About 60% of children taking antipsychotic medication do not receive recommended metabolic monitoring, according to an analysis of Medicaid data from two states.

The number and types of providers involved in a child’s care are associated with the likelihood that the child will receive metabolic monitoring, according to the study, which was published in Pediatrics.

The results suggest that primary care providers and mental health providers should collaborate to monitor children taking antipsychotics, the researchers said.

“Shared care arrangements between primary care physicians and mental health specialists significantly increased the chances that metabolic monitoring would be done, compared with care delivered by one provider,” reported Elizabeth A. Shenkman, PhD, chair of the department of health outcomes and biomedical informatics at the University of Florida, Gainesville, and colleagues. “The results of our study point to the importance of state Medicaid agencies and Medicaid managed care plans in identifying all providers caring for the children taking antipsychotic medication and using this information to engage the providers in quality improvement efforts to improve metabolic monitoring rates.”


 

Comparing specialties

Children who take antipsychotic medication are at risk for obesity, impaired glucose metabolism, and hyperlipidemia, but less than 40% receive recommended metabolic monitoring with glucose and cholesterol tests.

To examine how health care provider specialty influences the receipt of metabolic monitoring, Dr. Shenkman and colleagues analyzed Medicaid enrollment and health care and pharmacy claims data from Florida and Texas.

They focused on 41,078 children who had an antipsychotic medication dispensed at least twice in 2017 and were eligible for inclusion in the Centers for Medicare & Medicaid Services metabolic monitoring measure. The Metabolic Monitoring for Children and Adolescents on Antipsychotics measure is a “priority nationally and is currently on the CMS Child Core Set, which is used to annually assess state-specific performance on pediatric quality measures,” the authors wrote.

About 65% were boys, and the children had an average age of 12 years. The researchers compared metabolic monitoring rates when children received outpatient care from a primary care provider, a mental health provider with prescribing privileges, or both.

Less than 40% of the children received metabolic monitoring, that is, at least one diabetes test and at least one cholesterol test, during the year.

Most of the children (61%) saw both primary care providers and mental health providers. Approximately one-third had a primary care provider prescribe antipsychotic medication the majority of the time, and 60% had a mental health provider prescribe antipsychotic medication the majority of the time.

Patients who saw both types of providers were significantly more likely to receive metabolic monitoring, relative to those who saw primary care providers only (adjusted odds ratio, 1.42). Those seeing a mental health provider alone had adjusted odds of metabolic monitoring that were 23% lower than those seeing a primary care provider alone.

Children who had a mental health provider prescribe the medication the majority of the time were 25% more likely to receive metabolic monitoring, compared with those who had a primary care provider prescribing the medication the majority of the time.
 

Slipping through the cracks

Child psychiatrist Fred Volkmar, MD, commented that the results are “sadly” unsurprising and reflect issues that pertain to other psychotropic drugs as well as antipsychotics and to adults as well as children.

The researchers “are quite right to point to it,” and “we really do need to develop better plans for improving” monitoring, said Dr. Volkmar, the Irving B. Harris Professor in the Child Study Center and professor of psychology at Yale University, New Haven, Conn.

“Increasingly we are asking primary care providers ... to take care of folks who have important either developmental or mental health problems,” Dr. Volkmar said. While they can do a good job, they increasingly are underpaid. Monitoring patients takes work, and they may be less familiar with the medications. “Either they prescribe these medications or they are asked to monitor them in place of the specialist provider who may have started them or suggested them,” he said. Metabolic monitoring may not be prioritized and can easily “slip through the cracks.” At the same time, doctors need to be aware of the risk of serious side effects of antipsychotic medications, such as malignant hyperthermia.

These medications can be overused and inappropriately used, which is a further complication. And when patients are taking multiple medications, there may be a need for additional monitoring and awareness of drug interactions.

“These medications are very complicated to use,” and there needs to be a way to connect primary care providers with child psychiatrists who are best trained in their use, said Dr. Volkmar.

A system with reminders can facilitate effective metabolic monitoring, he suggested. Dr. Volkmar has established a routine while providing care for a group home of adults with autism. Every 3 months, he reviews lab results. “You just have to force yourself to do it.”

Shared care arrangements may be another way to promote metabolic monitoring, Dr. Shenkman and colleagues said.

“Attributing care back to the multiple providers is important for care coordination and development of strategies to ensure that the evidence-based care is delivered and there is appropriate follow-up with the family and child to be sure care is received,” the study authors wrote. “Formalized shared care arrangements and adaptation of existing care delivery models to support integrated care, which can vary in degree from external coordination to on-site intervention and collaboration, are effective methods to promote partnership between primary and mental health providers.”

It is possible that clinicians in the study ordered metabolic monitoring but families did not take the children for testing, the investigators noted. In addition, it is not clear how much information providers have about other providers their patients are seeing.

The study authors and Dr. Volkmar had no disclosures.

[email protected]

About 60% of children taking antipsychotic medication do not receive recommended metabolic monitoring, according to an analysis of Medicaid data from two states.

The number and types of providers involved in a child’s care are associated with the likelihood that the child will receive metabolic monitoring, according to the study, which was published in Pediatrics.

The results suggest that primary care providers and mental health providers should collaborate to monitor children taking antipsychotics, the researchers said.

“Shared care arrangements between primary care physicians and mental health specialists significantly increased the chances that metabolic monitoring would be done, compared with care delivered by one provider,” reported Elizabeth A. Shenkman, PhD, chair of the department of health outcomes and biomedical informatics at the University of Florida, Gainesville, and colleagues. “The results of our study point to the importance of state Medicaid agencies and Medicaid managed care plans in identifying all providers caring for the children taking antipsychotic medication and using this information to engage the providers in quality improvement efforts to improve metabolic monitoring rates.”


 

Comparing specialties

Children who take antipsychotic medication are at risk for obesity, impaired glucose metabolism, and hyperlipidemia, but less than 40% receive recommended metabolic monitoring with glucose and cholesterol tests.

To examine how health care provider specialty influences the receipt of metabolic monitoring, Dr. Shenkman and colleagues analyzed Medicaid enrollment and health care and pharmacy claims data from Florida and Texas.

They focused on 41,078 children who had an antipsychotic medication dispensed at least twice in 2017 and were eligible for inclusion in the Centers for Medicare & Medicaid Services metabolic monitoring measure. The Metabolic Monitoring for Children and Adolescents on Antipsychotics measure is a “priority nationally and is currently on the CMS Child Core Set, which is used to annually assess state-specific performance on pediatric quality measures,” the authors wrote.

About 65% were boys, and the children had an average age of 12 years. The researchers compared metabolic monitoring rates when children received outpatient care from a primary care provider, a mental health provider with prescribing privileges, or both.

Less than 40% of the children received metabolic monitoring, that is, at least one diabetes test and at least one cholesterol test, during the year.

Most of the children (61%) saw both primary care providers and mental health providers. Approximately one-third had a primary care provider prescribe antipsychotic medication the majority of the time, and 60% had a mental health provider prescribe antipsychotic medication the majority of the time.

Patients who saw both types of providers were significantly more likely to receive metabolic monitoring, relative to those who saw primary care providers only (adjusted odds ratio, 1.42). Those seeing a mental health provider alone had adjusted odds of metabolic monitoring that were 23% lower than those seeing a primary care provider alone.

Children who had a mental health provider prescribe the medication the majority of the time were 25% more likely to receive metabolic monitoring, compared with those who had a primary care provider prescribing the medication the majority of the time.
 

Slipping through the cracks

Child psychiatrist Fred Volkmar, MD, commented that the results are “sadly” unsurprising and reflect issues that pertain to other psychotropic drugs as well as antipsychotics and to adults as well as children.

The researchers “are quite right to point to it,” and “we really do need to develop better plans for improving” monitoring, said Dr. Volkmar, the Irving B. Harris Professor in the Child Study Center and professor of psychology at Yale University, New Haven, Conn.

“Increasingly we are asking primary care providers ... to take care of folks who have important either developmental or mental health problems,” Dr. Volkmar said. While they can do a good job, they increasingly are underpaid. Monitoring patients takes work, and they may be less familiar with the medications. “Either they prescribe these medications or they are asked to monitor them in place of the specialist provider who may have started them or suggested them,” he said. Metabolic monitoring may not be prioritized and can easily “slip through the cracks.” At the same time, doctors need to be aware of the risk of serious side effects of antipsychotic medications, such as malignant hyperthermia.

These medications can be overused and inappropriately used, which is a further complication. And when patients are taking multiple medications, there may be a need for additional monitoring and awareness of drug interactions.

“These medications are very complicated to use,” and there needs to be a way to connect primary care providers with child psychiatrists who are best trained in their use, said Dr. Volkmar.

A system with reminders can facilitate effective metabolic monitoring, he suggested. Dr. Volkmar has established a routine while providing care for a group home of adults with autism. Every 3 months, he reviews lab results. “You just have to force yourself to do it.”

Shared care arrangements may be another way to promote metabolic monitoring, Dr. Shenkman and colleagues said.

“Attributing care back to the multiple providers is important for care coordination and development of strategies to ensure that the evidence-based care is delivered and there is appropriate follow-up with the family and child to be sure care is received,” the study authors wrote. “Formalized shared care arrangements and adaptation of existing care delivery models to support integrated care, which can vary in degree from external coordination to on-site intervention and collaboration, are effective methods to promote partnership between primary and mental health providers.”

It is possible that clinicians in the study ordered metabolic monitoring but families did not take the children for testing, the investigators noted. In addition, it is not clear how much information providers have about other providers their patients are seeing.

The study authors and Dr. Volkmar had no disclosures.

[email protected]

About 60% of children taking antipsychotic medication do not receive recommended metabolic monitoring, according to an analysis of Medicaid data from two states.

The number and types of providers involved in a child’s care are associated with the likelihood that the child will receive metabolic monitoring, according to the study, which was published in Pediatrics.

The results suggest that primary care providers and mental health providers should collaborate to monitor children taking antipsychotics, the researchers said.

“Shared care arrangements between primary care physicians and mental health specialists significantly increased the chances that metabolic monitoring would be done, compared with care delivered by one provider,” reported Elizabeth A. Shenkman, PhD, chair of the department of health outcomes and biomedical informatics at the University of Florida, Gainesville, and colleagues. “The results of our study point to the importance of state Medicaid agencies and Medicaid managed care plans in identifying all providers caring for the children taking antipsychotic medication and using this information to engage the providers in quality improvement efforts to improve metabolic monitoring rates.”


 

Comparing specialties

Children who take antipsychotic medication are at risk for obesity, impaired glucose metabolism, and hyperlipidemia, but less than 40% receive recommended metabolic monitoring with glucose and cholesterol tests.

To examine how health care provider specialty influences the receipt of metabolic monitoring, Dr. Shenkman and colleagues analyzed Medicaid enrollment and health care and pharmacy claims data from Florida and Texas.

They focused on 41,078 children who had an antipsychotic medication dispensed at least twice in 2017 and were eligible for inclusion in the Centers for Medicare & Medicaid Services metabolic monitoring measure. The Metabolic Monitoring for Children and Adolescents on Antipsychotics measure is a “priority nationally and is currently on the CMS Child Core Set, which is used to annually assess state-specific performance on pediatric quality measures,” the authors wrote.

About 65% were boys, and the children had an average age of 12 years. The researchers compared metabolic monitoring rates when children received outpatient care from a primary care provider, a mental health provider with prescribing privileges, or both.

Less than 40% of the children received metabolic monitoring, that is, at least one diabetes test and at least one cholesterol test, during the year.

Most of the children (61%) saw both primary care providers and mental health providers. Approximately one-third had a primary care provider prescribe antipsychotic medication the majority of the time, and 60% had a mental health provider prescribe antipsychotic medication the majority of the time.

Patients who saw both types of providers were significantly more likely to receive metabolic monitoring, relative to those who saw primary care providers only (adjusted odds ratio, 1.42). Those seeing a mental health provider alone had adjusted odds of metabolic monitoring that were 23% lower than those seeing a primary care provider alone.

Children who had a mental health provider prescribe the medication the majority of the time were 25% more likely to receive metabolic monitoring, compared with those who had a primary care provider prescribing the medication the majority of the time.
 

Slipping through the cracks

Child psychiatrist Fred Volkmar, MD, commented that the results are “sadly” unsurprising and reflect issues that pertain to other psychotropic drugs as well as antipsychotics and to adults as well as children.

The researchers “are quite right to point to it,” and “we really do need to develop better plans for improving” monitoring, said Dr. Volkmar, the Irving B. Harris Professor in the Child Study Center and professor of psychology at Yale University, New Haven, Conn.

“Increasingly we are asking primary care providers ... to take care of folks who have important either developmental or mental health problems,” Dr. Volkmar said. While they can do a good job, they increasingly are underpaid. Monitoring patients takes work, and they may be less familiar with the medications. “Either they prescribe these medications or they are asked to monitor them in place of the specialist provider who may have started them or suggested them,” he said. Metabolic monitoring may not be prioritized and can easily “slip through the cracks.” At the same time, doctors need to be aware of the risk of serious side effects of antipsychotic medications, such as malignant hyperthermia.

These medications can be overused and inappropriately used, which is a further complication. And when patients are taking multiple medications, there may be a need for additional monitoring and awareness of drug interactions.

“These medications are very complicated to use,” and there needs to be a way to connect primary care providers with child psychiatrists who are best trained in their use, said Dr. Volkmar.

A system with reminders can facilitate effective metabolic monitoring, he suggested. Dr. Volkmar has established a routine while providing care for a group home of adults with autism. Every 3 months, he reviews lab results. “You just have to force yourself to do it.”

Shared care arrangements may be another way to promote metabolic monitoring, Dr. Shenkman and colleagues said.

“Attributing care back to the multiple providers is important for care coordination and development of strategies to ensure that the evidence-based care is delivered and there is appropriate follow-up with the family and child to be sure care is received,” the study authors wrote. “Formalized shared care arrangements and adaptation of existing care delivery models to support integrated care, which can vary in degree from external coordination to on-site intervention and collaboration, are effective methods to promote partnership between primary and mental health providers.”

It is possible that clinicians in the study ordered metabolic monitoring but families did not take the children for testing, the investigators noted. In addition, it is not clear how much information providers have about other providers their patients are seeing.

The study authors and Dr. Volkmar had no disclosures.

[email protected]

Cabenuva (cabotegravir and rilpivirine, a once-per-month injectable formulation) was approved by the Food and Drug Administration as a complete regimen for treatment of HIV-1 infection in adults. It is intended to replace current antiretroviral regimens in those patients who are virologically suppressed with no history of treatment failure and with no known or suspected resistance to either of the two component drugs.

Cabenuva is the first FDA-approved monthly injectable, complete regimen for HIV-infected adults, according to the agency’s announcement.

In addition, the FDA-approved Vocabria (cabotegravir, tablet formulation), a preparatory treatment intended to be taken in combination with oral rilpivirine (Edurant) for 1 month prior to starting treatment with Cabenuva to ensure the medications are well tolerated before switching to the extended-release injectable formulation. The FDA granted the approval of Cabenuva and Vocabria to ViiV Healthcare.

Cabotegravir is as an integrase strand transfer inhibitor that blocks HIV integrase by attaching to the active integrase site and inhibiting retroviral DNA integration, which is necessary in order for HIV to replicate. In contrast, rilpivirine acts as a diarylpyrimidine nonnucleoside reverse transcriptase inhibitor of HIV-1.

Approval of Cabenuva was based upon two randomized, open-label, controlled clinical trials in 1,182 HIV-infected adults who were virologically suppressed (HIV-1 RNA less than 50 copies/mL) before initiation of treatment with Cabenuva. The two pivotal phase three clinical studies were: Antiretroviral Therapy as Long-Acting Suppression (ATLAS; NCT02951052) and First Long-Acting Injectable Regimen (FLAIR; NCT02938520). Patients in both trials continued to show virologic suppression at the conclusion of each study, and no clinically relevant change from baseline in CD4+ cell counts was observed, according to the FDA announcement.

Adverse reactions with Cabenuva included injection-site reactions, fever, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash. The FDA warned that Cabenuva should not be used if there is a known previous hypersensitivity reaction to cabotegravir or rilpivirine, or in patients who are not virally suppressed (HIV-1 RNA greater than 50 copies/mL).

Cabenuva and Vocabria were granted Fast Track and Priority Review designation by the FDA. Prescribing information for Cabenuva is available on the ViiV Healthcare website.

[email protected]

Cabenuva (cabotegravir and rilpivirine, a once-per-month injectable formulation) was approved by the Food and Drug Administration as a complete regimen for treatment of HIV-1 infection in adults. It is intended to replace current antiretroviral regimens in those patients who are virologically suppressed with no history of treatment failure and with no known or suspected resistance to either of the two component drugs.

Cabenuva is the first FDA-approved monthly injectable, complete regimen for HIV-infected adults, according to the agency’s announcement.

In addition, the FDA-approved Vocabria (cabotegravir, tablet formulation), a preparatory treatment intended to be taken in combination with oral rilpivirine (Edurant) for 1 month prior to starting treatment with Cabenuva to ensure the medications are well tolerated before switching to the extended-release injectable formulation. The FDA granted the approval of Cabenuva and Vocabria to ViiV Healthcare.

Cabotegravir is as an integrase strand transfer inhibitor that blocks HIV integrase by attaching to the active integrase site and inhibiting retroviral DNA integration, which is necessary in order for HIV to replicate. In contrast, rilpivirine acts as a diarylpyrimidine nonnucleoside reverse transcriptase inhibitor of HIV-1.

Approval of Cabenuva was based upon two randomized, open-label, controlled clinical trials in 1,182 HIV-infected adults who were virologically suppressed (HIV-1 RNA less than 50 copies/mL) before initiation of treatment with Cabenuva. The two pivotal phase three clinical studies were: Antiretroviral Therapy as Long-Acting Suppression (ATLAS; NCT02951052) and First Long-Acting Injectable Regimen (FLAIR; NCT02938520). Patients in both trials continued to show virologic suppression at the conclusion of each study, and no clinically relevant change from baseline in CD4+ cell counts was observed, according to the FDA announcement.

Adverse reactions with Cabenuva included injection-site reactions, fever, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash. The FDA warned that Cabenuva should not be used if there is a known previous hypersensitivity reaction to cabotegravir or rilpivirine, or in patients who are not virally suppressed (HIV-1 RNA greater than 50 copies/mL).

Cabenuva and Vocabria were granted Fast Track and Priority Review designation by the FDA. Prescribing information for Cabenuva is available on the ViiV Healthcare website.

[email protected]

Cabenuva (cabotegravir and rilpivirine, a once-per-month injectable formulation) was approved by the Food and Drug Administration as a complete regimen for treatment of HIV-1 infection in adults. It is intended to replace current antiretroviral regimens in those patients who are virologically suppressed with no history of treatment failure and with no known or suspected resistance to either of the two component drugs.

Cabenuva is the first FDA-approved monthly injectable, complete regimen for HIV-infected adults, according to the agency’s announcement.

In addition, the FDA-approved Vocabria (cabotegravir, tablet formulation), a preparatory treatment intended to be taken in combination with oral rilpivirine (Edurant) for 1 month prior to starting treatment with Cabenuva to ensure the medications are well tolerated before switching to the extended-release injectable formulation. The FDA granted the approval of Cabenuva and Vocabria to ViiV Healthcare.

Cabotegravir is as an integrase strand transfer inhibitor that blocks HIV integrase by attaching to the active integrase site and inhibiting retroviral DNA integration, which is necessary in order for HIV to replicate. In contrast, rilpivirine acts as a diarylpyrimidine nonnucleoside reverse transcriptase inhibitor of HIV-1.

Approval of Cabenuva was based upon two randomized, open-label, controlled clinical trials in 1,182 HIV-infected adults who were virologically suppressed (HIV-1 RNA less than 50 copies/mL) before initiation of treatment with Cabenuva. The two pivotal phase three clinical studies were: Antiretroviral Therapy as Long-Acting Suppression (ATLAS; NCT02951052) and First Long-Acting Injectable Regimen (FLAIR; NCT02938520). Patients in both trials continued to show virologic suppression at the conclusion of each study, and no clinically relevant change from baseline in CD4+ cell counts was observed, according to the FDA announcement.

Adverse reactions with Cabenuva included injection-site reactions, fever, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash. The FDA warned that Cabenuva should not be used if there is a known previous hypersensitivity reaction to cabotegravir or rilpivirine, or in patients who are not virally suppressed (HIV-1 RNA greater than 50 copies/mL).

Cabenuva and Vocabria were granted Fast Track and Priority Review designation by the FDA. Prescribing information for Cabenuva is available on the ViiV Healthcare website.

[email protected]

The current COVID-19 vaccines may not be as effective against new coronavirus variants, but they should be powerful enough to still be beneficial, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said during a news briefing on Jan. 21.

Both vaccines from Pfizer-BioNTech and Moderna have such high efficacy rates that it creates a “cushion effect,” he said, meaning that new variants will likely only diminish vaccine efficacy slightly. To slow the spread of the new strains, Dr. Fauci said, people should get vaccinated as soon as possible. If viruses can’t spread as far or as quickly, they won’t mutate as much.

“Bottom line: We’re paying very close attention to it,” he said. “There are alternative plans if we ever have to modify the vaccine.”

The U.S. has reported 144 cases of the B.1.1.7 variant, which was first identified in the United Kingdom, according to the latest update from the CDC. So far, no cases of the variant strain identified in South Africa have been reported in the U.S., but Dr. Fauci said public health officials are looking for it.

“We’re following very carefully the one in South Africa, which is a little bit more concerning, but nonetheless not something that we don’t think we can handle,” he said.

Despite challenges with vaccine distribution and administration, the U.S. “can and should” vaccinate 70% to 85% of adults by the end of the summer, Dr. Fauci told CNN. If that happens, people could begin to return to some sense of normalcy by the fall, he added.

“When you put ... the pedal to the floor, you can get it done,” he said.

If the U.S. administered one million shots per day, it would take until the end of 2021 to fully vaccine 75% of adults, according to a CNN analysis. Dr. Fauci said he believes the U.S. can give more than one million shots per day. An updated tally from the CDC showed that 1.6 million shots were given in the past 24 hours, which was the largest single-day increase yet reported.

“I’d like it to be a lot more,” Dr. Fauci told CNN. “If we can do better than that, which I personally think we likely will, then great.”

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

The current COVID-19 vaccines may not be as effective against new coronavirus variants, but they should be powerful enough to still be beneficial, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said during a news briefing on Jan. 21.

Both vaccines from Pfizer-BioNTech and Moderna have such high efficacy rates that it creates a “cushion effect,” he said, meaning that new variants will likely only diminish vaccine efficacy slightly. To slow the spread of the new strains, Dr. Fauci said, people should get vaccinated as soon as possible. If viruses can’t spread as far or as quickly, they won’t mutate as much.

“Bottom line: We’re paying very close attention to it,” he said. “There are alternative plans if we ever have to modify the vaccine.”

The U.S. has reported 144 cases of the B.1.1.7 variant, which was first identified in the United Kingdom, according to the latest update from the CDC. So far, no cases of the variant strain identified in South Africa have been reported in the U.S., but Dr. Fauci said public health officials are looking for it.

“We’re following very carefully the one in South Africa, which is a little bit more concerning, but nonetheless not something that we don’t think we can handle,” he said.

Despite challenges with vaccine distribution and administration, the U.S. “can and should” vaccinate 70% to 85% of adults by the end of the summer, Dr. Fauci told CNN. If that happens, people could begin to return to some sense of normalcy by the fall, he added.

“When you put ... the pedal to the floor, you can get it done,” he said.

If the U.S. administered one million shots per day, it would take until the end of 2021 to fully vaccine 75% of adults, according to a CNN analysis. Dr. Fauci said he believes the U.S. can give more than one million shots per day. An updated tally from the CDC showed that 1.6 million shots were given in the past 24 hours, which was the largest single-day increase yet reported.

“I’d like it to be a lot more,” Dr. Fauci told CNN. “If we can do better than that, which I personally think we likely will, then great.”

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

The current COVID-19 vaccines may not be as effective against new coronavirus variants, but they should be powerful enough to still be beneficial, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said during a news briefing on Jan. 21.

Both vaccines from Pfizer-BioNTech and Moderna have such high efficacy rates that it creates a “cushion effect,” he said, meaning that new variants will likely only diminish vaccine efficacy slightly. To slow the spread of the new strains, Dr. Fauci said, people should get vaccinated as soon as possible. If viruses can’t spread as far or as quickly, they won’t mutate as much.

“Bottom line: We’re paying very close attention to it,” he said. “There are alternative plans if we ever have to modify the vaccine.”

The U.S. has reported 144 cases of the B.1.1.7 variant, which was first identified in the United Kingdom, according to the latest update from the CDC. So far, no cases of the variant strain identified in South Africa have been reported in the U.S., but Dr. Fauci said public health officials are looking for it.

“We’re following very carefully the one in South Africa, which is a little bit more concerning, but nonetheless not something that we don’t think we can handle,” he said.

Despite challenges with vaccine distribution and administration, the U.S. “can and should” vaccinate 70% to 85% of adults by the end of the summer, Dr. Fauci told CNN. If that happens, people could begin to return to some sense of normalcy by the fall, he added.

“When you put ... the pedal to the floor, you can get it done,” he said.

If the U.S. administered one million shots per day, it would take until the end of 2021 to fully vaccine 75% of adults, according to a CNN analysis. Dr. Fauci said he believes the U.S. can give more than one million shots per day. An updated tally from the CDC showed that 1.6 million shots were given in the past 24 hours, which was the largest single-day increase yet reported.

“I’d like it to be a lot more,” Dr. Fauci told CNN. “If we can do better than that, which I personally think we likely will, then great.”

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

The oral, anti-inflammatory drug colchicine can prevent complications and hospitalizations in nonhospitalized patients newly diagnosed with COVID-19, according to a press release from the ColCORONA trial investigators.

After 1 month of therapy, there was a 21% risk reduction in the primary composite endpoint of death or hospitalizations that missed statistical significance, compared with placebo among 4,488 outpatients enrolled in the global, phase 3 trial.

After excluding 329 patients without a confirmatory polymerase chain reaction test, however, the use of colchicine was reported to significantly reduce hospitalizations by 25%, the need for mechanical ventilation by 50%, and deaths by 44%.

“We believe that this is a medical breakthrough. There’s no approved therapy to prevent complications of COVID-19 in outpatients, to prevent them from reaching the hospital,” lead investigator Jean-Claude Tardif, MD, from the Montreal Heart Institute, said in an interview.

“I know that several countries will be reviewing the data very rapidly and that Greece approved it today,” he said. “So this is providing hope for patients.”

Having been burned by hydroxychloroquine and other treatments brought forth without peer review, the response to the announcement was tempered by a desire for more details.

Asked for comment, Steven E. Nissen, MD, of the Cleveland Clinic Foundation, was cautious. “The press release about the trial is vague and lacks details such as hazard ratios, confidence intervals, and P values,” he said in an interview.

“It is impossible to evaluate the results of this trial without these details. It is also uncertain how rigorously data were collected,” he added. “We’ll need to see the manuscript to adequately interpret the results.”

The evidence in the press release is hard to interpret, but early intervention with anti-inflammatory therapy has considerable biologic appeal in COVID, said Paul Ridker, MD, MPH, who led the pivotal CANTOS trial of the anti-inflammatory drug canakinumab in the post-MI setting, and is also chair of the ACTIV-4B trial currently investigating anticoagulants and antithrombotics in outpatient COVID-19.

“Colchicine is both inexpensive and generally well tolerated, and the apparent benefits so far reported are substantial,” Dr. Ridker, from Brigham and Women’s Hospital in Boston, said in an interview. “We are eager to see the full data as rapidly as possible.”

The commonly used gout and rheumatic disease agent costs about 26 cents in Canada and between $4 and $6 in the United States. As previously reported, it reduced the time to clinical deterioration and hospital stay but not mortality in the 105-patient Greek Study in the Effects of Colchicine in COVID-19 Complications Prevention (GRECCO-19) study.

Dr. Tardif said he’s looking forward to having the data in the public domain and that they acted swiftly because the evidence was “clinically persuasive” and “the health system is congested now.”

“We received the results Friday, Jan. 22 at 5 p.m., an hour later we were in meetings with our data safety monitoring board [DSMB], 2 hours later we issued a press release, and a day later we’re submitting a full manuscript to a major scientific journal, so I don’t know if anyone has done this at this speed,” he said. “So we are actually very proud of what we did.”

ColCORONA was designed to enroll 6,000 outpatients, at least 40 years of age, who were diagnosed with COVID-19 infection within the previous 24 hours, and had a least one high-risk criterion, including age at least 70 years, body mass index of at least 30 kg/m², diabetes mellitus, uncontrolled hypertension, known respiratory disease, heart failure or coronary disease, fever of at least 38.4° C within the last 48 hours, dyspnea at presentation, bicytopenia, pancytopenia, or the combination of high neutrophil count and low lymphocyte count.

Participants were randomly assigned to receive either placebo or colchicine 0.5 mg twice daily for 3 days and then once daily for another 27 days.

The number needed to prevent one COVID-19 complication is about 60 patients, Dr. Tardif said.

Colchicine was well tolerated and resulted in fewer serious adverse events than with placebo, he said. Diarrhea occurred more often with colchicine, but there was no increase in pneumonia. Caution should be used, however, in treating patients with severe renal disease.

Dr. Tardif said he would not prescribe colchicine to an 18-year-old COVID outpatient who doesn’t have any concomitant diseases, but would for those meeting the study protocol.

“As long as a patient appears to me to be at risk of a complication, I would prescribe it, without a doubt,” he said. “I can tell you that when we held the meeting with the DSMB Friday evening, I actually put each member on the spot and asked them: ‘If it were you – not even treating a patient, but if you had COVID today, would you take it based on the data you’ve seen?’ and all of the DSMB members said they would.

“So we’ll have that debate in the public domain when the paper is out, but I believe most physicians will use it to treat their patients.”

The trial was coordinated by the Montreal Heart Institute and funded by the government of Quebec; the U.S. National Heart, Lung, and Blood Institute; Montreal philanthropist Sophie Desmarais; and the COVID-19 Therapeutics Accelerator launched by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard. CGI, Dacima, and Pharmascience of Montreal were also collaborators.

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

The oral, anti-inflammatory drug colchicine can prevent complications and hospitalizations in nonhospitalized patients newly diagnosed with COVID-19, according to a press release from the ColCORONA trial investigators.

After 1 month of therapy, there was a 21% risk reduction in the primary composite endpoint of death or hospitalizations that missed statistical significance, compared with placebo among 4,488 outpatients enrolled in the global, phase 3 trial.

After excluding 329 patients without a confirmatory polymerase chain reaction test, however, the use of colchicine was reported to significantly reduce hospitalizations by 25%, the need for mechanical ventilation by 50%, and deaths by 44%.

“We believe that this is a medical breakthrough. There’s no approved therapy to prevent complications of COVID-19 in outpatients, to prevent them from reaching the hospital,” lead investigator Jean-Claude Tardif, MD, from the Montreal Heart Institute, said in an interview.

“I know that several countries will be reviewing the data very rapidly and that Greece approved it today,” he said. “So this is providing hope for patients.”

Having been burned by hydroxychloroquine and other treatments brought forth without peer review, the response to the announcement was tempered by a desire for more details.

Asked for comment, Steven E. Nissen, MD, of the Cleveland Clinic Foundation, was cautious. “The press release about the trial is vague and lacks details such as hazard ratios, confidence intervals, and P values,” he said in an interview.

“It is impossible to evaluate the results of this trial without these details. It is also uncertain how rigorously data were collected,” he added. “We’ll need to see the manuscript to adequately interpret the results.”

The evidence in the press release is hard to interpret, but early intervention with anti-inflammatory therapy has considerable biologic appeal in COVID, said Paul Ridker, MD, MPH, who led the pivotal CANTOS trial of the anti-inflammatory drug canakinumab in the post-MI setting, and is also chair of the ACTIV-4B trial currently investigating anticoagulants and antithrombotics in outpatient COVID-19.

“Colchicine is both inexpensive and generally well tolerated, and the apparent benefits so far reported are substantial,” Dr. Ridker, from Brigham and Women’s Hospital in Boston, said in an interview. “We are eager to see the full data as rapidly as possible.”

The commonly used gout and rheumatic disease agent costs about 26 cents in Canada and between $4 and $6 in the United States. As previously reported, it reduced the time to clinical deterioration and hospital stay but not mortality in the 105-patient Greek Study in the Effects of Colchicine in COVID-19 Complications Prevention (GRECCO-19) study.

Dr. Tardif said he’s looking forward to having the data in the public domain and that they acted swiftly because the evidence was “clinically persuasive” and “the health system is congested now.”

“We received the results Friday, Jan. 22 at 5 p.m., an hour later we were in meetings with our data safety monitoring board [DSMB], 2 hours later we issued a press release, and a day later we’re submitting a full manuscript to a major scientific journal, so I don’t know if anyone has done this at this speed,” he said. “So we are actually very proud of what we did.”

ColCORONA was designed to enroll 6,000 outpatients, at least 40 years of age, who were diagnosed with COVID-19 infection within the previous 24 hours, and had a least one high-risk criterion, including age at least 70 years, body mass index of at least 30 kg/m², diabetes mellitus, uncontrolled hypertension, known respiratory disease, heart failure or coronary disease, fever of at least 38.4° C within the last 48 hours, dyspnea at presentation, bicytopenia, pancytopenia, or the combination of high neutrophil count and low lymphocyte count.

Participants were randomly assigned to receive either placebo or colchicine 0.5 mg twice daily for 3 days and then once daily for another 27 days.

The number needed to prevent one COVID-19 complication is about 60 patients, Dr. Tardif said.

Colchicine was well tolerated and resulted in fewer serious adverse events than with placebo, he said. Diarrhea occurred more often with colchicine, but there was no increase in pneumonia. Caution should be used, however, in treating patients with severe renal disease.

Dr. Tardif said he would not prescribe colchicine to an 18-year-old COVID outpatient who doesn’t have any concomitant diseases, but would for those meeting the study protocol.

“As long as a patient appears to me to be at risk of a complication, I would prescribe it, without a doubt,” he said. “I can tell you that when we held the meeting with the DSMB Friday evening, I actually put each member on the spot and asked them: ‘If it were you – not even treating a patient, but if you had COVID today, would you take it based on the data you’ve seen?’ and all of the DSMB members said they would.

“So we’ll have that debate in the public domain when the paper is out, but I believe most physicians will use it to treat their patients.”

The trial was coordinated by the Montreal Heart Institute and funded by the government of Quebec; the U.S. National Heart, Lung, and Blood Institute; Montreal philanthropist Sophie Desmarais; and the COVID-19 Therapeutics Accelerator launched by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard. CGI, Dacima, and Pharmascience of Montreal were also collaborators.

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

The oral, anti-inflammatory drug colchicine can prevent complications and hospitalizations in nonhospitalized patients newly diagnosed with COVID-19, according to a press release from the ColCORONA trial investigators.

After 1 month of therapy, there was a 21% risk reduction in the primary composite endpoint of death or hospitalizations that missed statistical significance, compared with placebo among 4,488 outpatients enrolled in the global, phase 3 trial.

After excluding 329 patients without a confirmatory polymerase chain reaction test, however, the use of colchicine was reported to significantly reduce hospitalizations by 25%, the need for mechanical ventilation by 50%, and deaths by 44%.

“We believe that this is a medical breakthrough. There’s no approved therapy to prevent complications of COVID-19 in outpatients, to prevent them from reaching the hospital,” lead investigator Jean-Claude Tardif, MD, from the Montreal Heart Institute, said in an interview.

“I know that several countries will be reviewing the data very rapidly and that Greece approved it today,” he said. “So this is providing hope for patients.”

Having been burned by hydroxychloroquine and other treatments brought forth without peer review, the response to the announcement was tempered by a desire for more details.

Asked for comment, Steven E. Nissen, MD, of the Cleveland Clinic Foundation, was cautious. “The press release about the trial is vague and lacks details such as hazard ratios, confidence intervals, and P values,” he said in an interview.

“It is impossible to evaluate the results of this trial without these details. It is also uncertain how rigorously data were collected,” he added. “We’ll need to see the manuscript to adequately interpret the results.”

The evidence in the press release is hard to interpret, but early intervention with anti-inflammatory therapy has considerable biologic appeal in COVID, said Paul Ridker, MD, MPH, who led the pivotal CANTOS trial of the anti-inflammatory drug canakinumab in the post-MI setting, and is also chair of the ACTIV-4B trial currently investigating anticoagulants and antithrombotics in outpatient COVID-19.

“Colchicine is both inexpensive and generally well tolerated, and the apparent benefits so far reported are substantial,” Dr. Ridker, from Brigham and Women’s Hospital in Boston, said in an interview. “We are eager to see the full data as rapidly as possible.”

The commonly used gout and rheumatic disease agent costs about 26 cents in Canada and between $4 and $6 in the United States. As previously reported, it reduced the time to clinical deterioration and hospital stay but not mortality in the 105-patient Greek Study in the Effects of Colchicine in COVID-19 Complications Prevention (GRECCO-19) study.

Dr. Tardif said he’s looking forward to having the data in the public domain and that they acted swiftly because the evidence was “clinically persuasive” and “the health system is congested now.”

“We received the results Friday, Jan. 22 at 5 p.m., an hour later we were in meetings with our data safety monitoring board [DSMB], 2 hours later we issued a press release, and a day later we’re submitting a full manuscript to a major scientific journal, so I don’t know if anyone has done this at this speed,” he said. “So we are actually very proud of what we did.”

ColCORONA was designed to enroll 6,000 outpatients, at least 40 years of age, who were diagnosed with COVID-19 infection within the previous 24 hours, and had a least one high-risk criterion, including age at least 70 years, body mass index of at least 30 kg/m², diabetes mellitus, uncontrolled hypertension, known respiratory disease, heart failure or coronary disease, fever of at least 38.4° C within the last 48 hours, dyspnea at presentation, bicytopenia, pancytopenia, or the combination of high neutrophil count and low lymphocyte count.

Participants were randomly assigned to receive either placebo or colchicine 0.5 mg twice daily for 3 days and then once daily for another 27 days.

The number needed to prevent one COVID-19 complication is about 60 patients, Dr. Tardif said.

Colchicine was well tolerated and resulted in fewer serious adverse events than with placebo, he said. Diarrhea occurred more often with colchicine, but there was no increase in pneumonia. Caution should be used, however, in treating patients with severe renal disease.

Dr. Tardif said he would not prescribe colchicine to an 18-year-old COVID outpatient who doesn’t have any concomitant diseases, but would for those meeting the study protocol.

“As long as a patient appears to me to be at risk of a complication, I would prescribe it, without a doubt,” he said. “I can tell you that when we held the meeting with the DSMB Friday evening, I actually put each member on the spot and asked them: ‘If it were you – not even treating a patient, but if you had COVID today, would you take it based on the data you’ve seen?’ and all of the DSMB members said they would.

“So we’ll have that debate in the public domain when the paper is out, but I believe most physicians will use it to treat their patients.”

The trial was coordinated by the Montreal Heart Institute and funded by the government of Quebec; the U.S. National Heart, Lung, and Blood Institute; Montreal philanthropist Sophie Desmarais; and the COVID-19 Therapeutics Accelerator launched by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard. CGI, Dacima, and Pharmascience of Montreal were also collaborators.

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

Full-dose anticoagulation was superior to low, prophylactic doses in reducing the need for vital organ support such as ventilation in moderately ill patients hospitalized for COVID-19, according to a report released Jan. 22 by the National Institutes of Health (NIH).

“This is a major advance for patients hospitalized with COVID. Full dose of anticoagulation in these non-ICU patients improved outcomes and there’s a trend toward a reduction in mortality,” Judith Hochman, MD, director of the Cardiovascular Clinical Research Center at NYU Langone Medical Center, New York, said in an interview.

“We have treatments that are improving outcomes but not as many that reduce mortality, so we’re hopeful when the full dataset comes in that will be confirmed,” she said.

The observation of increased rates of blood clots and inflammation among COVID-19 patients, which can lead to complications such as lung failure, heart attack, and stroke, has given rise to various anticoagulant treatment protocols and a need for randomized data on routinely administering increased doses of anticoagulation to hospitalized patients.

Today’s top-line findings come from three linked clinical trials – REMAP-CAP, ACTIV-4, and ATTACC – examining the safety and efficacy of full-dose anticoagulation to treat moderately ill or critically ill adults hospitalized with COVID-19 compared with a lower dose typically used to prevent blood clots in hospitalized patients.

In December 2020, all three trials paused enrollment of the critically ill subgroup after results showed that full-dose anticoagulation started in the intensive care unit (ICU) was not beneficial and may have been harmful in some patients.

Moderately ill patients with COVID-19, defined as those who did not require ICU care or organ support, made up 80% of participants at enrollment in the three trials, Dr. Hochman said.

Among more than 1,000 moderately ill patients reviewed as of the data cut with the data safety monitoring board, full doses of low molecular weight or unfractionated heparin were superior to low prophylactic doses for the primary endpoint of need for ventilation or other organ supportive interventions at 21 days after randomization.

This met the predefined threshold for 99% probability of superiority and recruitment was stopped, Dr. Hochman reported. “Obviously safety figured into this decision. The risk/benefit ratio was very clear.”

The results do not pertain to patients with a previous indication for anticoagulation, who were excluded from the trials.

Data from an additional 1,000 patients will be reviewed and the data published sometime in the next 2-3 months, she said.

With large numbers of COVID-19 patients requiring hospitalization, the outcomes could help reduce the overload on intensive care units around the world, the NIH noted.

The results also highlight the critical role of timing in the course of COVID-19.

“We believe that full anticoagulation is effective early in the disease course,” Dr. Hochman said. “Based on the results so far from these three platform trials, those that were very, very sick at the time of enrollment really didn’t benefit and we needed to have caught them at an earlier stage.

“It’s possible that the people in the ICU are just different and the minute they get sick they need the ICU; so we haven’t clearly demonstrated this time course and when to intervene, but that’s the implication of the findings.”

The question of even earlier treatment is being examined in the partner ACTIV-4B trial, which is enrolling patients with COVID-19 illness not requiring hospitalization and randomizing them to the direct oral anticoagulant apixaban or aspirin or placebo.

“It’s a very important trial and we really want to get the message out that patients should volunteer for it,” said Dr. Hochman, principal investigator of the ACTIV-4 trial.

In the United States, the ACTIV-4 trial is being led by a collaborative effort involving a number of universities, including the University of Pittsburgh and New York University.

The REMAP-CAP, ACTIV-4, and ATTACC study platforms span five continents in more than 300 hospitals and are supported by multiple international funding organizations including the National Institutes of Health, Canadian Institutes of Health Research, the National Institute for Health Research (United Kingdom), the National Health and Medical Research Council (Australia), and the PREPARE and RECOVER consortia (European Union).

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

Full-dose anticoagulation was superior to low, prophylactic doses in reducing the need for vital organ support such as ventilation in moderately ill patients hospitalized for COVID-19, according to a report released Jan. 22 by the National Institutes of Health (NIH).

“This is a major advance for patients hospitalized with COVID. Full dose of anticoagulation in these non-ICU patients improved outcomes and there’s a trend toward a reduction in mortality,” Judith Hochman, MD, director of the Cardiovascular Clinical Research Center at NYU Langone Medical Center, New York, said in an interview.

“We have treatments that are improving outcomes but not as many that reduce mortality, so we’re hopeful when the full dataset comes in that will be confirmed,” she said.

The observation of increased rates of blood clots and inflammation among COVID-19 patients, which can lead to complications such as lung failure, heart attack, and stroke, has given rise to various anticoagulant treatment protocols and a need for randomized data on routinely administering increased doses of anticoagulation to hospitalized patients.

Today’s top-line findings come from three linked clinical trials – REMAP-CAP, ACTIV-4, and ATTACC – examining the safety and efficacy of full-dose anticoagulation to treat moderately ill or critically ill adults hospitalized with COVID-19 compared with a lower dose typically used to prevent blood clots in hospitalized patients.

In December 2020, all three trials paused enrollment of the critically ill subgroup after results showed that full-dose anticoagulation started in the intensive care unit (ICU) was not beneficial and may have been harmful in some patients.

Moderately ill patients with COVID-19, defined as those who did not require ICU care or organ support, made up 80% of participants at enrollment in the three trials, Dr. Hochman said.

Among more than 1,000 moderately ill patients reviewed as of the data cut with the data safety monitoring board, full doses of low molecular weight or unfractionated heparin were superior to low prophylactic doses for the primary endpoint of need for ventilation or other organ supportive interventions at 21 days after randomization.

This met the predefined threshold for 99% probability of superiority and recruitment was stopped, Dr. Hochman reported. “Obviously safety figured into this decision. The risk/benefit ratio was very clear.”

The results do not pertain to patients with a previous indication for anticoagulation, who were excluded from the trials.

Data from an additional 1,000 patients will be reviewed and the data published sometime in the next 2-3 months, she said.

With large numbers of COVID-19 patients requiring hospitalization, the outcomes could help reduce the overload on intensive care units around the world, the NIH noted.

The results also highlight the critical role of timing in the course of COVID-19.

“We believe that full anticoagulation is effective early in the disease course,” Dr. Hochman said. “Based on the results so far from these three platform trials, those that were very, very sick at the time of enrollment really didn’t benefit and we needed to have caught them at an earlier stage.

“It’s possible that the people in the ICU are just different and the minute they get sick they need the ICU; so we haven’t clearly demonstrated this time course and when to intervene, but that’s the implication of the findings.”

The question of even earlier treatment is being examined in the partner ACTIV-4B trial, which is enrolling patients with COVID-19 illness not requiring hospitalization and randomizing them to the direct oral anticoagulant apixaban or aspirin or placebo.

“It’s a very important trial and we really want to get the message out that patients should volunteer for it,” said Dr. Hochman, principal investigator of the ACTIV-4 trial.

In the United States, the ACTIV-4 trial is being led by a collaborative effort involving a number of universities, including the University of Pittsburgh and New York University.

The REMAP-CAP, ACTIV-4, and ATTACC study platforms span five continents in more than 300 hospitals and are supported by multiple international funding organizations including the National Institutes of Health, Canadian Institutes of Health Research, the National Institute for Health Research (United Kingdom), the National Health and Medical Research Council (Australia), and the PREPARE and RECOVER consortia (European Union).

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

Full-dose anticoagulation was superior to low, prophylactic doses in reducing the need for vital organ support such as ventilation in moderately ill patients hospitalized for COVID-19, according to a report released Jan. 22 by the National Institutes of Health (NIH).

“This is a major advance for patients hospitalized with COVID. Full dose of anticoagulation in these non-ICU patients improved outcomes and there’s a trend toward a reduction in mortality,” Judith Hochman, MD, director of the Cardiovascular Clinical Research Center at NYU Langone Medical Center, New York, said in an interview.

“We have treatments that are improving outcomes but not as many that reduce mortality, so we’re hopeful when the full dataset comes in that will be confirmed,” she said.

The observation of increased rates of blood clots and inflammation among COVID-19 patients, which can lead to complications such as lung failure, heart attack, and stroke, has given rise to various anticoagulant treatment protocols and a need for randomized data on routinely administering increased doses of anticoagulation to hospitalized patients.

Today’s top-line findings come from three linked clinical trials – REMAP-CAP, ACTIV-4, and ATTACC – examining the safety and efficacy of full-dose anticoagulation to treat moderately ill or critically ill adults hospitalized with COVID-19 compared with a lower dose typically used to prevent blood clots in hospitalized patients.

In December 2020, all three trials paused enrollment of the critically ill subgroup after results showed that full-dose anticoagulation started in the intensive care unit (ICU) was not beneficial and may have been harmful in some patients.

Moderately ill patients with COVID-19, defined as those who did not require ICU care or organ support, made up 80% of participants at enrollment in the three trials, Dr. Hochman said.

Among more than 1,000 moderately ill patients reviewed as of the data cut with the data safety monitoring board, full doses of low molecular weight or unfractionated heparin were superior to low prophylactic doses for the primary endpoint of need for ventilation or other organ supportive interventions at 21 days after randomization.

This met the predefined threshold for 99% probability of superiority and recruitment was stopped, Dr. Hochman reported. “Obviously safety figured into this decision. The risk/benefit ratio was very clear.”

The results do not pertain to patients with a previous indication for anticoagulation, who were excluded from the trials.

Data from an additional 1,000 patients will be reviewed and the data published sometime in the next 2-3 months, she said.

With large numbers of COVID-19 patients requiring hospitalization, the outcomes could help reduce the overload on intensive care units around the world, the NIH noted.

The results also highlight the critical role of timing in the course of COVID-19.

“We believe that full anticoagulation is effective early in the disease course,” Dr. Hochman said. “Based on the results so far from these three platform trials, those that were very, very sick at the time of enrollment really didn’t benefit and we needed to have caught them at an earlier stage.

“It’s possible that the people in the ICU are just different and the minute they get sick they need the ICU; so we haven’t clearly demonstrated this time course and when to intervene, but that’s the implication of the findings.”

The question of even earlier treatment is being examined in the partner ACTIV-4B trial, which is enrolling patients with COVID-19 illness not requiring hospitalization and randomizing them to the direct oral anticoagulant apixaban or aspirin or placebo.

“It’s a very important trial and we really want to get the message out that patients should volunteer for it,” said Dr. Hochman, principal investigator of the ACTIV-4 trial.

In the United States, the ACTIV-4 trial is being led by a collaborative effort involving a number of universities, including the University of Pittsburgh and New York University.

The REMAP-CAP, ACTIV-4, and ATTACC study platforms span five continents in more than 300 hospitals and are supported by multiple international funding organizations including the National Institutes of Health, Canadian Institutes of Health Research, the National Institute for Health Research (United Kingdom), the National Health and Medical Research Council (Australia), and the PREPARE and RECOVER consortia (European Union).

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

To improve the pediatric data in the State of Hospital Medicine (SoHM) Report, the Practice Analysis Committee (PAC) developed a pediatric task force to recommend content specific to pediatric practice and garner support for survey participation. The pediatric hospital medicine (PHM) community responded with its usual enthusiasm, resulting in a threefold increase in PHM participation (99 groups), making the data from 2020 SoHM Report the most meaningful ever for pediatric practices.

However, data collection for the 2020 SoHM Report concluded in February, just before the face of medical practice and hospital care changed dramatically. A recent report at the virtual Pediatric Hospital Medicine meeting stated that pre–COVID-19 hospital operating margins had already taken a significant decline (from 5% to 2%-3%), putting pressure on pediatric programs in community settings that typically do not generate much revenue. After COVID-19, hospital revenues took an even greater downturn, affecting many hospital-based pediatric programs. While the future direction of many PHM programs remains unclear, the robust nature of the pediatric data in the 2020 SoHM Report defines where we were and where we once again hope to be. In addition, the PAC conducted a supplemental survey designed to assess the impact of COVID-19 on the practice of hospital medicine. Here’s a quick review of PHM highlights from the 2020 SoHM Report, with preliminary findings from the supplemental survey.

Diversity of service and scope of practice: pediatric hospitalist programs continue to provide a wide variety of services beyond care on inpatient wards, with the most common being procedure performance (56.6%), care of healthy newborns (51.5%), and rapid response team (38.4%) coverage. In addition, most PHM programs have a role in comanagement of a wide variety of patient populations, with the greatest presence among the surgical specialties. Approximately 90% of programs report some role in the care of patients admitted to general surgery, orthopedic surgery, and other surgical subspecialties. The role for comanagement with medical specialties remains diverse, with PHM programs routinely having some role in caring for patients hospitalized for neurologic, gastroenterological, cardiac concerns, and others. With the recent decline in hospital revenues affecting PHM practices, one way to ensure program value is to continue to diversify. Based on data from the 2020 SoHM report, broadening of clinical coverage will not require a significant change in practice for most PHM programs.

PHM board certification: With the first certifying exam for PHM taking place just months before SoHM data collection, the survey sought to establish a baseline percentage of providers board certified in PHM. With 98 groups responding, an average of 26.4% of PHM practitioners per group were reported to be board certified. While no difference was seen based on academic status, practitioners in PHM programs employed by a hospital, health system, or integrated delivery system were much more likely to be board certified than those employed by a university or medical school (31% vs. 20%). Regional differences were noted as well, with the East region reporting a much higher median proportion of PHM-certified physicians. It will be interesting to watch the trend in board certification status evolve over the upcoming years.

Anticipated change of budgeted full-time equivalents in the next year/post–COVID-19 analysis: Of the PHM programs responding to the SoHM Survey, 46.5% predicted an increase in budgeted full-time equivalents in the next year, while only 5.1% anticipated a decrease. Expecting this to change in response to COVID-19, the supplemental survey sought to update this information. Of the 30 PHM respondents to the supplemental survey, 41% instituted a temporary hiring freeze because of COVID-19, while 8.3% instituted a hiring freeze felt likely to be permanent. As PHM programs gear up for the next viral season, we wait to see whether the impact of COVID-19 will continue to be reflected in the volume and variety of patients admitted. It is clear that PHM programs will need to remain nimble to stay ahead of the changing landscape of practice in the days ahead. View all data by obtaining access to the 2020 SoHM Report at hospitalmedicine.org/sohm.

Many thanks to pediatric task force members Jack Percelay, MD; Vivien Kon-Ea Sun, MD; Marcos Mestre, MD; Ann Allen, MD; Dimple Khona, MD; Jeff Grill, MD; and Michelle Marks, MD.

Dr. Gage is director of faculty development, pediatric hospital medicine, at Phoenix Children’s Hospital, and associate professor of pediatrics at the University of Arizona, Phoenix.

To improve the pediatric data in the State of Hospital Medicine (SoHM) Report, the Practice Analysis Committee (PAC) developed a pediatric task force to recommend content specific to pediatric practice and garner support for survey participation. The pediatric hospital medicine (PHM) community responded with its usual enthusiasm, resulting in a threefold increase in PHM participation (99 groups), making the data from 2020 SoHM Report the most meaningful ever for pediatric practices.

However, data collection for the 2020 SoHM Report concluded in February, just before the face of medical practice and hospital care changed dramatically. A recent report at the virtual Pediatric Hospital Medicine meeting stated that pre–COVID-19 hospital operating margins had already taken a significant decline (from 5% to 2%-3%), putting pressure on pediatric programs in community settings that typically do not generate much revenue. After COVID-19, hospital revenues took an even greater downturn, affecting many hospital-based pediatric programs. While the future direction of many PHM programs remains unclear, the robust nature of the pediatric data in the 2020 SoHM Report defines where we were and where we once again hope to be. In addition, the PAC conducted a supplemental survey designed to assess the impact of COVID-19 on the practice of hospital medicine. Here’s a quick review of PHM highlights from the 2020 SoHM Report, with preliminary findings from the supplemental survey.

Diversity of service and scope of practice: pediatric hospitalist programs continue to provide a wide variety of services beyond care on inpatient wards, with the most common being procedure performance (56.6%), care of healthy newborns (51.5%), and rapid response team (38.4%) coverage. In addition, most PHM programs have a role in comanagement of a wide variety of patient populations, with the greatest presence among the surgical specialties. Approximately 90% of programs report some role in the care of patients admitted to general surgery, orthopedic surgery, and other surgical subspecialties. The role for comanagement with medical specialties remains diverse, with PHM programs routinely having some role in caring for patients hospitalized for neurologic, gastroenterological, cardiac concerns, and others. With the recent decline in hospital revenues affecting PHM practices, one way to ensure program value is to continue to diversify. Based on data from the 2020 SoHM report, broadening of clinical coverage will not require a significant change in practice for most PHM programs.

PHM board certification: With the first certifying exam for PHM taking place just months before SoHM data collection, the survey sought to establish a baseline percentage of providers board certified in PHM. With 98 groups responding, an average of 26.4% of PHM practitioners per group were reported to be board certified. While no difference was seen based on academic status, practitioners in PHM programs employed by a hospital, health system, or integrated delivery system were much more likely to be board certified than those employed by a university or medical school (31% vs. 20%). Regional differences were noted as well, with the East region reporting a much higher median proportion of PHM-certified physicians. It will be interesting to watch the trend in board certification status evolve over the upcoming years.

Anticipated change of budgeted full-time equivalents in the next year/post–COVID-19 analysis: Of the PHM programs responding to the SoHM Survey, 46.5% predicted an increase in budgeted full-time equivalents in the next year, while only 5.1% anticipated a decrease. Expecting this to change in response to COVID-19, the supplemental survey sought to update this information. Of the 30 PHM respondents to the supplemental survey, 41% instituted a temporary hiring freeze because of COVID-19, while 8.3% instituted a hiring freeze felt likely to be permanent. As PHM programs gear up for the next viral season, we wait to see whether the impact of COVID-19 will continue to be reflected in the volume and variety of patients admitted. It is clear that PHM programs will need to remain nimble to stay ahead of the changing landscape of practice in the days ahead. View all data by obtaining access to the 2020 SoHM Report at hospitalmedicine.org/sohm.

Many thanks to pediatric task force members Jack Percelay, MD; Vivien Kon-Ea Sun, MD; Marcos Mestre, MD; Ann Allen, MD; Dimple Khona, MD; Jeff Grill, MD; and Michelle Marks, MD.

Dr. Gage is director of faculty development, pediatric hospital medicine, at Phoenix Children’s Hospital, and associate professor of pediatrics at the University of Arizona, Phoenix.

To improve the pediatric data in the State of Hospital Medicine (SoHM) Report, the Practice Analysis Committee (PAC) developed a pediatric task force to recommend content specific to pediatric practice and garner support for survey participation. The pediatric hospital medicine (PHM) community responded with its usual enthusiasm, resulting in a threefold increase in PHM participation (99 groups), making the data from 2020 SoHM Report the most meaningful ever for pediatric practices.

However, data collection for the 2020 SoHM Report concluded in February, just before the face of medical practice and hospital care changed dramatically. A recent report at the virtual Pediatric Hospital Medicine meeting stated that pre–COVID-19 hospital operating margins had already taken a significant decline (from 5% to 2%-3%), putting pressure on pediatric programs in community settings that typically do not generate much revenue. After COVID-19, hospital revenues took an even greater downturn, affecting many hospital-based pediatric programs. While the future direction of many PHM programs remains unclear, the robust nature of the pediatric data in the 2020 SoHM Report defines where we were and where we once again hope to be. In addition, the PAC conducted a supplemental survey designed to assess the impact of COVID-19 on the practice of hospital medicine. Here’s a quick review of PHM highlights from the 2020 SoHM Report, with preliminary findings from the supplemental survey.

Diversity of service and scope of practice: pediatric hospitalist programs continue to provide a wide variety of services beyond care on inpatient wards, with the most common being procedure performance (56.6%), care of healthy newborns (51.5%), and rapid response team (38.4%) coverage. In addition, most PHM programs have a role in comanagement of a wide variety of patient populations, with the greatest presence among the surgical specialties. Approximately 90% of programs report some role in the care of patients admitted to general surgery, orthopedic surgery, and other surgical subspecialties. The role for comanagement with medical specialties remains diverse, with PHM programs routinely having some role in caring for patients hospitalized for neurologic, gastroenterological, cardiac concerns, and others. With the recent decline in hospital revenues affecting PHM practices, one way to ensure program value is to continue to diversify. Based on data from the 2020 SoHM report, broadening of clinical coverage will not require a significant change in practice for most PHM programs.

PHM board certification: With the first certifying exam for PHM taking place just months before SoHM data collection, the survey sought to establish a baseline percentage of providers board certified in PHM. With 98 groups responding, an average of 26.4% of PHM practitioners per group were reported to be board certified. While no difference was seen based on academic status, practitioners in PHM programs employed by a hospital, health system, or integrated delivery system were much more likely to be board certified than those employed by a university or medical school (31% vs. 20%). Regional differences were noted as well, with the East region reporting a much higher median proportion of PHM-certified physicians. It will be interesting to watch the trend in board certification status evolve over the upcoming years.

Anticipated change of budgeted full-time equivalents in the next year/post–COVID-19 analysis: Of the PHM programs responding to the SoHM Survey, 46.5% predicted an increase in budgeted full-time equivalents in the next year, while only 5.1% anticipated a decrease. Expecting this to change in response to COVID-19, the supplemental survey sought to update this information. Of the 30 PHM respondents to the supplemental survey, 41% instituted a temporary hiring freeze because of COVID-19, while 8.3% instituted a hiring freeze felt likely to be permanent. As PHM programs gear up for the next viral season, we wait to see whether the impact of COVID-19 will continue to be reflected in the volume and variety of patients admitted. It is clear that PHM programs will need to remain nimble to stay ahead of the changing landscape of practice in the days ahead. View all data by obtaining access to the 2020 SoHM Report at hospitalmedicine.org/sohm.

Many thanks to pediatric task force members Jack Percelay, MD; Vivien Kon-Ea Sun, MD; Marcos Mestre, MD; Ann Allen, MD; Dimple Khona, MD; Jeff Grill, MD; and Michelle Marks, MD.

Dr. Gage is director of faculty development, pediatric hospital medicine, at Phoenix Children’s Hospital, and associate professor of pediatrics at the University of Arizona, Phoenix.

Physician burnout remains at a critical level, at 42% overall – the same percentage as last year – but COVID-19 has changed the specialties hit hardest, according to Medscape’s Death by 1,000 Cuts: Physician Burnout & Suicide Report.

Critical care physicians now top the list of those experiencing burnout, at 51%, up from 44% last year, followed by rheumatologists (50%, up from 46%) and infectious disease specialists (49%, up from 45%). Forty-nine percent of urologists reported burnout, but that was a reduction from 54% last year.

Last year, the specialties burdened most by burnout were urology, neurology, nephrology, endocrinology, and family medicine.
 

Women hit particularly hard

Women in medicine traditionally have experienced higher levels of burnout than men, and the pandemic seems to have widened that gap, with the divide now at 51% for women and 36% for men.

“Many women physicians are in families with children at home,” said Carol Bernstein, MD, psychiatrist at Montefiore Medical Center, New York. “It’s already known that women assume more responsibilities in the home than do men. The pressures have increased during COVID-19 – having to be their child’s teacher during home schooling, no child care, and the grandparents can’t babysit. In addition, all doctors and nurses are worried about bringing the virus home to their families.”

Data were collected from Aug. 30 through Nov. 5, 2020. More than 12,000 physicians from 29 specialties responded.

For many, (79%) burnout has been building over years, but for some (21%), it started with the pandemic. Factors cited include lack of adequate personal protective equipment, grief from losing patients, watching families suffer, long hours, and difficult working conditions.

More than 70% of those who responded feel that burnout has had at least a moderate impact on their lives.

“One-tenth consider it severe enough to consider leaving medicine,” survey authors wrote, “an unexpected outcome after having spent so many years in training to become a physician.”

Tragically, an estimated 300 physicians each year in the United States are consumed by the struggle and take their own lives.
 

One percent have attempted suicide

In this survey, 13% of physicians had thoughts of suicide, and 1% have attempted it; 81% said they had no thoughts of suicide; and 5% preferred not to answer.

By specialty, obstetricians/gynecologists were most likely to have thoughts of suicide (19%), followed by orthopedists (18%) and otolaryngologists and plastic surgeons (17%).

“I yell all the time, I am angry and frustrated all the time. I think about quitting all the time,” said an internist who admitted having suicidal thoughts. “No one in my organization cares about doing the right things for patients as much as I do.”

Yet, many with such thoughts tell no one. By age group, 32% of millennials, 40% of generation X physicians, and 41% of baby boomer physicians who had had thoughts of suicide said they had told no one about those thoughts.

Fear of being reported to the medical board, fear of colleagues finding out, and other factors perpetuate a cycle of burnout and depression, and most don’t seek help.

Top reasons physicians listed for not seeking help for burnout and depression include “symptoms are not severe enough” (52%); “I can deal with without help from a professional” (46%); and feeling “too busy” (40%).
 

Administrative tasks fuel burnout

The top driver of burnout continues to be “too many administrative tasks.” This year, 58% put it at the top. The next highest categories (named by 37%) were “spending too many hours at work” and “lack of respect from administrators/employers, colleagues or staff.” Others mentioned lack of control or insufficient compensation and government regulations.

Notably, only 8% said stress from treating COVID-19 patients was the top driver.

An internist said, “I’m working 6 days a week, nights, weekends, holidays!”

A general surgeon said, “Being forced to see four patients an hour when complicated patients and procedures are involved” was the biggest contributor to burnout.

One physician in the survey summarized it: “It’s all of these causes; it’s death by 1,000 cuts.”
 

Exercise tops coping list

Asked how they cope with stress and burnout, physicians put exercise at the top (48%). Next was talking with family and friends (43%), though 43% said they cope by isolating themselves.

Drinking alcohol and overeating junk food were up slightly in the past year: for alcohol, 26%, up from 24%; for junk food, 35%, up from 33%.

The action respondents said would help most to reduce burnout was “increased compensation to avoid financial stress,” chosen by 45%. Next, at 42%, was “more manageable work and schedule,” followed by greater respect from employers, colleagues, and staff (39%).

Asked whether their workplace offered programs to reduce stress and/or burnout, almost half (47%) of physicians said no; 35% said yes; and 18% didn’t know.

Participation in such programs has been low. Almost half (42%) of physicians in this survey said they would be unlikely to attend such a program. Thirty percent they would be likely to participate; 28% said they were neutral on the idea.

“Anti-stress/burnout programs focus on individual approaches to much larger problems,” Wendy K. Dean, MD, psychiatrist and president of Moral Injury of Healthcare, said in an interview. “The programs offer temporary symptomatic relief rather than lasting systemic change. Many physicians are frustrated by these approaches.”

A study last year by the Mayo Clinic found that “the most efficacious strategy to alleviate physician burnout will target organization-directed changes rather than the level of the individual.”

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

Physician burnout remains at a critical level, at 42% overall – the same percentage as last year – but COVID-19 has changed the specialties hit hardest, according to Medscape’s Death by 1,000 Cuts: Physician Burnout & Suicide Report.

Critical care physicians now top the list of those experiencing burnout, at 51%, up from 44% last year, followed by rheumatologists (50%, up from 46%) and infectious disease specialists (49%, up from 45%). Forty-nine percent of urologists reported burnout, but that was a reduction from 54% last year.

Last year, the specialties burdened most by burnout were urology, neurology, nephrology, endocrinology, and family medicine.
 

Women hit particularly hard

Women in medicine traditionally have experienced higher levels of burnout than men, and the pandemic seems to have widened that gap, with the divide now at 51% for women and 36% for men.

“Many women physicians are in families with children at home,” said Carol Bernstein, MD, psychiatrist at Montefiore Medical Center, New York. “It’s already known that women assume more responsibilities in the home than do men. The pressures have increased during COVID-19 – having to be their child’s teacher during home schooling, no child care, and the grandparents can’t babysit. In addition, all doctors and nurses are worried about bringing the virus home to their families.”

Data were collected from Aug. 30 through Nov. 5, 2020. More than 12,000 physicians from 29 specialties responded.

For many, (79%) burnout has been building over years, but for some (21%), it started with the pandemic. Factors cited include lack of adequate personal protective equipment, grief from losing patients, watching families suffer, long hours, and difficult working conditions.

More than 70% of those who responded feel that burnout has had at least a moderate impact on their lives.

“One-tenth consider it severe enough to consider leaving medicine,” survey authors wrote, “an unexpected outcome after having spent so many years in training to become a physician.”

Tragically, an estimated 300 physicians each year in the United States are consumed by the struggle and take their own lives.
 

One percent have attempted suicide

In this survey, 13% of physicians had thoughts of suicide, and 1% have attempted it; 81% said they had no thoughts of suicide; and 5% preferred not to answer.

By specialty, obstetricians/gynecologists were most likely to have thoughts of suicide (19%), followed by orthopedists (18%) and otolaryngologists and plastic surgeons (17%).

“I yell all the time, I am angry and frustrated all the time. I think about quitting all the time,” said an internist who admitted having suicidal thoughts. “No one in my organization cares about doing the right things for patients as much as I do.”

Yet, many with such thoughts tell no one. By age group, 32% of millennials, 40% of generation X physicians, and 41% of baby boomer physicians who had had thoughts of suicide said they had told no one about those thoughts.

Fear of being reported to the medical board, fear of colleagues finding out, and other factors perpetuate a cycle of burnout and depression, and most don’t seek help.

Top reasons physicians listed for not seeking help for burnout and depression include “symptoms are not severe enough” (52%); “I can deal with without help from a professional” (46%); and feeling “too busy” (40%).
 

Administrative tasks fuel burnout

The top driver of burnout continues to be “too many administrative tasks.” This year, 58% put it at the top. The next highest categories (named by 37%) were “spending too many hours at work” and “lack of respect from administrators/employers, colleagues or staff.” Others mentioned lack of control or insufficient compensation and government regulations.

Notably, only 8% said stress from treating COVID-19 patients was the top driver.

An internist said, “I’m working 6 days a week, nights, weekends, holidays!”

A general surgeon said, “Being forced to see four patients an hour when complicated patients and procedures are involved” was the biggest contributor to burnout.

One physician in the survey summarized it: “It’s all of these causes; it’s death by 1,000 cuts.”
 

Exercise tops coping list

Asked how they cope with stress and burnout, physicians put exercise at the top (48%). Next was talking with family and friends (43%), though 43% said they cope by isolating themselves.

Drinking alcohol and overeating junk food were up slightly in the past year: for alcohol, 26%, up from 24%; for junk food, 35%, up from 33%.

The action respondents said would help most to reduce burnout was “increased compensation to avoid financial stress,” chosen by 45%. Next, at 42%, was “more manageable work and schedule,” followed by greater respect from employers, colleagues, and staff (39%).

Asked whether their workplace offered programs to reduce stress and/or burnout, almost half (47%) of physicians said no; 35% said yes; and 18% didn’t know.

Participation in such programs has been low. Almost half (42%) of physicians in this survey said they would be unlikely to attend such a program. Thirty percent they would be likely to participate; 28% said they were neutral on the idea.

“Anti-stress/burnout programs focus on individual approaches to much larger problems,” Wendy K. Dean, MD, psychiatrist and president of Moral Injury of Healthcare, said in an interview. “The programs offer temporary symptomatic relief rather than lasting systemic change. Many physicians are frustrated by these approaches.”

A study last year by the Mayo Clinic found that “the most efficacious strategy to alleviate physician burnout will target organization-directed changes rather than the level of the individual.”

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

Physician burnout remains at a critical level, at 42% overall – the same percentage as last year – but COVID-19 has changed the specialties hit hardest, according to Medscape’s Death by 1,000 Cuts: Physician Burnout & Suicide Report.

Critical care physicians now top the list of those experiencing burnout, at 51%, up from 44% last year, followed by rheumatologists (50%, up from 46%) and infectious disease specialists (49%, up from 45%). Forty-nine percent of urologists reported burnout, but that was a reduction from 54% last year.

Last year, the specialties burdened most by burnout were urology, neurology, nephrology, endocrinology, and family medicine.
 

Women hit particularly hard

Women in medicine traditionally have experienced higher levels of burnout than men, and the pandemic seems to have widened that gap, with the divide now at 51% for women and 36% for men.

“Many women physicians are in families with children at home,” said Carol Bernstein, MD, psychiatrist at Montefiore Medical Center, New York. “It’s already known that women assume more responsibilities in the home than do men. The pressures have increased during COVID-19 – having to be their child’s teacher during home schooling, no child care, and the grandparents can’t babysit. In addition, all doctors and nurses are worried about bringing the virus home to their families.”

Data were collected from Aug. 30 through Nov. 5, 2020. More than 12,000 physicians from 29 specialties responded.

For many, (79%) burnout has been building over years, but for some (21%), it started with the pandemic. Factors cited include lack of adequate personal protective equipment, grief from losing patients, watching families suffer, long hours, and difficult working conditions.

More than 70% of those who responded feel that burnout has had at least a moderate impact on their lives.

“One-tenth consider it severe enough to consider leaving medicine,” survey authors wrote, “an unexpected outcome after having spent so many years in training to become a physician.”

Tragically, an estimated 300 physicians each year in the United States are consumed by the struggle and take their own lives.
 

One percent have attempted suicide

In this survey, 13% of physicians had thoughts of suicide, and 1% have attempted it; 81% said they had no thoughts of suicide; and 5% preferred not to answer.

By specialty, obstetricians/gynecologists were most likely to have thoughts of suicide (19%), followed by orthopedists (18%) and otolaryngologists and plastic surgeons (17%).

“I yell all the time, I am angry and frustrated all the time. I think about quitting all the time,” said an internist who admitted having suicidal thoughts. “No one in my organization cares about doing the right things for patients as much as I do.”

Yet, many with such thoughts tell no one. By age group, 32% of millennials, 40% of generation X physicians, and 41% of baby boomer physicians who had had thoughts of suicide said they had told no one about those thoughts.

Fear of being reported to the medical board, fear of colleagues finding out, and other factors perpetuate a cycle of burnout and depression, and most don’t seek help.

Top reasons physicians listed for not seeking help for burnout and depression include “symptoms are not severe enough” (52%); “I can deal with without help from a professional” (46%); and feeling “too busy” (40%).
 

Administrative tasks fuel burnout

The top driver of burnout continues to be “too many administrative tasks.” This year, 58% put it at the top. The next highest categories (named by 37%) were “spending too many hours at work” and “lack of respect from administrators/employers, colleagues or staff.” Others mentioned lack of control or insufficient compensation and government regulations.

Notably, only 8% said stress from treating COVID-19 patients was the top driver.

An internist said, “I’m working 6 days a week, nights, weekends, holidays!”

A general surgeon said, “Being forced to see four patients an hour when complicated patients and procedures are involved” was the biggest contributor to burnout.

One physician in the survey summarized it: “It’s all of these causes; it’s death by 1,000 cuts.”
 

Exercise tops coping list

Asked how they cope with stress and burnout, physicians put exercise at the top (48%). Next was talking with family and friends (43%), though 43% said they cope by isolating themselves.

Drinking alcohol and overeating junk food were up slightly in the past year: for alcohol, 26%, up from 24%; for junk food, 35%, up from 33%.

The action respondents said would help most to reduce burnout was “increased compensation to avoid financial stress,” chosen by 45%. Next, at 42%, was “more manageable work and schedule,” followed by greater respect from employers, colleagues, and staff (39%).

Asked whether their workplace offered programs to reduce stress and/or burnout, almost half (47%) of physicians said no; 35% said yes; and 18% didn’t know.

Participation in such programs has been low. Almost half (42%) of physicians in this survey said they would be unlikely to attend such a program. Thirty percent they would be likely to participate; 28% said they were neutral on the idea.

“Anti-stress/burnout programs focus on individual approaches to much larger problems,” Wendy K. Dean, MD, psychiatrist and president of Moral Injury of Healthcare, said in an interview. “The programs offer temporary symptomatic relief rather than lasting systemic change. Many physicians are frustrated by these approaches.”

A study last year by the Mayo Clinic found that “the most efficacious strategy to alleviate physician burnout will target organization-directed changes rather than the level of the individual.”

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

Income inequality corresponds to higher COVID-19 incidence and mortality beyond the effects of race and ethnicity, according to an analysis of U.S. county-level data.

Courtesy NIAID

The study, published in JAMA Network Open (2021 Jan 20. doi: 10.1001/jamanetworkopen.2020.34578), was led by Tim F. Liao, PhD, of the University of Illinois at Urbana-Champaign, and Fernando de Maio, of DePaul University, Chicago. They wrote: “This analysis confirms the association between racial/ethnic composition and COVID-19 incidence and mortality. A higher level of Black or Hispanic composition in a county is associated with a higher COVID-19 incidence and mortality; a higher level of economic inequality is also associated with a higher level of incidence and mortality.”

The analysis, which examined data from the first 200 days of the pandemic from January to August 2020, examined the joint associations between income inequality and racial and ethnic composition. Researchers mined data from the Centers for Disease Control and Prevention, the Census Bureau, the Kaiser Family Foundation, and other sources for 3,142 U.S. counties.

Income inequality was measured with the Gini index, on a 0-100 scale, with zero meaning perfect income equality (everyone has the same income) and 100 meaning perfect inequality (only one person or group has all of the income). The average Gini score across all the counties was 44.5, with a range of 25.6-66.5.

Researchers found that, for every 1.0% increase in a county’s Black population, there was a 1.9% increase in COVID-19 incidence (risk ratio, 1.019; 95% confidence interval, 1.016-1.022) and a 2.6% increase in COVID-19 mortality (RR, 1.026; 95% CI, 1.020-1.033). For every 1.0% increase in a county’s Hispanic population, there was a 2.4% increase in incidence (RR, 1.024; 95% CI, 1.012-1.025) and a 1.9% increase in mortality (RR, 1.019; 95% CI, 1.012-1.025).

Income inequality had an even greater effect on COVID-19 incidence and mortality. For each 1.0% rise in a county’s income inequality, there was a 2.0% rise in incidence (RR, 1.020; 95% CI, 1.012-1.027), and a 3.0% rise in mortality (RR, 1.030; 95% CI, 1.012-1.047).

In counties with lower percentages of Black and Hispanic population – up to about 50% for blacks and about 20%-30% for Hispanics – greater income inequality was correlated with higher COVID-19 incidence and mortality. But as the proportion of the Black and Hispanic population increased, race and ethnic population became the much more dominant predictive factor. In other words, the researchers said, income inequality seems to become less of a factor in COVID-related health as the minority population number grows in a given county.

“This finding implies that counties with relatively low proportions of Black or Hispanic residents may experience health effects of income inequality associated with the neomaterial pathway, which connects income inequality to population health through the breakdown of public infrastructure,” such as education, transportation and health care, the researchers said.

The study also examined the interaction between these factors and political attributes of a county, such as whether a governor faced a term limit, was Republican, or was male, and these were found to have no effect on COVID-19 incidence and mortality. Counties in states participating in Medicaid expansion under the Affordable Care Act had a 32% lower COVID-19 incidence rate, researchers found, but there was no correlation with mortality rates.

“This analysis found racial/ethnic composition, while important, does not reveal the full complexity of the story,” the researchers wrote. “Income inequality – a measure not typically included in public health county-level surveillance – also needs to be considered as a driver of the disproportionate burden borne by minoritized communities across the United States.”

The findings, they said, support using composite variables that “measure both income inequality and racial/ethnic composition simultaneously.”

The investigators had no disclosures.

Income inequality corresponds to higher COVID-19 incidence and mortality beyond the effects of race and ethnicity, according to an analysis of U.S. county-level data.

Courtesy NIAID

The study, published in JAMA Network Open (2021 Jan 20. doi: 10.1001/jamanetworkopen.2020.34578), was led by Tim F. Liao, PhD, of the University of Illinois at Urbana-Champaign, and Fernando de Maio, of DePaul University, Chicago. They wrote: “This analysis confirms the association between racial/ethnic composition and COVID-19 incidence and mortality. A higher level of Black or Hispanic composition in a county is associated with a higher COVID-19 incidence and mortality; a higher level of economic inequality is also associated with a higher level of incidence and mortality.”

The analysis, which examined data from the first 200 days of the pandemic from January to August 2020, examined the joint associations between income inequality and racial and ethnic composition. Researchers mined data from the Centers for Disease Control and Prevention, the Census Bureau, the Kaiser Family Foundation, and other sources for 3,142 U.S. counties.

Income inequality was measured with the Gini index, on a 0-100 scale, with zero meaning perfect income equality (everyone has the same income) and 100 meaning perfect inequality (only one person or group has all of the income). The average Gini score across all the counties was 44.5, with a range of 25.6-66.5.

Researchers found that, for every 1.0% increase in a county’s Black population, there was a 1.9% increase in COVID-19 incidence (risk ratio, 1.019; 95% confidence interval, 1.016-1.022) and a 2.6% increase in COVID-19 mortality (RR, 1.026; 95% CI, 1.020-1.033). For every 1.0% increase in a county’s Hispanic population, there was a 2.4% increase in incidence (RR, 1.024; 95% CI, 1.012-1.025) and a 1.9% increase in mortality (RR, 1.019; 95% CI, 1.012-1.025).

Income inequality had an even greater effect on COVID-19 incidence and mortality. For each 1.0% rise in a county’s income inequality, there was a 2.0% rise in incidence (RR, 1.020; 95% CI, 1.012-1.027), and a 3.0% rise in mortality (RR, 1.030; 95% CI, 1.012-1.047).

In counties with lower percentages of Black and Hispanic population – up to about 50% for blacks and about 20%-30% for Hispanics – greater income inequality was correlated with higher COVID-19 incidence and mortality. But as the proportion of the Black and Hispanic population increased, race and ethnic population became the much more dominant predictive factor. In other words, the researchers said, income inequality seems to become less of a factor in COVID-related health as the minority population number grows in a given county.

“This finding implies that counties with relatively low proportions of Black or Hispanic residents may experience health effects of income inequality associated with the neomaterial pathway, which connects income inequality to population health through the breakdown of public infrastructure,” such as education, transportation and health care, the researchers said.

The study also examined the interaction between these factors and political attributes of a county, such as whether a governor faced a term limit, was Republican, or was male, and these were found to have no effect on COVID-19 incidence and mortality. Counties in states participating in Medicaid expansion under the Affordable Care Act had a 32% lower COVID-19 incidence rate, researchers found, but there was no correlation with mortality rates.

“This analysis found racial/ethnic composition, while important, does not reveal the full complexity of the story,” the researchers wrote. “Income inequality – a measure not typically included in public health county-level surveillance – also needs to be considered as a driver of the disproportionate burden borne by minoritized communities across the United States.”

The findings, they said, support using composite variables that “measure both income inequality and racial/ethnic composition simultaneously.”

The investigators had no disclosures.

Income inequality corresponds to higher COVID-19 incidence and mortality beyond the effects of race and ethnicity, according to an analysis of U.S. county-level data.

Courtesy NIAID

The study, published in JAMA Network Open (2021 Jan 20. doi: 10.1001/jamanetworkopen.2020.34578), was led by Tim F. Liao, PhD, of the University of Illinois at Urbana-Champaign, and Fernando de Maio, of DePaul University, Chicago. They wrote: “This analysis confirms the association between racial/ethnic composition and COVID-19 incidence and mortality. A higher level of Black or Hispanic composition in a county is associated with a higher COVID-19 incidence and mortality; a higher level of economic inequality is also associated with a higher level of incidence and mortality.”

The analysis, which examined data from the first 200 days of the pandemic from January to August 2020, examined the joint associations between income inequality and racial and ethnic composition. Researchers mined data from the Centers for Disease Control and Prevention, the Census Bureau, the Kaiser Family Foundation, and other sources for 3,142 U.S. counties.

Income inequality was measured with the Gini index, on a 0-100 scale, with zero meaning perfect income equality (everyone has the same income) and 100 meaning perfect inequality (only one person or group has all of the income). The average Gini score across all the counties was 44.5, with a range of 25.6-66.5.

Researchers found that, for every 1.0% increase in a county’s Black population, there was a 1.9% increase in COVID-19 incidence (risk ratio, 1.019; 95% confidence interval, 1.016-1.022) and a 2.6% increase in COVID-19 mortality (RR, 1.026; 95% CI, 1.020-1.033). For every 1.0% increase in a county’s Hispanic population, there was a 2.4% increase in incidence (RR, 1.024; 95% CI, 1.012-1.025) and a 1.9% increase in mortality (RR, 1.019; 95% CI, 1.012-1.025).

Income inequality had an even greater effect on COVID-19 incidence and mortality. For each 1.0% rise in a county’s income inequality, there was a 2.0% rise in incidence (RR, 1.020; 95% CI, 1.012-1.027), and a 3.0% rise in mortality (RR, 1.030; 95% CI, 1.012-1.047).

In counties with lower percentages of Black and Hispanic population – up to about 50% for blacks and about 20%-30% for Hispanics – greater income inequality was correlated with higher COVID-19 incidence and mortality. But as the proportion of the Black and Hispanic population increased, race and ethnic population became the much more dominant predictive factor. In other words, the researchers said, income inequality seems to become less of a factor in COVID-related health as the minority population number grows in a given county.

“This finding implies that counties with relatively low proportions of Black or Hispanic residents may experience health effects of income inequality associated with the neomaterial pathway, which connects income inequality to population health through the breakdown of public infrastructure,” such as education, transportation and health care, the researchers said.

The study also examined the interaction between these factors and political attributes of a county, such as whether a governor faced a term limit, was Republican, or was male, and these were found to have no effect on COVID-19 incidence and mortality. Counties in states participating in Medicaid expansion under the Affordable Care Act had a 32% lower COVID-19 incidence rate, researchers found, but there was no correlation with mortality rates.

“This analysis found racial/ethnic composition, while important, does not reveal the full complexity of the story,” the researchers wrote. “Income inequality – a measure not typically included in public health county-level surveillance – also needs to be considered as a driver of the disproportionate burden borne by minoritized communities across the United States.”

The findings, they said, support using composite variables that “measure both income inequality and racial/ethnic composition simultaneously.”

The investigators had no disclosures.

Mounting evidence confirms what many clinicians have suspected for years: That daily moisturizers are the bedrock of atopic dermatitis management.

In an updated review of clinical evidence on the topic, Adelaide A. Hebert, MD, Noreen Heer Nicol, PhD, RN, FNP, and colleagues evaluated 13 trials that assessed daily moisturization for the treatment of AD published between 2006 and 2019. “The bottom line is, daily moisturization increased skin hydration and it decreased transepidermal water loss in all children and adults in the 13 studies we looked at,” Dr. Nicol, associate dean and associate professor of nursing at the University of Colorado, Denver, said at the Revolutionizing Atopic Dermatitis symposium.

Based on published evidence in the review, she and her coauthors assembled six points regarding the importance of essential skin repair in AD:

1. It strengthens the barrier that protects against environmental triggers such as skin irritants aeroallergens, dust mites, and pet dander.

2. It decreases moisture loss that perpetuates damage and can provoke inflammatory processes.

3. It promotes a healthy microbiome via induction of antimicrobial peptides.

4. It maintains stratum corneum acidification, which protects against pathogens.

5. It reduces recurrence of flares when used daily.

6. It prevents the onset of AD when applied early in life to at-risk children.

A separate review of optimal AD care authored by Dr. Nicol underscores the importance of foundational management, “meaning that we want you to use hydration and daily moisturizers as part of your everyday management,” she said. “Without good barrier repair, infections and allergens can break through. The intention is to have that barrier repair a key point of moisturizer use.”

In a 2014 published study, researchers investigated the role of proactive emollient therapy in preventing AD in 124 neonates in the United States and the United Kingdom with a first-degree relative with a history of allergic rhinitis, asthma, or AD. The treatment group received daily total body application of Aquaphor Healing Ointment, Cetaphil Cream, or sunflower seed oil, starting at 3 weeks of age, while the control group received no moisturizers. They found that daily emollient therapy significantly reduced the cumulative incidence of AD at 6 months (22% vs. 42% among controls). A follow-up study confirmed a protective but nonsignificant effect of daily moisturizer use at 12 months (AD was diagnosed in 13.2% of those in the treatment group vs. 25% in the control group), most likely due to the study being underpowered.

“The message here is simple,” Dr. Nicol said. “Wouldn’t it be wonderful if we could reduce the burden of AD by doing something as straightforward as moisturizer use in our neonates?”

With so many moisturizers on the market today, considerations include active ingredients, side effects, absorption, and amount required for efficacy. “On the average adult, head to toe, front to back, one time it takes about 30 grams or one ounce of something to cover them completely, so you want to make sure people are using enough,” Dr. Nicol said. “You don’t want to be prescribing people 15- and 30-gram tubes of product and hoping they have enough to cover their bodies multiple times.”

Ten years ago, a randomized, controlled trial found that Aquaphor Healing Ointment was 47 times more cost-effective than prescription barrier creams Atopiclair nonsteroidal cream and EpiCeram controlled release skin barrier emulsion. “The most expensive things do not have to be the best things to be used,” Dr. Nicol said. “Recognize what the properties of these products are and what the benefit is.”

A basic principle of skin care for AD patients recommended by Dr. Nicol and colleagues at National Jewish Health, Denver, includes applying a fragrance-free moisturizer within 3 minutes of finishing a bath or a shower. They recommend products sold in 1-pound jars or large tubes, such as Aquaphor Healing Ointment, Vaniply Ointment, Eucerin Creme (various formulations), Vanicream, CeraVe Cream, or Cetaphil cream. “Vaseline is a good occlusive preparation to seal in but is most effective after bath or shower,” the recommendations continue. “Topical maintenance medications may be used in place of moisturizers or sealer when prescribed.”

She recommends including a list of preferred moisturizers for patients to use into written action plans for skin care. “This adds a lot of benefit to patients,” she said. “Always put the patient at the center of your decision-making. Spend time listening to them, give them options of things that they are willing to use so that they can trust you.”

Dr. Nicol disclosed that she has served as an advisory board member for Eli Lilly & Co.

[email protected]

Mounting evidence confirms what many clinicians have suspected for years: That daily moisturizers are the bedrock of atopic dermatitis management.

In an updated review of clinical evidence on the topic, Adelaide A. Hebert, MD, Noreen Heer Nicol, PhD, RN, FNP, and colleagues evaluated 13 trials that assessed daily moisturization for the treatment of AD published between 2006 and 2019. “The bottom line is, daily moisturization increased skin hydration and it decreased transepidermal water loss in all children and adults in the 13 studies we looked at,” Dr. Nicol, associate dean and associate professor of nursing at the University of Colorado, Denver, said at the Revolutionizing Atopic Dermatitis symposium.

Based on published evidence in the review, she and her coauthors assembled six points regarding the importance of essential skin repair in AD:

1. It strengthens the barrier that protects against environmental triggers such as skin irritants aeroallergens, dust mites, and pet dander.

2. It decreases moisture loss that perpetuates damage and can provoke inflammatory processes.

3. It promotes a healthy microbiome via induction of antimicrobial peptides.

4. It maintains stratum corneum acidification, which protects against pathogens.

5. It reduces recurrence of flares when used daily.

6. It prevents the onset of AD when applied early in life to at-risk children.

A separate review of optimal AD care authored by Dr. Nicol underscores the importance of foundational management, “meaning that we want you to use hydration and daily moisturizers as part of your everyday management,” she said. “Without good barrier repair, infections and allergens can break through. The intention is to have that barrier repair a key point of moisturizer use.”

In a 2014 published study, researchers investigated the role of proactive emollient therapy in preventing AD in 124 neonates in the United States and the United Kingdom with a first-degree relative with a history of allergic rhinitis, asthma, or AD. The treatment group received daily total body application of Aquaphor Healing Ointment, Cetaphil Cream, or sunflower seed oil, starting at 3 weeks of age, while the control group received no moisturizers. They found that daily emollient therapy significantly reduced the cumulative incidence of AD at 6 months (22% vs. 42% among controls). A follow-up study confirmed a protective but nonsignificant effect of daily moisturizer use at 12 months (AD was diagnosed in 13.2% of those in the treatment group vs. 25% in the control group), most likely due to the study being underpowered.

“The message here is simple,” Dr. Nicol said. “Wouldn’t it be wonderful if we could reduce the burden of AD by doing something as straightforward as moisturizer use in our neonates?”

With so many moisturizers on the market today, considerations include active ingredients, side effects, absorption, and amount required for efficacy. “On the average adult, head to toe, front to back, one time it takes about 30 grams or one ounce of something to cover them completely, so you want to make sure people are using enough,” Dr. Nicol said. “You don’t want to be prescribing people 15- and 30-gram tubes of product and hoping they have enough to cover their bodies multiple times.”

Ten years ago, a randomized, controlled trial found that Aquaphor Healing Ointment was 47 times more cost-effective than prescription barrier creams Atopiclair nonsteroidal cream and EpiCeram controlled release skin barrier emulsion. “The most expensive things do not have to be the best things to be used,” Dr. Nicol said. “Recognize what the properties of these products are and what the benefit is.”

A basic principle of skin care for AD patients recommended by Dr. Nicol and colleagues at National Jewish Health, Denver, includes applying a fragrance-free moisturizer within 3 minutes of finishing a bath or a shower. They recommend products sold in 1-pound jars or large tubes, such as Aquaphor Healing Ointment, Vaniply Ointment, Eucerin Creme (various formulations), Vanicream, CeraVe Cream, or Cetaphil cream. “Vaseline is a good occlusive preparation to seal in but is most effective after bath or shower,” the recommendations continue. “Topical maintenance medications may be used in place of moisturizers or sealer when prescribed.”

She recommends including a list of preferred moisturizers for patients to use into written action plans for skin care. “This adds a lot of benefit to patients,” she said. “Always put the patient at the center of your decision-making. Spend time listening to them, give them options of things that they are willing to use so that they can trust you.”

Dr. Nicol disclosed that she has served as an advisory board member for Eli Lilly & Co.

[email protected]

Mounting evidence confirms what many clinicians have suspected for years: That daily moisturizers are the bedrock of atopic dermatitis management.

In an updated review of clinical evidence on the topic, Adelaide A. Hebert, MD, Noreen Heer Nicol, PhD, RN, FNP, and colleagues evaluated 13 trials that assessed daily moisturization for the treatment of AD published between 2006 and 2019. “The bottom line is, daily moisturization increased skin hydration and it decreased transepidermal water loss in all children and adults in the 13 studies we looked at,” Dr. Nicol, associate dean and associate professor of nursing at the University of Colorado, Denver, said at the Revolutionizing Atopic Dermatitis symposium.

Based on published evidence in the review, she and her coauthors assembled six points regarding the importance of essential skin repair in AD:

1. It strengthens the barrier that protects against environmental triggers such as skin irritants aeroallergens, dust mites, and pet dander.

2. It decreases moisture loss that perpetuates damage and can provoke inflammatory processes.

3. It promotes a healthy microbiome via induction of antimicrobial peptides.

4. It maintains stratum corneum acidification, which protects against pathogens.

5. It reduces recurrence of flares when used daily.

6. It prevents the onset of AD when applied early in life to at-risk children.

A separate review of optimal AD care authored by Dr. Nicol underscores the importance of foundational management, “meaning that we want you to use hydration and daily moisturizers as part of your everyday management,” she said. “Without good barrier repair, infections and allergens can break through. The intention is to have that barrier repair a key point of moisturizer use.”

In a 2014 published study, researchers investigated the role of proactive emollient therapy in preventing AD in 124 neonates in the United States and the United Kingdom with a first-degree relative with a history of allergic rhinitis, asthma, or AD. The treatment group received daily total body application of Aquaphor Healing Ointment, Cetaphil Cream, or sunflower seed oil, starting at 3 weeks of age, while the control group received no moisturizers. They found that daily emollient therapy significantly reduced the cumulative incidence of AD at 6 months (22% vs. 42% among controls). A follow-up study confirmed a protective but nonsignificant effect of daily moisturizer use at 12 months (AD was diagnosed in 13.2% of those in the treatment group vs. 25% in the control group), most likely due to the study being underpowered.

“The message here is simple,” Dr. Nicol said. “Wouldn’t it be wonderful if we could reduce the burden of AD by doing something as straightforward as moisturizer use in our neonates?”

With so many moisturizers on the market today, considerations include active ingredients, side effects, absorption, and amount required for efficacy. “On the average adult, head to toe, front to back, one time it takes about 30 grams or one ounce of something to cover them completely, so you want to make sure people are using enough,” Dr. Nicol said. “You don’t want to be prescribing people 15- and 30-gram tubes of product and hoping they have enough to cover their bodies multiple times.”

Ten years ago, a randomized, controlled trial found that Aquaphor Healing Ointment was 47 times more cost-effective than prescription barrier creams Atopiclair nonsteroidal cream and EpiCeram controlled release skin barrier emulsion. “The most expensive things do not have to be the best things to be used,” Dr. Nicol said. “Recognize what the properties of these products are and what the benefit is.”

A basic principle of skin care for AD patients recommended by Dr. Nicol and colleagues at National Jewish Health, Denver, includes applying a fragrance-free moisturizer within 3 minutes of finishing a bath or a shower. They recommend products sold in 1-pound jars or large tubes, such as Aquaphor Healing Ointment, Vaniply Ointment, Eucerin Creme (various formulations), Vanicream, CeraVe Cream, or Cetaphil cream. “Vaseline is a good occlusive preparation to seal in but is most effective after bath or shower,” the recommendations continue. “Topical maintenance medications may be used in place of moisturizers or sealer when prescribed.”

She recommends including a list of preferred moisturizers for patients to use into written action plans for skin care. “This adds a lot of benefit to patients,” she said. “Always put the patient at the center of your decision-making. Spend time listening to them, give them options of things that they are willing to use so that they can trust you.”

Dr. Nicol disclosed that she has served as an advisory board member for Eli Lilly & Co.

[email protected]

Many patients are receiving inadequate eradication therapy for Helicobacter pylori infection, according to analysis of a European registry.

In their analysis, published in the Journal of Clinical Gastroenterology, Olga P. Nyssen, BSc, PhD, of the Autonomous University of Madrid and colleagues discussed seven errors, which included prescribing a triple instead of quadruple regimen, prescribing therapy for too short of a duration, and prescribing a low dose of proton pump inhibitors (PPIs).

“[E]ven after more than 30 years of experience in H. pylori treatment, the ideal regimen to treat this infection remains undefined,” the investigators wrote. The European Registry on Helicobacter pylori management “represents a good mapping overview of the current situation regarding H. pylori management, allowing not only continuous assessment of the integration of clinical recommendations agreed on medical consensus, but also of the possible strategies for improvement.”

Patient data were drawn from registry-participating countries that each had more than 1,000 cases of H. pylori available; most came from Spain, followed by Russia, Italy, Slovenia, and Lithuania. Of these patients, data for 26,340 patients were analyzed, which ultimately represented 80% of the total registry from 2013 to 2019.

The first mistake discussed in the paper regarded use of less-effective triple therapies (typically PPI plus two antibiotics); one review showed that these regimens fail in 20%-40% of cases. Increasing antibiotic resistances have only worsened the success rate. According to this study, a triple regimen was given as first-line treatment in 46% of cases. Overall, frequency of triple-therapy prescriptions decreased from more than 50% in 2013 to about 40% in 2019. More significant improvements in this area were achieved in Spain, where use of triple therapies decreased from 24% in 2014 to 0% in 2019. According to the investigators, this finding serves as a “paradigmatic example of improvement with time.”

The authors pointed out that “overwhelming evidence” supports 14-day treatment; however, 69% of triple-therapy durations and 58% of quadruple therapy cases were for 7 or 10 days. Triple therapy at this duration showed only 81% cure rate, while it was 88% with 14 days, and quadruple therapy was only 80% effective at 7-10 days but 90% effective at 14 days.

“Fortunately,” the investigators wrote, “this mistake was progressively found less frequently and, at present, the prescription of 7-day standard triple therapy regimens has almost disappeared.”

The authors noted acid suppression via PPIs improves cure rates: In one meta-analysis, the cure rate of triple therapy regimens increased by 6%-10% with high doses of PPIs. However, the current study found that 48% of triple therapies included low-dose PPIs. This number decreased over time, the authors noted: from 67% in 2013 to 20% in 2019.

“From another perspective, the daily PPI dose has increased from a dose equivalent to 54 mg of omeprazole in 2013 to 104 mg in 2019,” they wrote.

The other four errors they discussed were failing to adequately consider penicillin allergies in prescription choices, failing to consider the importance of treatment compliance, repeating certain antibiotics after failures, and not checking eradication success after treatment.

Based on these findings, Dr. Nyssen and colleagues suggested that “penetration of recommendations in the participating European countries is still poor and delayed, even though some improvements from guidelines have been partially incorporated.”

According to Grigorios I. Leontiadis, MD, PhD, of McMaster University, Hamilton, Ont., who coauthored the 2017 American College of Gastroenterology H. pylori management guidelines and the Canadian Association of Gastroenterology “Toronto Consensus” in 2016, “This study is important and timely given the steadily increasing antibiotic resistance of H. pylori worldwide.”

Although Dr. Leontiadias described the results as “suboptimal,” he was partially reassured by the improvements over time, “especially following publication of the 2016 European clinical practice guidelines.” He also noted that some older clinical practice guidelines issued conditional recommendations, which could “justify the lower adherence seen in the early period of this study.”

“The unanswered question,” Dr. Leontiadias went on, “is whether the practice of gastroenterologists who volunteered to participate in this prospective registry is truly representative of how H. pylori is managed in Europe. Most likely it isn’t. Nonparticipating gastroenterologists and nongastroenterologist health care practitioners are probably less aware of and less adherent to clinical practice guidelines. This means that the actual situation in the real world is probably grimmer than what this study shows.”

William D. Chey, MD, Nostrant Collegiate Professor of Gastroenterology at the University of Michigan, Ann Arbor, considered the results “not entirely surprising, but nonetheless, noteworthy.”

Dr. Chey noted that the United States lacks a similar registry to compare real-world H. pylori management; even so, he suggested several findings that “bear reiteration” for clinicians in the United States.

“U.S. providers should consider regimens other than clarithromycin triple therapy when treating H. pylori infection,” Dr. Chey said. “Since U.S. providers do not have reliable data on H. pylori antimicrobial resistance, it is useful to ask about prior macrolide antibiotic exposure, and if a patient has received a macrolide for any reason, clarithromycin triple therapy should be avoided. Bismuth quadruple therapy remains a reliable first-line treatment option in the U.S. Another recently approved first-line treatment option is the combination of a proton pump inhibitor, rifabutin, and amoxicillin. Treatment regimens in the U.S. should be given for a minimum of 10 days and, preferably, for 14 days. Another point made by the article is that providers should be maximizing gastric acid suppression by using higher doses of proton pump inhibitors when treating H. pylori.”

Dr. Chey also noted an emerging treatment option that could soon be available. “Results from phase 3 trials in North America and Europe with the potassium-competitive acid blocker vonoprazan combined with amoxicillin, with and without clarithromycin, are expected in 2021 and may provide another novel first-line treatment option.”

Dr. Nyssen and colleagues disclosed relationships with Allergan, Mayoly, Janssen, and others. Dr. Chey is a consultant for Redhill, Phathom, and Takeda, which is developing vonoprazan. Dr. Leontiadias disclosed no conflicts of interest.

This article was updated 2/16/21.

Many patients are receiving inadequate eradication therapy for Helicobacter pylori infection, according to analysis of a European registry.

In their analysis, published in the Journal of Clinical Gastroenterology, Olga P. Nyssen, BSc, PhD, of the Autonomous University of Madrid and colleagues discussed seven errors, which included prescribing a triple instead of quadruple regimen, prescribing therapy for too short of a duration, and prescribing a low dose of proton pump inhibitors (PPIs).

“[E]ven after more than 30 years of experience in H. pylori treatment, the ideal regimen to treat this infection remains undefined,” the investigators wrote. The European Registry on Helicobacter pylori management “represents a good mapping overview of the current situation regarding H. pylori management, allowing not only continuous assessment of the integration of clinical recommendations agreed on medical consensus, but also of the possible strategies for improvement.”

Patient data were drawn from registry-participating countries that each had more than 1,000 cases of H. pylori available; most came from Spain, followed by Russia, Italy, Slovenia, and Lithuania. Of these patients, data for 26,340 patients were analyzed, which ultimately represented 80% of the total registry from 2013 to 2019.

The first mistake discussed in the paper regarded use of less-effective triple therapies (typically PPI plus two antibiotics); one review showed that these regimens fail in 20%-40% of cases. Increasing antibiotic resistances have only worsened the success rate. According to this study, a triple regimen was given as first-line treatment in 46% of cases. Overall, frequency of triple-therapy prescriptions decreased from more than 50% in 2013 to about 40% in 2019. More significant improvements in this area were achieved in Spain, where use of triple therapies decreased from 24% in 2014 to 0% in 2019. According to the investigators, this finding serves as a “paradigmatic example of improvement with time.”

The authors pointed out that “overwhelming evidence” supports 14-day treatment; however, 69% of triple-therapy durations and 58% of quadruple therapy cases were for 7 or 10 days. Triple therapy at this duration showed only 81% cure rate, while it was 88% with 14 days, and quadruple therapy was only 80% effective at 7-10 days but 90% effective at 14 days.

“Fortunately,” the investigators wrote, “this mistake was progressively found less frequently and, at present, the prescription of 7-day standard triple therapy regimens has almost disappeared.”

The authors noted acid suppression via PPIs improves cure rates: In one meta-analysis, the cure rate of triple therapy regimens increased by 6%-10% with high doses of PPIs. However, the current study found that 48% of triple therapies included low-dose PPIs. This number decreased over time, the authors noted: from 67% in 2013 to 20% in 2019.

“From another perspective, the daily PPI dose has increased from a dose equivalent to 54 mg of omeprazole in 2013 to 104 mg in 2019,” they wrote.

The other four errors they discussed were failing to adequately consider penicillin allergies in prescription choices, failing to consider the importance of treatment compliance, repeating certain antibiotics after failures, and not checking eradication success after treatment.

Based on these findings, Dr. Nyssen and colleagues suggested that “penetration of recommendations in the participating European countries is still poor and delayed, even though some improvements from guidelines have been partially incorporated.”

According to Grigorios I. Leontiadis, MD, PhD, of McMaster University, Hamilton, Ont., who coauthored the 2017 American College of Gastroenterology H. pylori management guidelines and the Canadian Association of Gastroenterology “Toronto Consensus” in 2016, “This study is important and timely given the steadily increasing antibiotic resistance of H. pylori worldwide.”

Although Dr. Leontiadias described the results as “suboptimal,” he was partially reassured by the improvements over time, “especially following publication of the 2016 European clinical practice guidelines.” He also noted that some older clinical practice guidelines issued conditional recommendations, which could “justify the lower adherence seen in the early period of this study.”

“The unanswered question,” Dr. Leontiadias went on, “is whether the practice of gastroenterologists who volunteered to participate in this prospective registry is truly representative of how H. pylori is managed in Europe. Most likely it isn’t. Nonparticipating gastroenterologists and nongastroenterologist health care practitioners are probably less aware of and less adherent to clinical practice guidelines. This means that the actual situation in the real world is probably grimmer than what this study shows.”

William D. Chey, MD, Nostrant Collegiate Professor of Gastroenterology at the University of Michigan, Ann Arbor, considered the results “not entirely surprising, but nonetheless, noteworthy.”

Dr. Chey noted that the United States lacks a similar registry to compare real-world H. pylori management; even so, he suggested several findings that “bear reiteration” for clinicians in the United States.

“U.S. providers should consider regimens other than clarithromycin triple therapy when treating H. pylori infection,” Dr. Chey said. “Since U.S. providers do not have reliable data on H. pylori antimicrobial resistance, it is useful to ask about prior macrolide antibiotic exposure, and if a patient has received a macrolide for any reason, clarithromycin triple therapy should be avoided. Bismuth quadruple therapy remains a reliable first-line treatment option in the U.S. Another recently approved first-line treatment option is the combination of a proton pump inhibitor, rifabutin, and amoxicillin. Treatment regimens in the U.S. should be given for a minimum of 10 days and, preferably, for 14 days. Another point made by the article is that providers should be maximizing gastric acid suppression by using higher doses of proton pump inhibitors when treating H. pylori.”

Dr. Chey also noted an emerging treatment option that could soon be available. “Results from phase 3 trials in North America and Europe with the potassium-competitive acid blocker vonoprazan combined with amoxicillin, with and without clarithromycin, are expected in 2021 and may provide another novel first-line treatment option.”

Dr. Nyssen and colleagues disclosed relationships with Allergan, Mayoly, Janssen, and others. Dr. Chey is a consultant for Redhill, Phathom, and Takeda, which is developing vonoprazan. Dr. Leontiadias disclosed no conflicts of interest.

This article was updated 2/16/21.

Many patients are receiving inadequate eradication therapy for Helicobacter pylori infection, according to analysis of a European registry.

In their analysis, published in the Journal of Clinical Gastroenterology, Olga P. Nyssen, BSc, PhD, of the Autonomous University of Madrid and colleagues discussed seven errors, which included prescribing a triple instead of quadruple regimen, prescribing therapy for too short of a duration, and prescribing a low dose of proton pump inhibitors (PPIs).

“[E]ven after more than 30 years of experience in H. pylori treatment, the ideal regimen to treat this infection remains undefined,” the investigators wrote. The European Registry on Helicobacter pylori management “represents a good mapping overview of the current situation regarding H. pylori management, allowing not only continuous assessment of the integration of clinical recommendations agreed on medical consensus, but also of the possible strategies for improvement.”

Patient data were drawn from registry-participating countries that each had more than 1,000 cases of H. pylori available; most came from Spain, followed by Russia, Italy, Slovenia, and Lithuania. Of these patients, data for 26,340 patients were analyzed, which ultimately represented 80% of the total registry from 2013 to 2019.

The first mistake discussed in the paper regarded use of less-effective triple therapies (typically PPI plus two antibiotics); one review showed that these regimens fail in 20%-40% of cases. Increasing antibiotic resistances have only worsened the success rate. According to this study, a triple regimen was given as first-line treatment in 46% of cases. Overall, frequency of triple-therapy prescriptions decreased from more than 50% in 2013 to about 40% in 2019. More significant improvements in this area were achieved in Spain, where use of triple therapies decreased from 24% in 2014 to 0% in 2019. According to the investigators, this finding serves as a “paradigmatic example of improvement with time.”

The authors pointed out that “overwhelming evidence” supports 14-day treatment; however, 69% of triple-therapy durations and 58% of quadruple therapy cases were for 7 or 10 days. Triple therapy at this duration showed only 81% cure rate, while it was 88% with 14 days, and quadruple therapy was only 80% effective at 7-10 days but 90% effective at 14 days.

“Fortunately,” the investigators wrote, “this mistake was progressively found less frequently and, at present, the prescription of 7-day standard triple therapy regimens has almost disappeared.”

The authors noted acid suppression via PPIs improves cure rates: In one meta-analysis, the cure rate of triple therapy regimens increased by 6%-10% with high doses of PPIs. However, the current study found that 48% of triple therapies included low-dose PPIs. This number decreased over time, the authors noted: from 67% in 2013 to 20% in 2019.

“From another perspective, the daily PPI dose has increased from a dose equivalent to 54 mg of omeprazole in 2013 to 104 mg in 2019,” they wrote.

The other four errors they discussed were failing to adequately consider penicillin allergies in prescription choices, failing to consider the importance of treatment compliance, repeating certain antibiotics after failures, and not checking eradication success after treatment.

Based on these findings, Dr. Nyssen and colleagues suggested that “penetration of recommendations in the participating European countries is still poor and delayed, even though some improvements from guidelines have been partially incorporated.”

According to Grigorios I. Leontiadis, MD, PhD, of McMaster University, Hamilton, Ont., who coauthored the 2017 American College of Gastroenterology H. pylori management guidelines and the Canadian Association of Gastroenterology “Toronto Consensus” in 2016, “This study is important and timely given the steadily increasing antibiotic resistance of H. pylori worldwide.”

Although Dr. Leontiadias described the results as “suboptimal,” he was partially reassured by the improvements over time, “especially following publication of the 2016 European clinical practice guidelines.” He also noted that some older clinical practice guidelines issued conditional recommendations, which could “justify the lower adherence seen in the early period of this study.”

“The unanswered question,” Dr. Leontiadias went on, “is whether the practice of gastroenterologists who volunteered to participate in this prospective registry is truly representative of how H. pylori is managed in Europe. Most likely it isn’t. Nonparticipating gastroenterologists and nongastroenterologist health care practitioners are probably less aware of and less adherent to clinical practice guidelines. This means that the actual situation in the real world is probably grimmer than what this study shows.”

William D. Chey, MD, Nostrant Collegiate Professor of Gastroenterology at the University of Michigan, Ann Arbor, considered the results “not entirely surprising, but nonetheless, noteworthy.”

Dr. Chey noted that the United States lacks a similar registry to compare real-world H. pylori management; even so, he suggested several findings that “bear reiteration” for clinicians in the United States.

“U.S. providers should consider regimens other than clarithromycin triple therapy when treating H. pylori infection,” Dr. Chey said. “Since U.S. providers do not have reliable data on H. pylori antimicrobial resistance, it is useful to ask about prior macrolide antibiotic exposure, and if a patient has received a macrolide for any reason, clarithromycin triple therapy should be avoided. Bismuth quadruple therapy remains a reliable first-line treatment option in the U.S. Another recently approved first-line treatment option is the combination of a proton pump inhibitor, rifabutin, and amoxicillin. Treatment regimens in the U.S. should be given for a minimum of 10 days and, preferably, for 14 days. Another point made by the article is that providers should be maximizing gastric acid suppression by using higher doses of proton pump inhibitors when treating H. pylori.”

Dr. Chey also noted an emerging treatment option that could soon be available. “Results from phase 3 trials in North America and Europe with the potassium-competitive acid blocker vonoprazan combined with amoxicillin, with and without clarithromycin, are expected in 2021 and may provide another novel first-line treatment option.”

Dr. Nyssen and colleagues disclosed relationships with Allergan, Mayoly, Janssen, and others. Dr. Chey is a consultant for Redhill, Phathom, and Takeda, which is developing vonoprazan. Dr. Leontiadias disclosed no conflicts of interest.

This article was updated 2/16/21.