Infectious Disease Practitioner

Scent-detecting dogs have long been used to sniff out medical conditions ranging from low blood sugar and cancer to malaria, impending seizures, and migraines – not to mention explosives and narcotics.

Recently, the sensitivity of the canine nose has been tested as a strategy for screening for SARS-CoV-2 infection in schoolchildren showing no outward symptoms of the virus. A pilot study led by Carol A. Glaser, DVM, MD, of the California Department of Public Health in Richmond, found that trained dogs had an accuracy of more than 95% for detecting the odor of volatile organic compounds, or VOCs, produced by COVID-infected individuals.

California Department of Public Health

The authors believe that odor-based diagnosis with dogs could eventually provide a rapid, inexpensive, and noninvasive way to screen large groups for COVID-19 without the need for antigen testing.

“This is a new program with research ongoing, so it would be premature to consider it from a consumer’s perspective,” Dr. Glaser said in an interview. “However, the data look promising and we are hopeful we can continue to pilot various programs in various settings to see where, and if, dogs can be used for biomedical detection.”
 

In the lab and in the field

In a study published online in JAMA Pediatrics, Dr. Glaser’s group found that after 2 months’ training on COVID-19 scent samples in the laboratory, the dogs detected the presence of the virus more than 95% of the time. Antigen tests were used as a comparative reference.

In medical terms, the dogs achieved a greater than 95% accuracy on two important measures of effectiveness: sensitivity – a test’s ability to correctly detect the positive presence of disease – and specificity – the ability of a test to accurately rule out the presence of disease and identify as negative an uninfected person.

Next, the researchers piloted field tests in 50 visits at 27 schools from April 1 to May 25, 2022, to compare dogs’ detection ability with that of standard laboratory antigen testing. Participants in the completely voluntary screening numbered 1,558 and ranged in age from 9 to 17 years. Of these, 56% were girls and 89% were students. Almost 70% were screened at least twice.

Overall, the field test compared 3,897 paired antigen-vs.-dog screenings. The dogs accurately signaled the presence of 85 infections and ruled out 3,411 infections, for an overall accuracy of 90%. In 383 cases, however, they inaccurately signaled the presence of infection (false positives) and missed 18 actual infections (false negatives). That translated to a sensitivity in the field of 83%, considerably lower than that of their lab performance.

Direct screening of individuals with dogs outside of the lab involved circumstantial factors that likely contributed to decreased sensitivity and specificity, the authors acknowledged. These included such distractions as noise and the presence of excitable young children as well environmental conditions such as wind and other odors. What about dog phobia and dog hair allergy? “Dog screening takes only a few seconds per student and the dogs do not generally touch the participant as they run a line and sniff at ankles,” Dr. Glaser explained.

As for allergies, the rapid, ankle-level screening occurred in outdoor settings. “The chance of allergies is very low. This would be similar to someone who is out walking on the sidewalk and walks by a dog,” Dr. Glaser said.

Last year, a British trial of almost 4,000 adults tested six dogs trained to detect differences in VOCs between COVID-infected and uninfected individuals. Given samples from both groups, the dogs were able to distinguish between infected and uninfected samples with a sensitivity for detecting the virus ranging from 82% to 94% and a specificity for ruling it out of 76% to 92%. And they were able to smell the VOCs even when the viral load was low. The study also tested organic sensors, which proved even more accurate than the canines.

According to lead author James G. Logan, PhD, a disease control expert at the London School of Hygiene & Tropical Medicine in London, “Odour-based diagnostics using dogs and/or sensors may prove a rapid and effective tool for screening large numbers of people. Mathematical modelling suggests that dog screening plus a confirmatory PCR test could detect up to 89% of SARS-CoV-2 infections, averting up to 2.2 times as much transmission compared to isolation of symptomatic individuals only.”

Funding was provided by the Centers for Disease Control and Prevention Foundation (CDCF) to Early Alert Canines for the purchase and care of the dogs and the support of the handlers and trainers. The CDCF had no other role in the study. Coauthor Carol A. Edwards of Early Alert Canines reported receiving grants from the CDCF.

Scent-detecting dogs have long been used to sniff out medical conditions ranging from low blood sugar and cancer to malaria, impending seizures, and migraines – not to mention explosives and narcotics.

Recently, the sensitivity of the canine nose has been tested as a strategy for screening for SARS-CoV-2 infection in schoolchildren showing no outward symptoms of the virus. A pilot study led by Carol A. Glaser, DVM, MD, of the California Department of Public Health in Richmond, found that trained dogs had an accuracy of more than 95% for detecting the odor of volatile organic compounds, or VOCs, produced by COVID-infected individuals.

California Department of Public Health

The authors believe that odor-based diagnosis with dogs could eventually provide a rapid, inexpensive, and noninvasive way to screen large groups for COVID-19 without the need for antigen testing.

“This is a new program with research ongoing, so it would be premature to consider it from a consumer’s perspective,” Dr. Glaser said in an interview. “However, the data look promising and we are hopeful we can continue to pilot various programs in various settings to see where, and if, dogs can be used for biomedical detection.”
 

In the lab and in the field

In a study published online in JAMA Pediatrics, Dr. Glaser’s group found that after 2 months’ training on COVID-19 scent samples in the laboratory, the dogs detected the presence of the virus more than 95% of the time. Antigen tests were used as a comparative reference.

In medical terms, the dogs achieved a greater than 95% accuracy on two important measures of effectiveness: sensitivity – a test’s ability to correctly detect the positive presence of disease – and specificity – the ability of a test to accurately rule out the presence of disease and identify as negative an uninfected person.

Next, the researchers piloted field tests in 50 visits at 27 schools from April 1 to May 25, 2022, to compare dogs’ detection ability with that of standard laboratory antigen testing. Participants in the completely voluntary screening numbered 1,558 and ranged in age from 9 to 17 years. Of these, 56% were girls and 89% were students. Almost 70% were screened at least twice.

Overall, the field test compared 3,897 paired antigen-vs.-dog screenings. The dogs accurately signaled the presence of 85 infections and ruled out 3,411 infections, for an overall accuracy of 90%. In 383 cases, however, they inaccurately signaled the presence of infection (false positives) and missed 18 actual infections (false negatives). That translated to a sensitivity in the field of 83%, considerably lower than that of their lab performance.

Direct screening of individuals with dogs outside of the lab involved circumstantial factors that likely contributed to decreased sensitivity and specificity, the authors acknowledged. These included such distractions as noise and the presence of excitable young children as well environmental conditions such as wind and other odors. What about dog phobia and dog hair allergy? “Dog screening takes only a few seconds per student and the dogs do not generally touch the participant as they run a line and sniff at ankles,” Dr. Glaser explained.

As for allergies, the rapid, ankle-level screening occurred in outdoor settings. “The chance of allergies is very low. This would be similar to someone who is out walking on the sidewalk and walks by a dog,” Dr. Glaser said.

Last year, a British trial of almost 4,000 adults tested six dogs trained to detect differences in VOCs between COVID-infected and uninfected individuals. Given samples from both groups, the dogs were able to distinguish between infected and uninfected samples with a sensitivity for detecting the virus ranging from 82% to 94% and a specificity for ruling it out of 76% to 92%. And they were able to smell the VOCs even when the viral load was low. The study also tested organic sensors, which proved even more accurate than the canines.

According to lead author James G. Logan, PhD, a disease control expert at the London School of Hygiene & Tropical Medicine in London, “Odour-based diagnostics using dogs and/or sensors may prove a rapid and effective tool for screening large numbers of people. Mathematical modelling suggests that dog screening plus a confirmatory PCR test could detect up to 89% of SARS-CoV-2 infections, averting up to 2.2 times as much transmission compared to isolation of symptomatic individuals only.”

Funding was provided by the Centers for Disease Control and Prevention Foundation (CDCF) to Early Alert Canines for the purchase and care of the dogs and the support of the handlers and trainers. The CDCF had no other role in the study. Coauthor Carol A. Edwards of Early Alert Canines reported receiving grants from the CDCF.

Scent-detecting dogs have long been used to sniff out medical conditions ranging from low blood sugar and cancer to malaria, impending seizures, and migraines – not to mention explosives and narcotics.

Recently, the sensitivity of the canine nose has been tested as a strategy for screening for SARS-CoV-2 infection in schoolchildren showing no outward symptoms of the virus. A pilot study led by Carol A. Glaser, DVM, MD, of the California Department of Public Health in Richmond, found that trained dogs had an accuracy of more than 95% for detecting the odor of volatile organic compounds, or VOCs, produced by COVID-infected individuals.

California Department of Public Health

The authors believe that odor-based diagnosis with dogs could eventually provide a rapid, inexpensive, and noninvasive way to screen large groups for COVID-19 without the need for antigen testing.

“This is a new program with research ongoing, so it would be premature to consider it from a consumer’s perspective,” Dr. Glaser said in an interview. “However, the data look promising and we are hopeful we can continue to pilot various programs in various settings to see where, and if, dogs can be used for biomedical detection.”
 

In the lab and in the field

In a study published online in JAMA Pediatrics, Dr. Glaser’s group found that after 2 months’ training on COVID-19 scent samples in the laboratory, the dogs detected the presence of the virus more than 95% of the time. Antigen tests were used as a comparative reference.

In medical terms, the dogs achieved a greater than 95% accuracy on two important measures of effectiveness: sensitivity – a test’s ability to correctly detect the positive presence of disease – and specificity – the ability of a test to accurately rule out the presence of disease and identify as negative an uninfected person.

Next, the researchers piloted field tests in 50 visits at 27 schools from April 1 to May 25, 2022, to compare dogs’ detection ability with that of standard laboratory antigen testing. Participants in the completely voluntary screening numbered 1,558 and ranged in age from 9 to 17 years. Of these, 56% were girls and 89% were students. Almost 70% were screened at least twice.

Overall, the field test compared 3,897 paired antigen-vs.-dog screenings. The dogs accurately signaled the presence of 85 infections and ruled out 3,411 infections, for an overall accuracy of 90%. In 383 cases, however, they inaccurately signaled the presence of infection (false positives) and missed 18 actual infections (false negatives). That translated to a sensitivity in the field of 83%, considerably lower than that of their lab performance.

Direct screening of individuals with dogs outside of the lab involved circumstantial factors that likely contributed to decreased sensitivity and specificity, the authors acknowledged. These included such distractions as noise and the presence of excitable young children as well environmental conditions such as wind and other odors. What about dog phobia and dog hair allergy? “Dog screening takes only a few seconds per student and the dogs do not generally touch the participant as they run a line and sniff at ankles,” Dr. Glaser explained.

As for allergies, the rapid, ankle-level screening occurred in outdoor settings. “The chance of allergies is very low. This would be similar to someone who is out walking on the sidewalk and walks by a dog,” Dr. Glaser said.

Last year, a British trial of almost 4,000 adults tested six dogs trained to detect differences in VOCs between COVID-infected and uninfected individuals. Given samples from both groups, the dogs were able to distinguish between infected and uninfected samples with a sensitivity for detecting the virus ranging from 82% to 94% and a specificity for ruling it out of 76% to 92%. And they were able to smell the VOCs even when the viral load was low. The study also tested organic sensors, which proved even more accurate than the canines.

According to lead author James G. Logan, PhD, a disease control expert at the London School of Hygiene & Tropical Medicine in London, “Odour-based diagnostics using dogs and/or sensors may prove a rapid and effective tool for screening large numbers of people. Mathematical modelling suggests that dog screening plus a confirmatory PCR test could detect up to 89% of SARS-CoV-2 infections, averting up to 2.2 times as much transmission compared to isolation of symptomatic individuals only.”

Funding was provided by the Centers for Disease Control and Prevention Foundation (CDCF) to Early Alert Canines for the purchase and care of the dogs and the support of the handlers and trainers. The CDCF had no other role in the study. Coauthor Carol A. Edwards of Early Alert Canines reported receiving grants from the CDCF.

Doctors’ groups are lining up to support new federal legislation to permanently tie Medicare physician payment updates to inflation.

Introduced by four physician U.S. House representatives, HR 2474 would link Medicare fee schedule updates to the Medicare Economic Index, a measure of inflation related to physicians’ practice costs and wages.

That’s a long-sought goal of the American Medical Association, which is leading 120 state medical societies and medical specialty groups in championing the bill.

The legislation is essential to enabling physician practices to better absorb payment distributions triggered by budget neutrality rules, performance adjustments, and periods of high inflation, the groups wrote in a joint letter sent to the bill’s sponsors. The sponsors say they hope the legislation will improve access to care, as low reimbursements cause some physicians to limit their number of Medicare patients.

Physicians groups for years have urged federal lawmakers to scrap short-term fixes staving off Medicare pay cuts in favor of permanent reforms. Unlike nearly all other Medicare clinicians including hospitals, physicians’ Medicare payment updates aren’t currently tied to inflation.

Adjusted for inflation, Medicare payments to physicians have declined 26% between 2001 and 2023, including a 2% payment reduction in 2023, according to the AMA. Small and rural physician practices have been disproportionately affected by these reductions, as have doctors treating low-income or uninsured patients, the AMA said.

Last month, an influential federal advisory panel recommended permanently tying Medicare physician pay increases to inflation. Clinicians’ cost of providing services, measured by the Medicare Economic Index, rose by 2.6% in 2021 and are estimated to have risen 4.7% in 2022, significantly more than in recent years, the Medicare Payment Advisory Commission said.

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

Doctors’ groups are lining up to support new federal legislation to permanently tie Medicare physician payment updates to inflation.

Introduced by four physician U.S. House representatives, HR 2474 would link Medicare fee schedule updates to the Medicare Economic Index, a measure of inflation related to physicians’ practice costs and wages.

That’s a long-sought goal of the American Medical Association, which is leading 120 state medical societies and medical specialty groups in championing the bill.

The legislation is essential to enabling physician practices to better absorb payment distributions triggered by budget neutrality rules, performance adjustments, and periods of high inflation, the groups wrote in a joint letter sent to the bill’s sponsors. The sponsors say they hope the legislation will improve access to care, as low reimbursements cause some physicians to limit their number of Medicare patients.

Physicians groups for years have urged federal lawmakers to scrap short-term fixes staving off Medicare pay cuts in favor of permanent reforms. Unlike nearly all other Medicare clinicians including hospitals, physicians’ Medicare payment updates aren’t currently tied to inflation.

Adjusted for inflation, Medicare payments to physicians have declined 26% between 2001 and 2023, including a 2% payment reduction in 2023, according to the AMA. Small and rural physician practices have been disproportionately affected by these reductions, as have doctors treating low-income or uninsured patients, the AMA said.

Last month, an influential federal advisory panel recommended permanently tying Medicare physician pay increases to inflation. Clinicians’ cost of providing services, measured by the Medicare Economic Index, rose by 2.6% in 2021 and are estimated to have risen 4.7% in 2022, significantly more than in recent years, the Medicare Payment Advisory Commission said.

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

Doctors’ groups are lining up to support new federal legislation to permanently tie Medicare physician payment updates to inflation.

Introduced by four physician U.S. House representatives, HR 2474 would link Medicare fee schedule updates to the Medicare Economic Index, a measure of inflation related to physicians’ practice costs and wages.

That’s a long-sought goal of the American Medical Association, which is leading 120 state medical societies and medical specialty groups in championing the bill.

The legislation is essential to enabling physician practices to better absorb payment distributions triggered by budget neutrality rules, performance adjustments, and periods of high inflation, the groups wrote in a joint letter sent to the bill’s sponsors. The sponsors say they hope the legislation will improve access to care, as low reimbursements cause some physicians to limit their number of Medicare patients.

Physicians groups for years have urged federal lawmakers to scrap short-term fixes staving off Medicare pay cuts in favor of permanent reforms. Unlike nearly all other Medicare clinicians including hospitals, physicians’ Medicare payment updates aren’t currently tied to inflation.

Adjusted for inflation, Medicare payments to physicians have declined 26% between 2001 and 2023, including a 2% payment reduction in 2023, according to the AMA. Small and rural physician practices have been disproportionately affected by these reductions, as have doctors treating low-income or uninsured patients, the AMA said.

Last month, an influential federal advisory panel recommended permanently tying Medicare physician pay increases to inflation. Clinicians’ cost of providing services, measured by the Medicare Economic Index, rose by 2.6% in 2021 and are estimated to have risen 4.7% in 2022, significantly more than in recent years, the Medicare Payment Advisory Commission said.

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

A new federal research project aims to answer lingering questions about long COVID using mobile monitoring devices to help track the condition.

The federally funded RECOVER Initiative expects to give out 10,000 sensors to people with long COVID to collect data in real time.

Terry Rudd/MDedge News

The hope is that researchers will be able to provide doctors and patients with a wealth of information to address gaps in knowledge about long COVID.

The project takes advantage of the approach other researchers have used to track patients’ health data on heart rate, exercise, and more using mobile monitoring devices such as Fitbits, smartwatches, and other remote sensors. 

Researchers believe the initiative could be particularly useful for people with long COVID – whose symptoms come and go. They can use a wristband sensor to passively collect data in real time.

For a condition defined by its symptoms, that kind of data promises to be useful, experts said. 

But not everyone has room in their budget for a smartwatch or a fitness tracker. Until recently, most clinical trials were BYOD: Bring your own device. At a time when researchers are trying to make sure that clinical trials reflect the diversity of the population, that leaves a lot of people out.

So, researchers are starting to supply subjects with their own monitors. The RECOVER Initiative expects to give out 10,000 sensors to people who are eligible based on race/ethnicity, income, and other demographic factors (rural residents for example). After 2 months, all people in the RECOVER study over the age of 13 will be eligible for the sensors.

The federal program builds on earlier research at places like The Scripps Institute, a center of research into remote monitoring. The institute supplied 7,000 monitors to people in an arm of the All of Us study, a 5-year-old multisite cohort that aims to collect medical information from 1 million people. 

The devices went to people who have been historically underrepresented in biomedical research, said Scripps researchers, who plan to give out more this year. 

In March of 2023, Scripps researchers published a study on the tracking data that found a significant post-COVID-19 drop in physical activity. But the data are incomplete because many people can’t always afford these devices. Most of the people in the study were “White, young, and active,” they wrote.

Researchers at an All of Us site at Vanderbilt University, which also used a BYOD approach, realized that they produced biased results. They reported their findings at the Pacific Symposium on Biocomputing in January.

“[The] majority of participants who provided Fitbit data reported being White and employed for wages,” they said. “However, these data represent participants who had their own Fitbit devices and consented to share EHR [electronic health record] data.”

Their solution: The program has begun providing Fitbit devices to all study participants who do not own one or cannot afford one. 

Now, the web page for the All of Us study asks visitors to “Learn about the All of Us WEAR study. You could get a Fitbit at no cost! … As a part of the WEAR Study, you could receive a new Fitbit to wear at no cost to you. All of Us will be able to get the data the Fitbit collects. This data may help us understand how behavior impacts health.”

Jennifer Radin, PhD, an epidemiologist at Scripps Research Translational Institute, is heading up the DETECT study, which is a remote monitoring research project that has enrolled over 40,000 people who have their own sensors – be it a smartwatch or Fitbit. She was looking at remote monitoring for disease before COVID emerged.

Dr. Radin said she began researching remote sensing after working in public health and dealing with outdated data collection systems. 

“They typically rely on case reports that are recorded by pen and paper and faxed or mailed in,” she said. “Then, they have to be entered into a database. “

In addition to offering objective data on a subject’s physical response to the infection, she said, the data collection can be long-term and continuous. 

DETECT collects data on resting heart rate, which is unique to every person, and activity levels. Both measures are meaningful for those with long COVID. Her research found differences in sleep, heart rate, and activity between those with COVID and those without.

Joseph Kvedar, MD, is a Harvard Medical School researcher and the editor of  NPJ Digital Medicine. He’s been studying digital health systems and called clinical research a “beachhead” for the use of data from monitors. But he also said problems remain that need to be worked out. The quality of the devices and their Bluetooth connections are better. But different devices measure different things, and a counted step can vary from person to person, he said. And the problems of the early days of electronic health records have not been fully resolved.

“We haven’t gotten to this universal language to connect all these things and make them relevant,” he said. 

The All of Us researchers are working with the RECOVER project to address some of those issues. Usually not focused on a single condition, the All of Us researchers are testing a machine-learning approach for identifying long COVID. 
 

A version of this article originally appeared on WebMD.com.

A new federal research project aims to answer lingering questions about long COVID using mobile monitoring devices to help track the condition.

The federally funded RECOVER Initiative expects to give out 10,000 sensors to people with long COVID to collect data in real time.

Terry Rudd/MDedge News

The hope is that researchers will be able to provide doctors and patients with a wealth of information to address gaps in knowledge about long COVID.

The project takes advantage of the approach other researchers have used to track patients’ health data on heart rate, exercise, and more using mobile monitoring devices such as Fitbits, smartwatches, and other remote sensors. 

Researchers believe the initiative could be particularly useful for people with long COVID – whose symptoms come and go. They can use a wristband sensor to passively collect data in real time.

For a condition defined by its symptoms, that kind of data promises to be useful, experts said. 

But not everyone has room in their budget for a smartwatch or a fitness tracker. Until recently, most clinical trials were BYOD: Bring your own device. At a time when researchers are trying to make sure that clinical trials reflect the diversity of the population, that leaves a lot of people out.

So, researchers are starting to supply subjects with their own monitors. The RECOVER Initiative expects to give out 10,000 sensors to people who are eligible based on race/ethnicity, income, and other demographic factors (rural residents for example). After 2 months, all people in the RECOVER study over the age of 13 will be eligible for the sensors.

The federal program builds on earlier research at places like The Scripps Institute, a center of research into remote monitoring. The institute supplied 7,000 monitors to people in an arm of the All of Us study, a 5-year-old multisite cohort that aims to collect medical information from 1 million people. 

The devices went to people who have been historically underrepresented in biomedical research, said Scripps researchers, who plan to give out more this year. 

In March of 2023, Scripps researchers published a study on the tracking data that found a significant post-COVID-19 drop in physical activity. But the data are incomplete because many people can’t always afford these devices. Most of the people in the study were “White, young, and active,” they wrote.

Researchers at an All of Us site at Vanderbilt University, which also used a BYOD approach, realized that they produced biased results. They reported their findings at the Pacific Symposium on Biocomputing in January.

“[The] majority of participants who provided Fitbit data reported being White and employed for wages,” they said. “However, these data represent participants who had their own Fitbit devices and consented to share EHR [electronic health record] data.”

Their solution: The program has begun providing Fitbit devices to all study participants who do not own one or cannot afford one. 

Now, the web page for the All of Us study asks visitors to “Learn about the All of Us WEAR study. You could get a Fitbit at no cost! … As a part of the WEAR Study, you could receive a new Fitbit to wear at no cost to you. All of Us will be able to get the data the Fitbit collects. This data may help us understand how behavior impacts health.”

Jennifer Radin, PhD, an epidemiologist at Scripps Research Translational Institute, is heading up the DETECT study, which is a remote monitoring research project that has enrolled over 40,000 people who have their own sensors – be it a smartwatch or Fitbit. She was looking at remote monitoring for disease before COVID emerged.

Dr. Radin said she began researching remote sensing after working in public health and dealing with outdated data collection systems. 

“They typically rely on case reports that are recorded by pen and paper and faxed or mailed in,” she said. “Then, they have to be entered into a database. “

In addition to offering objective data on a subject’s physical response to the infection, she said, the data collection can be long-term and continuous. 

DETECT collects data on resting heart rate, which is unique to every person, and activity levels. Both measures are meaningful for those with long COVID. Her research found differences in sleep, heart rate, and activity between those with COVID and those without.

Joseph Kvedar, MD, is a Harvard Medical School researcher and the editor of  NPJ Digital Medicine. He’s been studying digital health systems and called clinical research a “beachhead” for the use of data from monitors. But he also said problems remain that need to be worked out. The quality of the devices and their Bluetooth connections are better. But different devices measure different things, and a counted step can vary from person to person, he said. And the problems of the early days of electronic health records have not been fully resolved.

“We haven’t gotten to this universal language to connect all these things and make them relevant,” he said. 

The All of Us researchers are working with the RECOVER project to address some of those issues. Usually not focused on a single condition, the All of Us researchers are testing a machine-learning approach for identifying long COVID. 
 

A version of this article originally appeared on WebMD.com.

A new federal research project aims to answer lingering questions about long COVID using mobile monitoring devices to help track the condition.

The federally funded RECOVER Initiative expects to give out 10,000 sensors to people with long COVID to collect data in real time.

Terry Rudd/MDedge News

The hope is that researchers will be able to provide doctors and patients with a wealth of information to address gaps in knowledge about long COVID.

The project takes advantage of the approach other researchers have used to track patients’ health data on heart rate, exercise, and more using mobile monitoring devices such as Fitbits, smartwatches, and other remote sensors. 

Researchers believe the initiative could be particularly useful for people with long COVID – whose symptoms come and go. They can use a wristband sensor to passively collect data in real time.

For a condition defined by its symptoms, that kind of data promises to be useful, experts said. 

But not everyone has room in their budget for a smartwatch or a fitness tracker. Until recently, most clinical trials were BYOD: Bring your own device. At a time when researchers are trying to make sure that clinical trials reflect the diversity of the population, that leaves a lot of people out.

So, researchers are starting to supply subjects with their own monitors. The RECOVER Initiative expects to give out 10,000 sensors to people who are eligible based on race/ethnicity, income, and other demographic factors (rural residents for example). After 2 months, all people in the RECOVER study over the age of 13 will be eligible for the sensors.

The federal program builds on earlier research at places like The Scripps Institute, a center of research into remote monitoring. The institute supplied 7,000 monitors to people in an arm of the All of Us study, a 5-year-old multisite cohort that aims to collect medical information from 1 million people. 

The devices went to people who have been historically underrepresented in biomedical research, said Scripps researchers, who plan to give out more this year. 

In March of 2023, Scripps researchers published a study on the tracking data that found a significant post-COVID-19 drop in physical activity. But the data are incomplete because many people can’t always afford these devices. Most of the people in the study were “White, young, and active,” they wrote.

Researchers at an All of Us site at Vanderbilt University, which also used a BYOD approach, realized that they produced biased results. They reported their findings at the Pacific Symposium on Biocomputing in January.

“[The] majority of participants who provided Fitbit data reported being White and employed for wages,” they said. “However, these data represent participants who had their own Fitbit devices and consented to share EHR [electronic health record] data.”

Their solution: The program has begun providing Fitbit devices to all study participants who do not own one or cannot afford one. 

Now, the web page for the All of Us study asks visitors to “Learn about the All of Us WEAR study. You could get a Fitbit at no cost! … As a part of the WEAR Study, you could receive a new Fitbit to wear at no cost to you. All of Us will be able to get the data the Fitbit collects. This data may help us understand how behavior impacts health.”

Jennifer Radin, PhD, an epidemiologist at Scripps Research Translational Institute, is heading up the DETECT study, which is a remote monitoring research project that has enrolled over 40,000 people who have their own sensors – be it a smartwatch or Fitbit. She was looking at remote monitoring for disease before COVID emerged.

Dr. Radin said she began researching remote sensing after working in public health and dealing with outdated data collection systems. 

“They typically rely on case reports that are recorded by pen and paper and faxed or mailed in,” she said. “Then, they have to be entered into a database. “

In addition to offering objective data on a subject’s physical response to the infection, she said, the data collection can be long-term and continuous. 

DETECT collects data on resting heart rate, which is unique to every person, and activity levels. Both measures are meaningful for those with long COVID. Her research found differences in sleep, heart rate, and activity between those with COVID and those without.

Joseph Kvedar, MD, is a Harvard Medical School researcher and the editor of  NPJ Digital Medicine. He’s been studying digital health systems and called clinical research a “beachhead” for the use of data from monitors. But he also said problems remain that need to be worked out. The quality of the devices and their Bluetooth connections are better. But different devices measure different things, and a counted step can vary from person to person, he said. And the problems of the early days of electronic health records have not been fully resolved.

“We haven’t gotten to this universal language to connect all these things and make them relevant,” he said. 

The All of Us researchers are working with the RECOVER project to address some of those issues. Usually not focused on a single condition, the All of Us researchers are testing a machine-learning approach for identifying long COVID. 
 

A version of this article originally appeared on WebMD.com.

There have been increases in suspected suicidal cannabis exposures reported to U.S. poison control centers over the past 13 years. The increases were notable both during and after the pandemic and were highest among children and female persons.

Investigators examined closed cases of cannabis-related human exposures that were coded as intentional-suspected suicidal.

Of note, there was a statistically significant increase in cannabis poisonings in young children (5-13 years) in 2021, during the pandemic, compared with 2019, a prepandemic year (3.1% vs. 1.3%; P < .001), the researchers report.

“This may speak to both increased access to cannabis as well as poor mental health status during the pandemic period,” study investigator Tracy Klein, PhD, assistant director, Center for Cannabis Policy, Research and Outreach, Washington State University Vancouver, Mount Vista, said in an interview.

The study was published online  in JAMA Network Open.

Reports of intentional poisonings with cannabis increased by roughly 17% annually over the study period. Most cases occurred in recent years and involved individuals aged 14-64 years. Nearly all (96.5%) cases involved more than one substance.

“The resemblance of cannabis edibles, implicated in the majority of poisonings to candy, vitamins, and food products, is a risk to patients across the life span who may not fully understand what they are consuming or how potent it is,” Dr. Klein said in an interview.

Overall, nearly 1 in 10 exposures resulted in death or other major outcomes (life-threatening outcomes or outcomes involving major residual disability or disfigurement). For older adults, 19.4% of exposures led to death or other major harm.

“Elderly patients may also have comorbid conditions and polypharmacy, which contributes to their much more serious outcomes from cannabis poisoning,” Dr. Klein said.

The researchers caution that, owing to the cross-sectional nature of the data, they could not identify a causal association between cannabis use and suicide attempt.

With more states legalizing cannabis use by adults, increases in cannabis use will likely persist.

“It is important to further examine the suspected association between cannabis use and suicidal behaviors and how risks can be prevented or mitigated,” the researchers note.

Dr. Klein encourages health care providers to ask patients whether they are using cannabis and how they obtain and store it.

“As with all medications and substances, storage is a key safety issue that is elicited during a careful history,” said Dr. Klein.

Support for the study was provided in part by funds provided for medical and biological research by the State of Washington Initiative Measure No. 171. Dr. Klein has disclosed no relevant financial relationships.

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

There have been increases in suspected suicidal cannabis exposures reported to U.S. poison control centers over the past 13 years. The increases were notable both during and after the pandemic and were highest among children and female persons.

Investigators examined closed cases of cannabis-related human exposures that were coded as intentional-suspected suicidal.

Of note, there was a statistically significant increase in cannabis poisonings in young children (5-13 years) in 2021, during the pandemic, compared with 2019, a prepandemic year (3.1% vs. 1.3%; P < .001), the researchers report.

“This may speak to both increased access to cannabis as well as poor mental health status during the pandemic period,” study investigator Tracy Klein, PhD, assistant director, Center for Cannabis Policy, Research and Outreach, Washington State University Vancouver, Mount Vista, said in an interview.

The study was published online  in JAMA Network Open.

Reports of intentional poisonings with cannabis increased by roughly 17% annually over the study period. Most cases occurred in recent years and involved individuals aged 14-64 years. Nearly all (96.5%) cases involved more than one substance.

“The resemblance of cannabis edibles, implicated in the majority of poisonings to candy, vitamins, and food products, is a risk to patients across the life span who may not fully understand what they are consuming or how potent it is,” Dr. Klein said in an interview.

Overall, nearly 1 in 10 exposures resulted in death or other major outcomes (life-threatening outcomes or outcomes involving major residual disability or disfigurement). For older adults, 19.4% of exposures led to death or other major harm.

“Elderly patients may also have comorbid conditions and polypharmacy, which contributes to their much more serious outcomes from cannabis poisoning,” Dr. Klein said.

The researchers caution that, owing to the cross-sectional nature of the data, they could not identify a causal association between cannabis use and suicide attempt.

With more states legalizing cannabis use by adults, increases in cannabis use will likely persist.

“It is important to further examine the suspected association between cannabis use and suicidal behaviors and how risks can be prevented or mitigated,” the researchers note.

Dr. Klein encourages health care providers to ask patients whether they are using cannabis and how they obtain and store it.

“As with all medications and substances, storage is a key safety issue that is elicited during a careful history,” said Dr. Klein.

Support for the study was provided in part by funds provided for medical and biological research by the State of Washington Initiative Measure No. 171. Dr. Klein has disclosed no relevant financial relationships.

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

There have been increases in suspected suicidal cannabis exposures reported to U.S. poison control centers over the past 13 years. The increases were notable both during and after the pandemic and were highest among children and female persons.

Investigators examined closed cases of cannabis-related human exposures that were coded as intentional-suspected suicidal.

Of note, there was a statistically significant increase in cannabis poisonings in young children (5-13 years) in 2021, during the pandemic, compared with 2019, a prepandemic year (3.1% vs. 1.3%; P < .001), the researchers report.

“This may speak to both increased access to cannabis as well as poor mental health status during the pandemic period,” study investigator Tracy Klein, PhD, assistant director, Center for Cannabis Policy, Research and Outreach, Washington State University Vancouver, Mount Vista, said in an interview.

The study was published online  in JAMA Network Open.

Reports of intentional poisonings with cannabis increased by roughly 17% annually over the study period. Most cases occurred in recent years and involved individuals aged 14-64 years. Nearly all (96.5%) cases involved more than one substance.

“The resemblance of cannabis edibles, implicated in the majority of poisonings to candy, vitamins, and food products, is a risk to patients across the life span who may not fully understand what they are consuming or how potent it is,” Dr. Klein said in an interview.

Overall, nearly 1 in 10 exposures resulted in death or other major outcomes (life-threatening outcomes or outcomes involving major residual disability or disfigurement). For older adults, 19.4% of exposures led to death or other major harm.

“Elderly patients may also have comorbid conditions and polypharmacy, which contributes to their much more serious outcomes from cannabis poisoning,” Dr. Klein said.

The researchers caution that, owing to the cross-sectional nature of the data, they could not identify a causal association between cannabis use and suicide attempt.

With more states legalizing cannabis use by adults, increases in cannabis use will likely persist.

“It is important to further examine the suspected association between cannabis use and suicidal behaviors and how risks can be prevented or mitigated,” the researchers note.

Dr. Klein encourages health care providers to ask patients whether they are using cannabis and how they obtain and store it.

“As with all medications and substances, storage is a key safety issue that is elicited during a careful history,” said Dr. Klein.

Support for the study was provided in part by funds provided for medical and biological research by the State of Washington Initiative Measure No. 171. Dr. Klein has disclosed no relevant financial relationships.

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

In a phase 2 clinical trial of a potential treatment for fatigue associated with long COVID-19, people who received the medicine reported positive results over those receiving a placebo.

The study was conducted by researchers at the University of Oxford, England, and published in eClinical Medicine.

It was one of the first randomized double-blind placebo controlled trial for a possible treatment for long COVID, according to a press release from the university. 

“People living with long COVID in the trial who received AXA1125 had a significant improvement in fatigue compared to those who received a placebo,” the university reported.

Forty-one people participated. They had fatigue for 18 months beforehand. All completed the study, and none reported serious side effects.

AXA1125 was developed by U.S. pharmaceutical company Axcella Therapeutics.

“Potential causes [of long COVID fatigue] include reduced mitochondrial function and cellular bioenergetics,” the researchers reported.

“AXA1125 was tested in long COVID fatigue as previous data from Axcella showed effects on cellular energetics and inflammation. Emerging data on long COVID suggests that the virus targets the mitochondrial, which are essential to normal energy generation and control of inflammation,” the university noted in its press release. “AXA1125 may improve energy generation and reduce the amount of inflammation in the body.”

The study’s authors wrote that AXA1125 was tied to a “significant reduction in 28-day Chalder Fatigue Questionnaire score relative to placebo.” They said participants who reported less fatigue also had better mitochondrial health and walked farther in a 6-minute test.
 

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

In a phase 2 clinical trial of a potential treatment for fatigue associated with long COVID-19, people who received the medicine reported positive results over those receiving a placebo.

The study was conducted by researchers at the University of Oxford, England, and published in eClinical Medicine.

It was one of the first randomized double-blind placebo controlled trial for a possible treatment for long COVID, according to a press release from the university. 

“People living with long COVID in the trial who received AXA1125 had a significant improvement in fatigue compared to those who received a placebo,” the university reported.

Forty-one people participated. They had fatigue for 18 months beforehand. All completed the study, and none reported serious side effects.

AXA1125 was developed by U.S. pharmaceutical company Axcella Therapeutics.

“Potential causes [of long COVID fatigue] include reduced mitochondrial function and cellular bioenergetics,” the researchers reported.

“AXA1125 was tested in long COVID fatigue as previous data from Axcella showed effects on cellular energetics and inflammation. Emerging data on long COVID suggests that the virus targets the mitochondrial, which are essential to normal energy generation and control of inflammation,” the university noted in its press release. “AXA1125 may improve energy generation and reduce the amount of inflammation in the body.”

The study’s authors wrote that AXA1125 was tied to a “significant reduction in 28-day Chalder Fatigue Questionnaire score relative to placebo.” They said participants who reported less fatigue also had better mitochondrial health and walked farther in a 6-minute test.
 

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

In a phase 2 clinical trial of a potential treatment for fatigue associated with long COVID-19, people who received the medicine reported positive results over those receiving a placebo.

The study was conducted by researchers at the University of Oxford, England, and published in eClinical Medicine.

It was one of the first randomized double-blind placebo controlled trial for a possible treatment for long COVID, according to a press release from the university. 

“People living with long COVID in the trial who received AXA1125 had a significant improvement in fatigue compared to those who received a placebo,” the university reported.

Forty-one people participated. They had fatigue for 18 months beforehand. All completed the study, and none reported serious side effects.

AXA1125 was developed by U.S. pharmaceutical company Axcella Therapeutics.

“Potential causes [of long COVID fatigue] include reduced mitochondrial function and cellular bioenergetics,” the researchers reported.

“AXA1125 was tested in long COVID fatigue as previous data from Axcella showed effects on cellular energetics and inflammation. Emerging data on long COVID suggests that the virus targets the mitochondrial, which are essential to normal energy generation and control of inflammation,” the university noted in its press release. “AXA1125 may improve energy generation and reduce the amount of inflammation in the body.”

The study’s authors wrote that AXA1125 was tied to a “significant reduction in 28-day Chalder Fatigue Questionnaire score relative to placebo.” They said participants who reported less fatigue also had better mitochondrial health and walked farther in a 6-minute test.
 

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

COVID can more than triple the chance of being diagnosed with type 2 diabetes within a year of being infected, according to a new Canadian study.

Men who had even a mild case of COVID were significantly more likely than were noninfected men to be diagnosed with type 2 diabetes. Women didn’t have an increased risk unless they were severely ill.

Both men and women who had severe cases were at the highest risk. People who were hospitalized for COVID treatment had more than a doubled risk of being diagnosed with type 2 diabetes, and those who were admitted to intensive care units had more than a tripled risk.

“This is definitely a concern in terms of long-term outcomes,” researcher and University of British Columbia professor Naveed Z. Janjua, PhD, told The New York Times. “With a respiratory infection, you usually think, ‘Seven or eight days and I’m done with it, that’s it.’ [But] here we’re seeing lingering effects that are lifelong.”

The study was published in JAMA Network Open. Researchers analyzed health data from 2020 and 2021 for 629,935 people, 20% of whom were diagnosed with COVID during that time. Most people in the study had not been vaccinated because vaccines were not widely available then. The health information came from a registry maintained by public health officials in British Columbia. The follow-up period was 257 days.

The authors cautioned that their findings could not say that COVID causes type 2 diabetes; rather, in a commentary published along with the study, Pamela B. Davis, MD, PhD, said the link makes sense because COVID is known to impact the pancreas.

“Such a stress may move a patient from a prediabetic state into diabetes,” wrote Dr. Davis, former dean of Case Western Reserve University, Cleveland, where she is now a professor.

The researchers estimated that the increased pattern of diagnoses of diabetes following COVID infection could increase the rate of the disease occurring in the general population by 3%-5% overall.
 

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

COVID can more than triple the chance of being diagnosed with type 2 diabetes within a year of being infected, according to a new Canadian study.

Men who had even a mild case of COVID were significantly more likely than were noninfected men to be diagnosed with type 2 diabetes. Women didn’t have an increased risk unless they were severely ill.

Both men and women who had severe cases were at the highest risk. People who were hospitalized for COVID treatment had more than a doubled risk of being diagnosed with type 2 diabetes, and those who were admitted to intensive care units had more than a tripled risk.

“This is definitely a concern in terms of long-term outcomes,” researcher and University of British Columbia professor Naveed Z. Janjua, PhD, told The New York Times. “With a respiratory infection, you usually think, ‘Seven or eight days and I’m done with it, that’s it.’ [But] here we’re seeing lingering effects that are lifelong.”

The study was published in JAMA Network Open. Researchers analyzed health data from 2020 and 2021 for 629,935 people, 20% of whom were diagnosed with COVID during that time. Most people in the study had not been vaccinated because vaccines were not widely available then. The health information came from a registry maintained by public health officials in British Columbia. The follow-up period was 257 days.

The authors cautioned that their findings could not say that COVID causes type 2 diabetes; rather, in a commentary published along with the study, Pamela B. Davis, MD, PhD, said the link makes sense because COVID is known to impact the pancreas.

“Such a stress may move a patient from a prediabetic state into diabetes,” wrote Dr. Davis, former dean of Case Western Reserve University, Cleveland, where she is now a professor.

The researchers estimated that the increased pattern of diagnoses of diabetes following COVID infection could increase the rate of the disease occurring in the general population by 3%-5% overall.
 

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

COVID can more than triple the chance of being diagnosed with type 2 diabetes within a year of being infected, according to a new Canadian study.

Men who had even a mild case of COVID were significantly more likely than were noninfected men to be diagnosed with type 2 diabetes. Women didn’t have an increased risk unless they were severely ill.

Both men and women who had severe cases were at the highest risk. People who were hospitalized for COVID treatment had more than a doubled risk of being diagnosed with type 2 diabetes, and those who were admitted to intensive care units had more than a tripled risk.

“This is definitely a concern in terms of long-term outcomes,” researcher and University of British Columbia professor Naveed Z. Janjua, PhD, told The New York Times. “With a respiratory infection, you usually think, ‘Seven or eight days and I’m done with it, that’s it.’ [But] here we’re seeing lingering effects that are lifelong.”

The study was published in JAMA Network Open. Researchers analyzed health data from 2020 and 2021 for 629,935 people, 20% of whom were diagnosed with COVID during that time. Most people in the study had not been vaccinated because vaccines were not widely available then. The health information came from a registry maintained by public health officials in British Columbia. The follow-up period was 257 days.

The authors cautioned that their findings could not say that COVID causes type 2 diabetes; rather, in a commentary published along with the study, Pamela B. Davis, MD, PhD, said the link makes sense because COVID is known to impact the pancreas.

“Such a stress may move a patient from a prediabetic state into diabetes,” wrote Dr. Davis, former dean of Case Western Reserve University, Cleveland, where she is now a professor.

The researchers estimated that the increased pattern of diagnoses of diabetes following COVID infection could increase the rate of the disease occurring in the general population by 3%-5% overall.
 

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

A test that uses a single drop of dried blood to detect HIV, hepatitis B virus, and HCV has been validated and is now in use in some high-risk settings in Denmark, according to research presented at the annual European Congress of Clinical Microbiology & Infectious Diseases.

Molecular biologist Stephen Nilsson-Møller, MSc, and colleagues at the department of clinical microbiology, Copenhagen University Hospital, developed and validated the test, known as the Dried Blood Spot (DBS), for HIV, HBV, and HCV.

The “test that can detect low viral loads for all three viruses from a single drop of blood, and can be done using existing hospital equipment,” Mr. Nilsson-Møller said in an interview. “Importantly, it does not require venipuncture, but can be done from a drop of dried blood from the finger.”

He highlighted the utility of the new test in more challenging settings. “This method is particularly useful in high-risk settings such as homeless shelters, drug rehabilitation centers, and prisons, where needles might be misused, and it can be difficult to convince people to have the more invasive test.”

“Also, in some places – such as in low- and middle-income settings – there is a distinct risk of ruining blood samples before analysis due to limited refrigeration for transit and storage,” he added. “[Standard] blood samples need to be analyzed within 6 hours when kept at room temperature, while dried blood spots can last for 9 months at room temperature and can be mailed to a laboratory with the right equipment to analyze it.” 
 

Tiny amounts of virus detected

Mr. Nilsson-Møller was tasked with developing a test for use by the university’s department of infectious diseases to screen people in high-risk settings in the capital region of Copenhagen. The work forms part of a PhD project by Jonas Demant at the University of Copenhagen, for which he is screening for HIV, HBV, and HCV in drug rehabilitation centers, prisons, and homeless shelters. 

The study is the first to use the Hologic Panther system (a nucleic acid amplification test) combining all three viruses, Mr. Nilsson-Møller pointed out. “A tiny amount of virus can be detected because it is a very sensitive platform using transcription-mediated amplification.”

“If it detects low amounts of virus, it will create many copies very quickly, creating a signal that tells us that the sample is positive,” he explained.

The researchers collected whole blood from a finger prick, dried it out on a protein saver card (filter paper), and cut out a 1.2-cm diameter dry blood spot which was then prepared for analysis.

Twenty blood samples with known amounts of HIV, HBV, and HCV were analyzed via the DBS method (60 in total) and the viruses were detected in all of the samples.

To validate the method, the researchers used plasma with a known viral load, and a series of dilutions were performed to determine the lower limit for positive detection of all three viruses.

“Untreated patients typically have above 1 million IU/mL of viral loads in their plasma, and we found that we can detect much lower levels,” said Mr. Nilsson-Møller. “Ideally, 40 mcL of blood is good, but less should be sufficient if the test is on untreated patients.”
 

Early testing and treatment reduces morbidity and mortality

Elimination of HBV, HCV, and HIV by 2030 is a global health strategy set by the World Health Organization, but to meet this goal, new approaches for diagnostic testing are required. The DBS test for HIV, HBV, and HCV promises to make a significant contribution toward this goal.

“One in two people currently living with HIV is diagnosed late in the course of their infection, and an even larger proportion of the estimated 6 million Europeans living with chronic hepatitis B or C are not aware that they are infected,” said Anastasia Pharris, PhD, from the European Center for Disease Prevention and Control Principal Expert Infectious Diseases.

“Increasing testing coverage and uptake, especially for those most at risk, is an essential element of any strategy to eliminate HBV, HCV, and HIV in the European Union and European Economic Area,” she pointed out.

Dr. Pharris also highlighted that, while HIV, and often HBV infection, require lifelong treatment, HCV infection is now curable within a few weeks. “To maximize the benefits of individual treatment for all three infections, it is critical to test and diagnose people as soon as possible – in itself a challenge given that these infections can typically be asymptomatic for years.

“Early diagnosis of HBV, HCV, or HIV is vital as it allows people to access treatment, which significantly reduces associated long-term morbidity and mortality.

“In many cases, those most at risk of one of these infections are also more vulnerable to infection with one or both of the other viruses, making the argument for integrated testing even stronger,” she said in an interview.

Mr. Nilsson-Møller and Dr. Pharris reported no relevant financial relationships. Aptima kits for validation were provided by Hologic.

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

A test that uses a single drop of dried blood to detect HIV, hepatitis B virus, and HCV has been validated and is now in use in some high-risk settings in Denmark, according to research presented at the annual European Congress of Clinical Microbiology & Infectious Diseases.

Molecular biologist Stephen Nilsson-Møller, MSc, and colleagues at the department of clinical microbiology, Copenhagen University Hospital, developed and validated the test, known as the Dried Blood Spot (DBS), for HIV, HBV, and HCV.

The “test that can detect low viral loads for all three viruses from a single drop of blood, and can be done using existing hospital equipment,” Mr. Nilsson-Møller said in an interview. “Importantly, it does not require venipuncture, but can be done from a drop of dried blood from the finger.”

He highlighted the utility of the new test in more challenging settings. “This method is particularly useful in high-risk settings such as homeless shelters, drug rehabilitation centers, and prisons, where needles might be misused, and it can be difficult to convince people to have the more invasive test.”

“Also, in some places – such as in low- and middle-income settings – there is a distinct risk of ruining blood samples before analysis due to limited refrigeration for transit and storage,” he added. “[Standard] blood samples need to be analyzed within 6 hours when kept at room temperature, while dried blood spots can last for 9 months at room temperature and can be mailed to a laboratory with the right equipment to analyze it.” 
 

Tiny amounts of virus detected

Mr. Nilsson-Møller was tasked with developing a test for use by the university’s department of infectious diseases to screen people in high-risk settings in the capital region of Copenhagen. The work forms part of a PhD project by Jonas Demant at the University of Copenhagen, for which he is screening for HIV, HBV, and HCV in drug rehabilitation centers, prisons, and homeless shelters. 

The study is the first to use the Hologic Panther system (a nucleic acid amplification test) combining all three viruses, Mr. Nilsson-Møller pointed out. “A tiny amount of virus can be detected because it is a very sensitive platform using transcription-mediated amplification.”

“If it detects low amounts of virus, it will create many copies very quickly, creating a signal that tells us that the sample is positive,” he explained.

The researchers collected whole blood from a finger prick, dried it out on a protein saver card (filter paper), and cut out a 1.2-cm diameter dry blood spot which was then prepared for analysis.

Twenty blood samples with known amounts of HIV, HBV, and HCV were analyzed via the DBS method (60 in total) and the viruses were detected in all of the samples.

To validate the method, the researchers used plasma with a known viral load, and a series of dilutions were performed to determine the lower limit for positive detection of all three viruses.

“Untreated patients typically have above 1 million IU/mL of viral loads in their plasma, and we found that we can detect much lower levels,” said Mr. Nilsson-Møller. “Ideally, 40 mcL of blood is good, but less should be sufficient if the test is on untreated patients.”
 

Early testing and treatment reduces morbidity and mortality

Elimination of HBV, HCV, and HIV by 2030 is a global health strategy set by the World Health Organization, but to meet this goal, new approaches for diagnostic testing are required. The DBS test for HIV, HBV, and HCV promises to make a significant contribution toward this goal.

“One in two people currently living with HIV is diagnosed late in the course of their infection, and an even larger proportion of the estimated 6 million Europeans living with chronic hepatitis B or C are not aware that they are infected,” said Anastasia Pharris, PhD, from the European Center for Disease Prevention and Control Principal Expert Infectious Diseases.

“Increasing testing coverage and uptake, especially for those most at risk, is an essential element of any strategy to eliminate HBV, HCV, and HIV in the European Union and European Economic Area,” she pointed out.

Dr. Pharris also highlighted that, while HIV, and often HBV infection, require lifelong treatment, HCV infection is now curable within a few weeks. “To maximize the benefits of individual treatment for all three infections, it is critical to test and diagnose people as soon as possible – in itself a challenge given that these infections can typically be asymptomatic for years.

“Early diagnosis of HBV, HCV, or HIV is vital as it allows people to access treatment, which significantly reduces associated long-term morbidity and mortality.

“In many cases, those most at risk of one of these infections are also more vulnerable to infection with one or both of the other viruses, making the argument for integrated testing even stronger,” she said in an interview.

Mr. Nilsson-Møller and Dr. Pharris reported no relevant financial relationships. Aptima kits for validation were provided by Hologic.

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

A test that uses a single drop of dried blood to detect HIV, hepatitis B virus, and HCV has been validated and is now in use in some high-risk settings in Denmark, according to research presented at the annual European Congress of Clinical Microbiology & Infectious Diseases.

Molecular biologist Stephen Nilsson-Møller, MSc, and colleagues at the department of clinical microbiology, Copenhagen University Hospital, developed and validated the test, known as the Dried Blood Spot (DBS), for HIV, HBV, and HCV.

The “test that can detect low viral loads for all three viruses from a single drop of blood, and can be done using existing hospital equipment,” Mr. Nilsson-Møller said in an interview. “Importantly, it does not require venipuncture, but can be done from a drop of dried blood from the finger.”

He highlighted the utility of the new test in more challenging settings. “This method is particularly useful in high-risk settings such as homeless shelters, drug rehabilitation centers, and prisons, where needles might be misused, and it can be difficult to convince people to have the more invasive test.”

“Also, in some places – such as in low- and middle-income settings – there is a distinct risk of ruining blood samples before analysis due to limited refrigeration for transit and storage,” he added. “[Standard] blood samples need to be analyzed within 6 hours when kept at room temperature, while dried blood spots can last for 9 months at room temperature and can be mailed to a laboratory with the right equipment to analyze it.” 
 

Tiny amounts of virus detected

Mr. Nilsson-Møller was tasked with developing a test for use by the university’s department of infectious diseases to screen people in high-risk settings in the capital region of Copenhagen. The work forms part of a PhD project by Jonas Demant at the University of Copenhagen, for which he is screening for HIV, HBV, and HCV in drug rehabilitation centers, prisons, and homeless shelters. 

The study is the first to use the Hologic Panther system (a nucleic acid amplification test) combining all three viruses, Mr. Nilsson-Møller pointed out. “A tiny amount of virus can be detected because it is a very sensitive platform using transcription-mediated amplification.”

“If it detects low amounts of virus, it will create many copies very quickly, creating a signal that tells us that the sample is positive,” he explained.

The researchers collected whole blood from a finger prick, dried it out on a protein saver card (filter paper), and cut out a 1.2-cm diameter dry blood spot which was then prepared for analysis.

Twenty blood samples with known amounts of HIV, HBV, and HCV were analyzed via the DBS method (60 in total) and the viruses were detected in all of the samples.

To validate the method, the researchers used plasma with a known viral load, and a series of dilutions were performed to determine the lower limit for positive detection of all three viruses.

“Untreated patients typically have above 1 million IU/mL of viral loads in their plasma, and we found that we can detect much lower levels,” said Mr. Nilsson-Møller. “Ideally, 40 mcL of blood is good, but less should be sufficient if the test is on untreated patients.”
 

Early testing and treatment reduces morbidity and mortality

Elimination of HBV, HCV, and HIV by 2030 is a global health strategy set by the World Health Organization, but to meet this goal, new approaches for diagnostic testing are required. The DBS test for HIV, HBV, and HCV promises to make a significant contribution toward this goal.

“One in two people currently living with HIV is diagnosed late in the course of their infection, and an even larger proportion of the estimated 6 million Europeans living with chronic hepatitis B or C are not aware that they are infected,” said Anastasia Pharris, PhD, from the European Center for Disease Prevention and Control Principal Expert Infectious Diseases.

“Increasing testing coverage and uptake, especially for those most at risk, is an essential element of any strategy to eliminate HBV, HCV, and HIV in the European Union and European Economic Area,” she pointed out.

Dr. Pharris also highlighted that, while HIV, and often HBV infection, require lifelong treatment, HCV infection is now curable within a few weeks. “To maximize the benefits of individual treatment for all three infections, it is critical to test and diagnose people as soon as possible – in itself a challenge given that these infections can typically be asymptomatic for years.

“Early diagnosis of HBV, HCV, or HIV is vital as it allows people to access treatment, which significantly reduces associated long-term morbidity and mortality.

“In many cases, those most at risk of one of these infections are also more vulnerable to infection with one or both of the other viruses, making the argument for integrated testing even stronger,” she said in an interview.

Mr. Nilsson-Møller and Dr. Pharris reported no relevant financial relationships. Aptima kits for validation were provided by Hologic.

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

I recently posted a case about a smoker who became angry when I hesitated to prescribe antibiotics for his self-diagnosed bronchitis. He even threatened to retaliate by posting negative online reviews of my practice. In the end, I decided to use the strategy of a delayed prescription for antibiotics, instructing him to fill the prescription only if his symptoms worsened. I asked whether readers agreed with this approach. Thank you for the thoughtful comments regarding a case that certainly seemed familiar to many of you. I very much appreciate the chance to interact and share perspectives in a challenging clinical dilemma.
 

One theme that emerged through several comments was the perceived futility of the delayed prescriptions for antibiotics. To summarize, the collective logic stated that there is no point in delaying a prescription, because the patient will be very likely to fill that prescription right away despite counseling from the health care provider (HCP).

However, studies of delayed antibiotic prescriptions show that patients generally honor the advice to only fill the prescription if they are not improving clinically. In a study comparing immediate, delayed, or no antibiotic prescriptions among a cohort of children with uncomplicated respiratory infections, the overall rates of use of antibiotics in the three respective groups were 96%, 25.3%, and 12.0%. In another randomized trial exploring different strategies for delayed prescriptions among adults with upper respiratory infections, the rate of antibiotic use was 37% with delayed prescription strategies vs. 97% of patients prescribed antibiotics immediately. Neither of these prospective studies found a significant difference in clinical symptoms or complications in comparing the delayed and immediate antibiotic prescription groups.

Another common theme in the comments on this case focused on the challenge of online reviews of HCPs by patients. Multiple popular websites are devoted to patients’ unedited comments on HCPs and their practices, but there are still certain patterns to the comments. Some reviews describe the professionalism or empathy of the HCP, but others might focus more attention on the overall practice or office. These latter comments might emphasize issues such as timeliness of appointments, interactions with staff, or even parking and traffic. These are issues over which the HCP usually has little control.

HCPs are quite human, and therefore we might feel great about positive comments and dispirited or even angry with negative comments. So what is the best practice for HCPs in managing these online comments? A review by Dr Rebekah Bernard, which was published in the Sept. 25, 2018, issue of Medical Economics, offered some pragmatic advice:

Do not perseverate on one or two negative reviews. In fact, they might help! Dr. Bernard describes the psychological theory of the “pratfall effect,” in which people are more likely to prefer someone who is generally very good but not perfect to someone with nothing but exceptional reviews. HCPs with perfect reviews every time may be seen as intimidating or unapproachable.

Satisfied patients will frequently rally to support an HCP with an unfavorable review. This group may not be very motivated to complete online reviews until they see a comment which does at all match their own experience with the HCP.

Most importantly, HCPs can take an active role in minimizing the impact of negative online reviews while also enhancing their business model. Increasing your presence on the Internet and social media can help dilute negative reviews and push them down the list when someone performs a search on your name or practice. Creating a website for your practice is an effective means to be first on search engine lists, and HCPs should seek search-engine optimization features that promote this outcome. Adding social media contacts for yourself and/or your practice, as many as you can tolerate and maintain, allows HCPs to further control the narrative regarding their practice and central messaging to patients and the community.

In conclusion, delayed antibiotic prescriptions can reduce the use of unnecessary antibiotics for upper respiratory infections among children and adults, and they are not associated with worse clinical outcomes vs. immediate antibiotic prescriptions. They can also improve patient satisfaction for these visits, which can minimize the challenging issue of negative reviews of HCPs. HCPs should therefore consider delayed prescriptions as a strong option among patients without an indication for an antibiotic prescription.

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

I recently posted a case about a smoker who became angry when I hesitated to prescribe antibiotics for his self-diagnosed bronchitis. He even threatened to retaliate by posting negative online reviews of my practice. In the end, I decided to use the strategy of a delayed prescription for antibiotics, instructing him to fill the prescription only if his symptoms worsened. I asked whether readers agreed with this approach. Thank you for the thoughtful comments regarding a case that certainly seemed familiar to many of you. I very much appreciate the chance to interact and share perspectives in a challenging clinical dilemma.
 

One theme that emerged through several comments was the perceived futility of the delayed prescriptions for antibiotics. To summarize, the collective logic stated that there is no point in delaying a prescription, because the patient will be very likely to fill that prescription right away despite counseling from the health care provider (HCP).

However, studies of delayed antibiotic prescriptions show that patients generally honor the advice to only fill the prescription if they are not improving clinically. In a study comparing immediate, delayed, or no antibiotic prescriptions among a cohort of children with uncomplicated respiratory infections, the overall rates of use of antibiotics in the three respective groups were 96%, 25.3%, and 12.0%. In another randomized trial exploring different strategies for delayed prescriptions among adults with upper respiratory infections, the rate of antibiotic use was 37% with delayed prescription strategies vs. 97% of patients prescribed antibiotics immediately. Neither of these prospective studies found a significant difference in clinical symptoms or complications in comparing the delayed and immediate antibiotic prescription groups.

Another common theme in the comments on this case focused on the challenge of online reviews of HCPs by patients. Multiple popular websites are devoted to patients’ unedited comments on HCPs and their practices, but there are still certain patterns to the comments. Some reviews describe the professionalism or empathy of the HCP, but others might focus more attention on the overall practice or office. These latter comments might emphasize issues such as timeliness of appointments, interactions with staff, or even parking and traffic. These are issues over which the HCP usually has little control.

HCPs are quite human, and therefore we might feel great about positive comments and dispirited or even angry with negative comments. So what is the best practice for HCPs in managing these online comments? A review by Dr Rebekah Bernard, which was published in the Sept. 25, 2018, issue of Medical Economics, offered some pragmatic advice:

Do not perseverate on one or two negative reviews. In fact, they might help! Dr. Bernard describes the psychological theory of the “pratfall effect,” in which people are more likely to prefer someone who is generally very good but not perfect to someone with nothing but exceptional reviews. HCPs with perfect reviews every time may be seen as intimidating or unapproachable.

Satisfied patients will frequently rally to support an HCP with an unfavorable review. This group may not be very motivated to complete online reviews until they see a comment which does at all match their own experience with the HCP.

Most importantly, HCPs can take an active role in minimizing the impact of negative online reviews while also enhancing their business model. Increasing your presence on the Internet and social media can help dilute negative reviews and push them down the list when someone performs a search on your name or practice. Creating a website for your practice is an effective means to be first on search engine lists, and HCPs should seek search-engine optimization features that promote this outcome. Adding social media contacts for yourself and/or your practice, as many as you can tolerate and maintain, allows HCPs to further control the narrative regarding their practice and central messaging to patients and the community.

In conclusion, delayed antibiotic prescriptions can reduce the use of unnecessary antibiotics for upper respiratory infections among children and adults, and they are not associated with worse clinical outcomes vs. immediate antibiotic prescriptions. They can also improve patient satisfaction for these visits, which can minimize the challenging issue of negative reviews of HCPs. HCPs should therefore consider delayed prescriptions as a strong option among patients without an indication for an antibiotic prescription.

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

I recently posted a case about a smoker who became angry when I hesitated to prescribe antibiotics for his self-diagnosed bronchitis. He even threatened to retaliate by posting negative online reviews of my practice. In the end, I decided to use the strategy of a delayed prescription for antibiotics, instructing him to fill the prescription only if his symptoms worsened. I asked whether readers agreed with this approach. Thank you for the thoughtful comments regarding a case that certainly seemed familiar to many of you. I very much appreciate the chance to interact and share perspectives in a challenging clinical dilemma.
 

One theme that emerged through several comments was the perceived futility of the delayed prescriptions for antibiotics. To summarize, the collective logic stated that there is no point in delaying a prescription, because the patient will be very likely to fill that prescription right away despite counseling from the health care provider (HCP).

However, studies of delayed antibiotic prescriptions show that patients generally honor the advice to only fill the prescription if they are not improving clinically. In a study comparing immediate, delayed, or no antibiotic prescriptions among a cohort of children with uncomplicated respiratory infections, the overall rates of use of antibiotics in the three respective groups were 96%, 25.3%, and 12.0%. In another randomized trial exploring different strategies for delayed prescriptions among adults with upper respiratory infections, the rate of antibiotic use was 37% with delayed prescription strategies vs. 97% of patients prescribed antibiotics immediately. Neither of these prospective studies found a significant difference in clinical symptoms or complications in comparing the delayed and immediate antibiotic prescription groups.

Another common theme in the comments on this case focused on the challenge of online reviews of HCPs by patients. Multiple popular websites are devoted to patients’ unedited comments on HCPs and their practices, but there are still certain patterns to the comments. Some reviews describe the professionalism or empathy of the HCP, but others might focus more attention on the overall practice or office. These latter comments might emphasize issues such as timeliness of appointments, interactions with staff, or even parking and traffic. These are issues over which the HCP usually has little control.

HCPs are quite human, and therefore we might feel great about positive comments and dispirited or even angry with negative comments. So what is the best practice for HCPs in managing these online comments? A review by Dr Rebekah Bernard, which was published in the Sept. 25, 2018, issue of Medical Economics, offered some pragmatic advice:

Do not perseverate on one or two negative reviews. In fact, they might help! Dr. Bernard describes the psychological theory of the “pratfall effect,” in which people are more likely to prefer someone who is generally very good but not perfect to someone with nothing but exceptional reviews. HCPs with perfect reviews every time may be seen as intimidating or unapproachable.

Satisfied patients will frequently rally to support an HCP with an unfavorable review. This group may not be very motivated to complete online reviews until they see a comment which does at all match their own experience with the HCP.

Most importantly, HCPs can take an active role in minimizing the impact of negative online reviews while also enhancing their business model. Increasing your presence on the Internet and social media can help dilute negative reviews and push them down the list when someone performs a search on your name or practice. Creating a website for your practice is an effective means to be first on search engine lists, and HCPs should seek search-engine optimization features that promote this outcome. Adding social media contacts for yourself and/or your practice, as many as you can tolerate and maintain, allows HCPs to further control the narrative regarding their practice and central messaging to patients and the community.

In conclusion, delayed antibiotic prescriptions can reduce the use of unnecessary antibiotics for upper respiratory infections among children and adults, and they are not associated with worse clinical outcomes vs. immediate antibiotic prescriptions. They can also improve patient satisfaction for these visits, which can minimize the challenging issue of negative reviews of HCPs. HCPs should therefore consider delayed prescriptions as a strong option among patients without an indication for an antibiotic prescription.

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

The Centers for Medicare & Medicaid Services (CMS) released its annual update to the inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) PPS on April 10, with many changes centered around improving health equity and quality as well as alleviating rural clinician shortages.

“This proposed rule reflects our person-centric approach to better measure health care quality and safety in hospitals to reduce preventable harm and our commitment to ensure that people with Medicare in rural and underserved areas have improved access to high-quality health care,” said CMS Administrator Chiquita Brooks-LaSure said in a statement.

Here are 14 things to know about the fiscal year (FY) 2024 proposal:

1. New payment rate: Acute-care hospitals that report inpatient quality data and participate in the EHR Meaningful Use program will receive a 2.8% net increase in payment rates. The rate adjustment will send approximately $3.3 billion more funding to hospitals compared with 2023.

2. LTCH payments: CMS projects that the LTCH standard payment rate will increase by 2.9%, whereas discharge payments will decrease by 2.5% or $59 million.

3. Disproportionate share hospital payments: Medicare disproportionate share hospital payments and Medicare uncompensated care payments will decrease by about $115 million for FY 2024.

4. Health equity categories: CMS proposes adding 15 new health equity hospital categorizations for IPPS payments to advance the goals of its Framework for Health Equity initiative.   

5. Social determinants of health codes: To reflect increased resource utilization, the severity designation for the three International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnosis codes describing homelessness will change from noncomplication or comorbidity to complication or comorbidity.

6. Rural emergency hospitals: The proposed rule will allow designated rural emergency hospitals to serve as training sites and receive Medicare graduate medical education payments to address concerns over rural hospital closures.

7. COVID treatment add-on payments: If the public health emergency ends in May, add-on payments for discharges involving eligible products like convalescent plasma and nirmatrelvir-ritonavir will expire on Sept. 30.

8. Technology add-on payments: Requests for new technology add-on payments must include a complete, active Food and Drug Administration market authorization application. Beginning with FY 2025 applications, the FDA approval deadline will move from July 1 to May 1.

9. Physician-owned hospitals: To receive Medicare payment for services referred by a physician owner or investor, the hospital must satisfy all requirements of the whole hospital exception or the rural provider exception to the Stark Law. In either case, a hospital may not increase the aggregate number of operating rooms, procedure rooms, or beds above the level it was licensed for on March 23, 2010, unless CMS grants an exception.

10. Electronic clinical quality measures: The new rule will remove and modify several existing electronic clinical quality measures and add three new ones: hospital harm, pressure injury; hospital harm, acute kidney injury; and excessive radiation dose or inadequate image quality for diagnostic CT in adult inpatients.

11. HCAHPS survey: Beginning Jan. 1, 2025, modifications to the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey will extend the data collection period from 42 to 49 days, limit supplemental survey items to 12, and require an official Spanish translation for patients.

12. Safety-net hospitals request for information: CMS seeks public input about the unique challenges faced by safety-net hospitals and potential solutions to ensure that uninsured, underinsured, and other vulnerable populations have access to essential services.

13. LTCH quality reporting: CMS proposes several quality-measure updates, including a functional discharge score measure beginning in FY 2025 and reporting the percentage of patients current with Centers for Disease Control and Prevention–recommended COVID vaccinations starting in FY 2026.

14. Commenting period: CMS will accept comments on the proposed rule through June 9.
 

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

The Centers for Medicare & Medicaid Services (CMS) released its annual update to the inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) PPS on April 10, with many changes centered around improving health equity and quality as well as alleviating rural clinician shortages.

“This proposed rule reflects our person-centric approach to better measure health care quality and safety in hospitals to reduce preventable harm and our commitment to ensure that people with Medicare in rural and underserved areas have improved access to high-quality health care,” said CMS Administrator Chiquita Brooks-LaSure said in a statement.

Here are 14 things to know about the fiscal year (FY) 2024 proposal:

1. New payment rate: Acute-care hospitals that report inpatient quality data and participate in the EHR Meaningful Use program will receive a 2.8% net increase in payment rates. The rate adjustment will send approximately $3.3 billion more funding to hospitals compared with 2023.

2. LTCH payments: CMS projects that the LTCH standard payment rate will increase by 2.9%, whereas discharge payments will decrease by 2.5% or $59 million.

3. Disproportionate share hospital payments: Medicare disproportionate share hospital payments and Medicare uncompensated care payments will decrease by about $115 million for FY 2024.

4. Health equity categories: CMS proposes adding 15 new health equity hospital categorizations for IPPS payments to advance the goals of its Framework for Health Equity initiative.   

5. Social determinants of health codes: To reflect increased resource utilization, the severity designation for the three International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnosis codes describing homelessness will change from noncomplication or comorbidity to complication or comorbidity.

6. Rural emergency hospitals: The proposed rule will allow designated rural emergency hospitals to serve as training sites and receive Medicare graduate medical education payments to address concerns over rural hospital closures.

7. COVID treatment add-on payments: If the public health emergency ends in May, add-on payments for discharges involving eligible products like convalescent plasma and nirmatrelvir-ritonavir will expire on Sept. 30.

8. Technology add-on payments: Requests for new technology add-on payments must include a complete, active Food and Drug Administration market authorization application. Beginning with FY 2025 applications, the FDA approval deadline will move from July 1 to May 1.

9. Physician-owned hospitals: To receive Medicare payment for services referred by a physician owner or investor, the hospital must satisfy all requirements of the whole hospital exception or the rural provider exception to the Stark Law. In either case, a hospital may not increase the aggregate number of operating rooms, procedure rooms, or beds above the level it was licensed for on March 23, 2010, unless CMS grants an exception.

10. Electronic clinical quality measures: The new rule will remove and modify several existing electronic clinical quality measures and add three new ones: hospital harm, pressure injury; hospital harm, acute kidney injury; and excessive radiation dose or inadequate image quality for diagnostic CT in adult inpatients.

11. HCAHPS survey: Beginning Jan. 1, 2025, modifications to the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey will extend the data collection period from 42 to 49 days, limit supplemental survey items to 12, and require an official Spanish translation for patients.

12. Safety-net hospitals request for information: CMS seeks public input about the unique challenges faced by safety-net hospitals and potential solutions to ensure that uninsured, underinsured, and other vulnerable populations have access to essential services.

13. LTCH quality reporting: CMS proposes several quality-measure updates, including a functional discharge score measure beginning in FY 2025 and reporting the percentage of patients current with Centers for Disease Control and Prevention–recommended COVID vaccinations starting in FY 2026.

14. Commenting period: CMS will accept comments on the proposed rule through June 9.
 

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

The Centers for Medicare & Medicaid Services (CMS) released its annual update to the inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) PPS on April 10, with many changes centered around improving health equity and quality as well as alleviating rural clinician shortages.

“This proposed rule reflects our person-centric approach to better measure health care quality and safety in hospitals to reduce preventable harm and our commitment to ensure that people with Medicare in rural and underserved areas have improved access to high-quality health care,” said CMS Administrator Chiquita Brooks-LaSure said in a statement.

Here are 14 things to know about the fiscal year (FY) 2024 proposal:

1. New payment rate: Acute-care hospitals that report inpatient quality data and participate in the EHR Meaningful Use program will receive a 2.8% net increase in payment rates. The rate adjustment will send approximately $3.3 billion more funding to hospitals compared with 2023.

2. LTCH payments: CMS projects that the LTCH standard payment rate will increase by 2.9%, whereas discharge payments will decrease by 2.5% or $59 million.

3. Disproportionate share hospital payments: Medicare disproportionate share hospital payments and Medicare uncompensated care payments will decrease by about $115 million for FY 2024.

4. Health equity categories: CMS proposes adding 15 new health equity hospital categorizations for IPPS payments to advance the goals of its Framework for Health Equity initiative.   

5. Social determinants of health codes: To reflect increased resource utilization, the severity designation for the three International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnosis codes describing homelessness will change from noncomplication or comorbidity to complication or comorbidity.

6. Rural emergency hospitals: The proposed rule will allow designated rural emergency hospitals to serve as training sites and receive Medicare graduate medical education payments to address concerns over rural hospital closures.

7. COVID treatment add-on payments: If the public health emergency ends in May, add-on payments for discharges involving eligible products like convalescent plasma and nirmatrelvir-ritonavir will expire on Sept. 30.

8. Technology add-on payments: Requests for new technology add-on payments must include a complete, active Food and Drug Administration market authorization application. Beginning with FY 2025 applications, the FDA approval deadline will move from July 1 to May 1.

9. Physician-owned hospitals: To receive Medicare payment for services referred by a physician owner or investor, the hospital must satisfy all requirements of the whole hospital exception or the rural provider exception to the Stark Law. In either case, a hospital may not increase the aggregate number of operating rooms, procedure rooms, or beds above the level it was licensed for on March 23, 2010, unless CMS grants an exception.

10. Electronic clinical quality measures: The new rule will remove and modify several existing electronic clinical quality measures and add three new ones: hospital harm, pressure injury; hospital harm, acute kidney injury; and excessive radiation dose or inadequate image quality for diagnostic CT in adult inpatients.

11. HCAHPS survey: Beginning Jan. 1, 2025, modifications to the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey will extend the data collection period from 42 to 49 days, limit supplemental survey items to 12, and require an official Spanish translation for patients.

12. Safety-net hospitals request for information: CMS seeks public input about the unique challenges faced by safety-net hospitals and potential solutions to ensure that uninsured, underinsured, and other vulnerable populations have access to essential services.

13. LTCH quality reporting: CMS proposes several quality-measure updates, including a functional discharge score measure beginning in FY 2025 and reporting the percentage of patients current with Centers for Disease Control and Prevention–recommended COVID vaccinations starting in FY 2026.

14. Commenting period: CMS will accept comments on the proposed rule through June 9.
 

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

The Centers for Disease Control and Prevention has endorsed a plan to “allow” people over age 65 and those who are immunocompromised to get a second dose of the COVID-19 bivalent booster.

This backs the Food and Drug Administration’s authorization April 18 of the additional shot.

“Following FDA regulatory action, CDC has taken steps to simplify COVID-19 vaccine recommendations and allow more flexibility for people at higher risk who want the option of added protection from additional COVID-19 vaccine doses,” the CDC said in a statement.

The agency is following the recommendations made by its Advisory Committee on Immunization Practices (ACIP). While there was no vote, the group reaffirmed its commitment to boosters overall, proposing that all Americans over age 6 who have not had a bivalent mRNA COVID-19 booster vaccine go ahead and get one.

But most others who’ve already had the bivalent shot – which targets the original COVID strain and the two Omicron variants BA.4 and BA.5 – should wait until the fall to get whatever updated vaccine is available.

The panel did carve out exceptions for people over age 65 and those who are immunocompromised because they are at higher risk for severe COVID-19 complications, Evelyn Twentyman, MD, MPH, the lead official in the CDC’s COVID-19 Vaccine Policy Unit, said during the meeting.

People over 65 can now choose to get a second bivalent mRNA booster shot as long as it has been at least 4 months since the last one, she said, and people who are immunocompromised also should have the flexibility to receive one or more additional bivalent boosters at least 2 months after an initial dose.

Regardless of whether someone is unvaccinated, and regardless of how many single-strain COVID vaccines an individual has previously received, they should get a mRNA bivalent shot, Dr. Twentyman said.

If an individual has already received a bivalent mRNA booster – made by either Pfizer/BioNTech or Moderna – “your vaccination is complete,” she said. “No doses indicated at this time, come back and see us in autumn of 2023.”

The CDC is trying to encourage more people to get the updated COVID shot, as just 17% of Americans of any age have received a bivalent booster and only 43% of those age 65 and over.

The CDC followed the FDA’s lead in its statement, phasing out the original single-strain COVID vaccine, saying it will no longer be recommended for use in the United States.
 

‘Unnecessary drama’ over children’s recs

The CDC panel mostly followed the FDA’s guidance on who should get a booster, but many ACIP members expressed consternation and confusion about what was being recommended for children.

For children aged 6 months to 4 years, the CDC will offer tables to help physicians determine how many bivalent doses to give, depending on the child’s vaccination history.

All children those ages should get at least two vaccine doses, one of which is bivalent, Dr. Twentyman said. For children in that age group who have already received a monovalent series and a bivalent dose, “their vaccination is complete,” she said.

For 5-year-olds, the recommendations will be similar if they received a Pfizer monovalent series, but the shot regimen will have to be customized if they had previously received a Moderna shot, because of differences in the dosages.

ACIP member Sarah S. Long, MD, professor of pediatrics, Drexel University, Philadelphia, said that it was unclear why a set age couldn’t be established for COVID-19 vaccination as it had been for other immunizations.

“We picked 60 months for most immunizations in children,” Dr. Long said. “Immunologically there is not a difference between a 4-, a 5- and a 6-year-old.

“There isn’t a reason to have all this unnecessary drama around those ages,” she said, adding that having the different ages would make it harder for pediatricians to appropriately stock vaccines.

Dr. Twentyman said that the CDC would be providing more detailed guidance on its COVID-19 website soon and would be holding a call with health care professionals to discuss the updated recommendations on May 11.
 

New vaccine by fall

CDC and ACIP members both said they hoped to have an even simpler vaccine schedule by the fall, when it is anticipated that the FDA may have authorized a new, updated bivalent vaccine that targets other COVID variants.

“We all recognize this is a work in progress,” said ACIP Chair Grace M. Lee, MD, MPH, acknowledging that there is continued confusion over COVID-19 vaccination.

“The goal really is to try to simplify things over time to be able to help communicate with our provider community, and our patients and families what vaccine is right for them, when do they need it, and how often should they get it,” said Dr. Lee, professor of pediatrics, Stanford (Calif.) University.
 

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

The Centers for Disease Control and Prevention has endorsed a plan to “allow” people over age 65 and those who are immunocompromised to get a second dose of the COVID-19 bivalent booster.

This backs the Food and Drug Administration’s authorization April 18 of the additional shot.

“Following FDA regulatory action, CDC has taken steps to simplify COVID-19 vaccine recommendations and allow more flexibility for people at higher risk who want the option of added protection from additional COVID-19 vaccine doses,” the CDC said in a statement.

The agency is following the recommendations made by its Advisory Committee on Immunization Practices (ACIP). While there was no vote, the group reaffirmed its commitment to boosters overall, proposing that all Americans over age 6 who have not had a bivalent mRNA COVID-19 booster vaccine go ahead and get one.

But most others who’ve already had the bivalent shot – which targets the original COVID strain and the two Omicron variants BA.4 and BA.5 – should wait until the fall to get whatever updated vaccine is available.

The panel did carve out exceptions for people over age 65 and those who are immunocompromised because they are at higher risk for severe COVID-19 complications, Evelyn Twentyman, MD, MPH, the lead official in the CDC’s COVID-19 Vaccine Policy Unit, said during the meeting.

People over 65 can now choose to get a second bivalent mRNA booster shot as long as it has been at least 4 months since the last one, she said, and people who are immunocompromised also should have the flexibility to receive one or more additional bivalent boosters at least 2 months after an initial dose.

Regardless of whether someone is unvaccinated, and regardless of how many single-strain COVID vaccines an individual has previously received, they should get a mRNA bivalent shot, Dr. Twentyman said.

If an individual has already received a bivalent mRNA booster – made by either Pfizer/BioNTech or Moderna – “your vaccination is complete,” she said. “No doses indicated at this time, come back and see us in autumn of 2023.”

The CDC is trying to encourage more people to get the updated COVID shot, as just 17% of Americans of any age have received a bivalent booster and only 43% of those age 65 and over.

The CDC followed the FDA’s lead in its statement, phasing out the original single-strain COVID vaccine, saying it will no longer be recommended for use in the United States.
 

‘Unnecessary drama’ over children’s recs

The CDC panel mostly followed the FDA’s guidance on who should get a booster, but many ACIP members expressed consternation and confusion about what was being recommended for children.

For children aged 6 months to 4 years, the CDC will offer tables to help physicians determine how many bivalent doses to give, depending on the child’s vaccination history.

All children those ages should get at least two vaccine doses, one of which is bivalent, Dr. Twentyman said. For children in that age group who have already received a monovalent series and a bivalent dose, “their vaccination is complete,” she said.

For 5-year-olds, the recommendations will be similar if they received a Pfizer monovalent series, but the shot regimen will have to be customized if they had previously received a Moderna shot, because of differences in the dosages.

ACIP member Sarah S. Long, MD, professor of pediatrics, Drexel University, Philadelphia, said that it was unclear why a set age couldn’t be established for COVID-19 vaccination as it had been for other immunizations.

“We picked 60 months for most immunizations in children,” Dr. Long said. “Immunologically there is not a difference between a 4-, a 5- and a 6-year-old.

“There isn’t a reason to have all this unnecessary drama around those ages,” she said, adding that having the different ages would make it harder for pediatricians to appropriately stock vaccines.

Dr. Twentyman said that the CDC would be providing more detailed guidance on its COVID-19 website soon and would be holding a call with health care professionals to discuss the updated recommendations on May 11.
 

New vaccine by fall

CDC and ACIP members both said they hoped to have an even simpler vaccine schedule by the fall, when it is anticipated that the FDA may have authorized a new, updated bivalent vaccine that targets other COVID variants.

“We all recognize this is a work in progress,” said ACIP Chair Grace M. Lee, MD, MPH, acknowledging that there is continued confusion over COVID-19 vaccination.

“The goal really is to try to simplify things over time to be able to help communicate with our provider community, and our patients and families what vaccine is right for them, when do they need it, and how often should they get it,” said Dr. Lee, professor of pediatrics, Stanford (Calif.) University.
 

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

The Centers for Disease Control and Prevention has endorsed a plan to “allow” people over age 65 and those who are immunocompromised to get a second dose of the COVID-19 bivalent booster.

This backs the Food and Drug Administration’s authorization April 18 of the additional shot.

“Following FDA regulatory action, CDC has taken steps to simplify COVID-19 vaccine recommendations and allow more flexibility for people at higher risk who want the option of added protection from additional COVID-19 vaccine doses,” the CDC said in a statement.

The agency is following the recommendations made by its Advisory Committee on Immunization Practices (ACIP). While there was no vote, the group reaffirmed its commitment to boosters overall, proposing that all Americans over age 6 who have not had a bivalent mRNA COVID-19 booster vaccine go ahead and get one.

But most others who’ve already had the bivalent shot – which targets the original COVID strain and the two Omicron variants BA.4 and BA.5 – should wait until the fall to get whatever updated vaccine is available.

The panel did carve out exceptions for people over age 65 and those who are immunocompromised because they are at higher risk for severe COVID-19 complications, Evelyn Twentyman, MD, MPH, the lead official in the CDC’s COVID-19 Vaccine Policy Unit, said during the meeting.

People over 65 can now choose to get a second bivalent mRNA booster shot as long as it has been at least 4 months since the last one, she said, and people who are immunocompromised also should have the flexibility to receive one or more additional bivalent boosters at least 2 months after an initial dose.

Regardless of whether someone is unvaccinated, and regardless of how many single-strain COVID vaccines an individual has previously received, they should get a mRNA bivalent shot, Dr. Twentyman said.

If an individual has already received a bivalent mRNA booster – made by either Pfizer/BioNTech or Moderna – “your vaccination is complete,” she said. “No doses indicated at this time, come back and see us in autumn of 2023.”

The CDC is trying to encourage more people to get the updated COVID shot, as just 17% of Americans of any age have received a bivalent booster and only 43% of those age 65 and over.

The CDC followed the FDA’s lead in its statement, phasing out the original single-strain COVID vaccine, saying it will no longer be recommended for use in the United States.
 

‘Unnecessary drama’ over children’s recs

The CDC panel mostly followed the FDA’s guidance on who should get a booster, but many ACIP members expressed consternation and confusion about what was being recommended for children.

For children aged 6 months to 4 years, the CDC will offer tables to help physicians determine how many bivalent doses to give, depending on the child’s vaccination history.

All children those ages should get at least two vaccine doses, one of which is bivalent, Dr. Twentyman said. For children in that age group who have already received a monovalent series and a bivalent dose, “their vaccination is complete,” she said.

For 5-year-olds, the recommendations will be similar if they received a Pfizer monovalent series, but the shot regimen will have to be customized if they had previously received a Moderna shot, because of differences in the dosages.

ACIP member Sarah S. Long, MD, professor of pediatrics, Drexel University, Philadelphia, said that it was unclear why a set age couldn’t be established for COVID-19 vaccination as it had been for other immunizations.

“We picked 60 months for most immunizations in children,” Dr. Long said. “Immunologically there is not a difference between a 4-, a 5- and a 6-year-old.

“There isn’t a reason to have all this unnecessary drama around those ages,” she said, adding that having the different ages would make it harder for pediatricians to appropriately stock vaccines.

Dr. Twentyman said that the CDC would be providing more detailed guidance on its COVID-19 website soon and would be holding a call with health care professionals to discuss the updated recommendations on May 11.
 

New vaccine by fall

CDC and ACIP members both said they hoped to have an even simpler vaccine schedule by the fall, when it is anticipated that the FDA may have authorized a new, updated bivalent vaccine that targets other COVID variants.

“We all recognize this is a work in progress,” said ACIP Chair Grace M. Lee, MD, MPH, acknowledging that there is continued confusion over COVID-19 vaccination.

“The goal really is to try to simplify things over time to be able to help communicate with our provider community, and our patients and families what vaccine is right for them, when do they need it, and how often should they get it,” said Dr. Lee, professor of pediatrics, Stanford (Calif.) University.
 

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