Health Policy

The Centers for Disease Control and Prevention has long been the premier reference lab for the United States and, for some diseases, internationally. But the agency stopped testing for parasites more than 6 months ago, and public health experts say that’s putting vulnerable populations even more at risk.

In September 2021, the CDC stated on its website that it would stop testing for parasites, herpesvirus encephalitis, human herpesvirus 6 and 7, Epstein-Barr virus, and other viruses, saying, “We are working diligently to implement laboratory system improvements.”

At the time, the CDC said testing would be halted only for a few months.

In response to a query from this news organization, a CDC spokesperson replied, “While at present we are unable to share a detailed timeline, our highest priority is to resume high-quality testing operations in a phased, prioritized approach as soon as possible and to offer the same tests that were available before the pause.”

Several global health clinicians told this news organization that they were not aware of the halt and that they are now uncertain about the specific diagnosis and best treatment for some patients. Other patients have been lost to follow-up.

In response, a group of tropical disease specialists who focus on neglected tropical diseases (NTDs) wrote an editorial, “Neglected Testing for Neglected Tropical Diseases at the CDC,” which recently appeared in the American Journal of Tropical Medicine and Hygiene (AJTMH).

NTDs are caused by viruses, bacteria, and parasites. They include leprosy and worms; many such diseases are disfiguring, such as filariasis (which causes the hugely swollen extremities of elephantiasis) and onchocerciasis (river blindness). They also include some viral and bacterial diseases. Their common denominator is that they are diseases of poverty, primarily in Africa, Asia, and Latin America, so they garner little attention from “first world” countries.

The loss of testing for two devastating parasites – Chagas and Leishmania – was particularly significant. Few other labs in the United States test for these, and the tests can be expensive and of variable quality, experts said.

Norman Beatty, MD, a global health physician at the University of Florida, told this news organization, “Chagas confirmatory testing is only available at the CDC and is the most reliable testing we have access to in the United States. Leishmania species identification is also only available at the CDC and is important in determining which antiparasitic medications we will use.”

Chagas disease is caused by the parasite Trypanosoma cruzi and is transmitted by triatomine bugs, also known as kissing bugs. Chagas is a major cause of an enlarged heart and congestive heart failure, as well as a dramatically enlarged esophagus or colon.

Prior to the cuts and before COVID-19, the CDC reported that they ran 10,000 to 15,000 tests for parasitic diseases annually. Testing requests declined during COVID. In 2021, they ran 1,003 tests for Chagas.

Dr. Beatty said that he first became aware of the CDC’s testing cuts last fall when he sought care for a patient. He was first told the delay would be 2-3 weeks, then another 2-3 weeks. It’s now been 7 months, and only three tests have been resumed.

Dr. Beatty added that for Chagas disease in particular, there is urgency in testing because cardiac complications can be life-threatening. He said that “a lot of these diseases can be considered rare, but they also have a tremendous ability to cause morbidity and mortality.”

Leishmania infections are also serious. Following the bite of an infected sandfly, they can cause disfiguring skin infections, but, more importantly, they can affect the liver, spleen, and bone marrow. Dr. Beatty said that since testing was dropped at the CDC, some colleagues had to send specimens outside of the country.

Dr. Beatty emphasized that the cuts in testing at the CDC highlight disparities in our society. “There are other commercial reference laboratories who may have some of these tests available, but the vast majority of people who suffer from diseases are underserved and vulnerable. [My patients] most definitely will not have access to advanced testing commercial laboratories,” Dr. Beatty said. Those laboratories include Associated Regional University Pathologists laboratories, Quest Diagnostics, and LabCorp Diagnostics. But for some parasitic infections, there will simply be no testing, and patients will not receive appropriate therapy.

The CDC’s website says, “USAID and CDC work together on a shared agenda to advance global progress towards the control and elimination of NTDs that can be addressed with preventive chemotherapy. ... CDC has strong working relationships with WHO, regional reference laboratories/bodies, [and] national NTD programs ... working with these partners through the provision of unique laboratory, diagnostic, and epidemiological technical assistance.”

The WHO Roadmap for 2030 aims to prevent and control many NTDs, in part by “providing new interventions and effective, standardized, and affordable diagnostics.” Last year, the CDC said that they “will continue working with WHO and other global partners to meet the established goals.”

But testing for a number of NTDs is not currently available at the CDC. In response to questions from this news organization, a CDC spokesperson said the agency “supports the development of country capacity for NTD testing required ... but does not perform testing related to the WHO Roadmap.”

A group of CDC officials wrote an editorial response that was published in AJTMH, saying the agency has “three main priorities: reducing parasitic disease-related death, illness, and disability in the United States; reducing the global burden of malaria; and eliminating targeted neglected tropical diseases.”

In response to this news organization’s interview request, a CDC spokesperson wrote, “CDC is unwavering in our commitment to provide the highest quality laboratory diagnostic services for parasitic diseases. We understand the concerns expressed in the editorial and the challenges the pause in testing for parasitic diseases presents for health care providers, particularly those treating people at elevated risk for parasitic diseases.”

Michael Reich, PhD, Dr. Beatty’s co-author, is an international health policy expert at Harvard. He and the physicians had approached CDC about the elimination of services. He said in an interview, “We’re still unable to get clear responses except for something along the lines of, ‘We are working on it. It is complicated. It takes time. We’re doing our best.’”

Dr. Reich added, “For me, this raises troubling issues both of transparency and accountability – transparency about what is going on and what the problems are, and accountability in terms of who’s being held responsible for the closures and the impacts on both public health and patient treatment.”

Dr. Beatty concluded, “I think the goal of our group was to bring more awareness to the importance of having a national laboratory that can service all people, even the most underserved and vulnerable populations.” He added, “Chagas disease is a disease of inequity in Latin Americans. Without having access to an appropriate laboratory such as the CDC, we would be taking a backwards approach to tackle neglected tropical diseases in our country and worldwide.”

Dr. Beatty and Dr. Reich report no relevant financial relationships.

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

The Centers for Disease Control and Prevention has long been the premier reference lab for the United States and, for some diseases, internationally. But the agency stopped testing for parasites more than 6 months ago, and public health experts say that’s putting vulnerable populations even more at risk.

In September 2021, the CDC stated on its website that it would stop testing for parasites, herpesvirus encephalitis, human herpesvirus 6 and 7, Epstein-Barr virus, and other viruses, saying, “We are working diligently to implement laboratory system improvements.”

At the time, the CDC said testing would be halted only for a few months.

In response to a query from this news organization, a CDC spokesperson replied, “While at present we are unable to share a detailed timeline, our highest priority is to resume high-quality testing operations in a phased, prioritized approach as soon as possible and to offer the same tests that were available before the pause.”

Several global health clinicians told this news organization that they were not aware of the halt and that they are now uncertain about the specific diagnosis and best treatment for some patients. Other patients have been lost to follow-up.

In response, a group of tropical disease specialists who focus on neglected tropical diseases (NTDs) wrote an editorial, “Neglected Testing for Neglected Tropical Diseases at the CDC,” which recently appeared in the American Journal of Tropical Medicine and Hygiene (AJTMH).

NTDs are caused by viruses, bacteria, and parasites. They include leprosy and worms; many such diseases are disfiguring, such as filariasis (which causes the hugely swollen extremities of elephantiasis) and onchocerciasis (river blindness). They also include some viral and bacterial diseases. Their common denominator is that they are diseases of poverty, primarily in Africa, Asia, and Latin America, so they garner little attention from “first world” countries.

The loss of testing for two devastating parasites – Chagas and Leishmania – was particularly significant. Few other labs in the United States test for these, and the tests can be expensive and of variable quality, experts said.

Norman Beatty, MD, a global health physician at the University of Florida, told this news organization, “Chagas confirmatory testing is only available at the CDC and is the most reliable testing we have access to in the United States. Leishmania species identification is also only available at the CDC and is important in determining which antiparasitic medications we will use.”

Chagas disease is caused by the parasite Trypanosoma cruzi and is transmitted by triatomine bugs, also known as kissing bugs. Chagas is a major cause of an enlarged heart and congestive heart failure, as well as a dramatically enlarged esophagus or colon.

Prior to the cuts and before COVID-19, the CDC reported that they ran 10,000 to 15,000 tests for parasitic diseases annually. Testing requests declined during COVID. In 2021, they ran 1,003 tests for Chagas.

Dr. Beatty said that he first became aware of the CDC’s testing cuts last fall when he sought care for a patient. He was first told the delay would be 2-3 weeks, then another 2-3 weeks. It’s now been 7 months, and only three tests have been resumed.

Dr. Beatty added that for Chagas disease in particular, there is urgency in testing because cardiac complications can be life-threatening. He said that “a lot of these diseases can be considered rare, but they also have a tremendous ability to cause morbidity and mortality.”

Leishmania infections are also serious. Following the bite of an infected sandfly, they can cause disfiguring skin infections, but, more importantly, they can affect the liver, spleen, and bone marrow. Dr. Beatty said that since testing was dropped at the CDC, some colleagues had to send specimens outside of the country.

Dr. Beatty emphasized that the cuts in testing at the CDC highlight disparities in our society. “There are other commercial reference laboratories who may have some of these tests available, but the vast majority of people who suffer from diseases are underserved and vulnerable. [My patients] most definitely will not have access to advanced testing commercial laboratories,” Dr. Beatty said. Those laboratories include Associated Regional University Pathologists laboratories, Quest Diagnostics, and LabCorp Diagnostics. But for some parasitic infections, there will simply be no testing, and patients will not receive appropriate therapy.

The CDC’s website says, “USAID and CDC work together on a shared agenda to advance global progress towards the control and elimination of NTDs that can be addressed with preventive chemotherapy. ... CDC has strong working relationships with WHO, regional reference laboratories/bodies, [and] national NTD programs ... working with these partners through the provision of unique laboratory, diagnostic, and epidemiological technical assistance.”

The WHO Roadmap for 2030 aims to prevent and control many NTDs, in part by “providing new interventions and effective, standardized, and affordable diagnostics.” Last year, the CDC said that they “will continue working with WHO and other global partners to meet the established goals.”

But testing for a number of NTDs is not currently available at the CDC. In response to questions from this news organization, a CDC spokesperson said the agency “supports the development of country capacity for NTD testing required ... but does not perform testing related to the WHO Roadmap.”

A group of CDC officials wrote an editorial response that was published in AJTMH, saying the agency has “three main priorities: reducing parasitic disease-related death, illness, and disability in the United States; reducing the global burden of malaria; and eliminating targeted neglected tropical diseases.”

In response to this news organization’s interview request, a CDC spokesperson wrote, “CDC is unwavering in our commitment to provide the highest quality laboratory diagnostic services for parasitic diseases. We understand the concerns expressed in the editorial and the challenges the pause in testing for parasitic diseases presents for health care providers, particularly those treating people at elevated risk for parasitic diseases.”

Michael Reich, PhD, Dr. Beatty’s co-author, is an international health policy expert at Harvard. He and the physicians had approached CDC about the elimination of services. He said in an interview, “We’re still unable to get clear responses except for something along the lines of, ‘We are working on it. It is complicated. It takes time. We’re doing our best.’”

Dr. Reich added, “For me, this raises troubling issues both of transparency and accountability – transparency about what is going on and what the problems are, and accountability in terms of who’s being held responsible for the closures and the impacts on both public health and patient treatment.”

Dr. Beatty concluded, “I think the goal of our group was to bring more awareness to the importance of having a national laboratory that can service all people, even the most underserved and vulnerable populations.” He added, “Chagas disease is a disease of inequity in Latin Americans. Without having access to an appropriate laboratory such as the CDC, we would be taking a backwards approach to tackle neglected tropical diseases in our country and worldwide.”

Dr. Beatty and Dr. Reich report no relevant financial relationships.

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

The Centers for Disease Control and Prevention has long been the premier reference lab for the United States and, for some diseases, internationally. But the agency stopped testing for parasites more than 6 months ago, and public health experts say that’s putting vulnerable populations even more at risk.

In September 2021, the CDC stated on its website that it would stop testing for parasites, herpesvirus encephalitis, human herpesvirus 6 and 7, Epstein-Barr virus, and other viruses, saying, “We are working diligently to implement laboratory system improvements.”

At the time, the CDC said testing would be halted only for a few months.

In response to a query from this news organization, a CDC spokesperson replied, “While at present we are unable to share a detailed timeline, our highest priority is to resume high-quality testing operations in a phased, prioritized approach as soon as possible and to offer the same tests that were available before the pause.”

Several global health clinicians told this news organization that they were not aware of the halt and that they are now uncertain about the specific diagnosis and best treatment for some patients. Other patients have been lost to follow-up.

In response, a group of tropical disease specialists who focus on neglected tropical diseases (NTDs) wrote an editorial, “Neglected Testing for Neglected Tropical Diseases at the CDC,” which recently appeared in the American Journal of Tropical Medicine and Hygiene (AJTMH).

NTDs are caused by viruses, bacteria, and parasites. They include leprosy and worms; many such diseases are disfiguring, such as filariasis (which causes the hugely swollen extremities of elephantiasis) and onchocerciasis (river blindness). They also include some viral and bacterial diseases. Their common denominator is that they are diseases of poverty, primarily in Africa, Asia, and Latin America, so they garner little attention from “first world” countries.

The loss of testing for two devastating parasites – Chagas and Leishmania – was particularly significant. Few other labs in the United States test for these, and the tests can be expensive and of variable quality, experts said.

Norman Beatty, MD, a global health physician at the University of Florida, told this news organization, “Chagas confirmatory testing is only available at the CDC and is the most reliable testing we have access to in the United States. Leishmania species identification is also only available at the CDC and is important in determining which antiparasitic medications we will use.”

Chagas disease is caused by the parasite Trypanosoma cruzi and is transmitted by triatomine bugs, also known as kissing bugs. Chagas is a major cause of an enlarged heart and congestive heart failure, as well as a dramatically enlarged esophagus or colon.

Prior to the cuts and before COVID-19, the CDC reported that they ran 10,000 to 15,000 tests for parasitic diseases annually. Testing requests declined during COVID. In 2021, they ran 1,003 tests for Chagas.

Dr. Beatty said that he first became aware of the CDC’s testing cuts last fall when he sought care for a patient. He was first told the delay would be 2-3 weeks, then another 2-3 weeks. It’s now been 7 months, and only three tests have been resumed.

Dr. Beatty added that for Chagas disease in particular, there is urgency in testing because cardiac complications can be life-threatening. He said that “a lot of these diseases can be considered rare, but they also have a tremendous ability to cause morbidity and mortality.”

Leishmania infections are also serious. Following the bite of an infected sandfly, they can cause disfiguring skin infections, but, more importantly, they can affect the liver, spleen, and bone marrow. Dr. Beatty said that since testing was dropped at the CDC, some colleagues had to send specimens outside of the country.

Dr. Beatty emphasized that the cuts in testing at the CDC highlight disparities in our society. “There are other commercial reference laboratories who may have some of these tests available, but the vast majority of people who suffer from diseases are underserved and vulnerable. [My patients] most definitely will not have access to advanced testing commercial laboratories,” Dr. Beatty said. Those laboratories include Associated Regional University Pathologists laboratories, Quest Diagnostics, and LabCorp Diagnostics. But for some parasitic infections, there will simply be no testing, and patients will not receive appropriate therapy.

The CDC’s website says, “USAID and CDC work together on a shared agenda to advance global progress towards the control and elimination of NTDs that can be addressed with preventive chemotherapy. ... CDC has strong working relationships with WHO, regional reference laboratories/bodies, [and] national NTD programs ... working with these partners through the provision of unique laboratory, diagnostic, and epidemiological technical assistance.”

The WHO Roadmap for 2030 aims to prevent and control many NTDs, in part by “providing new interventions and effective, standardized, and affordable diagnostics.” Last year, the CDC said that they “will continue working with WHO and other global partners to meet the established goals.”

But testing for a number of NTDs is not currently available at the CDC. In response to questions from this news organization, a CDC spokesperson said the agency “supports the development of country capacity for NTD testing required ... but does not perform testing related to the WHO Roadmap.”

A group of CDC officials wrote an editorial response that was published in AJTMH, saying the agency has “three main priorities: reducing parasitic disease-related death, illness, and disability in the United States; reducing the global burden of malaria; and eliminating targeted neglected tropical diseases.”

In response to this news organization’s interview request, a CDC spokesperson wrote, “CDC is unwavering in our commitment to provide the highest quality laboratory diagnostic services for parasitic diseases. We understand the concerns expressed in the editorial and the challenges the pause in testing for parasitic diseases presents for health care providers, particularly those treating people at elevated risk for parasitic diseases.”

Michael Reich, PhD, Dr. Beatty’s co-author, is an international health policy expert at Harvard. He and the physicians had approached CDC about the elimination of services. He said in an interview, “We’re still unable to get clear responses except for something along the lines of, ‘We are working on it. It is complicated. It takes time. We’re doing our best.’”

Dr. Reich added, “For me, this raises troubling issues both of transparency and accountability – transparency about what is going on and what the problems are, and accountability in terms of who’s being held responsible for the closures and the impacts on both public health and patient treatment.”

Dr. Beatty concluded, “I think the goal of our group was to bring more awareness to the importance of having a national laboratory that can service all people, even the most underserved and vulnerable populations.” He added, “Chagas disease is a disease of inequity in Latin Americans. Without having access to an appropriate laboratory such as the CDC, we would be taking a backwards approach to tackle neglected tropical diseases in our country and worldwide.”

Dr. Beatty and Dr. Reich report no relevant financial relationships.

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

The Centers for Disease Control and Prevention is considering what to tell the public about second booster shots with mRNA vaccinations for COVID-19.

The U.S. Food and Drug Administration in March authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for people aged 50 and older and certain immunocompromised adults, even though many top infectious disease experts questioned the need before the agency’s decision.

In a meeting April 20, the CDC asked its Advisory Committee on Immunization Practices to discuss second booster shots, but did not ask the group of experts to vote on formal recommendations.

Instead, the experts talked about the potential timing of additional COVID-19 vaccines for those who already have had three shots, and challenges for vaccination efforts that likely will arise as the pandemic persists.

ACIP member Beth Bell, MD, MPH, of the University of Washington, Seattle, said she’s concerned about the potential for “booster fatigue.”

“A vaccination program that’s going to require boosting large proportions of the population every 4-6 months is really not sustainable and probably not something that most people want to participate in,” she said.

The benefit of additional COVID-19 shots for now appears to be smaller than what people get from the initial doses, Dr. Bell said.

Earlier in the meeting, CDC staff presented estimates about how well the COVID-19 vaccines work to prevent one case of hospitalization from the disease over 4 months among people aged 50 and older.

The major gain in preventing hospitalizations occurs with the first vaccination series and then wanes, the CDC said.

It appears that one hospitalization is prevented for every 135 people who get the first round of COVID-19 vaccinations. But it takes 674 people getting a first booster dose to prevent one hospitalization. A second booster prevents one hospitalization for every 1,205 people vaccinated.

Dr. Bell said she’s concerned about considering additional doses for “smaller and smaller return and creating an impression that we don’t have a very effective vaccination program,” even though the CDC’s data show a clear benefit.
 

Reasons to get a second booster

Elisha Hall, PhD, RD, of the CDC presented slides with some factors to help determine the urgency for a person to get a second booster:

• Having certain underlying medical conditions that increase the risk of severe COVID-19 illness.
• Being moderately or severely immunocompromised.
• Living with someone who is immunocompromised, at increased risk for severe disease, or who cannot be vaccinated because of age or contraindication.
• Being at increased risk of exposure to SARS-CoV-2, the virus that causes COVID-19, such as through occupational, institutional, or other activities (e.g., travel or large gatherings).
• Living or working in an area where there is a medium or high level of COVID-19 in the community.

In contrast, people might want to wait if they had been infected with SARS-CoV-2 within the past 3 months, Dr. Hall said in her presentation. Another reason for delay might be a concern that a booster dose may be more important later in the year.

The experts also addressed public confusion over boosters. For the Pfizer and Moderna mRNA vaccines, a second booster is a fourth dose, but for those who received the one-shot J&J vaccine, the second booster is a third dose.

Going forward, it may be easier to refer to subsequent doses as “annual boosters,” the CDC’s Sara Oliver, MD, MSPH, told the panel. It will be important to keep language about subsequent vaccinations clear and easy for the public to follow, she said.

Dr. Oliver also said there’s already been a drop-off in the acceptance of second rounds of COVID-19 vaccinations. CDC data show that 77% of people in the United States have had at least one dose of a COVID-19 vaccine, but only 66% of the population is fully vaccinated, and only 45% have had a first booster dose.

In her presentation, Dr. Oliver said the top priority in COVID-19 vaccination efforts remains initial vaccinations for people who haven’t gotten them.
 

Kids younger than 5

During the public comment session of the CDC meeting, several people called on the FDA to move quickly to expand authorization of COVID-19 vaccines to children aged 5 years and younger.

“We know that many parents and caregivers and health care providers are anxious to have COVID vaccines available” for young children, said Doran Fink, MD, PhD, a deputy director of the FDA’s vaccines division.

He said the agency is working to be ready to authorize the shots for young children while it awaits research results from the manufacturers.

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

The Centers for Disease Control and Prevention is considering what to tell the public about second booster shots with mRNA vaccinations for COVID-19.

The U.S. Food and Drug Administration in March authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for people aged 50 and older and certain immunocompromised adults, even though many top infectious disease experts questioned the need before the agency’s decision.

In a meeting April 20, the CDC asked its Advisory Committee on Immunization Practices to discuss second booster shots, but did not ask the group of experts to vote on formal recommendations.

Instead, the experts talked about the potential timing of additional COVID-19 vaccines for those who already have had three shots, and challenges for vaccination efforts that likely will arise as the pandemic persists.

ACIP member Beth Bell, MD, MPH, of the University of Washington, Seattle, said she’s concerned about the potential for “booster fatigue.”

“A vaccination program that’s going to require boosting large proportions of the population every 4-6 months is really not sustainable and probably not something that most people want to participate in,” she said.

The benefit of additional COVID-19 shots for now appears to be smaller than what people get from the initial doses, Dr. Bell said.

Earlier in the meeting, CDC staff presented estimates about how well the COVID-19 vaccines work to prevent one case of hospitalization from the disease over 4 months among people aged 50 and older.

The major gain in preventing hospitalizations occurs with the first vaccination series and then wanes, the CDC said.

It appears that one hospitalization is prevented for every 135 people who get the first round of COVID-19 vaccinations. But it takes 674 people getting a first booster dose to prevent one hospitalization. A second booster prevents one hospitalization for every 1,205 people vaccinated.

Dr. Bell said she’s concerned about considering additional doses for “smaller and smaller return and creating an impression that we don’t have a very effective vaccination program,” even though the CDC’s data show a clear benefit.
 

Reasons to get a second booster

Elisha Hall, PhD, RD, of the CDC presented slides with some factors to help determine the urgency for a person to get a second booster:

• Having certain underlying medical conditions that increase the risk of severe COVID-19 illness.
• Being moderately or severely immunocompromised.
• Living with someone who is immunocompromised, at increased risk for severe disease, or who cannot be vaccinated because of age or contraindication.
• Being at increased risk of exposure to SARS-CoV-2, the virus that causes COVID-19, such as through occupational, institutional, or other activities (e.g., travel or large gatherings).
• Living or working in an area where there is a medium or high level of COVID-19 in the community.

In contrast, people might want to wait if they had been infected with SARS-CoV-2 within the past 3 months, Dr. Hall said in her presentation. Another reason for delay might be a concern that a booster dose may be more important later in the year.

The experts also addressed public confusion over boosters. For the Pfizer and Moderna mRNA vaccines, a second booster is a fourth dose, but for those who received the one-shot J&J vaccine, the second booster is a third dose.

Going forward, it may be easier to refer to subsequent doses as “annual boosters,” the CDC’s Sara Oliver, MD, MSPH, told the panel. It will be important to keep language about subsequent vaccinations clear and easy for the public to follow, she said.

Dr. Oliver also said there’s already been a drop-off in the acceptance of second rounds of COVID-19 vaccinations. CDC data show that 77% of people in the United States have had at least one dose of a COVID-19 vaccine, but only 66% of the population is fully vaccinated, and only 45% have had a first booster dose.

In her presentation, Dr. Oliver said the top priority in COVID-19 vaccination efforts remains initial vaccinations for people who haven’t gotten them.
 

Kids younger than 5

During the public comment session of the CDC meeting, several people called on the FDA to move quickly to expand authorization of COVID-19 vaccines to children aged 5 years and younger.

“We know that many parents and caregivers and health care providers are anxious to have COVID vaccines available” for young children, said Doran Fink, MD, PhD, a deputy director of the FDA’s vaccines division.

He said the agency is working to be ready to authorize the shots for young children while it awaits research results from the manufacturers.

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

The Centers for Disease Control and Prevention is considering what to tell the public about second booster shots with mRNA vaccinations for COVID-19.

The U.S. Food and Drug Administration in March authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for people aged 50 and older and certain immunocompromised adults, even though many top infectious disease experts questioned the need before the agency’s decision.

In a meeting April 20, the CDC asked its Advisory Committee on Immunization Practices to discuss second booster shots, but did not ask the group of experts to vote on formal recommendations.

Instead, the experts talked about the potential timing of additional COVID-19 vaccines for those who already have had three shots, and challenges for vaccination efforts that likely will arise as the pandemic persists.

ACIP member Beth Bell, MD, MPH, of the University of Washington, Seattle, said she’s concerned about the potential for “booster fatigue.”

“A vaccination program that’s going to require boosting large proportions of the population every 4-6 months is really not sustainable and probably not something that most people want to participate in,” she said.

The benefit of additional COVID-19 shots for now appears to be smaller than what people get from the initial doses, Dr. Bell said.

Earlier in the meeting, CDC staff presented estimates about how well the COVID-19 vaccines work to prevent one case of hospitalization from the disease over 4 months among people aged 50 and older.

The major gain in preventing hospitalizations occurs with the first vaccination series and then wanes, the CDC said.

It appears that one hospitalization is prevented for every 135 people who get the first round of COVID-19 vaccinations. But it takes 674 people getting a first booster dose to prevent one hospitalization. A second booster prevents one hospitalization for every 1,205 people vaccinated.

Dr. Bell said she’s concerned about considering additional doses for “smaller and smaller return and creating an impression that we don’t have a very effective vaccination program,” even though the CDC’s data show a clear benefit.
 

Reasons to get a second booster

Elisha Hall, PhD, RD, of the CDC presented slides with some factors to help determine the urgency for a person to get a second booster:

• Having certain underlying medical conditions that increase the risk of severe COVID-19 illness.
• Being moderately or severely immunocompromised.
• Living with someone who is immunocompromised, at increased risk for severe disease, or who cannot be vaccinated because of age or contraindication.
• Being at increased risk of exposure to SARS-CoV-2, the virus that causes COVID-19, such as through occupational, institutional, or other activities (e.g., travel or large gatherings).
• Living or working in an area where there is a medium or high level of COVID-19 in the community.

In contrast, people might want to wait if they had been infected with SARS-CoV-2 within the past 3 months, Dr. Hall said in her presentation. Another reason for delay might be a concern that a booster dose may be more important later in the year.

The experts also addressed public confusion over boosters. For the Pfizer and Moderna mRNA vaccines, a second booster is a fourth dose, but for those who received the one-shot J&J vaccine, the second booster is a third dose.

Going forward, it may be easier to refer to subsequent doses as “annual boosters,” the CDC’s Sara Oliver, MD, MSPH, told the panel. It will be important to keep language about subsequent vaccinations clear and easy for the public to follow, she said.

Dr. Oliver also said there’s already been a drop-off in the acceptance of second rounds of COVID-19 vaccinations. CDC data show that 77% of people in the United States have had at least one dose of a COVID-19 vaccine, but only 66% of the population is fully vaccinated, and only 45% have had a first booster dose.

In her presentation, Dr. Oliver said the top priority in COVID-19 vaccination efforts remains initial vaccinations for people who haven’t gotten them.
 

Kids younger than 5

During the public comment session of the CDC meeting, several people called on the FDA to move quickly to expand authorization of COVID-19 vaccines to children aged 5 years and younger.

“We know that many parents and caregivers and health care providers are anxious to have COVID vaccines available” for young children, said Doran Fink, MD, PhD, a deputy director of the FDA’s vaccines division.

He said the agency is working to be ready to authorize the shots for young children while it awaits research results from the manufacturers.

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

The Food and Drug Administration issued warning letters to 12 companies selling over-the-counter (OTC) skin lightening products, the agency announced on April 19. All the products contain hydroquinone as the active ingredient, and don’t meet the requirements to be sold legally over the counter. The letters were dated April 13.

The 12 products with hydroquinone are “unapproved drugs and are not generally recognized as safe and effective” (abbreviated as GRASE), the FDA said.

Among the side effects associated with hydroquinone products reported to the FDA are skin rashes, facial swelling, and skin discoloration or ochronosis. The discoloration can be permanent, the FDA said. The lighteners are marketed for use on age or dark spots on the skin associated with melasma.

Tri-Luma, a prescription product for the treatment of moderate to severe melasma of the face, is the only FDA-approved drug containing hydroquinone, according to the FDA. It contains 4% hydroquinone and two other ingredients. It is meant to be used under the supervision of a health care professional. Tri-Luma is indicated for up to 8 weeks of treatment for moderate to severe melasma of the face. The OTC products contain up to 2%. (Generic versions of 4% hydroquinone are available by prescription, dermatologists said.)

“Hydroquinone is a very effective medication, and that’s exactly what it is, a medication,” said Lily Talakoub, MD, a dermatologist in McLean, Va., who supports the FDA action. “It’s very effective and very safe to use in the right hands, but when it is overused or used in the wrong situation, it can cause problems.” Those problems often occur, she said, when there is no health care professional overseeing the use of the OTC products, and when people use them over the long term.

The FDA action to ban the OTC products is “very appropriate,” said dermatologist Pooja Sodha, MD, assistant professor and director of the Center for Laser and Cosmetic Dermatology at George Washington University, Washington. “We know patients pick this up [an OTC product] and use it without physician oversight.” When patients use the products longer than is appropriate, which is also common, it can worsen the initial skin issue, she said.

The action follows reforms finalized under the CARES Act (Coronavirus Aid, Relief and Economic Security Act), which included not only COVID-19 response efforts but also updated the method in which certain OTC drugs are regulated. Manufacturers of the skin lightening products that don’t have FDA approval had been told to remove the products from the market by September 2020.

The recent letters were sent to a dozen companies still marketing their products without an FDA new drug approval. The agency asked the companies to take prompt action and respond with 15 days, stating what they have done to correct the violations.

The 12 companies are AMBI Enterprises, Clinical Formula, Elements Brands Inc., Genomma Lab USA, Intilight/Dr Thomas Balshi, M&M Beauty and Wellness, Neoteric Cosmetics/Scott’s Liquid Gold, Skin Authority, Skin Pro, Skin PS Brands, True Earth Health Products, and Ultimark Products.

Health care professionals and consumers can report adverse reactions associated with these products to the FDA’s MedWatch Adverse Event Reporting program.

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

The Food and Drug Administration issued warning letters to 12 companies selling over-the-counter (OTC) skin lightening products, the agency announced on April 19. All the products contain hydroquinone as the active ingredient, and don’t meet the requirements to be sold legally over the counter. The letters were dated April 13.

The 12 products with hydroquinone are “unapproved drugs and are not generally recognized as safe and effective” (abbreviated as GRASE), the FDA said.

Among the side effects associated with hydroquinone products reported to the FDA are skin rashes, facial swelling, and skin discoloration or ochronosis. The discoloration can be permanent, the FDA said. The lighteners are marketed for use on age or dark spots on the skin associated with melasma.

Tri-Luma, a prescription product for the treatment of moderate to severe melasma of the face, is the only FDA-approved drug containing hydroquinone, according to the FDA. It contains 4% hydroquinone and two other ingredients. It is meant to be used under the supervision of a health care professional. Tri-Luma is indicated for up to 8 weeks of treatment for moderate to severe melasma of the face. The OTC products contain up to 2%. (Generic versions of 4% hydroquinone are available by prescription, dermatologists said.)

“Hydroquinone is a very effective medication, and that’s exactly what it is, a medication,” said Lily Talakoub, MD, a dermatologist in McLean, Va., who supports the FDA action. “It’s very effective and very safe to use in the right hands, but when it is overused or used in the wrong situation, it can cause problems.” Those problems often occur, she said, when there is no health care professional overseeing the use of the OTC products, and when people use them over the long term.

The FDA action to ban the OTC products is “very appropriate,” said dermatologist Pooja Sodha, MD, assistant professor and director of the Center for Laser and Cosmetic Dermatology at George Washington University, Washington. “We know patients pick this up [an OTC product] and use it without physician oversight.” When patients use the products longer than is appropriate, which is also common, it can worsen the initial skin issue, she said.

The action follows reforms finalized under the CARES Act (Coronavirus Aid, Relief and Economic Security Act), which included not only COVID-19 response efforts but also updated the method in which certain OTC drugs are regulated. Manufacturers of the skin lightening products that don’t have FDA approval had been told to remove the products from the market by September 2020.

The recent letters were sent to a dozen companies still marketing their products without an FDA new drug approval. The agency asked the companies to take prompt action and respond with 15 days, stating what they have done to correct the violations.

The 12 companies are AMBI Enterprises, Clinical Formula, Elements Brands Inc., Genomma Lab USA, Intilight/Dr Thomas Balshi, M&M Beauty and Wellness, Neoteric Cosmetics/Scott’s Liquid Gold, Skin Authority, Skin Pro, Skin PS Brands, True Earth Health Products, and Ultimark Products.

Health care professionals and consumers can report adverse reactions associated with these products to the FDA’s MedWatch Adverse Event Reporting program.

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

The Food and Drug Administration issued warning letters to 12 companies selling over-the-counter (OTC) skin lightening products, the agency announced on April 19. All the products contain hydroquinone as the active ingredient, and don’t meet the requirements to be sold legally over the counter. The letters were dated April 13.

The 12 products with hydroquinone are “unapproved drugs and are not generally recognized as safe and effective” (abbreviated as GRASE), the FDA said.

Among the side effects associated with hydroquinone products reported to the FDA are skin rashes, facial swelling, and skin discoloration or ochronosis. The discoloration can be permanent, the FDA said. The lighteners are marketed for use on age or dark spots on the skin associated with melasma.

Tri-Luma, a prescription product for the treatment of moderate to severe melasma of the face, is the only FDA-approved drug containing hydroquinone, according to the FDA. It contains 4% hydroquinone and two other ingredients. It is meant to be used under the supervision of a health care professional. Tri-Luma is indicated for up to 8 weeks of treatment for moderate to severe melasma of the face. The OTC products contain up to 2%. (Generic versions of 4% hydroquinone are available by prescription, dermatologists said.)

“Hydroquinone is a very effective medication, and that’s exactly what it is, a medication,” said Lily Talakoub, MD, a dermatologist in McLean, Va., who supports the FDA action. “It’s very effective and very safe to use in the right hands, but when it is overused or used in the wrong situation, it can cause problems.” Those problems often occur, she said, when there is no health care professional overseeing the use of the OTC products, and when people use them over the long term.

The FDA action to ban the OTC products is “very appropriate,” said dermatologist Pooja Sodha, MD, assistant professor and director of the Center for Laser and Cosmetic Dermatology at George Washington University, Washington. “We know patients pick this up [an OTC product] and use it without physician oversight.” When patients use the products longer than is appropriate, which is also common, it can worsen the initial skin issue, she said.

The action follows reforms finalized under the CARES Act (Coronavirus Aid, Relief and Economic Security Act), which included not only COVID-19 response efforts but also updated the method in which certain OTC drugs are regulated. Manufacturers of the skin lightening products that don’t have FDA approval had been told to remove the products from the market by September 2020.

The recent letters were sent to a dozen companies still marketing their products without an FDA new drug approval. The agency asked the companies to take prompt action and respond with 15 days, stating what they have done to correct the violations.

The 12 companies are AMBI Enterprises, Clinical Formula, Elements Brands Inc., Genomma Lab USA, Intilight/Dr Thomas Balshi, M&M Beauty and Wellness, Neoteric Cosmetics/Scott’s Liquid Gold, Skin Authority, Skin Pro, Skin PS Brands, True Earth Health Products, and Ultimark Products.

Health care professionals and consumers can report adverse reactions associated with these products to the FDA’s MedWatch Adverse Event Reporting program.

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

The next generation of COVID-19 vaccines should be able to fight off a new strain and be given each year, a panel of experts that advises the Food and Drug Administration said April 6.

But members of the panel also acknowledged that it will be an uphill battle to reach that goal, especially given how quickly the virus continues to change.

The members of the Vaccines and Related Biological Products Advisory Committee said they want to find the balance that makes sure Americans are protected against severe illness and death but doesn’t wear them out with constant recommendations for boosters.

“We don’t feel comfortable with multiple boosters every 8 weeks,” said committee chairman Arnold Monto, MD, professor emeritus of public health at the University of Michigan, Ann Arbor. “We’d love to see an annual vaccination similar to influenza but realize that the evolution of the virus will dictate how we respond in terms of additional vaccine doses.”

The virus itself will dictate vaccination plans, he said.

The government must also keep its focus on convincing Americans who haven’t been vaccinated to join the club, said committee member Henry H. Bernstein, DO, given that “it seems quite obvious that those who are vaccinated do better than those who aren’t vaccinated.”

The government should clearly communicate to the public the goals of vaccination, he said.

“I would suggest that our overall aim is to prevent severe disease, hospitalization, and death more than just infection prevention,” said Dr. Bernstein, professor of pediatrics at Hofstra University, Hempstead, N.Y.

The FDA called the meeting of its advisers to discuss overall booster and vaccine strategy, even though it already authorized a fourth dose of the Pfizer and Moderna vaccines for certain immune compromised adults and for everyone over age 50.

Early in the all-day meeting, temporary committee member James Hildreth, MD, the president of Meharry Medical College, Nashville, Tenn., asked why that authorization was given without the panel’s input. Peter Marks, MD, the director of FDA’s Center for Biologics Evaluation and Research, said the decision was based on data from the United Kingdom and Israel that suggested immunity from a third shot was already waning.

Dr. Marks later said the fourth dose was “authorized as a stopgap measure until we could get something else in place,” because the aim was to protect older Americans who had died at a higher rate than younger individuals.

“I think we’re very much on board that we simply can’t be boosting people as frequently as we are,” said Dr. Marks.
 

Not enough information to make broader plan

The meeting was meant to be a larger conversation about how to keep pace with the evolving virus and to set up a vaccine selection and development process to better and more quickly respond to changes, such as new variants.

But committee members said they felt stymied by a lack of information. They wanted more data from vaccine manufacturers’ clinical trials. And they noted that so far, there’s no objective, reliable lab-based measurement of COVID-19 vaccine effectiveness – known as a correlate of immunity. Instead, public health officials have looked at rates of hospitalizations and deaths to measure whether the vaccine is still offering protection.

“The question is, what is insufficient protection?” asked H. Cody Meissner, MD, director of pediatric infectious disease at Tufts Medical Center in Boston. “At what point will we say the vaccine isn’t working well enough?”

Centers for Disease Control and Prevention officials presented data showing that a third shot has been more effective than a two-shot regimen in preventing serious disease and death, and that the three shots were significantly more protective than being unvaccinated.

In February, as the Omicron variant continued to rage, unvaccinated Americans aged 5 years and older had an almost three times higher risk of testing positive, and nine times higher risk of dying, compared with those who were considered fully vaccinated, said Heather Scobie, PhD, MPH, a member of the CDC’s COVID-19 Emergency Response team.

But only 98 million Americans – about half of those aged 12 years or older – have received a third dose, Dr. Scobie said.

It’s also still not clear how much more protection a fourth shot adds, or how long it will last. The committee heard data on a just-published study of a fourth dose of the Pfizer vaccine given to some 600,000 Israelis during the Omicron wave from January to March. The rate of severe COVID-19 was 3.5 times lower in the group that received a fourth dose, compared with those who had gotten only three shots, and protection lasted for at least 12 weeks.

Still, study authors said, any protection against infection itself was “short lived.”


 

More like flu vaccine?

The advisers discussed the possibility of making COVID-19 vaccine development similar to the process for the flu vaccine but acknowledged many difficulties.

The flu predictably hits during the winter in each hemisphere and a global surveillance network helps the World Health Organization decide on the vaccine strains each year. Then each nation’s regulatory and public health officials choose the strains for their shot and vaccine makers begin what is typically a 6-month-long manufacturing process.

COVID outbreaks have happened during all seasons and new variants haven’t always hit every country in a similar fashion. The COVID virus has mutated at five times the speed of the flu virus – producing a new dominant strain in a year, compared with the 3-5 years it takes for the flu virus to do so, said Trevor Bedford, PhD, a professor in the vaccine and infectious disease division at the Fred Hutchinson Cancer Research Center in Seattle.

Global COVID surveillance is patchy and the WHO has not yet created a program to help select strains for a COVID-19 vaccine but is working on a process. Currently, vaccine makers seem to be driving vaccine strain selection, said panelist Paul Offit, MD, professor of paediatrics at Children’s Hospital of Philadelphia. “I feel like to some extent the companies dictate the conversation. It shouldn’t come from them. It should come from us.”

“The important thing is that the public understands how complex this is,” said temporary committee member Oveta A. Fuller, PhD, associate professor of microbiology and immunology at the University of Michigan. “We didn’t get to understand influenza in 2 years. It’s taken years to get an imperfect but useful process to deal with flu.”

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

The next generation of COVID-19 vaccines should be able to fight off a new strain and be given each year, a panel of experts that advises the Food and Drug Administration said April 6.

But members of the panel also acknowledged that it will be an uphill battle to reach that goal, especially given how quickly the virus continues to change.

The members of the Vaccines and Related Biological Products Advisory Committee said they want to find the balance that makes sure Americans are protected against severe illness and death but doesn’t wear them out with constant recommendations for boosters.

“We don’t feel comfortable with multiple boosters every 8 weeks,” said committee chairman Arnold Monto, MD, professor emeritus of public health at the University of Michigan, Ann Arbor. “We’d love to see an annual vaccination similar to influenza but realize that the evolution of the virus will dictate how we respond in terms of additional vaccine doses.”

The virus itself will dictate vaccination plans, he said.

The government must also keep its focus on convincing Americans who haven’t been vaccinated to join the club, said committee member Henry H. Bernstein, DO, given that “it seems quite obvious that those who are vaccinated do better than those who aren’t vaccinated.”

The government should clearly communicate to the public the goals of vaccination, he said.

“I would suggest that our overall aim is to prevent severe disease, hospitalization, and death more than just infection prevention,” said Dr. Bernstein, professor of pediatrics at Hofstra University, Hempstead, N.Y.

The FDA called the meeting of its advisers to discuss overall booster and vaccine strategy, even though it already authorized a fourth dose of the Pfizer and Moderna vaccines for certain immune compromised adults and for everyone over age 50.

Early in the all-day meeting, temporary committee member James Hildreth, MD, the president of Meharry Medical College, Nashville, Tenn., asked why that authorization was given without the panel’s input. Peter Marks, MD, the director of FDA’s Center for Biologics Evaluation and Research, said the decision was based on data from the United Kingdom and Israel that suggested immunity from a third shot was already waning.

Dr. Marks later said the fourth dose was “authorized as a stopgap measure until we could get something else in place,” because the aim was to protect older Americans who had died at a higher rate than younger individuals.

“I think we’re very much on board that we simply can’t be boosting people as frequently as we are,” said Dr. Marks.
 

Not enough information to make broader plan

The meeting was meant to be a larger conversation about how to keep pace with the evolving virus and to set up a vaccine selection and development process to better and more quickly respond to changes, such as new variants.

But committee members said they felt stymied by a lack of information. They wanted more data from vaccine manufacturers’ clinical trials. And they noted that so far, there’s no objective, reliable lab-based measurement of COVID-19 vaccine effectiveness – known as a correlate of immunity. Instead, public health officials have looked at rates of hospitalizations and deaths to measure whether the vaccine is still offering protection.

“The question is, what is insufficient protection?” asked H. Cody Meissner, MD, director of pediatric infectious disease at Tufts Medical Center in Boston. “At what point will we say the vaccine isn’t working well enough?”

Centers for Disease Control and Prevention officials presented data showing that a third shot has been more effective than a two-shot regimen in preventing serious disease and death, and that the three shots were significantly more protective than being unvaccinated.

In February, as the Omicron variant continued to rage, unvaccinated Americans aged 5 years and older had an almost three times higher risk of testing positive, and nine times higher risk of dying, compared with those who were considered fully vaccinated, said Heather Scobie, PhD, MPH, a member of the CDC’s COVID-19 Emergency Response team.

But only 98 million Americans – about half of those aged 12 years or older – have received a third dose, Dr. Scobie said.

It’s also still not clear how much more protection a fourth shot adds, or how long it will last. The committee heard data on a just-published study of a fourth dose of the Pfizer vaccine given to some 600,000 Israelis during the Omicron wave from January to March. The rate of severe COVID-19 was 3.5 times lower in the group that received a fourth dose, compared with those who had gotten only three shots, and protection lasted for at least 12 weeks.

Still, study authors said, any protection against infection itself was “short lived.”


 

More like flu vaccine?

The advisers discussed the possibility of making COVID-19 vaccine development similar to the process for the flu vaccine but acknowledged many difficulties.

The flu predictably hits during the winter in each hemisphere and a global surveillance network helps the World Health Organization decide on the vaccine strains each year. Then each nation’s regulatory and public health officials choose the strains for their shot and vaccine makers begin what is typically a 6-month-long manufacturing process.

COVID outbreaks have happened during all seasons and new variants haven’t always hit every country in a similar fashion. The COVID virus has mutated at five times the speed of the flu virus – producing a new dominant strain in a year, compared with the 3-5 years it takes for the flu virus to do so, said Trevor Bedford, PhD, a professor in the vaccine and infectious disease division at the Fred Hutchinson Cancer Research Center in Seattle.

Global COVID surveillance is patchy and the WHO has not yet created a program to help select strains for a COVID-19 vaccine but is working on a process. Currently, vaccine makers seem to be driving vaccine strain selection, said panelist Paul Offit, MD, professor of paediatrics at Children’s Hospital of Philadelphia. “I feel like to some extent the companies dictate the conversation. It shouldn’t come from them. It should come from us.”

“The important thing is that the public understands how complex this is,” said temporary committee member Oveta A. Fuller, PhD, associate professor of microbiology and immunology at the University of Michigan. “We didn’t get to understand influenza in 2 years. It’s taken years to get an imperfect but useful process to deal with flu.”

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

The next generation of COVID-19 vaccines should be able to fight off a new strain and be given each year, a panel of experts that advises the Food and Drug Administration said April 6.

But members of the panel also acknowledged that it will be an uphill battle to reach that goal, especially given how quickly the virus continues to change.

The members of the Vaccines and Related Biological Products Advisory Committee said they want to find the balance that makes sure Americans are protected against severe illness and death but doesn’t wear them out with constant recommendations for boosters.

“We don’t feel comfortable with multiple boosters every 8 weeks,” said committee chairman Arnold Monto, MD, professor emeritus of public health at the University of Michigan, Ann Arbor. “We’d love to see an annual vaccination similar to influenza but realize that the evolution of the virus will dictate how we respond in terms of additional vaccine doses.”

The virus itself will dictate vaccination plans, he said.

The government must also keep its focus on convincing Americans who haven’t been vaccinated to join the club, said committee member Henry H. Bernstein, DO, given that “it seems quite obvious that those who are vaccinated do better than those who aren’t vaccinated.”

The government should clearly communicate to the public the goals of vaccination, he said.

“I would suggest that our overall aim is to prevent severe disease, hospitalization, and death more than just infection prevention,” said Dr. Bernstein, professor of pediatrics at Hofstra University, Hempstead, N.Y.

The FDA called the meeting of its advisers to discuss overall booster and vaccine strategy, even though it already authorized a fourth dose of the Pfizer and Moderna vaccines for certain immune compromised adults and for everyone over age 50.

Early in the all-day meeting, temporary committee member James Hildreth, MD, the president of Meharry Medical College, Nashville, Tenn., asked why that authorization was given without the panel’s input. Peter Marks, MD, the director of FDA’s Center for Biologics Evaluation and Research, said the decision was based on data from the United Kingdom and Israel that suggested immunity from a third shot was already waning.

Dr. Marks later said the fourth dose was “authorized as a stopgap measure until we could get something else in place,” because the aim was to protect older Americans who had died at a higher rate than younger individuals.

“I think we’re very much on board that we simply can’t be boosting people as frequently as we are,” said Dr. Marks.
 

Not enough information to make broader plan

The meeting was meant to be a larger conversation about how to keep pace with the evolving virus and to set up a vaccine selection and development process to better and more quickly respond to changes, such as new variants.

But committee members said they felt stymied by a lack of information. They wanted more data from vaccine manufacturers’ clinical trials. And they noted that so far, there’s no objective, reliable lab-based measurement of COVID-19 vaccine effectiveness – known as a correlate of immunity. Instead, public health officials have looked at rates of hospitalizations and deaths to measure whether the vaccine is still offering protection.

“The question is, what is insufficient protection?” asked H. Cody Meissner, MD, director of pediatric infectious disease at Tufts Medical Center in Boston. “At what point will we say the vaccine isn’t working well enough?”

Centers for Disease Control and Prevention officials presented data showing that a third shot has been more effective than a two-shot regimen in preventing serious disease and death, and that the three shots were significantly more protective than being unvaccinated.

In February, as the Omicron variant continued to rage, unvaccinated Americans aged 5 years and older had an almost three times higher risk of testing positive, and nine times higher risk of dying, compared with those who were considered fully vaccinated, said Heather Scobie, PhD, MPH, a member of the CDC’s COVID-19 Emergency Response team.

But only 98 million Americans – about half of those aged 12 years or older – have received a third dose, Dr. Scobie said.

It’s also still not clear how much more protection a fourth shot adds, or how long it will last. The committee heard data on a just-published study of a fourth dose of the Pfizer vaccine given to some 600,000 Israelis during the Omicron wave from January to March. The rate of severe COVID-19 was 3.5 times lower in the group that received a fourth dose, compared with those who had gotten only three shots, and protection lasted for at least 12 weeks.

Still, study authors said, any protection against infection itself was “short lived.”


 

More like flu vaccine?

The advisers discussed the possibility of making COVID-19 vaccine development similar to the process for the flu vaccine but acknowledged many difficulties.

The flu predictably hits during the winter in each hemisphere and a global surveillance network helps the World Health Organization decide on the vaccine strains each year. Then each nation’s regulatory and public health officials choose the strains for their shot and vaccine makers begin what is typically a 6-month-long manufacturing process.

COVID outbreaks have happened during all seasons and new variants haven’t always hit every country in a similar fashion. The COVID virus has mutated at five times the speed of the flu virus – producing a new dominant strain in a year, compared with the 3-5 years it takes for the flu virus to do so, said Trevor Bedford, PhD, a professor in the vaccine and infectious disease division at the Fred Hutchinson Cancer Research Center in Seattle.

Global COVID surveillance is patchy and the WHO has not yet created a program to help select strains for a COVID-19 vaccine but is working on a process. Currently, vaccine makers seem to be driving vaccine strain selection, said panelist Paul Offit, MD, professor of paediatrics at Children’s Hospital of Philadelphia. “I feel like to some extent the companies dictate the conversation. It shouldn’t come from them. It should come from us.”

“The important thing is that the public understands how complex this is,” said temporary committee member Oveta A. Fuller, PhD, associate professor of microbiology and immunology at the University of Michigan. “We didn’t get to understand influenza in 2 years. It’s taken years to get an imperfect but useful process to deal with flu.”

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

The Biden administration has announced a massive federal effort to better understand, diagnose, and treat the crippling effects of long COVID.

The National Research Action Plan on Long COVID will gather experts from various agencies, including the Department of Defense and the Department of Veterans Affairs, to expand existing long-COVID clinics and broaden research on symptoms of the virus that persist long after infection.

“We’ll collaborate with academic, industry, state and local partners to better understand long COVID,” Health and Human Services Secretary Xavier Becerra said at a White House briefing April 5. “We need to work as aggressively as we can to make sure no American is left behind.”

The plan will build on the RECOVER Initiative, a $1.15 billion effort announced last year that will study long COVID.

The COVID-19 Response Team also announced that the United States will donate tens of millions of pediatric coronavirus vaccines to other countries. More than 20 countries have asked for the donations, the team said.

The United States has delivered more than 500 million vaccine doses to 114 countries.

Meanwhile, national COVID-19 numbers continue to fall. CDC Director Rochelle Walensky, MD, reported that average daily cases are down 4% this week to 25,000; hospitalizations have dropped 17% to 1,400 per day; and daily deaths are down to 570 a day, which is a decrease of about 17%.

New national estimates show that Omicron’s subvariant BA.2 now accounts for 72% of circulating variants nationally, she said.

Top infectious disease expert Anthony Fauci, MD, reported that recent data supports the need for a second booster among certain people 50 and older – a move authorized by the Food and Drug Administration and Centers for Disease Control and Prevention last week.

“The effectiveness of the first booster dose we know wanes over time, and growing evidence shows a second dose can restore vaccine effectiveness for certain populations,” he said.

Dr. Fauci reported findings from an Israeli study of more than 1 million people 60 and older, which showed that an additional booster dose after 4 months lowered the rate of infection by two times and lowered the rate of severe infection by more than four times.

Another study from Israeli scientists showed that out of half a million people 60 and older, a second booster after 4 months brought a 78% reduction in death, compared to those who received only the first boost.

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

The Biden administration has announced a massive federal effort to better understand, diagnose, and treat the crippling effects of long COVID.

The National Research Action Plan on Long COVID will gather experts from various agencies, including the Department of Defense and the Department of Veterans Affairs, to expand existing long-COVID clinics and broaden research on symptoms of the virus that persist long after infection.

“We’ll collaborate with academic, industry, state and local partners to better understand long COVID,” Health and Human Services Secretary Xavier Becerra said at a White House briefing April 5. “We need to work as aggressively as we can to make sure no American is left behind.”

The plan will build on the RECOVER Initiative, a $1.15 billion effort announced last year that will study long COVID.

The COVID-19 Response Team also announced that the United States will donate tens of millions of pediatric coronavirus vaccines to other countries. More than 20 countries have asked for the donations, the team said.

The United States has delivered more than 500 million vaccine doses to 114 countries.

Meanwhile, national COVID-19 numbers continue to fall. CDC Director Rochelle Walensky, MD, reported that average daily cases are down 4% this week to 25,000; hospitalizations have dropped 17% to 1,400 per day; and daily deaths are down to 570 a day, which is a decrease of about 17%.

New national estimates show that Omicron’s subvariant BA.2 now accounts for 72% of circulating variants nationally, she said.

Top infectious disease expert Anthony Fauci, MD, reported that recent data supports the need for a second booster among certain people 50 and older – a move authorized by the Food and Drug Administration and Centers for Disease Control and Prevention last week.

“The effectiveness of the first booster dose we know wanes over time, and growing evidence shows a second dose can restore vaccine effectiveness for certain populations,” he said.

Dr. Fauci reported findings from an Israeli study of more than 1 million people 60 and older, which showed that an additional booster dose after 4 months lowered the rate of infection by two times and lowered the rate of severe infection by more than four times.

Another study from Israeli scientists showed that out of half a million people 60 and older, a second booster after 4 months brought a 78% reduction in death, compared to those who received only the first boost.

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

The Biden administration has announced a massive federal effort to better understand, diagnose, and treat the crippling effects of long COVID.

The National Research Action Plan on Long COVID will gather experts from various agencies, including the Department of Defense and the Department of Veterans Affairs, to expand existing long-COVID clinics and broaden research on symptoms of the virus that persist long after infection.

“We’ll collaborate with academic, industry, state and local partners to better understand long COVID,” Health and Human Services Secretary Xavier Becerra said at a White House briefing April 5. “We need to work as aggressively as we can to make sure no American is left behind.”

The plan will build on the RECOVER Initiative, a $1.15 billion effort announced last year that will study long COVID.

The COVID-19 Response Team also announced that the United States will donate tens of millions of pediatric coronavirus vaccines to other countries. More than 20 countries have asked for the donations, the team said.

The United States has delivered more than 500 million vaccine doses to 114 countries.

Meanwhile, national COVID-19 numbers continue to fall. CDC Director Rochelle Walensky, MD, reported that average daily cases are down 4% this week to 25,000; hospitalizations have dropped 17% to 1,400 per day; and daily deaths are down to 570 a day, which is a decrease of about 17%.

New national estimates show that Omicron’s subvariant BA.2 now accounts for 72% of circulating variants nationally, she said.

Top infectious disease expert Anthony Fauci, MD, reported that recent data supports the need for a second booster among certain people 50 and older – a move authorized by the Food and Drug Administration and Centers for Disease Control and Prevention last week.

“The effectiveness of the first booster dose we know wanes over time, and growing evidence shows a second dose can restore vaccine effectiveness for certain populations,” he said.

Dr. Fauci reported findings from an Israeli study of more than 1 million people 60 and older, which showed that an additional booster dose after 4 months lowered the rate of infection by two times and lowered the rate of severe infection by more than four times.

Another study from Israeli scientists showed that out of half a million people 60 and older, a second booster after 4 months brought a 78% reduction in death, compared to those who received only the first boost.

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

The Centers for Disease Control and Prevention has recommended that all adults aged 19-59 years receive a vaccination for hepatitis B.

It also added that adults aged 60 years or older without known risk factors for hepatitis B may get vaccinated.

The agency earlier recommended the vaccination for all infants and children under the age of 19 years and for adults aged 60 years or older with known risk factors.

The CDC said it wants to expand vaccinations because, after decades of progress, the number of new hepatitis B infections is increasing among adults. Acute hepatitis B infections among adults lead to chronic hepatitis B disease in an estimated 2%-6% of cases, and can result in cirrhosis, liver cancer, and death.

Among adults aged 40-49 years, the rate of cases increased from 1.9 per 100,000 people in 2011 to 2.7 per 100,000 in 2019. Among adults aged 50-59 years, the rate increased during this period from 1.1 to 1.6 per 100,000.

Most adults aren’t vaccinated. Among adults aged 19 years or older, only 30.0% reported that they’d received at least the three recommended doses of the vaccine. The rate was 40.3% for adults aged 19-49 years, and 19.1% for adults aged 50 years or older.

Hepatitis B infection rates are particularly elevated among African Americans.

Even among adults with chronic liver disease, the vaccination rate is only 33.0%. And, among travelers to countries where the virus has been endemic since 1995, only 38.9% were vaccinated.

In a 2018 survey of internal medicine and family physicians, 68% said their patients had not told them about risk factors, making it difficult to assess whether the patients needed the vaccine according to the recommendations at the time. These risk factors include injection drug use, incarceration, and multiple sex partners, experiences the patients may not have been willing to discuss.

CDC researchers calculated that universal adult hepatitis B vaccination would cost $153,000 for every quality-adjusted life-year (QALY) gained. For adults aged 19-59 years, a QALY would cost $117,000 because infections are more prevalent in that age group.

The CDC specified that it intends its new guidelines to prompt physicians to offer the vaccine to adults aged 60 years or older rather than wait for them to request it.

The Food and Drug Administration has approved both three-dose and two-dose hepatitis B vaccines, with evidence showing similar seroprotection and adverse events.

People who have already completed their vaccination or have a history of hepatitis B infection should only receive additional vaccinations in specific cases, as detailed in the CDC’s 2018 recommendations.

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

The Centers for Disease Control and Prevention has recommended that all adults aged 19-59 years receive a vaccination for hepatitis B.

It also added that adults aged 60 years or older without known risk factors for hepatitis B may get vaccinated.

The agency earlier recommended the vaccination for all infants and children under the age of 19 years and for adults aged 60 years or older with known risk factors.

The CDC said it wants to expand vaccinations because, after decades of progress, the number of new hepatitis B infections is increasing among adults. Acute hepatitis B infections among adults lead to chronic hepatitis B disease in an estimated 2%-6% of cases, and can result in cirrhosis, liver cancer, and death.

Among adults aged 40-49 years, the rate of cases increased from 1.9 per 100,000 people in 2011 to 2.7 per 100,000 in 2019. Among adults aged 50-59 years, the rate increased during this period from 1.1 to 1.6 per 100,000.

Most adults aren’t vaccinated. Among adults aged 19 years or older, only 30.0% reported that they’d received at least the three recommended doses of the vaccine. The rate was 40.3% for adults aged 19-49 years, and 19.1% for adults aged 50 years or older.

Hepatitis B infection rates are particularly elevated among African Americans.

Even among adults with chronic liver disease, the vaccination rate is only 33.0%. And, among travelers to countries where the virus has been endemic since 1995, only 38.9% were vaccinated.

In a 2018 survey of internal medicine and family physicians, 68% said their patients had not told them about risk factors, making it difficult to assess whether the patients needed the vaccine according to the recommendations at the time. These risk factors include injection drug use, incarceration, and multiple sex partners, experiences the patients may not have been willing to discuss.

CDC researchers calculated that universal adult hepatitis B vaccination would cost $153,000 for every quality-adjusted life-year (QALY) gained. For adults aged 19-59 years, a QALY would cost $117,000 because infections are more prevalent in that age group.

The CDC specified that it intends its new guidelines to prompt physicians to offer the vaccine to adults aged 60 years or older rather than wait for them to request it.

The Food and Drug Administration has approved both three-dose and two-dose hepatitis B vaccines, with evidence showing similar seroprotection and adverse events.

People who have already completed their vaccination or have a history of hepatitis B infection should only receive additional vaccinations in specific cases, as detailed in the CDC’s 2018 recommendations.

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

The Centers for Disease Control and Prevention has recommended that all adults aged 19-59 years receive a vaccination for hepatitis B.

It also added that adults aged 60 years or older without known risk factors for hepatitis B may get vaccinated.

The agency earlier recommended the vaccination for all infants and children under the age of 19 years and for adults aged 60 years or older with known risk factors.

The CDC said it wants to expand vaccinations because, after decades of progress, the number of new hepatitis B infections is increasing among adults. Acute hepatitis B infections among adults lead to chronic hepatitis B disease in an estimated 2%-6% of cases, and can result in cirrhosis, liver cancer, and death.

Among adults aged 40-49 years, the rate of cases increased from 1.9 per 100,000 people in 2011 to 2.7 per 100,000 in 2019. Among adults aged 50-59 years, the rate increased during this period from 1.1 to 1.6 per 100,000.

Most adults aren’t vaccinated. Among adults aged 19 years or older, only 30.0% reported that they’d received at least the three recommended doses of the vaccine. The rate was 40.3% for adults aged 19-49 years, and 19.1% for adults aged 50 years or older.

Hepatitis B infection rates are particularly elevated among African Americans.

Even among adults with chronic liver disease, the vaccination rate is only 33.0%. And, among travelers to countries where the virus has been endemic since 1995, only 38.9% were vaccinated.

In a 2018 survey of internal medicine and family physicians, 68% said their patients had not told them about risk factors, making it difficult to assess whether the patients needed the vaccine according to the recommendations at the time. These risk factors include injection drug use, incarceration, and multiple sex partners, experiences the patients may not have been willing to discuss.

CDC researchers calculated that universal adult hepatitis B vaccination would cost $153,000 for every quality-adjusted life-year (QALY) gained. For adults aged 19-59 years, a QALY would cost $117,000 because infections are more prevalent in that age group.

The CDC specified that it intends its new guidelines to prompt physicians to offer the vaccine to adults aged 60 years or older rather than wait for them to request it.

The Food and Drug Administration has approved both three-dose and two-dose hepatitis B vaccines, with evidence showing similar seroprotection and adverse events.

People who have already completed their vaccination or have a history of hepatitis B infection should only receive additional vaccinations in specific cases, as detailed in the CDC’s 2018 recommendations.

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

The Food and Drug Administration today authorized Americans over the age of 50 to receive a second COVID-19 booster shot, even though many top infectious disease experts questioned the need before the agency’s decision.

The FDA granted emergency use authorization for both Pfizer and Moderna to offer the second booster – and fourth shot overall – for adults over 50 as well as those over 18 with compromised immune systems.

The Centers for Control and Prevention must still sign off before those doses start reaching American arms. That approval could come at any time.

“The general consensus, certainly the CDC’s consensus, is that the current vaccines are still really quite effective against Omicron and this new BA.2 variant in keeping people out of the hospital, and preventing the development of severe disease,” William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville said prior to the FDA’s announcement March 29.

Of the 217.4 million Americans who are “fully vaccinated,” i.e., received two doses of either Pfizer or Moderna’s vaccines or one dose of the Johnson & Johnson vaccine, only 45% have also received a booster shot, according to the CDC.

“Given that, there’s no need at the moment for the general population to get a fourth inoculation,” Dr. Schaffner says. “Our current focus ought to be on making sure that as many people as possible get that [first] booster who are eligible.”

Monica Gandhi, MD, an infectious disease specialist at the University of California, San Francisco, agreed that another booster for everyone was unnecessary. The only people who would need a fourth shot (or third, if they had the Johnson & Johnson vaccine initially) are those over age 65 or 70 years, Dr. Gandhi says.

“Older people need those antibodies up high because they’re more susceptible to severe breakthroughs,” she said, also before the latest development.
 

To boost or not to boost

Daniel Kuritzkes, MD, chief of infectious diseases at Brigham & Women’s Hospital in Boston, said the timing of a booster and who should be eligible depends on what the nation is trying to achieve with its vaccination strategy.

“Is the goal to prevent any symptomatic infection with COVID-19, is the goal to prevent the spread of COVID-19, or is the goal to prevent severe disease that requires hospitalization?” asked Dr. Kuritzkes.

The current vaccine — with a booster — has prevented severe disease, he said.

An Israeli study showed, for instance, that a third Pfizer dose was 93% effective against hospitalization, 92% effective against severe illness, and 81% effective against death.

A just-published study in the New England Journal of Medicine found that a booster of the Pfizer vaccine was 95% effective against COVID-19 infection and that it did not raise any new safety issues.

A small Israeli study, also published in NEJM, of a fourth Pfizer dose given to health care workers found that it prevented symptomatic infection and illness, but that it was much less effective than previous doses — maybe 65% effective against symptomatic illness, the authors write.

Giving Americans another booster now — which has been shown to lose some effectiveness after about 4 months — means it might not offer protection this fall and winter, when there could be a seasonal surge of the virus, Dr. Kuritzkes says.

And, even if people receive boosters every few months, they are still likely to get a mild respiratory virus infection, he said.

“I’m pretty convinced that we cannot boost ourselves out of this pandemic,” said Dr. Kuritzkes. “We need to first of all ensure there’s global immunization so that all the people who have not been vaccinated at all get vaccinated. That’s far more important than boosting people a fourth time.”
 

Booster confusion

The April 6 FDA meeting of the agency’s Vaccines and Related Biological Products Advisory Committee comes as the two major COVID vaccine makers — Pfizer and Moderna — have applied for emergency use authorization for an additional booster.

Pfizer had asked for authorization for a fourth shot in patients over age 65 years, while Moderna wanted a booster to be available to all Americans over 18. The FDA instead granted authorization to both companies for those over 50 and anyone 18 or older who is immunocompromised.

What this means for the committee’s April 6 meeting is not clear. The original agenda says the committee will consider the evidence on safety and effectiveness of the additional vaccine doses and discuss how to set up a process — similar to that used for the influenza vaccine — to be able to determine the makeup of COVID vaccines as new variants emerge. That could lay the groundwork for an annual COVID shot, if needed.

The FDA advisers will not make recommendations nor vote on whether — and which — Americans should get a COVID booster. That is the job of the CDC’s Advisory Committee on Immunization Practices (ACIP).

The last time a booster was considered, CDC Director Rochelle Walensky, MD, overrode the committee and recommended that all Americans — not just older individuals — get an additional COVID shot, which became the first booster.

That past action worries Dr. Gandhi, who calls it confusing, and says it may have contributed to the fact that less than half of Americans have since chosen to get a booster.

Dr. Schaffner says he expects the FDA to authorize emergency use for fourth doses of the Pfizer and Moderna vaccines, but he doesn’t think the CDC committee will recommend routine use. As was seen before, however, the CDC director does not have to follow the committee’s advice.

The members of ACIP “might be more conservative or narrower in scope in terms of recommending who needs to be boosted and when boosting is appropriate,” Dr. Kuritzkes says.

Dr. Gandhi says she’s concerned the FDA’s deliberations could be swayed by Moderna and Pfizer’s influence and that “pharmaceutical companies are going to have more of a say than they should in the scientific process.”

There are similar worries for Dr. Schaffner. He says he’s “a bit grumpy” that the vaccine makers have been using press releases to argue for boosters.

“Press releases are no way to make vaccine recommendations,” Dr. Schaffner said, adding that he “would advise [vaccine makers] to sit down and be quiet and let the FDA and CDC advisory committee do their thing.”

Moderna Chief Medical Officer Paul Burton, MD, however, told WebMD last week that the signs point to why a fourth shot may be needed.

“We see waning of effectiveness, antibody levels come down, and certainly effectiveness against Omicron comes down in 3 to 6 months,” Burton said. “The natural history, from what we’re seeing around the world, is that BA.2 is definitely here, it’s highly transmissible, and I think we are going to get an additional wave of BA.2 here in the United States.”

Another wave is coming, he said, and “I think there will be waning of effectiveness. We need to be prepared for that, so that’s why we need the fourth dose.”
 

Supply issues?

Meanwhile, the United Kingdom has begun offering boosters to anyone over 75, and Sweden’s health authority has recommended a fourth shot to people over age 80.

That puts pressure on the United States — at least on its politicians and policymakers — to, in a sense, keep up, said the infectious disease specialists.

Indeed, the White House has been keeping fourth shots in the news, warning that it is running out of money to ensure that all Americans would have access to one, if recommended.

On March 23, outgoing White House COVID-19 Response Coordinator Jeff Zients said the federal government had enough vaccine for the immunocompromised to get a fourth dose “and, if authorized in the coming weeks, enough supply for fourth doses for our most vulnerable, including seniors.”

But he warned that without congressional approval of a COVID-19 funding package, “We can’t procure the necessary vaccine supply to support fourth shots for all Americans.”

Mr. Zients also noted that other countries, including Japan, Vietnam, and the Philippines had already secured future booster doses and added, “We should be securing additional supply right now.”

Dr. Schaffner says that while it would be nice to “have a booster on the shelf,” the United States needs to put more effort into creating a globally-coordinated process for ensuring that vaccines match circulating strains and that they are manufactured on a timely basis.

He says he and others “have been reminding the public that the COVID pandemic may indeed be diminishing and moving into the endemic, but that doesn’t mean COVID is over or finished or disappeared.”

Dr. Schaffner says that it may be that “perhaps we’d need a periodic reminder to our immune system to remain protected. In other words, we might have to get boosted perhaps annually like we do with influenza.”

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

The Food and Drug Administration today authorized Americans over the age of 50 to receive a second COVID-19 booster shot, even though many top infectious disease experts questioned the need before the agency’s decision.

The FDA granted emergency use authorization for both Pfizer and Moderna to offer the second booster – and fourth shot overall – for adults over 50 as well as those over 18 with compromised immune systems.

The Centers for Control and Prevention must still sign off before those doses start reaching American arms. That approval could come at any time.

“The general consensus, certainly the CDC’s consensus, is that the current vaccines are still really quite effective against Omicron and this new BA.2 variant in keeping people out of the hospital, and preventing the development of severe disease,” William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville said prior to the FDA’s announcement March 29.

Of the 217.4 million Americans who are “fully vaccinated,” i.e., received two doses of either Pfizer or Moderna’s vaccines or one dose of the Johnson & Johnson vaccine, only 45% have also received a booster shot, according to the CDC.

“Given that, there’s no need at the moment for the general population to get a fourth inoculation,” Dr. Schaffner says. “Our current focus ought to be on making sure that as many people as possible get that [first] booster who are eligible.”

Monica Gandhi, MD, an infectious disease specialist at the University of California, San Francisco, agreed that another booster for everyone was unnecessary. The only people who would need a fourth shot (or third, if they had the Johnson & Johnson vaccine initially) are those over age 65 or 70 years, Dr. Gandhi says.

“Older people need those antibodies up high because they’re more susceptible to severe breakthroughs,” she said, also before the latest development.
 

To boost or not to boost

Daniel Kuritzkes, MD, chief of infectious diseases at Brigham & Women’s Hospital in Boston, said the timing of a booster and who should be eligible depends on what the nation is trying to achieve with its vaccination strategy.

“Is the goal to prevent any symptomatic infection with COVID-19, is the goal to prevent the spread of COVID-19, or is the goal to prevent severe disease that requires hospitalization?” asked Dr. Kuritzkes.

The current vaccine — with a booster — has prevented severe disease, he said.

An Israeli study showed, for instance, that a third Pfizer dose was 93% effective against hospitalization, 92% effective against severe illness, and 81% effective against death.

A just-published study in the New England Journal of Medicine found that a booster of the Pfizer vaccine was 95% effective against COVID-19 infection and that it did not raise any new safety issues.

A small Israeli study, also published in NEJM, of a fourth Pfizer dose given to health care workers found that it prevented symptomatic infection and illness, but that it was much less effective than previous doses — maybe 65% effective against symptomatic illness, the authors write.

Giving Americans another booster now — which has been shown to lose some effectiveness after about 4 months — means it might not offer protection this fall and winter, when there could be a seasonal surge of the virus, Dr. Kuritzkes says.

And, even if people receive boosters every few months, they are still likely to get a mild respiratory virus infection, he said.

“I’m pretty convinced that we cannot boost ourselves out of this pandemic,” said Dr. Kuritzkes. “We need to first of all ensure there’s global immunization so that all the people who have not been vaccinated at all get vaccinated. That’s far more important than boosting people a fourth time.”
 

Booster confusion

The April 6 FDA meeting of the agency’s Vaccines and Related Biological Products Advisory Committee comes as the two major COVID vaccine makers — Pfizer and Moderna — have applied for emergency use authorization for an additional booster.

Pfizer had asked for authorization for a fourth shot in patients over age 65 years, while Moderna wanted a booster to be available to all Americans over 18. The FDA instead granted authorization to both companies for those over 50 and anyone 18 or older who is immunocompromised.

What this means for the committee’s April 6 meeting is not clear. The original agenda says the committee will consider the evidence on safety and effectiveness of the additional vaccine doses and discuss how to set up a process — similar to that used for the influenza vaccine — to be able to determine the makeup of COVID vaccines as new variants emerge. That could lay the groundwork for an annual COVID shot, if needed.

The FDA advisers will not make recommendations nor vote on whether — and which — Americans should get a COVID booster. That is the job of the CDC’s Advisory Committee on Immunization Practices (ACIP).

The last time a booster was considered, CDC Director Rochelle Walensky, MD, overrode the committee and recommended that all Americans — not just older individuals — get an additional COVID shot, which became the first booster.

That past action worries Dr. Gandhi, who calls it confusing, and says it may have contributed to the fact that less than half of Americans have since chosen to get a booster.

Dr. Schaffner says he expects the FDA to authorize emergency use for fourth doses of the Pfizer and Moderna vaccines, but he doesn’t think the CDC committee will recommend routine use. As was seen before, however, the CDC director does not have to follow the committee’s advice.

The members of ACIP “might be more conservative or narrower in scope in terms of recommending who needs to be boosted and when boosting is appropriate,” Dr. Kuritzkes says.

Dr. Gandhi says she’s concerned the FDA’s deliberations could be swayed by Moderna and Pfizer’s influence and that “pharmaceutical companies are going to have more of a say than they should in the scientific process.”

There are similar worries for Dr. Schaffner. He says he’s “a bit grumpy” that the vaccine makers have been using press releases to argue for boosters.

“Press releases are no way to make vaccine recommendations,” Dr. Schaffner said, adding that he “would advise [vaccine makers] to sit down and be quiet and let the FDA and CDC advisory committee do their thing.”

Moderna Chief Medical Officer Paul Burton, MD, however, told WebMD last week that the signs point to why a fourth shot may be needed.

“We see waning of effectiveness, antibody levels come down, and certainly effectiveness against Omicron comes down in 3 to 6 months,” Burton said. “The natural history, from what we’re seeing around the world, is that BA.2 is definitely here, it’s highly transmissible, and I think we are going to get an additional wave of BA.2 here in the United States.”

Another wave is coming, he said, and “I think there will be waning of effectiveness. We need to be prepared for that, so that’s why we need the fourth dose.”
 

Supply issues?

Meanwhile, the United Kingdom has begun offering boosters to anyone over 75, and Sweden’s health authority has recommended a fourth shot to people over age 80.

That puts pressure on the United States — at least on its politicians and policymakers — to, in a sense, keep up, said the infectious disease specialists.

Indeed, the White House has been keeping fourth shots in the news, warning that it is running out of money to ensure that all Americans would have access to one, if recommended.

On March 23, outgoing White House COVID-19 Response Coordinator Jeff Zients said the federal government had enough vaccine for the immunocompromised to get a fourth dose “and, if authorized in the coming weeks, enough supply for fourth doses for our most vulnerable, including seniors.”

But he warned that without congressional approval of a COVID-19 funding package, “We can’t procure the necessary vaccine supply to support fourth shots for all Americans.”

Mr. Zients also noted that other countries, including Japan, Vietnam, and the Philippines had already secured future booster doses and added, “We should be securing additional supply right now.”

Dr. Schaffner says that while it would be nice to “have a booster on the shelf,” the United States needs to put more effort into creating a globally-coordinated process for ensuring that vaccines match circulating strains and that they are manufactured on a timely basis.

He says he and others “have been reminding the public that the COVID pandemic may indeed be diminishing and moving into the endemic, but that doesn’t mean COVID is over or finished or disappeared.”

Dr. Schaffner says that it may be that “perhaps we’d need a periodic reminder to our immune system to remain protected. In other words, we might have to get boosted perhaps annually like we do with influenza.”

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

The Food and Drug Administration today authorized Americans over the age of 50 to receive a second COVID-19 booster shot, even though many top infectious disease experts questioned the need before the agency’s decision.

The FDA granted emergency use authorization for both Pfizer and Moderna to offer the second booster – and fourth shot overall – for adults over 50 as well as those over 18 with compromised immune systems.

The Centers for Control and Prevention must still sign off before those doses start reaching American arms. That approval could come at any time.

“The general consensus, certainly the CDC’s consensus, is that the current vaccines are still really quite effective against Omicron and this new BA.2 variant in keeping people out of the hospital, and preventing the development of severe disease,” William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville said prior to the FDA’s announcement March 29.

Of the 217.4 million Americans who are “fully vaccinated,” i.e., received two doses of either Pfizer or Moderna’s vaccines or one dose of the Johnson & Johnson vaccine, only 45% have also received a booster shot, according to the CDC.

“Given that, there’s no need at the moment for the general population to get a fourth inoculation,” Dr. Schaffner says. “Our current focus ought to be on making sure that as many people as possible get that [first] booster who are eligible.”

Monica Gandhi, MD, an infectious disease specialist at the University of California, San Francisco, agreed that another booster for everyone was unnecessary. The only people who would need a fourth shot (or third, if they had the Johnson & Johnson vaccine initially) are those over age 65 or 70 years, Dr. Gandhi says.

“Older people need those antibodies up high because they’re more susceptible to severe breakthroughs,” she said, also before the latest development.
 

To boost or not to boost

Daniel Kuritzkes, MD, chief of infectious diseases at Brigham & Women’s Hospital in Boston, said the timing of a booster and who should be eligible depends on what the nation is trying to achieve with its vaccination strategy.

“Is the goal to prevent any symptomatic infection with COVID-19, is the goal to prevent the spread of COVID-19, or is the goal to prevent severe disease that requires hospitalization?” asked Dr. Kuritzkes.

The current vaccine — with a booster — has prevented severe disease, he said.

An Israeli study showed, for instance, that a third Pfizer dose was 93% effective against hospitalization, 92% effective against severe illness, and 81% effective against death.

A just-published study in the New England Journal of Medicine found that a booster of the Pfizer vaccine was 95% effective against COVID-19 infection and that it did not raise any new safety issues.

A small Israeli study, also published in NEJM, of a fourth Pfizer dose given to health care workers found that it prevented symptomatic infection and illness, but that it was much less effective than previous doses — maybe 65% effective against symptomatic illness, the authors write.

Giving Americans another booster now — which has been shown to lose some effectiveness after about 4 months — means it might not offer protection this fall and winter, when there could be a seasonal surge of the virus, Dr. Kuritzkes says.

And, even if people receive boosters every few months, they are still likely to get a mild respiratory virus infection, he said.

“I’m pretty convinced that we cannot boost ourselves out of this pandemic,” said Dr. Kuritzkes. “We need to first of all ensure there’s global immunization so that all the people who have not been vaccinated at all get vaccinated. That’s far more important than boosting people a fourth time.”
 

Booster confusion

The April 6 FDA meeting of the agency’s Vaccines and Related Biological Products Advisory Committee comes as the two major COVID vaccine makers — Pfizer and Moderna — have applied for emergency use authorization for an additional booster.

Pfizer had asked for authorization for a fourth shot in patients over age 65 years, while Moderna wanted a booster to be available to all Americans over 18. The FDA instead granted authorization to both companies for those over 50 and anyone 18 or older who is immunocompromised.

What this means for the committee’s April 6 meeting is not clear. The original agenda says the committee will consider the evidence on safety and effectiveness of the additional vaccine doses and discuss how to set up a process — similar to that used for the influenza vaccine — to be able to determine the makeup of COVID vaccines as new variants emerge. That could lay the groundwork for an annual COVID shot, if needed.

The FDA advisers will not make recommendations nor vote on whether — and which — Americans should get a COVID booster. That is the job of the CDC’s Advisory Committee on Immunization Practices (ACIP).

The last time a booster was considered, CDC Director Rochelle Walensky, MD, overrode the committee and recommended that all Americans — not just older individuals — get an additional COVID shot, which became the first booster.

That past action worries Dr. Gandhi, who calls it confusing, and says it may have contributed to the fact that less than half of Americans have since chosen to get a booster.

Dr. Schaffner says he expects the FDA to authorize emergency use for fourth doses of the Pfizer and Moderna vaccines, but he doesn’t think the CDC committee will recommend routine use. As was seen before, however, the CDC director does not have to follow the committee’s advice.

The members of ACIP “might be more conservative or narrower in scope in terms of recommending who needs to be boosted and when boosting is appropriate,” Dr. Kuritzkes says.

Dr. Gandhi says she’s concerned the FDA’s deliberations could be swayed by Moderna and Pfizer’s influence and that “pharmaceutical companies are going to have more of a say than they should in the scientific process.”

There are similar worries for Dr. Schaffner. He says he’s “a bit grumpy” that the vaccine makers have been using press releases to argue for boosters.

“Press releases are no way to make vaccine recommendations,” Dr. Schaffner said, adding that he “would advise [vaccine makers] to sit down and be quiet and let the FDA and CDC advisory committee do their thing.”

Moderna Chief Medical Officer Paul Burton, MD, however, told WebMD last week that the signs point to why a fourth shot may be needed.

“We see waning of effectiveness, antibody levels come down, and certainly effectiveness against Omicron comes down in 3 to 6 months,” Burton said. “The natural history, from what we’re seeing around the world, is that BA.2 is definitely here, it’s highly transmissible, and I think we are going to get an additional wave of BA.2 here in the United States.”

Another wave is coming, he said, and “I think there will be waning of effectiveness. We need to be prepared for that, so that’s why we need the fourth dose.”
 

Supply issues?

Meanwhile, the United Kingdom has begun offering boosters to anyone over 75, and Sweden’s health authority has recommended a fourth shot to people over age 80.

That puts pressure on the United States — at least on its politicians and policymakers — to, in a sense, keep up, said the infectious disease specialists.

Indeed, the White House has been keeping fourth shots in the news, warning that it is running out of money to ensure that all Americans would have access to one, if recommended.

On March 23, outgoing White House COVID-19 Response Coordinator Jeff Zients said the federal government had enough vaccine for the immunocompromised to get a fourth dose “and, if authorized in the coming weeks, enough supply for fourth doses for our most vulnerable, including seniors.”

But he warned that without congressional approval of a COVID-19 funding package, “We can’t procure the necessary vaccine supply to support fourth shots for all Americans.”

Mr. Zients also noted that other countries, including Japan, Vietnam, and the Philippines had already secured future booster doses and added, “We should be securing additional supply right now.”

Dr. Schaffner says that while it would be nice to “have a booster on the shelf,” the United States needs to put more effort into creating a globally-coordinated process for ensuring that vaccines match circulating strains and that they are manufactured on a timely basis.

He says he and others “have been reminding the public that the COVID pandemic may indeed be diminishing and moving into the endemic, but that doesn’t mean COVID is over or finished or disappeared.”

Dr. Schaffner says that it may be that “perhaps we’d need a periodic reminder to our immune system to remain protected. In other words, we might have to get boosted perhaps annually like we do with influenza.”

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

A congressional oversight subcommittee is investigating the Food and Drug Administration’s regulation of a high-risk heart pump, citing safety issues detailed by ProPublica.

The HeartWare Ventricular Assist Device, created to treat patients with severe heart failure, stopped meeting key federal standards as early as 2014. But the FDA took no decisive action even as those problems persisted, and thousands of Americans continued to be implanted with the pump.

By the end of 2020, the FDA had received more than 3,000 reports of deaths related to the HeartWare device, according to a ProPublica data analysis. A father of four died as his children tried to resuscitate him when his device suddenly stopped. A teenager died after vomiting blood in the middle of the night, while his mother struggled to restart a faulty pump.

“I am concerned by FDA’s slow action, over multiple administrations, to protect patients from this product despite early warning signs,” Rep. Raja Krishnamoorthi, D-Ill., said in a scathing letter sent March 22 to the agency’s commissioner, Robert Califf, MD.

Mr. Krishnamoorthi, the chairman of the U.S. House Committee on Oversight and Reform’s Subcommittee on Economic and Consumer Policy, requested information on how the FDA made regulatory decisions related to the HeartWare device and why it didn’t take further action.

The FDA did not provide comment to ProPublica on the subcommittee’s investigation and said it would respond directly to Mr. Krishnamoorthi. It also reiterated its response to ProPublica’s findings and said the agency had been closely overseeing the HeartWare device since 2012, with patient safety as its “highest priority.”

Medtronic, the company that acquired HeartWare in 2016, took the device off the market in June 2021. The company said that new data showed a competing heart pump had better outcomes. In response to the ProPublica investigation 2 months later, the company said it took the FDA’s inspections seriously and had worked closely with the agency to address issues with the device.

Medtronic declined to comment on the subcommittee’s investigation.

Mr. Krishnamoorthi asked in the letter if any steps were being taken to address how patients, doctors and other federal agencies are notified of problems that the FDA finds with medical devices.

Many patients told ProPublica they were never informed of issues with the HeartWare pump before or after their implants. Some people who still have the device said they weren’t told when it was taken off the market. Medtronic said in December it had confirmed 90% of U.S. patients had received notification of the HeartWare discontinuation, but that it was still working to reach the other 10%.

About 2,000 patients still had HeartWare pumps as of last year. The FDA and Medtronic recommended against removing those devices barring medical necessity because the surgery to do so carries a high risk.

In his letter, Mr. Krishnamoorthi gave the FDA a deadline of April 5 to respond.
 

This story was originally published on ProPublica. ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive their biggest stories as soon as they’re published.

A congressional oversight subcommittee is investigating the Food and Drug Administration’s regulation of a high-risk heart pump, citing safety issues detailed by ProPublica.

The HeartWare Ventricular Assist Device, created to treat patients with severe heart failure, stopped meeting key federal standards as early as 2014. But the FDA took no decisive action even as those problems persisted, and thousands of Americans continued to be implanted with the pump.

By the end of 2020, the FDA had received more than 3,000 reports of deaths related to the HeartWare device, according to a ProPublica data analysis. A father of four died as his children tried to resuscitate him when his device suddenly stopped. A teenager died after vomiting blood in the middle of the night, while his mother struggled to restart a faulty pump.

“I am concerned by FDA’s slow action, over multiple administrations, to protect patients from this product despite early warning signs,” Rep. Raja Krishnamoorthi, D-Ill., said in a scathing letter sent March 22 to the agency’s commissioner, Robert Califf, MD.

Mr. Krishnamoorthi, the chairman of the U.S. House Committee on Oversight and Reform’s Subcommittee on Economic and Consumer Policy, requested information on how the FDA made regulatory decisions related to the HeartWare device and why it didn’t take further action.

The FDA did not provide comment to ProPublica on the subcommittee’s investigation and said it would respond directly to Mr. Krishnamoorthi. It also reiterated its response to ProPublica’s findings and said the agency had been closely overseeing the HeartWare device since 2012, with patient safety as its “highest priority.”

Medtronic, the company that acquired HeartWare in 2016, took the device off the market in June 2021. The company said that new data showed a competing heart pump had better outcomes. In response to the ProPublica investigation 2 months later, the company said it took the FDA’s inspections seriously and had worked closely with the agency to address issues with the device.

Medtronic declined to comment on the subcommittee’s investigation.

Mr. Krishnamoorthi asked in the letter if any steps were being taken to address how patients, doctors and other federal agencies are notified of problems that the FDA finds with medical devices.

Many patients told ProPublica they were never informed of issues with the HeartWare pump before or after their implants. Some people who still have the device said they weren’t told when it was taken off the market. Medtronic said in December it had confirmed 90% of U.S. patients had received notification of the HeartWare discontinuation, but that it was still working to reach the other 10%.

About 2,000 patients still had HeartWare pumps as of last year. The FDA and Medtronic recommended against removing those devices barring medical necessity because the surgery to do so carries a high risk.

In his letter, Mr. Krishnamoorthi gave the FDA a deadline of April 5 to respond.
 

This story was originally published on ProPublica. ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive their biggest stories as soon as they’re published.

A congressional oversight subcommittee is investigating the Food and Drug Administration’s regulation of a high-risk heart pump, citing safety issues detailed by ProPublica.

The HeartWare Ventricular Assist Device, created to treat patients with severe heart failure, stopped meeting key federal standards as early as 2014. But the FDA took no decisive action even as those problems persisted, and thousands of Americans continued to be implanted with the pump.

By the end of 2020, the FDA had received more than 3,000 reports of deaths related to the HeartWare device, according to a ProPublica data analysis. A father of four died as his children tried to resuscitate him when his device suddenly stopped. A teenager died after vomiting blood in the middle of the night, while his mother struggled to restart a faulty pump.

“I am concerned by FDA’s slow action, over multiple administrations, to protect patients from this product despite early warning signs,” Rep. Raja Krishnamoorthi, D-Ill., said in a scathing letter sent March 22 to the agency’s commissioner, Robert Califf, MD.

Mr. Krishnamoorthi, the chairman of the U.S. House Committee on Oversight and Reform’s Subcommittee on Economic and Consumer Policy, requested information on how the FDA made regulatory decisions related to the HeartWare device and why it didn’t take further action.

The FDA did not provide comment to ProPublica on the subcommittee’s investigation and said it would respond directly to Mr. Krishnamoorthi. It also reiterated its response to ProPublica’s findings and said the agency had been closely overseeing the HeartWare device since 2012, with patient safety as its “highest priority.”

Medtronic, the company that acquired HeartWare in 2016, took the device off the market in June 2021. The company said that new data showed a competing heart pump had better outcomes. In response to the ProPublica investigation 2 months later, the company said it took the FDA’s inspections seriously and had worked closely with the agency to address issues with the device.

Medtronic declined to comment on the subcommittee’s investigation.

Mr. Krishnamoorthi asked in the letter if any steps were being taken to address how patients, doctors and other federal agencies are notified of problems that the FDA finds with medical devices.

Many patients told ProPublica they were never informed of issues with the HeartWare pump before or after their implants. Some people who still have the device said they weren’t told when it was taken off the market. Medtronic said in December it had confirmed 90% of U.S. patients had received notification of the HeartWare discontinuation, but that it was still working to reach the other 10%.

About 2,000 patients still had HeartWare pumps as of last year. The FDA and Medtronic recommended against removing those devices barring medical necessity because the surgery to do so carries a high risk.

In his letter, Mr. Krishnamoorthi gave the FDA a deadline of April 5 to respond.
 

This story was originally published on ProPublica. ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive their biggest stories as soon as they’re published.

From Neurology/Chronic Pain Management Services, Department of Veterans Affairs (VA) Maryland Health Care System, Baltimore VA Medical Center, Baltimore, MD (Dr. Uche), and School of Nursing, Washburn University, Topeka, KS (Drs. Jamison and Waugh).

Abstract

Objective: The purpose of this quality improvement project was to abstract and analyze previously collected data from veterans with high-impact chronic pain who attended the Empower Veterans Program (EVP) offered by a Veterans Administration facility in the northeastern United States.

Methods: This quality improvement project used data collected from veterans with chronic pain who completed the veterans health care facility’s EVP between August 2017 and August 2019. Pre- and post-intervention data on pain intensity, pain interference, quality of life, and pain catastrophizing were compared using paired t-tests.

Results: Although data were abstracted from 115 patients, the final sample included 67 patients who completed both pre-and postintervention questionnaires. Baseline measures of completers and noncompleters were similar. Comparison of pre and post mean scores on completers showed statistically significant findings (P = .004) based on the Bonferroni correction. The medium and large effect sizes (Cohen’s d) indicated clinically significant improvements for veterans who completed the program. Veterans reported high levels of satisfaction with the program.

Conclusion: Veterans with chronic high-impact noncancer pain who completed the EVP had reduced pain intensity, pain interference, pain catastrophizing as well as improved quality of life and satisfaction with their health.

Keywords: musculoskeletal pain, Veterans Affairs, complementary and integrative health, acceptance and commitment therapy, mind-body therapies, whole health, multidisciplinary pain management.

More than 100 million American adults suffer from chronic pain; costs associated with managing chronic pain are approximately $635 billion each year.¹ Chronic pain is prevalent among military veterans, affecting one-third of the 9 million veterans who receive care from Veterans Health Administration (VHA) facilities.² The biopsychosocial impact of chronic pain on the general population, and specifically on veterans, has been compounded by the opioid crisis. The effects of chronic pain and the opioid crisis have fueled interest in the use of complementary and integrative health (CIH) modalities in the management of chronic noncancer pain. Providers are increasingly developing treatment programs that incorporate CIH in their management of chronic noncancer pain.

One such program is the Empower Veterans Program (EVP). Originally developed at the Atlanta Veterans Affairs Health Care System, the EVP is a CIH modality based on the biopsychosocial model of pain developed by psychiatrist George Engel in 1977.³ The biopsychosocial model of pain recognizes that pain is a complex, multidimensional, biopsychosocial experience. Under this model, the mind and body work in unison as interconnected entities. Because the model acknowledges biological, psychological, and social components of pain and illness,⁴ treatment focuses on all aspects of a person’s health, life, and relationships.

The EVP fits into the VHA Pain Management Stepped Care Model and is an adjunctive complement for that model.^5-7 The EVP complements care at the first step, where patient/family provide self-care and where care is provided by patient-aligned primary care teams, at the second step, which includes secondary consultation with multidisciplinary pain medicine specialty teams and other specialists, and at the third step, with the addition of tertiary interdisciplinary pain centers.

The VA Maryland Health Care System (VAMHCS) implemented the EVP as part of a quality improvement project for the management of chronic pain. The objectives of the program were to reduce pain intensity, pain catastrophizing, and pain interference, as well as improve functionality and quality of life among veterans with chronic high-impact noncancer pain. More than 2 years after the program was implemented, collected data had not been analyzed. The purpose of this quality improvement project was to abstract and analyze the previously collected data from veterans with high-impact chronic pain who attended an EVP offered by the VAMHCS. The results of the data analysis were used to inform decisions regarding the future of the program.

Methods

This quality improvement project used the Plan-Do-Study-Act (PDSA) process.⁸ The first 2 phases of the PDSA cycle (Plan and Do) were completed by a team of VA employees from the VAMHCS, who donated their time to establish and implement the program at the project site. This team consisted of psychologists, a physical therapist, a social worker, and a chaplain, and included support from medical administrative staff. This team planned and implemented the EVP at the VA facility based on the model developed at the Atlanta VA Health Care System. During the “Do” phase, the team collected data on pain intensity, pain interference, quality of life, and pain negative cognition (catastrophizing) before the intervention and post intervention. They also collected data on program outcome (patient treatment satisfaction) post intervention. Because these employees did not have time to retrieve and analyze the data, they welcomed the opportunity to have the data analyzed by the investigators during the Study phase of the PDSA cycle. Based on the results of the analysis, recommendations for program changes were made during the Act phase of the cycle.

Intervention

The EVP was developed as a 10-week (30 hours) interdisciplinary CIH approach that coached veterans with chronic pain to live fuller lives based on their individual values and what matters to them. EVP is the “What Else” management modality for the 5% of veterans with high-impact chronic pain.⁹ The EVP provided functional restoration through its components of whole health, mindfulness training, coaching calls, acceptance and commitment therapy, and mindful movement. It used the Wheel of Health with the 4 key components of me, self-care, professional care, and community.^10,11

Veterans who had a diagnosis of chronic nonmalignant pain for 3 months or more and who agreed to participate in the EVP at this facility attended 3-hour classes every Tuesday with a cohort of 8 to 12 peers and engaged in one-on-one coaching with interdisciplinary team members. During the class sessions, veterans were coached to understand and accept their pain and commit to maintaining function despite their pain. Mindful movement by the physical therapist emphasized the pivotal place of exercise in pain management. The therapist used the mantra “Motion is Lotion.”⁹ The guiding principle of the EVP was that small incremental changes can have a big impact on the individual’s whole life. Emphasis was placed on increasing self-efficacy and mindful awareness for veterans with high-impact pain by giving them “Skills before Pills.”⁹

Outcome Measures

Outcome measures included the Numerical Pain Rating Scale (NPRS), the Multidimensional Pain Inventory (MPI), the World Health Organization Quality of Life assessment (WHOQOL-BREF), the Pain Catastrophizing Scale (PCS), and the Pain Treatment Satisfaction Scale (PTSS). Cronbach alpha coefficients were calculated to assess internal consistency reliability of these measures in the sample of veterans who completed the EVP.

NPRS. The NPRS is ubiquitous as a screening tool in many health care environments and its use is mandated by the VA health care system.¹² The choice of the NPRS as the tool for pain screening in the VA health care system was based on a large body of research that supports the reliability and validity of the NPRS as a single index of pain intensity or severity. Studies suggest that the NPRS is valid for use in the assessment of acute, cancer, or chronic nonmalignant pain and in varied clinical settings.¹³ The NPRS has 4 items, each on a scale of 0 to 10. For the purpose of this project, only 3 items were used. The 3 items assessed the worst pain, usual pain, and the current pain (right now). The higher the score, the higher the pain intensity. Cronbach alpha coefficients on the NPRS obtained from the current sample of veterans were 0.85 on both pre- and postintervention assessments.

MPI. The MPI is an easily accessible, reliable, and valid self-report questionnaire that measures the impact of pain on an individual’s life, quality of social support, and general activity.¹⁴ This instrument is a short version of the West Haven-Yale MPI.¹⁵ The MPI contains 9 items rated on a scale from 0 to 6. The higher the score, the greater pain interference a person is experiencing. The MPI produces reliable, valid information for diagnostic purposes and for therapy outcome studies.¹⁶ The MPI had a Cronbach alpha of 0.90 on pre-intervention and 0.92 on postintervention assessments in the current sample.

WHOQOL-BREF. The WHOQOL-BREF is a measure of quality of life and is an abbreviated version of the WHOQOL-100. Quality of life is defined by the World Health Organization¹⁷ “as an individuals’ perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.” The WHOQOL-BREF contains 26 items. The first 2 items were examined separately; the first item asks individuals to rate their overall quality of life and the second asks individuals how satisfied they are with their health. The remaining 24 items were used to calculate the following 4 domain scores: physical health, psychological health, social relationship, and environment.¹⁸ Each item is measured on a scale of 1 to 5. Higher scores denote higher or better quality of life. Domain scores have demonstrated good reliability and validity.^19-21 Cronbach alpha coefficients for the domain subscales ranged from 0.63 to 0.84 in the current sample, with the lowest alphas for the 3-item Social Relationships Domain.

PCS. The PCS is a widely used measure of catastrophic thinking related to pain. Catastrophizing has been conceived by Sullivan and colleagues as “an exaggerated negative mental set brought to bear during actual or anticipated painful experience.”²² The PCS provides a total score and scores for the following subscales: rumination, magnification, and helplessness.²³ It has been used in a variety of chronic pain populations and has demonstrated good reliability and validity in clinical as well as nonclinical samples.^24-26 The PCS has 13 items rated on a scale of 0 to 4. Higher scores mean greater negative pain cognition (catastrophizing). In the current sample, the PCS total scale had a Cronbach alpha coefficient of 0.95 and 0.94 on the 2 assessments. The coefficients for the subscales ranged from 0.81 to 0.90.

PTSS. The PTSS is a 5-item tool that measures patient satisfaction with pain treatment. It includes items that address overall satisfaction, staff warmth, staff skill level, ease of scheduling appointments, and recommendation of the program to other veterans. It was derived from the post-treatment version of The Pain Outcome Questionnaire-VA and has demonstrated reliability and validity.²⁷ The questions are scaled from 0 to 10. High scores on the PTSS denote high patient satisfaction with the EVP. The Cronbach alpha coefficient on the PTSS obtained from the current sample was 0.80.

Data Gathering and Analysis

Prior to starting the Study phase, Washburn University’s Institutional Review Board (IRB) and the VA IRB approved the project. The VA IRB, through its affiliate, gave a Not Human Research Determination and granted a waiver of informed consent and the Health Insurance Portability and Accountability Act authorization. The VA facility’s Research and Development department also approved the quality improvement project.

Once these approvals were obtained, the Study phase began with the abstraction of retrospective data obtained from veterans who participated in the VA health care facility’s EVP between August 2017 and August 2019. Most of the measurement tools changed in August 2019, and for this reason data abstraction was limited to the time period August 2017 to August 2019. The first author (JUU) abstracted data for both program completers and noncompleters. The second (MJ) and third (SW) authors analyzed the data in SPSS 24 and calculated effect sizes.

Veterans who completed the program were compared to veterans who did not complete the program on age, gender, and baseline measures. The investigators used independent samples t-tests to compare completers and noncompleters on age, pain intensity, pain interference, quality of life, and pain catastrophizing. They used the chi-square test of independence to analyze the association between gender and program completion.

Data were included in the pre- and postintervention analysis if the veteran completed the NPRS, MPI, WHOQOL-BREF, and PCS pre and post intervention. This became an important eligibility requirement as some of the tools/measures were changed towards the end of the review period in 2019. Pre- and postintervention data on pain intensity, pain interference, quality of life, pain catastrophizing, and patient satisfaction were compared using paired samples t-test at .004 level of significance based on the Bonferroni correction.²⁸ Data on patient satisfaction with pain treatment were collected at program completion (week 8 or 10) and were analyzed using descriptive statistics.

Effect sizes (Cohen’s d) were calculated to determine the substantive significance or magnitude of the mean differences in scores. Effect sizes (expressed as absolute values of Cohen’s d) were calculated as the mean difference divided by the standard deviation. Values of 0.2 were considered a small effect size, 0.5 a medium effect size, and 0.8 a large effect size.²⁹

 

 

Results

Data were abstracted for 115 veterans who started the EVP. Of these, 48 left the program, leaving 67 veterans (58%) who completed the program. Completers and noncompleters were similar in age, gender, and baseline measures (Table 1). Fifty-three (79%) completers and 35 (73%) noncompleters were male. A chi-square test of independence showed no significant association between gender and program completion (χ^2₁ [N = 115] = .595, P = .440).

Comparison of pre-and postintervention mean scale scores resulted in statistically significant differences for all comparisons (Table 2). These comparisons yielded improvements in the desired direction. For example, the scores on the NPRS, the MPI, and the PCS (along with its subscales) decreased, revealing reductions in pain severity, the impact of pain on the veterans’ lives, and pain catastrophizing. The 2 individual item scores on the WHOQOL-BREF increased, indicating improvements in perceived quality of life and satisfaction with health. The domain scores on the WHOQOL-BREF increased, revealing improvements in pain-related quality of life. The moderate to large effect sizes indicated clinically significant improvements for veterans with chronic high-impact pain who completed the EVP.

Analysis of data obtained using the PTSS yielded high mean scores for items that focused on patient satisfaction with treatment (Table 3). Scaled statistics yielded a mean (SD) of 46.95 (4.40). These results denoted overall patient satisfaction with the EVP.

Discussion

The purpose of this quality improvement project was to abstract and analyze previously collected data from veterans with high-impact chronic pain who attended the EVP. Comparison of pre-intervention and postintervention data obtained from 67 veterans who completed the program revealed improvements in pain intensity, pain interference, negative cognition (catastrophizing), and quality of life. The differences were statistically significant and clinically meaningful, with medium and large effect sizes. In addition, veterans reported high satisfaction with the EVP.

The EVP includes CIH approaches that have demonstrated effectiveness among veterans and other populations with chronic pain. A wealth of studies, for example, support the effectiveness of CIH approaches among veterans.^30-34 Other studies focus on specific CIH approaches that are components of the EVP. Evidence supports, for example, the efficacy of mindfulness-based stress reduction,^35-39 acceptance and commitment therapy,^40-43 brief peer support intervention,⁴⁴ and interdisciplinary biopsychosocial rehabilitation.^45,46

While empirical evidence supports components of the EVP, only one study focused on the outcomes of the Atlanta VA EVP among veterans with chronic pain. Results of a qualitative study conducted by Penney and Haro⁴⁷ described the experience of veterans with the EVP. Those veterans reported adopting new self-care or lifestyle practices for pain management and health, accepting pain, being better able to adjust and set boundaries, feeling more in control, participating in life, and changing their medication use.

The mean baseline scores from the current sample were similar to samples of patients with chronic pain in other studies (NPRS,⁴⁸ MPI,⁴⁸ and PCS^48-51). After converting scores on the WHOQOL-BREF from those that ranged from 4 to 20 to those that ranged from 0 to 100,¹⁸ the scores from the current sample were similar to those of other studies of patients with chronic pain.^48,52,53Several strengths of the project should be noted. Data were collected using well established measurement tools that had previously demonstrated reliability and validity. All the tools used in data collection demonstrated good internal consistency reliabilities in the current sample of veterans. Weaknesses of the project include the use of a convenience sample of veterans and small sample size. Data were not available on the number of veterans who were offered participation or on how many veterans declined enrollment. The sample of veterans who chose to participate in the EVP may or may not have been representative of the population of veterans with high-impact chronic pain. As a pre- and postintervention design with no comparison group, the results are subject to multiple threats to internal validity, including the Hawthorne effect, maturation in the form of healing, and attrition. Reasons for leaving the program had not been recorded, so the investigators had no way of knowing factors that may have contributed to attrition. Also, data on when veterans left the program were unavailable. Research is needed with a control group to reduce the effect of confounding variables on the outcome measures. This project used data collected at a single VA facility, which limits its generalizability.

While completers and noncompleters of the EVP were similar on age, gender, and baseline measures, there may have been unidentified characteristics that influenced program completion. The investigators noticed the presence of more missing data among noncompleters compared to completers on the pre-intervention PCS; thus, noncompleters may have scored lower than completers on this instrument simply because there were more individual items that were unanswered/missing among this group of noncompleters.

Data were analyzed using a limited number of outcome measures that had previously been collected. Other outcome measures might include whether EVP participants reduced their use of medications, clinical resources, and personnel. Future projects, for example, could determine whether the EVP is effective in reducing opioid analgesic medication use and decreasing primary care and emergency department visits. Cost-benefit analyses could be completed to determine whether EVP is associated with financial savings.

Because no follow-up assessments were made to determine whether improvements were maintained over time, the project focus was limited to an evaluation of the short-term changes in the outcome measures. Future projects could include a follow-up assessment of the veterans 1- or 2-years post completion of the EVP.

Data for the project were collected prior to the COVID-19 pandemic, when the EVP was implemented through face-to-face meetings with participants and their peers. It is not clear how changes to the delivery of the program (such as offering it through telehealth) might impact veterans’ satisfaction with the program, willingness to complete it, and other variables of interest.

The results of this project were made available to stakeholders with recommendations for program expansion both at the current location and at other VA facilities, including the recommendation to hire additional personnel that would implement the program. As the VA network of facilities expand the EVP program and adapt it for telehealth delivery, the investigators recommended a similar analysis of data be performed following telehealth delivery. If delivery through telehealth is shown to improve outcome measures, the EVP could provide pain management treatment options for patients challenged by transportation barriers, including rural veterans.

Conclusion

This quality improvement project provided evidence of improvement in measures of pain severity, pain interference, negative cognition (catastrophizing), quality of life, and patient treatment satisfaction among veterans with chronic high-impact pain. Findings have been well received by the northeastern VA as well as the Veterans Integrated Systems Network 5. The results of the analyses were used to inform decisions regarding the future of the program.

Disclaimer: This material is the result of work supported with resources and the use of facilities at the VA Maryland Health Care System, Baltimore, Maryland. The views expressed are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs or the United States Government.

Acknowledgments: The authors thank Dr. Arianna Perra, the recent past coordinator of the Empower Veterans Program (EVP), who provided initial insights and support that motivated the decision to evaluate the program. We also thank the veterans and VA EVP clinicians who contributed data for the evaluation, and Dr. Michael Saenger (Director, TelePain-EVP: EVP) and Dr. Robert Lavin for their ongoing support, care, and concern for veteran patients. We also thank Dr. Beverly Bradley and the neurology service administrative team for their guidance in the process of obtaining necessary VA approvals for this project.

Corresponding author: Jessica U. Uche, DNP, CRNP-Family; [email protected]

doi:10.12788/jcom.0089

From Neurology/Chronic Pain Management Services, Department of Veterans Affairs (VA) Maryland Health Care System, Baltimore VA Medical Center, Baltimore, MD (Dr. Uche), and School of Nursing, Washburn University, Topeka, KS (Drs. Jamison and Waugh).

Abstract

Objective: The purpose of this quality improvement project was to abstract and analyze previously collected data from veterans with high-impact chronic pain who attended the Empower Veterans Program (EVP) offered by a Veterans Administration facility in the northeastern United States.

Methods: This quality improvement project used data collected from veterans with chronic pain who completed the veterans health care facility’s EVP between August 2017 and August 2019. Pre- and post-intervention data on pain intensity, pain interference, quality of life, and pain catastrophizing were compared using paired t-tests.

Results: Although data were abstracted from 115 patients, the final sample included 67 patients who completed both pre-and postintervention questionnaires. Baseline measures of completers and noncompleters were similar. Comparison of pre and post mean scores on completers showed statistically significant findings (P = .004) based on the Bonferroni correction. The medium and large effect sizes (Cohen’s d) indicated clinically significant improvements for veterans who completed the program. Veterans reported high levels of satisfaction with the program.

Conclusion: Veterans with chronic high-impact noncancer pain who completed the EVP had reduced pain intensity, pain interference, pain catastrophizing as well as improved quality of life and satisfaction with their health.

Keywords: musculoskeletal pain, Veterans Affairs, complementary and integrative health, acceptance and commitment therapy, mind-body therapies, whole health, multidisciplinary pain management.

More than 100 million American adults suffer from chronic pain; costs associated with managing chronic pain are approximately $635 billion each year.¹ Chronic pain is prevalent among military veterans, affecting one-third of the 9 million veterans who receive care from Veterans Health Administration (VHA) facilities.² The biopsychosocial impact of chronic pain on the general population, and specifically on veterans, has been compounded by the opioid crisis. The effects of chronic pain and the opioid crisis have fueled interest in the use of complementary and integrative health (CIH) modalities in the management of chronic noncancer pain. Providers are increasingly developing treatment programs that incorporate CIH in their management of chronic noncancer pain.

One such program is the Empower Veterans Program (EVP). Originally developed at the Atlanta Veterans Affairs Health Care System, the EVP is a CIH modality based on the biopsychosocial model of pain developed by psychiatrist George Engel in 1977.³ The biopsychosocial model of pain recognizes that pain is a complex, multidimensional, biopsychosocial experience. Under this model, the mind and body work in unison as interconnected entities. Because the model acknowledges biological, psychological, and social components of pain and illness,⁴ treatment focuses on all aspects of a person’s health, life, and relationships.

The EVP fits into the VHA Pain Management Stepped Care Model and is an adjunctive complement for that model.^5-7 The EVP complements care at the first step, where patient/family provide self-care and where care is provided by patient-aligned primary care teams, at the second step, which includes secondary consultation with multidisciplinary pain medicine specialty teams and other specialists, and at the third step, with the addition of tertiary interdisciplinary pain centers.

The VA Maryland Health Care System (VAMHCS) implemented the EVP as part of a quality improvement project for the management of chronic pain. The objectives of the program were to reduce pain intensity, pain catastrophizing, and pain interference, as well as improve functionality and quality of life among veterans with chronic high-impact noncancer pain. More than 2 years after the program was implemented, collected data had not been analyzed. The purpose of this quality improvement project was to abstract and analyze the previously collected data from veterans with high-impact chronic pain who attended an EVP offered by the VAMHCS. The results of the data analysis were used to inform decisions regarding the future of the program.

Methods

This quality improvement project used the Plan-Do-Study-Act (PDSA) process.⁸ The first 2 phases of the PDSA cycle (Plan and Do) were completed by a team of VA employees from the VAMHCS, who donated their time to establish and implement the program at the project site. This team consisted of psychologists, a physical therapist, a social worker, and a chaplain, and included support from medical administrative staff. This team planned and implemented the EVP at the VA facility based on the model developed at the Atlanta VA Health Care System. During the “Do” phase, the team collected data on pain intensity, pain interference, quality of life, and pain negative cognition (catastrophizing) before the intervention and post intervention. They also collected data on program outcome (patient treatment satisfaction) post intervention. Because these employees did not have time to retrieve and analyze the data, they welcomed the opportunity to have the data analyzed by the investigators during the Study phase of the PDSA cycle. Based on the results of the analysis, recommendations for program changes were made during the Act phase of the cycle.

Intervention

The EVP was developed as a 10-week (30 hours) interdisciplinary CIH approach that coached veterans with chronic pain to live fuller lives based on their individual values and what matters to them. EVP is the “What Else” management modality for the 5% of veterans with high-impact chronic pain.⁹ The EVP provided functional restoration through its components of whole health, mindfulness training, coaching calls, acceptance and commitment therapy, and mindful movement. It used the Wheel of Health with the 4 key components of me, self-care, professional care, and community.^10,11

Veterans who had a diagnosis of chronic nonmalignant pain for 3 months or more and who agreed to participate in the EVP at this facility attended 3-hour classes every Tuesday with a cohort of 8 to 12 peers and engaged in one-on-one coaching with interdisciplinary team members. During the class sessions, veterans were coached to understand and accept their pain and commit to maintaining function despite their pain. Mindful movement by the physical therapist emphasized the pivotal place of exercise in pain management. The therapist used the mantra “Motion is Lotion.”⁹ The guiding principle of the EVP was that small incremental changes can have a big impact on the individual’s whole life. Emphasis was placed on increasing self-efficacy and mindful awareness for veterans with high-impact pain by giving them “Skills before Pills.”⁹

Outcome Measures

Outcome measures included the Numerical Pain Rating Scale (NPRS), the Multidimensional Pain Inventory (MPI), the World Health Organization Quality of Life assessment (WHOQOL-BREF), the Pain Catastrophizing Scale (PCS), and the Pain Treatment Satisfaction Scale (PTSS). Cronbach alpha coefficients were calculated to assess internal consistency reliability of these measures in the sample of veterans who completed the EVP.

NPRS. The NPRS is ubiquitous as a screening tool in many health care environments and its use is mandated by the VA health care system.¹² The choice of the NPRS as the tool for pain screening in the VA health care system was based on a large body of research that supports the reliability and validity of the NPRS as a single index of pain intensity or severity. Studies suggest that the NPRS is valid for use in the assessment of acute, cancer, or chronic nonmalignant pain and in varied clinical settings.¹³ The NPRS has 4 items, each on a scale of 0 to 10. For the purpose of this project, only 3 items were used. The 3 items assessed the worst pain, usual pain, and the current pain (right now). The higher the score, the higher the pain intensity. Cronbach alpha coefficients on the NPRS obtained from the current sample of veterans were 0.85 on both pre- and postintervention assessments.

MPI. The MPI is an easily accessible, reliable, and valid self-report questionnaire that measures the impact of pain on an individual’s life, quality of social support, and general activity.¹⁴ This instrument is a short version of the West Haven-Yale MPI.¹⁵ The MPI contains 9 items rated on a scale from 0 to 6. The higher the score, the greater pain interference a person is experiencing. The MPI produces reliable, valid information for diagnostic purposes and for therapy outcome studies.¹⁶ The MPI had a Cronbach alpha of 0.90 on pre-intervention and 0.92 on postintervention assessments in the current sample.

WHOQOL-BREF. The WHOQOL-BREF is a measure of quality of life and is an abbreviated version of the WHOQOL-100. Quality of life is defined by the World Health Organization¹⁷ “as an individuals’ perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.” The WHOQOL-BREF contains 26 items. The first 2 items were examined separately; the first item asks individuals to rate their overall quality of life and the second asks individuals how satisfied they are with their health. The remaining 24 items were used to calculate the following 4 domain scores: physical health, psychological health, social relationship, and environment.¹⁸ Each item is measured on a scale of 1 to 5. Higher scores denote higher or better quality of life. Domain scores have demonstrated good reliability and validity.^19-21 Cronbach alpha coefficients for the domain subscales ranged from 0.63 to 0.84 in the current sample, with the lowest alphas for the 3-item Social Relationships Domain.

PCS. The PCS is a widely used measure of catastrophic thinking related to pain. Catastrophizing has been conceived by Sullivan and colleagues as “an exaggerated negative mental set brought to bear during actual or anticipated painful experience.”²² The PCS provides a total score and scores for the following subscales: rumination, magnification, and helplessness.²³ It has been used in a variety of chronic pain populations and has demonstrated good reliability and validity in clinical as well as nonclinical samples.^24-26 The PCS has 13 items rated on a scale of 0 to 4. Higher scores mean greater negative pain cognition (catastrophizing). In the current sample, the PCS total scale had a Cronbach alpha coefficient of 0.95 and 0.94 on the 2 assessments. The coefficients for the subscales ranged from 0.81 to 0.90.

PTSS. The PTSS is a 5-item tool that measures patient satisfaction with pain treatment. It includes items that address overall satisfaction, staff warmth, staff skill level, ease of scheduling appointments, and recommendation of the program to other veterans. It was derived from the post-treatment version of The Pain Outcome Questionnaire-VA and has demonstrated reliability and validity.²⁷ The questions are scaled from 0 to 10. High scores on the PTSS denote high patient satisfaction with the EVP. The Cronbach alpha coefficient on the PTSS obtained from the current sample was 0.80.

Data Gathering and Analysis

Prior to starting the Study phase, Washburn University’s Institutional Review Board (IRB) and the VA IRB approved the project. The VA IRB, through its affiliate, gave a Not Human Research Determination and granted a waiver of informed consent and the Health Insurance Portability and Accountability Act authorization. The VA facility’s Research and Development department also approved the quality improvement project.

Once these approvals were obtained, the Study phase began with the abstraction of retrospective data obtained from veterans who participated in the VA health care facility’s EVP between August 2017 and August 2019. Most of the measurement tools changed in August 2019, and for this reason data abstraction was limited to the time period August 2017 to August 2019. The first author (JUU) abstracted data for both program completers and noncompleters. The second (MJ) and third (SW) authors analyzed the data in SPSS 24 and calculated effect sizes.

Veterans who completed the program were compared to veterans who did not complete the program on age, gender, and baseline measures. The investigators used independent samples t-tests to compare completers and noncompleters on age, pain intensity, pain interference, quality of life, and pain catastrophizing. They used the chi-square test of independence to analyze the association between gender and program completion.

Data were included in the pre- and postintervention analysis if the veteran completed the NPRS, MPI, WHOQOL-BREF, and PCS pre and post intervention. This became an important eligibility requirement as some of the tools/measures were changed towards the end of the review period in 2019. Pre- and postintervention data on pain intensity, pain interference, quality of life, pain catastrophizing, and patient satisfaction were compared using paired samples t-test at .004 level of significance based on the Bonferroni correction.²⁸ Data on patient satisfaction with pain treatment were collected at program completion (week 8 or 10) and were analyzed using descriptive statistics.

Effect sizes (Cohen’s d) were calculated to determine the substantive significance or magnitude of the mean differences in scores. Effect sizes (expressed as absolute values of Cohen’s d) were calculated as the mean difference divided by the standard deviation. Values of 0.2 were considered a small effect size, 0.5 a medium effect size, and 0.8 a large effect size.²⁹

 

 

Results

Data were abstracted for 115 veterans who started the EVP. Of these, 48 left the program, leaving 67 veterans (58%) who completed the program. Completers and noncompleters were similar in age, gender, and baseline measures (Table 1). Fifty-three (79%) completers and 35 (73%) noncompleters were male. A chi-square test of independence showed no significant association between gender and program completion (χ^2₁ [N = 115] = .595, P = .440).

Comparison of pre-and postintervention mean scale scores resulted in statistically significant differences for all comparisons (Table 2). These comparisons yielded improvements in the desired direction. For example, the scores on the NPRS, the MPI, and the PCS (along with its subscales) decreased, revealing reductions in pain severity, the impact of pain on the veterans’ lives, and pain catastrophizing. The 2 individual item scores on the WHOQOL-BREF increased, indicating improvements in perceived quality of life and satisfaction with health. The domain scores on the WHOQOL-BREF increased, revealing improvements in pain-related quality of life. The moderate to large effect sizes indicated clinically significant improvements for veterans with chronic high-impact pain who completed the EVP.

Analysis of data obtained using the PTSS yielded high mean scores for items that focused on patient satisfaction with treatment (Table 3). Scaled statistics yielded a mean (SD) of 46.95 (4.40). These results denoted overall patient satisfaction with the EVP.

Discussion

The purpose of this quality improvement project was to abstract and analyze previously collected data from veterans with high-impact chronic pain who attended the EVP. Comparison of pre-intervention and postintervention data obtained from 67 veterans who completed the program revealed improvements in pain intensity, pain interference, negative cognition (catastrophizing), and quality of life. The differences were statistically significant and clinically meaningful, with medium and large effect sizes. In addition, veterans reported high satisfaction with the EVP.

The EVP includes CIH approaches that have demonstrated effectiveness among veterans and other populations with chronic pain. A wealth of studies, for example, support the effectiveness of CIH approaches among veterans.^30-34 Other studies focus on specific CIH approaches that are components of the EVP. Evidence supports, for example, the efficacy of mindfulness-based stress reduction,^35-39 acceptance and commitment therapy,^40-43 brief peer support intervention,⁴⁴ and interdisciplinary biopsychosocial rehabilitation.^45,46

While empirical evidence supports components of the EVP, only one study focused on the outcomes of the Atlanta VA EVP among veterans with chronic pain. Results of a qualitative study conducted by Penney and Haro⁴⁷ described the experience of veterans with the EVP. Those veterans reported adopting new self-care or lifestyle practices for pain management and health, accepting pain, being better able to adjust and set boundaries, feeling more in control, participating in life, and changing their medication use.

The mean baseline scores from the current sample were similar to samples of patients with chronic pain in other studies (NPRS,⁴⁸ MPI,⁴⁸ and PCS^48-51). After converting scores on the WHOQOL-BREF from those that ranged from 4 to 20 to those that ranged from 0 to 100,¹⁸ the scores from the current sample were similar to those of other studies of patients with chronic pain.^48,52,53Several strengths of the project should be noted. Data were collected using well established measurement tools that had previously demonstrated reliability and validity. All the tools used in data collection demonstrated good internal consistency reliabilities in the current sample of veterans. Weaknesses of the project include the use of a convenience sample of veterans and small sample size. Data were not available on the number of veterans who were offered participation or on how many veterans declined enrollment. The sample of veterans who chose to participate in the EVP may or may not have been representative of the population of veterans with high-impact chronic pain. As a pre- and postintervention design with no comparison group, the results are subject to multiple threats to internal validity, including the Hawthorne effect, maturation in the form of healing, and attrition. Reasons for leaving the program had not been recorded, so the investigators had no way of knowing factors that may have contributed to attrition. Also, data on when veterans left the program were unavailable. Research is needed with a control group to reduce the effect of confounding variables on the outcome measures. This project used data collected at a single VA facility, which limits its generalizability.

While completers and noncompleters of the EVP were similar on age, gender, and baseline measures, there may have been unidentified characteristics that influenced program completion. The investigators noticed the presence of more missing data among noncompleters compared to completers on the pre-intervention PCS; thus, noncompleters may have scored lower than completers on this instrument simply because there were more individual items that were unanswered/missing among this group of noncompleters.

Data were analyzed using a limited number of outcome measures that had previously been collected. Other outcome measures might include whether EVP participants reduced their use of medications, clinical resources, and personnel. Future projects, for example, could determine whether the EVP is effective in reducing opioid analgesic medication use and decreasing primary care and emergency department visits. Cost-benefit analyses could be completed to determine whether EVP is associated with financial savings.

Because no follow-up assessments were made to determine whether improvements were maintained over time, the project focus was limited to an evaluation of the short-term changes in the outcome measures. Future projects could include a follow-up assessment of the veterans 1- or 2-years post completion of the EVP.

Data for the project were collected prior to the COVID-19 pandemic, when the EVP was implemented through face-to-face meetings with participants and their peers. It is not clear how changes to the delivery of the program (such as offering it through telehealth) might impact veterans’ satisfaction with the program, willingness to complete it, and other variables of interest.

The results of this project were made available to stakeholders with recommendations for program expansion both at the current location and at other VA facilities, including the recommendation to hire additional personnel that would implement the program. As the VA network of facilities expand the EVP program and adapt it for telehealth delivery, the investigators recommended a similar analysis of data be performed following telehealth delivery. If delivery through telehealth is shown to improve outcome measures, the EVP could provide pain management treatment options for patients challenged by transportation barriers, including rural veterans.

Conclusion

This quality improvement project provided evidence of improvement in measures of pain severity, pain interference, negative cognition (catastrophizing), quality of life, and patient treatment satisfaction among veterans with chronic high-impact pain. Findings have been well received by the northeastern VA as well as the Veterans Integrated Systems Network 5. The results of the analyses were used to inform decisions regarding the future of the program.

Disclaimer: This material is the result of work supported with resources and the use of facilities at the VA Maryland Health Care System, Baltimore, Maryland. The views expressed are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs or the United States Government.

Acknowledgments: The authors thank Dr. Arianna Perra, the recent past coordinator of the Empower Veterans Program (EVP), who provided initial insights and support that motivated the decision to evaluate the program. We also thank the veterans and VA EVP clinicians who contributed data for the evaluation, and Dr. Michael Saenger (Director, TelePain-EVP: EVP) and Dr. Robert Lavin for their ongoing support, care, and concern for veteran patients. We also thank Dr. Beverly Bradley and the neurology service administrative team for their guidance in the process of obtaining necessary VA approvals for this project.

Corresponding author: Jessica U. Uche, DNP, CRNP-Family; [email protected]

doi:10.12788/jcom.0089

From Neurology/Chronic Pain Management Services, Department of Veterans Affairs (VA) Maryland Health Care System, Baltimore VA Medical Center, Baltimore, MD (Dr. Uche), and School of Nursing, Washburn University, Topeka, KS (Drs. Jamison and Waugh).

Abstract

Objective: The purpose of this quality improvement project was to abstract and analyze previously collected data from veterans with high-impact chronic pain who attended the Empower Veterans Program (EVP) offered by a Veterans Administration facility in the northeastern United States.

Methods: This quality improvement project used data collected from veterans with chronic pain who completed the veterans health care facility’s EVP between August 2017 and August 2019. Pre- and post-intervention data on pain intensity, pain interference, quality of life, and pain catastrophizing were compared using paired t-tests.

Results: Although data were abstracted from 115 patients, the final sample included 67 patients who completed both pre-and postintervention questionnaires. Baseline measures of completers and noncompleters were similar. Comparison of pre and post mean scores on completers showed statistically significant findings (P = .004) based on the Bonferroni correction. The medium and large effect sizes (Cohen’s d) indicated clinically significant improvements for veterans who completed the program. Veterans reported high levels of satisfaction with the program.

Conclusion: Veterans with chronic high-impact noncancer pain who completed the EVP had reduced pain intensity, pain interference, pain catastrophizing as well as improved quality of life and satisfaction with their health.

Keywords: musculoskeletal pain, Veterans Affairs, complementary and integrative health, acceptance and commitment therapy, mind-body therapies, whole health, multidisciplinary pain management.

More than 100 million American adults suffer from chronic pain; costs associated with managing chronic pain are approximately $635 billion each year.¹ Chronic pain is prevalent among military veterans, affecting one-third of the 9 million veterans who receive care from Veterans Health Administration (VHA) facilities.² The biopsychosocial impact of chronic pain on the general population, and specifically on veterans, has been compounded by the opioid crisis. The effects of chronic pain and the opioid crisis have fueled interest in the use of complementary and integrative health (CIH) modalities in the management of chronic noncancer pain. Providers are increasingly developing treatment programs that incorporate CIH in their management of chronic noncancer pain.

One such program is the Empower Veterans Program (EVP). Originally developed at the Atlanta Veterans Affairs Health Care System, the EVP is a CIH modality based on the biopsychosocial model of pain developed by psychiatrist George Engel in 1977.³ The biopsychosocial model of pain recognizes that pain is a complex, multidimensional, biopsychosocial experience. Under this model, the mind and body work in unison as interconnected entities. Because the model acknowledges biological, psychological, and social components of pain and illness,⁴ treatment focuses on all aspects of a person’s health, life, and relationships.

The EVP fits into the VHA Pain Management Stepped Care Model and is an adjunctive complement for that model.^5-7 The EVP complements care at the first step, where patient/family provide self-care and where care is provided by patient-aligned primary care teams, at the second step, which includes secondary consultation with multidisciplinary pain medicine specialty teams and other specialists, and at the third step, with the addition of tertiary interdisciplinary pain centers.

The VA Maryland Health Care System (VAMHCS) implemented the EVP as part of a quality improvement project for the management of chronic pain. The objectives of the program were to reduce pain intensity, pain catastrophizing, and pain interference, as well as improve functionality and quality of life among veterans with chronic high-impact noncancer pain. More than 2 years after the program was implemented, collected data had not been analyzed. The purpose of this quality improvement project was to abstract and analyze the previously collected data from veterans with high-impact chronic pain who attended an EVP offered by the VAMHCS. The results of the data analysis were used to inform decisions regarding the future of the program.

Methods

This quality improvement project used the Plan-Do-Study-Act (PDSA) process.⁸ The first 2 phases of the PDSA cycle (Plan and Do) were completed by a team of VA employees from the VAMHCS, who donated their time to establish and implement the program at the project site. This team consisted of psychologists, a physical therapist, a social worker, and a chaplain, and included support from medical administrative staff. This team planned and implemented the EVP at the VA facility based on the model developed at the Atlanta VA Health Care System. During the “Do” phase, the team collected data on pain intensity, pain interference, quality of life, and pain negative cognition (catastrophizing) before the intervention and post intervention. They also collected data on program outcome (patient treatment satisfaction) post intervention. Because these employees did not have time to retrieve and analyze the data, they welcomed the opportunity to have the data analyzed by the investigators during the Study phase of the PDSA cycle. Based on the results of the analysis, recommendations for program changes were made during the Act phase of the cycle.

Intervention

The EVP was developed as a 10-week (30 hours) interdisciplinary CIH approach that coached veterans with chronic pain to live fuller lives based on their individual values and what matters to them. EVP is the “What Else” management modality for the 5% of veterans with high-impact chronic pain.⁹ The EVP provided functional restoration through its components of whole health, mindfulness training, coaching calls, acceptance and commitment therapy, and mindful movement. It used the Wheel of Health with the 4 key components of me, self-care, professional care, and community.^10,11

Veterans who had a diagnosis of chronic nonmalignant pain for 3 months or more and who agreed to participate in the EVP at this facility attended 3-hour classes every Tuesday with a cohort of 8 to 12 peers and engaged in one-on-one coaching with interdisciplinary team members. During the class sessions, veterans were coached to understand and accept their pain and commit to maintaining function despite their pain. Mindful movement by the physical therapist emphasized the pivotal place of exercise in pain management. The therapist used the mantra “Motion is Lotion.”⁹ The guiding principle of the EVP was that small incremental changes can have a big impact on the individual’s whole life. Emphasis was placed on increasing self-efficacy and mindful awareness for veterans with high-impact pain by giving them “Skills before Pills.”⁹

Outcome Measures

Outcome measures included the Numerical Pain Rating Scale (NPRS), the Multidimensional Pain Inventory (MPI), the World Health Organization Quality of Life assessment (WHOQOL-BREF), the Pain Catastrophizing Scale (PCS), and the Pain Treatment Satisfaction Scale (PTSS). Cronbach alpha coefficients were calculated to assess internal consistency reliability of these measures in the sample of veterans who completed the EVP.

NPRS. The NPRS is ubiquitous as a screening tool in many health care environments and its use is mandated by the VA health care system.¹² The choice of the NPRS as the tool for pain screening in the VA health care system was based on a large body of research that supports the reliability and validity of the NPRS as a single index of pain intensity or severity. Studies suggest that the NPRS is valid for use in the assessment of acute, cancer, or chronic nonmalignant pain and in varied clinical settings.¹³ The NPRS has 4 items, each on a scale of 0 to 10. For the purpose of this project, only 3 items were used. The 3 items assessed the worst pain, usual pain, and the current pain (right now). The higher the score, the higher the pain intensity. Cronbach alpha coefficients on the NPRS obtained from the current sample of veterans were 0.85 on both pre- and postintervention assessments.

MPI. The MPI is an easily accessible, reliable, and valid self-report questionnaire that measures the impact of pain on an individual’s life, quality of social support, and general activity.¹⁴ This instrument is a short version of the West Haven-Yale MPI.¹⁵ The MPI contains 9 items rated on a scale from 0 to 6. The higher the score, the greater pain interference a person is experiencing. The MPI produces reliable, valid information for diagnostic purposes and for therapy outcome studies.¹⁶ The MPI had a Cronbach alpha of 0.90 on pre-intervention and 0.92 on postintervention assessments in the current sample.

WHOQOL-BREF. The WHOQOL-BREF is a measure of quality of life and is an abbreviated version of the WHOQOL-100. Quality of life is defined by the World Health Organization¹⁷ “as an individuals’ perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.” The WHOQOL-BREF contains 26 items. The first 2 items were examined separately; the first item asks individuals to rate their overall quality of life and the second asks individuals how satisfied they are with their health. The remaining 24 items were used to calculate the following 4 domain scores: physical health, psychological health, social relationship, and environment.¹⁸ Each item is measured on a scale of 1 to 5. Higher scores denote higher or better quality of life. Domain scores have demonstrated good reliability and validity.^19-21 Cronbach alpha coefficients for the domain subscales ranged from 0.63 to 0.84 in the current sample, with the lowest alphas for the 3-item Social Relationships Domain.

PCS. The PCS is a widely used measure of catastrophic thinking related to pain. Catastrophizing has been conceived by Sullivan and colleagues as “an exaggerated negative mental set brought to bear during actual or anticipated painful experience.”²² The PCS provides a total score and scores for the following subscales: rumination, magnification, and helplessness.²³ It has been used in a variety of chronic pain populations and has demonstrated good reliability and validity in clinical as well as nonclinical samples.^24-26 The PCS has 13 items rated on a scale of 0 to 4. Higher scores mean greater negative pain cognition (catastrophizing). In the current sample, the PCS total scale had a Cronbach alpha coefficient of 0.95 and 0.94 on the 2 assessments. The coefficients for the subscales ranged from 0.81 to 0.90.

PTSS. The PTSS is a 5-item tool that measures patient satisfaction with pain treatment. It includes items that address overall satisfaction, staff warmth, staff skill level, ease of scheduling appointments, and recommendation of the program to other veterans. It was derived from the post-treatment version of The Pain Outcome Questionnaire-VA and has demonstrated reliability and validity.²⁷ The questions are scaled from 0 to 10. High scores on the PTSS denote high patient satisfaction with the EVP. The Cronbach alpha coefficient on the PTSS obtained from the current sample was 0.80.

Data Gathering and Analysis

Prior to starting the Study phase, Washburn University’s Institutional Review Board (IRB) and the VA IRB approved the project. The VA IRB, through its affiliate, gave a Not Human Research Determination and granted a waiver of informed consent and the Health Insurance Portability and Accountability Act authorization. The VA facility’s Research and Development department also approved the quality improvement project.

Once these approvals were obtained, the Study phase began with the abstraction of retrospective data obtained from veterans who participated in the VA health care facility’s EVP between August 2017 and August 2019. Most of the measurement tools changed in August 2019, and for this reason data abstraction was limited to the time period August 2017 to August 2019. The first author (JUU) abstracted data for both program completers and noncompleters. The second (MJ) and third (SW) authors analyzed the data in SPSS 24 and calculated effect sizes.

Veterans who completed the program were compared to veterans who did not complete the program on age, gender, and baseline measures. The investigators used independent samples t-tests to compare completers and noncompleters on age, pain intensity, pain interference, quality of life, and pain catastrophizing. They used the chi-square test of independence to analyze the association between gender and program completion.

Data were included in the pre- and postintervention analysis if the veteran completed the NPRS, MPI, WHOQOL-BREF, and PCS pre and post intervention. This became an important eligibility requirement as some of the tools/measures were changed towards the end of the review period in 2019. Pre- and postintervention data on pain intensity, pain interference, quality of life, pain catastrophizing, and patient satisfaction were compared using paired samples t-test at .004 level of significance based on the Bonferroni correction.²⁸ Data on patient satisfaction with pain treatment were collected at program completion (week 8 or 10) and were analyzed using descriptive statistics.

Effect sizes (Cohen’s d) were calculated to determine the substantive significance or magnitude of the mean differences in scores. Effect sizes (expressed as absolute values of Cohen’s d) were calculated as the mean difference divided by the standard deviation. Values of 0.2 were considered a small effect size, 0.5 a medium effect size, and 0.8 a large effect size.²⁹

 

 

Results

Data were abstracted for 115 veterans who started the EVP. Of these, 48 left the program, leaving 67 veterans (58%) who completed the program. Completers and noncompleters were similar in age, gender, and baseline measures (Table 1). Fifty-three (79%) completers and 35 (73%) noncompleters were male. A chi-square test of independence showed no significant association between gender and program completion (χ^2₁ [N = 115] = .595, P = .440).

Comparison of pre-and postintervention mean scale scores resulted in statistically significant differences for all comparisons (Table 2). These comparisons yielded improvements in the desired direction. For example, the scores on the NPRS, the MPI, and the PCS (along with its subscales) decreased, revealing reductions in pain severity, the impact of pain on the veterans’ lives, and pain catastrophizing. The 2 individual item scores on the WHOQOL-BREF increased, indicating improvements in perceived quality of life and satisfaction with health. The domain scores on the WHOQOL-BREF increased, revealing improvements in pain-related quality of life. The moderate to large effect sizes indicated clinically significant improvements for veterans with chronic high-impact pain who completed the EVP.

Analysis of data obtained using the PTSS yielded high mean scores for items that focused on patient satisfaction with treatment (Table 3). Scaled statistics yielded a mean (SD) of 46.95 (4.40). These results denoted overall patient satisfaction with the EVP.

Discussion

The purpose of this quality improvement project was to abstract and analyze previously collected data from veterans with high-impact chronic pain who attended the EVP. Comparison of pre-intervention and postintervention data obtained from 67 veterans who completed the program revealed improvements in pain intensity, pain interference, negative cognition (catastrophizing), and quality of life. The differences were statistically significant and clinically meaningful, with medium and large effect sizes. In addition, veterans reported high satisfaction with the EVP.

The EVP includes CIH approaches that have demonstrated effectiveness among veterans and other populations with chronic pain. A wealth of studies, for example, support the effectiveness of CIH approaches among veterans.^30-34 Other studies focus on specific CIH approaches that are components of the EVP. Evidence supports, for example, the efficacy of mindfulness-based stress reduction,^35-39 acceptance and commitment therapy,^40-43 brief peer support intervention,⁴⁴ and interdisciplinary biopsychosocial rehabilitation.^45,46

While empirical evidence supports components of the EVP, only one study focused on the outcomes of the Atlanta VA EVP among veterans with chronic pain. Results of a qualitative study conducted by Penney and Haro⁴⁷ described the experience of veterans with the EVP. Those veterans reported adopting new self-care or lifestyle practices for pain management and health, accepting pain, being better able to adjust and set boundaries, feeling more in control, participating in life, and changing their medication use.

The mean baseline scores from the current sample were similar to samples of patients with chronic pain in other studies (NPRS,⁴⁸ MPI,⁴⁸ and PCS^48-51). After converting scores on the WHOQOL-BREF from those that ranged from 4 to 20 to those that ranged from 0 to 100,¹⁸ the scores from the current sample were similar to those of other studies of patients with chronic pain.^48,52,53Several strengths of the project should be noted. Data were collected using well established measurement tools that had previously demonstrated reliability and validity. All the tools used in data collection demonstrated good internal consistency reliabilities in the current sample of veterans. Weaknesses of the project include the use of a convenience sample of veterans and small sample size. Data were not available on the number of veterans who were offered participation or on how many veterans declined enrollment. The sample of veterans who chose to participate in the EVP may or may not have been representative of the population of veterans with high-impact chronic pain. As a pre- and postintervention design with no comparison group, the results are subject to multiple threats to internal validity, including the Hawthorne effect, maturation in the form of healing, and attrition. Reasons for leaving the program had not been recorded, so the investigators had no way of knowing factors that may have contributed to attrition. Also, data on when veterans left the program were unavailable. Research is needed with a control group to reduce the effect of confounding variables on the outcome measures. This project used data collected at a single VA facility, which limits its generalizability.

While completers and noncompleters of the EVP were similar on age, gender, and baseline measures, there may have been unidentified characteristics that influenced program completion. The investigators noticed the presence of more missing data among noncompleters compared to completers on the pre-intervention PCS; thus, noncompleters may have scored lower than completers on this instrument simply because there were more individual items that were unanswered/missing among this group of noncompleters.

Data were analyzed using a limited number of outcome measures that had previously been collected. Other outcome measures might include whether EVP participants reduced their use of medications, clinical resources, and personnel. Future projects, for example, could determine whether the EVP is effective in reducing opioid analgesic medication use and decreasing primary care and emergency department visits. Cost-benefit analyses could be completed to determine whether EVP is associated with financial savings.

Because no follow-up assessments were made to determine whether improvements were maintained over time, the project focus was limited to an evaluation of the short-term changes in the outcome measures. Future projects could include a follow-up assessment of the veterans 1- or 2-years post completion of the EVP.

Data for the project were collected prior to the COVID-19 pandemic, when the EVP was implemented through face-to-face meetings with participants and their peers. It is not clear how changes to the delivery of the program (such as offering it through telehealth) might impact veterans’ satisfaction with the program, willingness to complete it, and other variables of interest.

The results of this project were made available to stakeholders with recommendations for program expansion both at the current location and at other VA facilities, including the recommendation to hire additional personnel that would implement the program. As the VA network of facilities expand the EVP program and adapt it for telehealth delivery, the investigators recommended a similar analysis of data be performed following telehealth delivery. If delivery through telehealth is shown to improve outcome measures, the EVP could provide pain management treatment options for patients challenged by transportation barriers, including rural veterans.

Conclusion

This quality improvement project provided evidence of improvement in measures of pain severity, pain interference, negative cognition (catastrophizing), quality of life, and patient treatment satisfaction among veterans with chronic high-impact pain. Findings have been well received by the northeastern VA as well as the Veterans Integrated Systems Network 5. The results of the analyses were used to inform decisions regarding the future of the program.

Disclaimer: This material is the result of work supported with resources and the use of facilities at the VA Maryland Health Care System, Baltimore, Maryland. The views expressed are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs or the United States Government.

Acknowledgments: The authors thank Dr. Arianna Perra, the recent past coordinator of the Empower Veterans Program (EVP), who provided initial insights and support that motivated the decision to evaluate the program. We also thank the veterans and VA EVP clinicians who contributed data for the evaluation, and Dr. Michael Saenger (Director, TelePain-EVP: EVP) and Dr. Robert Lavin for their ongoing support, care, and concern for veteran patients. We also thank Dr. Beverly Bradley and the neurology service administrative team for their guidance in the process of obtaining necessary VA approvals for this project.

Corresponding author: Jessica U. Uche, DNP, CRNP-Family; [email protected]

doi:10.12788/jcom.0089

From the University of Miami Miller School of Medicine (Drs. Sosa, Ferreira, Gershengorn, Soto, Parekh, and Suarez), and the Quality Department of the University of Miami Hospital and Clinics (Estin Kelly, Ameena Shrestha, Julianne Burgos, and Sandeep Devabhaktuni), Miami, FL.

Abstract

Background: Case mix index (CMI) and expected mortality are determined based on comorbidities. Improving documentation and coding can impact performance indicators. During and prior to 2018, our patient acuity was under-represented, with low expected mortality and CMI. Those metrics motivated our quality team to develop the quality initiatives reported here.

Objectives: We sought to assess the impact of quality initiatives on number of comorbidities, diagnoses, CMI, and expected mortality at the University of Miami Health System.

Design: We conducted an observational study of a series of quality initiatives: (1) education of clinical documentation specialists (CDS) to capture comorbidities (10/2019); (2) facilitating the process for physician query response (2/2020); (3) implementation of computer logic to capture electrolyte disturbances and renal dysfunction (8/2020); (4) development of a tool to capture Elixhauser comorbidities (11/2020); and (5) provider education and electronic health record reviews by the quality team.

Setting and participants: All admissions during 2019 and 2020 at University of Miami Health System. The health system includes 2 academic inpatient facilities, a 560-bed tertiary hospital, and a 40-bed cancer facility. Our hospital is 1 of the 11 PPS-Exempt Cancer Hospitals and is the South Florida’s only NCI-Designated Cancer Center.

Measures: Number of coded diagnoses and Elixhauser comorbidities; CMI and expected mortality were compared between the pre-intervention and the intervention periods using t-tests and Chi-square test.

Results: There were 33 066 admissions during the study period—13 689 before the intervention and 19 377 during the intervention period. From pre-intervention to intervention, the mean (SD) number of comorbidities increased from 2.5 (1.7) to 3.1 (2.0) (P < .0001), diagnoses increased from 11.3 (7.3) to 18.5 (10.4) (P < .0001), CMI increased from 2.1 (1.9) to 2.4 (2.2) (P < .0001), and expected mortality increased from 1.8% (6.1) to 3.1% (9.2) (P < .0001).

Conclusion: The number of comorbidities, diagnoses, and CMI all improved, and expected mortality increased in the year of implementation of the quality initiatives.

Keywords: PS/QI, coding, case mix index, comorbidities, mortality.

Accurate documentation of the patient’s clinical course during hospitalization is essential for patient care. To date, Diagnosis Related Groups (DRG) remain the standard for calculating health care system–level risk-adjusted outcomes data and are essential for institutional reputation (eg, US News & World Report rankings).^1,2 With an ever-increasing emphasis on pay-for-performance and value-based purchasing within the US health care system, there is a pressing need for institutions to accurately capture the complexity and acuity of the patients they care for.

Adoption of comprehensive electronic health record (EHR) systems by US hospitals, defined as an EHR capable of meeting all core meaningful-use metrics including evaluation and tracking of quality metrics, has been steadily increasing.^3,4 Many institutions have looked to EHR system transitions as an inflection point to expand clinical documentation improvement (CDI) efforts. Over the past several years, our institution, an academic medical center, has endeavored to fully transition to a comprehensive EHR system (Epic from Epic Systems Corporation). Part of the purpose of this transition was to help study and improve outcomes, reduce readmissions, improve quality of care, and meet performance indicators.

Prior to 2019, our hospital’s patient acuity was low, with a CMI consistently below 2, ranging from 1.81 to 1.99, and an expected mortality consistently below 1.9%, ranging from 1.65% to 1.85%. Our concern that these values underestimated the real severity of illness of our patient population prompted the development of a quality improvement plan. In this report, we describe the processes we undertook to improve documentation and coding of comorbid illness, and report on the impact of these initiatives on performance indicators. We hypothesized that our initiatives would have a significant impact on our ability to capture patient complexity, and thus impact our CMI and expected mortality.

Methods

In the fall of 2019, we embarked on a multifaceted quality improvement project aimed at improving comorbidity capture for patients hospitalized at our institution. The health system includes 2 academic inpatient facilities, a 560-bed tertiary hospital and a 40-bed cancer facility. Since September 2017, we have used Epic as our EHR. In August 2019, we started working with Vizient Clinical Data Base⁵ to allow benchmarking with peer institutions. We assessed the impact of this initiative with a pre/post study design.

Quality Initiatives

This quality improvement project consisted of a series of 5 targeted interventions coupled with continuous monitoring and education.

1. Comorbidity coding. In October 2019, we met with the clinical documentation specialists (CDS) and the coding team to educate them on the value of coding all comorbidities that have an impact on CMI and expected mortality, not only those that optimize the DRG.

2. Physician query. In October 2019, we modified the process for physician query response, allowing physicians to answer queries in the EHR through a reply tool incorporated into the query and accept answers in the body of the Epic message as an active part of the EHR.

3. EHR logic. In August 2020, we developed an EHR smart logic to automatically capture fluid and electrolyte disturbances and renal dysfunction, based on the most recent laboratory values. The logic automatically populated potentially appropriate diagnoses in the assessment and plan of provider notes, which require provider acknowledgment and which providers are able to modify (eFigure 1).

Assessment of Quality Initiatives’ Impact

Data on the number of comorbidities and performance indicators were obtained retrospectively. The data included all hospital admissions from 2019 and 2020 divided into 2 periods: pre-intervention from January 1, 2019 through September 30, 2019, and intervention from October 1, 2019 through December 31, 2020. The primary outcome of this observational study was the rate of comorbidity capture during the intervention period. Comorbidity capture was assessed using the Vizient Clinical Data Base (CDB) health care performance tool.⁵ Vizient CDB uses the Agency for Healthcare Research and Quality Elixhauser index, which includes 29 of the initial 31 comorbidities described by Elixhauser,⁶ as it combines hypertension with and without complications into one. We secondarily aimed to examine the impact of the quality improvement initiatives on several institutional-level performance indicators, including total number of diagnoses, comorbidities or complications (CC), major comorbidities or complications (MCC), CMI, and expected mortality.

Case mix index is the average Medicare Severity-DRG (MS-DRG) weighted across all hospital discharges (appropriate to their discharge date). The expected mortality represents the average expected number of deaths based on diagnosed conditions, age, and gender within the same time frame, and it is based on coded diagnosis; we obtained the mortality index by dividing the observed mortality by the expected mortality. The Vizient CDB Mortality Risk Adjustment Model was used to assign an expected mortality (0%-100%) to each case based on factors such as demographics, admission type, diagnoses, and procedures.

Standard statistics were used to measure the outcomes. We used Excel to compare pre-intervention and intervention period characteristics and outcomes, using t-testing for continuous variables and Chi-square testing for categorial outcomes. P values <0.05 were considered statistically significant.

The study was reviewed by the institutional review board (IRB) of our institution (IRB ID: 20210070). The IRB determined that the proposed activity was not research involving human subjects, as defined by the Department of Health and Human Services and US Food and Drug Administration regulations, and that IRB review and approval by the organization were not required.

Results

The health system had a total of 33 066 admissions during the study period—13 689 pre-intervention (January 1, 2019 through September 30, 2019) and 19,377 during the intervention period (October 1, 2019 to December 31, 2020). Demographics were similar among the pre-intervention and intervention periods: mean age was 60 years and 61 years, 52% and 51% of patients were male, 72% and 71% were White, and 20% and 19% were Black, respectively (Table 1).

The multifaceted intervention resulted in a significant improvement in the primary outcome: mean comorbidity capture increased from 2.5 (SD, 1.7) before the intervention to 3.1 (SD, 2.0) during the intervention (P < .00001). Secondary outcomes also improved. The mean number of secondary diagnoses for admissions increased from 11.3 (SD, 7.3) prior to the intervention to 18.5 (SD, 10.4) (P < .00001) during the intervention period. The mean CMI increased from 2.1 (SD, 1.9) to 2.4 (SD, 2.2) post intervention (P < .00001), an increase during the intervention period of 14%. The expected mortality increased from 1.8% (SD, 6.1%) to 3.1% (SD, 9.2%) after the intervention (P < .00001) (Table 2).

Discussion

The need for accurate documentation by physicians has been recognized for many years.⁷Patient acuity at our institution during 2018 and prior was under-represented, with low expected mortality and CMI. Those metrics motivated our quality team to develop the initiatives described here. We had previously sought to improve documentation and performance indicators at our institution through educational initiatives. These unpublished interventions included quarterly data review by departments and divisions with physician educational didactics. These educational initiatives are necessary but require considerable workforce time and are limited to the targeted subgroup. While education and engagement of providers are essential to enhance documentation and were an important part of our interventions, we felt that additional, more sustainable interventions were needed. Leveraging the EHR to facilitate physician documentation was key. All our interventions, including our tool to help capture fluid and electrolyte abnormalities and renal dysfunction, together with our Elixhauser comorbidities tool, had a substantial impact on performance metrics.

With the growing complexity of the documentation and coding process, it is difficult for clinicians to keep up with the terminology required by the Centers for Medicare and Medicaid Services (CMS). Several different methods to improve documentation have been proposed. Prior interventions to standardize documentation templates in the trauma service have shown improvement in CMI.⁸ An educational program on coding for internal medicine that included a lecture series and creation of a laminated pocket card listing common CMS diagnoses, CC, and MCC has been implemented, with an improvement in the capture rate of CC and MCC from 42% to 48% and an impact on expected mortality.⁹ This program resulted in a 30% decrease in the median quarterly mortality index and an increase in CMI from 1.27 to 1.36.

Our results show that there was an increase in comorbidities documentation of admitted patients after all interventions were implemented, more accurately reflecting the complexity of our patient population in a tertiary care academic medical center. Our CMI increased by 14% during the intervention period. The estimated CMI dollar impact increased by 75% from the pre-intervention period (adjusted for PPS-exempt hospital). The hospital-expected mortality increased from 1.77 to 3.07 (peak at 4.74 during third quarter of 2020) during the implementation period, which is a key driver of quality rankings for national outcomes reporting services such as US News & World Report.

There was increased physician satisfaction as a result of the change of functionality of the query response system, and no additional monetary provider incentive for complete documentation was allocated, apart from education and 1:1 support that improved physician engagement. Our next steps include the implementation of an advanced program to concurrently and automatically capture and nudge providers to respond and complete their documentation in real time.

Limitations

The limitations of our study include those inherent to a retrospective review and are associative and observational in nature. Although we used expected mortality and CMI as a surrogate for patient acuity for comparison, there was no way to control for actual changes in patient acuity that contributed to the increase in CMI, although we believe that the population we served and the services provided and their structure did not change significantly during the intervention period. Additionally, the observed increase in CMI during the implementation period may be a result of described variabilities in CMI and would be better studied over a longer period. Also, during the year of our interventions, 2020, we were affected by the COVID-19 pandemic. Patients with COVID-19 are known to carry a lower-than-expected mortality, and that could have had a negative impact on our results. In fact, we did observe a decrease in our expected mortality during the last quarter of 2020, which correlated with one of our regional peaks for COVID-19, and that could be a confounding factor. While the described intervention process is potentially applicable to multiple EHR systems, the exact form to capture the Elixhauser comorbidities was built into the Epic EHR, limiting external applicability of this tool to other EHR software.

Conclusion

A continuous comprehensive series of interventions substantially increased our patient acuity scores. The increased scores have implications for reimbursement and quality comparisons for hospitals and physicians. Our institution can now be stratified more accurately with our peers and other hospitals. Accurate medical record documentation has become increasingly important, but also increasingly complex. Leveraging the EHR through quality initiatives that facilitate the workflow for providers can have an impact on documentation, coding, and ultimately risk-adjusted outcomes data that influence institutional reputation.

Corresponding author: Marie Anne Sosa, MD; 1120 NW 14th St., Suite 809, Miami, FL, 33134; [email protected]

Disclosures: None reported.

doi:10.12788/jcom.0088

From the University of Miami Miller School of Medicine (Drs. Sosa, Ferreira, Gershengorn, Soto, Parekh, and Suarez), and the Quality Department of the University of Miami Hospital and Clinics (Estin Kelly, Ameena Shrestha, Julianne Burgos, and Sandeep Devabhaktuni), Miami, FL.

Abstract

Background: Case mix index (CMI) and expected mortality are determined based on comorbidities. Improving documentation and coding can impact performance indicators. During and prior to 2018, our patient acuity was under-represented, with low expected mortality and CMI. Those metrics motivated our quality team to develop the quality initiatives reported here.

Objectives: We sought to assess the impact of quality initiatives on number of comorbidities, diagnoses, CMI, and expected mortality at the University of Miami Health System.

Design: We conducted an observational study of a series of quality initiatives: (1) education of clinical documentation specialists (CDS) to capture comorbidities (10/2019); (2) facilitating the process for physician query response (2/2020); (3) implementation of computer logic to capture electrolyte disturbances and renal dysfunction (8/2020); (4) development of a tool to capture Elixhauser comorbidities (11/2020); and (5) provider education and electronic health record reviews by the quality team.

Setting and participants: All admissions during 2019 and 2020 at University of Miami Health System. The health system includes 2 academic inpatient facilities, a 560-bed tertiary hospital, and a 40-bed cancer facility. Our hospital is 1 of the 11 PPS-Exempt Cancer Hospitals and is the South Florida’s only NCI-Designated Cancer Center.

Measures: Number of coded diagnoses and Elixhauser comorbidities; CMI and expected mortality were compared between the pre-intervention and the intervention periods using t-tests and Chi-square test.

Results: There were 33 066 admissions during the study period—13 689 before the intervention and 19 377 during the intervention period. From pre-intervention to intervention, the mean (SD) number of comorbidities increased from 2.5 (1.7) to 3.1 (2.0) (P < .0001), diagnoses increased from 11.3 (7.3) to 18.5 (10.4) (P < .0001), CMI increased from 2.1 (1.9) to 2.4 (2.2) (P < .0001), and expected mortality increased from 1.8% (6.1) to 3.1% (9.2) (P < .0001).

Conclusion: The number of comorbidities, diagnoses, and CMI all improved, and expected mortality increased in the year of implementation of the quality initiatives.

Keywords: PS/QI, coding, case mix index, comorbidities, mortality.

Accurate documentation of the patient’s clinical course during hospitalization is essential for patient care. To date, Diagnosis Related Groups (DRG) remain the standard for calculating health care system–level risk-adjusted outcomes data and are essential for institutional reputation (eg, US News & World Report rankings).^1,2 With an ever-increasing emphasis on pay-for-performance and value-based purchasing within the US health care system, there is a pressing need for institutions to accurately capture the complexity and acuity of the patients they care for.

Adoption of comprehensive electronic health record (EHR) systems by US hospitals, defined as an EHR capable of meeting all core meaningful-use metrics including evaluation and tracking of quality metrics, has been steadily increasing.^3,4 Many institutions have looked to EHR system transitions as an inflection point to expand clinical documentation improvement (CDI) efforts. Over the past several years, our institution, an academic medical center, has endeavored to fully transition to a comprehensive EHR system (Epic from Epic Systems Corporation). Part of the purpose of this transition was to help study and improve outcomes, reduce readmissions, improve quality of care, and meet performance indicators.

Prior to 2019, our hospital’s patient acuity was low, with a CMI consistently below 2, ranging from 1.81 to 1.99, and an expected mortality consistently below 1.9%, ranging from 1.65% to 1.85%. Our concern that these values underestimated the real severity of illness of our patient population prompted the development of a quality improvement plan. In this report, we describe the processes we undertook to improve documentation and coding of comorbid illness, and report on the impact of these initiatives on performance indicators. We hypothesized that our initiatives would have a significant impact on our ability to capture patient complexity, and thus impact our CMI and expected mortality.

Methods

In the fall of 2019, we embarked on a multifaceted quality improvement project aimed at improving comorbidity capture for patients hospitalized at our institution. The health system includes 2 academic inpatient facilities, a 560-bed tertiary hospital and a 40-bed cancer facility. Since September 2017, we have used Epic as our EHR. In August 2019, we started working with Vizient Clinical Data Base⁵ to allow benchmarking with peer institutions. We assessed the impact of this initiative with a pre/post study design.

Quality Initiatives

This quality improvement project consisted of a series of 5 targeted interventions coupled with continuous monitoring and education.

1. Comorbidity coding. In October 2019, we met with the clinical documentation specialists (CDS) and the coding team to educate them on the value of coding all comorbidities that have an impact on CMI and expected mortality, not only those that optimize the DRG.

2. Physician query. In October 2019, we modified the process for physician query response, allowing physicians to answer queries in the EHR through a reply tool incorporated into the query and accept answers in the body of the Epic message as an active part of the EHR.

3. EHR logic. In August 2020, we developed an EHR smart logic to automatically capture fluid and electrolyte disturbances and renal dysfunction, based on the most recent laboratory values. The logic automatically populated potentially appropriate diagnoses in the assessment and plan of provider notes, which require provider acknowledgment and which providers are able to modify (eFigure 1).

Assessment of Quality Initiatives’ Impact

Data on the number of comorbidities and performance indicators were obtained retrospectively. The data included all hospital admissions from 2019 and 2020 divided into 2 periods: pre-intervention from January 1, 2019 through September 30, 2019, and intervention from October 1, 2019 through December 31, 2020. The primary outcome of this observational study was the rate of comorbidity capture during the intervention period. Comorbidity capture was assessed using the Vizient Clinical Data Base (CDB) health care performance tool.⁵ Vizient CDB uses the Agency for Healthcare Research and Quality Elixhauser index, which includes 29 of the initial 31 comorbidities described by Elixhauser,⁶ as it combines hypertension with and without complications into one. We secondarily aimed to examine the impact of the quality improvement initiatives on several institutional-level performance indicators, including total number of diagnoses, comorbidities or complications (CC), major comorbidities or complications (MCC), CMI, and expected mortality.

Case mix index is the average Medicare Severity-DRG (MS-DRG) weighted across all hospital discharges (appropriate to their discharge date). The expected mortality represents the average expected number of deaths based on diagnosed conditions, age, and gender within the same time frame, and it is based on coded diagnosis; we obtained the mortality index by dividing the observed mortality by the expected mortality. The Vizient CDB Mortality Risk Adjustment Model was used to assign an expected mortality (0%-100%) to each case based on factors such as demographics, admission type, diagnoses, and procedures.

Standard statistics were used to measure the outcomes. We used Excel to compare pre-intervention and intervention period characteristics and outcomes, using t-testing for continuous variables and Chi-square testing for categorial outcomes. P values <0.05 were considered statistically significant.

The study was reviewed by the institutional review board (IRB) of our institution (IRB ID: 20210070). The IRB determined that the proposed activity was not research involving human subjects, as defined by the Department of Health and Human Services and US Food and Drug Administration regulations, and that IRB review and approval by the organization were not required.

Results

The health system had a total of 33 066 admissions during the study period—13 689 pre-intervention (January 1, 2019 through September 30, 2019) and 19,377 during the intervention period (October 1, 2019 to December 31, 2020). Demographics were similar among the pre-intervention and intervention periods: mean age was 60 years and 61 years, 52% and 51% of patients were male, 72% and 71% were White, and 20% and 19% were Black, respectively (Table 1).

The multifaceted intervention resulted in a significant improvement in the primary outcome: mean comorbidity capture increased from 2.5 (SD, 1.7) before the intervention to 3.1 (SD, 2.0) during the intervention (P < .00001). Secondary outcomes also improved. The mean number of secondary diagnoses for admissions increased from 11.3 (SD, 7.3) prior to the intervention to 18.5 (SD, 10.4) (P < .00001) during the intervention period. The mean CMI increased from 2.1 (SD, 1.9) to 2.4 (SD, 2.2) post intervention (P < .00001), an increase during the intervention period of 14%. The expected mortality increased from 1.8% (SD, 6.1%) to 3.1% (SD, 9.2%) after the intervention (P < .00001) (Table 2).

Discussion

The need for accurate documentation by physicians has been recognized for many years.⁷Patient acuity at our institution during 2018 and prior was under-represented, with low expected mortality and CMI. Those metrics motivated our quality team to develop the initiatives described here. We had previously sought to improve documentation and performance indicators at our institution through educational initiatives. These unpublished interventions included quarterly data review by departments and divisions with physician educational didactics. These educational initiatives are necessary but require considerable workforce time and are limited to the targeted subgroup. While education and engagement of providers are essential to enhance documentation and were an important part of our interventions, we felt that additional, more sustainable interventions were needed. Leveraging the EHR to facilitate physician documentation was key. All our interventions, including our tool to help capture fluid and electrolyte abnormalities and renal dysfunction, together with our Elixhauser comorbidities tool, had a substantial impact on performance metrics.

With the growing complexity of the documentation and coding process, it is difficult for clinicians to keep up with the terminology required by the Centers for Medicare and Medicaid Services (CMS). Several different methods to improve documentation have been proposed. Prior interventions to standardize documentation templates in the trauma service have shown improvement in CMI.⁸ An educational program on coding for internal medicine that included a lecture series and creation of a laminated pocket card listing common CMS diagnoses, CC, and MCC has been implemented, with an improvement in the capture rate of CC and MCC from 42% to 48% and an impact on expected mortality.⁹ This program resulted in a 30% decrease in the median quarterly mortality index and an increase in CMI from 1.27 to 1.36.

Our results show that there was an increase in comorbidities documentation of admitted patients after all interventions were implemented, more accurately reflecting the complexity of our patient population in a tertiary care academic medical center. Our CMI increased by 14% during the intervention period. The estimated CMI dollar impact increased by 75% from the pre-intervention period (adjusted for PPS-exempt hospital). The hospital-expected mortality increased from 1.77 to 3.07 (peak at 4.74 during third quarter of 2020) during the implementation period, which is a key driver of quality rankings for national outcomes reporting services such as US News & World Report.

There was increased physician satisfaction as a result of the change of functionality of the query response system, and no additional monetary provider incentive for complete documentation was allocated, apart from education and 1:1 support that improved physician engagement. Our next steps include the implementation of an advanced program to concurrently and automatically capture and nudge providers to respond and complete their documentation in real time.

Limitations

The limitations of our study include those inherent to a retrospective review and are associative and observational in nature. Although we used expected mortality and CMI as a surrogate for patient acuity for comparison, there was no way to control for actual changes in patient acuity that contributed to the increase in CMI, although we believe that the population we served and the services provided and their structure did not change significantly during the intervention period. Additionally, the observed increase in CMI during the implementation period may be a result of described variabilities in CMI and would be better studied over a longer period. Also, during the year of our interventions, 2020, we were affected by the COVID-19 pandemic. Patients with COVID-19 are known to carry a lower-than-expected mortality, and that could have had a negative impact on our results. In fact, we did observe a decrease in our expected mortality during the last quarter of 2020, which correlated with one of our regional peaks for COVID-19, and that could be a confounding factor. While the described intervention process is potentially applicable to multiple EHR systems, the exact form to capture the Elixhauser comorbidities was built into the Epic EHR, limiting external applicability of this tool to other EHR software.

Conclusion

A continuous comprehensive series of interventions substantially increased our patient acuity scores. The increased scores have implications for reimbursement and quality comparisons for hospitals and physicians. Our institution can now be stratified more accurately with our peers and other hospitals. Accurate medical record documentation has become increasingly important, but also increasingly complex. Leveraging the EHR through quality initiatives that facilitate the workflow for providers can have an impact on documentation, coding, and ultimately risk-adjusted outcomes data that influence institutional reputation.

Corresponding author: Marie Anne Sosa, MD; 1120 NW 14th St., Suite 809, Miami, FL, 33134; [email protected]

Disclosures: None reported.

doi:10.12788/jcom.0088

From the University of Miami Miller School of Medicine (Drs. Sosa, Ferreira, Gershengorn, Soto, Parekh, and Suarez), and the Quality Department of the University of Miami Hospital and Clinics (Estin Kelly, Ameena Shrestha, Julianne Burgos, and Sandeep Devabhaktuni), Miami, FL.

Abstract

Background: Case mix index (CMI) and expected mortality are determined based on comorbidities. Improving documentation and coding can impact performance indicators. During and prior to 2018, our patient acuity was under-represented, with low expected mortality and CMI. Those metrics motivated our quality team to develop the quality initiatives reported here.

Objectives: We sought to assess the impact of quality initiatives on number of comorbidities, diagnoses, CMI, and expected mortality at the University of Miami Health System.

Design: We conducted an observational study of a series of quality initiatives: (1) education of clinical documentation specialists (CDS) to capture comorbidities (10/2019); (2) facilitating the process for physician query response (2/2020); (3) implementation of computer logic to capture electrolyte disturbances and renal dysfunction (8/2020); (4) development of a tool to capture Elixhauser comorbidities (11/2020); and (5) provider education and electronic health record reviews by the quality team.

Setting and participants: All admissions during 2019 and 2020 at University of Miami Health System. The health system includes 2 academic inpatient facilities, a 560-bed tertiary hospital, and a 40-bed cancer facility. Our hospital is 1 of the 11 PPS-Exempt Cancer Hospitals and is the South Florida’s only NCI-Designated Cancer Center.

Measures: Number of coded diagnoses and Elixhauser comorbidities; CMI and expected mortality were compared between the pre-intervention and the intervention periods using t-tests and Chi-square test.

Results: There were 33 066 admissions during the study period—13 689 before the intervention and 19 377 during the intervention period. From pre-intervention to intervention, the mean (SD) number of comorbidities increased from 2.5 (1.7) to 3.1 (2.0) (P < .0001), diagnoses increased from 11.3 (7.3) to 18.5 (10.4) (P < .0001), CMI increased from 2.1 (1.9) to 2.4 (2.2) (P < .0001), and expected mortality increased from 1.8% (6.1) to 3.1% (9.2) (P < .0001).

Conclusion: The number of comorbidities, diagnoses, and CMI all improved, and expected mortality increased in the year of implementation of the quality initiatives.

Keywords: PS/QI, coding, case mix index, comorbidities, mortality.

Accurate documentation of the patient’s clinical course during hospitalization is essential for patient care. To date, Diagnosis Related Groups (DRG) remain the standard for calculating health care system–level risk-adjusted outcomes data and are essential for institutional reputation (eg, US News & World Report rankings).^1,2 With an ever-increasing emphasis on pay-for-performance and value-based purchasing within the US health care system, there is a pressing need for institutions to accurately capture the complexity and acuity of the patients they care for.

Adoption of comprehensive electronic health record (EHR) systems by US hospitals, defined as an EHR capable of meeting all core meaningful-use metrics including evaluation and tracking of quality metrics, has been steadily increasing.^3,4 Many institutions have looked to EHR system transitions as an inflection point to expand clinical documentation improvement (CDI) efforts. Over the past several years, our institution, an academic medical center, has endeavored to fully transition to a comprehensive EHR system (Epic from Epic Systems Corporation). Part of the purpose of this transition was to help study and improve outcomes, reduce readmissions, improve quality of care, and meet performance indicators.

Prior to 2019, our hospital’s patient acuity was low, with a CMI consistently below 2, ranging from 1.81 to 1.99, and an expected mortality consistently below 1.9%, ranging from 1.65% to 1.85%. Our concern that these values underestimated the real severity of illness of our patient population prompted the development of a quality improvement plan. In this report, we describe the processes we undertook to improve documentation and coding of comorbid illness, and report on the impact of these initiatives on performance indicators. We hypothesized that our initiatives would have a significant impact on our ability to capture patient complexity, and thus impact our CMI and expected mortality.

Methods

In the fall of 2019, we embarked on a multifaceted quality improvement project aimed at improving comorbidity capture for patients hospitalized at our institution. The health system includes 2 academic inpatient facilities, a 560-bed tertiary hospital and a 40-bed cancer facility. Since September 2017, we have used Epic as our EHR. In August 2019, we started working with Vizient Clinical Data Base⁵ to allow benchmarking with peer institutions. We assessed the impact of this initiative with a pre/post study design.

Quality Initiatives

This quality improvement project consisted of a series of 5 targeted interventions coupled with continuous monitoring and education.

1. Comorbidity coding. In October 2019, we met with the clinical documentation specialists (CDS) and the coding team to educate them on the value of coding all comorbidities that have an impact on CMI and expected mortality, not only those that optimize the DRG.

2. Physician query. In October 2019, we modified the process for physician query response, allowing physicians to answer queries in the EHR through a reply tool incorporated into the query and accept answers in the body of the Epic message as an active part of the EHR.

3. EHR logic. In August 2020, we developed an EHR smart logic to automatically capture fluid and electrolyte disturbances and renal dysfunction, based on the most recent laboratory values. The logic automatically populated potentially appropriate diagnoses in the assessment and plan of provider notes, which require provider acknowledgment and which providers are able to modify (eFigure 1).

Assessment of Quality Initiatives’ Impact

Data on the number of comorbidities and performance indicators were obtained retrospectively. The data included all hospital admissions from 2019 and 2020 divided into 2 periods: pre-intervention from January 1, 2019 through September 30, 2019, and intervention from October 1, 2019 through December 31, 2020. The primary outcome of this observational study was the rate of comorbidity capture during the intervention period. Comorbidity capture was assessed using the Vizient Clinical Data Base (CDB) health care performance tool.⁵ Vizient CDB uses the Agency for Healthcare Research and Quality Elixhauser index, which includes 29 of the initial 31 comorbidities described by Elixhauser,⁶ as it combines hypertension with and without complications into one. We secondarily aimed to examine the impact of the quality improvement initiatives on several institutional-level performance indicators, including total number of diagnoses, comorbidities or complications (CC), major comorbidities or complications (MCC), CMI, and expected mortality.

Case mix index is the average Medicare Severity-DRG (MS-DRG) weighted across all hospital discharges (appropriate to their discharge date). The expected mortality represents the average expected number of deaths based on diagnosed conditions, age, and gender within the same time frame, and it is based on coded diagnosis; we obtained the mortality index by dividing the observed mortality by the expected mortality. The Vizient CDB Mortality Risk Adjustment Model was used to assign an expected mortality (0%-100%) to each case based on factors such as demographics, admission type, diagnoses, and procedures.

Standard statistics were used to measure the outcomes. We used Excel to compare pre-intervention and intervention period characteristics and outcomes, using t-testing for continuous variables and Chi-square testing for categorial outcomes. P values <0.05 were considered statistically significant.

The study was reviewed by the institutional review board (IRB) of our institution (IRB ID: 20210070). The IRB determined that the proposed activity was not research involving human subjects, as defined by the Department of Health and Human Services and US Food and Drug Administration regulations, and that IRB review and approval by the organization were not required.

Results

The health system had a total of 33 066 admissions during the study period—13 689 pre-intervention (January 1, 2019 through September 30, 2019) and 19,377 during the intervention period (October 1, 2019 to December 31, 2020). Demographics were similar among the pre-intervention and intervention periods: mean age was 60 years and 61 years, 52% and 51% of patients were male, 72% and 71% were White, and 20% and 19% were Black, respectively (Table 1).

The multifaceted intervention resulted in a significant improvement in the primary outcome: mean comorbidity capture increased from 2.5 (SD, 1.7) before the intervention to 3.1 (SD, 2.0) during the intervention (P < .00001). Secondary outcomes also improved. The mean number of secondary diagnoses for admissions increased from 11.3 (SD, 7.3) prior to the intervention to 18.5 (SD, 10.4) (P < .00001) during the intervention period. The mean CMI increased from 2.1 (SD, 1.9) to 2.4 (SD, 2.2) post intervention (P < .00001), an increase during the intervention period of 14%. The expected mortality increased from 1.8% (SD, 6.1%) to 3.1% (SD, 9.2%) after the intervention (P < .00001) (Table 2).

Discussion

The need for accurate documentation by physicians has been recognized for many years.⁷Patient acuity at our institution during 2018 and prior was under-represented, with low expected mortality and CMI. Those metrics motivated our quality team to develop the initiatives described here. We had previously sought to improve documentation and performance indicators at our institution through educational initiatives. These unpublished interventions included quarterly data review by departments and divisions with physician educational didactics. These educational initiatives are necessary but require considerable workforce time and are limited to the targeted subgroup. While education and engagement of providers are essential to enhance documentation and were an important part of our interventions, we felt that additional, more sustainable interventions were needed. Leveraging the EHR to facilitate physician documentation was key. All our interventions, including our tool to help capture fluid and electrolyte abnormalities and renal dysfunction, together with our Elixhauser comorbidities tool, had a substantial impact on performance metrics.

With the growing complexity of the documentation and coding process, it is difficult for clinicians to keep up with the terminology required by the Centers for Medicare and Medicaid Services (CMS). Several different methods to improve documentation have been proposed. Prior interventions to standardize documentation templates in the trauma service have shown improvement in CMI.⁸ An educational program on coding for internal medicine that included a lecture series and creation of a laminated pocket card listing common CMS diagnoses, CC, and MCC has been implemented, with an improvement in the capture rate of CC and MCC from 42% to 48% and an impact on expected mortality.⁹ This program resulted in a 30% decrease in the median quarterly mortality index and an increase in CMI from 1.27 to 1.36.

Our results show that there was an increase in comorbidities documentation of admitted patients after all interventions were implemented, more accurately reflecting the complexity of our patient population in a tertiary care academic medical center. Our CMI increased by 14% during the intervention period. The estimated CMI dollar impact increased by 75% from the pre-intervention period (adjusted for PPS-exempt hospital). The hospital-expected mortality increased from 1.77 to 3.07 (peak at 4.74 during third quarter of 2020) during the implementation period, which is a key driver of quality rankings for national outcomes reporting services such as US News & World Report.

There was increased physician satisfaction as a result of the change of functionality of the query response system, and no additional monetary provider incentive for complete documentation was allocated, apart from education and 1:1 support that improved physician engagement. Our next steps include the implementation of an advanced program to concurrently and automatically capture and nudge providers to respond and complete their documentation in real time.

Limitations

The limitations of our study include those inherent to a retrospective review and are associative and observational in nature. Although we used expected mortality and CMI as a surrogate for patient acuity for comparison, there was no way to control for actual changes in patient acuity that contributed to the increase in CMI, although we believe that the population we served and the services provided and their structure did not change significantly during the intervention period. Additionally, the observed increase in CMI during the implementation period may be a result of described variabilities in CMI and would be better studied over a longer period. Also, during the year of our interventions, 2020, we were affected by the COVID-19 pandemic. Patients with COVID-19 are known to carry a lower-than-expected mortality, and that could have had a negative impact on our results. In fact, we did observe a decrease in our expected mortality during the last quarter of 2020, which correlated with one of our regional peaks for COVID-19, and that could be a confounding factor. While the described intervention process is potentially applicable to multiple EHR systems, the exact form to capture the Elixhauser comorbidities was built into the Epic EHR, limiting external applicability of this tool to other EHR software.

Conclusion

A continuous comprehensive series of interventions substantially increased our patient acuity scores. The increased scores have implications for reimbursement and quality comparisons for hospitals and physicians. Our institution can now be stratified more accurately with our peers and other hospitals. Accurate medical record documentation has become increasingly important, but also increasingly complex. Leveraging the EHR through quality initiatives that facilitate the workflow for providers can have an impact on documentation, coding, and ultimately risk-adjusted outcomes data that influence institutional reputation.

Corresponding author: Marie Anne Sosa, MD; 1120 NW 14th St., Suite 809, Miami, FL, 33134; [email protected]

Disclosures: None reported.

doi:10.12788/jcom.0088