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Lack of high school education vaccine hesitancy predictor

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Lack of a high school education is a predictor of whether a person will be resistant to getting the COVID-19 vaccine, a new study shows.

Researchers from the University of North Carolina looked at vaccination rates in 3,142 counties in the U.S. They compared them to population characteristics based on the CDC Social Vulnerability Index.

They found that more than half of the unvaccinated adults in the U.S. with strong vaccine hesitancy had a high school education or less. Vaccine hesitancy was defined as refusal to be vaccinated even if the COVID-19 vaccine was available.

The other main predictor for vaccine hesitancy was concern about vaccine availability and distribution, the researchers said.

“Our study suggests that low education levels are a major contributor to vaccine hesitancy and ultimately vaccination levels,” the authors wrote. The study was published in the American Journal of Infection Control. “Specifically, low vaccination levels were found in communities with a less educated population and with more concern about vaccine uptake capacity, suggesting that education is an ongoing challenge.”

“Our findings suggest that policy makers and community leaders should tailor vaccine information and efforts to those with limited education and specifically address knowledge concerns that are prevalent and likely more modifiable.”

The study was based on data gathered months ago. It says that as of May 9, 2021, 34.7% of the U.S. population was fully vaccinated and that 8% reported a strong unwillingness to get vaccinated.

At press time, the Centers for Disease Control and Prevention’s COVID Data Tracker showed that 62.5% of the U.S. population was fully vaccinated.

According to the study, other consistent characteristics of people who are vaccine hesitant are that they belong to a racial minority, are 65 or older, live in a household with children 18 or younger, or are unemployed.

When asked why they were vaccine hesitant, people gave these reasons: Lack of trust in COVID-19 vaccines (55%), concerns about side effects (48%), and lack of trust in government (46%).

Lack of access to vaccines, often cited in previous studies about resistance to other vaccines, was not cited as a reason for not getting the COVID-19 vaccine.

“COVID-19 vaccine hesitancy is a public health threat,” the researchers concluded. “Since education levels are not easily modifiable, our results suggest that policymakers would be best served by closing knowledge gaps to overcome negative perceptions of the vaccine through tailored interventions.”

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

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Lack of a high school education is a predictor of whether a person will be resistant to getting the COVID-19 vaccine, a new study shows.

Researchers from the University of North Carolina looked at vaccination rates in 3,142 counties in the U.S. They compared them to population characteristics based on the CDC Social Vulnerability Index.

They found that more than half of the unvaccinated adults in the U.S. with strong vaccine hesitancy had a high school education or less. Vaccine hesitancy was defined as refusal to be vaccinated even if the COVID-19 vaccine was available.

The other main predictor for vaccine hesitancy was concern about vaccine availability and distribution, the researchers said.

“Our study suggests that low education levels are a major contributor to vaccine hesitancy and ultimately vaccination levels,” the authors wrote. The study was published in the American Journal of Infection Control. “Specifically, low vaccination levels were found in communities with a less educated population and with more concern about vaccine uptake capacity, suggesting that education is an ongoing challenge.”

“Our findings suggest that policy makers and community leaders should tailor vaccine information and efforts to those with limited education and specifically address knowledge concerns that are prevalent and likely more modifiable.”

The study was based on data gathered months ago. It says that as of May 9, 2021, 34.7% of the U.S. population was fully vaccinated and that 8% reported a strong unwillingness to get vaccinated.

At press time, the Centers for Disease Control and Prevention’s COVID Data Tracker showed that 62.5% of the U.S. population was fully vaccinated.

According to the study, other consistent characteristics of people who are vaccine hesitant are that they belong to a racial minority, are 65 or older, live in a household with children 18 or younger, or are unemployed.

When asked why they were vaccine hesitant, people gave these reasons: Lack of trust in COVID-19 vaccines (55%), concerns about side effects (48%), and lack of trust in government (46%).

Lack of access to vaccines, often cited in previous studies about resistance to other vaccines, was not cited as a reason for not getting the COVID-19 vaccine.

“COVID-19 vaccine hesitancy is a public health threat,” the researchers concluded. “Since education levels are not easily modifiable, our results suggest that policymakers would be best served by closing knowledge gaps to overcome negative perceptions of the vaccine through tailored interventions.”

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

Lack of a high school education is a predictor of whether a person will be resistant to getting the COVID-19 vaccine, a new study shows.

Researchers from the University of North Carolina looked at vaccination rates in 3,142 counties in the U.S. They compared them to population characteristics based on the CDC Social Vulnerability Index.

They found that more than half of the unvaccinated adults in the U.S. with strong vaccine hesitancy had a high school education or less. Vaccine hesitancy was defined as refusal to be vaccinated even if the COVID-19 vaccine was available.

The other main predictor for vaccine hesitancy was concern about vaccine availability and distribution, the researchers said.

“Our study suggests that low education levels are a major contributor to vaccine hesitancy and ultimately vaccination levels,” the authors wrote. The study was published in the American Journal of Infection Control. “Specifically, low vaccination levels were found in communities with a less educated population and with more concern about vaccine uptake capacity, suggesting that education is an ongoing challenge.”

“Our findings suggest that policy makers and community leaders should tailor vaccine information and efforts to those with limited education and specifically address knowledge concerns that are prevalent and likely more modifiable.”

The study was based on data gathered months ago. It says that as of May 9, 2021, 34.7% of the U.S. population was fully vaccinated and that 8% reported a strong unwillingness to get vaccinated.

At press time, the Centers for Disease Control and Prevention’s COVID Data Tracker showed that 62.5% of the U.S. population was fully vaccinated.

According to the study, other consistent characteristics of people who are vaccine hesitant are that they belong to a racial minority, are 65 or older, live in a household with children 18 or younger, or are unemployed.

When asked why they were vaccine hesitant, people gave these reasons: Lack of trust in COVID-19 vaccines (55%), concerns about side effects (48%), and lack of trust in government (46%).

Lack of access to vaccines, often cited in previous studies about resistance to other vaccines, was not cited as a reason for not getting the COVID-19 vaccine.

“COVID-19 vaccine hesitancy is a public health threat,” the researchers concluded. “Since education levels are not easily modifiable, our results suggest that policymakers would be best served by closing knowledge gaps to overcome negative perceptions of the vaccine through tailored interventions.”

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

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FROM THE AMERICAN JOURNAL OF INFECTION CONTROL

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COVID-19 linked to increased diabetes risk in youth

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SARS-CoV-2 infection was associated with an increased risk for diabetes among youth, whereas other acute respiratory infections were not, new data from the U.S. Centers for Disease Control and Prevention indicate.

The results from two large U.S. health claims databases were published in an early release in the CDC’s Morbidity and Mortality Weekly Report by Catherine E. Barrett, PhD, and colleagues of the CDC’s COVID-19 Emergency Response Team and Division of Diabetes Translation.

Clinicians should monitor individuals younger than 18 years in the months following a SARS-CoV-2 infection for new diabetes onset, they advise.

The findings, which are supported by independent studies in adults, “underscore the importance of COVID-19 prevention among all age groups, including vaccination for all eligible children and adolescents, and chronic disease prevention and treatment,” Dr. Barrett and colleagues say.

Diabetes type couldn’t be reliably distinguished from the databases, which is noted as an important study limitation.

“SARS-CoV-2 infection might lead to type 1 or type 2 diabetes through complex and differing mechanisms,” they say.

Emerging evidence began to suggest, in mid-2020, that COVID-19 may trigger the onset of diabetes in healthy people. A new global registry was subsequently established to collect data on patients with COVID-19–related diabetes, called the CoviDiab registry.
 

Not clear if diabetes after COVID-19 is transient or permanent

From one of the databases used in the new study, known as IQVIA, 80,893 individuals aged younger than 18 years diagnosed with COVID-19 during March 2020 to February 26, 2021, were compared with age- and sex-matched people during that period who did not have COVID-19 and to prepandemic groups with and without a diagnosis of acute respiratory illness during March 1, 2017, to February 26, 2018.

From the second database, HealthVerity, 439,439 youth diagnosed with COVID-19 during March 1, 2020, to June 28, 2021, were compared with age- and sex-matched youth without COVID-19. Here, there was no prepandemic comparison group.

Diabetes diagnoses were coded in 0.08% with COVID-19 vs. 0.03% without COVID-19 in IQVIA and in 0.25% vs. 0.19% in HealthVerity.

Thus, new diabetes diagnoses were 166% and 31% more likely to occur in those with COVID-19 in IQVIA and HealthVerity, respectively. And in IQVIA, those with COVID-19 were 116% more likely to develop diabetes than were those with prepandemic acute respiratory illnesses. Those differences were all significant, whereas non–SARS-CoV-2 respiratory infections were not associated with diabetes, Dr. Barrett and colleagues say.

In both databases, diabetic ketoacidosis (DKA) was more common at diabetes onset among those with, vs. without, COVID-19: 48.5% vs. 13.6% in IQVIA and 40.2% vs. 29.7% in HealthVerity. In IQVIA, 22.0% with prepandemic acute respiratory illness presented with DKA.

Dr. Barrett and colleagues offer several potential explanations for the observed association between COVID-19 and diabetes, including a direct attack on pancreatic beta cells expressing angiotensin-converting enzyme 2 receptors, or via stress hyperglycemia resulting from cytokine storm and alterations in glucose metabolism.

Another possibility is the precipitation to diabetes from prediabetes; the latter is a condition present in one in five U.S. adolescents.

Steroid treatment during hospitalization might have led to transient hyperglycemia, but only 1.5% to 2.2% of diabetes codes were for drug- or chemical-induced diabetes. The majority were for type 1 or 2.

Alternatively, pandemic-associated weight gain might have also contributed to risks for both severe COVID-19 and type 2 diabetes.

“Although this study can provide information on the risk for diabetes following SARS-CoV-2 infection, additional data are needed to understand underlying pathogenic mechanisms, either those caused by SARS-CoV-2 infection itself or resulting from treatments, and whether a COVID-19–associated diabetes diagnosis is transient or leads to a chronic condition,” Dr. Barrett and colleagues conclude.

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

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SARS-CoV-2 infection was associated with an increased risk for diabetes among youth, whereas other acute respiratory infections were not, new data from the U.S. Centers for Disease Control and Prevention indicate.

The results from two large U.S. health claims databases were published in an early release in the CDC’s Morbidity and Mortality Weekly Report by Catherine E. Barrett, PhD, and colleagues of the CDC’s COVID-19 Emergency Response Team and Division of Diabetes Translation.

Clinicians should monitor individuals younger than 18 years in the months following a SARS-CoV-2 infection for new diabetes onset, they advise.

The findings, which are supported by independent studies in adults, “underscore the importance of COVID-19 prevention among all age groups, including vaccination for all eligible children and adolescents, and chronic disease prevention and treatment,” Dr. Barrett and colleagues say.

Diabetes type couldn’t be reliably distinguished from the databases, which is noted as an important study limitation.

“SARS-CoV-2 infection might lead to type 1 or type 2 diabetes through complex and differing mechanisms,” they say.

Emerging evidence began to suggest, in mid-2020, that COVID-19 may trigger the onset of diabetes in healthy people. A new global registry was subsequently established to collect data on patients with COVID-19–related diabetes, called the CoviDiab registry.
 

Not clear if diabetes after COVID-19 is transient or permanent

From one of the databases used in the new study, known as IQVIA, 80,893 individuals aged younger than 18 years diagnosed with COVID-19 during March 2020 to February 26, 2021, were compared with age- and sex-matched people during that period who did not have COVID-19 and to prepandemic groups with and without a diagnosis of acute respiratory illness during March 1, 2017, to February 26, 2018.

From the second database, HealthVerity, 439,439 youth diagnosed with COVID-19 during March 1, 2020, to June 28, 2021, were compared with age- and sex-matched youth without COVID-19. Here, there was no prepandemic comparison group.

Diabetes diagnoses were coded in 0.08% with COVID-19 vs. 0.03% without COVID-19 in IQVIA and in 0.25% vs. 0.19% in HealthVerity.

Thus, new diabetes diagnoses were 166% and 31% more likely to occur in those with COVID-19 in IQVIA and HealthVerity, respectively. And in IQVIA, those with COVID-19 were 116% more likely to develop diabetes than were those with prepandemic acute respiratory illnesses. Those differences were all significant, whereas non–SARS-CoV-2 respiratory infections were not associated with diabetes, Dr. Barrett and colleagues say.

In both databases, diabetic ketoacidosis (DKA) was more common at diabetes onset among those with, vs. without, COVID-19: 48.5% vs. 13.6% in IQVIA and 40.2% vs. 29.7% in HealthVerity. In IQVIA, 22.0% with prepandemic acute respiratory illness presented with DKA.

Dr. Barrett and colleagues offer several potential explanations for the observed association between COVID-19 and diabetes, including a direct attack on pancreatic beta cells expressing angiotensin-converting enzyme 2 receptors, or via stress hyperglycemia resulting from cytokine storm and alterations in glucose metabolism.

Another possibility is the precipitation to diabetes from prediabetes; the latter is a condition present in one in five U.S. adolescents.

Steroid treatment during hospitalization might have led to transient hyperglycemia, but only 1.5% to 2.2% of diabetes codes were for drug- or chemical-induced diabetes. The majority were for type 1 or 2.

Alternatively, pandemic-associated weight gain might have also contributed to risks for both severe COVID-19 and type 2 diabetes.

“Although this study can provide information on the risk for diabetes following SARS-CoV-2 infection, additional data are needed to understand underlying pathogenic mechanisms, either those caused by SARS-CoV-2 infection itself or resulting from treatments, and whether a COVID-19–associated diabetes diagnosis is transient or leads to a chronic condition,” Dr. Barrett and colleagues conclude.

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

SARS-CoV-2 infection was associated with an increased risk for diabetes among youth, whereas other acute respiratory infections were not, new data from the U.S. Centers for Disease Control and Prevention indicate.

The results from two large U.S. health claims databases were published in an early release in the CDC’s Morbidity and Mortality Weekly Report by Catherine E. Barrett, PhD, and colleagues of the CDC’s COVID-19 Emergency Response Team and Division of Diabetes Translation.

Clinicians should monitor individuals younger than 18 years in the months following a SARS-CoV-2 infection for new diabetes onset, they advise.

The findings, which are supported by independent studies in adults, “underscore the importance of COVID-19 prevention among all age groups, including vaccination for all eligible children and adolescents, and chronic disease prevention and treatment,” Dr. Barrett and colleagues say.

Diabetes type couldn’t be reliably distinguished from the databases, which is noted as an important study limitation.

“SARS-CoV-2 infection might lead to type 1 or type 2 diabetes through complex and differing mechanisms,” they say.

Emerging evidence began to suggest, in mid-2020, that COVID-19 may trigger the onset of diabetes in healthy people. A new global registry was subsequently established to collect data on patients with COVID-19–related diabetes, called the CoviDiab registry.
 

Not clear if diabetes after COVID-19 is transient or permanent

From one of the databases used in the new study, known as IQVIA, 80,893 individuals aged younger than 18 years diagnosed with COVID-19 during March 2020 to February 26, 2021, were compared with age- and sex-matched people during that period who did not have COVID-19 and to prepandemic groups with and without a diagnosis of acute respiratory illness during March 1, 2017, to February 26, 2018.

From the second database, HealthVerity, 439,439 youth diagnosed with COVID-19 during March 1, 2020, to June 28, 2021, were compared with age- and sex-matched youth without COVID-19. Here, there was no prepandemic comparison group.

Diabetes diagnoses were coded in 0.08% with COVID-19 vs. 0.03% without COVID-19 in IQVIA and in 0.25% vs. 0.19% in HealthVerity.

Thus, new diabetes diagnoses were 166% and 31% more likely to occur in those with COVID-19 in IQVIA and HealthVerity, respectively. And in IQVIA, those with COVID-19 were 116% more likely to develop diabetes than were those with prepandemic acute respiratory illnesses. Those differences were all significant, whereas non–SARS-CoV-2 respiratory infections were not associated with diabetes, Dr. Barrett and colleagues say.

In both databases, diabetic ketoacidosis (DKA) was more common at diabetes onset among those with, vs. without, COVID-19: 48.5% vs. 13.6% in IQVIA and 40.2% vs. 29.7% in HealthVerity. In IQVIA, 22.0% with prepandemic acute respiratory illness presented with DKA.

Dr. Barrett and colleagues offer several potential explanations for the observed association between COVID-19 and diabetes, including a direct attack on pancreatic beta cells expressing angiotensin-converting enzyme 2 receptors, or via stress hyperglycemia resulting from cytokine storm and alterations in glucose metabolism.

Another possibility is the precipitation to diabetes from prediabetes; the latter is a condition present in one in five U.S. adolescents.

Steroid treatment during hospitalization might have led to transient hyperglycemia, but only 1.5% to 2.2% of diabetes codes were for drug- or chemical-induced diabetes. The majority were for type 1 or 2.

Alternatively, pandemic-associated weight gain might have also contributed to risks for both severe COVID-19 and type 2 diabetes.

“Although this study can provide information on the risk for diabetes following SARS-CoV-2 infection, additional data are needed to understand underlying pathogenic mechanisms, either those caused by SARS-CoV-2 infection itself or resulting from treatments, and whether a COVID-19–associated diabetes diagnosis is transient or leads to a chronic condition,” Dr. Barrett and colleagues conclude.

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

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As pandemic regs expire, states get tougher on telehealth: report

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Many states have restored restrictions on telehealth use that they suspended earlier in the COVID-19 pandemic, according to a new report jointly prepared by the Reason Institute, the Pioneer Institute, and the Cicero Institute.

Among the most important restrictions that have been reinstated in some states are those barring requirements for insurers to cover telehealth and regulations that prohibit telehealth visits across state lines, unless the physician is licensed in both states.

“Only three states – Arizona, Florida, and Indiana – allow all health care providers to easily practice telehealth across state lines,” says a news release on the think tanks’ report. “Forty-seven others have arbitrary barriers in place that limit patients’ access to specialists and available appointments based purely on residency.”

“Once the [state-based] public health emergency declarations started to end or executive orders were withdrawn, many of the new flexibilities for providers, insurers, and patients were lost overnight,” Vittorio Nastasi, a policy analyst at Reason Foundation and a co-author of the report, says in the news release. “States need to adopt a number of telehealth reforms to provide their residents better access to this safe and effective virtual care.”

On a positive note, the report says, most states have removed the requirement that a patient must first see a provider in person before they can use telehealth services. The exceptions are Tennessee, Alaska, and West Virginia, which require an in-person visit before certain telehealth services can be provided.

In addition, 20 states allow nurse practitioners to conduct telehealth visits without being under the supervision of a physician. Prior to the pandemic, some states allowed only doctors to use telehealth, the report says, but, during the COVID crisis, “the acute shortage of providers in many counties adds to the need for more kinds of providers to be able to use it.”

A number of states place restrictions on the telehealth modalities that can be utilized. Under the definition by the American Telemedicine Association, telehealth includes audio-video visits, remote patient monitoring, and “store and forward” telemedicine, which entails collecting clinical information and sending it to another site for evaluation. The latter method is particularly useful for consultations with specialists, the report notes.
 

Coverage mandates and payment parity

The report also examines other parameters of telehealth regulations in each state, including whether they have telehealth coverage mandates and whether they require physicians to be paid the same amount for similar types of in-person and telehealth visits.

The report views insurance mandates as beneficial, but not if they require coverage of all virtual services. While telehealth can be a game changer for post-stroke care and for other “treatment-intensive conditions,” the report says, the evidence of better outcomes for other conditions treated through telehealth is far less certain. Therefore, it advises states to “protect flexibility so that new innovative models can emerge.”

Ateev Mehrotra, MD, a professor at Harvard Medical School who studies telehealth, agrees that it offers more value in some clinical situations than in others. “High value is improving quality or outcomes at a reasonable cost,” he told this news organization. “If a telemedicine visit for stroke can save a person’s life and prevent disability, let’s pay for it. A telemedicine visit for a cold may not be necessary. Mom’s chicken soup is fine.”

A little over half of the states still require payment parity, according to the report. While these regulations are intended to promote the use of telehealth, the authors note, they can increase the growth of health care costs. Moreover, they argue, it’s hard to defend equal payments for virtual visits when the overhead required to deliver them – such as office rental, utility, and labor costs – is much lower than that for in-person visits. Also, it makes no sense for health systems to charge facility fees for telehealth visits when these visits can be initiated from anywhere, they say.

Dr. Mehrotra concurs with this view. “If you see someone in your office, your fee includes all the overhead for your office, and it’s a substantial cost,” he says. “For many procedures, it’s more than half of the cost. If you have a telemedicine visit and you’re at home, why would you pay the same amount? The visit may take the same amount of time, but all the money that goes for overhead is not accounted for.”
 

 

 

Telemedicine across state lines

The report’s contention about the difficulty of conducting telehealth encounters across most state lines seems to be at odds with the growth in the Interstate Medical Licensure Compact, which makes it easier for physicians in one compact member state to get licensed in others. Currently, 35 states belong to the compact, Joe Knickrehm, vice president of communications for the Federation of State Medical Boards, told this news organization.

In addition, he says, “12 state boards issue a special purpose license, telemedicine license or certificate, or license to practice medicine across state lines to allow for the practice of telemedicine.”

The catch, Dr. Mehrotra says, is that, despite the streamlining of license applications in compact member states, the fees charged by the state boards are still very high – a point that the report also makes. “If I want to have broad scope of practice, I’d have to pay thousands of dollars to many states. The license fees start to add up. Also, I have to keep track of each state’s CME requirements, which are all different. Keeping up with all of that is an administration burden, and it’s a pain.”

Mr. Knickrehm contends that obtaining multiple licenses via the compact “is generally less expensive for physicians than the cost of requesting transcripts, fingerprints, and other necessary paperwork each time they apply for licensure in a new state. Physicians are seeing the benefits of an expedited process that allows them to begin practicing more quickly [in other states].”

Dr. Mehrotra says he has seen the same retrenchment in state telehealth regulations that the report references. However, he says, “CMS [the Centers for Medicare & Medicaid Services] has signaled that at least through 2022 and maybe into 2023, they’ll continue their extensions of telemedicine [pandemic regulations].” After that, Congress would have to decide whether to make the changes permanent.

“Right now, it’s hard for me to see how a payer is going to pull back on telehealth, unless there’s ample evidence of overuse of telehealth,” he argues. “With the public and providers liking telehealth, it’s hard to say on theoretical grounds that we should stop using it. That’s why Medicare and others have extended it and why Congress will too.”

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

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Many states have restored restrictions on telehealth use that they suspended earlier in the COVID-19 pandemic, according to a new report jointly prepared by the Reason Institute, the Pioneer Institute, and the Cicero Institute.

Among the most important restrictions that have been reinstated in some states are those barring requirements for insurers to cover telehealth and regulations that prohibit telehealth visits across state lines, unless the physician is licensed in both states.

“Only three states – Arizona, Florida, and Indiana – allow all health care providers to easily practice telehealth across state lines,” says a news release on the think tanks’ report. “Forty-seven others have arbitrary barriers in place that limit patients’ access to specialists and available appointments based purely on residency.”

“Once the [state-based] public health emergency declarations started to end or executive orders were withdrawn, many of the new flexibilities for providers, insurers, and patients were lost overnight,” Vittorio Nastasi, a policy analyst at Reason Foundation and a co-author of the report, says in the news release. “States need to adopt a number of telehealth reforms to provide their residents better access to this safe and effective virtual care.”

On a positive note, the report says, most states have removed the requirement that a patient must first see a provider in person before they can use telehealth services. The exceptions are Tennessee, Alaska, and West Virginia, which require an in-person visit before certain telehealth services can be provided.

In addition, 20 states allow nurse practitioners to conduct telehealth visits without being under the supervision of a physician. Prior to the pandemic, some states allowed only doctors to use telehealth, the report says, but, during the COVID crisis, “the acute shortage of providers in many counties adds to the need for more kinds of providers to be able to use it.”

A number of states place restrictions on the telehealth modalities that can be utilized. Under the definition by the American Telemedicine Association, telehealth includes audio-video visits, remote patient monitoring, and “store and forward” telemedicine, which entails collecting clinical information and sending it to another site for evaluation. The latter method is particularly useful for consultations with specialists, the report notes.
 

Coverage mandates and payment parity

The report also examines other parameters of telehealth regulations in each state, including whether they have telehealth coverage mandates and whether they require physicians to be paid the same amount for similar types of in-person and telehealth visits.

The report views insurance mandates as beneficial, but not if they require coverage of all virtual services. While telehealth can be a game changer for post-stroke care and for other “treatment-intensive conditions,” the report says, the evidence of better outcomes for other conditions treated through telehealth is far less certain. Therefore, it advises states to “protect flexibility so that new innovative models can emerge.”

Ateev Mehrotra, MD, a professor at Harvard Medical School who studies telehealth, agrees that it offers more value in some clinical situations than in others. “High value is improving quality or outcomes at a reasonable cost,” he told this news organization. “If a telemedicine visit for stroke can save a person’s life and prevent disability, let’s pay for it. A telemedicine visit for a cold may not be necessary. Mom’s chicken soup is fine.”

A little over half of the states still require payment parity, according to the report. While these regulations are intended to promote the use of telehealth, the authors note, they can increase the growth of health care costs. Moreover, they argue, it’s hard to defend equal payments for virtual visits when the overhead required to deliver them – such as office rental, utility, and labor costs – is much lower than that for in-person visits. Also, it makes no sense for health systems to charge facility fees for telehealth visits when these visits can be initiated from anywhere, they say.

Dr. Mehrotra concurs with this view. “If you see someone in your office, your fee includes all the overhead for your office, and it’s a substantial cost,” he says. “For many procedures, it’s more than half of the cost. If you have a telemedicine visit and you’re at home, why would you pay the same amount? The visit may take the same amount of time, but all the money that goes for overhead is not accounted for.”
 

 

 

Telemedicine across state lines

The report’s contention about the difficulty of conducting telehealth encounters across most state lines seems to be at odds with the growth in the Interstate Medical Licensure Compact, which makes it easier for physicians in one compact member state to get licensed in others. Currently, 35 states belong to the compact, Joe Knickrehm, vice president of communications for the Federation of State Medical Boards, told this news organization.

In addition, he says, “12 state boards issue a special purpose license, telemedicine license or certificate, or license to practice medicine across state lines to allow for the practice of telemedicine.”

The catch, Dr. Mehrotra says, is that, despite the streamlining of license applications in compact member states, the fees charged by the state boards are still very high – a point that the report also makes. “If I want to have broad scope of practice, I’d have to pay thousands of dollars to many states. The license fees start to add up. Also, I have to keep track of each state’s CME requirements, which are all different. Keeping up with all of that is an administration burden, and it’s a pain.”

Mr. Knickrehm contends that obtaining multiple licenses via the compact “is generally less expensive for physicians than the cost of requesting transcripts, fingerprints, and other necessary paperwork each time they apply for licensure in a new state. Physicians are seeing the benefits of an expedited process that allows them to begin practicing more quickly [in other states].”

Dr. Mehrotra says he has seen the same retrenchment in state telehealth regulations that the report references. However, he says, “CMS [the Centers for Medicare & Medicaid Services] has signaled that at least through 2022 and maybe into 2023, they’ll continue their extensions of telemedicine [pandemic regulations].” After that, Congress would have to decide whether to make the changes permanent.

“Right now, it’s hard for me to see how a payer is going to pull back on telehealth, unless there’s ample evidence of overuse of telehealth,” he argues. “With the public and providers liking telehealth, it’s hard to say on theoretical grounds that we should stop using it. That’s why Medicare and others have extended it and why Congress will too.”

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

Many states have restored restrictions on telehealth use that they suspended earlier in the COVID-19 pandemic, according to a new report jointly prepared by the Reason Institute, the Pioneer Institute, and the Cicero Institute.

Among the most important restrictions that have been reinstated in some states are those barring requirements for insurers to cover telehealth and regulations that prohibit telehealth visits across state lines, unless the physician is licensed in both states.

“Only three states – Arizona, Florida, and Indiana – allow all health care providers to easily practice telehealth across state lines,” says a news release on the think tanks’ report. “Forty-seven others have arbitrary barriers in place that limit patients’ access to specialists and available appointments based purely on residency.”

“Once the [state-based] public health emergency declarations started to end or executive orders were withdrawn, many of the new flexibilities for providers, insurers, and patients were lost overnight,” Vittorio Nastasi, a policy analyst at Reason Foundation and a co-author of the report, says in the news release. “States need to adopt a number of telehealth reforms to provide their residents better access to this safe and effective virtual care.”

On a positive note, the report says, most states have removed the requirement that a patient must first see a provider in person before they can use telehealth services. The exceptions are Tennessee, Alaska, and West Virginia, which require an in-person visit before certain telehealth services can be provided.

In addition, 20 states allow nurse practitioners to conduct telehealth visits without being under the supervision of a physician. Prior to the pandemic, some states allowed only doctors to use telehealth, the report says, but, during the COVID crisis, “the acute shortage of providers in many counties adds to the need for more kinds of providers to be able to use it.”

A number of states place restrictions on the telehealth modalities that can be utilized. Under the definition by the American Telemedicine Association, telehealth includes audio-video visits, remote patient monitoring, and “store and forward” telemedicine, which entails collecting clinical information and sending it to another site for evaluation. The latter method is particularly useful for consultations with specialists, the report notes.
 

Coverage mandates and payment parity

The report also examines other parameters of telehealth regulations in each state, including whether they have telehealth coverage mandates and whether they require physicians to be paid the same amount for similar types of in-person and telehealth visits.

The report views insurance mandates as beneficial, but not if they require coverage of all virtual services. While telehealth can be a game changer for post-stroke care and for other “treatment-intensive conditions,” the report says, the evidence of better outcomes for other conditions treated through telehealth is far less certain. Therefore, it advises states to “protect flexibility so that new innovative models can emerge.”

Ateev Mehrotra, MD, a professor at Harvard Medical School who studies telehealth, agrees that it offers more value in some clinical situations than in others. “High value is improving quality or outcomes at a reasonable cost,” he told this news organization. “If a telemedicine visit for stroke can save a person’s life and prevent disability, let’s pay for it. A telemedicine visit for a cold may not be necessary. Mom’s chicken soup is fine.”

A little over half of the states still require payment parity, according to the report. While these regulations are intended to promote the use of telehealth, the authors note, they can increase the growth of health care costs. Moreover, they argue, it’s hard to defend equal payments for virtual visits when the overhead required to deliver them – such as office rental, utility, and labor costs – is much lower than that for in-person visits. Also, it makes no sense for health systems to charge facility fees for telehealth visits when these visits can be initiated from anywhere, they say.

Dr. Mehrotra concurs with this view. “If you see someone in your office, your fee includes all the overhead for your office, and it’s a substantial cost,” he says. “For many procedures, it’s more than half of the cost. If you have a telemedicine visit and you’re at home, why would you pay the same amount? The visit may take the same amount of time, but all the money that goes for overhead is not accounted for.”
 

 

 

Telemedicine across state lines

The report’s contention about the difficulty of conducting telehealth encounters across most state lines seems to be at odds with the growth in the Interstate Medical Licensure Compact, which makes it easier for physicians in one compact member state to get licensed in others. Currently, 35 states belong to the compact, Joe Knickrehm, vice president of communications for the Federation of State Medical Boards, told this news organization.

In addition, he says, “12 state boards issue a special purpose license, telemedicine license or certificate, or license to practice medicine across state lines to allow for the practice of telemedicine.”

The catch, Dr. Mehrotra says, is that, despite the streamlining of license applications in compact member states, the fees charged by the state boards are still very high – a point that the report also makes. “If I want to have broad scope of practice, I’d have to pay thousands of dollars to many states. The license fees start to add up. Also, I have to keep track of each state’s CME requirements, which are all different. Keeping up with all of that is an administration burden, and it’s a pain.”

Mr. Knickrehm contends that obtaining multiple licenses via the compact “is generally less expensive for physicians than the cost of requesting transcripts, fingerprints, and other necessary paperwork each time they apply for licensure in a new state. Physicians are seeing the benefits of an expedited process that allows them to begin practicing more quickly [in other states].”

Dr. Mehrotra says he has seen the same retrenchment in state telehealth regulations that the report references. However, he says, “CMS [the Centers for Medicare & Medicaid Services] has signaled that at least through 2022 and maybe into 2023, they’ll continue their extensions of telemedicine [pandemic regulations].” After that, Congress would have to decide whether to make the changes permanent.

“Right now, it’s hard for me to see how a payer is going to pull back on telehealth, unless there’s ample evidence of overuse of telehealth,” he argues. “With the public and providers liking telehealth, it’s hard to say on theoretical grounds that we should stop using it. That’s why Medicare and others have extended it and why Congress will too.”

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

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Neonatal sepsis: WHO-recommended Rx needs a major rethink

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First-line treatment of neonatal sepsis in low- and middle-income countries (LMICs) with ampicillin-gentamicin – as recommended by the World Health Organization – needs to be reassessed, a retrospective, observational cohort study suggests. Rates of resistance to this particular antibiotic combination are extremely high in LMICs, and this treatment is unlikely to save many neonatal patients, according to the study’s results.

“The WHO guidelines are over 10 years old, and they are actually based on high-income country data, whereas data reported from low-income countries are reported by private labs, and they do not cater to the lower socioeconomic groups within these countries, which is important data to capture,” Timothy Walsh, MD, University of Oxford, United Kingdom, told this news organization.

“The main take-home message from our data is that ampicillin-gentamicin doesn’t work for most of the Gram-negative isolates we tested, and while there are alternatives, their use is confounded by [a lack of] financial support,” he added.

The study was published online in The Lancet Infectious Diseases.
 

BARNARDS study

In this substudy of the Burden of Antibiotic Resistance in Neonates from Developing Societies (BARNARDS) study, investigators focused on the effectiveness of antibiotic therapies after taking into account the high prevalence of pathogen resistance to ampicillin-gentamicin. Participating countries included Bangladesh, Ethiopia, India, Nigeria, Pakistan, Rwanda, and South Africa.

“Blood samples were obtained from neonates presenting with clinical signs of sepsis,” the authors note, “and WGS [whole-genome sequencing] and MICs [minimum inhibitory concentrations] for antibiotic treatment were determined for bacterial isolates from culture-confirmed sepsis.” Between Nov. 2015 and Feb. 2018, 36,285 neonates were enrolled into the main BARNARDS study, of whom 9,874 had clinically diagnosed sepsis and 5,749 had antibiotic data.

A total of 2,483 neonates had culture-confirmed sepsis, and WGS data were available for 457 isolates taken from 442 neonates. Slightly over three-quarters of the 5,749 neonates who had antibiotic data received first-line ampicillin-gentamicin. The other three most commonly prescribed antibiotic combinations were ceftazidime-amikacin, piperacillin-tazobactam-amikacin, and amoxicillin-clavulanate-amikacin.

Neonates treated with ceftazidime-amikacin had a 68% lower reported mortality than those treated with ampicillin-gentamicin at an adjusted hazard ratio of 0.32 (95% confidence interval, 0.14-0.72; P = .006), the investigators report. In contrast, no significant differences in mortality rates were reported for neonates treated with amoxicillin-clavulanate-amikacin or piperacillin-tazobactam-amikacin compared to those treated with ampicillin-gentamicin.

Investigators were careful to suggest that mortality effects associated with the different antibiotic combinations might have been confounded by either country-specific effects or underreporting of mortality, as a large proportion of neonates who were treated with ampicillin-gentamicin were followed for fewer than 10 days. However, in an unreported aspect of the same study, neonatal mortality from sepsis dropped by over 50% in two federally funded sites in Nigeria that changed their treatment from the WHO-recommended ampicillin-gentamicin regimen to ceftazidime-amikacin – which Dr. Walsh suggested was an endorsement of ceftazidime-amikacin over ampicillin-gentamicin if ever there was one.
 

Gram-negative resistance

In looking at resistance patterns to the antibiotic combinations used in these countries, investigators found that almost all Gram-negative isolates tested were “overwhelmingly resistant” to ampicillin, and over 70% of them were resistant to gentamicin as well. Extremely high resistance rates were also found against Staphylococcus spp, which are regarded as intrinsically resistant to ampicillin, rendering it basically useless in this particular treatment setting.

Amikacin had much lower level of resistance, with only about 26% of Gram-negative isolates showing resistance. In terms of coverage against Gram-negative isolates, the lowest level of coverage was provided by ampicillin-gentamicin at slightly over 28%, compared with about 73% for amoxicillin-clavulanate-amikacin, 77% for ceftazidime-amikacin, and 80% for piperacillin-tazobactam-amikacin.

In contrast, “Gram-positive isolates generally had reduced levels of resistance,” the authors state. As Dr. Walsh noted, the consortium also did an analysis assessing how much the antibiotic combinations cost and how much payment was deferred to the parents. For example, in Nigeria, the entire cost of treatment is passed down to the parents, “so if they are earning, say, $5.00 a day and the infant needs ceftazidime-amikacin, where the cost per dose is about $6.00 or $7.00 a day, parents can’t afford it,” Dr. Walsh observed.

This part of the conversation, he added, tends to get lost in many studies of antibiotic resistance in LMICs, which is a critical omission, because in many instances, the choice of treatment does come down to affordability. “It’s all very well for the WHO to sit there and say, ampicillin-gentamicin is perfect, but the combination actually doesn’t work in over 70% of the Gram-negative bacteria we looked at in these countries,” Dr. Walsh emphasized.

“The fact is that we have to be a lot more internationally engaged as to what’s actually happening in poorer populations, because unless we do, neonates are going to continue to die,” he said.
 

Editorial commentary

Commenting on the findings, lead editorialist Luregn Schlapbach, MD, PhD, of University Children’s Hospital Zurich, Switzerland, pointed out that the study has a number of limitations, including a high rate of dropouts from follow-up. This could possibly result in underestimation of neonatal mortality as well as country-specific biases. Nevertheless, Dr. Schlapbach feels that the integration of sequential clinical, genomic, microbiologic, drug, and cost data across a large network in LMIC settings is “exceptional” and will serve to inform “urgently needed” clinical trials in the field of neonatal sepsis.

“At present, increasing global antibiotic resistance is threatening progress against neonatal sepsis, prompting urgency to develop improved measures to effectively prevent and treat life-threatening infections in this high-risk group,” Dr. Schlapbach and colleagues write.

“The findings from the BARNARDS study call for randomized trials comparing mortality benefit and cost efficiency of different antibiotic combinations and management algorithms to safely reduce unnecessary antibiotic exposure for neonatal sepsis,” the editorialists concluded.

The authors and editorialists have disclosed no relevant financial relationships.

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

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First-line treatment of neonatal sepsis in low- and middle-income countries (LMICs) with ampicillin-gentamicin – as recommended by the World Health Organization – needs to be reassessed, a retrospective, observational cohort study suggests. Rates of resistance to this particular antibiotic combination are extremely high in LMICs, and this treatment is unlikely to save many neonatal patients, according to the study’s results.

“The WHO guidelines are over 10 years old, and they are actually based on high-income country data, whereas data reported from low-income countries are reported by private labs, and they do not cater to the lower socioeconomic groups within these countries, which is important data to capture,” Timothy Walsh, MD, University of Oxford, United Kingdom, told this news organization.

“The main take-home message from our data is that ampicillin-gentamicin doesn’t work for most of the Gram-negative isolates we tested, and while there are alternatives, their use is confounded by [a lack of] financial support,” he added.

The study was published online in The Lancet Infectious Diseases.
 

BARNARDS study

In this substudy of the Burden of Antibiotic Resistance in Neonates from Developing Societies (BARNARDS) study, investigators focused on the effectiveness of antibiotic therapies after taking into account the high prevalence of pathogen resistance to ampicillin-gentamicin. Participating countries included Bangladesh, Ethiopia, India, Nigeria, Pakistan, Rwanda, and South Africa.

“Blood samples were obtained from neonates presenting with clinical signs of sepsis,” the authors note, “and WGS [whole-genome sequencing] and MICs [minimum inhibitory concentrations] for antibiotic treatment were determined for bacterial isolates from culture-confirmed sepsis.” Between Nov. 2015 and Feb. 2018, 36,285 neonates were enrolled into the main BARNARDS study, of whom 9,874 had clinically diagnosed sepsis and 5,749 had antibiotic data.

A total of 2,483 neonates had culture-confirmed sepsis, and WGS data were available for 457 isolates taken from 442 neonates. Slightly over three-quarters of the 5,749 neonates who had antibiotic data received first-line ampicillin-gentamicin. The other three most commonly prescribed antibiotic combinations were ceftazidime-amikacin, piperacillin-tazobactam-amikacin, and amoxicillin-clavulanate-amikacin.

Neonates treated with ceftazidime-amikacin had a 68% lower reported mortality than those treated with ampicillin-gentamicin at an adjusted hazard ratio of 0.32 (95% confidence interval, 0.14-0.72; P = .006), the investigators report. In contrast, no significant differences in mortality rates were reported for neonates treated with amoxicillin-clavulanate-amikacin or piperacillin-tazobactam-amikacin compared to those treated with ampicillin-gentamicin.

Investigators were careful to suggest that mortality effects associated with the different antibiotic combinations might have been confounded by either country-specific effects or underreporting of mortality, as a large proportion of neonates who were treated with ampicillin-gentamicin were followed for fewer than 10 days. However, in an unreported aspect of the same study, neonatal mortality from sepsis dropped by over 50% in two federally funded sites in Nigeria that changed their treatment from the WHO-recommended ampicillin-gentamicin regimen to ceftazidime-amikacin – which Dr. Walsh suggested was an endorsement of ceftazidime-amikacin over ampicillin-gentamicin if ever there was one.
 

Gram-negative resistance

In looking at resistance patterns to the antibiotic combinations used in these countries, investigators found that almost all Gram-negative isolates tested were “overwhelmingly resistant” to ampicillin, and over 70% of them were resistant to gentamicin as well. Extremely high resistance rates were also found against Staphylococcus spp, which are regarded as intrinsically resistant to ampicillin, rendering it basically useless in this particular treatment setting.

Amikacin had much lower level of resistance, with only about 26% of Gram-negative isolates showing resistance. In terms of coverage against Gram-negative isolates, the lowest level of coverage was provided by ampicillin-gentamicin at slightly over 28%, compared with about 73% for amoxicillin-clavulanate-amikacin, 77% for ceftazidime-amikacin, and 80% for piperacillin-tazobactam-amikacin.

In contrast, “Gram-positive isolates generally had reduced levels of resistance,” the authors state. As Dr. Walsh noted, the consortium also did an analysis assessing how much the antibiotic combinations cost and how much payment was deferred to the parents. For example, in Nigeria, the entire cost of treatment is passed down to the parents, “so if they are earning, say, $5.00 a day and the infant needs ceftazidime-amikacin, where the cost per dose is about $6.00 or $7.00 a day, parents can’t afford it,” Dr. Walsh observed.

This part of the conversation, he added, tends to get lost in many studies of antibiotic resistance in LMICs, which is a critical omission, because in many instances, the choice of treatment does come down to affordability. “It’s all very well for the WHO to sit there and say, ampicillin-gentamicin is perfect, but the combination actually doesn’t work in over 70% of the Gram-negative bacteria we looked at in these countries,” Dr. Walsh emphasized.

“The fact is that we have to be a lot more internationally engaged as to what’s actually happening in poorer populations, because unless we do, neonates are going to continue to die,” he said.
 

Editorial commentary

Commenting on the findings, lead editorialist Luregn Schlapbach, MD, PhD, of University Children’s Hospital Zurich, Switzerland, pointed out that the study has a number of limitations, including a high rate of dropouts from follow-up. This could possibly result in underestimation of neonatal mortality as well as country-specific biases. Nevertheless, Dr. Schlapbach feels that the integration of sequential clinical, genomic, microbiologic, drug, and cost data across a large network in LMIC settings is “exceptional” and will serve to inform “urgently needed” clinical trials in the field of neonatal sepsis.

“At present, increasing global antibiotic resistance is threatening progress against neonatal sepsis, prompting urgency to develop improved measures to effectively prevent and treat life-threatening infections in this high-risk group,” Dr. Schlapbach and colleagues write.

“The findings from the BARNARDS study call for randomized trials comparing mortality benefit and cost efficiency of different antibiotic combinations and management algorithms to safely reduce unnecessary antibiotic exposure for neonatal sepsis,” the editorialists concluded.

The authors and editorialists have disclosed no relevant financial relationships.

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

First-line treatment of neonatal sepsis in low- and middle-income countries (LMICs) with ampicillin-gentamicin – as recommended by the World Health Organization – needs to be reassessed, a retrospective, observational cohort study suggests. Rates of resistance to this particular antibiotic combination are extremely high in LMICs, and this treatment is unlikely to save many neonatal patients, according to the study’s results.

“The WHO guidelines are over 10 years old, and they are actually based on high-income country data, whereas data reported from low-income countries are reported by private labs, and they do not cater to the lower socioeconomic groups within these countries, which is important data to capture,” Timothy Walsh, MD, University of Oxford, United Kingdom, told this news organization.

“The main take-home message from our data is that ampicillin-gentamicin doesn’t work for most of the Gram-negative isolates we tested, and while there are alternatives, their use is confounded by [a lack of] financial support,” he added.

The study was published online in The Lancet Infectious Diseases.
 

BARNARDS study

In this substudy of the Burden of Antibiotic Resistance in Neonates from Developing Societies (BARNARDS) study, investigators focused on the effectiveness of antibiotic therapies after taking into account the high prevalence of pathogen resistance to ampicillin-gentamicin. Participating countries included Bangladesh, Ethiopia, India, Nigeria, Pakistan, Rwanda, and South Africa.

“Blood samples were obtained from neonates presenting with clinical signs of sepsis,” the authors note, “and WGS [whole-genome sequencing] and MICs [minimum inhibitory concentrations] for antibiotic treatment were determined for bacterial isolates from culture-confirmed sepsis.” Between Nov. 2015 and Feb. 2018, 36,285 neonates were enrolled into the main BARNARDS study, of whom 9,874 had clinically diagnosed sepsis and 5,749 had antibiotic data.

A total of 2,483 neonates had culture-confirmed sepsis, and WGS data were available for 457 isolates taken from 442 neonates. Slightly over three-quarters of the 5,749 neonates who had antibiotic data received first-line ampicillin-gentamicin. The other three most commonly prescribed antibiotic combinations were ceftazidime-amikacin, piperacillin-tazobactam-amikacin, and amoxicillin-clavulanate-amikacin.

Neonates treated with ceftazidime-amikacin had a 68% lower reported mortality than those treated with ampicillin-gentamicin at an adjusted hazard ratio of 0.32 (95% confidence interval, 0.14-0.72; P = .006), the investigators report. In contrast, no significant differences in mortality rates were reported for neonates treated with amoxicillin-clavulanate-amikacin or piperacillin-tazobactam-amikacin compared to those treated with ampicillin-gentamicin.

Investigators were careful to suggest that mortality effects associated with the different antibiotic combinations might have been confounded by either country-specific effects or underreporting of mortality, as a large proportion of neonates who were treated with ampicillin-gentamicin were followed for fewer than 10 days. However, in an unreported aspect of the same study, neonatal mortality from sepsis dropped by over 50% in two federally funded sites in Nigeria that changed their treatment from the WHO-recommended ampicillin-gentamicin regimen to ceftazidime-amikacin – which Dr. Walsh suggested was an endorsement of ceftazidime-amikacin over ampicillin-gentamicin if ever there was one.
 

Gram-negative resistance

In looking at resistance patterns to the antibiotic combinations used in these countries, investigators found that almost all Gram-negative isolates tested were “overwhelmingly resistant” to ampicillin, and over 70% of them were resistant to gentamicin as well. Extremely high resistance rates were also found against Staphylococcus spp, which are regarded as intrinsically resistant to ampicillin, rendering it basically useless in this particular treatment setting.

Amikacin had much lower level of resistance, with only about 26% of Gram-negative isolates showing resistance. In terms of coverage against Gram-negative isolates, the lowest level of coverage was provided by ampicillin-gentamicin at slightly over 28%, compared with about 73% for amoxicillin-clavulanate-amikacin, 77% for ceftazidime-amikacin, and 80% for piperacillin-tazobactam-amikacin.

In contrast, “Gram-positive isolates generally had reduced levels of resistance,” the authors state. As Dr. Walsh noted, the consortium also did an analysis assessing how much the antibiotic combinations cost and how much payment was deferred to the parents. For example, in Nigeria, the entire cost of treatment is passed down to the parents, “so if they are earning, say, $5.00 a day and the infant needs ceftazidime-amikacin, where the cost per dose is about $6.00 or $7.00 a day, parents can’t afford it,” Dr. Walsh observed.

This part of the conversation, he added, tends to get lost in many studies of antibiotic resistance in LMICs, which is a critical omission, because in many instances, the choice of treatment does come down to affordability. “It’s all very well for the WHO to sit there and say, ampicillin-gentamicin is perfect, but the combination actually doesn’t work in over 70% of the Gram-negative bacteria we looked at in these countries,” Dr. Walsh emphasized.

“The fact is that we have to be a lot more internationally engaged as to what’s actually happening in poorer populations, because unless we do, neonates are going to continue to die,” he said.
 

Editorial commentary

Commenting on the findings, lead editorialist Luregn Schlapbach, MD, PhD, of University Children’s Hospital Zurich, Switzerland, pointed out that the study has a number of limitations, including a high rate of dropouts from follow-up. This could possibly result in underestimation of neonatal mortality as well as country-specific biases. Nevertheless, Dr. Schlapbach feels that the integration of sequential clinical, genomic, microbiologic, drug, and cost data across a large network in LMIC settings is “exceptional” and will serve to inform “urgently needed” clinical trials in the field of neonatal sepsis.

“At present, increasing global antibiotic resistance is threatening progress against neonatal sepsis, prompting urgency to develop improved measures to effectively prevent and treat life-threatening infections in this high-risk group,” Dr. Schlapbach and colleagues write.

“The findings from the BARNARDS study call for randomized trials comparing mortality benefit and cost efficiency of different antibiotic combinations and management algorithms to safely reduce unnecessary antibiotic exposure for neonatal sepsis,” the editorialists concluded.

The authors and editorialists have disclosed no relevant financial relationships.

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

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With sexually transmitted infections off the charts, California pushes at-home tests

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SACRAMENTO, CALIF. – California has become the first state to require health insurance plans to cover at-home tests for sexually transmitted infections such as HIV, chlamydia, and syphilis – which could help quell the STI epidemic that has raged nearly unchecked as public health departments have focused on COVID-19.

The rule, part of a broader law addressing the STI epidemic, took effect Jan. 1 for people with state-regulated private insurance plans and will kick in sometime later for the millions of low-income Californians enrolled in the state’s Medicaid program.

By making it easier and cheaper for Californians to self-administer tests in the privacy of their homes, the provision could bring better disease monitoring to rural and underserved parts of the state, reduce the stigma patients experience when seeking care, and give them more control over their health, say experts on infectious diseases.

“This is the first law of its kind, and I’d say it’s kind of cutting-edge,” said Stephanie Arnold Pang, senior director of policy and government relations for the National Coalition of STD Directors. “We want to bring down every single barrier for someone to get STI testing, and out-of-pocket cost is a huge factor.”

But being first has its downsides. Because the concept of insurance coverage for home STI tests is so new, the state’s Medicaid program, Medi-Cal, could not establish by Jan. 1 the billing codes it needs to start paying for tests. Federal regulators also haven’t approved the tests for home use, which could make labs reluctant to process them. And a state analysis predicts most in-network health care providers won’t start prescribing home tests for at least a year until they adjust their billing and other practices.

Nevertheless, the situation is urgent and requires action, said state Sen. Richard Pan (D-Sacramento), a pediatrician who wrote the law.

“We have children born in California with syphilis,” Dr. Pan said. “You’d think that went away in the Victorian era.”

Even before COVID, sexually transmitted infections hit all-time highs in the United States and California for 6 years in a row, according to 2019 data from the Centers for Disease Control and Prevention. Rates of congenital syphilis, which babies contract from their mothers, illustrate the severity of the STI epidemic: Cases were up 279% from 2015 to 2019 nationally and 232% in California. Of the 445 cases of congenital syphilis in California in 2019, 37 were stillbirths.

The pandemic only worsened the problem because health departments were overwhelmed responding to the COVID emergency, and stay-at-home orders kept people away from clinics.

In surveys of public health programs across the country since May 2020, the National Coalition of STD Directors found that most respondents – up to 78% in one survey – have diverted some of their STI workforces to test and monitor COVID. A report that accompanied the most recent survey found that some STIs were “completely unchecked” because of reductions in clinic hours, diversion of resources, shortages of testing kits and staff burnout.

Some at-home STI tests screen for a single disease but other kits can collect and send samples to check for a variety of infections. Depending on the test, patients collect a drop of blood with a lancet, or swab their mouth, vagina, anus, or penis.

Some tests require patients to send samples to a lab for analysis, while some oral HIV tests give results at home in a few minutes.

Ivan Beas, a 25-year-old graduate student at University of California, Los Angeles, was getting tested frequently as part of a 2-year research study. When clinics closed during the pandemic, researchers sent him a home kit.

The kit, which tests for HIV, hepatitis C, herpes, syphilis, chlamydia, gonorrhea, and trichomoniasis, was packaged discreetly and came with easy instructions. It took Mr. Beas about 10 minutes to prick his finger, swab his mouth and send the samples to the lab.

Mr. Beas wanted to continue screening himself every few months after the study ended, he said, but the kit he used retails for $289, which is out of reach for him.

The last time he went to a clinic in person, “I spent 2 hours waiting to even be seen by a doctor because of how busy they are,” he said. Until Medi-Cal begins covering home tests, he said, he will have to find time to get tested for free at a Planned Parenthood clinic.

“If insurance were to cover it, I’d definitely do it more,” he said.

Under California’s new law, plans regulated by the state must cover home STI tests when ordered by a health care provider.  

Privately insured Californians can take advantage of the coverage immediately. How much they will owe out-of-pocket for the tests – if anything – depends on the type of plan they have, whether their provider is in-network, and whether they fall into a category the federal government has designated for free screening.

Medi-Cal patients almost never face out-of-pocket expenses, but they will have to wait for coverage because the Department of Health Care Services, which administers Medi-Cal, is working with the American Medical Association and the federal government to create billing codes. The reimbursement rates for those codes will then need federal approval.

The state doesn’t know how long that process will take, according to department spokesperson Anthony Cava.

The rule does not apply to the millions of Californians whose job-based health insurance plans are regulated by the federal government.

Other states and organizations have experimented with at-home STI tests. The public health departments in Alabama and the District of Columbia send free kits to residents who request them, but neither jurisdiction requires insurance coverage for them. The National Coalition of STD Directors is sending free kits to people through health departments in Philadelphia; Iowa; Virginia; Indiana; Puerto Rico; and Navajo County, Arizona. The list of recipients is expected to grow this month.

Iwantthekit.org, a project of Johns Hopkins University, has been sending free kits to Maryland residents since 2004, and to Alaskans since 2011. The program is funded by grants and works with local health departments.

Charlotte Gaydos, cofounder of the project, said that requests for test kits during the pandemic nearly tripled – and that she would expand to every state if she could bill insurance the way the California law mandates.

The tests fall into a murky regulatory area. While they have been approved by the Food and Drug Administration, none have been cleared for use at home. Patients are supposed to collect their own samples within the walls of a health facility, and some labs may not analyze samples collected at home.

Public health officials cited other potential challenges: Patients may not have the same access to counseling, treatment, or referrals to other services such as food banks that they would receive at clinics. And although patients are supposed to self-report the results of their tests to public health authorities, some people won’t follow through.

Vlad Carrillo, 31, experienced such trade-offs recently. Mr. Carrillo used to get tested at a San Francisco clinic, where they could get counseling and other services. But Carrillo lost their apartment during the pandemic and moved about 7 hours away to Bishop, the only incorporated city in rural Inyo County.

“Being away from the city, it took me a whole year to find a way to get tested,” Carrillo said.

Carrillo eventually got the kit through the mail, avoiding the stigma of going to the clinic in Bishop, which is “more focused on straight stuff,” like preventing pregnancy. Without the test, Carrillo couldn’t get PrEP, a medication to prevent HIV.

“Going without it for so long was really hard on me,” Carrillo said.

This story was produced by Kaiser Health News (KHN), which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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SACRAMENTO, CALIF. – California has become the first state to require health insurance plans to cover at-home tests for sexually transmitted infections such as HIV, chlamydia, and syphilis – which could help quell the STI epidemic that has raged nearly unchecked as public health departments have focused on COVID-19.

The rule, part of a broader law addressing the STI epidemic, took effect Jan. 1 for people with state-regulated private insurance plans and will kick in sometime later for the millions of low-income Californians enrolled in the state’s Medicaid program.

By making it easier and cheaper for Californians to self-administer tests in the privacy of their homes, the provision could bring better disease monitoring to rural and underserved parts of the state, reduce the stigma patients experience when seeking care, and give them more control over their health, say experts on infectious diseases.

“This is the first law of its kind, and I’d say it’s kind of cutting-edge,” said Stephanie Arnold Pang, senior director of policy and government relations for the National Coalition of STD Directors. “We want to bring down every single barrier for someone to get STI testing, and out-of-pocket cost is a huge factor.”

But being first has its downsides. Because the concept of insurance coverage for home STI tests is so new, the state’s Medicaid program, Medi-Cal, could not establish by Jan. 1 the billing codes it needs to start paying for tests. Federal regulators also haven’t approved the tests for home use, which could make labs reluctant to process them. And a state analysis predicts most in-network health care providers won’t start prescribing home tests for at least a year until they adjust their billing and other practices.

Nevertheless, the situation is urgent and requires action, said state Sen. Richard Pan (D-Sacramento), a pediatrician who wrote the law.

“We have children born in California with syphilis,” Dr. Pan said. “You’d think that went away in the Victorian era.”

Even before COVID, sexually transmitted infections hit all-time highs in the United States and California for 6 years in a row, according to 2019 data from the Centers for Disease Control and Prevention. Rates of congenital syphilis, which babies contract from their mothers, illustrate the severity of the STI epidemic: Cases were up 279% from 2015 to 2019 nationally and 232% in California. Of the 445 cases of congenital syphilis in California in 2019, 37 were stillbirths.

The pandemic only worsened the problem because health departments were overwhelmed responding to the COVID emergency, and stay-at-home orders kept people away from clinics.

In surveys of public health programs across the country since May 2020, the National Coalition of STD Directors found that most respondents – up to 78% in one survey – have diverted some of their STI workforces to test and monitor COVID. A report that accompanied the most recent survey found that some STIs were “completely unchecked” because of reductions in clinic hours, diversion of resources, shortages of testing kits and staff burnout.

Some at-home STI tests screen for a single disease but other kits can collect and send samples to check for a variety of infections. Depending on the test, patients collect a drop of blood with a lancet, or swab their mouth, vagina, anus, or penis.

Some tests require patients to send samples to a lab for analysis, while some oral HIV tests give results at home in a few minutes.

Ivan Beas, a 25-year-old graduate student at University of California, Los Angeles, was getting tested frequently as part of a 2-year research study. When clinics closed during the pandemic, researchers sent him a home kit.

The kit, which tests for HIV, hepatitis C, herpes, syphilis, chlamydia, gonorrhea, and trichomoniasis, was packaged discreetly and came with easy instructions. It took Mr. Beas about 10 minutes to prick his finger, swab his mouth and send the samples to the lab.

Mr. Beas wanted to continue screening himself every few months after the study ended, he said, but the kit he used retails for $289, which is out of reach for him.

The last time he went to a clinic in person, “I spent 2 hours waiting to even be seen by a doctor because of how busy they are,” he said. Until Medi-Cal begins covering home tests, he said, he will have to find time to get tested for free at a Planned Parenthood clinic.

“If insurance were to cover it, I’d definitely do it more,” he said.

Under California’s new law, plans regulated by the state must cover home STI tests when ordered by a health care provider.  

Privately insured Californians can take advantage of the coverage immediately. How much they will owe out-of-pocket for the tests – if anything – depends on the type of plan they have, whether their provider is in-network, and whether they fall into a category the federal government has designated for free screening.

Medi-Cal patients almost never face out-of-pocket expenses, but they will have to wait for coverage because the Department of Health Care Services, which administers Medi-Cal, is working with the American Medical Association and the federal government to create billing codes. The reimbursement rates for those codes will then need federal approval.

The state doesn’t know how long that process will take, according to department spokesperson Anthony Cava.

The rule does not apply to the millions of Californians whose job-based health insurance plans are regulated by the federal government.

Other states and organizations have experimented with at-home STI tests. The public health departments in Alabama and the District of Columbia send free kits to residents who request them, but neither jurisdiction requires insurance coverage for them. The National Coalition of STD Directors is sending free kits to people through health departments in Philadelphia; Iowa; Virginia; Indiana; Puerto Rico; and Navajo County, Arizona. The list of recipients is expected to grow this month.

Iwantthekit.org, a project of Johns Hopkins University, has been sending free kits to Maryland residents since 2004, and to Alaskans since 2011. The program is funded by grants and works with local health departments.

Charlotte Gaydos, cofounder of the project, said that requests for test kits during the pandemic nearly tripled – and that she would expand to every state if she could bill insurance the way the California law mandates.

The tests fall into a murky regulatory area. While they have been approved by the Food and Drug Administration, none have been cleared for use at home. Patients are supposed to collect their own samples within the walls of a health facility, and some labs may not analyze samples collected at home.

Public health officials cited other potential challenges: Patients may not have the same access to counseling, treatment, or referrals to other services such as food banks that they would receive at clinics. And although patients are supposed to self-report the results of their tests to public health authorities, some people won’t follow through.

Vlad Carrillo, 31, experienced such trade-offs recently. Mr. Carrillo used to get tested at a San Francisco clinic, where they could get counseling and other services. But Carrillo lost their apartment during the pandemic and moved about 7 hours away to Bishop, the only incorporated city in rural Inyo County.

“Being away from the city, it took me a whole year to find a way to get tested,” Carrillo said.

Carrillo eventually got the kit through the mail, avoiding the stigma of going to the clinic in Bishop, which is “more focused on straight stuff,” like preventing pregnancy. Without the test, Carrillo couldn’t get PrEP, a medication to prevent HIV.

“Going without it for so long was really hard on me,” Carrillo said.

This story was produced by Kaiser Health News (KHN), which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

 



SACRAMENTO, CALIF. – California has become the first state to require health insurance plans to cover at-home tests for sexually transmitted infections such as HIV, chlamydia, and syphilis – which could help quell the STI epidemic that has raged nearly unchecked as public health departments have focused on COVID-19.

The rule, part of a broader law addressing the STI epidemic, took effect Jan. 1 for people with state-regulated private insurance plans and will kick in sometime later for the millions of low-income Californians enrolled in the state’s Medicaid program.

By making it easier and cheaper for Californians to self-administer tests in the privacy of their homes, the provision could bring better disease monitoring to rural and underserved parts of the state, reduce the stigma patients experience when seeking care, and give them more control over their health, say experts on infectious diseases.

“This is the first law of its kind, and I’d say it’s kind of cutting-edge,” said Stephanie Arnold Pang, senior director of policy and government relations for the National Coalition of STD Directors. “We want to bring down every single barrier for someone to get STI testing, and out-of-pocket cost is a huge factor.”

But being first has its downsides. Because the concept of insurance coverage for home STI tests is so new, the state’s Medicaid program, Medi-Cal, could not establish by Jan. 1 the billing codes it needs to start paying for tests. Federal regulators also haven’t approved the tests for home use, which could make labs reluctant to process them. And a state analysis predicts most in-network health care providers won’t start prescribing home tests for at least a year until they adjust their billing and other practices.

Nevertheless, the situation is urgent and requires action, said state Sen. Richard Pan (D-Sacramento), a pediatrician who wrote the law.

“We have children born in California with syphilis,” Dr. Pan said. “You’d think that went away in the Victorian era.”

Even before COVID, sexually transmitted infections hit all-time highs in the United States and California for 6 years in a row, according to 2019 data from the Centers for Disease Control and Prevention. Rates of congenital syphilis, which babies contract from their mothers, illustrate the severity of the STI epidemic: Cases were up 279% from 2015 to 2019 nationally and 232% in California. Of the 445 cases of congenital syphilis in California in 2019, 37 were stillbirths.

The pandemic only worsened the problem because health departments were overwhelmed responding to the COVID emergency, and stay-at-home orders kept people away from clinics.

In surveys of public health programs across the country since May 2020, the National Coalition of STD Directors found that most respondents – up to 78% in one survey – have diverted some of their STI workforces to test and monitor COVID. A report that accompanied the most recent survey found that some STIs were “completely unchecked” because of reductions in clinic hours, diversion of resources, shortages of testing kits and staff burnout.

Some at-home STI tests screen for a single disease but other kits can collect and send samples to check for a variety of infections. Depending on the test, patients collect a drop of blood with a lancet, or swab their mouth, vagina, anus, or penis.

Some tests require patients to send samples to a lab for analysis, while some oral HIV tests give results at home in a few minutes.

Ivan Beas, a 25-year-old graduate student at University of California, Los Angeles, was getting tested frequently as part of a 2-year research study. When clinics closed during the pandemic, researchers sent him a home kit.

The kit, which tests for HIV, hepatitis C, herpes, syphilis, chlamydia, gonorrhea, and trichomoniasis, was packaged discreetly and came with easy instructions. It took Mr. Beas about 10 minutes to prick his finger, swab his mouth and send the samples to the lab.

Mr. Beas wanted to continue screening himself every few months after the study ended, he said, but the kit he used retails for $289, which is out of reach for him.

The last time he went to a clinic in person, “I spent 2 hours waiting to even be seen by a doctor because of how busy they are,” he said. Until Medi-Cal begins covering home tests, he said, he will have to find time to get tested for free at a Planned Parenthood clinic.

“If insurance were to cover it, I’d definitely do it more,” he said.

Under California’s new law, plans regulated by the state must cover home STI tests when ordered by a health care provider.  

Privately insured Californians can take advantage of the coverage immediately. How much they will owe out-of-pocket for the tests – if anything – depends on the type of plan they have, whether their provider is in-network, and whether they fall into a category the federal government has designated for free screening.

Medi-Cal patients almost never face out-of-pocket expenses, but they will have to wait for coverage because the Department of Health Care Services, which administers Medi-Cal, is working with the American Medical Association and the federal government to create billing codes. The reimbursement rates for those codes will then need federal approval.

The state doesn’t know how long that process will take, according to department spokesperson Anthony Cava.

The rule does not apply to the millions of Californians whose job-based health insurance plans are regulated by the federal government.

Other states and organizations have experimented with at-home STI tests. The public health departments in Alabama and the District of Columbia send free kits to residents who request them, but neither jurisdiction requires insurance coverage for them. The National Coalition of STD Directors is sending free kits to people through health departments in Philadelphia; Iowa; Virginia; Indiana; Puerto Rico; and Navajo County, Arizona. The list of recipients is expected to grow this month.

Iwantthekit.org, a project of Johns Hopkins University, has been sending free kits to Maryland residents since 2004, and to Alaskans since 2011. The program is funded by grants and works with local health departments.

Charlotte Gaydos, cofounder of the project, said that requests for test kits during the pandemic nearly tripled – and that she would expand to every state if she could bill insurance the way the California law mandates.

The tests fall into a murky regulatory area. While they have been approved by the Food and Drug Administration, none have been cleared for use at home. Patients are supposed to collect their own samples within the walls of a health facility, and some labs may not analyze samples collected at home.

Public health officials cited other potential challenges: Patients may not have the same access to counseling, treatment, or referrals to other services such as food banks that they would receive at clinics. And although patients are supposed to self-report the results of their tests to public health authorities, some people won’t follow through.

Vlad Carrillo, 31, experienced such trade-offs recently. Mr. Carrillo used to get tested at a San Francisco clinic, where they could get counseling and other services. But Carrillo lost their apartment during the pandemic and moved about 7 hours away to Bishop, the only incorporated city in rural Inyo County.

“Being away from the city, it took me a whole year to find a way to get tested,” Carrillo said.

Carrillo eventually got the kit through the mail, avoiding the stigma of going to the clinic in Bishop, which is “more focused on straight stuff,” like preventing pregnancy. Without the test, Carrillo couldn’t get PrEP, a medication to prevent HIV.

“Going without it for so long was really hard on me,” Carrillo said.

This story was produced by Kaiser Health News (KHN), which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Mayo Clinic fires 700 employees for refusing COVID vaccine

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The Mayo Clinic fired 700 employees this week who didn’t comply with its COVID-19 vaccine mandate.

The medical center, which is Minnesota’s largest employer, has major campuses in Arizona, Florida, and Minnesota and operates hospitals in Iowa and Wisconsin.

Employees had until Jan. 3 to get vaccinated or receive approval for an exemption. On Jan. 4, the hospital fired those who didn’t meet the requirement, according to Action News Jax, a CBS affiliate in Florida.

The 700 employees make up about 1% of Mayo Clinic’s 73,000-person workforce. So far, none of the employees at the campus in Jacksonville, Fla., have been affected, the news outlet reported.

“Florida staff who are not in compliance with our vaccination program remain employed pending the outcome of litigation related to the Centers for Medicare & Medicaid Services requirements,” a Mayo Clinic spokesperson told Action News Jax.

The federal government and Florida remain at odds over vaccine mandates, and several lawsuits are winding through the court system. Florida Gov. Ron DeSantis signed legislation in November that bans private Florida employers from requiring all employees to get vaccinated and calls for various exemption options, according to The Florida Times-Union. The state law clashes with a federal rule that requires vaccinations for all health care workers at hospitals that receive Medicare and Medicaid funding.

The Mayo Clinic mandate required employees to receive at least one COVID-19 vaccine dose and not be “overdue” for a second dose, according to the statement. Only medical and religious exemptions were allowed, and most medical and religious exemptions were approved.

“While Mayo Clinic is saddened to lose valuable employees, we need to take all steps necessary to keep our patients, workforce, visitors, and communities safe,” Mayo Clinic wrote in its statement. “If individuals released from employment choose to get vaccinated at a later date, the opportunity exists for them to apply and return to Mayo Clinic for future job openings.”

With the latest surge in COVID-19 cases from the Omicron variant, the Mayo Clinic also encouraged unvaccinated people to get a shot and those who are eligible for a booster to get one “as soon as possible.”

“Based on science and data, it’s clear that vaccination keeps people out of the hospital and saves lives,” according to the statement. “That’s true for everyone in our communities – and it’s especially true for the many patients with serious or complex diseases who seek care at Mayo Clinic each day.”

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

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The Mayo Clinic fired 700 employees this week who didn’t comply with its COVID-19 vaccine mandate.

The medical center, which is Minnesota’s largest employer, has major campuses in Arizona, Florida, and Minnesota and operates hospitals in Iowa and Wisconsin.

Employees had until Jan. 3 to get vaccinated or receive approval for an exemption. On Jan. 4, the hospital fired those who didn’t meet the requirement, according to Action News Jax, a CBS affiliate in Florida.

The 700 employees make up about 1% of Mayo Clinic’s 73,000-person workforce. So far, none of the employees at the campus in Jacksonville, Fla., have been affected, the news outlet reported.

“Florida staff who are not in compliance with our vaccination program remain employed pending the outcome of litigation related to the Centers for Medicare & Medicaid Services requirements,” a Mayo Clinic spokesperson told Action News Jax.

The federal government and Florida remain at odds over vaccine mandates, and several lawsuits are winding through the court system. Florida Gov. Ron DeSantis signed legislation in November that bans private Florida employers from requiring all employees to get vaccinated and calls for various exemption options, according to The Florida Times-Union. The state law clashes with a federal rule that requires vaccinations for all health care workers at hospitals that receive Medicare and Medicaid funding.

The Mayo Clinic mandate required employees to receive at least one COVID-19 vaccine dose and not be “overdue” for a second dose, according to the statement. Only medical and religious exemptions were allowed, and most medical and religious exemptions were approved.

“While Mayo Clinic is saddened to lose valuable employees, we need to take all steps necessary to keep our patients, workforce, visitors, and communities safe,” Mayo Clinic wrote in its statement. “If individuals released from employment choose to get vaccinated at a later date, the opportunity exists for them to apply and return to Mayo Clinic for future job openings.”

With the latest surge in COVID-19 cases from the Omicron variant, the Mayo Clinic also encouraged unvaccinated people to get a shot and those who are eligible for a booster to get one “as soon as possible.”

“Based on science and data, it’s clear that vaccination keeps people out of the hospital and saves lives,” according to the statement. “That’s true for everyone in our communities – and it’s especially true for the many patients with serious or complex diseases who seek care at Mayo Clinic each day.”

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

 

The Mayo Clinic fired 700 employees this week who didn’t comply with its COVID-19 vaccine mandate.

The medical center, which is Minnesota’s largest employer, has major campuses in Arizona, Florida, and Minnesota and operates hospitals in Iowa and Wisconsin.

Employees had until Jan. 3 to get vaccinated or receive approval for an exemption. On Jan. 4, the hospital fired those who didn’t meet the requirement, according to Action News Jax, a CBS affiliate in Florida.

The 700 employees make up about 1% of Mayo Clinic’s 73,000-person workforce. So far, none of the employees at the campus in Jacksonville, Fla., have been affected, the news outlet reported.

“Florida staff who are not in compliance with our vaccination program remain employed pending the outcome of litigation related to the Centers for Medicare & Medicaid Services requirements,” a Mayo Clinic spokesperson told Action News Jax.

The federal government and Florida remain at odds over vaccine mandates, and several lawsuits are winding through the court system. Florida Gov. Ron DeSantis signed legislation in November that bans private Florida employers from requiring all employees to get vaccinated and calls for various exemption options, according to The Florida Times-Union. The state law clashes with a federal rule that requires vaccinations for all health care workers at hospitals that receive Medicare and Medicaid funding.

The Mayo Clinic mandate required employees to receive at least one COVID-19 vaccine dose and not be “overdue” for a second dose, according to the statement. Only medical and religious exemptions were allowed, and most medical and religious exemptions were approved.

“While Mayo Clinic is saddened to lose valuable employees, we need to take all steps necessary to keep our patients, workforce, visitors, and communities safe,” Mayo Clinic wrote in its statement. “If individuals released from employment choose to get vaccinated at a later date, the opportunity exists for them to apply and return to Mayo Clinic for future job openings.”

With the latest surge in COVID-19 cases from the Omicron variant, the Mayo Clinic also encouraged unvaccinated people to get a shot and those who are eligible for a booster to get one “as soon as possible.”

“Based on science and data, it’s clear that vaccination keeps people out of the hospital and saves lives,” according to the statement. “That’s true for everyone in our communities – and it’s especially true for the many patients with serious or complex diseases who seek care at Mayo Clinic each day.”

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

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Fossilized blood proteins from child illness may cause chalky teeth

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FROM FRONTIERS IN PHYSIOLOGY

Researchers have identified a potential cause of molar hypomineralization (MH), or “chalky teeth,” an underrecognized condition affecting one in five children worldwide. The discovery could lead to preventive medical therapies to reduce dental caries and extractions, they said.

According to a team led by biochemist Michael J. Hubbard, BDS, PhD, professor in the department of medicine, dentistry, and health sciences at the University of Melbourne, the “groundbreaking” research found that the failure of enamel to adequately harden is associated with exposure to serum albumin while teeth are developing. The blood protein “poisons” the growth of mineral crystals rather than injure the cells that deposit enamel, they reported.

The investigators, including researchers from Chile, said their findings hold promise for better clinical management of MH and open a new door into research on the broader pathogenesis and causes of the condition.

“We hope this breakthrough will eventually lead to medical prevention of MH, prompting global health benefits including major reductions in childhood tooth decay,” they wrote in an article published online Dec. 21 in Frontiers in Physiology.
 

More than cosmetic

Chalky teeth, characterized by discolored enamel spots, are not merely a cosmetic problem. The condition can lead to severe toothache, painful eating, tooth decay, and even abscesses and extractions. Although its triggers have eluded dental research for a century, Dr. Hubbard’s group said fossilized blood proteins such as albumin in the tooth appear to be at least one cause.

Biochemical evidence indicates that serum albumin surrounding developing teeth is normally excluded from enamel, Dr. Hubbard said in an interview. “Given that albumin binds strongly to hydroxyapatite-based mineral and blocks its growth, we infer that the epithelial barrier – the enamel-forming cells termed ameloblasts and normally responsible for excluding albumin – must break down in places in response to medical triggers.”

This breach enables localized infiltration of albumin, which then blocks further hardening of soft, immature enamel, leading to residual spots or patches of chalky enamel once the tooth eventually erupts into the mouth. “In other words, we infer that chalky enamel spots coincide with localized breaches of an epithelial barrier that are triggered by yet-to-be determined systemic insults,” he said.

Joseph Brofsky, DMD, section head of pediatric dentistry at North Shore LIJ Cohen Children’s Medical Center of New York, in Queens, agreed that that the definitive cause of MH has evaded identification for a hundred years. However, he expressed skepticism about the fossilized blood protein hypothesis.

“That’s a long shot. It’s a possibility, and I’m not ruling it out, but we’re not 100% sure,” said Dr. Brofsky, who was not involved in the research.

In his experience, MH is somewhat less prevalent in the United States, affecting about 1 in 10 children here, which is about half the global rate. “But it’s a problem, and we wish it would go away, but before we know beyond a reasonable doubt what causes this condition, it’s going to be hard to stop it.”

Most cases of MH involve hypomineralization of the 6-year molars, the first adult molars to erupt, but the process starts at birth. “For 6-year molars, normal hardening of dental enamel takes place from the early postnatal period through infancy,” Dr. Hubbard said.

The 2-year and 12-year molars are affected about half as frequently as their 6-year counterparts, “so this extends the medical-risk window out to early school days, and slightly back to the perinatal period for the 12-year and 2-year molars, respectively,” he said.

A critical question is which childhood illnesses are most likely to set the stage for MH, he added. “Forty-plus years of epidemiology have failed to nail a specific cause or causal association. But given the high prevalence of MH – 20% in otherwise healthy kids – naturally we suspect some common illnesses are the culprits,” he said. “But which diseases, which medications, and which combinations?”

Dr. Hubbard’s advice to pediatricians is to be alert to MH: “If you’re inspecting a child’s throat, then why not look at their back teeth, too – particularly when they’re getting their new molars at 2, 6, and 12 years?”

The study was supported by the Melbourne Research Unit for Facial Disorders Department of Pharmacology & Therapeutics, Department of Paediatrics, and Faculty of Medicine, Dentistry, and Health Sciences at the University of Melbourne. The authors and Dr. Brofsky have disclosed no relevant financial relationships.

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

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FROM FRONTIERS IN PHYSIOLOGY

Researchers have identified a potential cause of molar hypomineralization (MH), or “chalky teeth,” an underrecognized condition affecting one in five children worldwide. The discovery could lead to preventive medical therapies to reduce dental caries and extractions, they said.

According to a team led by biochemist Michael J. Hubbard, BDS, PhD, professor in the department of medicine, dentistry, and health sciences at the University of Melbourne, the “groundbreaking” research found that the failure of enamel to adequately harden is associated with exposure to serum albumin while teeth are developing. The blood protein “poisons” the growth of mineral crystals rather than injure the cells that deposit enamel, they reported.

The investigators, including researchers from Chile, said their findings hold promise for better clinical management of MH and open a new door into research on the broader pathogenesis and causes of the condition.

“We hope this breakthrough will eventually lead to medical prevention of MH, prompting global health benefits including major reductions in childhood tooth decay,” they wrote in an article published online Dec. 21 in Frontiers in Physiology.
 

More than cosmetic

Chalky teeth, characterized by discolored enamel spots, are not merely a cosmetic problem. The condition can lead to severe toothache, painful eating, tooth decay, and even abscesses and extractions. Although its triggers have eluded dental research for a century, Dr. Hubbard’s group said fossilized blood proteins such as albumin in the tooth appear to be at least one cause.

Biochemical evidence indicates that serum albumin surrounding developing teeth is normally excluded from enamel, Dr. Hubbard said in an interview. “Given that albumin binds strongly to hydroxyapatite-based mineral and blocks its growth, we infer that the epithelial barrier – the enamel-forming cells termed ameloblasts and normally responsible for excluding albumin – must break down in places in response to medical triggers.”

This breach enables localized infiltration of albumin, which then blocks further hardening of soft, immature enamel, leading to residual spots or patches of chalky enamel once the tooth eventually erupts into the mouth. “In other words, we infer that chalky enamel spots coincide with localized breaches of an epithelial barrier that are triggered by yet-to-be determined systemic insults,” he said.

Joseph Brofsky, DMD, section head of pediatric dentistry at North Shore LIJ Cohen Children’s Medical Center of New York, in Queens, agreed that that the definitive cause of MH has evaded identification for a hundred years. However, he expressed skepticism about the fossilized blood protein hypothesis.

“That’s a long shot. It’s a possibility, and I’m not ruling it out, but we’re not 100% sure,” said Dr. Brofsky, who was not involved in the research.

In his experience, MH is somewhat less prevalent in the United States, affecting about 1 in 10 children here, which is about half the global rate. “But it’s a problem, and we wish it would go away, but before we know beyond a reasonable doubt what causes this condition, it’s going to be hard to stop it.”

Most cases of MH involve hypomineralization of the 6-year molars, the first adult molars to erupt, but the process starts at birth. “For 6-year molars, normal hardening of dental enamel takes place from the early postnatal period through infancy,” Dr. Hubbard said.

The 2-year and 12-year molars are affected about half as frequently as their 6-year counterparts, “so this extends the medical-risk window out to early school days, and slightly back to the perinatal period for the 12-year and 2-year molars, respectively,” he said.

A critical question is which childhood illnesses are most likely to set the stage for MH, he added. “Forty-plus years of epidemiology have failed to nail a specific cause or causal association. But given the high prevalence of MH – 20% in otherwise healthy kids – naturally we suspect some common illnesses are the culprits,” he said. “But which diseases, which medications, and which combinations?”

Dr. Hubbard’s advice to pediatricians is to be alert to MH: “If you’re inspecting a child’s throat, then why not look at their back teeth, too – particularly when they’re getting their new molars at 2, 6, and 12 years?”

The study was supported by the Melbourne Research Unit for Facial Disorders Department of Pharmacology & Therapeutics, Department of Paediatrics, and Faculty of Medicine, Dentistry, and Health Sciences at the University of Melbourne. The authors and Dr. Brofsky have disclosed no relevant financial relationships.

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

 

FROM FRONTIERS IN PHYSIOLOGY

Researchers have identified a potential cause of molar hypomineralization (MH), or “chalky teeth,” an underrecognized condition affecting one in five children worldwide. The discovery could lead to preventive medical therapies to reduce dental caries and extractions, they said.

According to a team led by biochemist Michael J. Hubbard, BDS, PhD, professor in the department of medicine, dentistry, and health sciences at the University of Melbourne, the “groundbreaking” research found that the failure of enamel to adequately harden is associated with exposure to serum albumin while teeth are developing. The blood protein “poisons” the growth of mineral crystals rather than injure the cells that deposit enamel, they reported.

The investigators, including researchers from Chile, said their findings hold promise for better clinical management of MH and open a new door into research on the broader pathogenesis and causes of the condition.

“We hope this breakthrough will eventually lead to medical prevention of MH, prompting global health benefits including major reductions in childhood tooth decay,” they wrote in an article published online Dec. 21 in Frontiers in Physiology.
 

More than cosmetic

Chalky teeth, characterized by discolored enamel spots, are not merely a cosmetic problem. The condition can lead to severe toothache, painful eating, tooth decay, and even abscesses and extractions. Although its triggers have eluded dental research for a century, Dr. Hubbard’s group said fossilized blood proteins such as albumin in the tooth appear to be at least one cause.

Biochemical evidence indicates that serum albumin surrounding developing teeth is normally excluded from enamel, Dr. Hubbard said in an interview. “Given that albumin binds strongly to hydroxyapatite-based mineral and blocks its growth, we infer that the epithelial barrier – the enamel-forming cells termed ameloblasts and normally responsible for excluding albumin – must break down in places in response to medical triggers.”

This breach enables localized infiltration of albumin, which then blocks further hardening of soft, immature enamel, leading to residual spots or patches of chalky enamel once the tooth eventually erupts into the mouth. “In other words, we infer that chalky enamel spots coincide with localized breaches of an epithelial barrier that are triggered by yet-to-be determined systemic insults,” he said.

Joseph Brofsky, DMD, section head of pediatric dentistry at North Shore LIJ Cohen Children’s Medical Center of New York, in Queens, agreed that that the definitive cause of MH has evaded identification for a hundred years. However, he expressed skepticism about the fossilized blood protein hypothesis.

“That’s a long shot. It’s a possibility, and I’m not ruling it out, but we’re not 100% sure,” said Dr. Brofsky, who was not involved in the research.

In his experience, MH is somewhat less prevalent in the United States, affecting about 1 in 10 children here, which is about half the global rate. “But it’s a problem, and we wish it would go away, but before we know beyond a reasonable doubt what causes this condition, it’s going to be hard to stop it.”

Most cases of MH involve hypomineralization of the 6-year molars, the first adult molars to erupt, but the process starts at birth. “For 6-year molars, normal hardening of dental enamel takes place from the early postnatal period through infancy,” Dr. Hubbard said.

The 2-year and 12-year molars are affected about half as frequently as their 6-year counterparts, “so this extends the medical-risk window out to early school days, and slightly back to the perinatal period for the 12-year and 2-year molars, respectively,” he said.

A critical question is which childhood illnesses are most likely to set the stage for MH, he added. “Forty-plus years of epidemiology have failed to nail a specific cause or causal association. But given the high prevalence of MH – 20% in otherwise healthy kids – naturally we suspect some common illnesses are the culprits,” he said. “But which diseases, which medications, and which combinations?”

Dr. Hubbard’s advice to pediatricians is to be alert to MH: “If you’re inspecting a child’s throat, then why not look at their back teeth, too – particularly when they’re getting their new molars at 2, 6, and 12 years?”

The study was supported by the Melbourne Research Unit for Facial Disorders Department of Pharmacology & Therapeutics, Department of Paediatrics, and Faculty of Medicine, Dentistry, and Health Sciences at the University of Melbourne. The authors and Dr. Brofsky have disclosed no relevant financial relationships.

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

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First ‘flurona’ cases reported in the U.S.

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Health authorities in California, Texas, and Kansas have reported cases of “flurona,” in which people have seasonal flu and COVID-19 at the same time.

The first known case was detected in Israel, but until the first week of January no cases had been reported in the United States.

In Los Angeles, a teenaged boy tested positive for both illnesses at a COVID testing site in Brentwood, the Los Angeles Times reported. The child’s mother tested positive for COVID the next day.

“This is the first one that we’re aware of,” Steve Farzam, chief operating officer of 911 COVID Testing, told the LA Times. “In and of itself, it’s not overly concerning; however, it is concerning and can be problematic for someone who has pre-existing medical conditions, anyone who is immunocompromised.”

The teen and his family of five had just returned from vacation in Cabo San Lucas, Mexico. All said they tested negative before the trip, but they tested again when they got home because one of the children had a runny nose, Mr. Farzam said.

The boy, who had not been vaccinated for COVID or the flu, doesn’t have serious symptoms and is recovering at home.

In Houston, a 17-year-old boy, his siblings, and his father felt sick a few days before Christmas and went in for testing, TV station KTRK reported. The teen tested positive for both the flu and COVID.

“I ended up getting tested the day before Christmas for strep throat, flu and COVID,” the teenager, Alec Zierlein, told KTRK. “I didn’t think I had any of the three. It felt like a mild cold.”

Health officials reported Jan. 5 that a flurona case was detected in Hays, Kan., TV station WIBW reported. The patient was being treated in the ICU. No other details were provided. In Israel, flurona was first found in an unvaccinated pregnant woman at Rabin Medical Center in Petach Tikva, according to the Times of Israel. She tested positive for both viruses when she arrived at the medical center, and doctors double-checked to confirm her diagnosis. The woman had mild symptoms and was released in good condition, the news outlet reported.

Public health officials in Israel said they are concerned that an increase in both viruses at the same time could lead to many hospitalizations.

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

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Health authorities in California, Texas, and Kansas have reported cases of “flurona,” in which people have seasonal flu and COVID-19 at the same time.

The first known case was detected in Israel, but until the first week of January no cases had been reported in the United States.

In Los Angeles, a teenaged boy tested positive for both illnesses at a COVID testing site in Brentwood, the Los Angeles Times reported. The child’s mother tested positive for COVID the next day.

“This is the first one that we’re aware of,” Steve Farzam, chief operating officer of 911 COVID Testing, told the LA Times. “In and of itself, it’s not overly concerning; however, it is concerning and can be problematic for someone who has pre-existing medical conditions, anyone who is immunocompromised.”

The teen and his family of five had just returned from vacation in Cabo San Lucas, Mexico. All said they tested negative before the trip, but they tested again when they got home because one of the children had a runny nose, Mr. Farzam said.

The boy, who had not been vaccinated for COVID or the flu, doesn’t have serious symptoms and is recovering at home.

In Houston, a 17-year-old boy, his siblings, and his father felt sick a few days before Christmas and went in for testing, TV station KTRK reported. The teen tested positive for both the flu and COVID.

“I ended up getting tested the day before Christmas for strep throat, flu and COVID,” the teenager, Alec Zierlein, told KTRK. “I didn’t think I had any of the three. It felt like a mild cold.”

Health officials reported Jan. 5 that a flurona case was detected in Hays, Kan., TV station WIBW reported. The patient was being treated in the ICU. No other details were provided. In Israel, flurona was first found in an unvaccinated pregnant woman at Rabin Medical Center in Petach Tikva, according to the Times of Israel. She tested positive for both viruses when she arrived at the medical center, and doctors double-checked to confirm her diagnosis. The woman had mild symptoms and was released in good condition, the news outlet reported.

Public health officials in Israel said they are concerned that an increase in both viruses at the same time could lead to many hospitalizations.

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

 

Health authorities in California, Texas, and Kansas have reported cases of “flurona,” in which people have seasonal flu and COVID-19 at the same time.

The first known case was detected in Israel, but until the first week of January no cases had been reported in the United States.

In Los Angeles, a teenaged boy tested positive for both illnesses at a COVID testing site in Brentwood, the Los Angeles Times reported. The child’s mother tested positive for COVID the next day.

“This is the first one that we’re aware of,” Steve Farzam, chief operating officer of 911 COVID Testing, told the LA Times. “In and of itself, it’s not overly concerning; however, it is concerning and can be problematic for someone who has pre-existing medical conditions, anyone who is immunocompromised.”

The teen and his family of five had just returned from vacation in Cabo San Lucas, Mexico. All said they tested negative before the trip, but they tested again when they got home because one of the children had a runny nose, Mr. Farzam said.

The boy, who had not been vaccinated for COVID or the flu, doesn’t have serious symptoms and is recovering at home.

In Houston, a 17-year-old boy, his siblings, and his father felt sick a few days before Christmas and went in for testing, TV station KTRK reported. The teen tested positive for both the flu and COVID.

“I ended up getting tested the day before Christmas for strep throat, flu and COVID,” the teenager, Alec Zierlein, told KTRK. “I didn’t think I had any of the three. It felt like a mild cold.”

Health officials reported Jan. 5 that a flurona case was detected in Hays, Kan., TV station WIBW reported. The patient was being treated in the ICU. No other details were provided. In Israel, flurona was first found in an unvaccinated pregnant woman at Rabin Medical Center in Petach Tikva, according to the Times of Israel. She tested positive for both viruses when she arrived at the medical center, and doctors double-checked to confirm her diagnosis. The woman had mild symptoms and was released in good condition, the news outlet reported.

Public health officials in Israel said they are concerned that an increase in both viruses at the same time could lead to many hospitalizations.

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

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Pneumonia in infancy predicts respiratory problems in early childhood

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Preschoolers who experienced community-acquired pneumonia in infancy were significantly more likely than were those with no history of pneumonia to develop chronic respiratory disorders, based on data from approximately 7,000 individuals.

“Lower respiratory tract infections (LRTI) during the first years of life cause injury to the rapidly developing lung at its most critical stage,” wrote Rotem Lapidot, MD, of Boston University, and colleagues. Previous research has linked pneumonia with subsequent chronic cough, bronchitis, and recurrent pneumonia in children, but data are needed to assess the impact of early community-acquired pneumonia (CAP) on respiratory health in otherwise healthy infants, the researchers said.

In a retrospective matched cohort study published in Respiratory Medicine , the researchers identified 1,343 infants who had CAP in the first 2 years of life, and 6,715 controls, using a large electronic health records dataset (Optum EHR dataset) for the period from Jan. 2011 through June 2018.

The primary outcomes were the development of any chronic respiratory disorders, reactive airway disease, and CAP hospitalizations between ages 2 and 5 years. Infants in the CAP group were otherwise healthy; those with congenital or other conditions that might predispose them to pneumonia were excluded. Baseline characteristics were similar between the CAP patients and controls.
 

Future risk

Overall, the rates per 100 patient-years for any chronic respiratory disorder were 11.6 for CAP patients versus 4.9 for controls (relative risk, 2.4). Rates for reactive airway disease and CAP hospitalization were 6.1 versus 1.9 per 100 patient-years (RR, 3.2) and 1.0 versus 0.2 per 100 patient-years (RR, 6.3) for the CAP patients and controls, respectively.

The distribution of CAP etiology of CAP in infants at the first hospitalization was 20% bacterial, 27% viral, and 53% unspecified. The relative rates of later respiratory illness were similar across etiologies of the initial hospitalization for CAP, which support the association between infant CAP and later respiratory disease, the researchers said.

Nearly all (97%) of the CAP patients had only one qualifying hospitalization for CAP before 2 years of age, and the mean age at the first hospitalization was 8.9 months. “Rates and relative rates of any chronic respiratory disorder, and our composite for reactive airway disease, increased with age at which the initial CAP hospitalization occurred,” and were highest for children hospitalized at close to 2 years of age, the researchers noted.
 

Persistent inflammation?

“Our findings add to the evolving hypothesis that persistent inflammation following pneumonia creates an increased risk for subsequent respiratory disease and exacerbations of underlying disease,” the researchers wrote.

The study findings were limited by several factors, including the potential for misclassification of some infants with and without underlying conditions, reliance on discharge information for etiology, and possible lack of generalizability to other populations, the researchers noted.

However, the results indicate an increased risk for respiratory illness in early childhood among infants with CAP, and support the need for greater attention to CAP prevention and for strategies to reduce inflammation after pneumonia, they said. “Further study is needed to confirm the long-term consequences of infant CAP and the underlying mechanisms that lead to such long-term sequelae,” they concluded.

Dr. Lapidot and several coauthors disclosed ties with Pfizer, the study sponsor.

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

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Preschoolers who experienced community-acquired pneumonia in infancy were significantly more likely than were those with no history of pneumonia to develop chronic respiratory disorders, based on data from approximately 7,000 individuals.

“Lower respiratory tract infections (LRTI) during the first years of life cause injury to the rapidly developing lung at its most critical stage,” wrote Rotem Lapidot, MD, of Boston University, and colleagues. Previous research has linked pneumonia with subsequent chronic cough, bronchitis, and recurrent pneumonia in children, but data are needed to assess the impact of early community-acquired pneumonia (CAP) on respiratory health in otherwise healthy infants, the researchers said.

In a retrospective matched cohort study published in Respiratory Medicine , the researchers identified 1,343 infants who had CAP in the first 2 years of life, and 6,715 controls, using a large electronic health records dataset (Optum EHR dataset) for the period from Jan. 2011 through June 2018.

The primary outcomes were the development of any chronic respiratory disorders, reactive airway disease, and CAP hospitalizations between ages 2 and 5 years. Infants in the CAP group were otherwise healthy; those with congenital or other conditions that might predispose them to pneumonia were excluded. Baseline characteristics were similar between the CAP patients and controls.
 

Future risk

Overall, the rates per 100 patient-years for any chronic respiratory disorder were 11.6 for CAP patients versus 4.9 for controls (relative risk, 2.4). Rates for reactive airway disease and CAP hospitalization were 6.1 versus 1.9 per 100 patient-years (RR, 3.2) and 1.0 versus 0.2 per 100 patient-years (RR, 6.3) for the CAP patients and controls, respectively.

The distribution of CAP etiology of CAP in infants at the first hospitalization was 20% bacterial, 27% viral, and 53% unspecified. The relative rates of later respiratory illness were similar across etiologies of the initial hospitalization for CAP, which support the association between infant CAP and later respiratory disease, the researchers said.

Nearly all (97%) of the CAP patients had only one qualifying hospitalization for CAP before 2 years of age, and the mean age at the first hospitalization was 8.9 months. “Rates and relative rates of any chronic respiratory disorder, and our composite for reactive airway disease, increased with age at which the initial CAP hospitalization occurred,” and were highest for children hospitalized at close to 2 years of age, the researchers noted.
 

Persistent inflammation?

“Our findings add to the evolving hypothesis that persistent inflammation following pneumonia creates an increased risk for subsequent respiratory disease and exacerbations of underlying disease,” the researchers wrote.

The study findings were limited by several factors, including the potential for misclassification of some infants with and without underlying conditions, reliance on discharge information for etiology, and possible lack of generalizability to other populations, the researchers noted.

However, the results indicate an increased risk for respiratory illness in early childhood among infants with CAP, and support the need for greater attention to CAP prevention and for strategies to reduce inflammation after pneumonia, they said. “Further study is needed to confirm the long-term consequences of infant CAP and the underlying mechanisms that lead to such long-term sequelae,” they concluded.

Dr. Lapidot and several coauthors disclosed ties with Pfizer, the study sponsor.

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

 

Preschoolers who experienced community-acquired pneumonia in infancy were significantly more likely than were those with no history of pneumonia to develop chronic respiratory disorders, based on data from approximately 7,000 individuals.

“Lower respiratory tract infections (LRTI) during the first years of life cause injury to the rapidly developing lung at its most critical stage,” wrote Rotem Lapidot, MD, of Boston University, and colleagues. Previous research has linked pneumonia with subsequent chronic cough, bronchitis, and recurrent pneumonia in children, but data are needed to assess the impact of early community-acquired pneumonia (CAP) on respiratory health in otherwise healthy infants, the researchers said.

In a retrospective matched cohort study published in Respiratory Medicine , the researchers identified 1,343 infants who had CAP in the first 2 years of life, and 6,715 controls, using a large electronic health records dataset (Optum EHR dataset) for the period from Jan. 2011 through June 2018.

The primary outcomes were the development of any chronic respiratory disorders, reactive airway disease, and CAP hospitalizations between ages 2 and 5 years. Infants in the CAP group were otherwise healthy; those with congenital or other conditions that might predispose them to pneumonia were excluded. Baseline characteristics were similar between the CAP patients and controls.
 

Future risk

Overall, the rates per 100 patient-years for any chronic respiratory disorder were 11.6 for CAP patients versus 4.9 for controls (relative risk, 2.4). Rates for reactive airway disease and CAP hospitalization were 6.1 versus 1.9 per 100 patient-years (RR, 3.2) and 1.0 versus 0.2 per 100 patient-years (RR, 6.3) for the CAP patients and controls, respectively.

The distribution of CAP etiology of CAP in infants at the first hospitalization was 20% bacterial, 27% viral, and 53% unspecified. The relative rates of later respiratory illness were similar across etiologies of the initial hospitalization for CAP, which support the association between infant CAP and later respiratory disease, the researchers said.

Nearly all (97%) of the CAP patients had only one qualifying hospitalization for CAP before 2 years of age, and the mean age at the first hospitalization was 8.9 months. “Rates and relative rates of any chronic respiratory disorder, and our composite for reactive airway disease, increased with age at which the initial CAP hospitalization occurred,” and were highest for children hospitalized at close to 2 years of age, the researchers noted.
 

Persistent inflammation?

“Our findings add to the evolving hypothesis that persistent inflammation following pneumonia creates an increased risk for subsequent respiratory disease and exacerbations of underlying disease,” the researchers wrote.

The study findings were limited by several factors, including the potential for misclassification of some infants with and without underlying conditions, reliance on discharge information for etiology, and possible lack of generalizability to other populations, the researchers noted.

However, the results indicate an increased risk for respiratory illness in early childhood among infants with CAP, and support the need for greater attention to CAP prevention and for strategies to reduce inflammation after pneumonia, they said. “Further study is needed to confirm the long-term consequences of infant CAP and the underlying mechanisms that lead to such long-term sequelae,” they concluded.

Dr. Lapidot and several coauthors disclosed ties with Pfizer, the study sponsor.

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

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HIV+ patients get good outcomes after kidney or liver transplant

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Liver or kidney transplant recipients who are HIV-positive show outcomes that are similar to those without HIV at 15-years post-transplant, in new research that represents some of the longest follow-up on these patients to date.

The findings further support the inclusion of people with HIV in transplant resource allocation, say the researchers.

“Overall, the excellent outcomes following liver and kidney transplant recipients in HIV-infected recipients justify the utilization of a scarce resource,” senior author Peter G. Stock, MD, PhD, surgical director of the Kidney and Pancreas Transplant Program and surgical director of the Pediatric Renal Transplant Program at the University of California, San Francisco (UCSF), said in an interview.

“Many centers still view HIV as a strict contraindication [for transplantation]. This data shows it is not,” he emphasized.

The study, published in JAMA Surgery, involved HIV-positive patients who received kidney or liver transplants between 2000 and 2019 at UCSF, which has unique access to some of the longest-term data on those outcomes.

“UCSF was the first U.S. center to do transplants routinely in people with HIV, and based on the large volume of transplants that are performed, we were able to use propensity matching to address the comparison of HIV-positive and negative liver and kidney transplant recipients at a single center,” Dr. Stock explained.

“To the best of our knowledge, there are no long-term reports [greater than 10 years] on [transplant] outcomes in the HIV-positive population.”

Commenting on the study, David Klassen, MD, chief medical officer of the United Network for Organ Sharing (UNOS), noted that the findings “confirm previous research done at UCSF and reported in the New England Journal of Medicine” in 2010. “It extends the previous findings.”

“The take-home message is that these HIV-positive patients can be successfully transplanted with expected good outcomes and will derive substantial benefit from transplantation,” Dr. Klassen said.
 

Kidney transplant patient survival lower, graft survival similar

For the kidney transplant analysis, 119 HIV-positive recipients were propensity matched with 655 recipients who were HIV-negative, with the patients’ mean age about 52 and approximately 70% male.

At 15-years post-transplant, patient survival was 53.6% among the HIV-positive patients versus 79.6% for HIV-negative (P = .03).

Graft survival among the kidney transplant patients was proportionally higher among HIV-positive patients after 15 years (75% vs. 57%); however, the difference was not statistically significant (P = .77).

First author Arya Zarinsefat, MD, of the Department of Surgery at UCSF, speculated that the lower long-term patient survival among HIV-positive kidney transplant recipients may reflect known cardiovascular risks among those patients.

“We postulated that part of this may be due to the fact that HIV-positive patients certainly have additional comorbidities, specifically cardiovascular” ones, he told this news organization.

“When looking at the survival curve, survival was nearly identical at 5 years and only started to diverge at 10 years post-transplant,” he noted.

A further evaluation of patients with HIV who were co-infected with hepatitis C (HCV) showed that those with HIV-HCV co-infection prior to the center’s introduction of anti-HCV direct-acting antiviral (DAA) medications in 2014 had the lowest survival rate of all subgroups, at 57.1% at 5 years post-transplant (P = .045 vs. those treated after 2014).
 

 

 

Liver transplant patient survival similar

In terms of liver transplant outcomes, among 83 HIV-positive recipients who were propensity-matched with 468 HIV-negative recipients, the mean age was about 53 and about 66% were male.

The patient survival rates at 15 years were not significantly different between the groups, at 70% for HIV-positive and 75.7% for HIV-negative, (P = .12).

Similar to the kidney transplant recipients, the worst survival among all liver transplant subgroups was among HIV-HCV co-infected patients prior to access to HCV direct-acting antivirals in 2014, with a 5-year survival of 59.5% (P = .04).

“Since the advent of HCV direct-acting antivirals, liver transplant outcomes in HCV mono-infected patients are comparable to HCV/HIV co-infected recipients,” Dr. Stock said.
 

Acute rejection rates higher with HIV-positivity versus national averages

The rates of acute rejection at 1 year in the kidney and liver transplant, HIV-positive groups – at about 20% and 30%, respectively – were, however, higher than national average incidence rates of about 10% at 1 year.

Long-term data on those patients showed the acute rejection affected graft survival outcomes with kidney transplant recipients: HIV-positive kidney transplant recipients who had at least one episode of acute rejection had a graft survival of just 52.8% at 15 years post-transplant, compared with 91.8% among recipients without acute rejection.

Such differences were not observed among HIV-positive liver transplant recipients.

The authors note that the increased risk of acute rejection in HIV-positive kidney transplant patients is consistent with previous studies, with causes that may be multifactorial.

Top theories include drug interactions with protease inhibitors, resulting in some centers transitioning HIV-infected patients from those regimens to integrase-based regimens prior to transplant.

“The management and prevention of acute rejection in HIV-positive kidney transplant [patients] will therefore continue to be a key component in the care of these patients,” the authors note in their study.

The study was supported in part by the National Institutes of Health. The study authors and Dr. Klassen have disclosed no relevant financial relationships.

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

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Liver or kidney transplant recipients who are HIV-positive show outcomes that are similar to those without HIV at 15-years post-transplant, in new research that represents some of the longest follow-up on these patients to date.

The findings further support the inclusion of people with HIV in transplant resource allocation, say the researchers.

“Overall, the excellent outcomes following liver and kidney transplant recipients in HIV-infected recipients justify the utilization of a scarce resource,” senior author Peter G. Stock, MD, PhD, surgical director of the Kidney and Pancreas Transplant Program and surgical director of the Pediatric Renal Transplant Program at the University of California, San Francisco (UCSF), said in an interview.

“Many centers still view HIV as a strict contraindication [for transplantation]. This data shows it is not,” he emphasized.

The study, published in JAMA Surgery, involved HIV-positive patients who received kidney or liver transplants between 2000 and 2019 at UCSF, which has unique access to some of the longest-term data on those outcomes.

“UCSF was the first U.S. center to do transplants routinely in people with HIV, and based on the large volume of transplants that are performed, we were able to use propensity matching to address the comparison of HIV-positive and negative liver and kidney transplant recipients at a single center,” Dr. Stock explained.

“To the best of our knowledge, there are no long-term reports [greater than 10 years] on [transplant] outcomes in the HIV-positive population.”

Commenting on the study, David Klassen, MD, chief medical officer of the United Network for Organ Sharing (UNOS), noted that the findings “confirm previous research done at UCSF and reported in the New England Journal of Medicine” in 2010. “It extends the previous findings.”

“The take-home message is that these HIV-positive patients can be successfully transplanted with expected good outcomes and will derive substantial benefit from transplantation,” Dr. Klassen said.
 

Kidney transplant patient survival lower, graft survival similar

For the kidney transplant analysis, 119 HIV-positive recipients were propensity matched with 655 recipients who were HIV-negative, with the patients’ mean age about 52 and approximately 70% male.

At 15-years post-transplant, patient survival was 53.6% among the HIV-positive patients versus 79.6% for HIV-negative (P = .03).

Graft survival among the kidney transplant patients was proportionally higher among HIV-positive patients after 15 years (75% vs. 57%); however, the difference was not statistically significant (P = .77).

First author Arya Zarinsefat, MD, of the Department of Surgery at UCSF, speculated that the lower long-term patient survival among HIV-positive kidney transplant recipients may reflect known cardiovascular risks among those patients.

“We postulated that part of this may be due to the fact that HIV-positive patients certainly have additional comorbidities, specifically cardiovascular” ones, he told this news organization.

“When looking at the survival curve, survival was nearly identical at 5 years and only started to diverge at 10 years post-transplant,” he noted.

A further evaluation of patients with HIV who were co-infected with hepatitis C (HCV) showed that those with HIV-HCV co-infection prior to the center’s introduction of anti-HCV direct-acting antiviral (DAA) medications in 2014 had the lowest survival rate of all subgroups, at 57.1% at 5 years post-transplant (P = .045 vs. those treated after 2014).
 

 

 

Liver transplant patient survival similar

In terms of liver transplant outcomes, among 83 HIV-positive recipients who were propensity-matched with 468 HIV-negative recipients, the mean age was about 53 and about 66% were male.

The patient survival rates at 15 years were not significantly different between the groups, at 70% for HIV-positive and 75.7% for HIV-negative, (P = .12).

Similar to the kidney transplant recipients, the worst survival among all liver transplant subgroups was among HIV-HCV co-infected patients prior to access to HCV direct-acting antivirals in 2014, with a 5-year survival of 59.5% (P = .04).

“Since the advent of HCV direct-acting antivirals, liver transplant outcomes in HCV mono-infected patients are comparable to HCV/HIV co-infected recipients,” Dr. Stock said.
 

Acute rejection rates higher with HIV-positivity versus national averages

The rates of acute rejection at 1 year in the kidney and liver transplant, HIV-positive groups – at about 20% and 30%, respectively – were, however, higher than national average incidence rates of about 10% at 1 year.

Long-term data on those patients showed the acute rejection affected graft survival outcomes with kidney transplant recipients: HIV-positive kidney transplant recipients who had at least one episode of acute rejection had a graft survival of just 52.8% at 15 years post-transplant, compared with 91.8% among recipients without acute rejection.

Such differences were not observed among HIV-positive liver transplant recipients.

The authors note that the increased risk of acute rejection in HIV-positive kidney transplant patients is consistent with previous studies, with causes that may be multifactorial.

Top theories include drug interactions with protease inhibitors, resulting in some centers transitioning HIV-infected patients from those regimens to integrase-based regimens prior to transplant.

“The management and prevention of acute rejection in HIV-positive kidney transplant [patients] will therefore continue to be a key component in the care of these patients,” the authors note in their study.

The study was supported in part by the National Institutes of Health. The study authors and Dr. Klassen have disclosed no relevant financial relationships.

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

Liver or kidney transplant recipients who are HIV-positive show outcomes that are similar to those without HIV at 15-years post-transplant, in new research that represents some of the longest follow-up on these patients to date.

The findings further support the inclusion of people with HIV in transplant resource allocation, say the researchers.

“Overall, the excellent outcomes following liver and kidney transplant recipients in HIV-infected recipients justify the utilization of a scarce resource,” senior author Peter G. Stock, MD, PhD, surgical director of the Kidney and Pancreas Transplant Program and surgical director of the Pediatric Renal Transplant Program at the University of California, San Francisco (UCSF), said in an interview.

“Many centers still view HIV as a strict contraindication [for transplantation]. This data shows it is not,” he emphasized.

The study, published in JAMA Surgery, involved HIV-positive patients who received kidney or liver transplants between 2000 and 2019 at UCSF, which has unique access to some of the longest-term data on those outcomes.

“UCSF was the first U.S. center to do transplants routinely in people with HIV, and based on the large volume of transplants that are performed, we were able to use propensity matching to address the comparison of HIV-positive and negative liver and kidney transplant recipients at a single center,” Dr. Stock explained.

“To the best of our knowledge, there are no long-term reports [greater than 10 years] on [transplant] outcomes in the HIV-positive population.”

Commenting on the study, David Klassen, MD, chief medical officer of the United Network for Organ Sharing (UNOS), noted that the findings “confirm previous research done at UCSF and reported in the New England Journal of Medicine” in 2010. “It extends the previous findings.”

“The take-home message is that these HIV-positive patients can be successfully transplanted with expected good outcomes and will derive substantial benefit from transplantation,” Dr. Klassen said.
 

Kidney transplant patient survival lower, graft survival similar

For the kidney transplant analysis, 119 HIV-positive recipients were propensity matched with 655 recipients who were HIV-negative, with the patients’ mean age about 52 and approximately 70% male.

At 15-years post-transplant, patient survival was 53.6% among the HIV-positive patients versus 79.6% for HIV-negative (P = .03).

Graft survival among the kidney transplant patients was proportionally higher among HIV-positive patients after 15 years (75% vs. 57%); however, the difference was not statistically significant (P = .77).

First author Arya Zarinsefat, MD, of the Department of Surgery at UCSF, speculated that the lower long-term patient survival among HIV-positive kidney transplant recipients may reflect known cardiovascular risks among those patients.

“We postulated that part of this may be due to the fact that HIV-positive patients certainly have additional comorbidities, specifically cardiovascular” ones, he told this news organization.

“When looking at the survival curve, survival was nearly identical at 5 years and only started to diverge at 10 years post-transplant,” he noted.

A further evaluation of patients with HIV who were co-infected with hepatitis C (HCV) showed that those with HIV-HCV co-infection prior to the center’s introduction of anti-HCV direct-acting antiviral (DAA) medications in 2014 had the lowest survival rate of all subgroups, at 57.1% at 5 years post-transplant (P = .045 vs. those treated after 2014).
 

 

 

Liver transplant patient survival similar

In terms of liver transplant outcomes, among 83 HIV-positive recipients who were propensity-matched with 468 HIV-negative recipients, the mean age was about 53 and about 66% were male.

The patient survival rates at 15 years were not significantly different between the groups, at 70% for HIV-positive and 75.7% for HIV-negative, (P = .12).

Similar to the kidney transplant recipients, the worst survival among all liver transplant subgroups was among HIV-HCV co-infected patients prior to access to HCV direct-acting antivirals in 2014, with a 5-year survival of 59.5% (P = .04).

“Since the advent of HCV direct-acting antivirals, liver transplant outcomes in HCV mono-infected patients are comparable to HCV/HIV co-infected recipients,” Dr. Stock said.
 

Acute rejection rates higher with HIV-positivity versus national averages

The rates of acute rejection at 1 year in the kidney and liver transplant, HIV-positive groups – at about 20% and 30%, respectively – were, however, higher than national average incidence rates of about 10% at 1 year.

Long-term data on those patients showed the acute rejection affected graft survival outcomes with kidney transplant recipients: HIV-positive kidney transplant recipients who had at least one episode of acute rejection had a graft survival of just 52.8% at 15 years post-transplant, compared with 91.8% among recipients without acute rejection.

Such differences were not observed among HIV-positive liver transplant recipients.

The authors note that the increased risk of acute rejection in HIV-positive kidney transplant patients is consistent with previous studies, with causes that may be multifactorial.

Top theories include drug interactions with protease inhibitors, resulting in some centers transitioning HIV-infected patients from those regimens to integrase-based regimens prior to transplant.

“The management and prevention of acute rejection in HIV-positive kidney transplant [patients] will therefore continue to be a key component in the care of these patients,” the authors note in their study.

The study was supported in part by the National Institutes of Health. The study authors and Dr. Klassen have disclosed no relevant financial relationships.

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

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