us in response to COVID? No way!

Alexander Zvir/Pexels

Here’s the deal: The government of the Chinese coastal city of Xiamen has decided that it’s not just the workers on returning fishing boats who have the potential to introduce COVID to the rest of the population. The fish also present a problem. So when the authorities say that everyone needs to be tested before they can enter the city, they mean everyone.

An employee of the municipal ocean development bureau told local media that “all people in Xiamen City need nucleic acid testing, and the fish catches must be tested as well,” according to the Guardian, which also said that “TV news reports showed officials swabbing the mouths of fish and the underside of crabs.”

In the words of George Takei: “Oh my.”

Hold on there a second, George Takei, because we here in the good old US of A have still got Los Angeles, where COVID testing also has taken a nonhuman turn. The LA County public health department recently announced that pets are now eligible for a free SARS-CoV-2 test through veterinarians and other animal care facilities.

“Our goal is to test many different species of animals including wildlife (deer, bats, raccoons), pets (dogs, cats, hamsters, pocket pets), marine mammals (seals), and more,” Veterinary Public Health announced.

Hegemony restored.
 

Not even God could save them from worms

The Dark Ages may not have been as dark and violent as many people think, but there’s no denying that life in medieval Europe kind of sucked. The only real alternative to serfdom was a job with the Catholic Church. Medieval friars, for example, lived in stone buildings, had access to fresh fruits and vegetables, and even had latrines and running water. Luxuries compared with the life of the average peasant.

Cambridge Archaeological Unit

So why then, despite having access to more modern sanitation and amenities, did the friars have so many gut parasites? That’s the question raised by a group of researchers from the University of Cambridge, who conducted a study of 19 medieval friars buried at a local friary (Oh, doesn’t your town have one of those?) and 25 local people buried at a nonreligious cemetery during a similar time period. Of those 19 friars, 11 were infected with worms and parasites, compared with just 8 of 25 townspeople.

This doesn’t make a lot of sense. The friars had a good life by old-time standards: They had basic sanitation down and a solid diet. These things should lead to a healthier population. The problem, the researchers found, is two pronged and a vicious cycle. First off, the friars had plenty of fresh food, but they used human feces to fertilize their produce. There’s a reason modern practice for human waste fertilization is to let the waste compost for 6 months: The waiting period allows the parasites a chance to kindly die off, which prevents reinfection.

Secondly, the friars’ diet of fresh fruits and vegetables mixed together into a salad, while appealing to our modern-day sensibilities, was not a great choice. By comparison, laypeople tended to eat a boiled mishmash of whatever they could find, and while that’s kind of gross, the key here is that their food was cooked. And heat kills parasites. The uncooked salads did no such thing, so the monks ate infected food, expelled infected poop, and grew more infected food with their infected poop.

Once the worms arrived, they never left, making them the worst kind of house guest. Read the room, worms, take your dinner and move on. You don’t have to go home, but you can’t stay here.
 

What’s a shared genotype between friends?

Do you find it hard to tell the difference between Katy Perry and Zooey Deschanel? They look alike, but they’re not related. Or are they? According to new research, people who look and act very similar but are not related may share DNA.

François Brunelle

“Our study provides a rare insight into human likeness by showing that people with extreme look-alike faces share common genotypes, whereas they are discordant at the epigenome and microbiome levels,” senior author Manel Esteller of the Josep Carreras Leukemia Research Institute in Barcelona said in a written statement. “Genomics clusters them together, and the rest sets them apart.”

The Internet has been a great source in being able to find look-alikes. The research team found photos of doppelgangers photographed by François Brunelle, a Canadian artist. Using facial recognition algorithms, the investigators were able to measure likeness between the each pair of look-alikes. The participants also completed a questionnaire about lifestyle and provided a saliva sample.

The results showed that the look-alikes had similar genotypes but different DNA methylation and microbiome landscapes. The look-alikes also seemed to have similarities in weight, height, and behaviors such as smoking, proving that doppelgangers not only look alike but also share common interests.

Next time someone tells you that you look like their best friend Steve, you won’t have to wonder much what Steve is like.
 

The secret to a good relationship? It’s a secret

Strong relationships are built on honesty and trust, right? Being open with your partner and/or friends is usually a good practice for keeping the relationship healthy, but the latest evidence suggests that maybe you shouldn’t share everything.

bilderlounge

According to the first known study on the emotional, behavioral, and relational aspect of consumer behavior, not disclosing certain purchases to your partner can actually be a good thing for the relationship. How? Well, it all has to do with guilt.

In a series of studies, the researchers asked couples about their secret consumptions. The most commonly hidden thing by far was a product (65%).

“We found that 90% of people have recently kept everyday consumer behaviors a secret from a close other – like a friend or spouse – even though they also report that they don’t think their partner would care if they knew about it,” Kelley Gullo Wight, one of the study’s two lead authors, said in a written statement.

Keeping a hidden stash of chocolate produces guilt, which the researchers found to be the key factor, making the perpetrator want to do more in the relationship to ease that sense of betrayal or dishonesty. They called it a “greater relationship investment,” meaning the person is more likely to do a little extra for their partner, like shell out more money for the next anniversary gift or yield to watching their partner’s favorite program.

So don’t feel too bad about that secret Amazon purchase. As long as the other person doesn’t see the box, nobody has to know. Your relationship can only improve.

Something about this COVID testing smells fishy

The Chinese have been challenging America’s political and economic hegemony (yes, we did have to look that one up – you’re rude to ask) for some time, but now they’ve gone too far. Are we going to just sit here and let China do something more ridiculous than us in response to COVID? No way!

Alexander Zvir/Pexels

Here’s the deal: The government of the Chinese coastal city of Xiamen has decided that it’s not just the workers on returning fishing boats who have the potential to introduce COVID to the rest of the population. The fish also present a problem. So when the authorities say that everyone needs to be tested before they can enter the city, they mean everyone.

An employee of the municipal ocean development bureau told local media that “all people in Xiamen City need nucleic acid testing, and the fish catches must be tested as well,” according to the Guardian, which also said that “TV news reports showed officials swabbing the mouths of fish and the underside of crabs.”

In the words of George Takei: “Oh my.”

Hold on there a second, George Takei, because we here in the good old US of A have still got Los Angeles, where COVID testing also has taken a nonhuman turn. The LA County public health department recently announced that pets are now eligible for a free SARS-CoV-2 test through veterinarians and other animal care facilities.

“Our goal is to test many different species of animals including wildlife (deer, bats, raccoons), pets (dogs, cats, hamsters, pocket pets), marine mammals (seals), and more,” Veterinary Public Health announced.

Hegemony restored.
 

Not even God could save them from worms

The Dark Ages may not have been as dark and violent as many people think, but there’s no denying that life in medieval Europe kind of sucked. The only real alternative to serfdom was a job with the Catholic Church. Medieval friars, for example, lived in stone buildings, had access to fresh fruits and vegetables, and even had latrines and running water. Luxuries compared with the life of the average peasant.

Cambridge Archaeological Unit

So why then, despite having access to more modern sanitation and amenities, did the friars have so many gut parasites? That’s the question raised by a group of researchers from the University of Cambridge, who conducted a study of 19 medieval friars buried at a local friary (Oh, doesn’t your town have one of those?) and 25 local people buried at a nonreligious cemetery during a similar time period. Of those 19 friars, 11 were infected with worms and parasites, compared with just 8 of 25 townspeople.

This doesn’t make a lot of sense. The friars had a good life by old-time standards: They had basic sanitation down and a solid diet. These things should lead to a healthier population. The problem, the researchers found, is two pronged and a vicious cycle. First off, the friars had plenty of fresh food, but they used human feces to fertilize their produce. There’s a reason modern practice for human waste fertilization is to let the waste compost for 6 months: The waiting period allows the parasites a chance to kindly die off, which prevents reinfection.

Secondly, the friars’ diet of fresh fruits and vegetables mixed together into a salad, while appealing to our modern-day sensibilities, was not a great choice. By comparison, laypeople tended to eat a boiled mishmash of whatever they could find, and while that’s kind of gross, the key here is that their food was cooked. And heat kills parasites. The uncooked salads did no such thing, so the monks ate infected food, expelled infected poop, and grew more infected food with their infected poop.

Once the worms arrived, they never left, making them the worst kind of house guest. Read the room, worms, take your dinner and move on. You don’t have to go home, but you can’t stay here.
 

What’s a shared genotype between friends?

Do you find it hard to tell the difference between Katy Perry and Zooey Deschanel? They look alike, but they’re not related. Or are they? According to new research, people who look and act very similar but are not related may share DNA.

François Brunelle

“Our study provides a rare insight into human likeness by showing that people with extreme look-alike faces share common genotypes, whereas they are discordant at the epigenome and microbiome levels,” senior author Manel Esteller of the Josep Carreras Leukemia Research Institute in Barcelona said in a written statement. “Genomics clusters them together, and the rest sets them apart.”

The Internet has been a great source in being able to find look-alikes. The research team found photos of doppelgangers photographed by François Brunelle, a Canadian artist. Using facial recognition algorithms, the investigators were able to measure likeness between the each pair of look-alikes. The participants also completed a questionnaire about lifestyle and provided a saliva sample.

The results showed that the look-alikes had similar genotypes but different DNA methylation and microbiome landscapes. The look-alikes also seemed to have similarities in weight, height, and behaviors such as smoking, proving that doppelgangers not only look alike but also share common interests.

Next time someone tells you that you look like their best friend Steve, you won’t have to wonder much what Steve is like.
 

The secret to a good relationship? It’s a secret

Strong relationships are built on honesty and trust, right? Being open with your partner and/or friends is usually a good practice for keeping the relationship healthy, but the latest evidence suggests that maybe you shouldn’t share everything.

bilderlounge

According to the first known study on the emotional, behavioral, and relational aspect of consumer behavior, not disclosing certain purchases to your partner can actually be a good thing for the relationship. How? Well, it all has to do with guilt.

In a series of studies, the researchers asked couples about their secret consumptions. The most commonly hidden thing by far was a product (65%).

“We found that 90% of people have recently kept everyday consumer behaviors a secret from a close other – like a friend or spouse – even though they also report that they don’t think their partner would care if they knew about it,” Kelley Gullo Wight, one of the study’s two lead authors, said in a written statement.

Keeping a hidden stash of chocolate produces guilt, which the researchers found to be the key factor, making the perpetrator want to do more in the relationship to ease that sense of betrayal or dishonesty. They called it a “greater relationship investment,” meaning the person is more likely to do a little extra for their partner, like shell out more money for the next anniversary gift or yield to watching their partner’s favorite program.

So don’t feel too bad about that secret Amazon purchase. As long as the other person doesn’t see the box, nobody has to know. Your relationship can only improve.

Something about this COVID testing smells fishy

The Chinese have been challenging America’s political and economic hegemony (yes, we did have to look that one up – you’re rude to ask) for some time, but now they’ve gone too far. Are we going to just sit here and let China do something more ridiculous than us in response to COVID? No way!

Alexander Zvir/Pexels

Here’s the deal: The government of the Chinese coastal city of Xiamen has decided that it’s not just the workers on returning fishing boats who have the potential to introduce COVID to the rest of the population. The fish also present a problem. So when the authorities say that everyone needs to be tested before they can enter the city, they mean everyone.

An employee of the municipal ocean development bureau told local media that “all people in Xiamen City need nucleic acid testing, and the fish catches must be tested as well,” according to the Guardian, which also said that “TV news reports showed officials swabbing the mouths of fish and the underside of crabs.”

In the words of George Takei: “Oh my.”

Hold on there a second, George Takei, because we here in the good old US of A have still got Los Angeles, where COVID testing also has taken a nonhuman turn. The LA County public health department recently announced that pets are now eligible for a free SARS-CoV-2 test through veterinarians and other animal care facilities.

“Our goal is to test many different species of animals including wildlife (deer, bats, raccoons), pets (dogs, cats, hamsters, pocket pets), marine mammals (seals), and more,” Veterinary Public Health announced.

Hegemony restored.
 

Not even God could save them from worms

The Dark Ages may not have been as dark and violent as many people think, but there’s no denying that life in medieval Europe kind of sucked. The only real alternative to serfdom was a job with the Catholic Church. Medieval friars, for example, lived in stone buildings, had access to fresh fruits and vegetables, and even had latrines and running water. Luxuries compared with the life of the average peasant.

Cambridge Archaeological Unit

So why then, despite having access to more modern sanitation and amenities, did the friars have so many gut parasites? That’s the question raised by a group of researchers from the University of Cambridge, who conducted a study of 19 medieval friars buried at a local friary (Oh, doesn’t your town have one of those?) and 25 local people buried at a nonreligious cemetery during a similar time period. Of those 19 friars, 11 were infected with worms and parasites, compared with just 8 of 25 townspeople.

This doesn’t make a lot of sense. The friars had a good life by old-time standards: They had basic sanitation down and a solid diet. These things should lead to a healthier population. The problem, the researchers found, is two pronged and a vicious cycle. First off, the friars had plenty of fresh food, but they used human feces to fertilize their produce. There’s a reason modern practice for human waste fertilization is to let the waste compost for 6 months: The waiting period allows the parasites a chance to kindly die off, which prevents reinfection.

Secondly, the friars’ diet of fresh fruits and vegetables mixed together into a salad, while appealing to our modern-day sensibilities, was not a great choice. By comparison, laypeople tended to eat a boiled mishmash of whatever they could find, and while that’s kind of gross, the key here is that their food was cooked. And heat kills parasites. The uncooked salads did no such thing, so the monks ate infected food, expelled infected poop, and grew more infected food with their infected poop.

Once the worms arrived, they never left, making them the worst kind of house guest. Read the room, worms, take your dinner and move on. You don’t have to go home, but you can’t stay here.
 

What’s a shared genotype between friends?

Do you find it hard to tell the difference between Katy Perry and Zooey Deschanel? They look alike, but they’re not related. Or are they? According to new research, people who look and act very similar but are not related may share DNA.

François Brunelle

“Our study provides a rare insight into human likeness by showing that people with extreme look-alike faces share common genotypes, whereas they are discordant at the epigenome and microbiome levels,” senior author Manel Esteller of the Josep Carreras Leukemia Research Institute in Barcelona said in a written statement. “Genomics clusters them together, and the rest sets them apart.”

The Internet has been a great source in being able to find look-alikes. The research team found photos of doppelgangers photographed by François Brunelle, a Canadian artist. Using facial recognition algorithms, the investigators were able to measure likeness between the each pair of look-alikes. The participants also completed a questionnaire about lifestyle and provided a saliva sample.

The results showed that the look-alikes had similar genotypes but different DNA methylation and microbiome landscapes. The look-alikes also seemed to have similarities in weight, height, and behaviors such as smoking, proving that doppelgangers not only look alike but also share common interests.

Next time someone tells you that you look like their best friend Steve, you won’t have to wonder much what Steve is like.
 

The secret to a good relationship? It’s a secret

Strong relationships are built on honesty and trust, right? Being open with your partner and/or friends is usually a good practice for keeping the relationship healthy, but the latest evidence suggests that maybe you shouldn’t share everything.

bilderlounge

According to the first known study on the emotional, behavioral, and relational aspect of consumer behavior, not disclosing certain purchases to your partner can actually be a good thing for the relationship. How? Well, it all has to do with guilt.

In a series of studies, the researchers asked couples about their secret consumptions. The most commonly hidden thing by far was a product (65%).

“We found that 90% of people have recently kept everyday consumer behaviors a secret from a close other – like a friend or spouse – even though they also report that they don’t think their partner would care if they knew about it,” Kelley Gullo Wight, one of the study’s two lead authors, said in a written statement.

Keeping a hidden stash of chocolate produces guilt, which the researchers found to be the key factor, making the perpetrator want to do more in the relationship to ease that sense of betrayal or dishonesty. They called it a “greater relationship investment,” meaning the person is more likely to do a little extra for their partner, like shell out more money for the next anniversary gift or yield to watching their partner’s favorite program.

So don’t feel too bad about that secret Amazon purchase. As long as the other person doesn’t see the box, nobody has to know. Your relationship can only improve.

Adults aged 85 years and older who logged an hour or more of walking each week had a 40% reduced risk of all-cause mortality compared with less active peers, according to data from more than 7,000 individuals.

“Aging is accompanied by reduced physical activity and increased sedentary behavior, and reduced physical activity is associated with decreased life expectancy,” Moo-Nyun Jin, MD, of Inje University Sanggye Paik Hospital, Seoul, South Korea, said in an interview.

Reduced physical activity was especially likely in the elderly during the COVID-19 pandemic, he added.

oneinchpunch/Thinkstock

“Promoting walking may be a simple way to help older adults avoid inactivity and encourage an active lifestyle for all-cause and cardiovascular mortality risk reduction,” Dr. Jin said.

Although walking is generally an easy form of exercise for the older adult population, the specific benefit of walking on reducing mortality has not been well studied, according to Dr. Jin and colleagues.

For adults of any age, current guidelines recommend at least 150 minutes per week of moderate activity or 75 minutes per week of vigorous activity, but the amount of physical activity tends to decline with age, and activity recommendations are more difficult to meet, the authors wrote in a press release accompanying their study.

In the study, to be presented at the European Society of Cardiology Congress on Aug. 28 (Abstract 85643), the researchers reviewed data from 7,047 adults aged 85 years and older who participated in the Korean National Health Screening Program. The average age of the study population was 87 years, and 68% were women. Participants completed questionnaires about the amount of time spent in leisure time activities each week, including walking at a slow pace, moderate activity (such as cycling or brisk walking), and vigorous activity (such as running).

Those who walked at a slow pace for at least 1 hour per week had a 40% reduced risk of all-cause mortality and a 39% reduced risk of cardiovascular mortality, compared with inactive participants.

The proportions of participants who reported walking, moderate activity,­ and vigorous ­intensity physical activity were 42.5%, 14.7%, and 11.0%, respectively. Roughly one-third (33%) of those who reported slow walking each week also reported moderate or vigorous physical activity.

However, walking for 1 hour per week significantly reduced the risk for all-cause mortality and cardiovascular mortality among individuals who reported walking only, without other moderate or vigorous physical activity (hazard ratio, 0.50 and 0.46, respectively).

“Walking was linked with a lower likelihood of dying in older adults, regardless of whether or not they did any moderate to vigorous intensity physical activity,” Dr. Jin told this news organization. “Our study indicates that walking even just 1 hour every week is advantageous to those aged 85 years and older compared to being inactive.”

The hour of walking need not be in long bouts, 10 minutes each day will do, Dr. Jin added.

The participants were divided into five groups based on reported amount of weekly walking. More than half (57.5%) reported no slow walking, 8.5% walked less than 1 hour per week, 12.0% walked 1-2 hours, 8.7% walked 2-3 hours, and 13.3% walked more than 3 hours.

Although the study was limited by the reliance on self-reports, the results were strengthened by the large sample size and support the value of easy walking for adults aged 85 years and older compared to being inactive.

“Walking may present an opportunity for promoting physical activity among the elderly population, offering a simple way to avoid inactivity and increase physical activity,” said Dr. Jin. However, more research is needed to evaluate the association between mortality and walking by objective measurement of walking levels, using a device such as a smart watch, he noted.

 

Results are preliminary

“This is an observational study, not an experiment, so it means causality cannot be presumed,” said Maria Fiatarone Singh, MD, a geriatrician with a focus on exercise physiology at the University of Sydney, in an interview. “In other words, it is possible that diseases resulting in mortality prevented people from walking rather than the other way around,” she noted. The only published experimental study on exercise and mortality in older adults was conducted by Dr. Fiatarone Singh and colleagues in Norway. In that study, published in the British Medical Journal in 2020, high-intensity training programs were associated with reduced all-cause mortality compared with inactive controls and individuals who engaged in moderate intensity exercise.

The current study “would have needed to control for many factors related to mortality, such as cardiovascular disease, hypertension, diabetes, malnutrition, and dementia to see what residual benefit might be related to walking,” Dr. Fiatarone Singh said.

“Although walking seems easy and safe, in fact people who are frail, sarcopenic, osteoporotic, or have fallen are recommended to do resistance and balance training rather than walking, and add walking later when they are able to do it safely,” she emphasized.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Fiatarone Singh had no financial conflicts to disclose.

Adults aged 85 years and older who logged an hour or more of walking each week had a 40% reduced risk of all-cause mortality compared with less active peers, according to data from more than 7,000 individuals.

“Aging is accompanied by reduced physical activity and increased sedentary behavior, and reduced physical activity is associated with decreased life expectancy,” Moo-Nyun Jin, MD, of Inje University Sanggye Paik Hospital, Seoul, South Korea, said in an interview.

Reduced physical activity was especially likely in the elderly during the COVID-19 pandemic, he added.

oneinchpunch/Thinkstock

“Promoting walking may be a simple way to help older adults avoid inactivity and encourage an active lifestyle for all-cause and cardiovascular mortality risk reduction,” Dr. Jin said.

Although walking is generally an easy form of exercise for the older adult population, the specific benefit of walking on reducing mortality has not been well studied, according to Dr. Jin and colleagues.

For adults of any age, current guidelines recommend at least 150 minutes per week of moderate activity or 75 minutes per week of vigorous activity, but the amount of physical activity tends to decline with age, and activity recommendations are more difficult to meet, the authors wrote in a press release accompanying their study.

In the study, to be presented at the European Society of Cardiology Congress on Aug. 28 (Abstract 85643), the researchers reviewed data from 7,047 adults aged 85 years and older who participated in the Korean National Health Screening Program. The average age of the study population was 87 years, and 68% were women. Participants completed questionnaires about the amount of time spent in leisure time activities each week, including walking at a slow pace, moderate activity (such as cycling or brisk walking), and vigorous activity (such as running).

Those who walked at a slow pace for at least 1 hour per week had a 40% reduced risk of all-cause mortality and a 39% reduced risk of cardiovascular mortality, compared with inactive participants.

The proportions of participants who reported walking, moderate activity,­ and vigorous ­intensity physical activity were 42.5%, 14.7%, and 11.0%, respectively. Roughly one-third (33%) of those who reported slow walking each week also reported moderate or vigorous physical activity.

However, walking for 1 hour per week significantly reduced the risk for all-cause mortality and cardiovascular mortality among individuals who reported walking only, without other moderate or vigorous physical activity (hazard ratio, 0.50 and 0.46, respectively).

“Walking was linked with a lower likelihood of dying in older adults, regardless of whether or not they did any moderate to vigorous intensity physical activity,” Dr. Jin told this news organization. “Our study indicates that walking even just 1 hour every week is advantageous to those aged 85 years and older compared to being inactive.”

The hour of walking need not be in long bouts, 10 minutes each day will do, Dr. Jin added.

The participants were divided into five groups based on reported amount of weekly walking. More than half (57.5%) reported no slow walking, 8.5% walked less than 1 hour per week, 12.0% walked 1-2 hours, 8.7% walked 2-3 hours, and 13.3% walked more than 3 hours.

Although the study was limited by the reliance on self-reports, the results were strengthened by the large sample size and support the value of easy walking for adults aged 85 years and older compared to being inactive.

“Walking may present an opportunity for promoting physical activity among the elderly population, offering a simple way to avoid inactivity and increase physical activity,” said Dr. Jin. However, more research is needed to evaluate the association between mortality and walking by objective measurement of walking levels, using a device such as a smart watch, he noted.

 

Results are preliminary

“This is an observational study, not an experiment, so it means causality cannot be presumed,” said Maria Fiatarone Singh, MD, a geriatrician with a focus on exercise physiology at the University of Sydney, in an interview. “In other words, it is possible that diseases resulting in mortality prevented people from walking rather than the other way around,” she noted. The only published experimental study on exercise and mortality in older adults was conducted by Dr. Fiatarone Singh and colleagues in Norway. In that study, published in the British Medical Journal in 2020, high-intensity training programs were associated with reduced all-cause mortality compared with inactive controls and individuals who engaged in moderate intensity exercise.

The current study “would have needed to control for many factors related to mortality, such as cardiovascular disease, hypertension, diabetes, malnutrition, and dementia to see what residual benefit might be related to walking,” Dr. Fiatarone Singh said.

“Although walking seems easy and safe, in fact people who are frail, sarcopenic, osteoporotic, or have fallen are recommended to do resistance and balance training rather than walking, and add walking later when they are able to do it safely,” she emphasized.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Fiatarone Singh had no financial conflicts to disclose.

Adults aged 85 years and older who logged an hour or more of walking each week had a 40% reduced risk of all-cause mortality compared with less active peers, according to data from more than 7,000 individuals.

“Aging is accompanied by reduced physical activity and increased sedentary behavior, and reduced physical activity is associated with decreased life expectancy,” Moo-Nyun Jin, MD, of Inje University Sanggye Paik Hospital, Seoul, South Korea, said in an interview.

Reduced physical activity was especially likely in the elderly during the COVID-19 pandemic, he added.

oneinchpunch/Thinkstock

“Promoting walking may be a simple way to help older adults avoid inactivity and encourage an active lifestyle for all-cause and cardiovascular mortality risk reduction,” Dr. Jin said.

Although walking is generally an easy form of exercise for the older adult population, the specific benefit of walking on reducing mortality has not been well studied, according to Dr. Jin and colleagues.

For adults of any age, current guidelines recommend at least 150 minutes per week of moderate activity or 75 minutes per week of vigorous activity, but the amount of physical activity tends to decline with age, and activity recommendations are more difficult to meet, the authors wrote in a press release accompanying their study.

In the study, to be presented at the European Society of Cardiology Congress on Aug. 28 (Abstract 85643), the researchers reviewed data from 7,047 adults aged 85 years and older who participated in the Korean National Health Screening Program. The average age of the study population was 87 years, and 68% were women. Participants completed questionnaires about the amount of time spent in leisure time activities each week, including walking at a slow pace, moderate activity (such as cycling or brisk walking), and vigorous activity (such as running).

Those who walked at a slow pace for at least 1 hour per week had a 40% reduced risk of all-cause mortality and a 39% reduced risk of cardiovascular mortality, compared with inactive participants.

The proportions of participants who reported walking, moderate activity,­ and vigorous ­intensity physical activity were 42.5%, 14.7%, and 11.0%, respectively. Roughly one-third (33%) of those who reported slow walking each week also reported moderate or vigorous physical activity.

However, walking for 1 hour per week significantly reduced the risk for all-cause mortality and cardiovascular mortality among individuals who reported walking only, without other moderate or vigorous physical activity (hazard ratio, 0.50 and 0.46, respectively).

“Walking was linked with a lower likelihood of dying in older adults, regardless of whether or not they did any moderate to vigorous intensity physical activity,” Dr. Jin told this news organization. “Our study indicates that walking even just 1 hour every week is advantageous to those aged 85 years and older compared to being inactive.”

The hour of walking need not be in long bouts, 10 minutes each day will do, Dr. Jin added.

The participants were divided into five groups based on reported amount of weekly walking. More than half (57.5%) reported no slow walking, 8.5% walked less than 1 hour per week, 12.0% walked 1-2 hours, 8.7% walked 2-3 hours, and 13.3% walked more than 3 hours.

Although the study was limited by the reliance on self-reports, the results were strengthened by the large sample size and support the value of easy walking for adults aged 85 years and older compared to being inactive.

“Walking may present an opportunity for promoting physical activity among the elderly population, offering a simple way to avoid inactivity and increase physical activity,” said Dr. Jin. However, more research is needed to evaluate the association between mortality and walking by objective measurement of walking levels, using a device such as a smart watch, he noted.

 

Results are preliminary

“This is an observational study, not an experiment, so it means causality cannot be presumed,” said Maria Fiatarone Singh, MD, a geriatrician with a focus on exercise physiology at the University of Sydney, in an interview. “In other words, it is possible that diseases resulting in mortality prevented people from walking rather than the other way around,” she noted. The only published experimental study on exercise and mortality in older adults was conducted by Dr. Fiatarone Singh and colleagues in Norway. In that study, published in the British Medical Journal in 2020, high-intensity training programs were associated with reduced all-cause mortality compared with inactive controls and individuals who engaged in moderate intensity exercise.

The current study “would have needed to control for many factors related to mortality, such as cardiovascular disease, hypertension, diabetes, malnutrition, and dementia to see what residual benefit might be related to walking,” Dr. Fiatarone Singh said.

“Although walking seems easy and safe, in fact people who are frail, sarcopenic, osteoporotic, or have fallen are recommended to do resistance and balance training rather than walking, and add walking later when they are able to do it safely,” she emphasized.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Fiatarone Singh had no financial conflicts to disclose.

A cell phone app that combines white noise, active game-based therapy, and counseling could help “rewire” the brain to provide relief from tinnitus symptoms, new research suggests. In a randomized controlled trial, results at 12 weeks showed patients with tinnitus reported clinically meaningful reductions in ratings of annoyance, inability to ignore, unpleasantness, and loudness after using a digital polytherapeutic app prototype that focuses on relief, relaxation, and attention-focused retraining. In addition, their improvements were significantly greater than for the control group, which received a common white noise app.

Researchers called the results “promising” for a condition that has no cure and few successful treatments. “What this therapy does is essentially rewire the brain in a way that de-emphasizes the sound of the tinnitus to a background noise that has no meaning or relevance to the listener,” lead author Grant Searchfield, PhD, associate professor of audiology at the University of Auckland, New Zealand, said in a press release.

The findings were published online in Frontiers in Neurology.
 

Worldwide problem

A recent study showed more than 740 million adults worldwide (nearly 15% of the population) have experienced at least one symptom of tinnitus – and about 120 million are severely affected. Tinnitus is the perception of a ringing, buzzing, whistling, or hissing noise in one or both ears when no external source of the sound is present. Often caused by damage to the auditory system, tinnitus can also be a symptom of a wide range of medical conditions and has been identified as a side effect of COVID-19 vaccination. In its most severe form, which is associated with hearing loss, tinnitus can also affect a patient’s mental, emotional, and social health.

For the current study, participants with tinnitus were randomly assigned to a popular app that uses white noise (control group, n = 30) or to the UpSilent app (n = 31). The UpSilent group received a smartphone app, Bluetooth bone conduction headphones, a Bluetooth neck pillow speaker for sleep, and written counseling materials. Participants in the control group received a widely available app called “White Noise” and in-ear wired headphones.
 

‘Quicker and more effective’

Both groups reported reductions in ratings of annoyance, inability to ignore, unpleasantness, and loudness at 12 weeks. But significantly more of the UpSilent group reported clinically meaningful improvement compared with the control group (65% vs. 43%, respectively; P = .049).

“Earlier trials have found white noise, goal-based counseling, goal-oriented games, and other technology-based therapies are effective for some people some of the time,” Dr. Searchfield said. “This is quicker and more effective, taking 12 weeks rather than 12 months for more individuals to gain some control,” he added.

The investigators noted that the study was not designed to determine which of the app’s functions of passive listening, active listening, or counseling contributed to symptom improvement.

The next step will be to refine the prototype and proceed to larger local and international trials with a view toward approval by the U.S. Food and Drug Administration, they reported.

The researchers hope the app will be clinically available in about 6 months.

The study was funded by Return on Science, Auckland UniServices. Dr. Searchfield is a founder and scientific officer for TrueSilence, a spinout company of the University of Auckland, and has a financial interest in TrueSilence. His coauthor has reported no relevant financial relationships.

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

A cell phone app that combines white noise, active game-based therapy, and counseling could help “rewire” the brain to provide relief from tinnitus symptoms, new research suggests. In a randomized controlled trial, results at 12 weeks showed patients with tinnitus reported clinically meaningful reductions in ratings of annoyance, inability to ignore, unpleasantness, and loudness after using a digital polytherapeutic app prototype that focuses on relief, relaxation, and attention-focused retraining. In addition, their improvements were significantly greater than for the control group, which received a common white noise app.

Researchers called the results “promising” for a condition that has no cure and few successful treatments. “What this therapy does is essentially rewire the brain in a way that de-emphasizes the sound of the tinnitus to a background noise that has no meaning or relevance to the listener,” lead author Grant Searchfield, PhD, associate professor of audiology at the University of Auckland, New Zealand, said in a press release.

The findings were published online in Frontiers in Neurology.
 

Worldwide problem

A recent study showed more than 740 million adults worldwide (nearly 15% of the population) have experienced at least one symptom of tinnitus – and about 120 million are severely affected. Tinnitus is the perception of a ringing, buzzing, whistling, or hissing noise in one or both ears when no external source of the sound is present. Often caused by damage to the auditory system, tinnitus can also be a symptom of a wide range of medical conditions and has been identified as a side effect of COVID-19 vaccination. In its most severe form, which is associated with hearing loss, tinnitus can also affect a patient’s mental, emotional, and social health.

For the current study, participants with tinnitus were randomly assigned to a popular app that uses white noise (control group, n = 30) or to the UpSilent app (n = 31). The UpSilent group received a smartphone app, Bluetooth bone conduction headphones, a Bluetooth neck pillow speaker for sleep, and written counseling materials. Participants in the control group received a widely available app called “White Noise” and in-ear wired headphones.
 

‘Quicker and more effective’

Both groups reported reductions in ratings of annoyance, inability to ignore, unpleasantness, and loudness at 12 weeks. But significantly more of the UpSilent group reported clinically meaningful improvement compared with the control group (65% vs. 43%, respectively; P = .049).

“Earlier trials have found white noise, goal-based counseling, goal-oriented games, and other technology-based therapies are effective for some people some of the time,” Dr. Searchfield said. “This is quicker and more effective, taking 12 weeks rather than 12 months for more individuals to gain some control,” he added.

The investigators noted that the study was not designed to determine which of the app’s functions of passive listening, active listening, or counseling contributed to symptom improvement.

The next step will be to refine the prototype and proceed to larger local and international trials with a view toward approval by the U.S. Food and Drug Administration, they reported.

The researchers hope the app will be clinically available in about 6 months.

The study was funded by Return on Science, Auckland UniServices. Dr. Searchfield is a founder and scientific officer for TrueSilence, a spinout company of the University of Auckland, and has a financial interest in TrueSilence. His coauthor has reported no relevant financial relationships.

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

A cell phone app that combines white noise, active game-based therapy, and counseling could help “rewire” the brain to provide relief from tinnitus symptoms, new research suggests. In a randomized controlled trial, results at 12 weeks showed patients with tinnitus reported clinically meaningful reductions in ratings of annoyance, inability to ignore, unpleasantness, and loudness after using a digital polytherapeutic app prototype that focuses on relief, relaxation, and attention-focused retraining. In addition, their improvements were significantly greater than for the control group, which received a common white noise app.

Researchers called the results “promising” for a condition that has no cure and few successful treatments. “What this therapy does is essentially rewire the brain in a way that de-emphasizes the sound of the tinnitus to a background noise that has no meaning or relevance to the listener,” lead author Grant Searchfield, PhD, associate professor of audiology at the University of Auckland, New Zealand, said in a press release.

The findings were published online in Frontiers in Neurology.
 

Worldwide problem

A recent study showed more than 740 million adults worldwide (nearly 15% of the population) have experienced at least one symptom of tinnitus – and about 120 million are severely affected. Tinnitus is the perception of a ringing, buzzing, whistling, or hissing noise in one or both ears when no external source of the sound is present. Often caused by damage to the auditory system, tinnitus can also be a symptom of a wide range of medical conditions and has been identified as a side effect of COVID-19 vaccination. In its most severe form, which is associated with hearing loss, tinnitus can also affect a patient’s mental, emotional, and social health.

For the current study, participants with tinnitus were randomly assigned to a popular app that uses white noise (control group, n = 30) or to the UpSilent app (n = 31). The UpSilent group received a smartphone app, Bluetooth bone conduction headphones, a Bluetooth neck pillow speaker for sleep, and written counseling materials. Participants in the control group received a widely available app called “White Noise” and in-ear wired headphones.
 

‘Quicker and more effective’

Both groups reported reductions in ratings of annoyance, inability to ignore, unpleasantness, and loudness at 12 weeks. But significantly more of the UpSilent group reported clinically meaningful improvement compared with the control group (65% vs. 43%, respectively; P = .049).

“Earlier trials have found white noise, goal-based counseling, goal-oriented games, and other technology-based therapies are effective for some people some of the time,” Dr. Searchfield said. “This is quicker and more effective, taking 12 weeks rather than 12 months for more individuals to gain some control,” he added.

The investigators noted that the study was not designed to determine which of the app’s functions of passive listening, active listening, or counseling contributed to symptom improvement.

The next step will be to refine the prototype and proceed to larger local and international trials with a view toward approval by the U.S. Food and Drug Administration, they reported.

The researchers hope the app will be clinically available in about 6 months.

The study was funded by Return on Science, Auckland UniServices. Dr. Searchfield is a founder and scientific officer for TrueSilence, a spinout company of the University of Auckland, and has a financial interest in TrueSilence. His coauthor has reported no relevant financial relationships.

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

To the Editor:

Dermatofibromas (also known as fibrous histiocytomas) are benign fibrous nodules that most often arise as solitary lesions on the lower extremities. Multiple eruptive dermatofibromas (MEDFs) are uncommon and have been defined as more than 15 in number¹ or 5 to 8 dermatofibromas appearing within 4 months.² They have been reported in association with a number of conditions of immune dysregulation such as systemic lupus erythematosus, Sjögren syndrome, HIV infection, and leukemia.³ Multiple eruptive dermatofibromas also have been described in patients with Down syndrome (DS).^4-7 We report a case of MEDFs in a patient with DS and review the literature on the association between MEDFs and DS.

A 38-year-old woman with DS, hidradenitis suppurativa, and hypothyroidism presented with multiple cutaneous lesions developing over the last year. The lesions continued to increase in number but were otherwise asymptomatic. Physical examination revealed approximately 20 rubbery, pink-tan papules measuring less than 1 cm in diameter that were scattered along the trunk (Figure, A), arms, and legs (Figure, B).

The patient had no known history of immunosuppression or rheumatologic disease and was otherwise healthy. Basic laboratory tests including a complete blood cell count and antinuclear antibody titer were within reference range. The lesions were clinically consistent with dermatofibromas, but due to their increasing number within a short period of time, a biopsy of a representative lesion was performed to confirm the diagnosis.

The exact incidence of MEDFs is unknown, but they are rare, with one review finding only 50 cases reported from 1960 to 2002.⁸ They are increasingly recognized as a sign of potential immune dysregulation. Approximately 56% to 70% of cases are seen in patients with an underlying disease state; 80% are immune mediated.^8,9 Interestingly, DS has long been associated with notable immune dysfunction,^10,11 with evidence suggesting that trisomy 21 may result in widespread changes in gene expression that can lead to interferon activation.¹²

A PubMed search of articles indexed for MEDLINE using the terms dermatofibroma and Down, dermatofibroma and Down syndrome, eruptive dermatofibroma and Down syndrome, and multiple dermatofibroma and Down syndrome revealed 6 cases of MEDFs in patients with DS that have been reported since 2005.^4-7 An additional report by Honda et al¹³ described a patient with DS who developed 7 dermatofibromas, but no time frame of development was specified. We reviewed the characteristics of 8 patients with DS with MEDFs, which included our patient (Table). The average age at time of presentation was 39 years (median age, 40 years). Six patients (75%) were female and 2 (25%) were male. Dermatofibromas were reported to appear over the course of months to years. Comorbidities included psoriatic arthritis (treated with methotrexate),⁶ thyroid disorders (ie, Graves disease),⁶ hypercholesterolemia,⁶ hidradenitis suppurativa, long-standing mild lymphopenia (1.4×10⁹/L [reference range, 1.5−4.0×10⁹/L]),⁴ and acute megakaryoblastic leukemia¹³ treated 15 years before the appearance of dermatofibromas.

Many dermatologic conditions have been reported at increased rates in individuals with DS, including seborrheic dermatitis, alopecia areata, syringomas, elastosis perforans serpiginosa, cutis marmorata, xerosis, and palmoplantar hyperkeratosis.^14,15 Although drawing conclusions about associations between MEDFs and DS is limited by our small sample size, we have reported this case and reviewed existing cases of MEDFs in DS to highlight a potential association that may be underrecognized or underreported. More evidence is needed to determine the strength of the association between MEDFs and DS, but dermatologists should be aware that MEDFs may be an additional skin finding associated with DS that is related to the syndrome’s immune dysregulation.

To the Editor:

Dermatofibromas (also known as fibrous histiocytomas) are benign fibrous nodules that most often arise as solitary lesions on the lower extremities. Multiple eruptive dermatofibromas (MEDFs) are uncommon and have been defined as more than 15 in number¹ or 5 to 8 dermatofibromas appearing within 4 months.² They have been reported in association with a number of conditions of immune dysregulation such as systemic lupus erythematosus, Sjögren syndrome, HIV infection, and leukemia.³ Multiple eruptive dermatofibromas also have been described in patients with Down syndrome (DS).^4-7 We report a case of MEDFs in a patient with DS and review the literature on the association between MEDFs and DS.

A 38-year-old woman with DS, hidradenitis suppurativa, and hypothyroidism presented with multiple cutaneous lesions developing over the last year. The lesions continued to increase in number but were otherwise asymptomatic. Physical examination revealed approximately 20 rubbery, pink-tan papules measuring less than 1 cm in diameter that were scattered along the trunk (Figure, A), arms, and legs (Figure, B).

The patient had no known history of immunosuppression or rheumatologic disease and was otherwise healthy. Basic laboratory tests including a complete blood cell count and antinuclear antibody titer were within reference range. The lesions were clinically consistent with dermatofibromas, but due to their increasing number within a short period of time, a biopsy of a representative lesion was performed to confirm the diagnosis.

The exact incidence of MEDFs is unknown, but they are rare, with one review finding only 50 cases reported from 1960 to 2002.⁸ They are increasingly recognized as a sign of potential immune dysregulation. Approximately 56% to 70% of cases are seen in patients with an underlying disease state; 80% are immune mediated.^8,9 Interestingly, DS has long been associated with notable immune dysfunction,^10,11 with evidence suggesting that trisomy 21 may result in widespread changes in gene expression that can lead to interferon activation.¹²

A PubMed search of articles indexed for MEDLINE using the terms dermatofibroma and Down, dermatofibroma and Down syndrome, eruptive dermatofibroma and Down syndrome, and multiple dermatofibroma and Down syndrome revealed 6 cases of MEDFs in patients with DS that have been reported since 2005.^4-7 An additional report by Honda et al¹³ described a patient with DS who developed 7 dermatofibromas, but no time frame of development was specified. We reviewed the characteristics of 8 patients with DS with MEDFs, which included our patient (Table). The average age at time of presentation was 39 years (median age, 40 years). Six patients (75%) were female and 2 (25%) were male. Dermatofibromas were reported to appear over the course of months to years. Comorbidities included psoriatic arthritis (treated with methotrexate),⁶ thyroid disorders (ie, Graves disease),⁶ hypercholesterolemia,⁶ hidradenitis suppurativa, long-standing mild lymphopenia (1.4×10⁹/L [reference range, 1.5−4.0×10⁹/L]),⁴ and acute megakaryoblastic leukemia¹³ treated 15 years before the appearance of dermatofibromas.

Many dermatologic conditions have been reported at increased rates in individuals with DS, including seborrheic dermatitis, alopecia areata, syringomas, elastosis perforans serpiginosa, cutis marmorata, xerosis, and palmoplantar hyperkeratosis.^14,15 Although drawing conclusions about associations between MEDFs and DS is limited by our small sample size, we have reported this case and reviewed existing cases of MEDFs in DS to highlight a potential association that may be underrecognized or underreported. More evidence is needed to determine the strength of the association between MEDFs and DS, but dermatologists should be aware that MEDFs may be an additional skin finding associated with DS that is related to the syndrome’s immune dysregulation.

To the Editor:

Dermatofibromas (also known as fibrous histiocytomas) are benign fibrous nodules that most often arise as solitary lesions on the lower extremities. Multiple eruptive dermatofibromas (MEDFs) are uncommon and have been defined as more than 15 in number¹ or 5 to 8 dermatofibromas appearing within 4 months.² They have been reported in association with a number of conditions of immune dysregulation such as systemic lupus erythematosus, Sjögren syndrome, HIV infection, and leukemia.³ Multiple eruptive dermatofibromas also have been described in patients with Down syndrome (DS).^4-7 We report a case of MEDFs in a patient with DS and review the literature on the association between MEDFs and DS.

A 38-year-old woman with DS, hidradenitis suppurativa, and hypothyroidism presented with multiple cutaneous lesions developing over the last year. The lesions continued to increase in number but were otherwise asymptomatic. Physical examination revealed approximately 20 rubbery, pink-tan papules measuring less than 1 cm in diameter that were scattered along the trunk (Figure, A), arms, and legs (Figure, B).

The patient had no known history of immunosuppression or rheumatologic disease and was otherwise healthy. Basic laboratory tests including a complete blood cell count and antinuclear antibody titer were within reference range. The lesions were clinically consistent with dermatofibromas, but due to their increasing number within a short period of time, a biopsy of a representative lesion was performed to confirm the diagnosis.

The exact incidence of MEDFs is unknown, but they are rare, with one review finding only 50 cases reported from 1960 to 2002.⁸ They are increasingly recognized as a sign of potential immune dysregulation. Approximately 56% to 70% of cases are seen in patients with an underlying disease state; 80% are immune mediated.^8,9 Interestingly, DS has long been associated with notable immune dysfunction,^10,11 with evidence suggesting that trisomy 21 may result in widespread changes in gene expression that can lead to interferon activation.¹²

A PubMed search of articles indexed for MEDLINE using the terms dermatofibroma and Down, dermatofibroma and Down syndrome, eruptive dermatofibroma and Down syndrome, and multiple dermatofibroma and Down syndrome revealed 6 cases of MEDFs in patients with DS that have been reported since 2005.^4-7 An additional report by Honda et al¹³ described a patient with DS who developed 7 dermatofibromas, but no time frame of development was specified. We reviewed the characteristics of 8 patients with DS with MEDFs, which included our patient (Table). The average age at time of presentation was 39 years (median age, 40 years). Six patients (75%) were female and 2 (25%) were male. Dermatofibromas were reported to appear over the course of months to years. Comorbidities included psoriatic arthritis (treated with methotrexate),⁶ thyroid disorders (ie, Graves disease),⁶ hypercholesterolemia,⁶ hidradenitis suppurativa, long-standing mild lymphopenia (1.4×10⁹/L [reference range, 1.5−4.0×10⁹/L]),⁴ and acute megakaryoblastic leukemia¹³ treated 15 years before the appearance of dermatofibromas.

Many dermatologic conditions have been reported at increased rates in individuals with DS, including seborrheic dermatitis, alopecia areata, syringomas, elastosis perforans serpiginosa, cutis marmorata, xerosis, and palmoplantar hyperkeratosis.^14,15 Although drawing conclusions about associations between MEDFs and DS is limited by our small sample size, we have reported this case and reviewed existing cases of MEDFs in DS to highlight a potential association that may be underrecognized or underreported. More evidence is needed to determine the strength of the association between MEDFs and DS, but dermatologists should be aware that MEDFs may be an additional skin finding associated with DS that is related to the syndrome’s immune dysregulation.