Health Policy

Illinois has a new law designed to boost the mental health care workforce at a time when it has been devastated by the COVID-19 pandemic, say state leaders.

Governor J.B. Pritzker (D) signed the legislation, which took effect on June 10.

The law seeks to attract psychologists, social workers, and counselors who have left the workforce within the past 5 years by temporarily ending relicensing requirements, including the need for continuing education credit completion, passing new exams, and fee payments. It also eases the process for those practicing in other states to become licensed in Illinois.

State legislators said there is currently a crushing need for mental health providers, estimating that there are only 14 behavioral health care professionals for every 10,000 Illinois residents. The preamble to the law noted that there will be 8,353 unfilled mental health care jobs in Illinois by 2026.

“We need a mental health care workforce that is robust enough to get people help when they need it – not after months on a waiting list,” Governor Pritzker said in news release. “This legislation invests in mental health infrastructure – and that infrastructure is people,” he added.
 

Grant pathway

“Being told you have to wait weeks – or months – for care is extremely discouraging,” State Senator Laura Fine (D), a lead sponsor of the legislation, noted in the release.

“We need to support people struggling with mental and behavioral health issues, as well as address difficulties our mental health providers are facing trying to see as many patients as possible,” said Senator Fine.

Marvin Lindsey, CEO of the Community Behavioral Healthcare Association, added that the law would “accelerate the process for out-of-state professionals to obtain their Illinois licensure and [increase] the pipeline and diversity of the behavioral health workforce by implementing a funding mechanism that supports new or existing licensure training of interns.”

The law sets up a grant pathway for community mental health centers, which often serve as training sites. The grants would provide funds to establish or enhance training and supervision of interns and behavioral health providers-in-training seeking to become licensed clinical social workers, licensed clinical professional counselors, or licensed marriage and family therapists.

The money for those grants still has to be appropriated.

The law will also allow patient visits at Specialized Mental Health Rehabilitation Facilities conducted by either a psychiatrist or an advanced practice registered mental health or psychiatric nurse.

Finally, it would establish tax credits for employers who hire individuals in recovery from a substance use disorder or a behavioral disorder. Beginning in January 2023, employers will be eligible for up to $2,000 in credits per employee hired.

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

Illinois has a new law designed to boost the mental health care workforce at a time when it has been devastated by the COVID-19 pandemic, say state leaders.

Governor J.B. Pritzker (D) signed the legislation, which took effect on June 10.

The law seeks to attract psychologists, social workers, and counselors who have left the workforce within the past 5 years by temporarily ending relicensing requirements, including the need for continuing education credit completion, passing new exams, and fee payments. It also eases the process for those practicing in other states to become licensed in Illinois.

State legislators said there is currently a crushing need for mental health providers, estimating that there are only 14 behavioral health care professionals for every 10,000 Illinois residents. The preamble to the law noted that there will be 8,353 unfilled mental health care jobs in Illinois by 2026.

“We need a mental health care workforce that is robust enough to get people help when they need it – not after months on a waiting list,” Governor Pritzker said in news release. “This legislation invests in mental health infrastructure – and that infrastructure is people,” he added.
 

Grant pathway

“Being told you have to wait weeks – or months – for care is extremely discouraging,” State Senator Laura Fine (D), a lead sponsor of the legislation, noted in the release.

“We need to support people struggling with mental and behavioral health issues, as well as address difficulties our mental health providers are facing trying to see as many patients as possible,” said Senator Fine.

Marvin Lindsey, CEO of the Community Behavioral Healthcare Association, added that the law would “accelerate the process for out-of-state professionals to obtain their Illinois licensure and [increase] the pipeline and diversity of the behavioral health workforce by implementing a funding mechanism that supports new or existing licensure training of interns.”

The law sets up a grant pathway for community mental health centers, which often serve as training sites. The grants would provide funds to establish or enhance training and supervision of interns and behavioral health providers-in-training seeking to become licensed clinical social workers, licensed clinical professional counselors, or licensed marriage and family therapists.

The money for those grants still has to be appropriated.

The law will also allow patient visits at Specialized Mental Health Rehabilitation Facilities conducted by either a psychiatrist or an advanced practice registered mental health or psychiatric nurse.

Finally, it would establish tax credits for employers who hire individuals in recovery from a substance use disorder or a behavioral disorder. Beginning in January 2023, employers will be eligible for up to $2,000 in credits per employee hired.

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

Illinois has a new law designed to boost the mental health care workforce at a time when it has been devastated by the COVID-19 pandemic, say state leaders.

Governor J.B. Pritzker (D) signed the legislation, which took effect on June 10.

The law seeks to attract psychologists, social workers, and counselors who have left the workforce within the past 5 years by temporarily ending relicensing requirements, including the need for continuing education credit completion, passing new exams, and fee payments. It also eases the process for those practicing in other states to become licensed in Illinois.

State legislators said there is currently a crushing need for mental health providers, estimating that there are only 14 behavioral health care professionals for every 10,000 Illinois residents. The preamble to the law noted that there will be 8,353 unfilled mental health care jobs in Illinois by 2026.

“We need a mental health care workforce that is robust enough to get people help when they need it – not after months on a waiting list,” Governor Pritzker said in news release. “This legislation invests in mental health infrastructure – and that infrastructure is people,” he added.
 

Grant pathway

“Being told you have to wait weeks – or months – for care is extremely discouraging,” State Senator Laura Fine (D), a lead sponsor of the legislation, noted in the release.

“We need to support people struggling with mental and behavioral health issues, as well as address difficulties our mental health providers are facing trying to see as many patients as possible,” said Senator Fine.

Marvin Lindsey, CEO of the Community Behavioral Healthcare Association, added that the law would “accelerate the process for out-of-state professionals to obtain their Illinois licensure and [increase] the pipeline and diversity of the behavioral health workforce by implementing a funding mechanism that supports new or existing licensure training of interns.”

The law sets up a grant pathway for community mental health centers, which often serve as training sites. The grants would provide funds to establish or enhance training and supervision of interns and behavioral health providers-in-training seeking to become licensed clinical social workers, licensed clinical professional counselors, or licensed marriage and family therapists.

The money for those grants still has to be appropriated.

The law will also allow patient visits at Specialized Mental Health Rehabilitation Facilities conducted by either a psychiatrist or an advanced practice registered mental health or psychiatric nurse.

Finally, it would establish tax credits for employers who hire individuals in recovery from a substance use disorder or a behavioral disorder. Beginning in January 2023, employers will be eligible for up to $2,000 in credits per employee hired.

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

The World Health Organization has announced that it will rename the monkeypox virus after a group of scientists voiced concerns that the name is “discriminatory and stigmatizing.”

The virus has infected more than 1,600 people in 39 countries so far this year, the WHO said, including 32 countries where the virus isn’t typically detected.

“WHO is working with partners and experts from around the world on changing the name of monkeypox virus, its clades, and the disease it causes,” Tedros Adhanom Ghebreyesus, PhD, the WHO’s director-general, said during a press briefing.

“We will make announcements about the new names as soon as possible,” he said.

Last week, more than 30 international scientists urged the public health community to change the name of the virus. The scientists posted a letter on June 10, which included support from the Africa Centres for Disease Control and Prevention, noting that the name should change with the ongoing transmission among humans this year.

“The prevailing perception in the international media and scientific literature is that MPXV is endemic in people in some African countries. However, it is well established that nearly all MPXV outbreaks in Africa prior to the 2022 outbreak have been the result of spillover from animals and humans and only rarely have there been reports of sustained human-to-human transmissions,” they wrote.

“In the context of the current global outbreak, continued reference to, and nomenclature of this virus being African is not only inaccurate but is also discriminatory and stigmatizing,” they added.

As one example, they noted, news outlets have used images of African patients to depict the pox lesions, although most stories about the current outbreak have focused on the global north. The Foreign Press Association of Africa has urged the global media to stop using images of Black people to highlight the outbreak in Europe.

“Although the origin of the new global MPXV outbreak is still unknown, there is growing evidence that the most likely scenario is that cross-continent, cryptic human transmission has been ongoing for longer than previously thought,” they wrote.

The WHO has listed two known clades of the monkeypox virus in recent updates – “one identified in West Africa and one in the Congo Basin region.” The group of scientists wrote that this approach is “counter to the best practice of avoiding geographic locations in the nomenclature of diseases and disease groups.”

The scientists proposed a new classification that would name three clades in order of detection – 1, 2, and 3 – for the viral genomes detected in Central Africa, Western Africa, and the localized spillover events detected this year in global north countries. More genome sequencing could uncover additional clades, they noted.

Even within the most recent clade, there is already notable diversity among the genomes, the scientists said. Like the new naming convention adopted for the coronavirus pandemic, the nomenclature for human monkeypox could be donated as “A.1, A.2, A.1.1,” they wrote.

The largest current outbreak is in the United Kingdom, where health officials have detected 524 cases, according to the latest update from the U.K. Health Security Agency.

As of June 15, 72 cases have been reported in the United States, including 15 in California and 15 in New York, according to the latest Centers for Disease Control and Prevention data.

Also on June 15, the WHO published interim guidance on the use of smallpox vaccines for monkeypox. The WHO doesn’t recommend mass vaccination against monkeypox and said vaccines should be used on a case-by-case basis.

The WHO will convene an emergency meeting next week to determine whether the spread of the virus should be considered a global public health emergency.

“The global outbreak of monkeypox is clearly unusual and concerning,” Dr. Tedros said June 15. “It’s for that reason that I have decided to convene the emergency committee under the International Health Regulations next week to assess whether this outbreak represents a public health emergency of international concern.”

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

The World Health Organization has announced that it will rename the monkeypox virus after a group of scientists voiced concerns that the name is “discriminatory and stigmatizing.”

The virus has infected more than 1,600 people in 39 countries so far this year, the WHO said, including 32 countries where the virus isn’t typically detected.

“WHO is working with partners and experts from around the world on changing the name of monkeypox virus, its clades, and the disease it causes,” Tedros Adhanom Ghebreyesus, PhD, the WHO’s director-general, said during a press briefing.

“We will make announcements about the new names as soon as possible,” he said.

Last week, more than 30 international scientists urged the public health community to change the name of the virus. The scientists posted a letter on June 10, which included support from the Africa Centres for Disease Control and Prevention, noting that the name should change with the ongoing transmission among humans this year.

“The prevailing perception in the international media and scientific literature is that MPXV is endemic in people in some African countries. However, it is well established that nearly all MPXV outbreaks in Africa prior to the 2022 outbreak have been the result of spillover from animals and humans and only rarely have there been reports of sustained human-to-human transmissions,” they wrote.

“In the context of the current global outbreak, continued reference to, and nomenclature of this virus being African is not only inaccurate but is also discriminatory and stigmatizing,” they added.

As one example, they noted, news outlets have used images of African patients to depict the pox lesions, although most stories about the current outbreak have focused on the global north. The Foreign Press Association of Africa has urged the global media to stop using images of Black people to highlight the outbreak in Europe.

“Although the origin of the new global MPXV outbreak is still unknown, there is growing evidence that the most likely scenario is that cross-continent, cryptic human transmission has been ongoing for longer than previously thought,” they wrote.

The WHO has listed two known clades of the monkeypox virus in recent updates – “one identified in West Africa and one in the Congo Basin region.” The group of scientists wrote that this approach is “counter to the best practice of avoiding geographic locations in the nomenclature of diseases and disease groups.”

The scientists proposed a new classification that would name three clades in order of detection – 1, 2, and 3 – for the viral genomes detected in Central Africa, Western Africa, and the localized spillover events detected this year in global north countries. More genome sequencing could uncover additional clades, they noted.

Even within the most recent clade, there is already notable diversity among the genomes, the scientists said. Like the new naming convention adopted for the coronavirus pandemic, the nomenclature for human monkeypox could be donated as “A.1, A.2, A.1.1,” they wrote.

The largest current outbreak is in the United Kingdom, where health officials have detected 524 cases, according to the latest update from the U.K. Health Security Agency.

As of June 15, 72 cases have been reported in the United States, including 15 in California and 15 in New York, according to the latest Centers for Disease Control and Prevention data.

Also on June 15, the WHO published interim guidance on the use of smallpox vaccines for monkeypox. The WHO doesn’t recommend mass vaccination against monkeypox and said vaccines should be used on a case-by-case basis.

The WHO will convene an emergency meeting next week to determine whether the spread of the virus should be considered a global public health emergency.

“The global outbreak of monkeypox is clearly unusual and concerning,” Dr. Tedros said June 15. “It’s for that reason that I have decided to convene the emergency committee under the International Health Regulations next week to assess whether this outbreak represents a public health emergency of international concern.”

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

The World Health Organization has announced that it will rename the monkeypox virus after a group of scientists voiced concerns that the name is “discriminatory and stigmatizing.”

The virus has infected more than 1,600 people in 39 countries so far this year, the WHO said, including 32 countries where the virus isn’t typically detected.

“WHO is working with partners and experts from around the world on changing the name of monkeypox virus, its clades, and the disease it causes,” Tedros Adhanom Ghebreyesus, PhD, the WHO’s director-general, said during a press briefing.

“We will make announcements about the new names as soon as possible,” he said.

Last week, more than 30 international scientists urged the public health community to change the name of the virus. The scientists posted a letter on June 10, which included support from the Africa Centres for Disease Control and Prevention, noting that the name should change with the ongoing transmission among humans this year.

“The prevailing perception in the international media and scientific literature is that MPXV is endemic in people in some African countries. However, it is well established that nearly all MPXV outbreaks in Africa prior to the 2022 outbreak have been the result of spillover from animals and humans and only rarely have there been reports of sustained human-to-human transmissions,” they wrote.

“In the context of the current global outbreak, continued reference to, and nomenclature of this virus being African is not only inaccurate but is also discriminatory and stigmatizing,” they added.

As one example, they noted, news outlets have used images of African patients to depict the pox lesions, although most stories about the current outbreak have focused on the global north. The Foreign Press Association of Africa has urged the global media to stop using images of Black people to highlight the outbreak in Europe.

“Although the origin of the new global MPXV outbreak is still unknown, there is growing evidence that the most likely scenario is that cross-continent, cryptic human transmission has been ongoing for longer than previously thought,” they wrote.

The WHO has listed two known clades of the monkeypox virus in recent updates – “one identified in West Africa and one in the Congo Basin region.” The group of scientists wrote that this approach is “counter to the best practice of avoiding geographic locations in the nomenclature of diseases and disease groups.”

The scientists proposed a new classification that would name three clades in order of detection – 1, 2, and 3 – for the viral genomes detected in Central Africa, Western Africa, and the localized spillover events detected this year in global north countries. More genome sequencing could uncover additional clades, they noted.

Even within the most recent clade, there is already notable diversity among the genomes, the scientists said. Like the new naming convention adopted for the coronavirus pandemic, the nomenclature for human monkeypox could be donated as “A.1, A.2, A.1.1,” they wrote.

The largest current outbreak is in the United Kingdom, where health officials have detected 524 cases, according to the latest update from the U.K. Health Security Agency.

As of June 15, 72 cases have been reported in the United States, including 15 in California and 15 in New York, according to the latest Centers for Disease Control and Prevention data.

Also on June 15, the WHO published interim guidance on the use of smallpox vaccines for monkeypox. The WHO doesn’t recommend mass vaccination against monkeypox and said vaccines should be used on a case-by-case basis.

The WHO will convene an emergency meeting next week to determine whether the spread of the virus should be considered a global public health emergency.

“The global outbreak of monkeypox is clearly unusual and concerning,” Dr. Tedros said June 15. “It’s for that reason that I have decided to convene the emergency committee under the International Health Regulations next week to assess whether this outbreak represents a public health emergency of international concern.”

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

Federal advisers to the U.S. Food and Drug Administration voted unanimously June 15 to recommend the use of the Moderna and Pfizer-BioNTech COVID-19 vaccines in infants and young children.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the FDA voted 21-0 to say that benefits of a two-dose series of Moderna’s mRNA vaccine outweigh risk for use in infants and children 6 months through 5 years of age.

The panel then voted 21-0 to say that benefits of a three-dose series of the Pfizer-BioNTech mRNA vaccine outweigh risk for use in infants and children 6 months through 4 years of age.

The FDA is not bound to follow the suggestions of its advisory committees, but it often does. Moderna and Pfizer are seeking to expand emergency use authorization (EUA) for their vaccines. EUAs are special clearances used to allow use of products in connection with public health crises such as the pandemic.

The Pfizer vaccine has standard, nonemergency FDA approval for use in people 16 years of age and older. The FDA also has granted EUA clearance for use of the shot in people ages 5 to 15.

The VRBPAC on June 15 recommended granting EUA clearance for Moderna’s COVID-19 vaccine for people ages 6 to 17. The Moderna vaccine already has full approval for use in people 18 years of age and older.

Many parents have been waiting for a clearance of COVID vaccines for their infants and young children, seeking protection for them at a time of continued spread of the virus.

The White House on June 9 outlined plans for making 10 million doses of COVID vaccines available for children under the age of 5 in the coming weeks.

The Centers for Disease Control and Prevention (CDC) has scheduled a June 18 meeting of its Advisory Committee on Immunization Practices, where members of that panel will vote on recommendations about use of the Moderna and Pfizer-BioNTech vaccines in infants and young children. The last step in the approval process to get shots into arms will be endorsement by the CDC director if the committee votes in favor of the vaccines.

For and against

During the public session during the June 15 FDA meeting, speakers offered varied opinions.

Some urged the panel to vote against the EUA expansion, citing concerns about risks of COVID vaccines in general.

But at the close of the meeting, top FDA vaccine official Peter Marks, MD, PhD, urged the public to be cautious about drawing conclusions from reading incident reports of side effects.

He said he has seen a “Twitter storm” during the day about claims of side effects. but stressed that the FDA has reported to the public on the rare side effects linked to the COVID vaccines, such as myocarditis, with advisories based on a review of reports of side effects. But many of these reports, gathered from the Vaccine Adverse Event Reporting System (VAERS) system, will turn out on further inspection not to be related to vaccination.

Many other speakers urged members of the panel to support expanded use of the vaccines for infants and young children. These speakers emphasized how lack of a vaccine to date has isolated young children who remain unprotected, even with about 83% of those age 5 and older in the United States having received at least one COVID shot.

Dr. Marks noted that there have been 442 deaths from COVID among children under 4 years of age during the pandemic, a number that he compared with the 78 deaths reported in the H1N1 flu. He urged the panel “to be careful that we don’t become numb to the number of pediatric deaths because of the overwhelming number of older deaths here.”

Panelist H. Cody Meissner, MD, a pediatric infectious disease specialist from Tufts University, said the vaccine should be made available -- particularly for children considered to be at high risk for complications from COVID --but health officials need to present a clear picture of the relatively low risks to children of harm from the vaccines-- and from COVID.

“That has to be communicated clearly to parents so that they can participate in the decision about vaccinating a child in this age group,” Dr. Meissner said.

The results presented June 15 from studies of the shots in younger children were less impressive than those from the initial COVID vaccine trials done in adults. This was not a surprise to panelists given the rise of the omicron variant and the evolution of the pandemic, but it still led to comments about the need for further continued study of the vaccines in young children even if they are authorized.

Consider that in 2020, Pfizer won the first EUA for a COVID vaccine of any kind with data that pegged the shot’s efficacy rate at 95%. Statisticians estimated a likely possible range, or 95% confidence interval, for the vaccine efficacy rate at 90.3% to 97.6%.

Those estimates were based on finding eight cases of COVID reported among 18,198 study participants who got the Pfizer-BioNTech shot, compared with 162 cases among the 18,325 people in the placebo group, according to the FDA review of Pifzer’s initial application.

Study data

But on June 15, FDA advisers had to consider an EUA application for which the data did not make as strong a case for the vaccine’s benefit among younger patients.

Pfizer presented what the FDA called a “preliminary descriptive analysis” of vaccine efficacy among participants in Study C4591007 who received three study vaccinations, following accrual of 10 total confirmed COVID-19 cases occurring at least 7 days after the third dose.

Looking at results for study participants ages 6 to 23 months of age, there was one case in the group that got the Pfizer-BioNTech shot and two in the placebo group, pegged as a 75.6% vaccine efficacy rate -- but one with caveats to the small numbers of cases. The 95% confidence interval for this vaccine efficacy rate was reported as-369.1% to 99.6% according to the FDA staff review.

For participants 2-4 years of age with and without evidence of prior SARS-CoV-

2 infection, there were two cases in the group that got the shot and five in the placebo group showing a vaccine efficacy rate of 82.4%, with a 95% confidence interval estimated ranging between -7.6% and 98.3%. For the combined analysis of both age groups, the efficacy rate was estimated at 80.4%, with a 95% confidence interval of 14.1% and 96.7%.

Doran Fink, MD, PhD, a top official in the FDA’s vaccines division, noted that the current EUA application for expanded pediatric use involved “some very preliminary” results that involved “a small number of cases and limited follow up time.”

But he stressed that the evidence gathered to date for the Pifzer application for use of its COVID shot in infants and young children met the threshold for conditional clearance during a crisis.

“We do feel very confident that the evidentiary standard for benefit for an EUA has been met here,” but added that more data would be needed to address questions about the efficacy of the vaccine beyond a third dose and whether an additional dose may be needed.

Pfizer also used a comparison known as “immunobridging” in support of the application. This looked at SARS- CoV-2 50% neutralizing antibody titers for the children in the age group covered by the EUA application and compared them to a randomly selected subset of 16-25-year-old participants in another study,

Key data for the pending Moderna EUA for use of its shot in infants and young children came from study P204. In it, Moderna found 51 cases of COVID among 1,511 children ages 6 months to 23 months who got the vaccines, versus 34 cases among 513 children who received a placebo, according to an FDA staff review.

That resulted in a vaccine efficacy rate pegged at 50.6%, with a 95% confidence interval of 21.4% to 68.6%.

Looking at the children ages 2 to 5 years in the P204 study, there were 119 cases out of 2,594 participants who got the shot, versus 61 cases of 858 in the placebo arm, or 7.1%. That translated to a 36.8% vaccine efficacy rate, with a confidence interval 12.5% to 54.0%.

Panelist Jay Portnoy, MD, of Children’s Mercy Hospital in Kansas City said all of the pediatricians he knows are waiting for the FDA to authorize the new uses of these vaccines in infants and young children.

“The death rate from COVID in young children may not be extremely high, but it’s absolutely terrifying to parents to have their child be sick, have to go to the hospital or even go to the emergency room or their primary care doctor because they’re sick and having trouble breathing,” said Dr. Portnoy, who served as the panel’s consumer representative.

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

This article was updated on 6/16/22.

Federal advisers to the U.S. Food and Drug Administration voted unanimously June 15 to recommend the use of the Moderna and Pfizer-BioNTech COVID-19 vaccines in infants and young children.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the FDA voted 21-0 to say that benefits of a two-dose series of Moderna’s mRNA vaccine outweigh risk for use in infants and children 6 months through 5 years of age.

The panel then voted 21-0 to say that benefits of a three-dose series of the Pfizer-BioNTech mRNA vaccine outweigh risk for use in infants and children 6 months through 4 years of age.

The FDA is not bound to follow the suggestions of its advisory committees, but it often does. Moderna and Pfizer are seeking to expand emergency use authorization (EUA) for their vaccines. EUAs are special clearances used to allow use of products in connection with public health crises such as the pandemic.

The Pfizer vaccine has standard, nonemergency FDA approval for use in people 16 years of age and older. The FDA also has granted EUA clearance for use of the shot in people ages 5 to 15.

The VRBPAC on June 15 recommended granting EUA clearance for Moderna’s COVID-19 vaccine for people ages 6 to 17. The Moderna vaccine already has full approval for use in people 18 years of age and older.

Many parents have been waiting for a clearance of COVID vaccines for their infants and young children, seeking protection for them at a time of continued spread of the virus.

The White House on June 9 outlined plans for making 10 million doses of COVID vaccines available for children under the age of 5 in the coming weeks.

The Centers for Disease Control and Prevention (CDC) has scheduled a June 18 meeting of its Advisory Committee on Immunization Practices, where members of that panel will vote on recommendations about use of the Moderna and Pfizer-BioNTech vaccines in infants and young children. The last step in the approval process to get shots into arms will be endorsement by the CDC director if the committee votes in favor of the vaccines.

For and against

During the public session during the June 15 FDA meeting, speakers offered varied opinions.

Some urged the panel to vote against the EUA expansion, citing concerns about risks of COVID vaccines in general.

But at the close of the meeting, top FDA vaccine official Peter Marks, MD, PhD, urged the public to be cautious about drawing conclusions from reading incident reports of side effects.

He said he has seen a “Twitter storm” during the day about claims of side effects. but stressed that the FDA has reported to the public on the rare side effects linked to the COVID vaccines, such as myocarditis, with advisories based on a review of reports of side effects. But many of these reports, gathered from the Vaccine Adverse Event Reporting System (VAERS) system, will turn out on further inspection not to be related to vaccination.

Many other speakers urged members of the panel to support expanded use of the vaccines for infants and young children. These speakers emphasized how lack of a vaccine to date has isolated young children who remain unprotected, even with about 83% of those age 5 and older in the United States having received at least one COVID shot.

Dr. Marks noted that there have been 442 deaths from COVID among children under 4 years of age during the pandemic, a number that he compared with the 78 deaths reported in the H1N1 flu. He urged the panel “to be careful that we don’t become numb to the number of pediatric deaths because of the overwhelming number of older deaths here.”

Panelist H. Cody Meissner, MD, a pediatric infectious disease specialist from Tufts University, said the vaccine should be made available -- particularly for children considered to be at high risk for complications from COVID --but health officials need to present a clear picture of the relatively low risks to children of harm from the vaccines-- and from COVID.

“That has to be communicated clearly to parents so that they can participate in the decision about vaccinating a child in this age group,” Dr. Meissner said.

The results presented June 15 from studies of the shots in younger children were less impressive than those from the initial COVID vaccine trials done in adults. This was not a surprise to panelists given the rise of the omicron variant and the evolution of the pandemic, but it still led to comments about the need for further continued study of the vaccines in young children even if they are authorized.

Consider that in 2020, Pfizer won the first EUA for a COVID vaccine of any kind with data that pegged the shot’s efficacy rate at 95%. Statisticians estimated a likely possible range, or 95% confidence interval, for the vaccine efficacy rate at 90.3% to 97.6%.

Those estimates were based on finding eight cases of COVID reported among 18,198 study participants who got the Pfizer-BioNTech shot, compared with 162 cases among the 18,325 people in the placebo group, according to the FDA review of Pifzer’s initial application.

Study data

But on June 15, FDA advisers had to consider an EUA application for which the data did not make as strong a case for the vaccine’s benefit among younger patients.

Pfizer presented what the FDA called a “preliminary descriptive analysis” of vaccine efficacy among participants in Study C4591007 who received three study vaccinations, following accrual of 10 total confirmed COVID-19 cases occurring at least 7 days after the third dose.

Looking at results for study participants ages 6 to 23 months of age, there was one case in the group that got the Pfizer-BioNTech shot and two in the placebo group, pegged as a 75.6% vaccine efficacy rate -- but one with caveats to the small numbers of cases. The 95% confidence interval for this vaccine efficacy rate was reported as-369.1% to 99.6% according to the FDA staff review.

For participants 2-4 years of age with and without evidence of prior SARS-CoV-

2 infection, there were two cases in the group that got the shot and five in the placebo group showing a vaccine efficacy rate of 82.4%, with a 95% confidence interval estimated ranging between -7.6% and 98.3%. For the combined analysis of both age groups, the efficacy rate was estimated at 80.4%, with a 95% confidence interval of 14.1% and 96.7%.

Doran Fink, MD, PhD, a top official in the FDA’s vaccines division, noted that the current EUA application for expanded pediatric use involved “some very preliminary” results that involved “a small number of cases and limited follow up time.”

But he stressed that the evidence gathered to date for the Pifzer application for use of its COVID shot in infants and young children met the threshold for conditional clearance during a crisis.

“We do feel very confident that the evidentiary standard for benefit for an EUA has been met here,” but added that more data would be needed to address questions about the efficacy of the vaccine beyond a third dose and whether an additional dose may be needed.

Pfizer also used a comparison known as “immunobridging” in support of the application. This looked at SARS- CoV-2 50% neutralizing antibody titers for the children in the age group covered by the EUA application and compared them to a randomly selected subset of 16-25-year-old participants in another study,

Key data for the pending Moderna EUA for use of its shot in infants and young children came from study P204. In it, Moderna found 51 cases of COVID among 1,511 children ages 6 months to 23 months who got the vaccines, versus 34 cases among 513 children who received a placebo, according to an FDA staff review.

That resulted in a vaccine efficacy rate pegged at 50.6%, with a 95% confidence interval of 21.4% to 68.6%.

Looking at the children ages 2 to 5 years in the P204 study, there were 119 cases out of 2,594 participants who got the shot, versus 61 cases of 858 in the placebo arm, or 7.1%. That translated to a 36.8% vaccine efficacy rate, with a confidence interval 12.5% to 54.0%.

Panelist Jay Portnoy, MD, of Children’s Mercy Hospital in Kansas City said all of the pediatricians he knows are waiting for the FDA to authorize the new uses of these vaccines in infants and young children.

“The death rate from COVID in young children may not be extremely high, but it’s absolutely terrifying to parents to have their child be sick, have to go to the hospital or even go to the emergency room or their primary care doctor because they’re sick and having trouble breathing,” said Dr. Portnoy, who served as the panel’s consumer representative.

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

This article was updated on 6/16/22.

Federal advisers to the U.S. Food and Drug Administration voted unanimously June 15 to recommend the use of the Moderna and Pfizer-BioNTech COVID-19 vaccines in infants and young children.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the FDA voted 21-0 to say that benefits of a two-dose series of Moderna’s mRNA vaccine outweigh risk for use in infants and children 6 months through 5 years of age.

The panel then voted 21-0 to say that benefits of a three-dose series of the Pfizer-BioNTech mRNA vaccine outweigh risk for use in infants and children 6 months through 4 years of age.

The FDA is not bound to follow the suggestions of its advisory committees, but it often does. Moderna and Pfizer are seeking to expand emergency use authorization (EUA) for their vaccines. EUAs are special clearances used to allow use of products in connection with public health crises such as the pandemic.

The Pfizer vaccine has standard, nonemergency FDA approval for use in people 16 years of age and older. The FDA also has granted EUA clearance for use of the shot in people ages 5 to 15.

The VRBPAC on June 15 recommended granting EUA clearance for Moderna’s COVID-19 vaccine for people ages 6 to 17. The Moderna vaccine already has full approval for use in people 18 years of age and older.

Many parents have been waiting for a clearance of COVID vaccines for their infants and young children, seeking protection for them at a time of continued spread of the virus.

The White House on June 9 outlined plans for making 10 million doses of COVID vaccines available for children under the age of 5 in the coming weeks.

The Centers for Disease Control and Prevention (CDC) has scheduled a June 18 meeting of its Advisory Committee on Immunization Practices, where members of that panel will vote on recommendations about use of the Moderna and Pfizer-BioNTech vaccines in infants and young children. The last step in the approval process to get shots into arms will be endorsement by the CDC director if the committee votes in favor of the vaccines.

For and against

During the public session during the June 15 FDA meeting, speakers offered varied opinions.

Some urged the panel to vote against the EUA expansion, citing concerns about risks of COVID vaccines in general.

But at the close of the meeting, top FDA vaccine official Peter Marks, MD, PhD, urged the public to be cautious about drawing conclusions from reading incident reports of side effects.

He said he has seen a “Twitter storm” during the day about claims of side effects. but stressed that the FDA has reported to the public on the rare side effects linked to the COVID vaccines, such as myocarditis, with advisories based on a review of reports of side effects. But many of these reports, gathered from the Vaccine Adverse Event Reporting System (VAERS) system, will turn out on further inspection not to be related to vaccination.

Many other speakers urged members of the panel to support expanded use of the vaccines for infants and young children. These speakers emphasized how lack of a vaccine to date has isolated young children who remain unprotected, even with about 83% of those age 5 and older in the United States having received at least one COVID shot.

Dr. Marks noted that there have been 442 deaths from COVID among children under 4 years of age during the pandemic, a number that he compared with the 78 deaths reported in the H1N1 flu. He urged the panel “to be careful that we don’t become numb to the number of pediatric deaths because of the overwhelming number of older deaths here.”

Panelist H. Cody Meissner, MD, a pediatric infectious disease specialist from Tufts University, said the vaccine should be made available -- particularly for children considered to be at high risk for complications from COVID --but health officials need to present a clear picture of the relatively low risks to children of harm from the vaccines-- and from COVID.

“That has to be communicated clearly to parents so that they can participate in the decision about vaccinating a child in this age group,” Dr. Meissner said.

The results presented June 15 from studies of the shots in younger children were less impressive than those from the initial COVID vaccine trials done in adults. This was not a surprise to panelists given the rise of the omicron variant and the evolution of the pandemic, but it still led to comments about the need for further continued study of the vaccines in young children even if they are authorized.

Consider that in 2020, Pfizer won the first EUA for a COVID vaccine of any kind with data that pegged the shot’s efficacy rate at 95%. Statisticians estimated a likely possible range, or 95% confidence interval, for the vaccine efficacy rate at 90.3% to 97.6%.

Those estimates were based on finding eight cases of COVID reported among 18,198 study participants who got the Pfizer-BioNTech shot, compared with 162 cases among the 18,325 people in the placebo group, according to the FDA review of Pifzer’s initial application.

Study data

But on June 15, FDA advisers had to consider an EUA application for which the data did not make as strong a case for the vaccine’s benefit among younger patients.

Pfizer presented what the FDA called a “preliminary descriptive analysis” of vaccine efficacy among participants in Study C4591007 who received three study vaccinations, following accrual of 10 total confirmed COVID-19 cases occurring at least 7 days after the third dose.

Looking at results for study participants ages 6 to 23 months of age, there was one case in the group that got the Pfizer-BioNTech shot and two in the placebo group, pegged as a 75.6% vaccine efficacy rate -- but one with caveats to the small numbers of cases. The 95% confidence interval for this vaccine efficacy rate was reported as-369.1% to 99.6% according to the FDA staff review.

For participants 2-4 years of age with and without evidence of prior SARS-CoV-

2 infection, there were two cases in the group that got the shot and five in the placebo group showing a vaccine efficacy rate of 82.4%, with a 95% confidence interval estimated ranging between -7.6% and 98.3%. For the combined analysis of both age groups, the efficacy rate was estimated at 80.4%, with a 95% confidence interval of 14.1% and 96.7%.

Doran Fink, MD, PhD, a top official in the FDA’s vaccines division, noted that the current EUA application for expanded pediatric use involved “some very preliminary” results that involved “a small number of cases and limited follow up time.”

But he stressed that the evidence gathered to date for the Pifzer application for use of its COVID shot in infants and young children met the threshold for conditional clearance during a crisis.

“We do feel very confident that the evidentiary standard for benefit for an EUA has been met here,” but added that more data would be needed to address questions about the efficacy of the vaccine beyond a third dose and whether an additional dose may be needed.

Pfizer also used a comparison known as “immunobridging” in support of the application. This looked at SARS- CoV-2 50% neutralizing antibody titers for the children in the age group covered by the EUA application and compared them to a randomly selected subset of 16-25-year-old participants in another study,

Key data for the pending Moderna EUA for use of its shot in infants and young children came from study P204. In it, Moderna found 51 cases of COVID among 1,511 children ages 6 months to 23 months who got the vaccines, versus 34 cases among 513 children who received a placebo, according to an FDA staff review.

That resulted in a vaccine efficacy rate pegged at 50.6%, with a 95% confidence interval of 21.4% to 68.6%.

Looking at the children ages 2 to 5 years in the P204 study, there were 119 cases out of 2,594 participants who got the shot, versus 61 cases of 858 in the placebo arm, or 7.1%. That translated to a 36.8% vaccine efficacy rate, with a confidence interval 12.5% to 54.0%.

Panelist Jay Portnoy, MD, of Children’s Mercy Hospital in Kansas City said all of the pediatricians he knows are waiting for the FDA to authorize the new uses of these vaccines in infants and young children.

“The death rate from COVID in young children may not be extremely high, but it’s absolutely terrifying to parents to have their child be sick, have to go to the hospital or even go to the emergency room or their primary care doctor because they’re sick and having trouble breathing,” said Dr. Portnoy, who served as the panel’s consumer representative.

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

This article was updated on 6/16/22.

The 1973 Supreme Court of the United States (SCOTUS) decision in Roe v Wade was a landmark ruling,¹ establishing that the United States Constitution provides a fundamental “right to privacy,” protecting pregnant people’s freedom to access all available reproductive health care options. Recognizing that the right to abortion was not absolute, the majority of justices supported a trimester system. In the first trimester, decisions about abortion care are fully controlled by patients and clinicians, and no government could place restrictions on access to abortion. In the second trimester, SCOTUS ruled that states may choose to regulate abortion to protect maternal health. (As an example of such state restrictions, in Massachusetts, for many years, but no longer, the state required that abortions occur in a hospital when the patient was between 18 and 24 weeks’ gestation in order to facilitate comprehensive emergency care for complications.) Beginning in the third trimester, a point at which a fetus could be viable, the Court ruled that a government could prohibit abortion except when an abortion was necessary to protect the life or health of the pregnant person. In 1992, the SCOTUS decision in Planned Parenthood v Casey² rejected the trimester system, reaffirming the right to an abortion before fetal viability, and adopting a new standard that states may not create an undue burden on a person seeking an abortion before fetal viability. SCOTUS ruled that an undue burden exists if the purpose of a regulation is to place substantial obstacles in the path of a person seeking an abortion.

If, as anticipated, the 2022 SCOTUS decision in Dobbs v Jackson Women’s Health Organization³ overturns the precedents set in Roe v Wade and Planned Parenthood v Casey, decisions on abortion law will be relegated to elected legislators and state courts.⁴ It is expected that at least 26 state legislatures and governors will enact stringent new restrictions on access to abortion. This cataclysmic reversal of judicial opinion creates a historic challenge to obstetrician-gynecologists and their patients and could threaten access to other vital reproductive services beyond abortion, like contraception. We will be fighting, state by state, for people’s right to access all available reproductive health procedures. This will also significantly affect the ability for providers in women’s reproductive health to obtain appropriate and necessary education and training in a critical skills. If access to safe abortion is restricted, we fear patients may be forced to consider unsafe abortion, raising the specter of a return to the 1960s, when an epidemic of unsafe abortion caused countless injuries and deaths.^5,6

How do we best prepare for these challenges?

• We will need to be flexible and continually evolve our clinical practices to be adherent with state and local legislation and regulation.
• To reduce unintended pregnancies, we need to strengthen our efforts to ensure that every patient has ready access to all available contraceptive options with no out-of-pocket cost.
• When a contraceptive is desired, we will focus on educating people about effectiveness, and offering them highly reliable contraception, such as the implant or intrauterine devices.
• We need to ensure timely access to abortion if state-based laws permit abortion before 6 or 7 weeks’ gestation. Providing medication abortion without an in-person visit using a telehealth option would be one option to expand rapid access to early first trimester abortion.
• Clinicians in states with access to abortion services will need to collaborate with colleagues in states with restrictions on abortion services to improve patient access across state borders.

On a national level, advancing our effective advocacy in Congress may lead to national legislation passed and signed by the President. This could supersede most state laws prohibiting access to comprehensive women’s reproductive health and create a unified, national approach to abortion care, allowing for the appropriate training of all obstetrician-gynecologists. We will also need to develop teams in every state capable of advocating for laws that ensure access to all reproductive health care options. The American College of Obstetricians and Gynecologists has leaders trained and tasked with legislative advocacy in every state.⁷ This network will be a foundation upon which to build additional advocacy efforts.

As women’s health care professionals, our responsibility to our patients, is to work to ensure universal access to safe and effective comprehensive reproductive options, and to ensure that our workforce is prepared to meet the needs of our patients by defending the patient-clinician relationship. Abortion care saves lives of pregnant patients and reduces maternal morbidity.⁸ Access to safe abortion care as part of comprehensive reproductive services is an important component of health care. ●

The 1973 Supreme Court of the United States (SCOTUS) decision in Roe v Wade was a landmark ruling,¹ establishing that the United States Constitution provides a fundamental “right to privacy,” protecting pregnant people’s freedom to access all available reproductive health care options. Recognizing that the right to abortion was not absolute, the majority of justices supported a trimester system. In the first trimester, decisions about abortion care are fully controlled by patients and clinicians, and no government could place restrictions on access to abortion. In the second trimester, SCOTUS ruled that states may choose to regulate abortion to protect maternal health. (As an example of such state restrictions, in Massachusetts, for many years, but no longer, the state required that abortions occur in a hospital when the patient was between 18 and 24 weeks’ gestation in order to facilitate comprehensive emergency care for complications.) Beginning in the third trimester, a point at which a fetus could be viable, the Court ruled that a government could prohibit abortion except when an abortion was necessary to protect the life or health of the pregnant person. In 1992, the SCOTUS decision in Planned Parenthood v Casey² rejected the trimester system, reaffirming the right to an abortion before fetal viability, and adopting a new standard that states may not create an undue burden on a person seeking an abortion before fetal viability. SCOTUS ruled that an undue burden exists if the purpose of a regulation is to place substantial obstacles in the path of a person seeking an abortion.

If, as anticipated, the 2022 SCOTUS decision in Dobbs v Jackson Women’s Health Organization³ overturns the precedents set in Roe v Wade and Planned Parenthood v Casey, decisions on abortion law will be relegated to elected legislators and state courts.⁴ It is expected that at least 26 state legislatures and governors will enact stringent new restrictions on access to abortion. This cataclysmic reversal of judicial opinion creates a historic challenge to obstetrician-gynecologists and their patients and could threaten access to other vital reproductive services beyond abortion, like contraception. We will be fighting, state by state, for people’s right to access all available reproductive health procedures. This will also significantly affect the ability for providers in women’s reproductive health to obtain appropriate and necessary education and training in a critical skills. If access to safe abortion is restricted, we fear patients may be forced to consider unsafe abortion, raising the specter of a return to the 1960s, when an epidemic of unsafe abortion caused countless injuries and deaths.^5,6

How do we best prepare for these challenges?

• We will need to be flexible and continually evolve our clinical practices to be adherent with state and local legislation and regulation.
• To reduce unintended pregnancies, we need to strengthen our efforts to ensure that every patient has ready access to all available contraceptive options with no out-of-pocket cost.
• When a contraceptive is desired, we will focus on educating people about effectiveness, and offering them highly reliable contraception, such as the implant or intrauterine devices.
• We need to ensure timely access to abortion if state-based laws permit abortion before 6 or 7 weeks’ gestation. Providing medication abortion without an in-person visit using a telehealth option would be one option to expand rapid access to early first trimester abortion.
• Clinicians in states with access to abortion services will need to collaborate with colleagues in states with restrictions on abortion services to improve patient access across state borders.

On a national level, advancing our effective advocacy in Congress may lead to national legislation passed and signed by the President. This could supersede most state laws prohibiting access to comprehensive women’s reproductive health and create a unified, national approach to abortion care, allowing for the appropriate training of all obstetrician-gynecologists. We will also need to develop teams in every state capable of advocating for laws that ensure access to all reproductive health care options. The American College of Obstetricians and Gynecologists has leaders trained and tasked with legislative advocacy in every state.⁷ This network will be a foundation upon which to build additional advocacy efforts.

As women’s health care professionals, our responsibility to our patients, is to work to ensure universal access to safe and effective comprehensive reproductive options, and to ensure that our workforce is prepared to meet the needs of our patients by defending the patient-clinician relationship. Abortion care saves lives of pregnant patients and reduces maternal morbidity.⁸ Access to safe abortion care as part of comprehensive reproductive services is an important component of health care. ●

The 1973 Supreme Court of the United States (SCOTUS) decision in Roe v Wade was a landmark ruling,¹ establishing that the United States Constitution provides a fundamental “right to privacy,” protecting pregnant people’s freedom to access all available reproductive health care options. Recognizing that the right to abortion was not absolute, the majority of justices supported a trimester system. In the first trimester, decisions about abortion care are fully controlled by patients and clinicians, and no government could place restrictions on access to abortion. In the second trimester, SCOTUS ruled that states may choose to regulate abortion to protect maternal health. (As an example of such state restrictions, in Massachusetts, for many years, but no longer, the state required that abortions occur in a hospital when the patient was between 18 and 24 weeks’ gestation in order to facilitate comprehensive emergency care for complications.) Beginning in the third trimester, a point at which a fetus could be viable, the Court ruled that a government could prohibit abortion except when an abortion was necessary to protect the life or health of the pregnant person. In 1992, the SCOTUS decision in Planned Parenthood v Casey² rejected the trimester system, reaffirming the right to an abortion before fetal viability, and adopting a new standard that states may not create an undue burden on a person seeking an abortion before fetal viability. SCOTUS ruled that an undue burden exists if the purpose of a regulation is to place substantial obstacles in the path of a person seeking an abortion.

If, as anticipated, the 2022 SCOTUS decision in Dobbs v Jackson Women’s Health Organization³ overturns the precedents set in Roe v Wade and Planned Parenthood v Casey, decisions on abortion law will be relegated to elected legislators and state courts.⁴ It is expected that at least 26 state legislatures and governors will enact stringent new restrictions on access to abortion. This cataclysmic reversal of judicial opinion creates a historic challenge to obstetrician-gynecologists and their patients and could threaten access to other vital reproductive services beyond abortion, like contraception. We will be fighting, state by state, for people’s right to access all available reproductive health procedures. This will also significantly affect the ability for providers in women’s reproductive health to obtain appropriate and necessary education and training in a critical skills. If access to safe abortion is restricted, we fear patients may be forced to consider unsafe abortion, raising the specter of a return to the 1960s, when an epidemic of unsafe abortion caused countless injuries and deaths.^5,6

How do we best prepare for these challenges?

• We will need to be flexible and continually evolve our clinical practices to be adherent with state and local legislation and regulation.
• To reduce unintended pregnancies, we need to strengthen our efforts to ensure that every patient has ready access to all available contraceptive options with no out-of-pocket cost.
• When a contraceptive is desired, we will focus on educating people about effectiveness, and offering them highly reliable contraception, such as the implant or intrauterine devices.
• We need to ensure timely access to abortion if state-based laws permit abortion before 6 or 7 weeks’ gestation. Providing medication abortion without an in-person visit using a telehealth option would be one option to expand rapid access to early first trimester abortion.
• Clinicians in states with access to abortion services will need to collaborate with colleagues in states with restrictions on abortion services to improve patient access across state borders.

On a national level, advancing our effective advocacy in Congress may lead to national legislation passed and signed by the President. This could supersede most state laws prohibiting access to comprehensive women’s reproductive health and create a unified, national approach to abortion care, allowing for the appropriate training of all obstetrician-gynecologists. We will also need to develop teams in every state capable of advocating for laws that ensure access to all reproductive health care options. The American College of Obstetricians and Gynecologists has leaders trained and tasked with legislative advocacy in every state.⁷ This network will be a foundation upon which to build additional advocacy efforts.

As women’s health care professionals, our responsibility to our patients, is to work to ensure universal access to safe and effective comprehensive reproductive options, and to ensure that our workforce is prepared to meet the needs of our patients by defending the patient-clinician relationship. Abortion care saves lives of pregnant patients and reduces maternal morbidity.⁸ Access to safe abortion care as part of comprehensive reproductive services is an important component of health care. ●

The U.S. Food and Drug Administration has declined to take further action against a group of investigators at Hennepin County Medical Center/Hennepin Healthcare (HCMC) who conducted controversial studies involving ketamine and other sedatives on agitated persons without their consent.

A citizen petition filed by Public Citizen, a consumer advocacy group, had asked the FDA to initiate clinical-investigator disqualification proceedings against Jon Cole, MD, and Lauren Klein, MD, along with other researchers who participated in the studies, for “repeatedly and deliberately initiating and conducting clinical investigations of investigational drug products” without having submitted or having in effect the investigational new drug applications (INDs) required by the FDA.

In certain situations, wherein the FDA alleges that a clinical investigator has violated applicable regulations, the agency may initiate clinical investigator disqualification proceedings. The names of the disqualified researchers are then added to a federal database.

The petition, which was filed in November 2021, also requested that the FDA initiate disqualification proceedings against the institutional review board (IRB) at HCMC for repeatedly failing to comply with federal regulations that adversely affected the rights and welfare of the individuals who were enrolled in the study without their consent.

Of note, Public Citizen stated that the FDA should have required the hospital to contact the more than 1,700 patients who “were unwittingly enrolled in unethical experiments” and inform them that their rights had been violated and their health potentially endangered by the research team.

Michael A. Carome, MD, director of Public Citizen’s Health Research Group, told this news organization that it is uncommon for the FDA to disqualify researchers. “It should be more common than it is,” he said. “I think that FDA is just reluctant to take more action.”

The actions of the Hennepin investigators were “repetitive and appeared to be in deliberate violation of regulations,” he added. “The case for the FDA disqualifying the HCMC researchers is overwhelming. The FDA’s slap-on-the-wrist approach to such appalling regulatory and ethical violations risks emboldening other researchers to disregard the rights and welfare of human subjects.”

Carl Elliott, MD, PhD, a bioethicist at the University of Minnesota, Minneapolis, agrees that the researcher from HCMC should be disqualified. “They didn’t just conduct risky, exploitative studies – they conducted them after the FDA had warned them not to proceed,” he said. “The message sent by this slap on the wrist is that investigators can do whatever they want to nonconsenting subjects, and the FDA will look the other way.”
 

Initial complaint

Public Citizen initially filed a complaint with the FDA in 2018, after learning that researchers affiliated with HCMC were conducting high-risk clinical trials involving ketamine to control agitation outside of the hospital setting. The complaint was cosigned by 64 doctors, bioethicists, and academic researchers and was also submitted to the Office for Human Research Protections.

The FDA typically allows investigational drugs to be used in emergency situation without obtaining informed consent if the therapies are known to carry a minimal risk. The IRB at HCMC had determined that this was the case with ketamine and approved the trials.

But according to Public Citizen’s complaint, prior research had suggested that ketamine could cause more complications and severe adverse events, compared with other sedatives.

The trials were conducted between 2014 and 2018, and in its letter, Public Citizen alleged that the investigators and the IRB had allowed these trials to proceed without obtaining informed consent from patients. The goal was to evaluate how well ketamine worked, compared with other drugs in calming agitated individuals: “The patients were given either ketamine or haloperidol for agitation by paramedics who responded to medical emergencies, and the goal was to see which drug worked faster,” said Dr. Carome. “Patients were only notified afterwards that they had received a sedative. Informed consent had been waived by IRB.”

In the first clinical trial conducted by HCMC, published in 2016, the researchers had hypothesized that 5 mg/kg of intramuscular ketamine would be superior to 10 mg of intramuscular haloperidol for severe prehospital agitation. Time to adequate sedation was the primary outcome measure. The study included 146 people; 64 received ketamine and 82 received haloperidol. They found that ketamine worked far more quickly than haloperidol (5 minutes vs. 17 minutes) but that the risk for complications was much higher. Complications occurred in 49% of patients receiving ketamine, compared with 5%.

“There was a 10-fold risk of adverse events,” said Dr. Carome. “And 39% of patients given ketamine had respiratory problems requiring intubation, compared to 4% who received haloperidol.”

A second study was launched in 2017, wherein ketamine was compared with midazolam in agitated patients. During the first 6-month period of the study, individuals would receive a ketamine-based protocol for prehospital agitation, and during the second 6 months, that would switch to midazolam. However, the study was halted in June 2018 after the local newspaper, the Star Tribune, reported that the city police had encouraged medical personnel to sedate agitated patients. This included individuals who had already been physically restrained.

The report stated that “in many cases, the individual being detained or arrested was not only handcuffed but strapped down on a stretcher in an ambulance before receiving ketamine,” and that it raised a “concerning question” over why these people were given the drug before they were transported to the hospital, “given the immediate effects on breathing and heart function that the drug induces.”

Along with halting the trial, HCMC asked for a review of cases involving its paramedics; an independent investigation led by former U.S. Deputy Attorney General Sally Yates was initiated to assess whether the Minneapolis police had crossed a line and urged paramedics to use ketamine.

“The decision to use ketamine was based on the study’s timeline and not on clinical judgment,” said Dr. Carome.

The FDA acknowledged receipt of the complaint and inspected the IRB records and the clinical trial data. Preliminary reports received by Public Citizen confirmed their allegations. “There were not appropriate protections for vulnerable subjects,” he said. “In 2019, the FDA did further investigations, and those reports had similar findings.”
 

FDA letters

The FDA had sent warning letters to Dr. Cole and Dr. Klein, citing them for ignoring federal safety laws in experimental research on the public. In their investigations, the FDA cited “objectionable conditions” for the studies led by Dr. Cole and Dr. Klein, according to the letters. Both researchers seemingly ignored FDA regulations and used practices that subjected patients to “significantly increased risk,” and the hospital defended its research with “factually incorrect” statements.

In a letter to Dr. Cole, the FDA noted that he never filed INDs for the trials with the FDA, as required by law, and that he also failed to write appropriate protocols to ensure that children and pregnant women were not enrolled in the research. Individuals under the influence of intoxicants also were not excluded, though the use of ketamine is cautioned in this population.

“Administration of the investigational drugs to these subjects placed them at significantly increased risk of the adverse events associated with the investigational products and decreased the acceptability of those risks,” the FDA said in its letter. “Your failure to exclude, and the lack of any precautions for, subjects under the influence of various intoxicants significantly increased the risks and/or decreased the acceptability of the risks associated with the investigational drugs.”

However, Dr. Cole conducted both studies in the prehospital setting and failed to initiate any specific measures to protect study participants, according to the FDA.
 

Petition denied

Dr. Carome noted that the researchers had committed repetitive egregious regulatory violations over a 4-year period, which were documented by the FDA in their warning letters to Dr. Cole and Dr. Klein. “We felt that they were so egregious that we need to send a signal to the community that this sort of behavior will not be tolerated,” he said. “The FDA denied our petition, and we think that sends the wrong signal to the research community.”

In their response, the FDA noted that as with judicial enforcement, “the Agency makes decisions regarding whether to pursue administrative enforcement action, including disqualification proceedings, on a case-by-case basis, considering all relevant facts and circumstances.” They added that at this time, they would not be taking further action against Dr. Cole and Dr. Klein.

“However, we intend to continue to consider all the options available to the Agency as we determine whether to pursue additional compliance actions related to this matter,” the FDA concluded.

The FDA declined to comment further on their decision.

Dr. Cole also declined to comment, but Hennepin Healthcare told this news organization that the “decision by the FDA to deny the petition validates the changes we made to strengthen and improve the clinical research program across the institution since the closing of the studies in 2018. We look forward to continuing to work with the FDA to ensure full compliance with the standards in place to protect research subjects.”

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

The U.S. Food and Drug Administration has declined to take further action against a group of investigators at Hennepin County Medical Center/Hennepin Healthcare (HCMC) who conducted controversial studies involving ketamine and other sedatives on agitated persons without their consent.

A citizen petition filed by Public Citizen, a consumer advocacy group, had asked the FDA to initiate clinical-investigator disqualification proceedings against Jon Cole, MD, and Lauren Klein, MD, along with other researchers who participated in the studies, for “repeatedly and deliberately initiating and conducting clinical investigations of investigational drug products” without having submitted or having in effect the investigational new drug applications (INDs) required by the FDA.

In certain situations, wherein the FDA alleges that a clinical investigator has violated applicable regulations, the agency may initiate clinical investigator disqualification proceedings. The names of the disqualified researchers are then added to a federal database.

The petition, which was filed in November 2021, also requested that the FDA initiate disqualification proceedings against the institutional review board (IRB) at HCMC for repeatedly failing to comply with federal regulations that adversely affected the rights and welfare of the individuals who were enrolled in the study without their consent.

Of note, Public Citizen stated that the FDA should have required the hospital to contact the more than 1,700 patients who “were unwittingly enrolled in unethical experiments” and inform them that their rights had been violated and their health potentially endangered by the research team.

Michael A. Carome, MD, director of Public Citizen’s Health Research Group, told this news organization that it is uncommon for the FDA to disqualify researchers. “It should be more common than it is,” he said. “I think that FDA is just reluctant to take more action.”

The actions of the Hennepin investigators were “repetitive and appeared to be in deliberate violation of regulations,” he added. “The case for the FDA disqualifying the HCMC researchers is overwhelming. The FDA’s slap-on-the-wrist approach to such appalling regulatory and ethical violations risks emboldening other researchers to disregard the rights and welfare of human subjects.”

Carl Elliott, MD, PhD, a bioethicist at the University of Minnesota, Minneapolis, agrees that the researcher from HCMC should be disqualified. “They didn’t just conduct risky, exploitative studies – they conducted them after the FDA had warned them not to proceed,” he said. “The message sent by this slap on the wrist is that investigators can do whatever they want to nonconsenting subjects, and the FDA will look the other way.”
 

Initial complaint

Public Citizen initially filed a complaint with the FDA in 2018, after learning that researchers affiliated with HCMC were conducting high-risk clinical trials involving ketamine to control agitation outside of the hospital setting. The complaint was cosigned by 64 doctors, bioethicists, and academic researchers and was also submitted to the Office for Human Research Protections.

The FDA typically allows investigational drugs to be used in emergency situation without obtaining informed consent if the therapies are known to carry a minimal risk. The IRB at HCMC had determined that this was the case with ketamine and approved the trials.

But according to Public Citizen’s complaint, prior research had suggested that ketamine could cause more complications and severe adverse events, compared with other sedatives.

The trials were conducted between 2014 and 2018, and in its letter, Public Citizen alleged that the investigators and the IRB had allowed these trials to proceed without obtaining informed consent from patients. The goal was to evaluate how well ketamine worked, compared with other drugs in calming agitated individuals: “The patients were given either ketamine or haloperidol for agitation by paramedics who responded to medical emergencies, and the goal was to see which drug worked faster,” said Dr. Carome. “Patients were only notified afterwards that they had received a sedative. Informed consent had been waived by IRB.”

In the first clinical trial conducted by HCMC, published in 2016, the researchers had hypothesized that 5 mg/kg of intramuscular ketamine would be superior to 10 mg of intramuscular haloperidol for severe prehospital agitation. Time to adequate sedation was the primary outcome measure. The study included 146 people; 64 received ketamine and 82 received haloperidol. They found that ketamine worked far more quickly than haloperidol (5 minutes vs. 17 minutes) but that the risk for complications was much higher. Complications occurred in 49% of patients receiving ketamine, compared with 5%.

“There was a 10-fold risk of adverse events,” said Dr. Carome. “And 39% of patients given ketamine had respiratory problems requiring intubation, compared to 4% who received haloperidol.”

A second study was launched in 2017, wherein ketamine was compared with midazolam in agitated patients. During the first 6-month period of the study, individuals would receive a ketamine-based protocol for prehospital agitation, and during the second 6 months, that would switch to midazolam. However, the study was halted in June 2018 after the local newspaper, the Star Tribune, reported that the city police had encouraged medical personnel to sedate agitated patients. This included individuals who had already been physically restrained.

The report stated that “in many cases, the individual being detained or arrested was not only handcuffed but strapped down on a stretcher in an ambulance before receiving ketamine,” and that it raised a “concerning question” over why these people were given the drug before they were transported to the hospital, “given the immediate effects on breathing and heart function that the drug induces.”

Along with halting the trial, HCMC asked for a review of cases involving its paramedics; an independent investigation led by former U.S. Deputy Attorney General Sally Yates was initiated to assess whether the Minneapolis police had crossed a line and urged paramedics to use ketamine.

“The decision to use ketamine was based on the study’s timeline and not on clinical judgment,” said Dr. Carome.

The FDA acknowledged receipt of the complaint and inspected the IRB records and the clinical trial data. Preliminary reports received by Public Citizen confirmed their allegations. “There were not appropriate protections for vulnerable subjects,” he said. “In 2019, the FDA did further investigations, and those reports had similar findings.”
 

FDA letters

The FDA had sent warning letters to Dr. Cole and Dr. Klein, citing them for ignoring federal safety laws in experimental research on the public. In their investigations, the FDA cited “objectionable conditions” for the studies led by Dr. Cole and Dr. Klein, according to the letters. Both researchers seemingly ignored FDA regulations and used practices that subjected patients to “significantly increased risk,” and the hospital defended its research with “factually incorrect” statements.

In a letter to Dr. Cole, the FDA noted that he never filed INDs for the trials with the FDA, as required by law, and that he also failed to write appropriate protocols to ensure that children and pregnant women were not enrolled in the research. Individuals under the influence of intoxicants also were not excluded, though the use of ketamine is cautioned in this population.

“Administration of the investigational drugs to these subjects placed them at significantly increased risk of the adverse events associated with the investigational products and decreased the acceptability of those risks,” the FDA said in its letter. “Your failure to exclude, and the lack of any precautions for, subjects under the influence of various intoxicants significantly increased the risks and/or decreased the acceptability of the risks associated with the investigational drugs.”

However, Dr. Cole conducted both studies in the prehospital setting and failed to initiate any specific measures to protect study participants, according to the FDA.
 

Petition denied

Dr. Carome noted that the researchers had committed repetitive egregious regulatory violations over a 4-year period, which were documented by the FDA in their warning letters to Dr. Cole and Dr. Klein. “We felt that they were so egregious that we need to send a signal to the community that this sort of behavior will not be tolerated,” he said. “The FDA denied our petition, and we think that sends the wrong signal to the research community.”

In their response, the FDA noted that as with judicial enforcement, “the Agency makes decisions regarding whether to pursue administrative enforcement action, including disqualification proceedings, on a case-by-case basis, considering all relevant facts and circumstances.” They added that at this time, they would not be taking further action against Dr. Cole and Dr. Klein.

“However, we intend to continue to consider all the options available to the Agency as we determine whether to pursue additional compliance actions related to this matter,” the FDA concluded.

The FDA declined to comment further on their decision.

Dr. Cole also declined to comment, but Hennepin Healthcare told this news organization that the “decision by the FDA to deny the petition validates the changes we made to strengthen and improve the clinical research program across the institution since the closing of the studies in 2018. We look forward to continuing to work with the FDA to ensure full compliance with the standards in place to protect research subjects.”

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

The U.S. Food and Drug Administration has declined to take further action against a group of investigators at Hennepin County Medical Center/Hennepin Healthcare (HCMC) who conducted controversial studies involving ketamine and other sedatives on agitated persons without their consent.

A citizen petition filed by Public Citizen, a consumer advocacy group, had asked the FDA to initiate clinical-investigator disqualification proceedings against Jon Cole, MD, and Lauren Klein, MD, along with other researchers who participated in the studies, for “repeatedly and deliberately initiating and conducting clinical investigations of investigational drug products” without having submitted or having in effect the investigational new drug applications (INDs) required by the FDA.

In certain situations, wherein the FDA alleges that a clinical investigator has violated applicable regulations, the agency may initiate clinical investigator disqualification proceedings. The names of the disqualified researchers are then added to a federal database.

The petition, which was filed in November 2021, also requested that the FDA initiate disqualification proceedings against the institutional review board (IRB) at HCMC for repeatedly failing to comply with federal regulations that adversely affected the rights and welfare of the individuals who were enrolled in the study without their consent.

Of note, Public Citizen stated that the FDA should have required the hospital to contact the more than 1,700 patients who “were unwittingly enrolled in unethical experiments” and inform them that their rights had been violated and their health potentially endangered by the research team.

Michael A. Carome, MD, director of Public Citizen’s Health Research Group, told this news organization that it is uncommon for the FDA to disqualify researchers. “It should be more common than it is,” he said. “I think that FDA is just reluctant to take more action.”

The actions of the Hennepin investigators were “repetitive and appeared to be in deliberate violation of regulations,” he added. “The case for the FDA disqualifying the HCMC researchers is overwhelming. The FDA’s slap-on-the-wrist approach to such appalling regulatory and ethical violations risks emboldening other researchers to disregard the rights and welfare of human subjects.”

Carl Elliott, MD, PhD, a bioethicist at the University of Minnesota, Minneapolis, agrees that the researcher from HCMC should be disqualified. “They didn’t just conduct risky, exploitative studies – they conducted them after the FDA had warned them not to proceed,” he said. “The message sent by this slap on the wrist is that investigators can do whatever they want to nonconsenting subjects, and the FDA will look the other way.”
 

Initial complaint

Public Citizen initially filed a complaint with the FDA in 2018, after learning that researchers affiliated with HCMC were conducting high-risk clinical trials involving ketamine to control agitation outside of the hospital setting. The complaint was cosigned by 64 doctors, bioethicists, and academic researchers and was also submitted to the Office for Human Research Protections.

The FDA typically allows investigational drugs to be used in emergency situation without obtaining informed consent if the therapies are known to carry a minimal risk. The IRB at HCMC had determined that this was the case with ketamine and approved the trials.

But according to Public Citizen’s complaint, prior research had suggested that ketamine could cause more complications and severe adverse events, compared with other sedatives.

The trials were conducted between 2014 and 2018, and in its letter, Public Citizen alleged that the investigators and the IRB had allowed these trials to proceed without obtaining informed consent from patients. The goal was to evaluate how well ketamine worked, compared with other drugs in calming agitated individuals: “The patients were given either ketamine or haloperidol for agitation by paramedics who responded to medical emergencies, and the goal was to see which drug worked faster,” said Dr. Carome. “Patients were only notified afterwards that they had received a sedative. Informed consent had been waived by IRB.”

In the first clinical trial conducted by HCMC, published in 2016, the researchers had hypothesized that 5 mg/kg of intramuscular ketamine would be superior to 10 mg of intramuscular haloperidol for severe prehospital agitation. Time to adequate sedation was the primary outcome measure. The study included 146 people; 64 received ketamine and 82 received haloperidol. They found that ketamine worked far more quickly than haloperidol (5 minutes vs. 17 minutes) but that the risk for complications was much higher. Complications occurred in 49% of patients receiving ketamine, compared with 5%.

“There was a 10-fold risk of adverse events,” said Dr. Carome. “And 39% of patients given ketamine had respiratory problems requiring intubation, compared to 4% who received haloperidol.”

A second study was launched in 2017, wherein ketamine was compared with midazolam in agitated patients. During the first 6-month period of the study, individuals would receive a ketamine-based protocol for prehospital agitation, and during the second 6 months, that would switch to midazolam. However, the study was halted in June 2018 after the local newspaper, the Star Tribune, reported that the city police had encouraged medical personnel to sedate agitated patients. This included individuals who had already been physically restrained.

The report stated that “in many cases, the individual being detained or arrested was not only handcuffed but strapped down on a stretcher in an ambulance before receiving ketamine,” and that it raised a “concerning question” over why these people were given the drug before they were transported to the hospital, “given the immediate effects on breathing and heart function that the drug induces.”

Along with halting the trial, HCMC asked for a review of cases involving its paramedics; an independent investigation led by former U.S. Deputy Attorney General Sally Yates was initiated to assess whether the Minneapolis police had crossed a line and urged paramedics to use ketamine.

“The decision to use ketamine was based on the study’s timeline and not on clinical judgment,” said Dr. Carome.

The FDA acknowledged receipt of the complaint and inspected the IRB records and the clinical trial data. Preliminary reports received by Public Citizen confirmed their allegations. “There were not appropriate protections for vulnerable subjects,” he said. “In 2019, the FDA did further investigations, and those reports had similar findings.”
 

FDA letters

The FDA had sent warning letters to Dr. Cole and Dr. Klein, citing them for ignoring federal safety laws in experimental research on the public. In their investigations, the FDA cited “objectionable conditions” for the studies led by Dr. Cole and Dr. Klein, according to the letters. Both researchers seemingly ignored FDA regulations and used practices that subjected patients to “significantly increased risk,” and the hospital defended its research with “factually incorrect” statements.

In a letter to Dr. Cole, the FDA noted that he never filed INDs for the trials with the FDA, as required by law, and that he also failed to write appropriate protocols to ensure that children and pregnant women were not enrolled in the research. Individuals under the influence of intoxicants also were not excluded, though the use of ketamine is cautioned in this population.

“Administration of the investigational drugs to these subjects placed them at significantly increased risk of the adverse events associated with the investigational products and decreased the acceptability of those risks,” the FDA said in its letter. “Your failure to exclude, and the lack of any precautions for, subjects under the influence of various intoxicants significantly increased the risks and/or decreased the acceptability of the risks associated with the investigational drugs.”

However, Dr. Cole conducted both studies in the prehospital setting and failed to initiate any specific measures to protect study participants, according to the FDA.
 

Petition denied

Dr. Carome noted that the researchers had committed repetitive egregious regulatory violations over a 4-year period, which were documented by the FDA in their warning letters to Dr. Cole and Dr. Klein. “We felt that they were so egregious that we need to send a signal to the community that this sort of behavior will not be tolerated,” he said. “The FDA denied our petition, and we think that sends the wrong signal to the research community.”

In their response, the FDA noted that as with judicial enforcement, “the Agency makes decisions regarding whether to pursue administrative enforcement action, including disqualification proceedings, on a case-by-case basis, considering all relevant facts and circumstances.” They added that at this time, they would not be taking further action against Dr. Cole and Dr. Klein.

“However, we intend to continue to consider all the options available to the Agency as we determine whether to pursue additional compliance actions related to this matter,” the FDA concluded.

The FDA declined to comment further on their decision.

Dr. Cole also declined to comment, but Hennepin Healthcare told this news organization that the “decision by the FDA to deny the petition validates the changes we made to strengthen and improve the clinical research program across the institution since the closing of the studies in 2018. We look forward to continuing to work with the FDA to ensure full compliance with the standards in place to protect research subjects.”

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

From Medically Home Group, Boston, MA.

Brick-and-mortar hospitals in the United States have historically been considered the dominant setting for providing care to patients. The coordination and delivery of care has previously been bound to physical hospitals largely because multidisciplinary services were only accessible in an individual location. While the fundamental make-up of these services remains unchanged, these services are now available in alternate settings. Some of these services include access to a patient care team, supplies, diagnostics, pharmacy, and advanced therapeutic interventions. Presently, the physical environment is becoming increasingly irrelevant as the core of what makes the traditional hospital—the professional staff, collaborative work processes, and the dynamics of the space—have all been translated into a modern digitally integrated environment. The elements necessary to providing safe, effective care in a physical hospital setting are now available in a patient’s home.

Impetus for the Model

As hospitals reconsider how and where they deliver patient care because of limited resources, the hospital-at-home model has gained significant momentum and interest. This model transforms a home into a hospital. The inpatient acute care episode is entirely substituted with an intensive at-home hospital admission enabled by technology, multidisciplinary teams, and ancillary services. Furthermore, patients requiring post-acute support can be transitioned to their next phase of care seamlessly. Given the nationwide nursing shortage, aging population, challenges uncovered by the COVID-19 pandemic, rising hospital costs, nurse/provider burnout related to challenging work environments, and capacity constraints, a shift toward the combination of virtual and in-home care is imperative. The hospital-at-home model has been associated with superior patient outcomes, including reduced risks of delirium, improved functional status, improved patient and family member satisfaction, reduced mortality, reduced readmissions, and significantly lower costs.¹ COVID-19 alone has unmasked major facility-based deficiencies and limitations of our health care system. While the pandemic is not the impetus for the hospital-at-home model, the extended stress of this event has created a unique opportunity to reimagine and transform our health care delivery system so that it is less fragmented and more flexible.

Nursing in the Model

Nursing is central to the hospital-at-home model. Virtual nurses provide meticulous care plan oversight, assessment, and documentation across in-home service providers, to ensure holistic, safe, transparent, and continuous progression toward care plan milestones. The virtual nurse monitors patients using in-home technology that is set up at the time of admission. Connecting with patients to verify social and medical needs, the virtual nurse advocates for their patients and uses these technologies to care and deploy on-demand hands-on services to the patient. Service providers such as paramedics, infusion nurses, or home health nurses may be deployed to provide services in the patient’s home. By bringing in supplies, therapeutics, and interdisciplinary team members, the capabilities of a brick-and-mortar hospital are replicated in the home. All actions that occur wherever the patient is receiving care are overseen by professional nursing staff; in short, virtual nurses are the equivalent of bedside nurses in the brick-and-mortar health care facilities.

Potential Benefits

There are many benefits to the hospital-at-home model (Table). This health care model can be particularly helpful for patients who require frequent admission to acute care facilities, and is well suited for patients with a range of conditions, including those with COVID-19, pneumonia, cellulitis, or congestive heart failure. This care model helps eliminate some of the stressors for patients who have chronic illnesses or other conditions that require frequent hospital admissions. Patients can independently recover at home and can also be surrounded by their loved ones and pets while recovering. This care approach additionally eliminates the risk of hospital-acquired infections and injuries. The hospital-at-home model allows for increased mobility,² as patients are familiar with their surroundings, resulting in reduced onset of delirium. Additionally, patients with improved mobility performance are less likely to experience negative health outcomes.³ There is less chance of sleep disruption as the patient is sleeping in their own bed—no unfamiliar roommate, no call bells or health care personnel frequently coming into the room. The in-home technology set up for remote patient monitoring is designed with the user in mind. Ease of use empowers the patient to collaborate with their care team on their own terms and center the priorities of themselves and their families.

Positive Outcomes

The hospital-at-home model is associated with positive outcomes. The authors of a systematic review identified 10 randomized controlled trials of hospital-at-home programs (with a total of 1372 patients), but were able to obtain data for only 5 of these trials (with a total of 844 patients).⁴ They found a 38% reduction in 6-month mortality for patients who received hospital care at home, as well as significantly higher patient satisfaction across a range of medical conditions, including patients with cellulitis and community-acquired pneumonia, as well as elderly patients with multiple medical conditions. The authors concluded that hospital care at home was less expensive than admission to an acute care hospital.⁴ Similarly, a meta-analysis done by Caplan et al⁵ that included 61 randomized controlled trials concluded that hospital at home is associated with reductions in mortality, readmission rates, and cost, and increases in patient and caregiver satisfaction. Levine et al² found reduced costs and utilization with home hospitalization compared to in-hospital care, as well as improved patient mobility status.

The home is the ideal place to empower patients and caregivers to engage in self-management.² Receiving hospital care at home eliminates the need for dealing with transportation arrangements, traffic, road tolls, and time/scheduling constraints, or finding care for a dependent family member, some of the many stressors that may be experienced by patients who require frequent trips to the hospital. For patients who may not be clinically suitable candidates for hospital at home, such as those requiring critical care intervention and support, the brick-and-mortar hospital is still the appropriate site of care. The hospital-at-home model helps prevent bed shortages in brick-and-mortar hospital settings by allowing hospital care at home for patients who meet preset criteria. These patients can be hospitalized in alternative locations such as their own homes or the residence of a friend. This helps increase health system capacity as well as resiliency.

In addition to expanding safe and appropriate treatment spaces, the hospital-at-home model helps increase access to care for patients during nonstandard hours, including weekends, holidays, or when the waiting time in the emergency room is painfully long. Furthermore, providing care in the home gives the clinical team valuable insight into the patient’s daily life and routine. Performing medication reconciliation with the medicine cabinet in sight and dietary education in a patient’s kitchen are powerful touch points.² For example, a patient with congestive heart failure who must undergo diuresis is much more likely to meet their care goals when their home diet is aligned with the treatment goal. By being able to see exactly what is in a patient’s pantry and fridge, the care team can create a much more tailored approach to sodium intake and fluid management. Providers can create and execute true patient-centric care as they gain direct insight into the patient’s lifestyle, which is clearly valuable when creating care plans for complex chronic health issues.

Although there are clear benefits to hospital at home, how to best implement and scale this model presents a challenge. In addition to educating patients and families about this model of care, health care systems must expand their hospital-at-home programs and provide education about this model to clinical staff and trainees, and insurers must create reimbursement paradigms. Patients meeting eligibility criteria to enroll in hospital at home is the easiest hurdle, as hospital-at-home programs function best when they enroll and service as many patients as possible, including underserved populations.

Upfront Costs and Cost Savings

While there are upfront costs to set up technology and coordinate services, hospital at home also provides significant total cost savings when compared to coordination associated with brick-and-mortar admission. Hospital care accounts for about one-third of total medical expenditures and is a leading cause of debt.² Eliminating fixed hospital costs such as facility, overhead, and equipment costs through adoption of the hospital-at-home model can lead to a reduction in expenditures. It has been found that fewer laboratory and diagnostic tests are ordered for hospital-at-home patients when compared to similar patients in brick-and-mortar hospital settings, with comparable or better clinical patient outcomes.⁶ Furthermore, it is estimated that there are cost savings of 19% to 30% when compared to traditional inpatient care.⁶ Without legislative action, upon the end of the current COVID-19 public health emergency, the Centers for Medicare & Medicaid Service’s Acute Hospital Care at Home waiver will terminate. This could slow down scaling of the model.However, over the past 2 years there has been enough buy-in from major health systems and patients to continue the momentum of the model’s growth. When setting up a hospital-at-home program, it would be wise to consider a few factors: where in the hospital or health system entity structure the hospital-at-home program will reside, which existing resources can be leveraged within the hospital or health system, and what are the state or federal regulatory requirements for such a program. This type of program continues to fill gaps within the US health care system, meeting the needs of widely overlooked populations and increasing access to essential ancillary services.

Conclusion

It is time to consider our bias toward hospital-first options when managing the care needs of our patients. Health care providers have the option to advocate for holistic care, better experience, and better outcomes. Home-based options are safe, equitable, and patient-centric. Increased costs, consumerism, and technology have pushed us to think about alternative approaches to patient care delivery, and the pandemic created a unique opportunity to see just how far the health care system could stretch itself with capacity constraints, insufficient resources, and staff shortages. In light of new possibilities, it is time to reimagine and transform our health care delivery system so that it is unified, seamless, cohesive, and flexible.

Corresponding author: Payal Sharma, DNP, MSN, RN, FNP-BC, CBN; psharma@medicallyhome.com.

Disclosures: None reported.

From Medically Home Group, Boston, MA.

Brick-and-mortar hospitals in the United States have historically been considered the dominant setting for providing care to patients. The coordination and delivery of care has previously been bound to physical hospitals largely because multidisciplinary services were only accessible in an individual location. While the fundamental make-up of these services remains unchanged, these services are now available in alternate settings. Some of these services include access to a patient care team, supplies, diagnostics, pharmacy, and advanced therapeutic interventions. Presently, the physical environment is becoming increasingly irrelevant as the core of what makes the traditional hospital—the professional staff, collaborative work processes, and the dynamics of the space—have all been translated into a modern digitally integrated environment. The elements necessary to providing safe, effective care in a physical hospital setting are now available in a patient’s home.

Impetus for the Model

As hospitals reconsider how and where they deliver patient care because of limited resources, the hospital-at-home model has gained significant momentum and interest. This model transforms a home into a hospital. The inpatient acute care episode is entirely substituted with an intensive at-home hospital admission enabled by technology, multidisciplinary teams, and ancillary services. Furthermore, patients requiring post-acute support can be transitioned to their next phase of care seamlessly. Given the nationwide nursing shortage, aging population, challenges uncovered by the COVID-19 pandemic, rising hospital costs, nurse/provider burnout related to challenging work environments, and capacity constraints, a shift toward the combination of virtual and in-home care is imperative. The hospital-at-home model has been associated with superior patient outcomes, including reduced risks of delirium, improved functional status, improved patient and family member satisfaction, reduced mortality, reduced readmissions, and significantly lower costs.¹ COVID-19 alone has unmasked major facility-based deficiencies and limitations of our health care system. While the pandemic is not the impetus for the hospital-at-home model, the extended stress of this event has created a unique opportunity to reimagine and transform our health care delivery system so that it is less fragmented and more flexible.

Nursing in the Model

Nursing is central to the hospital-at-home model. Virtual nurses provide meticulous care plan oversight, assessment, and documentation across in-home service providers, to ensure holistic, safe, transparent, and continuous progression toward care plan milestones. The virtual nurse monitors patients using in-home technology that is set up at the time of admission. Connecting with patients to verify social and medical needs, the virtual nurse advocates for their patients and uses these technologies to care and deploy on-demand hands-on services to the patient. Service providers such as paramedics, infusion nurses, or home health nurses may be deployed to provide services in the patient’s home. By bringing in supplies, therapeutics, and interdisciplinary team members, the capabilities of a brick-and-mortar hospital are replicated in the home. All actions that occur wherever the patient is receiving care are overseen by professional nursing staff; in short, virtual nurses are the equivalent of bedside nurses in the brick-and-mortar health care facilities.

Potential Benefits

There are many benefits to the hospital-at-home model (Table). This health care model can be particularly helpful for patients who require frequent admission to acute care facilities, and is well suited for patients with a range of conditions, including those with COVID-19, pneumonia, cellulitis, or congestive heart failure. This care model helps eliminate some of the stressors for patients who have chronic illnesses or other conditions that require frequent hospital admissions. Patients can independently recover at home and can also be surrounded by their loved ones and pets while recovering. This care approach additionally eliminates the risk of hospital-acquired infections and injuries. The hospital-at-home model allows for increased mobility,² as patients are familiar with their surroundings, resulting in reduced onset of delirium. Additionally, patients with improved mobility performance are less likely to experience negative health outcomes.³ There is less chance of sleep disruption as the patient is sleeping in their own bed—no unfamiliar roommate, no call bells or health care personnel frequently coming into the room. The in-home technology set up for remote patient monitoring is designed with the user in mind. Ease of use empowers the patient to collaborate with their care team on their own terms and center the priorities of themselves and their families.

Positive Outcomes

The hospital-at-home model is associated with positive outcomes. The authors of a systematic review identified 10 randomized controlled trials of hospital-at-home programs (with a total of 1372 patients), but were able to obtain data for only 5 of these trials (with a total of 844 patients).⁴ They found a 38% reduction in 6-month mortality for patients who received hospital care at home, as well as significantly higher patient satisfaction across a range of medical conditions, including patients with cellulitis and community-acquired pneumonia, as well as elderly patients with multiple medical conditions. The authors concluded that hospital care at home was less expensive than admission to an acute care hospital.⁴ Similarly, a meta-analysis done by Caplan et al⁵ that included 61 randomized controlled trials concluded that hospital at home is associated with reductions in mortality, readmission rates, and cost, and increases in patient and caregiver satisfaction. Levine et al² found reduced costs and utilization with home hospitalization compared to in-hospital care, as well as improved patient mobility status.

The home is the ideal place to empower patients and caregivers to engage in self-management.² Receiving hospital care at home eliminates the need for dealing with transportation arrangements, traffic, road tolls, and time/scheduling constraints, or finding care for a dependent family member, some of the many stressors that may be experienced by patients who require frequent trips to the hospital. For patients who may not be clinically suitable candidates for hospital at home, such as those requiring critical care intervention and support, the brick-and-mortar hospital is still the appropriate site of care. The hospital-at-home model helps prevent bed shortages in brick-and-mortar hospital settings by allowing hospital care at home for patients who meet preset criteria. These patients can be hospitalized in alternative locations such as their own homes or the residence of a friend. This helps increase health system capacity as well as resiliency.

In addition to expanding safe and appropriate treatment spaces, the hospital-at-home model helps increase access to care for patients during nonstandard hours, including weekends, holidays, or when the waiting time in the emergency room is painfully long. Furthermore, providing care in the home gives the clinical team valuable insight into the patient’s daily life and routine. Performing medication reconciliation with the medicine cabinet in sight and dietary education in a patient’s kitchen are powerful touch points.² For example, a patient with congestive heart failure who must undergo diuresis is much more likely to meet their care goals when their home diet is aligned with the treatment goal. By being able to see exactly what is in a patient’s pantry and fridge, the care team can create a much more tailored approach to sodium intake and fluid management. Providers can create and execute true patient-centric care as they gain direct insight into the patient’s lifestyle, which is clearly valuable when creating care plans for complex chronic health issues.

Although there are clear benefits to hospital at home, how to best implement and scale this model presents a challenge. In addition to educating patients and families about this model of care, health care systems must expand their hospital-at-home programs and provide education about this model to clinical staff and trainees, and insurers must create reimbursement paradigms. Patients meeting eligibility criteria to enroll in hospital at home is the easiest hurdle, as hospital-at-home programs function best when they enroll and service as many patients as possible, including underserved populations.

Upfront Costs and Cost Savings

While there are upfront costs to set up technology and coordinate services, hospital at home also provides significant total cost savings when compared to coordination associated with brick-and-mortar admission. Hospital care accounts for about one-third of total medical expenditures and is a leading cause of debt.² Eliminating fixed hospital costs such as facility, overhead, and equipment costs through adoption of the hospital-at-home model can lead to a reduction in expenditures. It has been found that fewer laboratory and diagnostic tests are ordered for hospital-at-home patients when compared to similar patients in brick-and-mortar hospital settings, with comparable or better clinical patient outcomes.⁶ Furthermore, it is estimated that there are cost savings of 19% to 30% when compared to traditional inpatient care.⁶ Without legislative action, upon the end of the current COVID-19 public health emergency, the Centers for Medicare & Medicaid Service’s Acute Hospital Care at Home waiver will terminate. This could slow down scaling of the model.However, over the past 2 years there has been enough buy-in from major health systems and patients to continue the momentum of the model’s growth. When setting up a hospital-at-home program, it would be wise to consider a few factors: where in the hospital or health system entity structure the hospital-at-home program will reside, which existing resources can be leveraged within the hospital or health system, and what are the state or federal regulatory requirements for such a program. This type of program continues to fill gaps within the US health care system, meeting the needs of widely overlooked populations and increasing access to essential ancillary services.

Conclusion

It is time to consider our bias toward hospital-first options when managing the care needs of our patients. Health care providers have the option to advocate for holistic care, better experience, and better outcomes. Home-based options are safe, equitable, and patient-centric. Increased costs, consumerism, and technology have pushed us to think about alternative approaches to patient care delivery, and the pandemic created a unique opportunity to see just how far the health care system could stretch itself with capacity constraints, insufficient resources, and staff shortages. In light of new possibilities, it is time to reimagine and transform our health care delivery system so that it is unified, seamless, cohesive, and flexible.

Corresponding author: Payal Sharma, DNP, MSN, RN, FNP-BC, CBN; psharma@medicallyhome.com.

Disclosures: None reported.

From Medically Home Group, Boston, MA.

Brick-and-mortar hospitals in the United States have historically been considered the dominant setting for providing care to patients. The coordination and delivery of care has previously been bound to physical hospitals largely because multidisciplinary services were only accessible in an individual location. While the fundamental make-up of these services remains unchanged, these services are now available in alternate settings. Some of these services include access to a patient care team, supplies, diagnostics, pharmacy, and advanced therapeutic interventions. Presently, the physical environment is becoming increasingly irrelevant as the core of what makes the traditional hospital—the professional staff, collaborative work processes, and the dynamics of the space—have all been translated into a modern digitally integrated environment. The elements necessary to providing safe, effective care in a physical hospital setting are now available in a patient’s home.

Impetus for the Model

As hospitals reconsider how and where they deliver patient care because of limited resources, the hospital-at-home model has gained significant momentum and interest. This model transforms a home into a hospital. The inpatient acute care episode is entirely substituted with an intensive at-home hospital admission enabled by technology, multidisciplinary teams, and ancillary services. Furthermore, patients requiring post-acute support can be transitioned to their next phase of care seamlessly. Given the nationwide nursing shortage, aging population, challenges uncovered by the COVID-19 pandemic, rising hospital costs, nurse/provider burnout related to challenging work environments, and capacity constraints, a shift toward the combination of virtual and in-home care is imperative. The hospital-at-home model has been associated with superior patient outcomes, including reduced risks of delirium, improved functional status, improved patient and family member satisfaction, reduced mortality, reduced readmissions, and significantly lower costs.¹ COVID-19 alone has unmasked major facility-based deficiencies and limitations of our health care system. While the pandemic is not the impetus for the hospital-at-home model, the extended stress of this event has created a unique opportunity to reimagine and transform our health care delivery system so that it is less fragmented and more flexible.

Nursing in the Model

Nursing is central to the hospital-at-home model. Virtual nurses provide meticulous care plan oversight, assessment, and documentation across in-home service providers, to ensure holistic, safe, transparent, and continuous progression toward care plan milestones. The virtual nurse monitors patients using in-home technology that is set up at the time of admission. Connecting with patients to verify social and medical needs, the virtual nurse advocates for their patients and uses these technologies to care and deploy on-demand hands-on services to the patient. Service providers such as paramedics, infusion nurses, or home health nurses may be deployed to provide services in the patient’s home. By bringing in supplies, therapeutics, and interdisciplinary team members, the capabilities of a brick-and-mortar hospital are replicated in the home. All actions that occur wherever the patient is receiving care are overseen by professional nursing staff; in short, virtual nurses are the equivalent of bedside nurses in the brick-and-mortar health care facilities.

Potential Benefits

There are many benefits to the hospital-at-home model (Table). This health care model can be particularly helpful for patients who require frequent admission to acute care facilities, and is well suited for patients with a range of conditions, including those with COVID-19, pneumonia, cellulitis, or congestive heart failure. This care model helps eliminate some of the stressors for patients who have chronic illnesses or other conditions that require frequent hospital admissions. Patients can independently recover at home and can also be surrounded by their loved ones and pets while recovering. This care approach additionally eliminates the risk of hospital-acquired infections and injuries. The hospital-at-home model allows for increased mobility,² as patients are familiar with their surroundings, resulting in reduced onset of delirium. Additionally, patients with improved mobility performance are less likely to experience negative health outcomes.³ There is less chance of sleep disruption as the patient is sleeping in their own bed—no unfamiliar roommate, no call bells or health care personnel frequently coming into the room. The in-home technology set up for remote patient monitoring is designed with the user in mind. Ease of use empowers the patient to collaborate with their care team on their own terms and center the priorities of themselves and their families.

Positive Outcomes

The hospital-at-home model is associated with positive outcomes. The authors of a systematic review identified 10 randomized controlled trials of hospital-at-home programs (with a total of 1372 patients), but were able to obtain data for only 5 of these trials (with a total of 844 patients).⁴ They found a 38% reduction in 6-month mortality for patients who received hospital care at home, as well as significantly higher patient satisfaction across a range of medical conditions, including patients with cellulitis and community-acquired pneumonia, as well as elderly patients with multiple medical conditions. The authors concluded that hospital care at home was less expensive than admission to an acute care hospital.⁴ Similarly, a meta-analysis done by Caplan et al⁵ that included 61 randomized controlled trials concluded that hospital at home is associated with reductions in mortality, readmission rates, and cost, and increases in patient and caregiver satisfaction. Levine et al² found reduced costs and utilization with home hospitalization compared to in-hospital care, as well as improved patient mobility status.

The home is the ideal place to empower patients and caregivers to engage in self-management.² Receiving hospital care at home eliminates the need for dealing with transportation arrangements, traffic, road tolls, and time/scheduling constraints, or finding care for a dependent family member, some of the many stressors that may be experienced by patients who require frequent trips to the hospital. For patients who may not be clinically suitable candidates for hospital at home, such as those requiring critical care intervention and support, the brick-and-mortar hospital is still the appropriate site of care. The hospital-at-home model helps prevent bed shortages in brick-and-mortar hospital settings by allowing hospital care at home for patients who meet preset criteria. These patients can be hospitalized in alternative locations such as their own homes or the residence of a friend. This helps increase health system capacity as well as resiliency.

In addition to expanding safe and appropriate treatment spaces, the hospital-at-home model helps increase access to care for patients during nonstandard hours, including weekends, holidays, or when the waiting time in the emergency room is painfully long. Furthermore, providing care in the home gives the clinical team valuable insight into the patient’s daily life and routine. Performing medication reconciliation with the medicine cabinet in sight and dietary education in a patient’s kitchen are powerful touch points.² For example, a patient with congestive heart failure who must undergo diuresis is much more likely to meet their care goals when their home diet is aligned with the treatment goal. By being able to see exactly what is in a patient’s pantry and fridge, the care team can create a much more tailored approach to sodium intake and fluid management. Providers can create and execute true patient-centric care as they gain direct insight into the patient’s lifestyle, which is clearly valuable when creating care plans for complex chronic health issues.

Although there are clear benefits to hospital at home, how to best implement and scale this model presents a challenge. In addition to educating patients and families about this model of care, health care systems must expand their hospital-at-home programs and provide education about this model to clinical staff and trainees, and insurers must create reimbursement paradigms. Patients meeting eligibility criteria to enroll in hospital at home is the easiest hurdle, as hospital-at-home programs function best when they enroll and service as many patients as possible, including underserved populations.

Upfront Costs and Cost Savings

While there are upfront costs to set up technology and coordinate services, hospital at home also provides significant total cost savings when compared to coordination associated with brick-and-mortar admission. Hospital care accounts for about one-third of total medical expenditures and is a leading cause of debt.² Eliminating fixed hospital costs such as facility, overhead, and equipment costs through adoption of the hospital-at-home model can lead to a reduction in expenditures. It has been found that fewer laboratory and diagnostic tests are ordered for hospital-at-home patients when compared to similar patients in brick-and-mortar hospital settings, with comparable or better clinical patient outcomes.⁶ Furthermore, it is estimated that there are cost savings of 19% to 30% when compared to traditional inpatient care.⁶ Without legislative action, upon the end of the current COVID-19 public health emergency, the Centers for Medicare & Medicaid Service’s Acute Hospital Care at Home waiver will terminate. This could slow down scaling of the model.However, over the past 2 years there has been enough buy-in from major health systems and patients to continue the momentum of the model’s growth. When setting up a hospital-at-home program, it would be wise to consider a few factors: where in the hospital or health system entity structure the hospital-at-home program will reside, which existing resources can be leveraged within the hospital or health system, and what are the state or federal regulatory requirements for such a program. This type of program continues to fill gaps within the US health care system, meeting the needs of widely overlooked populations and increasing access to essential ancillary services.

Conclusion

It is time to consider our bias toward hospital-first options when managing the care needs of our patients. Health care providers have the option to advocate for holistic care, better experience, and better outcomes. Home-based options are safe, equitable, and patient-centric. Increased costs, consumerism, and technology have pushed us to think about alternative approaches to patient care delivery, and the pandemic created a unique opportunity to see just how far the health care system could stretch itself with capacity constraints, insufficient resources, and staff shortages. In light of new possibilities, it is time to reimagine and transform our health care delivery system so that it is unified, seamless, cohesive, and flexible.

Corresponding author: Payal Sharma, DNP, MSN, RN, FNP-BC, CBN; psharma@medicallyhome.com.

Disclosures: None reported.

The Institute of Medicine brought much-needed attention to the need for process improvement in medicine with its seminal report To Err Is Human: Building a Safer Health System, which was issued in 1999, leading to the quality movement’s call to close health care performance gaps in Crossing the Quality Chasm: A New Health System for the 21st Century.^1,2 Quality improvement science in medicine has evolved over the past 2 decades to include a broad spectrum of approaches, from agile improvement to continuous learning and improvement. Current efforts focus on Lean-based process improvement along with a reduction in variation in clinical practice to align practice with the principles of evidence-based medicine in a patient-centered approach.³ Further, the definition of quality improvement under the Affordable Care Act was framed as an equitable, timely, value-based, patient-centered approach to achieving population-level health goals.⁴ Thus, the science of quality improvement drives the core principles of care delivery improvement, and the rigorous evidence needed to expand innovation is embedded within the same framework.^5,6 In clinical practice, quality improvement projects aim to define gaps and then specific steps are undertaken to improve the evidence-based practice of a specific process. The overarching goal is to enhance the efficacy of the practice by reducing waste within a particular domain. Thus, quality improvement and implementation research eventually unify how clinical practice is advanced concurrently to bridge identified gaps.⁷

System redesign through a patient-centered framework forms the core of an overarching strategy to support system-level processes. Both require a deep understanding of the fields of quality improvement science and implementation science.⁸ Furthermore, aligning clinical research needs, system aims, patients’ values, and clinical care give the new design a clear path forward. Patient-centered improvement includes the essential elements of system redesign around human factors, including communication, physical resources, and updated information during episodes of care. The patient-centered improvement design is juxtaposed with care planning and establishing continuum of care processes.⁹ It is essential to note that safety is rooted within the quality domain as a top priority in medicine.¹⁰ The best implementation methods and approaches are discussed and debated, and the improvement progress continues on multiple fronts.¹¹ Patient safety systems are implemented simultaneously during the redesign phase. Moreover, identifying and testing the health care delivery methods in the era of competing strategic priorities to achieve the desirable clinical outcomes highlights the importance of implementation, while contemplating the methods of dissemination, scalability, and sustainability of the best evidence-based clinical practice.

The cycle of quality improvement research completes the system implementation efforts. The conceptual framework of quality improvement includes multiple areas of care and transition, along with applying the best clinical practices in a culture that emphasizes continuous improvement and learning. At the same time, the operating principles should include continuous improvement in a simple and continuous system of learning as a core concept. Our proposed implementation approach involves taking simple and practical steps while separating the process from the outcomes measures, extracting effectiveness throughout the process. It is essential to keep in mind that building a proactive and systematic improvement environment requires a framework for safety, reliability, and effective care, as well as the alignment of the physical system, communication, and professional environment and culture (Figure).

In summary, system design for quality improvement research should incorporate the principles and conceptual framework that embody effective implementation strategies, with a focus on operational and practical steps. Continuous improvement will be reached through the multidimensional development of current health care system metrics and the incorporation of implementation science methods.

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine, Brigham and Women’s Hospital, Boston, MA; ebarkoudah@bwh.harvard.edu

Disclosures: None reported.

The Institute of Medicine brought much-needed attention to the need for process improvement in medicine with its seminal report To Err Is Human: Building a Safer Health System, which was issued in 1999, leading to the quality movement’s call to close health care performance gaps in Crossing the Quality Chasm: A New Health System for the 21st Century.^1,2 Quality improvement science in medicine has evolved over the past 2 decades to include a broad spectrum of approaches, from agile improvement to continuous learning and improvement. Current efforts focus on Lean-based process improvement along with a reduction in variation in clinical practice to align practice with the principles of evidence-based medicine in a patient-centered approach.³ Further, the definition of quality improvement under the Affordable Care Act was framed as an equitable, timely, value-based, patient-centered approach to achieving population-level health goals.⁴ Thus, the science of quality improvement drives the core principles of care delivery improvement, and the rigorous evidence needed to expand innovation is embedded within the same framework.^5,6 In clinical practice, quality improvement projects aim to define gaps and then specific steps are undertaken to improve the evidence-based practice of a specific process. The overarching goal is to enhance the efficacy of the practice by reducing waste within a particular domain. Thus, quality improvement and implementation research eventually unify how clinical practice is advanced concurrently to bridge identified gaps.⁷

System redesign through a patient-centered framework forms the core of an overarching strategy to support system-level processes. Both require a deep understanding of the fields of quality improvement science and implementation science.⁸ Furthermore, aligning clinical research needs, system aims, patients’ values, and clinical care give the new design a clear path forward. Patient-centered improvement includes the essential elements of system redesign around human factors, including communication, physical resources, and updated information during episodes of care. The patient-centered improvement design is juxtaposed with care planning and establishing continuum of care processes.⁹ It is essential to note that safety is rooted within the quality domain as a top priority in medicine.¹⁰ The best implementation methods and approaches are discussed and debated, and the improvement progress continues on multiple fronts.¹¹ Patient safety systems are implemented simultaneously during the redesign phase. Moreover, identifying and testing the health care delivery methods in the era of competing strategic priorities to achieve the desirable clinical outcomes highlights the importance of implementation, while contemplating the methods of dissemination, scalability, and sustainability of the best evidence-based clinical practice.

The cycle of quality improvement research completes the system implementation efforts. The conceptual framework of quality improvement includes multiple areas of care and transition, along with applying the best clinical practices in a culture that emphasizes continuous improvement and learning. At the same time, the operating principles should include continuous improvement in a simple and continuous system of learning as a core concept. Our proposed implementation approach involves taking simple and practical steps while separating the process from the outcomes measures, extracting effectiveness throughout the process. It is essential to keep in mind that building a proactive and systematic improvement environment requires a framework for safety, reliability, and effective care, as well as the alignment of the physical system, communication, and professional environment and culture (Figure).

In summary, system design for quality improvement research should incorporate the principles and conceptual framework that embody effective implementation strategies, with a focus on operational and practical steps. Continuous improvement will be reached through the multidimensional development of current health care system metrics and the incorporation of implementation science methods.

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine, Brigham and Women’s Hospital, Boston, MA; ebarkoudah@bwh.harvard.edu

Disclosures: None reported.

The Institute of Medicine brought much-needed attention to the need for process improvement in medicine with its seminal report To Err Is Human: Building a Safer Health System, which was issued in 1999, leading to the quality movement’s call to close health care performance gaps in Crossing the Quality Chasm: A New Health System for the 21st Century.^1,2 Quality improvement science in medicine has evolved over the past 2 decades to include a broad spectrum of approaches, from agile improvement to continuous learning and improvement. Current efforts focus on Lean-based process improvement along with a reduction in variation in clinical practice to align practice with the principles of evidence-based medicine in a patient-centered approach.³ Further, the definition of quality improvement under the Affordable Care Act was framed as an equitable, timely, value-based, patient-centered approach to achieving population-level health goals.⁴ Thus, the science of quality improvement drives the core principles of care delivery improvement, and the rigorous evidence needed to expand innovation is embedded within the same framework.^5,6 In clinical practice, quality improvement projects aim to define gaps and then specific steps are undertaken to improve the evidence-based practice of a specific process. The overarching goal is to enhance the efficacy of the practice by reducing waste within a particular domain. Thus, quality improvement and implementation research eventually unify how clinical practice is advanced concurrently to bridge identified gaps.⁷

System redesign through a patient-centered framework forms the core of an overarching strategy to support system-level processes. Both require a deep understanding of the fields of quality improvement science and implementation science.⁸ Furthermore, aligning clinical research needs, system aims, patients’ values, and clinical care give the new design a clear path forward. Patient-centered improvement includes the essential elements of system redesign around human factors, including communication, physical resources, and updated information during episodes of care. The patient-centered improvement design is juxtaposed with care planning and establishing continuum of care processes.⁹ It is essential to note that safety is rooted within the quality domain as a top priority in medicine.¹⁰ The best implementation methods and approaches are discussed and debated, and the improvement progress continues on multiple fronts.¹¹ Patient safety systems are implemented simultaneously during the redesign phase. Moreover, identifying and testing the health care delivery methods in the era of competing strategic priorities to achieve the desirable clinical outcomes highlights the importance of implementation, while contemplating the methods of dissemination, scalability, and sustainability of the best evidence-based clinical practice.

The cycle of quality improvement research completes the system implementation efforts. The conceptual framework of quality improvement includes multiple areas of care and transition, along with applying the best clinical practices in a culture that emphasizes continuous improvement and learning. At the same time, the operating principles should include continuous improvement in a simple and continuous system of learning as a core concept. Our proposed implementation approach involves taking simple and practical steps while separating the process from the outcomes measures, extracting effectiveness throughout the process. It is essential to keep in mind that building a proactive and systematic improvement environment requires a framework for safety, reliability, and effective care, as well as the alignment of the physical system, communication, and professional environment and culture (Figure).

In summary, system design for quality improvement research should incorporate the principles and conceptual framework that embody effective implementation strategies, with a focus on operational and practical steps. Continuous improvement will be reached through the multidimensional development of current health care system metrics and the incorporation of implementation science methods.

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine, Brigham and Women’s Hospital, Boston, MA; ebarkoudah@bwh.harvard.edu

Disclosures: None reported.

Study 1 Overview (Bhasin et al)

Objective: To examine the effect of a multifactorial intervention for fall prevention on fall injury in community-dwelling older adults.

Design: This was a pragmatic, cluster randomized trial conducted in 86 primary care practices across 10 health care systems.

Setting and participants: The primary care sites were selected based on the prespecified criteria of size, ability to implement the intervention, proximity to other practices, accessibility to electronic health records, and access to community-based exercise programs. The primary care practices were randomly assigned to intervention or control.

Eligibility criteria for participants at those practices included age 70 years or older, dwelling in the community, and having an increased risk of falls, as determined by a history of fall-related injury in the past year, 2 or more falls in the past year, or being afraid of falling because of problems with balance or walking. Exclusion criteria were inability to provide consent or lack of proxy consent for participants who were determined to have cognitive impairment based on screening, and inability to speak English or Spanish. A total of 2802 participants were enrolled in the intervention group, and 2649 participants were enrolled in the control group.

Intervention: The intervention contained 5 components: a standardized assessment of 7 modifiable risk factors for fall injuries; standardized protocol-driven recommendations for management of risk factors; an individualized care plan focused on 1 to 3 risk factors; implementation of care plans, including referrals to community-based programs; and follow-up care conducted by telephone or in person. The modifiable risk factors included impairment of strength, gait, or balance; use of medications related to falls; postural hypotension; problems with feet or footwear; visual impairment; osteoporosis or vitamin D deficiency; and home safety hazards. The intervention was delivered by nurses who had completed online training modules and face-to-face training sessions focused on the intervention and motivational interviewing along with continuing education, in partnership with participants and their primary care providers. In the control group, participants received enhanced usual care, including an informational pamphlet, and were encouraged to discuss fall prevention with their primary care provider, including the results of their screening evaluation.

Main outcome measures: The primary outcome of the study was the first serious fall injury in a time-to-event analysis, defined as a fall resulting in a fracture (other than thoracic or lumbar vertebral fracture), joint dislocation, cut requiring closure, head injury requiring hospitalization, sprain or strain, bruising or swelling, or other serious injury. The secondary outcome was first patient-reported fall injury, also in a time-to-event analysis, ascertained by telephone interviews conducted every 4 months. Other outcomes included hospital admissions, emergency department visits, and other health care utilization. Adjudication of fall events and injuries was conducted by a team blinded to treatment assignment and verified using administrative claims data, encounter data, or electronic health record review.

Main results: The intervention and control groups were similar in terms of sex and age: 62.5% vs 61.5% of participants were women, and mean (SD) age was 79.9 (5.7) years and 79.5 (5.8) years, respectively. Other demographic characteristics were similar between groups. For the primary outcome, the rate of first serious injury was 4.9 per 100 person-years in the intervention group and 5.3 per 100 person-years in the control group, with a hazard ratio of 0.92 (95% CI, 0.80-1.06; P = .25). For the secondary outcome of patient-reported fall injury, there were 25.6 events per 100 person-years in the intervention group and 28.6 in the control group, with a hazard ratio of 0.90 (95% CI, 0.83-0.99; P =0.004). Rates of hospitalization and other secondary outcomes were similar between groups.

Conclusion: The multifactorial STRIDE intervention did not reduce the rate of serious fall injury when compared to enhanced usual care. The intervention did result in lower rates of fall injury by patient report, but no other significant outcomes were seen.

Study 2 Overview (Stark et al)

Objective: To examine the effect of a behavioral home hazard removal intervention for fall prevention on risk of fall in community-dwelling older adults.

Design: This randomized clinical trial was conducted at a single site in St. Louis, Missouri. Participants were community-dwelling older adults who received services from the Area Agency on Aging (AAA). Inclusion criteria included age 65 years and older, having 1 or more falls in the previous 12 months or being worried about falling by self report, and currently receiving services from an AAA. Exclusion criteria included living in an institution or being severely cognitively impaired and unable to follow directions or report falls. Participants who met the criteria were contacted by phone and invited to participate. A total of 310 participants were enrolled in the study, with an equal number of participants assigned to the intervention and control groups.

Intervention: The intervention included hazard identification and removal after a comprehensive assessment of participants, their behaviors, and the environment; this assessment took place during the first visit, which lasted approximately 80 minutes. A home hazard removal plan was developed, and in the second session, which lasted approximately 40 minutes, remediation of hazards was carried out. A third session for home modification that lasted approximately 30 minutes was conducted, if needed. At 6 months after the intervention, a booster session to identify and remediate any new home hazards and address issues was conducted. Specific interventions, as identified by the assessment, included minor home repair such as grab bars, adaptive equipment, task modification, and education. Shared decision making that enabled older adults to control changes in their homes, self-management strategies to improve awareness, and motivational enhancement strategies to improve acceptance were employed. Scripted algorithms and checklists were used to deliver the intervention. For usual care, an annual assessment and referrals to community services, if needed, were conducted in the AAA.

Main outcome measures: The primary outcome of the study was the number of days to first fall in 12 months. Falls were defined as unintentional movements to the floor, ground, or object below knee level, and falls were recorded through a daily journal for 12 months. Participants were contacted by phone if they did not return the journal or reported a fall. Participants were interviewed to verify falls and determine whether a fall was injurious. Secondary outcomes included rate of falls per person per 12 months; daily activity performance measured using the Older Americans Resources and Services Activities of Daily Living scale; falls self-efficacy, which measures confidence performing daily activities without falling; and quality of life using the SF-36 at 12 months.

Main results: Most of the study participants were women (74%), and mean (SD) age was 75 (7.4) years. Study retention was similar between the intervention and control groups, with 82% completing the study in the intervention group compared with 81% in the control group. Fidelity to the intervention, as measured by a checklist by the interventionist, was 99%, and adherence to home modification, as measured by number of home modifications in use by self report, was high at 92% at 6 months and 91% at 12 months. For the primary outcome, fall hazard was not different between the intervention and control groups (hazard ratio, 0.9; 95% CI, 0.66-1.27). For the secondary outcomes, the rate of falling was lower in the intervention group compared with the control group, with a relative risk of 0.62 (95% CI, 0.40-0.95). There was no difference in other secondary outcomes of daily activity performance, falls self-efficacy, or quality of life.

Conclusion: Despite high adherence to home modifications and fidelity to the intervention, this home hazard removal program did not reduce the risk of falling when compared to usual care. It did reduce the rate of falls, although no other effects were observed.

Commentary

Observational studies have identified factors that contribute to falls,¹ and over the past 30 years a number of intervention trials designed to reduce the risk of falling have been conducted. A recent Cochrane review, published prior to the Bhasin et al and Stark et al trials, looked at the effect of multifactorial interventions for fall prevention across 62 trials that included 19,935 older adults living in the community. The review concluded that multifactorial interventions may reduce the rate of falls, but this conclusion was based on low-quality evidence and there was significant heterogeneity across the studies.²

The STRIDE randomized trial represents the latest effort to address the evidence gap around fall prevention, with the STRIDE investigators hoping this would be the definitive trial that leads to practice change in fall prevention. Smaller trials that have demonstrated effectiveness were brought to scale in this large randomized trial that included 86 practices and more than 5000 participants. The investigators used risk of injurious falls as the primary outcome, as this outcome is considered the most clinically meaningful for the study population. The results, however, were disappointing: the multifactorial intervention in STRIDE did not result in a reduction of risk of injurious falls. Challenges in the implementation of this large trial may have contributed to its results; falls care managers, key to this multifactorial intervention, reported difficulties in navigating complex relationships with patients, families, study staff, and primary care practices during the study. Barriers reported included clinical space limitations, variable buy-in from providers, and turnover of practice staff and providers.³ Such implementation factors may have resulted in the divergent results between smaller clinical trials and this large-scale trial conducted across multiple settings.

The second study, by Stark et al, examined a home modification program and its effect on risk of falls. A prior Cochrane review examining the effect of home safety assessment and modification indicates that these strategies are effective in reducing the rate of falls as well as the risk of falling.⁴ The results of the current trial showed a reduction in the rate of falls but not in the risk of falling; however, this study did not examine outcomes of serious injurious falls, which may be more clinically meaningful. The Stark et al study adds to the existing literature showing that home modification may have an impact on fall rates. One noteworthy aspect of the Stark et al trial is the high adherence rate to home modification in a community-based approach; perhaps the investigators’ approach can be translated to real-world use.

Applications for Clinical Practice and System Implementation

The role of exercise programs in reducing fall rates is well established,⁵ but neither of these studies focused on exercise interventions. STRIDE offered community-based exercise program referral, but there is variability in such programs and study staff reported challenges in matching participants with appropriate exercise programs.³ Further studies that examine combinations of multifactorial falls risk reduction, exercise, and home safety, with careful consideration of implementation challenges to assure fidelity and adherence to the intervention, are needed to ascertain the best strategy for fall prevention for older adults at risk.

Given the results of these trials, it is difficult to recommend one falls prevention intervention over another. Clinicians should continue to identify falls risk factors using standardized assessments and determine which factors are modifiable.

Practice Points

• Incorporating assessments of falls risk in primary care is feasible, and such assessments can identify important risk factors.
• Clinicians and health systems should identify avenues, such as developing programmatic approaches, to providing home safety assessment and intervention, exercise options, medication review, and modification of other risk factors.
• Ensuring delivery of these elements reliably through programmatic approaches with adequate follow-up is key to preventing falls in this population.

—William W. Hung, MD, MPH

Study 1 Overview (Bhasin et al)

Objective: To examine the effect of a multifactorial intervention for fall prevention on fall injury in community-dwelling older adults.

Design: This was a pragmatic, cluster randomized trial conducted in 86 primary care practices across 10 health care systems.

Setting and participants: The primary care sites were selected based on the prespecified criteria of size, ability to implement the intervention, proximity to other practices, accessibility to electronic health records, and access to community-based exercise programs. The primary care practices were randomly assigned to intervention or control.

Eligibility criteria for participants at those practices included age 70 years or older, dwelling in the community, and having an increased risk of falls, as determined by a history of fall-related injury in the past year, 2 or more falls in the past year, or being afraid of falling because of problems with balance or walking. Exclusion criteria were inability to provide consent or lack of proxy consent for participants who were determined to have cognitive impairment based on screening, and inability to speak English or Spanish. A total of 2802 participants were enrolled in the intervention group, and 2649 participants were enrolled in the control group.

Intervention: The intervention contained 5 components: a standardized assessment of 7 modifiable risk factors for fall injuries; standardized protocol-driven recommendations for management of risk factors; an individualized care plan focused on 1 to 3 risk factors; implementation of care plans, including referrals to community-based programs; and follow-up care conducted by telephone or in person. The modifiable risk factors included impairment of strength, gait, or balance; use of medications related to falls; postural hypotension; problems with feet or footwear; visual impairment; osteoporosis or vitamin D deficiency; and home safety hazards. The intervention was delivered by nurses who had completed online training modules and face-to-face training sessions focused on the intervention and motivational interviewing along with continuing education, in partnership with participants and their primary care providers. In the control group, participants received enhanced usual care, including an informational pamphlet, and were encouraged to discuss fall prevention with their primary care provider, including the results of their screening evaluation.

Main outcome measures: The primary outcome of the study was the first serious fall injury in a time-to-event analysis, defined as a fall resulting in a fracture (other than thoracic or lumbar vertebral fracture), joint dislocation, cut requiring closure, head injury requiring hospitalization, sprain or strain, bruising or swelling, or other serious injury. The secondary outcome was first patient-reported fall injury, also in a time-to-event analysis, ascertained by telephone interviews conducted every 4 months. Other outcomes included hospital admissions, emergency department visits, and other health care utilization. Adjudication of fall events and injuries was conducted by a team blinded to treatment assignment and verified using administrative claims data, encounter data, or electronic health record review.

Main results: The intervention and control groups were similar in terms of sex and age: 62.5% vs 61.5% of participants were women, and mean (SD) age was 79.9 (5.7) years and 79.5 (5.8) years, respectively. Other demographic characteristics were similar between groups. For the primary outcome, the rate of first serious injury was 4.9 per 100 person-years in the intervention group and 5.3 per 100 person-years in the control group, with a hazard ratio of 0.92 (95% CI, 0.80-1.06; P = .25). For the secondary outcome of patient-reported fall injury, there were 25.6 events per 100 person-years in the intervention group and 28.6 in the control group, with a hazard ratio of 0.90 (95% CI, 0.83-0.99; P =0.004). Rates of hospitalization and other secondary outcomes were similar between groups.

Conclusion: The multifactorial STRIDE intervention did not reduce the rate of serious fall injury when compared to enhanced usual care. The intervention did result in lower rates of fall injury by patient report, but no other significant outcomes were seen.

Study 2 Overview (Stark et al)

Objective: To examine the effect of a behavioral home hazard removal intervention for fall prevention on risk of fall in community-dwelling older adults.

Design: This randomized clinical trial was conducted at a single site in St. Louis, Missouri. Participants were community-dwelling older adults who received services from the Area Agency on Aging (AAA). Inclusion criteria included age 65 years and older, having 1 or more falls in the previous 12 months or being worried about falling by self report, and currently receiving services from an AAA. Exclusion criteria included living in an institution or being severely cognitively impaired and unable to follow directions or report falls. Participants who met the criteria were contacted by phone and invited to participate. A total of 310 participants were enrolled in the study, with an equal number of participants assigned to the intervention and control groups.

Intervention: The intervention included hazard identification and removal after a comprehensive assessment of participants, their behaviors, and the environment; this assessment took place during the first visit, which lasted approximately 80 minutes. A home hazard removal plan was developed, and in the second session, which lasted approximately 40 minutes, remediation of hazards was carried out. A third session for home modification that lasted approximately 30 minutes was conducted, if needed. At 6 months after the intervention, a booster session to identify and remediate any new home hazards and address issues was conducted. Specific interventions, as identified by the assessment, included minor home repair such as grab bars, adaptive equipment, task modification, and education. Shared decision making that enabled older adults to control changes in their homes, self-management strategies to improve awareness, and motivational enhancement strategies to improve acceptance were employed. Scripted algorithms and checklists were used to deliver the intervention. For usual care, an annual assessment and referrals to community services, if needed, were conducted in the AAA.

Main outcome measures: The primary outcome of the study was the number of days to first fall in 12 months. Falls were defined as unintentional movements to the floor, ground, or object below knee level, and falls were recorded through a daily journal for 12 months. Participants were contacted by phone if they did not return the journal or reported a fall. Participants were interviewed to verify falls and determine whether a fall was injurious. Secondary outcomes included rate of falls per person per 12 months; daily activity performance measured using the Older Americans Resources and Services Activities of Daily Living scale; falls self-efficacy, which measures confidence performing daily activities without falling; and quality of life using the SF-36 at 12 months.

Main results: Most of the study participants were women (74%), and mean (SD) age was 75 (7.4) years. Study retention was similar between the intervention and control groups, with 82% completing the study in the intervention group compared with 81% in the control group. Fidelity to the intervention, as measured by a checklist by the interventionist, was 99%, and adherence to home modification, as measured by number of home modifications in use by self report, was high at 92% at 6 months and 91% at 12 months. For the primary outcome, fall hazard was not different between the intervention and control groups (hazard ratio, 0.9; 95% CI, 0.66-1.27). For the secondary outcomes, the rate of falling was lower in the intervention group compared with the control group, with a relative risk of 0.62 (95% CI, 0.40-0.95). There was no difference in other secondary outcomes of daily activity performance, falls self-efficacy, or quality of life.

Conclusion: Despite high adherence to home modifications and fidelity to the intervention, this home hazard removal program did not reduce the risk of falling when compared to usual care. It did reduce the rate of falls, although no other effects were observed.

Commentary

Observational studies have identified factors that contribute to falls,¹ and over the past 30 years a number of intervention trials designed to reduce the risk of falling have been conducted. A recent Cochrane review, published prior to the Bhasin et al and Stark et al trials, looked at the effect of multifactorial interventions for fall prevention across 62 trials that included 19,935 older adults living in the community. The review concluded that multifactorial interventions may reduce the rate of falls, but this conclusion was based on low-quality evidence and there was significant heterogeneity across the studies.²

The STRIDE randomized trial represents the latest effort to address the evidence gap around fall prevention, with the STRIDE investigators hoping this would be the definitive trial that leads to practice change in fall prevention. Smaller trials that have demonstrated effectiveness were brought to scale in this large randomized trial that included 86 practices and more than 5000 participants. The investigators used risk of injurious falls as the primary outcome, as this outcome is considered the most clinically meaningful for the study population. The results, however, were disappointing: the multifactorial intervention in STRIDE did not result in a reduction of risk of injurious falls. Challenges in the implementation of this large trial may have contributed to its results; falls care managers, key to this multifactorial intervention, reported difficulties in navigating complex relationships with patients, families, study staff, and primary care practices during the study. Barriers reported included clinical space limitations, variable buy-in from providers, and turnover of practice staff and providers.³ Such implementation factors may have resulted in the divergent results between smaller clinical trials and this large-scale trial conducted across multiple settings.

The second study, by Stark et al, examined a home modification program and its effect on risk of falls. A prior Cochrane review examining the effect of home safety assessment and modification indicates that these strategies are effective in reducing the rate of falls as well as the risk of falling.⁴ The results of the current trial showed a reduction in the rate of falls but not in the risk of falling; however, this study did not examine outcomes of serious injurious falls, which may be more clinically meaningful. The Stark et al study adds to the existing literature showing that home modification may have an impact on fall rates. One noteworthy aspect of the Stark et al trial is the high adherence rate to home modification in a community-based approach; perhaps the investigators’ approach can be translated to real-world use.

Applications for Clinical Practice and System Implementation

The role of exercise programs in reducing fall rates is well established,⁵ but neither of these studies focused on exercise interventions. STRIDE offered community-based exercise program referral, but there is variability in such programs and study staff reported challenges in matching participants with appropriate exercise programs.³ Further studies that examine combinations of multifactorial falls risk reduction, exercise, and home safety, with careful consideration of implementation challenges to assure fidelity and adherence to the intervention, are needed to ascertain the best strategy for fall prevention for older adults at risk.

Given the results of these trials, it is difficult to recommend one falls prevention intervention over another. Clinicians should continue to identify falls risk factors using standardized assessments and determine which factors are modifiable.

Practice Points

• Incorporating assessments of falls risk in primary care is feasible, and such assessments can identify important risk factors.
• Clinicians and health systems should identify avenues, such as developing programmatic approaches, to providing home safety assessment and intervention, exercise options, medication review, and modification of other risk factors.
• Ensuring delivery of these elements reliably through programmatic approaches with adequate follow-up is key to preventing falls in this population.

—William W. Hung, MD, MPH

Study 1 Overview (Bhasin et al)

Objective: To examine the effect of a multifactorial intervention for fall prevention on fall injury in community-dwelling older adults.

Design: This was a pragmatic, cluster randomized trial conducted in 86 primary care practices across 10 health care systems.

Setting and participants: The primary care sites were selected based on the prespecified criteria of size, ability to implement the intervention, proximity to other practices, accessibility to electronic health records, and access to community-based exercise programs. The primary care practices were randomly assigned to intervention or control.

Eligibility criteria for participants at those practices included age 70 years or older, dwelling in the community, and having an increased risk of falls, as determined by a history of fall-related injury in the past year, 2 or more falls in the past year, or being afraid of falling because of problems with balance or walking. Exclusion criteria were inability to provide consent or lack of proxy consent for participants who were determined to have cognitive impairment based on screening, and inability to speak English or Spanish. A total of 2802 participants were enrolled in the intervention group, and 2649 participants were enrolled in the control group.

Intervention: The intervention contained 5 components: a standardized assessment of 7 modifiable risk factors for fall injuries; standardized protocol-driven recommendations for management of risk factors; an individualized care plan focused on 1 to 3 risk factors; implementation of care plans, including referrals to community-based programs; and follow-up care conducted by telephone or in person. The modifiable risk factors included impairment of strength, gait, or balance; use of medications related to falls; postural hypotension; problems with feet or footwear; visual impairment; osteoporosis or vitamin D deficiency; and home safety hazards. The intervention was delivered by nurses who had completed online training modules and face-to-face training sessions focused on the intervention and motivational interviewing along with continuing education, in partnership with participants and their primary care providers. In the control group, participants received enhanced usual care, including an informational pamphlet, and were encouraged to discuss fall prevention with their primary care provider, including the results of their screening evaluation.

Main outcome measures: The primary outcome of the study was the first serious fall injury in a time-to-event analysis, defined as a fall resulting in a fracture (other than thoracic or lumbar vertebral fracture), joint dislocation, cut requiring closure, head injury requiring hospitalization, sprain or strain, bruising or swelling, or other serious injury. The secondary outcome was first patient-reported fall injury, also in a time-to-event analysis, ascertained by telephone interviews conducted every 4 months. Other outcomes included hospital admissions, emergency department visits, and other health care utilization. Adjudication of fall events and injuries was conducted by a team blinded to treatment assignment and verified using administrative claims data, encounter data, or electronic health record review.

Main results: The intervention and control groups were similar in terms of sex and age: 62.5% vs 61.5% of participants were women, and mean (SD) age was 79.9 (5.7) years and 79.5 (5.8) years, respectively. Other demographic characteristics were similar between groups. For the primary outcome, the rate of first serious injury was 4.9 per 100 person-years in the intervention group and 5.3 per 100 person-years in the control group, with a hazard ratio of 0.92 (95% CI, 0.80-1.06; P = .25). For the secondary outcome of patient-reported fall injury, there were 25.6 events per 100 person-years in the intervention group and 28.6 in the control group, with a hazard ratio of 0.90 (95% CI, 0.83-0.99; P =0.004). Rates of hospitalization and other secondary outcomes were similar between groups.

Conclusion: The multifactorial STRIDE intervention did not reduce the rate of serious fall injury when compared to enhanced usual care. The intervention did result in lower rates of fall injury by patient report, but no other significant outcomes were seen.

Study 2 Overview (Stark et al)

Objective: To examine the effect of a behavioral home hazard removal intervention for fall prevention on risk of fall in community-dwelling older adults.

Design: This randomized clinical trial was conducted at a single site in St. Louis, Missouri. Participants were community-dwelling older adults who received services from the Area Agency on Aging (AAA). Inclusion criteria included age 65 years and older, having 1 or more falls in the previous 12 months or being worried about falling by self report, and currently receiving services from an AAA. Exclusion criteria included living in an institution or being severely cognitively impaired and unable to follow directions or report falls. Participants who met the criteria were contacted by phone and invited to participate. A total of 310 participants were enrolled in the study, with an equal number of participants assigned to the intervention and control groups.

Intervention: The intervention included hazard identification and removal after a comprehensive assessment of participants, their behaviors, and the environment; this assessment took place during the first visit, which lasted approximately 80 minutes. A home hazard removal plan was developed, and in the second session, which lasted approximately 40 minutes, remediation of hazards was carried out. A third session for home modification that lasted approximately 30 minutes was conducted, if needed. At 6 months after the intervention, a booster session to identify and remediate any new home hazards and address issues was conducted. Specific interventions, as identified by the assessment, included minor home repair such as grab bars, adaptive equipment, task modification, and education. Shared decision making that enabled older adults to control changes in their homes, self-management strategies to improve awareness, and motivational enhancement strategies to improve acceptance were employed. Scripted algorithms and checklists were used to deliver the intervention. For usual care, an annual assessment and referrals to community services, if needed, were conducted in the AAA.

Main outcome measures: The primary outcome of the study was the number of days to first fall in 12 months. Falls were defined as unintentional movements to the floor, ground, or object below knee level, and falls were recorded through a daily journal for 12 months. Participants were contacted by phone if they did not return the journal or reported a fall. Participants were interviewed to verify falls and determine whether a fall was injurious. Secondary outcomes included rate of falls per person per 12 months; daily activity performance measured using the Older Americans Resources and Services Activities of Daily Living scale; falls self-efficacy, which measures confidence performing daily activities without falling; and quality of life using the SF-36 at 12 months.

Main results: Most of the study participants were women (74%), and mean (SD) age was 75 (7.4) years. Study retention was similar between the intervention and control groups, with 82% completing the study in the intervention group compared with 81% in the control group. Fidelity to the intervention, as measured by a checklist by the interventionist, was 99%, and adherence to home modification, as measured by number of home modifications in use by self report, was high at 92% at 6 months and 91% at 12 months. For the primary outcome, fall hazard was not different between the intervention and control groups (hazard ratio, 0.9; 95% CI, 0.66-1.27). For the secondary outcomes, the rate of falling was lower in the intervention group compared with the control group, with a relative risk of 0.62 (95% CI, 0.40-0.95). There was no difference in other secondary outcomes of daily activity performance, falls self-efficacy, or quality of life.

Conclusion: Despite high adherence to home modifications and fidelity to the intervention, this home hazard removal program did not reduce the risk of falling when compared to usual care. It did reduce the rate of falls, although no other effects were observed.

Commentary

Observational studies have identified factors that contribute to falls,¹ and over the past 30 years a number of intervention trials designed to reduce the risk of falling have been conducted. A recent Cochrane review, published prior to the Bhasin et al and Stark et al trials, looked at the effect of multifactorial interventions for fall prevention across 62 trials that included 19,935 older adults living in the community. The review concluded that multifactorial interventions may reduce the rate of falls, but this conclusion was based on low-quality evidence and there was significant heterogeneity across the studies.²

The STRIDE randomized trial represents the latest effort to address the evidence gap around fall prevention, with the STRIDE investigators hoping this would be the definitive trial that leads to practice change in fall prevention. Smaller trials that have demonstrated effectiveness were brought to scale in this large randomized trial that included 86 practices and more than 5000 participants. The investigators used risk of injurious falls as the primary outcome, as this outcome is considered the most clinically meaningful for the study population. The results, however, were disappointing: the multifactorial intervention in STRIDE did not result in a reduction of risk of injurious falls. Challenges in the implementation of this large trial may have contributed to its results; falls care managers, key to this multifactorial intervention, reported difficulties in navigating complex relationships with patients, families, study staff, and primary care practices during the study. Barriers reported included clinical space limitations, variable buy-in from providers, and turnover of practice staff and providers.³ Such implementation factors may have resulted in the divergent results between smaller clinical trials and this large-scale trial conducted across multiple settings.

The second study, by Stark et al, examined a home modification program and its effect on risk of falls. A prior Cochrane review examining the effect of home safety assessment and modification indicates that these strategies are effective in reducing the rate of falls as well as the risk of falling.⁴ The results of the current trial showed a reduction in the rate of falls but not in the risk of falling; however, this study did not examine outcomes of serious injurious falls, which may be more clinically meaningful. The Stark et al study adds to the existing literature showing that home modification may have an impact on fall rates. One noteworthy aspect of the Stark et al trial is the high adherence rate to home modification in a community-based approach; perhaps the investigators’ approach can be translated to real-world use.

Applications for Clinical Practice and System Implementation

The role of exercise programs in reducing fall rates is well established,⁵ but neither of these studies focused on exercise interventions. STRIDE offered community-based exercise program referral, but there is variability in such programs and study staff reported challenges in matching participants with appropriate exercise programs.³ Further studies that examine combinations of multifactorial falls risk reduction, exercise, and home safety, with careful consideration of implementation challenges to assure fidelity and adherence to the intervention, are needed to ascertain the best strategy for fall prevention for older adults at risk.

Given the results of these trials, it is difficult to recommend one falls prevention intervention over another. Clinicians should continue to identify falls risk factors using standardized assessments and determine which factors are modifiable.

Practice Points

• Incorporating assessments of falls risk in primary care is feasible, and such assessments can identify important risk factors.
• Clinicians and health systems should identify avenues, such as developing programmatic approaches, to providing home safety assessment and intervention, exercise options, medication review, and modification of other risk factors.
• Ensuring delivery of these elements reliably through programmatic approaches with adequate follow-up is key to preventing falls in this population.

—William W. Hung, MD, MPH

The U.S. Food and Drug Administration is easing rules to allow infant formula imports from the United Kingdom, which would bring about 2 million cans to the U.S. in coming weeks.

Kendal Nutricare will be able to offer certain infant formula products under the Kendamil brand to ease the nationwide formula shortage.

“Importantly, we anticipate additional infant formula products may be safely and quickly imported in the U.S. in the near-term, based on ongoing discussions with manufacturers and suppliers worldwide,” Robert Califf, MD, the FDA commissioner, said in a statement.

Kendal Nutricare has more than 40,000 cans in stock for immediate dispatch, the FDA said, and the U.S. Department of Health and Human Services is talking to the company about the best ways to get the products to the U.S. as quickly as possible.

Kendamil has set up a website for consumers to receive updates and find products once they arrive in the U.S.

After an evaluation, the FDA said it had no safety or nutrition concerns about the products. The evaluation reviewed the company’s microbiological testing, labeling, and information about facility production and inspection history.

On May 24, the FDA announced that Abbott Nutrition will release about 300,000 cans of its EleCare specialty amino acid-based formula to families that need urgent, life-sustaining supplies. The products had more tests for microbes before release.

Although some EleCare products were included in Abbott’s infant formula recall earlier this year, the cans that will be released were in different lots, have never been released, and have been maintained in storage, the FDA said.

“These EleCare product lots were not part of the recall but have been on hold due to concerns that they were produced under unsanitary conditions observed at Abbott Nutrition’s Sturgis, Michigan, facility,” the FDA wrote.

The FDA encourages parents and caregivers to talk with their health care providers to weigh the potential risk of bacterial infection with the critical need for the product, based on its special dietary formulation for infants with severe food allergies or gut disorders.

The FDA also said that Abbott confirmed the EleCare products will be the first formula produced at the Sturgis facility when it restarts production soon. Other specialty metabolic formulas will follow.

Abbott plans to restart production at the Sturgis facility on June 4, the company said in a statement, noting that the early batches of EleCare would be available to consumers around June 20.

The products being released now are EleCare (for infants under 1 year) and EleCare Jr. (for ages 1 and older). Those who want to request products should contact their health care providers or call Abbott directly at 800-881-0876.

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

The U.S. Food and Drug Administration is easing rules to allow infant formula imports from the United Kingdom, which would bring about 2 million cans to the U.S. in coming weeks.

Kendal Nutricare will be able to offer certain infant formula products under the Kendamil brand to ease the nationwide formula shortage.

“Importantly, we anticipate additional infant formula products may be safely and quickly imported in the U.S. in the near-term, based on ongoing discussions with manufacturers and suppliers worldwide,” Robert Califf, MD, the FDA commissioner, said in a statement.

Kendal Nutricare has more than 40,000 cans in stock for immediate dispatch, the FDA said, and the U.S. Department of Health and Human Services is talking to the company about the best ways to get the products to the U.S. as quickly as possible.

Kendamil has set up a website for consumers to receive updates and find products once they arrive in the U.S.

After an evaluation, the FDA said it had no safety or nutrition concerns about the products. The evaluation reviewed the company’s microbiological testing, labeling, and information about facility production and inspection history.

On May 24, the FDA announced that Abbott Nutrition will release about 300,000 cans of its EleCare specialty amino acid-based formula to families that need urgent, life-sustaining supplies. The products had more tests for microbes before release.

Although some EleCare products were included in Abbott’s infant formula recall earlier this year, the cans that will be released were in different lots, have never been released, and have been maintained in storage, the FDA said.

“These EleCare product lots were not part of the recall but have been on hold due to concerns that they were produced under unsanitary conditions observed at Abbott Nutrition’s Sturgis, Michigan, facility,” the FDA wrote.

The FDA encourages parents and caregivers to talk with their health care providers to weigh the potential risk of bacterial infection with the critical need for the product, based on its special dietary formulation for infants with severe food allergies or gut disorders.

The FDA also said that Abbott confirmed the EleCare products will be the first formula produced at the Sturgis facility when it restarts production soon. Other specialty metabolic formulas will follow.

Abbott plans to restart production at the Sturgis facility on June 4, the company said in a statement, noting that the early batches of EleCare would be available to consumers around June 20.

The products being released now are EleCare (for infants under 1 year) and EleCare Jr. (for ages 1 and older). Those who want to request products should contact their health care providers or call Abbott directly at 800-881-0876.

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

The U.S. Food and Drug Administration is easing rules to allow infant formula imports from the United Kingdom, which would bring about 2 million cans to the U.S. in coming weeks.

Kendal Nutricare will be able to offer certain infant formula products under the Kendamil brand to ease the nationwide formula shortage.

“Importantly, we anticipate additional infant formula products may be safely and quickly imported in the U.S. in the near-term, based on ongoing discussions with manufacturers and suppliers worldwide,” Robert Califf, MD, the FDA commissioner, said in a statement.

Kendal Nutricare has more than 40,000 cans in stock for immediate dispatch, the FDA said, and the U.S. Department of Health and Human Services is talking to the company about the best ways to get the products to the U.S. as quickly as possible.

Kendamil has set up a website for consumers to receive updates and find products once they arrive in the U.S.

After an evaluation, the FDA said it had no safety or nutrition concerns about the products. The evaluation reviewed the company’s microbiological testing, labeling, and information about facility production and inspection history.

On May 24, the FDA announced that Abbott Nutrition will release about 300,000 cans of its EleCare specialty amino acid-based formula to families that need urgent, life-sustaining supplies. The products had more tests for microbes before release.

Although some EleCare products were included in Abbott’s infant formula recall earlier this year, the cans that will be released were in different lots, have never been released, and have been maintained in storage, the FDA said.

“These EleCare product lots were not part of the recall but have been on hold due to concerns that they were produced under unsanitary conditions observed at Abbott Nutrition’s Sturgis, Michigan, facility,” the FDA wrote.

The FDA encourages parents and caregivers to talk with their health care providers to weigh the potential risk of bacterial infection with the critical need for the product, based on its special dietary formulation for infants with severe food allergies or gut disorders.

The FDA also said that Abbott confirmed the EleCare products will be the first formula produced at the Sturgis facility when it restarts production soon. Other specialty metabolic formulas will follow.

Abbott plans to restart production at the Sturgis facility on June 4, the company said in a statement, noting that the early batches of EleCare would be available to consumers around June 20.

The products being released now are EleCare (for infants under 1 year) and EleCare Jr. (for ages 1 and older). Those who want to request products should contact their health care providers or call Abbott directly at 800-881-0876.

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

Centers for Disease Control and Prevention Director Rochelle Walensky, MD, signed off May 19 on an advisory panel’s recommendation that children ages 5 to 11 years should receive a Pfizer-BioNTech COVID-19 vaccine booster dose at least 5 months after completion of the primary series.

The CDC’s Advisory Committee on Immunization Practices (ACIP) voted 11:1, with one abstention, on a question about whether it recommended these additional shots in this age group.

The U.S. Food and Drug Administration on May 17 amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to cover a single booster dose for administration to individuals 5 through 11 years of age.

At the request of CDC staff, ACIP members considered whether there should be softer wording for this recommendation, stating that children in this age group “may” receive a booster. This kind of phrasing would better reflect uncertainty about the course of COVID in the months ahead and allow flexibility for a stronger recommendation in the fall.

ACIP panelists and members of key groups argued strongly for a “should” recommendation, despite the uncertainties.

They also called for stronger efforts to make sure eligible children received their initial COVID-19 shots. Data gathered between November and April show only 14.4% of children ages 5 to 11 in rural areas have received at least one dose of COVID-19 vaccination, with top rates of 39.8% in large urban communities and 36% in larger suburban regions, CDC staff said.

CDC staff also said nearly 40% of parents in rural areas reported that their children’s pediatricians did not recommend COVID-19 vaccinations, compared with only 8% of parents in urban communities. These figures concerned ACIP members and liaisons from medical associations who take part in the panel’s deliberations but not in its votes.

“People will hear the word ‘m-a-y’ as ‘m-e-h’,” said Patricia Stinchfield, RN, MS, who served as the liaison for National Association of Pediatric Nurse Practitioners to ACIP. “I think we need to add urgency” to efforts to increase use of COVID vaccinations, she said.

Voting no on Thursday was Helen Keipp Talbot, MD, of Vanderbilt University. She explained after the vote that she is in favor of having young children vaccinated, but she’s concerned about the low rates of initial uptake of the COVID-19 shots.

“Boosters are great once we’ve gotten everyone their first round,” she said. “That needs to be our priority in this.”

Sandra Fryhofer, MD, the American Medical Association’s liaison to ACIP, stressed the add-on benefits from more widespread vaccination of children against COVID. Dr. Fryhofer said she serves adults in her practice as an internal medicine physician, with many of her patients being at high risk for complications from COVID.

Too many people are assuming the spread of infections in the community has lessened the risk of the virus, Dr. Fryhofer said.

“Not everyone’s had COVID yet, and my patients will be likely to get COVID if their grandchildren get it. We’re going through pandemic fatigue in this country,” she said. “Unfortunately, masks are now more off than on. Winter’s coming. They’re more variants” of the virus likely to emerge.

The data emerging so far suggests COVID vaccines will become a three-dose medicine, as is already accepted for other shots like hepatitis B vaccine, Dr. Fryhofer said.

Data gathered to date show the vaccine decreases risk of hospitalization for COVID and for complications such as multisystem inflammatory syndrome in children (MIS-C), she said.

“The bottom line is children in this age group are getting COVID,” Dr. Fryhofer said of the 5- to 11-year-olds. “Some do fine. Some are getting real sick. Some are hospitalized, some have died.”

At the meeting, CDC staff cited data from a paper published in the New England Journal of Medicine in March showing that vaccination had reduced the risk of hospitalization for COVID-19 among children 5 to 11 years of age by two-thirds during the Omicron period; most children with critical COVID-19 were unvaccinated.

COVID-19 led to 66 deaths among children ages 5 to 11 in the October 2020 to October 2021 timeframe, said ACIP member Matthew F. Daley, MD, of Kaiser Permanente Colorado during a presentation to his fellow panel members.

Parents may underestimate children’s risk from COVID and thus hold off on vaccinations, stressed AMA President Gerald E. Harmon, MD, in a statement issued after the meeting.

“It is concerning that only 1 in 3 children between the ages of 5 and 11 in the United States have received two doses of the vaccine, in part because parents believe them to be at lower risk for severe disease than adults,” Dr. Harmon said. “But the Omicron variant brought about change that should alter that calculus.”
 

Responding to early data

As Dr. Fryhofer put it, the medical community has been learning in “real time” about how COVID vaccines work and how to use them.

The EUA granted on May 17 for booster shots for children ages 5 to 11 was based on an analysis of immune response data in a subset of children from an ongoing randomized placebo-controlled trial, the FDA said.

Antibody responses were evaluated in 67 study participants who received a booster dose 7 to 9 months after completing a two-dose primary series of the Pfizer-BioNTech COVID-19 Vaccine. The EUA for the booster shot was intended to respond to emerging data that suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine, the FDA said.
 

CDC seeks help tracking vaccine complications

At the ACIP meeting, a top CDC vaccine-safety official, Tom Shimabukuro, MD, MPH, MBA, asked physicians to make sure their patients know about the agency’s V-Safe program for gathering reports from the public about their experiences with COVID vaccines. This is intended to help the CDC monitor for side effects of these medications.

“We need your help,” he said during a presentation about adverse events reported to date in children ages 5 to 11 who took the Pfizer vaccine.

About 18.1 million doses of Pfizer-BioNTech vaccine have been administered to children ages 5 to 11 years in the United States so far. Most of the reports of adverse events following vaccination were not serious, he said. But there were 20 reports of myocarditis verified to meet CDC case definition among children ages 5 to 11 years.

One case involved a death with histopathologic evidence of myocarditis on autopsy. The CDC continues to assist with case review, he said.

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

Centers for Disease Control and Prevention Director Rochelle Walensky, MD, signed off May 19 on an advisory panel’s recommendation that children ages 5 to 11 years should receive a Pfizer-BioNTech COVID-19 vaccine booster dose at least 5 months after completion of the primary series.

The CDC’s Advisory Committee on Immunization Practices (ACIP) voted 11:1, with one abstention, on a question about whether it recommended these additional shots in this age group.

The U.S. Food and Drug Administration on May 17 amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to cover a single booster dose for administration to individuals 5 through 11 years of age.

At the request of CDC staff, ACIP members considered whether there should be softer wording for this recommendation, stating that children in this age group “may” receive a booster. This kind of phrasing would better reflect uncertainty about the course of COVID in the months ahead and allow flexibility for a stronger recommendation in the fall.

ACIP panelists and members of key groups argued strongly for a “should” recommendation, despite the uncertainties.

They also called for stronger efforts to make sure eligible children received their initial COVID-19 shots. Data gathered between November and April show only 14.4% of children ages 5 to 11 in rural areas have received at least one dose of COVID-19 vaccination, with top rates of 39.8% in large urban communities and 36% in larger suburban regions, CDC staff said.

CDC staff also said nearly 40% of parents in rural areas reported that their children’s pediatricians did not recommend COVID-19 vaccinations, compared with only 8% of parents in urban communities. These figures concerned ACIP members and liaisons from medical associations who take part in the panel’s deliberations but not in its votes.

“People will hear the word ‘m-a-y’ as ‘m-e-h’,” said Patricia Stinchfield, RN, MS, who served as the liaison for National Association of Pediatric Nurse Practitioners to ACIP. “I think we need to add urgency” to efforts to increase use of COVID vaccinations, she said.

Voting no on Thursday was Helen Keipp Talbot, MD, of Vanderbilt University. She explained after the vote that she is in favor of having young children vaccinated, but she’s concerned about the low rates of initial uptake of the COVID-19 shots.

“Boosters are great once we’ve gotten everyone their first round,” she said. “That needs to be our priority in this.”

Sandra Fryhofer, MD, the American Medical Association’s liaison to ACIP, stressed the add-on benefits from more widespread vaccination of children against COVID. Dr. Fryhofer said she serves adults in her practice as an internal medicine physician, with many of her patients being at high risk for complications from COVID.

Too many people are assuming the spread of infections in the community has lessened the risk of the virus, Dr. Fryhofer said.

“Not everyone’s had COVID yet, and my patients will be likely to get COVID if their grandchildren get it. We’re going through pandemic fatigue in this country,” she said. “Unfortunately, masks are now more off than on. Winter’s coming. They’re more variants” of the virus likely to emerge.

The data emerging so far suggests COVID vaccines will become a three-dose medicine, as is already accepted for other shots like hepatitis B vaccine, Dr. Fryhofer said.

Data gathered to date show the vaccine decreases risk of hospitalization for COVID and for complications such as multisystem inflammatory syndrome in children (MIS-C), she said.

“The bottom line is children in this age group are getting COVID,” Dr. Fryhofer said of the 5- to 11-year-olds. “Some do fine. Some are getting real sick. Some are hospitalized, some have died.”

At the meeting, CDC staff cited data from a paper published in the New England Journal of Medicine in March showing that vaccination had reduced the risk of hospitalization for COVID-19 among children 5 to 11 years of age by two-thirds during the Omicron period; most children with critical COVID-19 were unvaccinated.

COVID-19 led to 66 deaths among children ages 5 to 11 in the October 2020 to October 2021 timeframe, said ACIP member Matthew F. Daley, MD, of Kaiser Permanente Colorado during a presentation to his fellow panel members.

Parents may underestimate children’s risk from COVID and thus hold off on vaccinations, stressed AMA President Gerald E. Harmon, MD, in a statement issued after the meeting.

“It is concerning that only 1 in 3 children between the ages of 5 and 11 in the United States have received two doses of the vaccine, in part because parents believe them to be at lower risk for severe disease than adults,” Dr. Harmon said. “But the Omicron variant brought about change that should alter that calculus.”
 

Responding to early data

As Dr. Fryhofer put it, the medical community has been learning in “real time” about how COVID vaccines work and how to use them.

The EUA granted on May 17 for booster shots for children ages 5 to 11 was based on an analysis of immune response data in a subset of children from an ongoing randomized placebo-controlled trial, the FDA said.

Antibody responses were evaluated in 67 study participants who received a booster dose 7 to 9 months after completing a two-dose primary series of the Pfizer-BioNTech COVID-19 Vaccine. The EUA for the booster shot was intended to respond to emerging data that suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine, the FDA said.
 

CDC seeks help tracking vaccine complications

At the ACIP meeting, a top CDC vaccine-safety official, Tom Shimabukuro, MD, MPH, MBA, asked physicians to make sure their patients know about the agency’s V-Safe program for gathering reports from the public about their experiences with COVID vaccines. This is intended to help the CDC monitor for side effects of these medications.

“We need your help,” he said during a presentation about adverse events reported to date in children ages 5 to 11 who took the Pfizer vaccine.

About 18.1 million doses of Pfizer-BioNTech vaccine have been administered to children ages 5 to 11 years in the United States so far. Most of the reports of adverse events following vaccination were not serious, he said. But there were 20 reports of myocarditis verified to meet CDC case definition among children ages 5 to 11 years.

One case involved a death with histopathologic evidence of myocarditis on autopsy. The CDC continues to assist with case review, he said.

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

Centers for Disease Control and Prevention Director Rochelle Walensky, MD, signed off May 19 on an advisory panel’s recommendation that children ages 5 to 11 years should receive a Pfizer-BioNTech COVID-19 vaccine booster dose at least 5 months after completion of the primary series.

The CDC’s Advisory Committee on Immunization Practices (ACIP) voted 11:1, with one abstention, on a question about whether it recommended these additional shots in this age group.

The U.S. Food and Drug Administration on May 17 amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to cover a single booster dose for administration to individuals 5 through 11 years of age.

At the request of CDC staff, ACIP members considered whether there should be softer wording for this recommendation, stating that children in this age group “may” receive a booster. This kind of phrasing would better reflect uncertainty about the course of COVID in the months ahead and allow flexibility for a stronger recommendation in the fall.

ACIP panelists and members of key groups argued strongly for a “should” recommendation, despite the uncertainties.

They also called for stronger efforts to make sure eligible children received their initial COVID-19 shots. Data gathered between November and April show only 14.4% of children ages 5 to 11 in rural areas have received at least one dose of COVID-19 vaccination, with top rates of 39.8% in large urban communities and 36% in larger suburban regions, CDC staff said.

CDC staff also said nearly 40% of parents in rural areas reported that their children’s pediatricians did not recommend COVID-19 vaccinations, compared with only 8% of parents in urban communities. These figures concerned ACIP members and liaisons from medical associations who take part in the panel’s deliberations but not in its votes.

“People will hear the word ‘m-a-y’ as ‘m-e-h’,” said Patricia Stinchfield, RN, MS, who served as the liaison for National Association of Pediatric Nurse Practitioners to ACIP. “I think we need to add urgency” to efforts to increase use of COVID vaccinations, she said.

Voting no on Thursday was Helen Keipp Talbot, MD, of Vanderbilt University. She explained after the vote that she is in favor of having young children vaccinated, but she’s concerned about the low rates of initial uptake of the COVID-19 shots.

“Boosters are great once we’ve gotten everyone their first round,” she said. “That needs to be our priority in this.”

Sandra Fryhofer, MD, the American Medical Association’s liaison to ACIP, stressed the add-on benefits from more widespread vaccination of children against COVID. Dr. Fryhofer said she serves adults in her practice as an internal medicine physician, with many of her patients being at high risk for complications from COVID.

Too many people are assuming the spread of infections in the community has lessened the risk of the virus, Dr. Fryhofer said.

“Not everyone’s had COVID yet, and my patients will be likely to get COVID if their grandchildren get it. We’re going through pandemic fatigue in this country,” she said. “Unfortunately, masks are now more off than on. Winter’s coming. They’re more variants” of the virus likely to emerge.

The data emerging so far suggests COVID vaccines will become a three-dose medicine, as is already accepted for other shots like hepatitis B vaccine, Dr. Fryhofer said.

Data gathered to date show the vaccine decreases risk of hospitalization for COVID and for complications such as multisystem inflammatory syndrome in children (MIS-C), she said.

“The bottom line is children in this age group are getting COVID,” Dr. Fryhofer said of the 5- to 11-year-olds. “Some do fine. Some are getting real sick. Some are hospitalized, some have died.”

At the meeting, CDC staff cited data from a paper published in the New England Journal of Medicine in March showing that vaccination had reduced the risk of hospitalization for COVID-19 among children 5 to 11 years of age by two-thirds during the Omicron period; most children with critical COVID-19 were unvaccinated.

COVID-19 led to 66 deaths among children ages 5 to 11 in the October 2020 to October 2021 timeframe, said ACIP member Matthew F. Daley, MD, of Kaiser Permanente Colorado during a presentation to his fellow panel members.

Parents may underestimate children’s risk from COVID and thus hold off on vaccinations, stressed AMA President Gerald E. Harmon, MD, in a statement issued after the meeting.

“It is concerning that only 1 in 3 children between the ages of 5 and 11 in the United States have received two doses of the vaccine, in part because parents believe them to be at lower risk for severe disease than adults,” Dr. Harmon said. “But the Omicron variant brought about change that should alter that calculus.”
 

Responding to early data

As Dr. Fryhofer put it, the medical community has been learning in “real time” about how COVID vaccines work and how to use them.

The EUA granted on May 17 for booster shots for children ages 5 to 11 was based on an analysis of immune response data in a subset of children from an ongoing randomized placebo-controlled trial, the FDA said.

Antibody responses were evaluated in 67 study participants who received a booster dose 7 to 9 months after completing a two-dose primary series of the Pfizer-BioNTech COVID-19 Vaccine. The EUA for the booster shot was intended to respond to emerging data that suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine, the FDA said.
 

CDC seeks help tracking vaccine complications

At the ACIP meeting, a top CDC vaccine-safety official, Tom Shimabukuro, MD, MPH, MBA, asked physicians to make sure their patients know about the agency’s V-Safe program for gathering reports from the public about their experiences with COVID vaccines. This is intended to help the CDC monitor for side effects of these medications.

“We need your help,” he said during a presentation about adverse events reported to date in children ages 5 to 11 who took the Pfizer vaccine.

About 18.1 million doses of Pfizer-BioNTech vaccine have been administered to children ages 5 to 11 years in the United States so far. Most of the reports of adverse events following vaccination were not serious, he said. But there were 20 reports of myocarditis verified to meet CDC case definition among children ages 5 to 11 years.

One case involved a death with histopathologic evidence of myocarditis on autopsy. The CDC continues to assist with case review, he said.

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