Marcia Frellick

The Centers for Disease Control and Prevention has issued a report alerting clinicians to emerging cases of alpha-gal syndrome (AGS) linked with tick bites.

AGS causes patients to become allergic to meat, and in some cases the reaction can be life-threatening. Symptoms typically start 2-6 hours after eating the meat.

The American Gastroenterological Association published a Clinical Practice Update in February notifying gastroenterologists that a subset of AGS patients are presenting with abdominal pain, nausea, diarrhea or vomiting, without skin changes or anaphylaxis. If alpha-gal is suspected, serum tests for immunoglobulin E (IgE) antibodies should be performed.

“It is important for gastroenterologists to be aware of this condition and to be capable of diagnosing and treating it in a timely manner,” wrote authors of the clinical practice update in Clinical Gastroenterology and Hepatology.

A Morbidity and Mortality Weekly Report demonstrates that health care provider knowledge is low surrounding AGS. Almost half of the 1,500 health care providers surveyed (42%) had never heard of the syndrome and another 35% were not confident in diagnosing or managing affected patients.

The low knowledge is concerning because the range of the lone star tick, which is the species primarily associated with this syndrome, is expanding. The knowledge gaps may lead to delayed or overlooked diagnoses.

“Improved health care provider education might facilitate a rapid diagnosis of AGS, improve patient care, and support public health understanding of this emerging condition,” write the report authors, led by Ann Carpenter, DVM, with the CDC.

Another Morbidity and Mortality Weekly Report, with lead author Johanna S. Salzer, DVM, PhD, of the CDC, also issued on July 28, notes that specific symptoms and severity of AGS vary and no cure or treatment is currently available. From 2010 to 2018, there were more than 34,000 suspected cases of AGS in the United States, but current knowledge of where the cases have occurred is limited, the study authors write.

According to the report, the suspected AGS cases were concentrated in areas where the lone star tick is known to be found, particularly throughout Arkansas, Kentucky, Missouri, and Suffolk County, N.Y.

The report also notes that, “during 2017-2021, there was an annual increase in positive test results for AGS in the United States. More than 90,000 suspected AGS cases were identified during the study period, and the number of new suspected cases increased by approximately 15,000 each year during the study.”

An AGS diagnosis “can be made with GI distress and increased serum alpha-gal IgE antibodies whose symptoms are relieved adequately on an alpha-gal avoidance diet that eliminates pork, beef, and mammalian-derived products,” the practice update says.

Patients whose symptoms also include facial swelling, urticaria, and trouble breathing should be referred to allergists, the AGA update states.

Patients should also be counseled to avoid further tick bites because additional bites can worsen the allergy.

The authors declare no relevant financial relationships.

The Centers for Disease Control and Prevention has issued a report alerting clinicians to emerging cases of alpha-gal syndrome (AGS) linked with tick bites.

AGS causes patients to become allergic to meat, and in some cases the reaction can be life-threatening. Symptoms typically start 2-6 hours after eating the meat.

The American Gastroenterological Association published a Clinical Practice Update in February notifying gastroenterologists that a subset of AGS patients are presenting with abdominal pain, nausea, diarrhea or vomiting, without skin changes or anaphylaxis. If alpha-gal is suspected, serum tests for immunoglobulin E (IgE) antibodies should be performed.

“It is important for gastroenterologists to be aware of this condition and to be capable of diagnosing and treating it in a timely manner,” wrote authors of the clinical practice update in Clinical Gastroenterology and Hepatology.

A Morbidity and Mortality Weekly Report demonstrates that health care provider knowledge is low surrounding AGS. Almost half of the 1,500 health care providers surveyed (42%) had never heard of the syndrome and another 35% were not confident in diagnosing or managing affected patients.

The low knowledge is concerning because the range of the lone star tick, which is the species primarily associated with this syndrome, is expanding. The knowledge gaps may lead to delayed or overlooked diagnoses.

“Improved health care provider education might facilitate a rapid diagnosis of AGS, improve patient care, and support public health understanding of this emerging condition,” write the report authors, led by Ann Carpenter, DVM, with the CDC.

Another Morbidity and Mortality Weekly Report, with lead author Johanna S. Salzer, DVM, PhD, of the CDC, also issued on July 28, notes that specific symptoms and severity of AGS vary and no cure or treatment is currently available. From 2010 to 2018, there were more than 34,000 suspected cases of AGS in the United States, but current knowledge of where the cases have occurred is limited, the study authors write.

According to the report, the suspected AGS cases were concentrated in areas where the lone star tick is known to be found, particularly throughout Arkansas, Kentucky, Missouri, and Suffolk County, N.Y.

The report also notes that, “during 2017-2021, there was an annual increase in positive test results for AGS in the United States. More than 90,000 suspected AGS cases were identified during the study period, and the number of new suspected cases increased by approximately 15,000 each year during the study.”

An AGS diagnosis “can be made with GI distress and increased serum alpha-gal IgE antibodies whose symptoms are relieved adequately on an alpha-gal avoidance diet that eliminates pork, beef, and mammalian-derived products,” the practice update says.

Patients whose symptoms also include facial swelling, urticaria, and trouble breathing should be referred to allergists, the AGA update states.

Patients should also be counseled to avoid further tick bites because additional bites can worsen the allergy.

The authors declare no relevant financial relationships.

The Centers for Disease Control and Prevention has issued a report alerting clinicians to emerging cases of alpha-gal syndrome (AGS) linked with tick bites.

AGS causes patients to become allergic to meat, and in some cases the reaction can be life-threatening. Symptoms typically start 2-6 hours after eating the meat.

The American Gastroenterological Association published a Clinical Practice Update in February notifying gastroenterologists that a subset of AGS patients are presenting with abdominal pain, nausea, diarrhea or vomiting, without skin changes or anaphylaxis. If alpha-gal is suspected, serum tests for immunoglobulin E (IgE) antibodies should be performed.

“It is important for gastroenterologists to be aware of this condition and to be capable of diagnosing and treating it in a timely manner,” wrote authors of the clinical practice update in Clinical Gastroenterology and Hepatology.

A Morbidity and Mortality Weekly Report demonstrates that health care provider knowledge is low surrounding AGS. Almost half of the 1,500 health care providers surveyed (42%) had never heard of the syndrome and another 35% were not confident in diagnosing or managing affected patients.

The low knowledge is concerning because the range of the lone star tick, which is the species primarily associated with this syndrome, is expanding. The knowledge gaps may lead to delayed or overlooked diagnoses.

“Improved health care provider education might facilitate a rapid diagnosis of AGS, improve patient care, and support public health understanding of this emerging condition,” write the report authors, led by Ann Carpenter, DVM, with the CDC.

Another Morbidity and Mortality Weekly Report, with lead author Johanna S. Salzer, DVM, PhD, of the CDC, also issued on July 28, notes that specific symptoms and severity of AGS vary and no cure or treatment is currently available. From 2010 to 2018, there were more than 34,000 suspected cases of AGS in the United States, but current knowledge of where the cases have occurred is limited, the study authors write.

According to the report, the suspected AGS cases were concentrated in areas where the lone star tick is known to be found, particularly throughout Arkansas, Kentucky, Missouri, and Suffolk County, N.Y.

The report also notes that, “during 2017-2021, there was an annual increase in positive test results for AGS in the United States. More than 90,000 suspected AGS cases were identified during the study period, and the number of new suspected cases increased by approximately 15,000 each year during the study.”

An AGS diagnosis “can be made with GI distress and increased serum alpha-gal IgE antibodies whose symptoms are relieved adequately on an alpha-gal avoidance diet that eliminates pork, beef, and mammalian-derived products,” the practice update says.

Patients whose symptoms also include facial swelling, urticaria, and trouble breathing should be referred to allergists, the AGA update states.

Patients should also be counseled to avoid further tick bites because additional bites can worsen the allergy.

The authors declare no relevant financial relationships.

Several signs are pointing to an impending surge in the number of human cases of West Nile virus in several regions of the United States.

West Nile virus is spread by infected mosquitoes and currently there is no cure or virus-specific treatment. In rare cases, it can be deadly. It can infect humans, birds, horses, and other mammals.

West Nile Virus is the leading cause of mosquito-borne disease in the continental United States. As of Aug. 8, 126 human cases had been identified across 22 states, according to the Centers for Disease Control and Prevention.

“Particularly here in California, it’s peak risk right now,” said Vicki Kramer, PhD, chief of vector-borne diseases in the California Department of Public Health. She said scientists there are seeing higher mosquito and infected mosquito numbers.
 

“Peak risk right now”

Dead birds are tested for the virus and by Aug. 4, 181 of the 913 birds tested in California have been positive, three times the total testing positive by this time in 2022.

“Last year at this time, we had 60 positive dead birds out of 817 tested,” Dr. Kramer said.

Severe flooding and high heat can contribute to the rise in mosquito populations and many parts of the country have seen plenty of both.

One of the ways scientists track infected mosquito patterns in California is by using flocks of strategically placed sentinel chickens.

“Chickens are a mosquito magnet,” Dr. Kramer said.

Chickens don’t get sick with the virus, but they do build antibodies to it. Surveillance teams check their blood every other week to track the virus.

Daniel Pastula, MD, MHS, chief of neuroinfectious diseases and global neurology at the University of Colorado School of Medicine and the Colorado School of Public Health, said the state is watching troubling signs as well.

“The concern this year,” Dr. Pastula said, “particularly along the Front Range in Colorado, is we’ve found many more mosquitoes [that are] positive for West Nile earlier in the season compared with other years.

“We’re bracing for higher-than-baseline human cases,” he said.

Asked about this year’s first human case, reported in Toronto, a region with a long winter and low incidence of the virus, he said that provides a further example that people need to be prepared even in climates not known to be mosquito-dense.

He added, however, that climate is only one factor in the severity of the season. Others include birds’ immunity and migratory patterns.

Dr. Pastula said that fluctuations in temperature and rainfall are rising with climate change and are disrupting normal baseline levels of West Nile.

“That shows we need to be prepared for West Nile virus and other mosquito-borne diseases in any place in North America or really the world. We recently saw malaria cases in the southern United States. It just shows you how dangerous mosquitoes can be.”
 

Avoid mosquito bites

Dr. Pastula and Dr. Kramer list the precautions people can take to protect themselves from West Nile virus:

• Limit outdoor exposure particularly at dusk and dawn.
• Wear protective clothing.
• Use .
• Repair window screens so mosquitoes cannot fly through.
• Dump and drain standing water on your property and maintain swimming pools.

Dr. Pastula noted that summer is the time human cases start to mount – typically from July and August to the first hard freeze.

“We have been warning people here up and down the Front Range of Colorado to take prevention very seriously,” Dr. Pastula said.

He pointed out that 80% who are infected with West Nile will have no symptoms.

About 20% will have flu-like illness – high fever, body and joint aches, rash, diarrhea, or headaches. Symptoms may last for weeks. About 1% of the time, he said, people can get neuroinvasive West Nile.

Dr. Pastula explained that the virus can infect the covering of the brain and spinal cord causing meningitis with very high fever, severe headaches, stiff neck, and sensitivity to light.

So far this year, there have been 89 neuroinvasive cases reported nationally, according to the CDC.

With West Nile encephalitis, the virus “can infect the brain itself causing altered mental status, movement disorders, or weakness,” Dr. Pastula said.

Sometimes it can infect the gray matter of the spinal cord causing a West Nile virus poliomyelitis, which brings polio-like symptoms.

“The West Nile encephalitis and poliomyelitis can cause permanent deficits or even death,” he said. “It’s uncommon but it’s not trivial.”

Several vaccine candidates are in development, Dr. Pastula said, but none has reached clinical trials. Part of the reason for that, he said, is that scientists must be able to predict the timing of an outbreak.

“We’re not really great at predicting outbreaks,” he said.

Although the risk for neuroinvasive disease is small, it can be higher in certain groups, he said – those who are over age 60 years or are immunocompromised; those who have diabetes, cancer, or kidney disease; or those who have undergone organ transplants.

Those infected should see a health care professional and may be able to get relief with the usual medications for flu-like illness.

Some with severe infection may need to go to the hospital, Dr. Pastula said.
 

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

Several signs are pointing to an impending surge in the number of human cases of West Nile virus in several regions of the United States.

West Nile virus is spread by infected mosquitoes and currently there is no cure or virus-specific treatment. In rare cases, it can be deadly. It can infect humans, birds, horses, and other mammals.

West Nile Virus is the leading cause of mosquito-borne disease in the continental United States. As of Aug. 8, 126 human cases had been identified across 22 states, according to the Centers for Disease Control and Prevention.

“Particularly here in California, it’s peak risk right now,” said Vicki Kramer, PhD, chief of vector-borne diseases in the California Department of Public Health. She said scientists there are seeing higher mosquito and infected mosquito numbers.
 

“Peak risk right now”

Dead birds are tested for the virus and by Aug. 4, 181 of the 913 birds tested in California have been positive, three times the total testing positive by this time in 2022.

“Last year at this time, we had 60 positive dead birds out of 817 tested,” Dr. Kramer said.

Severe flooding and high heat can contribute to the rise in mosquito populations and many parts of the country have seen plenty of both.

One of the ways scientists track infected mosquito patterns in California is by using flocks of strategically placed sentinel chickens.

“Chickens are a mosquito magnet,” Dr. Kramer said.

Chickens don’t get sick with the virus, but they do build antibodies to it. Surveillance teams check their blood every other week to track the virus.

Daniel Pastula, MD, MHS, chief of neuroinfectious diseases and global neurology at the University of Colorado School of Medicine and the Colorado School of Public Health, said the state is watching troubling signs as well.

“The concern this year,” Dr. Pastula said, “particularly along the Front Range in Colorado, is we’ve found many more mosquitoes [that are] positive for West Nile earlier in the season compared with other years.

“We’re bracing for higher-than-baseline human cases,” he said.

Asked about this year’s first human case, reported in Toronto, a region with a long winter and low incidence of the virus, he said that provides a further example that people need to be prepared even in climates not known to be mosquito-dense.

He added, however, that climate is only one factor in the severity of the season. Others include birds’ immunity and migratory patterns.

Dr. Pastula said that fluctuations in temperature and rainfall are rising with climate change and are disrupting normal baseline levels of West Nile.

“That shows we need to be prepared for West Nile virus and other mosquito-borne diseases in any place in North America or really the world. We recently saw malaria cases in the southern United States. It just shows you how dangerous mosquitoes can be.”
 

Avoid mosquito bites

Dr. Pastula and Dr. Kramer list the precautions people can take to protect themselves from West Nile virus:

• Limit outdoor exposure particularly at dusk and dawn.
• Wear protective clothing.
• Use .
• Repair window screens so mosquitoes cannot fly through.
• Dump and drain standing water on your property and maintain swimming pools.

Dr. Pastula noted that summer is the time human cases start to mount – typically from July and August to the first hard freeze.

“We have been warning people here up and down the Front Range of Colorado to take prevention very seriously,” Dr. Pastula said.

He pointed out that 80% who are infected with West Nile will have no symptoms.

About 20% will have flu-like illness – high fever, body and joint aches, rash, diarrhea, or headaches. Symptoms may last for weeks. About 1% of the time, he said, people can get neuroinvasive West Nile.

Dr. Pastula explained that the virus can infect the covering of the brain and spinal cord causing meningitis with very high fever, severe headaches, stiff neck, and sensitivity to light.

So far this year, there have been 89 neuroinvasive cases reported nationally, according to the CDC.

With West Nile encephalitis, the virus “can infect the brain itself causing altered mental status, movement disorders, or weakness,” Dr. Pastula said.

Sometimes it can infect the gray matter of the spinal cord causing a West Nile virus poliomyelitis, which brings polio-like symptoms.

“The West Nile encephalitis and poliomyelitis can cause permanent deficits or even death,” he said. “It’s uncommon but it’s not trivial.”

Several vaccine candidates are in development, Dr. Pastula said, but none has reached clinical trials. Part of the reason for that, he said, is that scientists must be able to predict the timing of an outbreak.

“We’re not really great at predicting outbreaks,” he said.

Although the risk for neuroinvasive disease is small, it can be higher in certain groups, he said – those who are over age 60 years or are immunocompromised; those who have diabetes, cancer, or kidney disease; or those who have undergone organ transplants.

Those infected should see a health care professional and may be able to get relief with the usual medications for flu-like illness.

Some with severe infection may need to go to the hospital, Dr. Pastula said.
 

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

Several signs are pointing to an impending surge in the number of human cases of West Nile virus in several regions of the United States.

West Nile virus is spread by infected mosquitoes and currently there is no cure or virus-specific treatment. In rare cases, it can be deadly. It can infect humans, birds, horses, and other mammals.

West Nile Virus is the leading cause of mosquito-borne disease in the continental United States. As of Aug. 8, 126 human cases had been identified across 22 states, according to the Centers for Disease Control and Prevention.

“Particularly here in California, it’s peak risk right now,” said Vicki Kramer, PhD, chief of vector-borne diseases in the California Department of Public Health. She said scientists there are seeing higher mosquito and infected mosquito numbers.
 

“Peak risk right now”

Dead birds are tested for the virus and by Aug. 4, 181 of the 913 birds tested in California have been positive, three times the total testing positive by this time in 2022.

“Last year at this time, we had 60 positive dead birds out of 817 tested,” Dr. Kramer said.

Severe flooding and high heat can contribute to the rise in mosquito populations and many parts of the country have seen plenty of both.

One of the ways scientists track infected mosquito patterns in California is by using flocks of strategically placed sentinel chickens.

“Chickens are a mosquito magnet,” Dr. Kramer said.

Chickens don’t get sick with the virus, but they do build antibodies to it. Surveillance teams check their blood every other week to track the virus.

Daniel Pastula, MD, MHS, chief of neuroinfectious diseases and global neurology at the University of Colorado School of Medicine and the Colorado School of Public Health, said the state is watching troubling signs as well.

“The concern this year,” Dr. Pastula said, “particularly along the Front Range in Colorado, is we’ve found many more mosquitoes [that are] positive for West Nile earlier in the season compared with other years.

“We’re bracing for higher-than-baseline human cases,” he said.

Asked about this year’s first human case, reported in Toronto, a region with a long winter and low incidence of the virus, he said that provides a further example that people need to be prepared even in climates not known to be mosquito-dense.

He added, however, that climate is only one factor in the severity of the season. Others include birds’ immunity and migratory patterns.

Dr. Pastula said that fluctuations in temperature and rainfall are rising with climate change and are disrupting normal baseline levels of West Nile.

“That shows we need to be prepared for West Nile virus and other mosquito-borne diseases in any place in North America or really the world. We recently saw malaria cases in the southern United States. It just shows you how dangerous mosquitoes can be.”
 

Avoid mosquito bites

Dr. Pastula and Dr. Kramer list the precautions people can take to protect themselves from West Nile virus:

• Limit outdoor exposure particularly at dusk and dawn.
• Wear protective clothing.
• Use .
• Repair window screens so mosquitoes cannot fly through.
• Dump and drain standing water on your property and maintain swimming pools.

Dr. Pastula noted that summer is the time human cases start to mount – typically from July and August to the first hard freeze.

“We have been warning people here up and down the Front Range of Colorado to take prevention very seriously,” Dr. Pastula said.

He pointed out that 80% who are infected with West Nile will have no symptoms.

About 20% will have flu-like illness – high fever, body and joint aches, rash, diarrhea, or headaches. Symptoms may last for weeks. About 1% of the time, he said, people can get neuroinvasive West Nile.

Dr. Pastula explained that the virus can infect the covering of the brain and spinal cord causing meningitis with very high fever, severe headaches, stiff neck, and sensitivity to light.

So far this year, there have been 89 neuroinvasive cases reported nationally, according to the CDC.

With West Nile encephalitis, the virus “can infect the brain itself causing altered mental status, movement disorders, or weakness,” Dr. Pastula said.

Sometimes it can infect the gray matter of the spinal cord causing a West Nile virus poliomyelitis, which brings polio-like symptoms.

“The West Nile encephalitis and poliomyelitis can cause permanent deficits or even death,” he said. “It’s uncommon but it’s not trivial.”

Several vaccine candidates are in development, Dr. Pastula said, but none has reached clinical trials. Part of the reason for that, he said, is that scientists must be able to predict the timing of an outbreak.

“We’re not really great at predicting outbreaks,” he said.

Although the risk for neuroinvasive disease is small, it can be higher in certain groups, he said – those who are over age 60 years or are immunocompromised; those who have diabetes, cancer, or kidney disease; or those who have undergone organ transplants.

Those infected should see a health care professional and may be able to get relief with the usual medications for flu-like illness.

Some with severe infection may need to go to the hospital, Dr. Pastula said.
 

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

Four themes in responses to a survey describe the multilevel barriers that make it difficult for primary care teams to incorporate medication for opioid use disorder (MOUD) in their practices, according to research published in JAMA Network Open.

Elizabeth J. Austin, PhD, MPH, with the department of health systems and population health at the University of Washington, Seattle, and colleagues describe the four major themes in the answers:

• Structural barriers delay or limit primary care team responsiveness to patients needing opioid-related care.
• Patient engagement was more challenging than expected.
• Prescribing physicians needed tools and to be able to see the patients on an ongoing basis.
• Teams had conflicting views on expanding MOUD care.

The survey

The researchers used a cohort of 12 clinics diverse in geography and structure and explored the experiences multidisciplinary primary care teams had in expanding MOUD services, such as use of buprenorphine and naltrexone.

A sample of 62 team members completed the survey for a response rate of 77%. Two-thirds (66%) identified as female and 46 (74%) identified as White. Evaluation of responses occurred between 2020 and 2022 in a sample of primary care clinics that agreed to participate in the Collaborating to Heal Addiction and Mental Health in Primary Care (CHAMP) study. The trial is ongoing.
 

Rigid scheduling a barrier

Some respondents said inflexible scheduling tied their hands.

One clinician responded, “[M]y practice has been really busy right now ... it’s been tough to find openings for my current patients as it is.”

Others described closed or limited patient panels, often set by their health systems. Twenty clinicians (32%) said they were worried their clinic couldn’t accommodate the volume of patients seeking OUD treatment.

Some reported productivity pressure from their health systems to keep the schedule full, which doesn’t allow for walk-in patients needing MOUD.
 

Frustration with no-shows

Some responses indicated frustration in locating patients and with no-shows.

One responded, “[W]e can’t find these people for months and months. [...] I’m spending 3 weeks, 4 weeks, trying to get them in.” Another said, “[I]t’s frustrating when patients don’t show up when they have been referred.”

Margret Chang, MD, a primary care doctor at Tri-River Family Health Center of Worcester, Mass., who was not part of the study, said the four categories the authors describe ring true.
 

Stigma for providers and patients

Dr. Chang said the biggest overarching part of those barriers comes down to stigma, but she says it’s not just a problem for patients, but for providers as well.

In fact, a responder in the Austin et al. survey wrote, “Our faculty group as a whole has expressed that that’s not the direction they want for our clinic; we already provide more psychiatric care and addiction medicine than other clinics, but we can’t be like the addiction medicine clinic in town either.”

Dr. Chang’s clinic, on the other hand, recruits addicted patients to their primary care practice by making a local drug court, addiction-support services in the community, and their colleagues in the UMass Health System aware that their services are available. Patients also refer their friends to the clinic and the clinic has a steady influx.

“I honestly feel that primary care is the discipline that really should be involved in substance disorder treatment,” says Dr. Chang, who is an assistant professor of medicine and the addiction curriculum director for internal medicine at UMass Chan Medical School, Worcester. “In medicine there’s a huge stigma around even being able to help these patients even though we have medications that are pretty effective.”

She runs a medication-assisted treatment program and said her semirural clinic and one other are the only two primary care clinics in the Worcester area with such a program.

Patients also have “huge inertia around taking a medication to recover from addiction or substance abuse,” she says.
 

Confidence lacking in treating patients

Dr. Chang said primary care residents in recent years are coming out of medical school with knowledge about treating OUD, but they often run into more experienced physicians who didn’t get training in the treatment so they feel intimidated about initiating the treatment.

At their clinic, Dr. Chang says, they have a nurse dedicated to OUD, which helps alleviate some of the barriers described in the survey. Patients know they can contact a particular person at the clinic who is dedicated to their needs. The nurse can track down patients who may miss appointments or be hard to locate so physicians don’t have to add that to their workload. They can collect fluid samples and connect patients to services.

Dr. Chang says a nurse might say, “I see we had you on (buprenorphine-naloxone) for opioid use disorder but I see you also have cocaine in your urine. How can we keep you safe?”

Having a health team member, whether a nurse or medical assistant or social worker, designated to help with people who need OUD treatment really makes a difference, she says.

People living with addiction “have a lot of needs,” she says, “and they are hard to address in the typical template a primary care provider might have.”

Family medicine, she says, has been more open to adding support staff for this population than other specialties.

Coauthor Andrew J. Saxon, MD, reported grants from the National Institute of Mental Health (NIMH) during the conduct of the study as well as personal fees from Indivior and royalties from UpToDate outside the submitted work. Coauthor John C. Fortney, PhD, reported grants from the Patient-Centered Outcomes Research Institute during the conduct of the study. Coauthor Anna D. Ratzliff, MD, PhD, reported grants from the University of Washington during the conduct of the study and royalties from Wiley outside the submitted work. No other disclosures were reported.

This story was updated on 8/15/2023.

Four themes in responses to a survey describe the multilevel barriers that make it difficult for primary care teams to incorporate medication for opioid use disorder (MOUD) in their practices, according to research published in JAMA Network Open.

Elizabeth J. Austin, PhD, MPH, with the department of health systems and population health at the University of Washington, Seattle, and colleagues describe the four major themes in the answers:

• Structural barriers delay or limit primary care team responsiveness to patients needing opioid-related care.
• Patient engagement was more challenging than expected.
• Prescribing physicians needed tools and to be able to see the patients on an ongoing basis.
• Teams had conflicting views on expanding MOUD care.

The survey

The researchers used a cohort of 12 clinics diverse in geography and structure and explored the experiences multidisciplinary primary care teams had in expanding MOUD services, such as use of buprenorphine and naltrexone.

A sample of 62 team members completed the survey for a response rate of 77%. Two-thirds (66%) identified as female and 46 (74%) identified as White. Evaluation of responses occurred between 2020 and 2022 in a sample of primary care clinics that agreed to participate in the Collaborating to Heal Addiction and Mental Health in Primary Care (CHAMP) study. The trial is ongoing.
 

Rigid scheduling a barrier

Some respondents said inflexible scheduling tied their hands.

One clinician responded, “[M]y practice has been really busy right now ... it’s been tough to find openings for my current patients as it is.”

Others described closed or limited patient panels, often set by their health systems. Twenty clinicians (32%) said they were worried their clinic couldn’t accommodate the volume of patients seeking OUD treatment.

Some reported productivity pressure from their health systems to keep the schedule full, which doesn’t allow for walk-in patients needing MOUD.
 

Frustration with no-shows

Some responses indicated frustration in locating patients and with no-shows.

One responded, “[W]e can’t find these people for months and months. [...] I’m spending 3 weeks, 4 weeks, trying to get them in.” Another said, “[I]t’s frustrating when patients don’t show up when they have been referred.”

Margret Chang, MD, a primary care doctor at Tri-River Family Health Center of Worcester, Mass., who was not part of the study, said the four categories the authors describe ring true.
 

Stigma for providers and patients

Dr. Chang said the biggest overarching part of those barriers comes down to stigma, but she says it’s not just a problem for patients, but for providers as well.

In fact, a responder in the Austin et al. survey wrote, “Our faculty group as a whole has expressed that that’s not the direction they want for our clinic; we already provide more psychiatric care and addiction medicine than other clinics, but we can’t be like the addiction medicine clinic in town either.”

Dr. Chang’s clinic, on the other hand, recruits addicted patients to their primary care practice by making a local drug court, addiction-support services in the community, and their colleagues in the UMass Health System aware that their services are available. Patients also refer their friends to the clinic and the clinic has a steady influx.

“I honestly feel that primary care is the discipline that really should be involved in substance disorder treatment,” says Dr. Chang, who is an assistant professor of medicine and the addiction curriculum director for internal medicine at UMass Chan Medical School, Worcester. “In medicine there’s a huge stigma around even being able to help these patients even though we have medications that are pretty effective.”

She runs a medication-assisted treatment program and said her semirural clinic and one other are the only two primary care clinics in the Worcester area with such a program.

Patients also have “huge inertia around taking a medication to recover from addiction or substance abuse,” she says.
 

Confidence lacking in treating patients

Dr. Chang said primary care residents in recent years are coming out of medical school with knowledge about treating OUD, but they often run into more experienced physicians who didn’t get training in the treatment so they feel intimidated about initiating the treatment.

At their clinic, Dr. Chang says, they have a nurse dedicated to OUD, which helps alleviate some of the barriers described in the survey. Patients know they can contact a particular person at the clinic who is dedicated to their needs. The nurse can track down patients who may miss appointments or be hard to locate so physicians don’t have to add that to their workload. They can collect fluid samples and connect patients to services.

Dr. Chang says a nurse might say, “I see we had you on (buprenorphine-naloxone) for opioid use disorder but I see you also have cocaine in your urine. How can we keep you safe?”

Having a health team member, whether a nurse or medical assistant or social worker, designated to help with people who need OUD treatment really makes a difference, she says.

People living with addiction “have a lot of needs,” she says, “and they are hard to address in the typical template a primary care provider might have.”

Family medicine, she says, has been more open to adding support staff for this population than other specialties.

Coauthor Andrew J. Saxon, MD, reported grants from the National Institute of Mental Health (NIMH) during the conduct of the study as well as personal fees from Indivior and royalties from UpToDate outside the submitted work. Coauthor John C. Fortney, PhD, reported grants from the Patient-Centered Outcomes Research Institute during the conduct of the study. Coauthor Anna D. Ratzliff, MD, PhD, reported grants from the University of Washington during the conduct of the study and royalties from Wiley outside the submitted work. No other disclosures were reported.

This story was updated on 8/15/2023.

Four themes in responses to a survey describe the multilevel barriers that make it difficult for primary care teams to incorporate medication for opioid use disorder (MOUD) in their practices, according to research published in JAMA Network Open.

Elizabeth J. Austin, PhD, MPH, with the department of health systems and population health at the University of Washington, Seattle, and colleagues describe the four major themes in the answers:

• Structural barriers delay or limit primary care team responsiveness to patients needing opioid-related care.
• Patient engagement was more challenging than expected.
• Prescribing physicians needed tools and to be able to see the patients on an ongoing basis.
• Teams had conflicting views on expanding MOUD care.

The survey

The researchers used a cohort of 12 clinics diverse in geography and structure and explored the experiences multidisciplinary primary care teams had in expanding MOUD services, such as use of buprenorphine and naltrexone.

A sample of 62 team members completed the survey for a response rate of 77%. Two-thirds (66%) identified as female and 46 (74%) identified as White. Evaluation of responses occurred between 2020 and 2022 in a sample of primary care clinics that agreed to participate in the Collaborating to Heal Addiction and Mental Health in Primary Care (CHAMP) study. The trial is ongoing.
 

Rigid scheduling a barrier

Some respondents said inflexible scheduling tied their hands.

One clinician responded, “[M]y practice has been really busy right now ... it’s been tough to find openings for my current patients as it is.”

Others described closed or limited patient panels, often set by their health systems. Twenty clinicians (32%) said they were worried their clinic couldn’t accommodate the volume of patients seeking OUD treatment.

Some reported productivity pressure from their health systems to keep the schedule full, which doesn’t allow for walk-in patients needing MOUD.
 

Frustration with no-shows

Some responses indicated frustration in locating patients and with no-shows.

One responded, “[W]e can’t find these people for months and months. [...] I’m spending 3 weeks, 4 weeks, trying to get them in.” Another said, “[I]t’s frustrating when patients don’t show up when they have been referred.”

Margret Chang, MD, a primary care doctor at Tri-River Family Health Center of Worcester, Mass., who was not part of the study, said the four categories the authors describe ring true.
 

Stigma for providers and patients

Dr. Chang said the biggest overarching part of those barriers comes down to stigma, but she says it’s not just a problem for patients, but for providers as well.

In fact, a responder in the Austin et al. survey wrote, “Our faculty group as a whole has expressed that that’s not the direction they want for our clinic; we already provide more psychiatric care and addiction medicine than other clinics, but we can’t be like the addiction medicine clinic in town either.”

Dr. Chang’s clinic, on the other hand, recruits addicted patients to their primary care practice by making a local drug court, addiction-support services in the community, and their colleagues in the UMass Health System aware that their services are available. Patients also refer their friends to the clinic and the clinic has a steady influx.

“I honestly feel that primary care is the discipline that really should be involved in substance disorder treatment,” says Dr. Chang, who is an assistant professor of medicine and the addiction curriculum director for internal medicine at UMass Chan Medical School, Worcester. “In medicine there’s a huge stigma around even being able to help these patients even though we have medications that are pretty effective.”

She runs a medication-assisted treatment program and said her semirural clinic and one other are the only two primary care clinics in the Worcester area with such a program.

Patients also have “huge inertia around taking a medication to recover from addiction or substance abuse,” she says.
 

Confidence lacking in treating patients

Dr. Chang said primary care residents in recent years are coming out of medical school with knowledge about treating OUD, but they often run into more experienced physicians who didn’t get training in the treatment so they feel intimidated about initiating the treatment.

At their clinic, Dr. Chang says, they have a nurse dedicated to OUD, which helps alleviate some of the barriers described in the survey. Patients know they can contact a particular person at the clinic who is dedicated to their needs. The nurse can track down patients who may miss appointments or be hard to locate so physicians don’t have to add that to their workload. They can collect fluid samples and connect patients to services.

Dr. Chang says a nurse might say, “I see we had you on (buprenorphine-naloxone) for opioid use disorder but I see you also have cocaine in your urine. How can we keep you safe?”

Having a health team member, whether a nurse or medical assistant or social worker, designated to help with people who need OUD treatment really makes a difference, she says.

People living with addiction “have a lot of needs,” she says, “and they are hard to address in the typical template a primary care provider might have.”

Family medicine, she says, has been more open to adding support staff for this population than other specialties.

Coauthor Andrew J. Saxon, MD, reported grants from the National Institute of Mental Health (NIMH) during the conduct of the study as well as personal fees from Indivior and royalties from UpToDate outside the submitted work. Coauthor John C. Fortney, PhD, reported grants from the Patient-Centered Outcomes Research Institute during the conduct of the study. Coauthor Anna D. Ratzliff, MD, PhD, reported grants from the University of Washington during the conduct of the study and royalties from Wiley outside the submitted work. No other disclosures were reported.

This story was updated on 8/15/2023.

Consuming a higher percentage of calories from added sugars is linked with a higher prevalence of kidney stones, new research suggests.

Though added sugars have been linked with multiple poor health outcomes, their link with kidney stones has been unclear.

Added sugars are sugars or caloric sweeteners added to foods or drinks during processing or preparation to add flavor or shelf life. They do not include natural sugars such as lactose in milk and fructose in fruits.

Researchers, led by Shan Yin, a urologist at Affiliated Hospital of North Sichuan Medical College, in Nanchong, China, compared the added-sugar intake by quartiles in the U.S. National Health and Nutrition Examination Survey 2007-2018.

A total of 28,303 adults were included in this study, with an average age of 48. Women who consumed less than 600 or more than 3,500 kcal or men who consumed less than 800 or more than 4,200 kcal were excluded.

Researchers adjusted for factors including age, race, education, income, physical activity, and marital, employment, and smoking status.

Compared with the first quartile of percentage added-sugar calorie intake, the population in the fourth quartile, with the highest added sugar intake, had a higher prevalence of kidney stones (odds ratio, 1.39; 95% confidence interval, 1.17-1.65).

Compared with the group with fewer than 5% of calories from added sugar, the group that consumed at least 25% of calories from added sugar had nearly twice the prevalence of kidney stones (OR, 1.88; 95% CI, 1.52-2.32).

Findings were published online in Frontiers in Nutrition.

“By identifying this association, policymakers and health professionals can emphasize the need for public health initiatives to reduce added sugar consumption and promote healthy dietary habits,” the authors write.
 

Added sugar in the U.S. diet

Sugar-sweetened beverages such as soft drinks and energy and sports drinks account for 34.4% of added sugars in the American diet. Previous studies have shown the relationship between consuming sugar-sweetened beverages and a higher risk of obesity, diabetes, and cardiovascular disease, diseases that often co-occur with kidney stones.

Researchers note that even though most added sugars in the United States come from sugar-sweetened beverages, it’s unclear whether the association between added sugars and kidney stones is caused by the beverages or other sources. For instance, fructose intake has been found to be independently associated with kidney stones.

How much is too much?

The recommended upper limit on added sugar is controversial and varies widely by health organization. The American Heart Association says daily average intake from added sugars should be no more than 150 kcal for adult males (about 9 teaspoons) and no more than 100 kcal for women (about 6 teaspoons). The Institute of Medicine allows up to 25% of calories to be consumed from added sugars. The 2020 Dietary Guidelines for Americans and World Health Organization set 10% of calories as the recommended upper limit.

Further investigating what causes kidney stones is critical as kidney stones are common worldwide, affecting about 1 in 10 people in the United States alone, and occurrence is increasing. Kidney stones have a high recurrence rate – about half of people who get them have a second episode within 10 years, the authors note.

The researchers acknowledge that because participants self-reported food intake, there is the potential for recall bias. Additionally, because of the cross-sectional design, the researchers were not able to determine whether sugar intake or kidney stone occurrence came first.

This work was supported by the Doctoral Fund Project of North Sichuan Medical College. The authors declare no relevant financial relationships.

Consuming a higher percentage of calories from added sugars is linked with a higher prevalence of kidney stones, new research suggests.

Though added sugars have been linked with multiple poor health outcomes, their link with kidney stones has been unclear.

Added sugars are sugars or caloric sweeteners added to foods or drinks during processing or preparation to add flavor or shelf life. They do not include natural sugars such as lactose in milk and fructose in fruits.

Researchers, led by Shan Yin, a urologist at Affiliated Hospital of North Sichuan Medical College, in Nanchong, China, compared the added-sugar intake by quartiles in the U.S. National Health and Nutrition Examination Survey 2007-2018.

A total of 28,303 adults were included in this study, with an average age of 48. Women who consumed less than 600 or more than 3,500 kcal or men who consumed less than 800 or more than 4,200 kcal were excluded.

Researchers adjusted for factors including age, race, education, income, physical activity, and marital, employment, and smoking status.

Compared with the first quartile of percentage added-sugar calorie intake, the population in the fourth quartile, with the highest added sugar intake, had a higher prevalence of kidney stones (odds ratio, 1.39; 95% confidence interval, 1.17-1.65).

Compared with the group with fewer than 5% of calories from added sugar, the group that consumed at least 25% of calories from added sugar had nearly twice the prevalence of kidney stones (OR, 1.88; 95% CI, 1.52-2.32).

Findings were published online in Frontiers in Nutrition.

“By identifying this association, policymakers and health professionals can emphasize the need for public health initiatives to reduce added sugar consumption and promote healthy dietary habits,” the authors write.
 

Added sugar in the U.S. diet

Sugar-sweetened beverages such as soft drinks and energy and sports drinks account for 34.4% of added sugars in the American diet. Previous studies have shown the relationship between consuming sugar-sweetened beverages and a higher risk of obesity, diabetes, and cardiovascular disease, diseases that often co-occur with kidney stones.

Researchers note that even though most added sugars in the United States come from sugar-sweetened beverages, it’s unclear whether the association between added sugars and kidney stones is caused by the beverages or other sources. For instance, fructose intake has been found to be independently associated with kidney stones.

How much is too much?

The recommended upper limit on added sugar is controversial and varies widely by health organization. The American Heart Association says daily average intake from added sugars should be no more than 150 kcal for adult males (about 9 teaspoons) and no more than 100 kcal for women (about 6 teaspoons). The Institute of Medicine allows up to 25% of calories to be consumed from added sugars. The 2020 Dietary Guidelines for Americans and World Health Organization set 10% of calories as the recommended upper limit.

Further investigating what causes kidney stones is critical as kidney stones are common worldwide, affecting about 1 in 10 people in the United States alone, and occurrence is increasing. Kidney stones have a high recurrence rate – about half of people who get them have a second episode within 10 years, the authors note.

The researchers acknowledge that because participants self-reported food intake, there is the potential for recall bias. Additionally, because of the cross-sectional design, the researchers were not able to determine whether sugar intake or kidney stone occurrence came first.

This work was supported by the Doctoral Fund Project of North Sichuan Medical College. The authors declare no relevant financial relationships.

Consuming a higher percentage of calories from added sugars is linked with a higher prevalence of kidney stones, new research suggests.

Though added sugars have been linked with multiple poor health outcomes, their link with kidney stones has been unclear.

Added sugars are sugars or caloric sweeteners added to foods or drinks during processing or preparation to add flavor or shelf life. They do not include natural sugars such as lactose in milk and fructose in fruits.

Researchers, led by Shan Yin, a urologist at Affiliated Hospital of North Sichuan Medical College, in Nanchong, China, compared the added-sugar intake by quartiles in the U.S. National Health and Nutrition Examination Survey 2007-2018.

A total of 28,303 adults were included in this study, with an average age of 48. Women who consumed less than 600 or more than 3,500 kcal or men who consumed less than 800 or more than 4,200 kcal were excluded.

Researchers adjusted for factors including age, race, education, income, physical activity, and marital, employment, and smoking status.

Compared with the first quartile of percentage added-sugar calorie intake, the population in the fourth quartile, with the highest added sugar intake, had a higher prevalence of kidney stones (odds ratio, 1.39; 95% confidence interval, 1.17-1.65).

Compared with the group with fewer than 5% of calories from added sugar, the group that consumed at least 25% of calories from added sugar had nearly twice the prevalence of kidney stones (OR, 1.88; 95% CI, 1.52-2.32).

Findings were published online in Frontiers in Nutrition.

“By identifying this association, policymakers and health professionals can emphasize the need for public health initiatives to reduce added sugar consumption and promote healthy dietary habits,” the authors write.
 

Added sugar in the U.S. diet

Sugar-sweetened beverages such as soft drinks and energy and sports drinks account for 34.4% of added sugars in the American diet. Previous studies have shown the relationship between consuming sugar-sweetened beverages and a higher risk of obesity, diabetes, and cardiovascular disease, diseases that often co-occur with kidney stones.

Researchers note that even though most added sugars in the United States come from sugar-sweetened beverages, it’s unclear whether the association between added sugars and kidney stones is caused by the beverages or other sources. For instance, fructose intake has been found to be independently associated with kidney stones.

How much is too much?

The recommended upper limit on added sugar is controversial and varies widely by health organization. The American Heart Association says daily average intake from added sugars should be no more than 150 kcal for adult males (about 9 teaspoons) and no more than 100 kcal for women (about 6 teaspoons). The Institute of Medicine allows up to 25% of calories to be consumed from added sugars. The 2020 Dietary Guidelines for Americans and World Health Organization set 10% of calories as the recommended upper limit.

Further investigating what causes kidney stones is critical as kidney stones are common worldwide, affecting about 1 in 10 people in the United States alone, and occurrence is increasing. Kidney stones have a high recurrence rate – about half of people who get them have a second episode within 10 years, the authors note.

The researchers acknowledge that because participants self-reported food intake, there is the potential for recall bias. Additionally, because of the cross-sectional design, the researchers were not able to determine whether sugar intake or kidney stone occurrence came first.

This work was supported by the Doctoral Fund Project of North Sichuan Medical College. The authors declare no relevant financial relationships.

Family physicians receive less private insurer reimbursement for the human papillomavirus (HPV) vaccine than do pediatricians, according to a new analysis in Family Medicine.

HPV is the most expensive of all routine pediatric vaccines and the reimbursement by third-party payers varies widely. The concerns about HPV reimbursement often appear on clinician surveys.

This study, led by Yenan Zhu, PhD, who was with the department of public health sciences, college of medicine, Medical University of South Carolina, Charleston, at the time of the research, found that, on average, pediatricians received higher reimbursement ($216.07) for HPV vaccine cost when compared with family physicians ($211.33), internists ($212.97), nurse practitioners ($212.91), and “other” clinicians who administer the vaccine ($213.29) (P values for all comparisons were < .001).

The final sample for this study included 34,247 clinicians.

The net return from vaccine cost reimbursements was lowest for family physicians ($0.34 per HPV vaccine dose administered) and highest for pediatricians ($5.08 per HPV vaccine dose administered).

“Adequate cost reimbursement by third-party payers is a critical enabling factor for clinicians to continue offering vaccines,” the authors wrote.

The authors concluded that “reimbursement for HPV vaccine costs by private payers is adequate; however, return margins are small for nonpediatric specialties.”
 

CDC, AAP differ in recommendations

In the United States, private insurers use the Centers for Disease Control and Prevention vaccine list price as a benchmark.

Overall in this study, HPV vaccine cost reimbursement by private payers was at or above the CDC list price of $210.99 but below the American Academy of Pediatrics recommendations ($263.74). 

The study found that every $1 increment in return was associated with an increase in HPV vaccine doses administered. That was highest for family physicians at 0.08% per dollar.

The modeling showed that changing the HPV vaccine reimbursement to the AAP-recommended level could translate to “an estimated 18,643 additional HPV vaccine doses administrated by pediatricians, 4,041 additional doses by family physicians, and 433 doses by ‘other’ specialties in 2017-2018.”

The authors noted that U.S. vaccination coverage has improved in recent years but initiation and completion rates are lower among privately insured adolescents (4.6% lower for initiation and 2.0% points lower for completion in 2021), compared with adolescents covered under public insurance.

Why the difference among specialties?

Variation in reimbursements might be tied to the ability to negotiate reimbursements for adolescent vaccines, the authors said.

“For instance, pediatricians may be able to negotiate higher cost reimbursement, compared with nonpediatric specialties, given that adolescents constitute a large fraction of their patient volume,” they wrote.

Dr. Zhu and colleagues wrote that it should be noted that HPV vaccine cost reimbursement to family practitioners was considerably less than other specialties and they are barely breaking even though they have the second-highest volume of HPV vaccinations (after pediatricians).

The authors acknowledged that it may not be possible to raise reimbursement to the AAP level, but added that “a reasonable increase that can cover direct and indirect expenses (acquisition cost, storage cost, personnel cost for monitoring inventory, insurance, waste, and lost opportunity costs) will reduce the financial strain on nonpediatric clinicians.” That may encourage clinicians to stock and offer the vaccine.
 

Limitations

The researchers acknowledged several limitations. The models did not account for factors such as vaccination bundling, physicians’ recommendation style or differences in knowledge of the vaccination schedule.

The models were also not able to adjust for whether a clinic had reminder prompts in the electronic health records, the overhead costs of vaccines, or vaccine knowledge or hesitancy on the part of the adolescents’ parents.

Additionally, they used data from one private payer, which limits generalizability.

Researchers identified a sample of adolescents eligible for the HPV vaccine (9-14 years old) enrolled in a large private health insurance plan during 2017-2018. Data from states with universal or universal select vaccine purchasing were excluded. These states included Alaska, Hawaii, Idaho, Maine, Massachusetts, South Dakota, New Hampshire, New Mexico, Rhode Island, Vermont, Washington, Wisconsin, and Wyoming.

One coauthor reported receiving a consulting fee from Merck on unrelated projects. Another coauthor has provided consultancy to Value Analytics Labs on unrelated projects. All other authors declared no competing interests.

Family physicians receive less private insurer reimbursement for the human papillomavirus (HPV) vaccine than do pediatricians, according to a new analysis in Family Medicine.

HPV is the most expensive of all routine pediatric vaccines and the reimbursement by third-party payers varies widely. The concerns about HPV reimbursement often appear on clinician surveys.

This study, led by Yenan Zhu, PhD, who was with the department of public health sciences, college of medicine, Medical University of South Carolina, Charleston, at the time of the research, found that, on average, pediatricians received higher reimbursement ($216.07) for HPV vaccine cost when compared with family physicians ($211.33), internists ($212.97), nurse practitioners ($212.91), and “other” clinicians who administer the vaccine ($213.29) (P values for all comparisons were < .001).

The final sample for this study included 34,247 clinicians.

The net return from vaccine cost reimbursements was lowest for family physicians ($0.34 per HPV vaccine dose administered) and highest for pediatricians ($5.08 per HPV vaccine dose administered).

“Adequate cost reimbursement by third-party payers is a critical enabling factor for clinicians to continue offering vaccines,” the authors wrote.

The authors concluded that “reimbursement for HPV vaccine costs by private payers is adequate; however, return margins are small for nonpediatric specialties.”
 

CDC, AAP differ in recommendations

In the United States, private insurers use the Centers for Disease Control and Prevention vaccine list price as a benchmark.

Overall in this study, HPV vaccine cost reimbursement by private payers was at or above the CDC list price of $210.99 but below the American Academy of Pediatrics recommendations ($263.74). 

The study found that every $1 increment in return was associated with an increase in HPV vaccine doses administered. That was highest for family physicians at 0.08% per dollar.

The modeling showed that changing the HPV vaccine reimbursement to the AAP-recommended level could translate to “an estimated 18,643 additional HPV vaccine doses administrated by pediatricians, 4,041 additional doses by family physicians, and 433 doses by ‘other’ specialties in 2017-2018.”

The authors noted that U.S. vaccination coverage has improved in recent years but initiation and completion rates are lower among privately insured adolescents (4.6% lower for initiation and 2.0% points lower for completion in 2021), compared with adolescents covered under public insurance.

Why the difference among specialties?

Variation in reimbursements might be tied to the ability to negotiate reimbursements for adolescent vaccines, the authors said.

“For instance, pediatricians may be able to negotiate higher cost reimbursement, compared with nonpediatric specialties, given that adolescents constitute a large fraction of their patient volume,” they wrote.

Dr. Zhu and colleagues wrote that it should be noted that HPV vaccine cost reimbursement to family practitioners was considerably less than other specialties and they are barely breaking even though they have the second-highest volume of HPV vaccinations (after pediatricians).

The authors acknowledged that it may not be possible to raise reimbursement to the AAP level, but added that “a reasonable increase that can cover direct and indirect expenses (acquisition cost, storage cost, personnel cost for monitoring inventory, insurance, waste, and lost opportunity costs) will reduce the financial strain on nonpediatric clinicians.” That may encourage clinicians to stock and offer the vaccine.
 

Limitations

The researchers acknowledged several limitations. The models did not account for factors such as vaccination bundling, physicians’ recommendation style or differences in knowledge of the vaccination schedule.

The models were also not able to adjust for whether a clinic had reminder prompts in the electronic health records, the overhead costs of vaccines, or vaccine knowledge or hesitancy on the part of the adolescents’ parents.

Additionally, they used data from one private payer, which limits generalizability.

Researchers identified a sample of adolescents eligible for the HPV vaccine (9-14 years old) enrolled in a large private health insurance plan during 2017-2018. Data from states with universal or universal select vaccine purchasing were excluded. These states included Alaska, Hawaii, Idaho, Maine, Massachusetts, South Dakota, New Hampshire, New Mexico, Rhode Island, Vermont, Washington, Wisconsin, and Wyoming.

One coauthor reported receiving a consulting fee from Merck on unrelated projects. Another coauthor has provided consultancy to Value Analytics Labs on unrelated projects. All other authors declared no competing interests.

Family physicians receive less private insurer reimbursement for the human papillomavirus (HPV) vaccine than do pediatricians, according to a new analysis in Family Medicine.

HPV is the most expensive of all routine pediatric vaccines and the reimbursement by third-party payers varies widely. The concerns about HPV reimbursement often appear on clinician surveys.

This study, led by Yenan Zhu, PhD, who was with the department of public health sciences, college of medicine, Medical University of South Carolina, Charleston, at the time of the research, found that, on average, pediatricians received higher reimbursement ($216.07) for HPV vaccine cost when compared with family physicians ($211.33), internists ($212.97), nurse practitioners ($212.91), and “other” clinicians who administer the vaccine ($213.29) (P values for all comparisons were < .001).

The final sample for this study included 34,247 clinicians.

The net return from vaccine cost reimbursements was lowest for family physicians ($0.34 per HPV vaccine dose administered) and highest for pediatricians ($5.08 per HPV vaccine dose administered).

“Adequate cost reimbursement by third-party payers is a critical enabling factor for clinicians to continue offering vaccines,” the authors wrote.

The authors concluded that “reimbursement for HPV vaccine costs by private payers is adequate; however, return margins are small for nonpediatric specialties.”
 

CDC, AAP differ in recommendations

In the United States, private insurers use the Centers for Disease Control and Prevention vaccine list price as a benchmark.

Overall in this study, HPV vaccine cost reimbursement by private payers was at or above the CDC list price of $210.99 but below the American Academy of Pediatrics recommendations ($263.74). 

The study found that every $1 increment in return was associated with an increase in HPV vaccine doses administered. That was highest for family physicians at 0.08% per dollar.

The modeling showed that changing the HPV vaccine reimbursement to the AAP-recommended level could translate to “an estimated 18,643 additional HPV vaccine doses administrated by pediatricians, 4,041 additional doses by family physicians, and 433 doses by ‘other’ specialties in 2017-2018.”

The authors noted that U.S. vaccination coverage has improved in recent years but initiation and completion rates are lower among privately insured adolescents (4.6% lower for initiation and 2.0% points lower for completion in 2021), compared with adolescents covered under public insurance.

Why the difference among specialties?

Variation in reimbursements might be tied to the ability to negotiate reimbursements for adolescent vaccines, the authors said.

“For instance, pediatricians may be able to negotiate higher cost reimbursement, compared with nonpediatric specialties, given that adolescents constitute a large fraction of their patient volume,” they wrote.

Dr. Zhu and colleagues wrote that it should be noted that HPV vaccine cost reimbursement to family practitioners was considerably less than other specialties and they are barely breaking even though they have the second-highest volume of HPV vaccinations (after pediatricians).

The authors acknowledged that it may not be possible to raise reimbursement to the AAP level, but added that “a reasonable increase that can cover direct and indirect expenses (acquisition cost, storage cost, personnel cost for monitoring inventory, insurance, waste, and lost opportunity costs) will reduce the financial strain on nonpediatric clinicians.” That may encourage clinicians to stock and offer the vaccine.
 

Limitations

The researchers acknowledged several limitations. The models did not account for factors such as vaccination bundling, physicians’ recommendation style or differences in knowledge of the vaccination schedule.

The models were also not able to adjust for whether a clinic had reminder prompts in the electronic health records, the overhead costs of vaccines, or vaccine knowledge or hesitancy on the part of the adolescents’ parents.

Additionally, they used data from one private payer, which limits generalizability.

Researchers identified a sample of adolescents eligible for the HPV vaccine (9-14 years old) enrolled in a large private health insurance plan during 2017-2018. Data from states with universal or universal select vaccine purchasing were excluded. These states included Alaska, Hawaii, Idaho, Maine, Massachusetts, South Dakota, New Hampshire, New Mexico, Rhode Island, Vermont, Washington, Wisconsin, and Wyoming.

One coauthor reported receiving a consulting fee from Merck on unrelated projects. Another coauthor has provided consultancy to Value Analytics Labs on unrelated projects. All other authors declared no competing interests.

Nonalcohol substance use disorder (SUD) was 2.5 times more common in people who had gastric bypass surgery, compared with a control group who received usual obesity care, a new prospective study has found.

The findings suggest that the risk for nonalcohol SUD should be carefully explained to patients getting a gastric bypass and that the risk should be considered in care before and after the surgery, said the study authors and editorialists.

Though alcohol use disorder is a well-known side effect for some bariatric procedures, little is known about the link between the procedures and other substance abuse, wrote the study authors, led by Per-Arne Svensson, PhD, with the department of molecular and clinical medicine, Institute of Medicine, at the University of Gothenburg (Sweden).

The study was published online in Obesity.

The researchers analyzed data from the SOS study. It was originally designed to compare bariatric surgery with usual obesity care, with overall mortality as the primary outcome. The protocol also called for reporting negative effects of included treatments.

The study was conducted throughout Sweden at 25 public surgical departments and 480 primary health centers. Participants were between ages 37 and 60 years and had a body mass index of at least 34 kg/m² for men and 38 for women.

After people with previous nonalcoholic SUD were excluded, the study population included 1,990 patients who had undergone bariatric surgery between September 1987 and January 2001, as well as 2,030 matched controls who received usual obesity care. The three types of bariatric surgery were gastric bypass (264 patients), vertical banded gastroplasty (1,353), and gastric banding (373), as chosen by the surgeons.

The follow-up was nearly 24 years.
 

Link found only with gastric bypass

The researchers identified participants who had nonalcoholic SUDs using the ICD from the Swedish National Patient Register covering hospital treatment (hospital stays or hospital-based outpatient care) but not primary care.

Only gastric bypass was associated with an increased incidence of nonalcoholic SUD (adjusted hazard ratio, 2.54; 95% confidence interval, 1.14-5.65), compared with controls during the follow-up period.

Among those who had gastric bypass surgery, three developed opioid-related disorders; three had sedative-, hypnotic-, or anxiolytic-related disorders; and three had other psychoactive substance–related disorders, the study authors wrote.

The researchers found no statistical difference in the incidence of nonalcoholic SUD when the groups who had undergone different surgical procedures were compared with each other.

“It is important to acknowledge that the number of affected patients was relatively low, in the single digits,” Jihad Kudsi, MD, a bariatric surgeon and chairman of surgery at Duly Health and Care, Oak Brook, Ill., said in a press release.

The findings “highlight the critical role of bariatric behavioral health clinicians in the comprehensive evaluation and care of patients both before and after weight loss surgery,” added Dr. Kudsi, who was not associated with the research.
 

Bariatric surgery candidates should be warned, monitored

The data indicate that patients who are candidates for bariatric surgery should be “carefully warned” about risks for nonalcoholic SUD and be monitored after the procedure, wrote James E. Mitchell, MD, a psychiatrist with the department of psychiatry and behavioral science, University of North Dakota, Fargo, and Devika Umashanker, MD, with Obesity Medicine, Hartford (Conn.) Health Care, in an accompanying editorial.

They acknowledged, however, that monitoring can be difficult given the typical low rate of follow-up of these patients.

Though the reasons for the rise in nonalcoholic SUD are not clear, Dr. Mitchell and Dr. Umashanker said biologic and psychosocial issues may be contributors to the increase.

The persistence of medical comorbidities and a lack of noted improvement in quality of life or physical mobility after the surgery has been addressed in a paper on suicide risk after bariatric surgery, the study authors also noted.

Dr. Svensson said in an interview that a mechanism for alcohol abuse after gastric bypass surgery is more evident, as measured by “increased blood alcohol levels after the surgery for a given amount of alcohol.” However, for other addictive substances, the mechanism is not obvious and needs further study.

The editorialists reminded clinicians that measuring phosphatidylethanol can be very useful in identifying and quantifying recent alcohol intake, suggesting that all clinicians, not just those in bariatric surgery clinics, should be aware of the connection between the procedures and subsequent alcohol abuse and monitor those patients carefully.

Both the study authors and the editorialists pointed out that the SOS cohort was recruited when vertical banded gastroplasty and banding were commonly used, and both methods are now rarely, if ever, used. Gastric sleeve procedures are now the most common approach, and those patients were not included in the study.

“However, gastric bypass surgery patients were included, albeit in a minority of the sample,” Dr. Mitchell and Dr. Umashanker wrote. In addition, the sample size of patients with SUD was too small to determine the drugs that were being abused.

Dr. Svensson said in an interview the main limitation is that SUD events were identified in the Swedish National Patient Register, which misses nonhospitalized patients.

“This register is very complete for hospitals, but it does not include SUD events detected in the primary health care setting,” he said. “Hence, the absolute number of events is probably a clear underestimation. However, it is unlikely that this limitation would affect the study groups (control group vs. groups with different surgical procedures) in different ways and hence the conclusions from this study are most likely valid.”

The study authors and the editorialists reported no relevant financial relationships.

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

Nonalcohol substance use disorder (SUD) was 2.5 times more common in people who had gastric bypass surgery, compared with a control group who received usual obesity care, a new prospective study has found.

The findings suggest that the risk for nonalcohol SUD should be carefully explained to patients getting a gastric bypass and that the risk should be considered in care before and after the surgery, said the study authors and editorialists.

Though alcohol use disorder is a well-known side effect for some bariatric procedures, little is known about the link between the procedures and other substance abuse, wrote the study authors, led by Per-Arne Svensson, PhD, with the department of molecular and clinical medicine, Institute of Medicine, at the University of Gothenburg (Sweden).

The study was published online in Obesity.

The researchers analyzed data from the SOS study. It was originally designed to compare bariatric surgery with usual obesity care, with overall mortality as the primary outcome. The protocol also called for reporting negative effects of included treatments.

The study was conducted throughout Sweden at 25 public surgical departments and 480 primary health centers. Participants were between ages 37 and 60 years and had a body mass index of at least 34 kg/m² for men and 38 for women.

After people with previous nonalcoholic SUD were excluded, the study population included 1,990 patients who had undergone bariatric surgery between September 1987 and January 2001, as well as 2,030 matched controls who received usual obesity care. The three types of bariatric surgery were gastric bypass (264 patients), vertical banded gastroplasty (1,353), and gastric banding (373), as chosen by the surgeons.

The follow-up was nearly 24 years.
 

Link found only with gastric bypass

The researchers identified participants who had nonalcoholic SUDs using the ICD from the Swedish National Patient Register covering hospital treatment (hospital stays or hospital-based outpatient care) but not primary care.

Only gastric bypass was associated with an increased incidence of nonalcoholic SUD (adjusted hazard ratio, 2.54; 95% confidence interval, 1.14-5.65), compared with controls during the follow-up period.

Among those who had gastric bypass surgery, three developed opioid-related disorders; three had sedative-, hypnotic-, or anxiolytic-related disorders; and three had other psychoactive substance–related disorders, the study authors wrote.

The researchers found no statistical difference in the incidence of nonalcoholic SUD when the groups who had undergone different surgical procedures were compared with each other.

“It is important to acknowledge that the number of affected patients was relatively low, in the single digits,” Jihad Kudsi, MD, a bariatric surgeon and chairman of surgery at Duly Health and Care, Oak Brook, Ill., said in a press release.

The findings “highlight the critical role of bariatric behavioral health clinicians in the comprehensive evaluation and care of patients both before and after weight loss surgery,” added Dr. Kudsi, who was not associated with the research.
 

Bariatric surgery candidates should be warned, monitored

The data indicate that patients who are candidates for bariatric surgery should be “carefully warned” about risks for nonalcoholic SUD and be monitored after the procedure, wrote James E. Mitchell, MD, a psychiatrist with the department of psychiatry and behavioral science, University of North Dakota, Fargo, and Devika Umashanker, MD, with Obesity Medicine, Hartford (Conn.) Health Care, in an accompanying editorial.

They acknowledged, however, that monitoring can be difficult given the typical low rate of follow-up of these patients.

Though the reasons for the rise in nonalcoholic SUD are not clear, Dr. Mitchell and Dr. Umashanker said biologic and psychosocial issues may be contributors to the increase.

The persistence of medical comorbidities and a lack of noted improvement in quality of life or physical mobility after the surgery has been addressed in a paper on suicide risk after bariatric surgery, the study authors also noted.

Dr. Svensson said in an interview that a mechanism for alcohol abuse after gastric bypass surgery is more evident, as measured by “increased blood alcohol levels after the surgery for a given amount of alcohol.” However, for other addictive substances, the mechanism is not obvious and needs further study.

The editorialists reminded clinicians that measuring phosphatidylethanol can be very useful in identifying and quantifying recent alcohol intake, suggesting that all clinicians, not just those in bariatric surgery clinics, should be aware of the connection between the procedures and subsequent alcohol abuse and monitor those patients carefully.

Both the study authors and the editorialists pointed out that the SOS cohort was recruited when vertical banded gastroplasty and banding were commonly used, and both methods are now rarely, if ever, used. Gastric sleeve procedures are now the most common approach, and those patients were not included in the study.

“However, gastric bypass surgery patients were included, albeit in a minority of the sample,” Dr. Mitchell and Dr. Umashanker wrote. In addition, the sample size of patients with SUD was too small to determine the drugs that were being abused.

Dr. Svensson said in an interview the main limitation is that SUD events were identified in the Swedish National Patient Register, which misses nonhospitalized patients.

“This register is very complete for hospitals, but it does not include SUD events detected in the primary health care setting,” he said. “Hence, the absolute number of events is probably a clear underestimation. However, it is unlikely that this limitation would affect the study groups (control group vs. groups with different surgical procedures) in different ways and hence the conclusions from this study are most likely valid.”

The study authors and the editorialists reported no relevant financial relationships.

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

Nonalcohol substance use disorder (SUD) was 2.5 times more common in people who had gastric bypass surgery, compared with a control group who received usual obesity care, a new prospective study has found.

The findings suggest that the risk for nonalcohol SUD should be carefully explained to patients getting a gastric bypass and that the risk should be considered in care before and after the surgery, said the study authors and editorialists.

Though alcohol use disorder is a well-known side effect for some bariatric procedures, little is known about the link between the procedures and other substance abuse, wrote the study authors, led by Per-Arne Svensson, PhD, with the department of molecular and clinical medicine, Institute of Medicine, at the University of Gothenburg (Sweden).

The study was published online in Obesity.

The researchers analyzed data from the SOS study. It was originally designed to compare bariatric surgery with usual obesity care, with overall mortality as the primary outcome. The protocol also called for reporting negative effects of included treatments.

The study was conducted throughout Sweden at 25 public surgical departments and 480 primary health centers. Participants were between ages 37 and 60 years and had a body mass index of at least 34 kg/m² for men and 38 for women.

After people with previous nonalcoholic SUD were excluded, the study population included 1,990 patients who had undergone bariatric surgery between September 1987 and January 2001, as well as 2,030 matched controls who received usual obesity care. The three types of bariatric surgery were gastric bypass (264 patients), vertical banded gastroplasty (1,353), and gastric banding (373), as chosen by the surgeons.

The follow-up was nearly 24 years.
 

Link found only with gastric bypass

The researchers identified participants who had nonalcoholic SUDs using the ICD from the Swedish National Patient Register covering hospital treatment (hospital stays or hospital-based outpatient care) but not primary care.

Only gastric bypass was associated with an increased incidence of nonalcoholic SUD (adjusted hazard ratio, 2.54; 95% confidence interval, 1.14-5.65), compared with controls during the follow-up period.

Among those who had gastric bypass surgery, three developed opioid-related disorders; three had sedative-, hypnotic-, or anxiolytic-related disorders; and three had other psychoactive substance–related disorders, the study authors wrote.

The researchers found no statistical difference in the incidence of nonalcoholic SUD when the groups who had undergone different surgical procedures were compared with each other.

“It is important to acknowledge that the number of affected patients was relatively low, in the single digits,” Jihad Kudsi, MD, a bariatric surgeon and chairman of surgery at Duly Health and Care, Oak Brook, Ill., said in a press release.

The findings “highlight the critical role of bariatric behavioral health clinicians in the comprehensive evaluation and care of patients both before and after weight loss surgery,” added Dr. Kudsi, who was not associated with the research.
 

Bariatric surgery candidates should be warned, monitored

The data indicate that patients who are candidates for bariatric surgery should be “carefully warned” about risks for nonalcoholic SUD and be monitored after the procedure, wrote James E. Mitchell, MD, a psychiatrist with the department of psychiatry and behavioral science, University of North Dakota, Fargo, and Devika Umashanker, MD, with Obesity Medicine, Hartford (Conn.) Health Care, in an accompanying editorial.

They acknowledged, however, that monitoring can be difficult given the typical low rate of follow-up of these patients.

Though the reasons for the rise in nonalcoholic SUD are not clear, Dr. Mitchell and Dr. Umashanker said biologic and psychosocial issues may be contributors to the increase.

The persistence of medical comorbidities and a lack of noted improvement in quality of life or physical mobility after the surgery has been addressed in a paper on suicide risk after bariatric surgery, the study authors also noted.

Dr. Svensson said in an interview that a mechanism for alcohol abuse after gastric bypass surgery is more evident, as measured by “increased blood alcohol levels after the surgery for a given amount of alcohol.” However, for other addictive substances, the mechanism is not obvious and needs further study.

The editorialists reminded clinicians that measuring phosphatidylethanol can be very useful in identifying and quantifying recent alcohol intake, suggesting that all clinicians, not just those in bariatric surgery clinics, should be aware of the connection between the procedures and subsequent alcohol abuse and monitor those patients carefully.

Both the study authors and the editorialists pointed out that the SOS cohort was recruited when vertical banded gastroplasty and banding were commonly used, and both methods are now rarely, if ever, used. Gastric sleeve procedures are now the most common approach, and those patients were not included in the study.

“However, gastric bypass surgery patients were included, albeit in a minority of the sample,” Dr. Mitchell and Dr. Umashanker wrote. In addition, the sample size of patients with SUD was too small to determine the drugs that were being abused.

Dr. Svensson said in an interview the main limitation is that SUD events were identified in the Swedish National Patient Register, which misses nonhospitalized patients.

“This register is very complete for hospitals, but it does not include SUD events detected in the primary health care setting,” he said. “Hence, the absolute number of events is probably a clear underestimation. However, it is unlikely that this limitation would affect the study groups (control group vs. groups with different surgical procedures) in different ways and hence the conclusions from this study are most likely valid.”

The study authors and the editorialists reported no relevant financial relationships.

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

The U.S. Food and Drug Administration today cleared an artificial intelligence (AI)-assisted colonoscopy device called the MAGENTIQ-COLO, according to the Israeli-based manufacturer of the same name.

The device helps identify lesions in real time and is associated with a significant increase in the adenoma detection rate (ADR), according to the press release.

The device was cleared under the FDA’s 510(k) process, and follows the European CE Mark and Israel AMAR approval, which were received in mid-2021. It will be available in the United States in the coming weeks.

FDA_icon_web.jpg

In a study performed in 2022 with 29 endoscopy experts and more than 950 patients, the device was validated as “one of the best-performing AI solutions in the category, increasing ADR by 26% relatively (7% in absolute values), which translated into a 21% decrease in colorectal cancer occurrence and a 35% decrease in patient mortality,” according to the press release.

In this multicenter, randomized, controlled trial conducted at 10 hospitals in Europe, the United States, and Israel, and presented at United European Gastroenterology Week 2022, the authors noted that “apart from diminutive lesions, [MAGENTIQ-COLO] increased the detection of 6- to 9-mm adenomas, suggesting that this novel [computer-aided polyp detection] system is also able to detect more clinically relevant lesions.”

The device “takes the video out of the colonoscopy device, breaks it into frames, and analyzes them in real time with its AI engine to detect polyps in them,” Dror Zur, founder and CEO of MAGENTIQ-EYE, explained in an interview. “If a polyp is detected, then MAGENTIQ-COLO signs it with a bounding box on the video’s overlay and sends it as a video with an overlay to the display monitor so the doctor can look at it and find more polyps.”

As previously reported by this news organization, research has shown that conventional colonoscopies miss about a quarter of adenomas. Many AI systems have recently come on the market, promising to improve detection by overcoming human error in detecting polyps.

Colonoscopy has become standard in most developed countries, with 15-20 million procedures performed every year in the United States alone; however, high missed rates and undetected adenomas during the procedures mean that even patients who get regular, recommended screenings are still at risk of developing colon cancer, notes the press release.

“A missed polyp can lead to interval cancer, which accounts for approximately 8%-10% of all CRC in the U.S., translated to over 13,500 cancer cases that could be prevented every year with better detection,” the press release also states.

According to the National Institutes of Health, colorectal cancer is the third leading cause of cancer-related death in the United States.

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

The U.S. Food and Drug Administration today cleared an artificial intelligence (AI)-assisted colonoscopy device called the MAGENTIQ-COLO, according to the Israeli-based manufacturer of the same name.

The device helps identify lesions in real time and is associated with a significant increase in the adenoma detection rate (ADR), according to the press release.

The device was cleared under the FDA’s 510(k) process, and follows the European CE Mark and Israel AMAR approval, which were received in mid-2021. It will be available in the United States in the coming weeks.

FDA_icon_web.jpg

In a study performed in 2022 with 29 endoscopy experts and more than 950 patients, the device was validated as “one of the best-performing AI solutions in the category, increasing ADR by 26% relatively (7% in absolute values), which translated into a 21% decrease in colorectal cancer occurrence and a 35% decrease in patient mortality,” according to the press release.

In this multicenter, randomized, controlled trial conducted at 10 hospitals in Europe, the United States, and Israel, and presented at United European Gastroenterology Week 2022, the authors noted that “apart from diminutive lesions, [MAGENTIQ-COLO] increased the detection of 6- to 9-mm adenomas, suggesting that this novel [computer-aided polyp detection] system is also able to detect more clinically relevant lesions.”

The device “takes the video out of the colonoscopy device, breaks it into frames, and analyzes them in real time with its AI engine to detect polyps in them,” Dror Zur, founder and CEO of MAGENTIQ-EYE, explained in an interview. “If a polyp is detected, then MAGENTIQ-COLO signs it with a bounding box on the video’s overlay and sends it as a video with an overlay to the display monitor so the doctor can look at it and find more polyps.”

As previously reported by this news organization, research has shown that conventional colonoscopies miss about a quarter of adenomas. Many AI systems have recently come on the market, promising to improve detection by overcoming human error in detecting polyps.

Colonoscopy has become standard in most developed countries, with 15-20 million procedures performed every year in the United States alone; however, high missed rates and undetected adenomas during the procedures mean that even patients who get regular, recommended screenings are still at risk of developing colon cancer, notes the press release.

“A missed polyp can lead to interval cancer, which accounts for approximately 8%-10% of all CRC in the U.S., translated to over 13,500 cancer cases that could be prevented every year with better detection,” the press release also states.

According to the National Institutes of Health, colorectal cancer is the third leading cause of cancer-related death in the United States.

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

The U.S. Food and Drug Administration today cleared an artificial intelligence (AI)-assisted colonoscopy device called the MAGENTIQ-COLO, according to the Israeli-based manufacturer of the same name.

The device helps identify lesions in real time and is associated with a significant increase in the adenoma detection rate (ADR), according to the press release.

The device was cleared under the FDA’s 510(k) process, and follows the European CE Mark and Israel AMAR approval, which were received in mid-2021. It will be available in the United States in the coming weeks.

FDA_icon_web.jpg

In a study performed in 2022 with 29 endoscopy experts and more than 950 patients, the device was validated as “one of the best-performing AI solutions in the category, increasing ADR by 26% relatively (7% in absolute values), which translated into a 21% decrease in colorectal cancer occurrence and a 35% decrease in patient mortality,” according to the press release.

In this multicenter, randomized, controlled trial conducted at 10 hospitals in Europe, the United States, and Israel, and presented at United European Gastroenterology Week 2022, the authors noted that “apart from diminutive lesions, [MAGENTIQ-COLO] increased the detection of 6- to 9-mm adenomas, suggesting that this novel [computer-aided polyp detection] system is also able to detect more clinically relevant lesions.”

The device “takes the video out of the colonoscopy device, breaks it into frames, and analyzes them in real time with its AI engine to detect polyps in them,” Dror Zur, founder and CEO of MAGENTIQ-EYE, explained in an interview. “If a polyp is detected, then MAGENTIQ-COLO signs it with a bounding box on the video’s overlay and sends it as a video with an overlay to the display monitor so the doctor can look at it and find more polyps.”

As previously reported by this news organization, research has shown that conventional colonoscopies miss about a quarter of adenomas. Many AI systems have recently come on the market, promising to improve detection by overcoming human error in detecting polyps.

Colonoscopy has become standard in most developed countries, with 15-20 million procedures performed every year in the United States alone; however, high missed rates and undetected adenomas during the procedures mean that even patients who get regular, recommended screenings are still at risk of developing colon cancer, notes the press release.

“A missed polyp can lead to interval cancer, which accounts for approximately 8%-10% of all CRC in the U.S., translated to over 13,500 cancer cases that could be prevented every year with better detection,” the press release also states.

According to the National Institutes of Health, colorectal cancer is the third leading cause of cancer-related death in the United States.

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

At the new Walnut Creek Clinic in the East Bay of the San Francisco Bay area, kids get a “Comfort Promise.”

The clinic extends the work of the Stad Center for Pediatric Pain, Palliative & Integrative Medicine beyond the locations in University of California San Francisco Benioff Children’s Hospitals in San Francisco and Oakland.

At Walnut Creek, clinical acupuncturists, massage therapists, and specialists in hypnosis complement advanced medical care with integrative techniques.

The “Comfort Promise” program, which is being rolled out at that clinic and other UCSF pediatric clinics through the end of 2024, is the clinicians’ pledge to do everything in their power to make tests, infusions, and vaccinations “practically pain free.”

Needle sticks, for example, can be a common source of pain and anxiety for kids. Techniques to minimize pain vary by age. Among the ways the clinicians minimize needle pain for a child 6- to 12-years-old are:

• Giving the child control options to pick which arm; and watch the injection, pause it, or stop it with a communication sign.
• Introducing memory shaping by asking the child about the experience afterward and presenting it in a positive way by praising the acts of sitting still, breathing deeply, or being brave.
• Using distractors such as asking the child to hold a favorite item from home, storytelling, coloring, singing, or using breathing exercises.

Stefan Friedrichsdorf, MD, chief of the UCSF division of pediatric pain, palliative & integrative medicine, said in a statement: “For kids with chronic pain, complex pain medications can cause more harm than benefit. Our goal is to combine exercise and physical therapy with integrative medicine and skills-based psychotherapy to help them become pain free in their everyday life.”
 

Bundling appointments for early impact

At Lurie Children’s Hospital of Chicago, the chronic pain treatment program bundles visits with experts in several disciplines, include social workers, psychologists, and physical therapists, in addition to the medical team, so that patients can complete a first round of visits with multiple specialists in a short period, as opposed to several months.

Natalie Weatherred, APRN-NP, CPNP-PC, a pediatric nurse practitioner in anesthesiology and the pain clinic coordinator, said in an interview that the up-front visits involve between four and eight follow-up sessions in a short period with everybody in the multidisciplinary team “to really help jump-start their pain treatment.”

She pointed out that many families come from distant parts of the state or beyond so the bundled appointments are also important for easing burden on families.

Sarah Duggan, APRN-NP, CPNP-PC, also a pediatric nurse practitioner in anesthesiology at Lurie’s, pointed out that patients at their clinic often have other chronic conditions as well, such as such as postural orthostatic tachycardia syndrome so the care integration is particularly important.

“We can get them the appropriate care that they need and the resources they need, much sooner than we would have been able to do 5 or 10 years ago,” Ms. Duggan said.
 

Virtual reality distraction instead of sedation

Henry Huang, MD, anesthesiologist and pain physician at Texas Children’s Hospital, Houston, said a special team there collaborates with the Chariot Program at Stanford (Calif.) University and incorporates virtual reality to distract children from pain and anxiety and harness their imaginations during induction for anesthesia, intravenous placement, and vaccinations.

“At our institution we’ve been recruiting patients to do a proof of concept to do virtual reality distraction for pain procedures, such as nerve blocks or steroid injections,” Dr. Huang said.

Traditionally, kids would have received oral or intravenous sedation to help them cope with the fear and pain.

“We’ve been successful in several cases without relying on any sedation,” he said. “The next target is to expand that to the chronic pain population.”

The distraction techniques are promising for a wide range of ages, he said, and the programming is tailored to the child’s ability to interact with the technology.

He said he is also part of a group promoting use of ultrasound instead of x-rays to guide injections to the spine and chest to reduce children’s exposure to radiation. His group is helping teach these methods to other clinicians nationally.

Dr. Huang said the most important development in chronic pediatric pain has been the growth of rehab centers that include the medical team, and practitioners from psychology as well as occupational and physical therapy.

“More and more hospitals are recognizing the importance of these pain rehab centers,” he said.

The problem, Dr. Huang said, is that these programs have always been resource intensive and involve highly specialized clinicians. The cost and the limited number of specialists make it difficult for widespread rollout.

“That’s always been the challenge from the pediatric pain world,” he said.
 

Recognizing the complexity of kids’ chronic pain

Angela Garcia, MD, a consulting physician for pediatric rehabilitation medicine at UPMC Children’s Hospital of Pittsburgh said recognizing the validity and complexity of pediatric pain has led to multidisciplinary approaches and specialty clinics for chronic pain instead of primarily pharmaceutical solutions.

Techniques such as biofeedback and acupuncture are becoming more mainstream in pediatric chronic care, she said.

At the UPMC clinic, children and their families talk with a care team about their values and what they want to accomplish in managing the child’s pain. They ask what the pain is preventing the child from doing.

“Their goals really are our goals,” she said.

She said she also refers almost all patients to one of the center’s pain psychologists.

“Pain is biopsychosocial,” she said. “We want to make sure we’re addressing how to cope with pain.”

Dr. Garcia said she hopes nutritional therapy is one of the next approaches the clinic will incorporate, particularly surrounding how dietary changes can reduce inflammation “and heal the body from the inside out.”

She said the hospital is also looking at developing an inpatient pain program for kids whose functioning has changed so drastically that they need more intensive therapies.

Whatever the treatment approach, she said, addressing the pain early is critical.

“There is an increased risk of a child with chronic pain becoming an adult with chronic pain,” Dr. Garcia pointed out, “and that can lead to a decrease in the ability to participate in society.”

Ms. Weatherred, Ms. Duggan, Dr. Huang, and Dr. Garcia reported no relevant financial relationships.

At the new Walnut Creek Clinic in the East Bay of the San Francisco Bay area, kids get a “Comfort Promise.”

The clinic extends the work of the Stad Center for Pediatric Pain, Palliative & Integrative Medicine beyond the locations in University of California San Francisco Benioff Children’s Hospitals in San Francisco and Oakland.

At Walnut Creek, clinical acupuncturists, massage therapists, and specialists in hypnosis complement advanced medical care with integrative techniques.

The “Comfort Promise” program, which is being rolled out at that clinic and other UCSF pediatric clinics through the end of 2024, is the clinicians’ pledge to do everything in their power to make tests, infusions, and vaccinations “practically pain free.”

Needle sticks, for example, can be a common source of pain and anxiety for kids. Techniques to minimize pain vary by age. Among the ways the clinicians minimize needle pain for a child 6- to 12-years-old are:

• Giving the child control options to pick which arm; and watch the injection, pause it, or stop it with a communication sign.
• Introducing memory shaping by asking the child about the experience afterward and presenting it in a positive way by praising the acts of sitting still, breathing deeply, or being brave.
• Using distractors such as asking the child to hold a favorite item from home, storytelling, coloring, singing, or using breathing exercises.

Stefan Friedrichsdorf, MD, chief of the UCSF division of pediatric pain, palliative & integrative medicine, said in a statement: “For kids with chronic pain, complex pain medications can cause more harm than benefit. Our goal is to combine exercise and physical therapy with integrative medicine and skills-based psychotherapy to help them become pain free in their everyday life.”
 

Bundling appointments for early impact

At Lurie Children’s Hospital of Chicago, the chronic pain treatment program bundles visits with experts in several disciplines, include social workers, psychologists, and physical therapists, in addition to the medical team, so that patients can complete a first round of visits with multiple specialists in a short period, as opposed to several months.

Natalie Weatherred, APRN-NP, CPNP-PC, a pediatric nurse practitioner in anesthesiology and the pain clinic coordinator, said in an interview that the up-front visits involve between four and eight follow-up sessions in a short period with everybody in the multidisciplinary team “to really help jump-start their pain treatment.”

She pointed out that many families come from distant parts of the state or beyond so the bundled appointments are also important for easing burden on families.

Sarah Duggan, APRN-NP, CPNP-PC, also a pediatric nurse practitioner in anesthesiology at Lurie’s, pointed out that patients at their clinic often have other chronic conditions as well, such as such as postural orthostatic tachycardia syndrome so the care integration is particularly important.

“We can get them the appropriate care that they need and the resources they need, much sooner than we would have been able to do 5 or 10 years ago,” Ms. Duggan said.
 

Virtual reality distraction instead of sedation

Henry Huang, MD, anesthesiologist and pain physician at Texas Children’s Hospital, Houston, said a special team there collaborates with the Chariot Program at Stanford (Calif.) University and incorporates virtual reality to distract children from pain and anxiety and harness their imaginations during induction for anesthesia, intravenous placement, and vaccinations.

“At our institution we’ve been recruiting patients to do a proof of concept to do virtual reality distraction for pain procedures, such as nerve blocks or steroid injections,” Dr. Huang said.

Traditionally, kids would have received oral or intravenous sedation to help them cope with the fear and pain.

“We’ve been successful in several cases without relying on any sedation,” he said. “The next target is to expand that to the chronic pain population.”

The distraction techniques are promising for a wide range of ages, he said, and the programming is tailored to the child’s ability to interact with the technology.

He said he is also part of a group promoting use of ultrasound instead of x-rays to guide injections to the spine and chest to reduce children’s exposure to radiation. His group is helping teach these methods to other clinicians nationally.

Dr. Huang said the most important development in chronic pediatric pain has been the growth of rehab centers that include the medical team, and practitioners from psychology as well as occupational and physical therapy.

“More and more hospitals are recognizing the importance of these pain rehab centers,” he said.

The problem, Dr. Huang said, is that these programs have always been resource intensive and involve highly specialized clinicians. The cost and the limited number of specialists make it difficult for widespread rollout.

“That’s always been the challenge from the pediatric pain world,” he said.
 

Recognizing the complexity of kids’ chronic pain

Angela Garcia, MD, a consulting physician for pediatric rehabilitation medicine at UPMC Children’s Hospital of Pittsburgh said recognizing the validity and complexity of pediatric pain has led to multidisciplinary approaches and specialty clinics for chronic pain instead of primarily pharmaceutical solutions.

Techniques such as biofeedback and acupuncture are becoming more mainstream in pediatric chronic care, she said.

At the UPMC clinic, children and their families talk with a care team about their values and what they want to accomplish in managing the child’s pain. They ask what the pain is preventing the child from doing.

“Their goals really are our goals,” she said.

She said she also refers almost all patients to one of the center’s pain psychologists.

“Pain is biopsychosocial,” she said. “We want to make sure we’re addressing how to cope with pain.”

Dr. Garcia said she hopes nutritional therapy is one of the next approaches the clinic will incorporate, particularly surrounding how dietary changes can reduce inflammation “and heal the body from the inside out.”

She said the hospital is also looking at developing an inpatient pain program for kids whose functioning has changed so drastically that they need more intensive therapies.

Whatever the treatment approach, she said, addressing the pain early is critical.

“There is an increased risk of a child with chronic pain becoming an adult with chronic pain,” Dr. Garcia pointed out, “and that can lead to a decrease in the ability to participate in society.”

Ms. Weatherred, Ms. Duggan, Dr. Huang, and Dr. Garcia reported no relevant financial relationships.

At the new Walnut Creek Clinic in the East Bay of the San Francisco Bay area, kids get a “Comfort Promise.”

The clinic extends the work of the Stad Center for Pediatric Pain, Palliative & Integrative Medicine beyond the locations in University of California San Francisco Benioff Children’s Hospitals in San Francisco and Oakland.

At Walnut Creek, clinical acupuncturists, massage therapists, and specialists in hypnosis complement advanced medical care with integrative techniques.

The “Comfort Promise” program, which is being rolled out at that clinic and other UCSF pediatric clinics through the end of 2024, is the clinicians’ pledge to do everything in their power to make tests, infusions, and vaccinations “practically pain free.”

Needle sticks, for example, can be a common source of pain and anxiety for kids. Techniques to minimize pain vary by age. Among the ways the clinicians minimize needle pain for a child 6- to 12-years-old are:

• Giving the child control options to pick which arm; and watch the injection, pause it, or stop it with a communication sign.
• Introducing memory shaping by asking the child about the experience afterward and presenting it in a positive way by praising the acts of sitting still, breathing deeply, or being brave.
• Using distractors such as asking the child to hold a favorite item from home, storytelling, coloring, singing, or using breathing exercises.

Stefan Friedrichsdorf, MD, chief of the UCSF division of pediatric pain, palliative & integrative medicine, said in a statement: “For kids with chronic pain, complex pain medications can cause more harm than benefit. Our goal is to combine exercise and physical therapy with integrative medicine and skills-based psychotherapy to help them become pain free in their everyday life.”
 

Bundling appointments for early impact

At Lurie Children’s Hospital of Chicago, the chronic pain treatment program bundles visits with experts in several disciplines, include social workers, psychologists, and physical therapists, in addition to the medical team, so that patients can complete a first round of visits with multiple specialists in a short period, as opposed to several months.

Natalie Weatherred, APRN-NP, CPNP-PC, a pediatric nurse practitioner in anesthesiology and the pain clinic coordinator, said in an interview that the up-front visits involve between four and eight follow-up sessions in a short period with everybody in the multidisciplinary team “to really help jump-start their pain treatment.”

She pointed out that many families come from distant parts of the state or beyond so the bundled appointments are also important for easing burden on families.

Sarah Duggan, APRN-NP, CPNP-PC, also a pediatric nurse practitioner in anesthesiology at Lurie’s, pointed out that patients at their clinic often have other chronic conditions as well, such as such as postural orthostatic tachycardia syndrome so the care integration is particularly important.

“We can get them the appropriate care that they need and the resources they need, much sooner than we would have been able to do 5 or 10 years ago,” Ms. Duggan said.
 

Virtual reality distraction instead of sedation

Henry Huang, MD, anesthesiologist and pain physician at Texas Children’s Hospital, Houston, said a special team there collaborates with the Chariot Program at Stanford (Calif.) University and incorporates virtual reality to distract children from pain and anxiety and harness their imaginations during induction for anesthesia, intravenous placement, and vaccinations.

“At our institution we’ve been recruiting patients to do a proof of concept to do virtual reality distraction for pain procedures, such as nerve blocks or steroid injections,” Dr. Huang said.

Traditionally, kids would have received oral or intravenous sedation to help them cope with the fear and pain.

“We’ve been successful in several cases without relying on any sedation,” he said. “The next target is to expand that to the chronic pain population.”

The distraction techniques are promising for a wide range of ages, he said, and the programming is tailored to the child’s ability to interact with the technology.

He said he is also part of a group promoting use of ultrasound instead of x-rays to guide injections to the spine and chest to reduce children’s exposure to radiation. His group is helping teach these methods to other clinicians nationally.

Dr. Huang said the most important development in chronic pediatric pain has been the growth of rehab centers that include the medical team, and practitioners from psychology as well as occupational and physical therapy.

“More and more hospitals are recognizing the importance of these pain rehab centers,” he said.

The problem, Dr. Huang said, is that these programs have always been resource intensive and involve highly specialized clinicians. The cost and the limited number of specialists make it difficult for widespread rollout.

“That’s always been the challenge from the pediatric pain world,” he said.
 

Recognizing the complexity of kids’ chronic pain

Angela Garcia, MD, a consulting physician for pediatric rehabilitation medicine at UPMC Children’s Hospital of Pittsburgh said recognizing the validity and complexity of pediatric pain has led to multidisciplinary approaches and specialty clinics for chronic pain instead of primarily pharmaceutical solutions.

Techniques such as biofeedback and acupuncture are becoming more mainstream in pediatric chronic care, she said.

At the UPMC clinic, children and their families talk with a care team about their values and what they want to accomplish in managing the child’s pain. They ask what the pain is preventing the child from doing.

“Their goals really are our goals,” she said.

She said she also refers almost all patients to one of the center’s pain psychologists.

“Pain is biopsychosocial,” she said. “We want to make sure we’re addressing how to cope with pain.”

Dr. Garcia said she hopes nutritional therapy is one of the next approaches the clinic will incorporate, particularly surrounding how dietary changes can reduce inflammation “and heal the body from the inside out.”

She said the hospital is also looking at developing an inpatient pain program for kids whose functioning has changed so drastically that they need more intensive therapies.

Whatever the treatment approach, she said, addressing the pain early is critical.

“There is an increased risk of a child with chronic pain becoming an adult with chronic pain,” Dr. Garcia pointed out, “and that can lead to a decrease in the ability to participate in society.”

Ms. Weatherred, Ms. Duggan, Dr. Huang, and Dr. Garcia reported no relevant financial relationships.

Two newly approved respiratory syncytial virus (RSV) vaccines for adults aged 60 years and older may be able to prevent illness in those at risk for severe RSV disease.

Most adult RSV illness occurs among the older age group and results in an estimated 60,000-160,000 hospitalizations and 6,000-10,000 deaths per year among people aged at least 65 years.

Older adults deciding whether to get the vaccines should weigh risks and their own preferences and make the decision in consultation with their clinicians, said authors of a Centers for Disease Control and Prevention report.

Michael Melgar, MD, with the Coronavirus and Other Respiratory Viruses Division at the CDC, was lead author on the report, published in the Morbidity and Mortality Weekly Report.
 

Two new vaccines

In May, the Food and Drug Administration approved the first of two vaccines for preventing RSV lower respiratory tract disease for adults aged at least 60 years.

On June 21, the Advisory Committee on Immunization Practices (ACIP) recommended that people in that age group receive a single dose of RSV vaccine using shared decision-making.

The recommendation for shared decision-making makes the ACIP decision different from routine and risk-based vaccine recommendations. Rather than targeting all in a particular age group or risk group, the decision calls for consideration of a patients’ risk for disease and their characteristics, preferences, and values; the health care professional’s clinical discretion; and performance of the vaccine.

Dr. Melgar and colleagues reported that vaccination with one dose of the GSK or Pfizer RSV vaccines has proved moderately to highly effective in preventing symptomatic RSV-associated lower respiratory tract disease over two consecutive RSV seasons among people aged 60 and older.

The trials that led to approval weren’t powered to gauge efficacy against RSV-associated hospitalization and death. However, the authors wrote, the prevention of lower respiratory tract disease, including medically attended illness, suggests that the shots might prevent considerable morbidity from RSV disease among those aged 60 and older.

Both vaccines were generally well tolerated with a good safety profile. However, six cases of inflammatory neurologic events (including Guillain-Barré Syndrome, acute disseminated encephalomyelitis, and others) were reported in clinical trials after RSV vaccination.

“Whether these events occurred due to chance, or whether RSV vaccination increases the risk for inflammatory neurologic events, is currently unknown,” the authors wrote.

Postmarketing surveillance may help clarify the existence of any potential risk, but until those results are clearer, the CDC researchers said, RSV vaccinations should be targeted to older adults at highest risk for severe RSV and those most likely to benefit from the shots.
 

At higher risk

Some adults with certain medical conditions have a higher risk for RSV-associated hospitalization, according to the report.

Those conditions include chronic obstructive pulmonary disease, asthma, heart failure, coronary artery disease, cerebrovascular disease, diabetes mellitus, and chronic kidney disease.

People who are frail and of advanced age also are at higher risk for RSV hospitalization. That risk increases with age and the highest risk is for people aged at least 75 years.

The researchers added that RSV can cause severe disease in those with compromised immunity, including people who have received hematopoietic stem cell transplants and patients taking immunosuppressive drugs such as those used with solid organ transplants, cancer treatment, or other conditions.

As for when physicians should offer the vaccinations, shots are optimally given before the start of the RSV season.

However, the COVID-19 pandemic interrupted the seasonality and the timing has not yet returned to prepandemic patterns.

For the 2023-24 season, this report states, clinicians should offer RSV vaccination to adults aged at least 60 years using shared clinical decision-making as early as vaccine supply is available and should continue to offer vaccination to eligible adults who remain unvaccinated.

RSV vaccines can be administered with other adult vaccines during the same visit, the authors confirmed.
 

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

Two newly approved respiratory syncytial virus (RSV) vaccines for adults aged 60 years and older may be able to prevent illness in those at risk for severe RSV disease.

Most adult RSV illness occurs among the older age group and results in an estimated 60,000-160,000 hospitalizations and 6,000-10,000 deaths per year among people aged at least 65 years.

Older adults deciding whether to get the vaccines should weigh risks and their own preferences and make the decision in consultation with their clinicians, said authors of a Centers for Disease Control and Prevention report.

Michael Melgar, MD, with the Coronavirus and Other Respiratory Viruses Division at the CDC, was lead author on the report, published in the Morbidity and Mortality Weekly Report.
 

Two new vaccines

In May, the Food and Drug Administration approved the first of two vaccines for preventing RSV lower respiratory tract disease for adults aged at least 60 years.

On June 21, the Advisory Committee on Immunization Practices (ACIP) recommended that people in that age group receive a single dose of RSV vaccine using shared decision-making.

The recommendation for shared decision-making makes the ACIP decision different from routine and risk-based vaccine recommendations. Rather than targeting all in a particular age group or risk group, the decision calls for consideration of a patients’ risk for disease and their characteristics, preferences, and values; the health care professional’s clinical discretion; and performance of the vaccine.

Dr. Melgar and colleagues reported that vaccination with one dose of the GSK or Pfizer RSV vaccines has proved moderately to highly effective in preventing symptomatic RSV-associated lower respiratory tract disease over two consecutive RSV seasons among people aged 60 and older.

The trials that led to approval weren’t powered to gauge efficacy against RSV-associated hospitalization and death. However, the authors wrote, the prevention of lower respiratory tract disease, including medically attended illness, suggests that the shots might prevent considerable morbidity from RSV disease among those aged 60 and older.

Both vaccines were generally well tolerated with a good safety profile. However, six cases of inflammatory neurologic events (including Guillain-Barré Syndrome, acute disseminated encephalomyelitis, and others) were reported in clinical trials after RSV vaccination.

“Whether these events occurred due to chance, or whether RSV vaccination increases the risk for inflammatory neurologic events, is currently unknown,” the authors wrote.

Postmarketing surveillance may help clarify the existence of any potential risk, but until those results are clearer, the CDC researchers said, RSV vaccinations should be targeted to older adults at highest risk for severe RSV and those most likely to benefit from the shots.
 

At higher risk

Some adults with certain medical conditions have a higher risk for RSV-associated hospitalization, according to the report.

Those conditions include chronic obstructive pulmonary disease, asthma, heart failure, coronary artery disease, cerebrovascular disease, diabetes mellitus, and chronic kidney disease.

People who are frail and of advanced age also are at higher risk for RSV hospitalization. That risk increases with age and the highest risk is for people aged at least 75 years.

The researchers added that RSV can cause severe disease in those with compromised immunity, including people who have received hematopoietic stem cell transplants and patients taking immunosuppressive drugs such as those used with solid organ transplants, cancer treatment, or other conditions.

As for when physicians should offer the vaccinations, shots are optimally given before the start of the RSV season.

However, the COVID-19 pandemic interrupted the seasonality and the timing has not yet returned to prepandemic patterns.

For the 2023-24 season, this report states, clinicians should offer RSV vaccination to adults aged at least 60 years using shared clinical decision-making as early as vaccine supply is available and should continue to offer vaccination to eligible adults who remain unvaccinated.

RSV vaccines can be administered with other adult vaccines during the same visit, the authors confirmed.
 

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

Two newly approved respiratory syncytial virus (RSV) vaccines for adults aged 60 years and older may be able to prevent illness in those at risk for severe RSV disease.

Most adult RSV illness occurs among the older age group and results in an estimated 60,000-160,000 hospitalizations and 6,000-10,000 deaths per year among people aged at least 65 years.

Older adults deciding whether to get the vaccines should weigh risks and their own preferences and make the decision in consultation with their clinicians, said authors of a Centers for Disease Control and Prevention report.

Michael Melgar, MD, with the Coronavirus and Other Respiratory Viruses Division at the CDC, was lead author on the report, published in the Morbidity and Mortality Weekly Report.
 

Two new vaccines

In May, the Food and Drug Administration approved the first of two vaccines for preventing RSV lower respiratory tract disease for adults aged at least 60 years.

On June 21, the Advisory Committee on Immunization Practices (ACIP) recommended that people in that age group receive a single dose of RSV vaccine using shared decision-making.

The recommendation for shared decision-making makes the ACIP decision different from routine and risk-based vaccine recommendations. Rather than targeting all in a particular age group or risk group, the decision calls for consideration of a patients’ risk for disease and their characteristics, preferences, and values; the health care professional’s clinical discretion; and performance of the vaccine.

Dr. Melgar and colleagues reported that vaccination with one dose of the GSK or Pfizer RSV vaccines has proved moderately to highly effective in preventing symptomatic RSV-associated lower respiratory tract disease over two consecutive RSV seasons among people aged 60 and older.

The trials that led to approval weren’t powered to gauge efficacy against RSV-associated hospitalization and death. However, the authors wrote, the prevention of lower respiratory tract disease, including medically attended illness, suggests that the shots might prevent considerable morbidity from RSV disease among those aged 60 and older.

Both vaccines were generally well tolerated with a good safety profile. However, six cases of inflammatory neurologic events (including Guillain-Barré Syndrome, acute disseminated encephalomyelitis, and others) were reported in clinical trials after RSV vaccination.

“Whether these events occurred due to chance, or whether RSV vaccination increases the risk for inflammatory neurologic events, is currently unknown,” the authors wrote.

Postmarketing surveillance may help clarify the existence of any potential risk, but until those results are clearer, the CDC researchers said, RSV vaccinations should be targeted to older adults at highest risk for severe RSV and those most likely to benefit from the shots.
 

At higher risk

Some adults with certain medical conditions have a higher risk for RSV-associated hospitalization, according to the report.

Those conditions include chronic obstructive pulmonary disease, asthma, heart failure, coronary artery disease, cerebrovascular disease, diabetes mellitus, and chronic kidney disease.

People who are frail and of advanced age also are at higher risk for RSV hospitalization. That risk increases with age and the highest risk is for people aged at least 75 years.

The researchers added that RSV can cause severe disease in those with compromised immunity, including people who have received hematopoietic stem cell transplants and patients taking immunosuppressive drugs such as those used with solid organ transplants, cancer treatment, or other conditions.

As for when physicians should offer the vaccinations, shots are optimally given before the start of the RSV season.

However, the COVID-19 pandemic interrupted the seasonality and the timing has not yet returned to prepandemic patterns.

For the 2023-24 season, this report states, clinicians should offer RSV vaccination to adults aged at least 60 years using shared clinical decision-making as early as vaccine supply is available and should continue to offer vaccination to eligible adults who remain unvaccinated.

RSV vaccines can be administered with other adult vaccines during the same visit, the authors confirmed.
 

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

A U.S. Food and Drug Administration investigation of injection-site necrosis in some people who received the 23-valent pneumococcal vaccine has concluded that the benefits of the vaccine outweigh the risks.

FDA_icon3_web.jpg

No similar safety signal has been detected for the more recently approved 15-valent and 20-valent pneumococcal conjugate vaccines, explain the investigators, led by Brendan Day, MD, MPH, from the FDA’s Center for Biologics Evaluation and Research, in their report published online in JAMA Internal Medicine.

Reports of injection-site necrosis emerged after the vaccine (Pneumovax 23, Merck) had been approved by the FDA and was administered to a large, diverse, real-world population.

Rare safety events can emerge after FDA approval, as clinical trials may not be able to detect them in a study-group population.

Therefore, “postmarketing safety surveillance is critical to further characterize the safety profile of licensed vaccines,” the investigators point out.

The FDA and the Centers for Disease Control and Prevention monitor the postmarketing safety of licensed vaccines using the Vaccine Adverse Event Reporting System (VAERS), which relies on people who get the vaccines to report adverse events.
 

Real-world finding

After reports indicated a safety signal in 2020, the researchers conducted a case-series review, calculated the reporting rate, and did a PubMed search for similar reports.

They found that the reporting rate for injection-site necrosis was less than 0.2 cases per 1 million vaccine doses administered. The PubMed search yielded two cases of injection-site necrosis after the vaccine.

The 23-valent vaccine helps protect people from pneumococcus bacterial infection. The manufacturer reports that it is for people at least 50 years of age and for children who are at least 2 years of age with medical conditions that put them at elevated risk for infection.

The U.S. package insert has been updated, in the Post-Marketing Experience section, to include injection-site necrosis.

Of the 104 VAERS reports identified by the researchers, 48 met the case definition. Of those cases, most were for skin necrosis (n = 43), five of which also included fat necrosis. The remaining five cases of necrosis affected fascia (n = 2); fat and fascia (n = 1); fat, fascia, and muscle (n = 1); and muscle (n = 1).

In 23 of the 48 cases (47.9%), the reactions were serious and included one death (unrelated to vaccination).

Seventeen patients (35.4%) were hospitalized and 26 (54.2%) required surgery, most commonly debridement. Eight patients (16.7%) underwent multiple surgical procedures and three (6.3%) required a skin graft.

For patients with skin necrosis (n = 43), the median age was 67 years, and most patients were female (n = 36). Twelve patients were immunocompromised.

Concomitant vaccinations were reported in 10 patients, five of whom got the shot in the same arm as the 23-valent pneumococcal vaccine. A concurrent diagnosis of cellulitis was reported in 16 patients and an abscess was reported in three patients. There were too few cases of fat, fascia, or muscle necrosis to draw conclusions, the researchers report.

Often, skin necrosis was seen after a progression of symptoms, such as redness, pain, or swelling.

“These reports are consistent with published descriptions of injection-site necrosis, which has been reported as a rare complication for many vaccines and injectable drugs,” the investigators report.

Although the researchers couldn’t conclude from the VAERS reports alone that the vaccine injection caused the necrosis, “the timing and the location of reactions at the injection site suggest a possible causal association with the vaccine,” they explain. However, they add, patient comorbidities and poor injection technique may also be contributors.

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

A U.S. Food and Drug Administration investigation of injection-site necrosis in some people who received the 23-valent pneumococcal vaccine has concluded that the benefits of the vaccine outweigh the risks.

FDA_icon3_web.jpg

No similar safety signal has been detected for the more recently approved 15-valent and 20-valent pneumococcal conjugate vaccines, explain the investigators, led by Brendan Day, MD, MPH, from the FDA’s Center for Biologics Evaluation and Research, in their report published online in JAMA Internal Medicine.

Reports of injection-site necrosis emerged after the vaccine (Pneumovax 23, Merck) had been approved by the FDA and was administered to a large, diverse, real-world population.

Rare safety events can emerge after FDA approval, as clinical trials may not be able to detect them in a study-group population.

Therefore, “postmarketing safety surveillance is critical to further characterize the safety profile of licensed vaccines,” the investigators point out.

The FDA and the Centers for Disease Control and Prevention monitor the postmarketing safety of licensed vaccines using the Vaccine Adverse Event Reporting System (VAERS), which relies on people who get the vaccines to report adverse events.
 

Real-world finding

After reports indicated a safety signal in 2020, the researchers conducted a case-series review, calculated the reporting rate, and did a PubMed search for similar reports.

They found that the reporting rate for injection-site necrosis was less than 0.2 cases per 1 million vaccine doses administered. The PubMed search yielded two cases of injection-site necrosis after the vaccine.

The 23-valent vaccine helps protect people from pneumococcus bacterial infection. The manufacturer reports that it is for people at least 50 years of age and for children who are at least 2 years of age with medical conditions that put them at elevated risk for infection.

The U.S. package insert has been updated, in the Post-Marketing Experience section, to include injection-site necrosis.

Of the 104 VAERS reports identified by the researchers, 48 met the case definition. Of those cases, most were for skin necrosis (n = 43), five of which also included fat necrosis. The remaining five cases of necrosis affected fascia (n = 2); fat and fascia (n = 1); fat, fascia, and muscle (n = 1); and muscle (n = 1).

In 23 of the 48 cases (47.9%), the reactions were serious and included one death (unrelated to vaccination).

Seventeen patients (35.4%) were hospitalized and 26 (54.2%) required surgery, most commonly debridement. Eight patients (16.7%) underwent multiple surgical procedures and three (6.3%) required a skin graft.

For patients with skin necrosis (n = 43), the median age was 67 years, and most patients were female (n = 36). Twelve patients were immunocompromised.

Concomitant vaccinations were reported in 10 patients, five of whom got the shot in the same arm as the 23-valent pneumococcal vaccine. A concurrent diagnosis of cellulitis was reported in 16 patients and an abscess was reported in three patients. There were too few cases of fat, fascia, or muscle necrosis to draw conclusions, the researchers report.

Often, skin necrosis was seen after a progression of symptoms, such as redness, pain, or swelling.

“These reports are consistent with published descriptions of injection-site necrosis, which has been reported as a rare complication for many vaccines and injectable drugs,” the investigators report.

Although the researchers couldn’t conclude from the VAERS reports alone that the vaccine injection caused the necrosis, “the timing and the location of reactions at the injection site suggest a possible causal association with the vaccine,” they explain. However, they add, patient comorbidities and poor injection technique may also be contributors.

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

A U.S. Food and Drug Administration investigation of injection-site necrosis in some people who received the 23-valent pneumococcal vaccine has concluded that the benefits of the vaccine outweigh the risks.

FDA_icon3_web.jpg

No similar safety signal has been detected for the more recently approved 15-valent and 20-valent pneumococcal conjugate vaccines, explain the investigators, led by Brendan Day, MD, MPH, from the FDA’s Center for Biologics Evaluation and Research, in their report published online in JAMA Internal Medicine.

Reports of injection-site necrosis emerged after the vaccine (Pneumovax 23, Merck) had been approved by the FDA and was administered to a large, diverse, real-world population.

Rare safety events can emerge after FDA approval, as clinical trials may not be able to detect them in a study-group population.

Therefore, “postmarketing safety surveillance is critical to further characterize the safety profile of licensed vaccines,” the investigators point out.

The FDA and the Centers for Disease Control and Prevention monitor the postmarketing safety of licensed vaccines using the Vaccine Adverse Event Reporting System (VAERS), which relies on people who get the vaccines to report adverse events.
 

Real-world finding

After reports indicated a safety signal in 2020, the researchers conducted a case-series review, calculated the reporting rate, and did a PubMed search for similar reports.

They found that the reporting rate for injection-site necrosis was less than 0.2 cases per 1 million vaccine doses administered. The PubMed search yielded two cases of injection-site necrosis after the vaccine.

The 23-valent vaccine helps protect people from pneumococcus bacterial infection. The manufacturer reports that it is for people at least 50 years of age and for children who are at least 2 years of age with medical conditions that put them at elevated risk for infection.

The U.S. package insert has been updated, in the Post-Marketing Experience section, to include injection-site necrosis.

Of the 104 VAERS reports identified by the researchers, 48 met the case definition. Of those cases, most were for skin necrosis (n = 43), five of which also included fat necrosis. The remaining five cases of necrosis affected fascia (n = 2); fat and fascia (n = 1); fat, fascia, and muscle (n = 1); and muscle (n = 1).

In 23 of the 48 cases (47.9%), the reactions were serious and included one death (unrelated to vaccination).

Seventeen patients (35.4%) were hospitalized and 26 (54.2%) required surgery, most commonly debridement. Eight patients (16.7%) underwent multiple surgical procedures and three (6.3%) required a skin graft.

For patients with skin necrosis (n = 43), the median age was 67 years, and most patients were female (n = 36). Twelve patients were immunocompromised.

Concomitant vaccinations were reported in 10 patients, five of whom got the shot in the same arm as the 23-valent pneumococcal vaccine. A concurrent diagnosis of cellulitis was reported in 16 patients and an abscess was reported in three patients. There were too few cases of fat, fascia, or muscle necrosis to draw conclusions, the researchers report.

Often, skin necrosis was seen after a progression of symptoms, such as redness, pain, or swelling.

“These reports are consistent with published descriptions of injection-site necrosis, which has been reported as a rare complication for many vaccines and injectable drugs,” the investigators report.

Although the researchers couldn’t conclude from the VAERS reports alone that the vaccine injection caused the necrosis, “the timing and the location of reactions at the injection site suggest a possible causal association with the vaccine,” they explain. However, they add, patient comorbidities and poor injection technique may also be contributors.

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