Tixagevimab copackaged with cilgavimab (Evusheld) is a safe and effective preexposure prophylaxis (PrEP) in patients undergoing B-cell-depleting therapies who have poor immune response to COVID-19 vaccination and are at high risk for serious COVID-19 illness, a small, single-site study suggests.

Evusheld, the only COVID-19 PrEP option available, has Emergency Use Authorization (EUA) from the Food and Drug Administration for treatment of immunocompromised patients who may not respond sufficiently to COVID-19 vaccination and patients who’ve had a severe adverse reaction to COVID-19 vaccination.

“We report the largest real-world experience of Evusheld in this population, and our findings are encouraging,” lead study author Cassandra Calabrese, DO, rheumatologist and infectious disease specialist at Cleveland Clinic, said in an interview.

“Of 412 patients who received Evusheld, 12 [2.9%] developed breakthrough COVID-19, with 11 having mild courses and 1 who required hospitalization but recovered,” she added.

“Our data suggest that Evusheld PrEP, in combination with aggressive outpatient treatment of COVID-19, is likely effective in lowering risk of severe COVID in this vulnerable group.

“Practitioners who care for patients with immune-mediated inflammatory diseases should triage high-risk patients for Evusheld as well as rapid diagnosis and aggressive outpatient therapy if infected,” Dr. Calabrese advised.

For the study, Dr. Calabrese and colleagues at Cleveland Clinic searched the health care system pharmacy records for patients with immune‐mediated inflammatory diseases (IMIDs) or inborn errors of humoral immunity (IEI) who met the criteria to receive Evusheld. The researchers included patients on B-cell-depleting therapies or with humoral IEI who had received at least one dose of Evusheld and were later diagnosed with COVID-19, and they excluded those treated with B-cell-depleting therapies for cancer.
 

EVUSHELD was well tolerated

After extracting data on COVID-19 infection, vaccination status, and outcomes, they found that, between Jan. 18 and May 28, 2022, 412 patients with IMIDs or humoral IEI received Evusheld. No deaths occurred among these patients and, overall, they tolerated the medication well.

All 12 patients who experienced breakthrough COVID-19 infection were treated with B-cell-depleting therapies. Among the 12 patients:

• Six patients developed infection 13-84 (median 19) days after receiving 150 mg/150 mg tixagevimab/cilgavimab.
• Six patients developed infection 19-72 (median of 38.5) days after either a single dose of 300 mg/300 mg or a second dose of 150 mg/150 mg.
• Eleven patients had mild illness and recovered at home; one patient was hospitalized and treated with high-flow oxygen. All cases had been vaccinated against COVID-19 (five received two vaccinations, six received three, and one received four).
• One possible serious adverse event involved a patient with COVID-19 and immune-mediated thrombocytopenia (ITP) who was hospitalized soon after receiving Evusheld with ITP flare that resolved with intravenous immunoglobulin.

Dr. Calabrese acknowledged limitations to the study, including few patients, lack of a comparator group, and the study period falling during the Omicron wave.

“Also, nine of the breakthrough cases received additional COVID-19 therapy (oral antiviral or monoclonal antibody), which falls within standard of care for this high-risk group but prevents ascribing effectiveness to individual components of the regimen,” she added.

“Evusheld is authorized for PrEP against COVID-19 in patients at high risk for severe COVID due to suboptimal vaccine responses. This includes patients receiving B-cell-depleting drugs like rituximab, and patients with inborn errors of humoral immunity,” Dr. Calabrese explained.

“It is well known that this group of patients is at very high risk for severe COVID and death, even when fully vaccinated, and it has become clear that more strategies are needed to protect this vulnerable group, including use of Evusheld as well as aggressive treatment if infected,” she added.  
 

Evusheld not always easy to obtain

Although the medication has been available in the United States since January 2022, Dr. Calabrese said, patients may not receive it because of barriers including lack of both awareness and access.

Davey Smith, MD, professor of medicine and head of infectious diseases and global public health at the University of California San Diego, in La Jolla, said in an interview that he was not surprised by the results, but added that the study was conducted in too few patients to draw any strong conclusions or affect patient care.

“This small study that showed that breakthrough infections occurred but were generally mild, provides a small glimpse of real-world use of tixagevimab/cilgavimab as PrEP for immunocompromised persons,” said Dr. Smith, who was not involved in the study.

“In the setting of Omicron and vaccination, I would expect the same outcomes reported even without the treatment,” he added.

Dr. Smith recommends larger related randomized, controlled trials to provide clinicians with sufficient data to guide them in their patient care.

Graham Snyder, MD, associate professor in the division of infectious diseases at the University of Pittsburgh and medical director of infection prevention and hospital epidemiology at the University of Pittsburgh Medical Center, noted that the study “adds to a quickly growing literature on the real-world benefits of tixagevimab/cilgavimab to protect vulnerable individuals with weakened immune systems from the complications of COVID-19.

“This study provides a modest addition to our understanding of the role and benefit of Evusheld,” Dr. Snyder said in an interview. “By characterizing only patients who have received Evusheld without an untreated comparison group, we can’t draw any inference about the extent of benefit the agent provided to these patients.

“Substantial data already show that this agent is effective in preventing complications of COVID-19 infection in immunocompromised individuals,” added Dr. Snyder, who was not involved in the study.

“ ‘Immunocompromised’ represents a very diverse set of clinical conditions,” he said. “The research agenda should therefore focus on a more refined description of the effect in specific populations and a continued understanding of the effect of Evusheld in the context of updated vaccination strategies and changing virus ecology.”

Dr. Calabrese and her colleagues wrote that larger, controlled trials are underway.

 

FDA: Evusheld may not neutralize certain SARS-CoV-2 variants

“The biggest unanswered question is how Evusheld will hold up against new variants,” Dr. Calabrese said.

In an Oct. 3, 2022, update, the Food and Drug Administration released a statement about the risk of developing COVID-19 from SARS-CoV-2 variants that are not neutralized by Evusheld. The statement mentions an updated fact sheet that describes reduced protection from Evusheld against the Omicron subvariant BA.4.6, which accounted for nearly 13% of all new COVID-19 cases in the United States in the week ending Oct. 1.

There was no outside funding for the study. Dr. Smith reported no relevant financial conflicts of interest. Dr. Snyder said he is an unpaid adviser to an AstraZeneca observational study that’s assessing the real-world effectiveness of Evusheld.

Tixagevimab copackaged with cilgavimab (Evusheld) is a safe and effective preexposure prophylaxis (PrEP) in patients undergoing B-cell-depleting therapies who have poor immune response to COVID-19 vaccination and are at high risk for serious COVID-19 illness, a small, single-site study suggests.

Evusheld, the only COVID-19 PrEP option available, has Emergency Use Authorization (EUA) from the Food and Drug Administration for treatment of immunocompromised patients who may not respond sufficiently to COVID-19 vaccination and patients who’ve had a severe adverse reaction to COVID-19 vaccination.

“We report the largest real-world experience of Evusheld in this population, and our findings are encouraging,” lead study author Cassandra Calabrese, DO, rheumatologist and infectious disease specialist at Cleveland Clinic, said in an interview.

“Of 412 patients who received Evusheld, 12 [2.9%] developed breakthrough COVID-19, with 11 having mild courses and 1 who required hospitalization but recovered,” she added.

“Our data suggest that Evusheld PrEP, in combination with aggressive outpatient treatment of COVID-19, is likely effective in lowering risk of severe COVID in this vulnerable group.

“Practitioners who care for patients with immune-mediated inflammatory diseases should triage high-risk patients for Evusheld as well as rapid diagnosis and aggressive outpatient therapy if infected,” Dr. Calabrese advised.

For the study, Dr. Calabrese and colleagues at Cleveland Clinic searched the health care system pharmacy records for patients with immune‐mediated inflammatory diseases (IMIDs) or inborn errors of humoral immunity (IEI) who met the criteria to receive Evusheld. The researchers included patients on B-cell-depleting therapies or with humoral IEI who had received at least one dose of Evusheld and were later diagnosed with COVID-19, and they excluded those treated with B-cell-depleting therapies for cancer.
 

EVUSHELD was well tolerated

After extracting data on COVID-19 infection, vaccination status, and outcomes, they found that, between Jan. 18 and May 28, 2022, 412 patients with IMIDs or humoral IEI received Evusheld. No deaths occurred among these patients and, overall, they tolerated the medication well.

All 12 patients who experienced breakthrough COVID-19 infection were treated with B-cell-depleting therapies. Among the 12 patients:

• Six patients developed infection 13-84 (median 19) days after receiving 150 mg/150 mg tixagevimab/cilgavimab.
• Six patients developed infection 19-72 (median of 38.5) days after either a single dose of 300 mg/300 mg or a second dose of 150 mg/150 mg.
• Eleven patients had mild illness and recovered at home; one patient was hospitalized and treated with high-flow oxygen. All cases had been vaccinated against COVID-19 (five received two vaccinations, six received three, and one received four).
• One possible serious adverse event involved a patient with COVID-19 and immune-mediated thrombocytopenia (ITP) who was hospitalized soon after receiving Evusheld with ITP flare that resolved with intravenous immunoglobulin.

Dr. Calabrese acknowledged limitations to the study, including few patients, lack of a comparator group, and the study period falling during the Omicron wave.

“Also, nine of the breakthrough cases received additional COVID-19 therapy (oral antiviral or monoclonal antibody), which falls within standard of care for this high-risk group but prevents ascribing effectiveness to individual components of the regimen,” she added.

“Evusheld is authorized for PrEP against COVID-19 in patients at high risk for severe COVID due to suboptimal vaccine responses. This includes patients receiving B-cell-depleting drugs like rituximab, and patients with inborn errors of humoral immunity,” Dr. Calabrese explained.

“It is well known that this group of patients is at very high risk for severe COVID and death, even when fully vaccinated, and it has become clear that more strategies are needed to protect this vulnerable group, including use of Evusheld as well as aggressive treatment if infected,” she added.  
 

Evusheld not always easy to obtain

Although the medication has been available in the United States since January 2022, Dr. Calabrese said, patients may not receive it because of barriers including lack of both awareness and access.

Davey Smith, MD, professor of medicine and head of infectious diseases and global public health at the University of California San Diego, in La Jolla, said in an interview that he was not surprised by the results, but added that the study was conducted in too few patients to draw any strong conclusions or affect patient care.

“This small study that showed that breakthrough infections occurred but were generally mild, provides a small glimpse of real-world use of tixagevimab/cilgavimab as PrEP for immunocompromised persons,” said Dr. Smith, who was not involved in the study.

“In the setting of Omicron and vaccination, I would expect the same outcomes reported even without the treatment,” he added.

Dr. Smith recommends larger related randomized, controlled trials to provide clinicians with sufficient data to guide them in their patient care.

Graham Snyder, MD, associate professor in the division of infectious diseases at the University of Pittsburgh and medical director of infection prevention and hospital epidemiology at the University of Pittsburgh Medical Center, noted that the study “adds to a quickly growing literature on the real-world benefits of tixagevimab/cilgavimab to protect vulnerable individuals with weakened immune systems from the complications of COVID-19.

“This study provides a modest addition to our understanding of the role and benefit of Evusheld,” Dr. Snyder said in an interview. “By characterizing only patients who have received Evusheld without an untreated comparison group, we can’t draw any inference about the extent of benefit the agent provided to these patients.

“Substantial data already show that this agent is effective in preventing complications of COVID-19 infection in immunocompromised individuals,” added Dr. Snyder, who was not involved in the study.

“ ‘Immunocompromised’ represents a very diverse set of clinical conditions,” he said. “The research agenda should therefore focus on a more refined description of the effect in specific populations and a continued understanding of the effect of Evusheld in the context of updated vaccination strategies and changing virus ecology.”

Dr. Calabrese and her colleagues wrote that larger, controlled trials are underway.

 

FDA: Evusheld may not neutralize certain SARS-CoV-2 variants

“The biggest unanswered question is how Evusheld will hold up against new variants,” Dr. Calabrese said.

In an Oct. 3, 2022, update, the Food and Drug Administration released a statement about the risk of developing COVID-19 from SARS-CoV-2 variants that are not neutralized by Evusheld. The statement mentions an updated fact sheet that describes reduced protection from Evusheld against the Omicron subvariant BA.4.6, which accounted for nearly 13% of all new COVID-19 cases in the United States in the week ending Oct. 1.

There was no outside funding for the study. Dr. Smith reported no relevant financial conflicts of interest. Dr. Snyder said he is an unpaid adviser to an AstraZeneca observational study that’s assessing the real-world effectiveness of Evusheld.

Tixagevimab copackaged with cilgavimab (Evusheld) is a safe and effective preexposure prophylaxis (PrEP) in patients undergoing B-cell-depleting therapies who have poor immune response to COVID-19 vaccination and are at high risk for serious COVID-19 illness, a small, single-site study suggests.

Evusheld, the only COVID-19 PrEP option available, has Emergency Use Authorization (EUA) from the Food and Drug Administration for treatment of immunocompromised patients who may not respond sufficiently to COVID-19 vaccination and patients who’ve had a severe adverse reaction to COVID-19 vaccination.

“We report the largest real-world experience of Evusheld in this population, and our findings are encouraging,” lead study author Cassandra Calabrese, DO, rheumatologist and infectious disease specialist at Cleveland Clinic, said in an interview.

“Of 412 patients who received Evusheld, 12 [2.9%] developed breakthrough COVID-19, with 11 having mild courses and 1 who required hospitalization but recovered,” she added.

“Our data suggest that Evusheld PrEP, in combination with aggressive outpatient treatment of COVID-19, is likely effective in lowering risk of severe COVID in this vulnerable group.

“Practitioners who care for patients with immune-mediated inflammatory diseases should triage high-risk patients for Evusheld as well as rapid diagnosis and aggressive outpatient therapy if infected,” Dr. Calabrese advised.

For the study, Dr. Calabrese and colleagues at Cleveland Clinic searched the health care system pharmacy records for patients with immune‐mediated inflammatory diseases (IMIDs) or inborn errors of humoral immunity (IEI) who met the criteria to receive Evusheld. The researchers included patients on B-cell-depleting therapies or with humoral IEI who had received at least one dose of Evusheld and were later diagnosed with COVID-19, and they excluded those treated with B-cell-depleting therapies for cancer.
 

EVUSHELD was well tolerated

After extracting data on COVID-19 infection, vaccination status, and outcomes, they found that, between Jan. 18 and May 28, 2022, 412 patients with IMIDs or humoral IEI received Evusheld. No deaths occurred among these patients and, overall, they tolerated the medication well.

All 12 patients who experienced breakthrough COVID-19 infection were treated with B-cell-depleting therapies. Among the 12 patients:

• Six patients developed infection 13-84 (median 19) days after receiving 150 mg/150 mg tixagevimab/cilgavimab.
• Six patients developed infection 19-72 (median of 38.5) days after either a single dose of 300 mg/300 mg or a second dose of 150 mg/150 mg.
• Eleven patients had mild illness and recovered at home; one patient was hospitalized and treated with high-flow oxygen. All cases had been vaccinated against COVID-19 (five received two vaccinations, six received three, and one received four).
• One possible serious adverse event involved a patient with COVID-19 and immune-mediated thrombocytopenia (ITP) who was hospitalized soon after receiving Evusheld with ITP flare that resolved with intravenous immunoglobulin.

Dr. Calabrese acknowledged limitations to the study, including few patients, lack of a comparator group, and the study period falling during the Omicron wave.

“Also, nine of the breakthrough cases received additional COVID-19 therapy (oral antiviral or monoclonal antibody), which falls within standard of care for this high-risk group but prevents ascribing effectiveness to individual components of the regimen,” she added.

“Evusheld is authorized for PrEP against COVID-19 in patients at high risk for severe COVID due to suboptimal vaccine responses. This includes patients receiving B-cell-depleting drugs like rituximab, and patients with inborn errors of humoral immunity,” Dr. Calabrese explained.

“It is well known that this group of patients is at very high risk for severe COVID and death, even when fully vaccinated, and it has become clear that more strategies are needed to protect this vulnerable group, including use of Evusheld as well as aggressive treatment if infected,” she added.  
 

Evusheld not always easy to obtain

Although the medication has been available in the United States since January 2022, Dr. Calabrese said, patients may not receive it because of barriers including lack of both awareness and access.

Davey Smith, MD, professor of medicine and head of infectious diseases and global public health at the University of California San Diego, in La Jolla, said in an interview that he was not surprised by the results, but added that the study was conducted in too few patients to draw any strong conclusions or affect patient care.

“This small study that showed that breakthrough infections occurred but were generally mild, provides a small glimpse of real-world use of tixagevimab/cilgavimab as PrEP for immunocompromised persons,” said Dr. Smith, who was not involved in the study.

“In the setting of Omicron and vaccination, I would expect the same outcomes reported even without the treatment,” he added.

Dr. Smith recommends larger related randomized, controlled trials to provide clinicians with sufficient data to guide them in their patient care.

Graham Snyder, MD, associate professor in the division of infectious diseases at the University of Pittsburgh and medical director of infection prevention and hospital epidemiology at the University of Pittsburgh Medical Center, noted that the study “adds to a quickly growing literature on the real-world benefits of tixagevimab/cilgavimab to protect vulnerable individuals with weakened immune systems from the complications of COVID-19.

“This study provides a modest addition to our understanding of the role and benefit of Evusheld,” Dr. Snyder said in an interview. “By characterizing only patients who have received Evusheld without an untreated comparison group, we can’t draw any inference about the extent of benefit the agent provided to these patients.

“Substantial data already show that this agent is effective in preventing complications of COVID-19 infection in immunocompromised individuals,” added Dr. Snyder, who was not involved in the study.

“ ‘Immunocompromised’ represents a very diverse set of clinical conditions,” he said. “The research agenda should therefore focus on a more refined description of the effect in specific populations and a continued understanding of the effect of Evusheld in the context of updated vaccination strategies and changing virus ecology.”

Dr. Calabrese and her colleagues wrote that larger, controlled trials are underway.

 

FDA: Evusheld may not neutralize certain SARS-CoV-2 variants

“The biggest unanswered question is how Evusheld will hold up against new variants,” Dr. Calabrese said.

In an Oct. 3, 2022, update, the Food and Drug Administration released a statement about the risk of developing COVID-19 from SARS-CoV-2 variants that are not neutralized by Evusheld. The statement mentions an updated fact sheet that describes reduced protection from Evusheld against the Omicron subvariant BA.4.6, which accounted for nearly 13% of all new COVID-19 cases in the United States in the week ending Oct. 1.

There was no outside funding for the study. Dr. Smith reported no relevant financial conflicts of interest. Dr. Snyder said he is an unpaid adviser to an AstraZeneca observational study that’s assessing the real-world effectiveness of Evusheld.

Could taking vitamin C help reduce the chances of developing gout? A new study sheds light on this possibility.

Gout is a form of inflammatory arthritis that has been on the rise in the United States in recent decades. Considered a lifestyle disease, some research has shown that instances of the condition have more than doubled in recent years as rates of obesity have skyrocketed. It’s caused by uric acid in the blood that builds up and crystallizes in the joints. Flare-ups are so intense that the joints can turn a cherry red and vibrate with intense – and sometimes seemingly intolerable – pain.

Dmytro Panchenko/iStockphoto

While there are effective treatments, many people fail to take their medications when they’re not in pain, and if the condition goes unchecked, it can get much worse and cause permanent damage to the joints.

“Gout can cause flare-ups that vary in frequency and severity; but sometimes when people aren’t experiencing them, they’re less likely to stay on top of their medications,” said Stephen Juraschek, MD, an assistant professor of medicine at Harvard Medical School, Boston.

That’s why lifestyle interventions are seen as particularly relevant to a disease like gout. Vitamin C, for example, has few side effects, and for those with higher levels of uric acid in the blood, it could reduce the likelihood of getting the condition. A recent study published in The American Journal of Clinical Nutrition found that people who were given 500 mg of vitamin C versus a placebo had a 12% reduced risk of getting gout. The study of over 14,000 male doctors showed that men who weren’t overweight had the most significant reduction in the risk of getting the condition. (Excess weight has been shown to increase the risk of gout.)

As part of the study, participants responded to a questionnaire that asked whether they had ever been diagnosed with gout. Other studies have shown that vitamin C reduced the levels of urate in people without gout and broke down uric crystals in the blood, but this study took it a step further to show that the supplement actually reduced the risk of getting the condition.

“In addition to lowering levels of uric acid in the body, it’s thought that vitamin C may also minimize the inflammatory response to urate crystals,” said Dr. Juraschek. That’s because when flare-ups develop in joints throughout the body, much of the painful irritation is caused by the immune system’s response as it fights to break down the crystals.

Dr. Juraschek said this likely wouldn’t change recommendations for patients with serious gout, but it could still have an impact.

“For individuals who were told that they have gout but have had fewer flare-ups, they might be more open to taking vitamin C,” he said.

Will Settle, 42, of Hilton Head, S.C., was not involved in the study, but he said he would be inclined to try most any safe preventive method. Gout runs in his family. His father and grandfather had it, and now, so does he. His flare-ups have slowed in recent years, which he said has a lot to do with his diet and lifestyle. He stopped eating seafood, started drinking more water, and stopped drinking as much alcohol – all of which he thinks has had a huge impact on the severity of his condition. (Both seafood and beer contain high levels of purines, which have been shown to increase the buildup of uric acid in the blood.) Mr. Settle said that other simple lifestyle changes like vitamin C would be an easy addition to his routine with few downsides. Plus, he hates having to take colchicine, a medication that’s meant to relieve pain but causes him intense diarrhea when he takes it.

“Anything to reduce my flare-ups without having to take colchicine,” he said.

But the jury is still out as to whether vitamin C will have any real benefits. Study coauthor Robert H. Shmerling, MD, is the former clinical chief of the division of rheumatology at Beth Israel Deaconess Medical Center, New York. He said the study shows that the effect of vitamin C in those undiagnosed with gout was rather modest. Also, vitamin C did not show a reduction in gout flare-ups in those who were already diagnosed with the condition. Not to mention that the study lacked diversity, as the people in it were all male and mostly white. Still, there’s little downside risk to taking vitamin C, and it might end up being worthwhile.

“Maybe it will turn out to be an effective treatment in those who are at high risk, but we’re not there yet,” he said.

Robert Terkeltaub, MD, chief of rheumatology at the Veterans Administration Medical Center in San Diego and a professor of medicine at the University of California, San Diego, said there’s an unmet need when it comes to tools for gout prevention.

“The disease impacts some 10 million Americans, and we need to better identify these individuals so we can intervene earlier,” he said.

While vitamin C had a small but significant association with fewer new cases of gout, it did not lower it in those who already had the disease, said Dr. Terkeltaub. What’s more, researchers didn’t measure the levels of uric acid in the blood, which would have painted a more accurate picture of whether vitamin C actually reduced it in the body.

“There remains no clarity on the potential role of vitamin C in either prevention or treatment of gout. That said, future research would be of interest,” he said.

Still, gout patients like Mr. Settle aren’t ruling it out. Anything to avoid the pain that, at times, makes it difficult for him to get out of bed. He’s seen the benefit that simple lifestyle changes can make, and he’s willing to try just about anything to live a normal, arthritis-free life.

“I’m always looking for simple ways to keep my flare-ups at bay,” he said.

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

Could taking vitamin C help reduce the chances of developing gout? A new study sheds light on this possibility.

Gout is a form of inflammatory arthritis that has been on the rise in the United States in recent decades. Considered a lifestyle disease, some research has shown that instances of the condition have more than doubled in recent years as rates of obesity have skyrocketed. It’s caused by uric acid in the blood that builds up and crystallizes in the joints. Flare-ups are so intense that the joints can turn a cherry red and vibrate with intense – and sometimes seemingly intolerable – pain.

Dmytro Panchenko/iStockphoto

While there are effective treatments, many people fail to take their medications when they’re not in pain, and if the condition goes unchecked, it can get much worse and cause permanent damage to the joints.

“Gout can cause flare-ups that vary in frequency and severity; but sometimes when people aren’t experiencing them, they’re less likely to stay on top of their medications,” said Stephen Juraschek, MD, an assistant professor of medicine at Harvard Medical School, Boston.

That’s why lifestyle interventions are seen as particularly relevant to a disease like gout. Vitamin C, for example, has few side effects, and for those with higher levels of uric acid in the blood, it could reduce the likelihood of getting the condition. A recent study published in The American Journal of Clinical Nutrition found that people who were given 500 mg of vitamin C versus a placebo had a 12% reduced risk of getting gout. The study of over 14,000 male doctors showed that men who weren’t overweight had the most significant reduction in the risk of getting the condition. (Excess weight has been shown to increase the risk of gout.)

As part of the study, participants responded to a questionnaire that asked whether they had ever been diagnosed with gout. Other studies have shown that vitamin C reduced the levels of urate in people without gout and broke down uric crystals in the blood, but this study took it a step further to show that the supplement actually reduced the risk of getting the condition.

“In addition to lowering levels of uric acid in the body, it’s thought that vitamin C may also minimize the inflammatory response to urate crystals,” said Dr. Juraschek. That’s because when flare-ups develop in joints throughout the body, much of the painful irritation is caused by the immune system’s response as it fights to break down the crystals.

Dr. Juraschek said this likely wouldn’t change recommendations for patients with serious gout, but it could still have an impact.

“For individuals who were told that they have gout but have had fewer flare-ups, they might be more open to taking vitamin C,” he said.

Will Settle, 42, of Hilton Head, S.C., was not involved in the study, but he said he would be inclined to try most any safe preventive method. Gout runs in his family. His father and grandfather had it, and now, so does he. His flare-ups have slowed in recent years, which he said has a lot to do with his diet and lifestyle. He stopped eating seafood, started drinking more water, and stopped drinking as much alcohol – all of which he thinks has had a huge impact on the severity of his condition. (Both seafood and beer contain high levels of purines, which have been shown to increase the buildup of uric acid in the blood.) Mr. Settle said that other simple lifestyle changes like vitamin C would be an easy addition to his routine with few downsides. Plus, he hates having to take colchicine, a medication that’s meant to relieve pain but causes him intense diarrhea when he takes it.

“Anything to reduce my flare-ups without having to take colchicine,” he said.

But the jury is still out as to whether vitamin C will have any real benefits. Study coauthor Robert H. Shmerling, MD, is the former clinical chief of the division of rheumatology at Beth Israel Deaconess Medical Center, New York. He said the study shows that the effect of vitamin C in those undiagnosed with gout was rather modest. Also, vitamin C did not show a reduction in gout flare-ups in those who were already diagnosed with the condition. Not to mention that the study lacked diversity, as the people in it were all male and mostly white. Still, there’s little downside risk to taking vitamin C, and it might end up being worthwhile.

“Maybe it will turn out to be an effective treatment in those who are at high risk, but we’re not there yet,” he said.

Robert Terkeltaub, MD, chief of rheumatology at the Veterans Administration Medical Center in San Diego and a professor of medicine at the University of California, San Diego, said there’s an unmet need when it comes to tools for gout prevention.

“The disease impacts some 10 million Americans, and we need to better identify these individuals so we can intervene earlier,” he said.

While vitamin C had a small but significant association with fewer new cases of gout, it did not lower it in those who already had the disease, said Dr. Terkeltaub. What’s more, researchers didn’t measure the levels of uric acid in the blood, which would have painted a more accurate picture of whether vitamin C actually reduced it in the body.

“There remains no clarity on the potential role of vitamin C in either prevention or treatment of gout. That said, future research would be of interest,” he said.

Still, gout patients like Mr. Settle aren’t ruling it out. Anything to avoid the pain that, at times, makes it difficult for him to get out of bed. He’s seen the benefit that simple lifestyle changes can make, and he’s willing to try just about anything to live a normal, arthritis-free life.

“I’m always looking for simple ways to keep my flare-ups at bay,” he said.

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

Could taking vitamin C help reduce the chances of developing gout? A new study sheds light on this possibility.

Gout is a form of inflammatory arthritis that has been on the rise in the United States in recent decades. Considered a lifestyle disease, some research has shown that instances of the condition have more than doubled in recent years as rates of obesity have skyrocketed. It’s caused by uric acid in the blood that builds up and crystallizes in the joints. Flare-ups are so intense that the joints can turn a cherry red and vibrate with intense – and sometimes seemingly intolerable – pain.

Dmytro Panchenko/iStockphoto

While there are effective treatments, many people fail to take their medications when they’re not in pain, and if the condition goes unchecked, it can get much worse and cause permanent damage to the joints.

“Gout can cause flare-ups that vary in frequency and severity; but sometimes when people aren’t experiencing them, they’re less likely to stay on top of their medications,” said Stephen Juraschek, MD, an assistant professor of medicine at Harvard Medical School, Boston.

That’s why lifestyle interventions are seen as particularly relevant to a disease like gout. Vitamin C, for example, has few side effects, and for those with higher levels of uric acid in the blood, it could reduce the likelihood of getting the condition. A recent study published in The American Journal of Clinical Nutrition found that people who were given 500 mg of vitamin C versus a placebo had a 12% reduced risk of getting gout. The study of over 14,000 male doctors showed that men who weren’t overweight had the most significant reduction in the risk of getting the condition. (Excess weight has been shown to increase the risk of gout.)

As part of the study, participants responded to a questionnaire that asked whether they had ever been diagnosed with gout. Other studies have shown that vitamin C reduced the levels of urate in people without gout and broke down uric crystals in the blood, but this study took it a step further to show that the supplement actually reduced the risk of getting the condition.

“In addition to lowering levels of uric acid in the body, it’s thought that vitamin C may also minimize the inflammatory response to urate crystals,” said Dr. Juraschek. That’s because when flare-ups develop in joints throughout the body, much of the painful irritation is caused by the immune system’s response as it fights to break down the crystals.

Dr. Juraschek said this likely wouldn’t change recommendations for patients with serious gout, but it could still have an impact.

“For individuals who were told that they have gout but have had fewer flare-ups, they might be more open to taking vitamin C,” he said.

Will Settle, 42, of Hilton Head, S.C., was not involved in the study, but he said he would be inclined to try most any safe preventive method. Gout runs in his family. His father and grandfather had it, and now, so does he. His flare-ups have slowed in recent years, which he said has a lot to do with his diet and lifestyle. He stopped eating seafood, started drinking more water, and stopped drinking as much alcohol – all of which he thinks has had a huge impact on the severity of his condition. (Both seafood and beer contain high levels of purines, which have been shown to increase the buildup of uric acid in the blood.) Mr. Settle said that other simple lifestyle changes like vitamin C would be an easy addition to his routine with few downsides. Plus, he hates having to take colchicine, a medication that’s meant to relieve pain but causes him intense diarrhea when he takes it.

“Anything to reduce my flare-ups without having to take colchicine,” he said.

But the jury is still out as to whether vitamin C will have any real benefits. Study coauthor Robert H. Shmerling, MD, is the former clinical chief of the division of rheumatology at Beth Israel Deaconess Medical Center, New York. He said the study shows that the effect of vitamin C in those undiagnosed with gout was rather modest. Also, vitamin C did not show a reduction in gout flare-ups in those who were already diagnosed with the condition. Not to mention that the study lacked diversity, as the people in it were all male and mostly white. Still, there’s little downside risk to taking vitamin C, and it might end up being worthwhile.

“Maybe it will turn out to be an effective treatment in those who are at high risk, but we’re not there yet,” he said.

Robert Terkeltaub, MD, chief of rheumatology at the Veterans Administration Medical Center in San Diego and a professor of medicine at the University of California, San Diego, said there’s an unmet need when it comes to tools for gout prevention.

“The disease impacts some 10 million Americans, and we need to better identify these individuals so we can intervene earlier,” he said.

While vitamin C had a small but significant association with fewer new cases of gout, it did not lower it in those who already had the disease, said Dr. Terkeltaub. What’s more, researchers didn’t measure the levels of uric acid in the blood, which would have painted a more accurate picture of whether vitamin C actually reduced it in the body.

“There remains no clarity on the potential role of vitamin C in either prevention or treatment of gout. That said, future research would be of interest,” he said.

Still, gout patients like Mr. Settle aren’t ruling it out. Anything to avoid the pain that, at times, makes it difficult for him to get out of bed. He’s seen the benefit that simple lifestyle changes can make, and he’s willing to try just about anything to live a normal, arthritis-free life.

“I’m always looking for simple ways to keep my flare-ups at bay,” he said.

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

Changes to HIV pre-exposure prophylaxis (PrEP) access during the COVID-19 pandemic were linked to higher rates of HIV infection among young sexual minority men and gender-diverse individuals who identified as Black and/or Hispanic/Latino, according to a national survey.

“The public health crisis surrounding COVID-19 had clear impact on PrEP access and risk of HIV acquisition overall,” said lead investigator Ethan Morgan, PhD, College of Nursing and the Infectious Disease Institute at Ohio State University, Columbus.

“This is a stark lesson that when novel public health emergencies arise, extant ones cannot go by the wayside, or we risk exacerbating them, such as we see here,” he said in an interview.

The online survey was administered in four waves during the first year and a half of the pandemic, starting in March 2020. Participants were recruited through mailing lists, national networks, community partners, and social media.

Among 796 baseline respondents, 300 agreed to three follow-up surveys administered between February and March 2021, between July and August 2021, and between October and November 2021.

Inclusion required participants to identify as Black and/or Hispanic/Latino, be between ages 18-29 years, be assigned male at birth, reside in the United States, and have reported anal intercourse with a man in the past 12 months. The researchers noted that given the limited uptake of and adherence to PrEP in the targeted population, they prioritized baseline respondents who reported either current PrEP use or use at least once in their lifetime.

The researchers used separate multivariable logistic regression models to assess the association between odds of testing positive for HIV and other STIs across the four online study visits and pandemic-related changes to PrEP access, and pandemic-related changes to sexual activity.

Changes in PrEP access were reported by a total of 109 (13.8%) of baseline respondents, and HIV seroconversion was reported in 25 of 292 respondents (8.6%) who reported their HIV and other STI status at follow-up. STI positivity was reported 25.6% of the baseline cohort (n = 204).

Compared with respondents who reported no changes to PrEP access, those who did report change to access were significantly more likely to report HIV seroconversion (adjusted odds ratio, 2.80; 95% confidence interval, 1.02-7.68). However, Dr. Morgan emphasized that the study question did not ask how PrEP had changed, only if it had.

“While we presume this survey question corresponds to a diminished access to PrEP medication during the COVID-19 pandemic, the question was: ‘Has your access to PrEP been impacted by the COVID-19 pandemic?’ So, it is unfortunately unclear whether access was diminished or improved,” he explained. STI positivity was not associated with PrEP access.

The survey also asked respondents how much the pandemic had impacted their sexual activity (measured on a Likert scale of not at all, a little, moderately, quite a bit, and extremely). Respondents reporting greater impact on their sexual activity were more likely to report an STI (aOR, 1.24; 95% CI, 1.10-1.40) during the study period.

In addition, though participants reported a mean of 2.8 sexual partners in the past 3 months, those reporting a greater number were more likely to report an STI (aOR, 1.29; 95% CI, 1.21-1.38).

The researchers suggested that expansion of telehealth and mail-order prescriptions as well as structural-level interventions addressing pandemic-related unemployment and loss of health insurance could have helped preserve access to PrEP.

Commenting on the study, Monica Gandhi, MD, MPH, who was not involved in the research, noted that self-reported data can be subject to bias. “However, reduction in services for other medical care has been reported frequently throughout COVID and so this finding of reduced PrEP access, and subsequent HIV infection, is completely in line with the other studies,” she said in an interview.

Dr. Gandhi, who is director of the University of California, San Francisco Center for AIDS Research and medical director of the HIV/AIDS Clinic (“Ward 86”) at San Francisco General Hospital, added: “We knew early on in the COVID-19 pandemic that access to and uptake of PrEP was decreased based on data from Boston’s Fenway Institute.”

The Boston data, reported July 2020 at the virtual International AIDS Conference, prompted “a real attempt” by clinicians to increase PrEP access and uptake – raising community awareness, dispensing PrEP through mobile units, and changing prescribing patterns, Dr. Gandhi said. “We usually see patients every 3 months for PrEP but with HIV self-testing, we can extend that interval to every 6 months, and we did so in many centers during COVID.”

The study was funded by National Institute on Drug Abuse, part of the National Institutes of Health.

Dr. Morgan and Dr. Gandhi reported no conflicts of interest.

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

Changes to HIV pre-exposure prophylaxis (PrEP) access during the COVID-19 pandemic were linked to higher rates of HIV infection among young sexual minority men and gender-diverse individuals who identified as Black and/or Hispanic/Latino, according to a national survey.

“The public health crisis surrounding COVID-19 had clear impact on PrEP access and risk of HIV acquisition overall,” said lead investigator Ethan Morgan, PhD, College of Nursing and the Infectious Disease Institute at Ohio State University, Columbus.

“This is a stark lesson that when novel public health emergencies arise, extant ones cannot go by the wayside, or we risk exacerbating them, such as we see here,” he said in an interview.

The online survey was administered in four waves during the first year and a half of the pandemic, starting in March 2020. Participants were recruited through mailing lists, national networks, community partners, and social media.

Among 796 baseline respondents, 300 agreed to three follow-up surveys administered between February and March 2021, between July and August 2021, and between October and November 2021.

Inclusion required participants to identify as Black and/or Hispanic/Latino, be between ages 18-29 years, be assigned male at birth, reside in the United States, and have reported anal intercourse with a man in the past 12 months. The researchers noted that given the limited uptake of and adherence to PrEP in the targeted population, they prioritized baseline respondents who reported either current PrEP use or use at least once in their lifetime.

The researchers used separate multivariable logistic regression models to assess the association between odds of testing positive for HIV and other STIs across the four online study visits and pandemic-related changes to PrEP access, and pandemic-related changes to sexual activity.

Changes in PrEP access were reported by a total of 109 (13.8%) of baseline respondents, and HIV seroconversion was reported in 25 of 292 respondents (8.6%) who reported their HIV and other STI status at follow-up. STI positivity was reported 25.6% of the baseline cohort (n = 204).

Compared with respondents who reported no changes to PrEP access, those who did report change to access were significantly more likely to report HIV seroconversion (adjusted odds ratio, 2.80; 95% confidence interval, 1.02-7.68). However, Dr. Morgan emphasized that the study question did not ask how PrEP had changed, only if it had.

“While we presume this survey question corresponds to a diminished access to PrEP medication during the COVID-19 pandemic, the question was: ‘Has your access to PrEP been impacted by the COVID-19 pandemic?’ So, it is unfortunately unclear whether access was diminished or improved,” he explained. STI positivity was not associated with PrEP access.

The survey also asked respondents how much the pandemic had impacted their sexual activity (measured on a Likert scale of not at all, a little, moderately, quite a bit, and extremely). Respondents reporting greater impact on their sexual activity were more likely to report an STI (aOR, 1.24; 95% CI, 1.10-1.40) during the study period.

In addition, though participants reported a mean of 2.8 sexual partners in the past 3 months, those reporting a greater number were more likely to report an STI (aOR, 1.29; 95% CI, 1.21-1.38).

The researchers suggested that expansion of telehealth and mail-order prescriptions as well as structural-level interventions addressing pandemic-related unemployment and loss of health insurance could have helped preserve access to PrEP.

Commenting on the study, Monica Gandhi, MD, MPH, who was not involved in the research, noted that self-reported data can be subject to bias. “However, reduction in services for other medical care has been reported frequently throughout COVID and so this finding of reduced PrEP access, and subsequent HIV infection, is completely in line with the other studies,” she said in an interview.

Dr. Gandhi, who is director of the University of California, San Francisco Center for AIDS Research and medical director of the HIV/AIDS Clinic (“Ward 86”) at San Francisco General Hospital, added: “We knew early on in the COVID-19 pandemic that access to and uptake of PrEP was decreased based on data from Boston’s Fenway Institute.”

The Boston data, reported July 2020 at the virtual International AIDS Conference, prompted “a real attempt” by clinicians to increase PrEP access and uptake – raising community awareness, dispensing PrEP through mobile units, and changing prescribing patterns, Dr. Gandhi said. “We usually see patients every 3 months for PrEP but with HIV self-testing, we can extend that interval to every 6 months, and we did so in many centers during COVID.”

The study was funded by National Institute on Drug Abuse, part of the National Institutes of Health.

Dr. Morgan and Dr. Gandhi reported no conflicts of interest.

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

Changes to HIV pre-exposure prophylaxis (PrEP) access during the COVID-19 pandemic were linked to higher rates of HIV infection among young sexual minority men and gender-diverse individuals who identified as Black and/or Hispanic/Latino, according to a national survey.

“The public health crisis surrounding COVID-19 had clear impact on PrEP access and risk of HIV acquisition overall,” said lead investigator Ethan Morgan, PhD, College of Nursing and the Infectious Disease Institute at Ohio State University, Columbus.

“This is a stark lesson that when novel public health emergencies arise, extant ones cannot go by the wayside, or we risk exacerbating them, such as we see here,” he said in an interview.

The online survey was administered in four waves during the first year and a half of the pandemic, starting in March 2020. Participants were recruited through mailing lists, national networks, community partners, and social media.

Among 796 baseline respondents, 300 agreed to three follow-up surveys administered between February and March 2021, between July and August 2021, and between October and November 2021.

Inclusion required participants to identify as Black and/or Hispanic/Latino, be between ages 18-29 years, be assigned male at birth, reside in the United States, and have reported anal intercourse with a man in the past 12 months. The researchers noted that given the limited uptake of and adherence to PrEP in the targeted population, they prioritized baseline respondents who reported either current PrEP use or use at least once in their lifetime.

The researchers used separate multivariable logistic regression models to assess the association between odds of testing positive for HIV and other STIs across the four online study visits and pandemic-related changes to PrEP access, and pandemic-related changes to sexual activity.

Changes in PrEP access were reported by a total of 109 (13.8%) of baseline respondents, and HIV seroconversion was reported in 25 of 292 respondents (8.6%) who reported their HIV and other STI status at follow-up. STI positivity was reported 25.6% of the baseline cohort (n = 204).

Compared with respondents who reported no changes to PrEP access, those who did report change to access were significantly more likely to report HIV seroconversion (adjusted odds ratio, 2.80; 95% confidence interval, 1.02-7.68). However, Dr. Morgan emphasized that the study question did not ask how PrEP had changed, only if it had.

“While we presume this survey question corresponds to a diminished access to PrEP medication during the COVID-19 pandemic, the question was: ‘Has your access to PrEP been impacted by the COVID-19 pandemic?’ So, it is unfortunately unclear whether access was diminished or improved,” he explained. STI positivity was not associated with PrEP access.

The survey also asked respondents how much the pandemic had impacted their sexual activity (measured on a Likert scale of not at all, a little, moderately, quite a bit, and extremely). Respondents reporting greater impact on their sexual activity were more likely to report an STI (aOR, 1.24; 95% CI, 1.10-1.40) during the study period.

In addition, though participants reported a mean of 2.8 sexual partners in the past 3 months, those reporting a greater number were more likely to report an STI (aOR, 1.29; 95% CI, 1.21-1.38).

The researchers suggested that expansion of telehealth and mail-order prescriptions as well as structural-level interventions addressing pandemic-related unemployment and loss of health insurance could have helped preserve access to PrEP.

Commenting on the study, Monica Gandhi, MD, MPH, who was not involved in the research, noted that self-reported data can be subject to bias. “However, reduction in services for other medical care has been reported frequently throughout COVID and so this finding of reduced PrEP access, and subsequent HIV infection, is completely in line with the other studies,” she said in an interview.

Dr. Gandhi, who is director of the University of California, San Francisco Center for AIDS Research and medical director of the HIV/AIDS Clinic (“Ward 86”) at San Francisco General Hospital, added: “We knew early on in the COVID-19 pandemic that access to and uptake of PrEP was decreased based on data from Boston’s Fenway Institute.”

The Boston data, reported July 2020 at the virtual International AIDS Conference, prompted “a real attempt” by clinicians to increase PrEP access and uptake – raising community awareness, dispensing PrEP through mobile units, and changing prescribing patterns, Dr. Gandhi said. “We usually see patients every 3 months for PrEP but with HIV self-testing, we can extend that interval to every 6 months, and we did so in many centers during COVID.”

The study was funded by National Institute on Drug Abuse, part of the National Institutes of Health.

Dr. Morgan and Dr. Gandhi reported no conflicts of interest.

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

Pregnant women living with HIV were more likely to be infected with human papillomavirus (HPV) than were pregnant women without HIV, a recent systematic review and meta-analysis reports.

“High prevalence of HPV was documented in pregnant WLWH [women living with HIV], exceeding the prevalence among pregnant women without HIV,” Elisabeth McClymont, PhD, of the University of British Columbia, Vancouver, and colleagues wrote in the Journal of Acquired Immune Deficiency Syndrome.

Their results contribute to two major global public health goals: eliminating cervical cancer and improving the health outcomes of newborn babies.

“Our findings of a high prevalence of HPV infection during pregnancy in WLWH, particularly of highly oncogenic HPV types, emphasize the need for HPV screening and vaccination in WLWH,” they added. “WLWH are a key population for both HPV and adverse pregnancy outcome prevention.”

Emerging evidence suggests that being infected with HPV during pregnancy may be linked with adverse pregnancy outcomes. Although women living with HIV have higher rates of HPV infection and adverse pregnancy outcomes, no prior reviews have reported on HPV infection during pregnancy in women living with HIV, the authors explained.
 

A study of studies

Dr. McClymont and colleagues searched the standard medical research databases through Jan. 18, 2022, for pooled and type-specific HPV prevalence and associated pregnancy outcomes among pregnant women living with HIV, including available within-study comparators of women without HIV.

They performed subgroup analyses according to polymerase chain reaction primers used to detect HPV type and according to region (Africa, Asia and Europe, the Americas).

Their analysis of 10 studies describing HPV prevalence in 1,594 pregnant women living with HIV found:

• The pooled HPV prevalence in pregnant women living with HIV was 75.5% (95% confidence interval, 50.2%-90.4%) but ranged from 23% to 98% between individual studies.
• Among the five studies that also analyzed HPV prevalence in pregnant women without HIV, the pooled prevalence was 48.1% (95% CI, 27.1%-69.8%).
• Pregnant women living with HIV had 54% higher odds of being HPV positive than did pregnant women without HIV.
• HPV-16 was the most common HPV type detected in pregnant women living with HIV, followed by HPV-52; other common types included HPV-18 and HPV-58.
• One study provided data on pregnancy outcomes in women living with HIV but did not correlate pregnancy outcomes with HPV status.

Experts urge HPV, cervical cancer screening for women living with HIV

“HPV is a common virus that can lead to cervical dysplasia and cervical cancer,” cautioned Clara Paik, MD, professor and clinic medical director of obstetrics and gynecology at UC Davis Health, Sacramento.

“HPV can also be associated with adverse pregnancy outcomes, including preterm birth and premature membrane rupture,” she said in an interview. “It is important to know the prevalence of HPV infection in pregnant women living with HIV in order to assess if this specific population is at higher risk for adverse pregnancy outcomes.”

Dr. Paik, who was not involved in the study, would like these results to lead to better HPV screening in pregnant women living with HIV.

“The study’s strengths include the large number of women studied when all the research studies were pooled,” she said. “A weakness is that, if individual studies had limitations, a systematic review based on weaker studies may not necessarily yield results that are conclusive.”

Linda Eckert, MD, professor of obstetrics and gynecology at the University of Washington, Seattle, said that the study highlights the importance of including cervical cancer screening in antepartum care, especially in areas of high HIV prevalence.

“Women living with HIV have a sixfold increased rate of developing cervical cancer compared to women without HIV,” she added, citing a 2020 analysis in The Lancet Global Health that estimated global cervical cancer risk among women living with HIV.

“This [new] study allows us to definitively say that pregnant women living with HIV have higher rates of HPV than do pregnant women without HIV,” noted Dr. Eckert, who was not involved in either study. “And HPV type 16 – the HPV type most associated with developing cervical cancer – was the most common high-risk HPV type found in these patients.”
 

HPV vaccination recommended

The World Health Organization’s call to eliminate cervical cancer has generated interest and funding for cervical cancer screening of women with HIV, Dr. Eckert said. “WHO recommends that women living with HIV who are 25 years of age and above be screened for cervical cancer annually.”

The authors urged that women living with HIV not only be screened for HPV but that they also be vaccinated against HPV.

“We know that HPV vaccination is unprecedented in its ability to prevent HPV infections when it is received prior to acquiring HPV infection,” Dr. Eckert said, “but currently data showing that HPV vaccination would treat HPV16 in pregnant women already infected with HPV16 are lacking.

“This study points to the need for a trial to investigate HPV vaccination in pregnant women living with HIV who have the high-risk HPV types,” she suggested.

Dr. Eckert contributed to the American College of Obstetricians and Gynecologists’ 2020 Human Papillomavirus Vaccination Committee Opinion. One study coauthor reported financial relationships with Merck. Dr. McClymont, the other coauthors, as well as Dr. Paik and Dr. Eckert reported no relevant financial relationships.

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

Pregnant women living with HIV were more likely to be infected with human papillomavirus (HPV) than were pregnant women without HIV, a recent systematic review and meta-analysis reports.

“High prevalence of HPV was documented in pregnant WLWH [women living with HIV], exceeding the prevalence among pregnant women without HIV,” Elisabeth McClymont, PhD, of the University of British Columbia, Vancouver, and colleagues wrote in the Journal of Acquired Immune Deficiency Syndrome.

Their results contribute to two major global public health goals: eliminating cervical cancer and improving the health outcomes of newborn babies.

“Our findings of a high prevalence of HPV infection during pregnancy in WLWH, particularly of highly oncogenic HPV types, emphasize the need for HPV screening and vaccination in WLWH,” they added. “WLWH are a key population for both HPV and adverse pregnancy outcome prevention.”

Emerging evidence suggests that being infected with HPV during pregnancy may be linked with adverse pregnancy outcomes. Although women living with HIV have higher rates of HPV infection and adverse pregnancy outcomes, no prior reviews have reported on HPV infection during pregnancy in women living with HIV, the authors explained.
 

A study of studies

Dr. McClymont and colleagues searched the standard medical research databases through Jan. 18, 2022, for pooled and type-specific HPV prevalence and associated pregnancy outcomes among pregnant women living with HIV, including available within-study comparators of women without HIV.

They performed subgroup analyses according to polymerase chain reaction primers used to detect HPV type and according to region (Africa, Asia and Europe, the Americas).

Their analysis of 10 studies describing HPV prevalence in 1,594 pregnant women living with HIV found:

• The pooled HPV prevalence in pregnant women living with HIV was 75.5% (95% confidence interval, 50.2%-90.4%) but ranged from 23% to 98% between individual studies.
• Among the five studies that also analyzed HPV prevalence in pregnant women without HIV, the pooled prevalence was 48.1% (95% CI, 27.1%-69.8%).
• Pregnant women living with HIV had 54% higher odds of being HPV positive than did pregnant women without HIV.
• HPV-16 was the most common HPV type detected in pregnant women living with HIV, followed by HPV-52; other common types included HPV-18 and HPV-58.
• One study provided data on pregnancy outcomes in women living with HIV but did not correlate pregnancy outcomes with HPV status.

Experts urge HPV, cervical cancer screening for women living with HIV

“HPV is a common virus that can lead to cervical dysplasia and cervical cancer,” cautioned Clara Paik, MD, professor and clinic medical director of obstetrics and gynecology at UC Davis Health, Sacramento.

“HPV can also be associated with adverse pregnancy outcomes, including preterm birth and premature membrane rupture,” she said in an interview. “It is important to know the prevalence of HPV infection in pregnant women living with HIV in order to assess if this specific population is at higher risk for adverse pregnancy outcomes.”

Dr. Paik, who was not involved in the study, would like these results to lead to better HPV screening in pregnant women living with HIV.

“The study’s strengths include the large number of women studied when all the research studies were pooled,” she said. “A weakness is that, if individual studies had limitations, a systematic review based on weaker studies may not necessarily yield results that are conclusive.”

Linda Eckert, MD, professor of obstetrics and gynecology at the University of Washington, Seattle, said that the study highlights the importance of including cervical cancer screening in antepartum care, especially in areas of high HIV prevalence.

“Women living with HIV have a sixfold increased rate of developing cervical cancer compared to women without HIV,” she added, citing a 2020 analysis in The Lancet Global Health that estimated global cervical cancer risk among women living with HIV.

“This [new] study allows us to definitively say that pregnant women living with HIV have higher rates of HPV than do pregnant women without HIV,” noted Dr. Eckert, who was not involved in either study. “And HPV type 16 – the HPV type most associated with developing cervical cancer – was the most common high-risk HPV type found in these patients.”
 

HPV vaccination recommended

The World Health Organization’s call to eliminate cervical cancer has generated interest and funding for cervical cancer screening of women with HIV, Dr. Eckert said. “WHO recommends that women living with HIV who are 25 years of age and above be screened for cervical cancer annually.”

The authors urged that women living with HIV not only be screened for HPV but that they also be vaccinated against HPV.

“We know that HPV vaccination is unprecedented in its ability to prevent HPV infections when it is received prior to acquiring HPV infection,” Dr. Eckert said, “but currently data showing that HPV vaccination would treat HPV16 in pregnant women already infected with HPV16 are lacking.

“This study points to the need for a trial to investigate HPV vaccination in pregnant women living with HIV who have the high-risk HPV types,” she suggested.

Dr. Eckert contributed to the American College of Obstetricians and Gynecologists’ 2020 Human Papillomavirus Vaccination Committee Opinion. One study coauthor reported financial relationships with Merck. Dr. McClymont, the other coauthors, as well as Dr. Paik and Dr. Eckert reported no relevant financial relationships.

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

Pregnant women living with HIV were more likely to be infected with human papillomavirus (HPV) than were pregnant women without HIV, a recent systematic review and meta-analysis reports.

“High prevalence of HPV was documented in pregnant WLWH [women living with HIV], exceeding the prevalence among pregnant women without HIV,” Elisabeth McClymont, PhD, of the University of British Columbia, Vancouver, and colleagues wrote in the Journal of Acquired Immune Deficiency Syndrome.

Their results contribute to two major global public health goals: eliminating cervical cancer and improving the health outcomes of newborn babies.

“Our findings of a high prevalence of HPV infection during pregnancy in WLWH, particularly of highly oncogenic HPV types, emphasize the need for HPV screening and vaccination in WLWH,” they added. “WLWH are a key population for both HPV and adverse pregnancy outcome prevention.”

Emerging evidence suggests that being infected with HPV during pregnancy may be linked with adverse pregnancy outcomes. Although women living with HIV have higher rates of HPV infection and adverse pregnancy outcomes, no prior reviews have reported on HPV infection during pregnancy in women living with HIV, the authors explained.
 

A study of studies

Dr. McClymont and colleagues searched the standard medical research databases through Jan. 18, 2022, for pooled and type-specific HPV prevalence and associated pregnancy outcomes among pregnant women living with HIV, including available within-study comparators of women without HIV.

They performed subgroup analyses according to polymerase chain reaction primers used to detect HPV type and according to region (Africa, Asia and Europe, the Americas).

Their analysis of 10 studies describing HPV prevalence in 1,594 pregnant women living with HIV found:

• The pooled HPV prevalence in pregnant women living with HIV was 75.5% (95% confidence interval, 50.2%-90.4%) but ranged from 23% to 98% between individual studies.
• Among the five studies that also analyzed HPV prevalence in pregnant women without HIV, the pooled prevalence was 48.1% (95% CI, 27.1%-69.8%).
• Pregnant women living with HIV had 54% higher odds of being HPV positive than did pregnant women without HIV.
• HPV-16 was the most common HPV type detected in pregnant women living with HIV, followed by HPV-52; other common types included HPV-18 and HPV-58.
• One study provided data on pregnancy outcomes in women living with HIV but did not correlate pregnancy outcomes with HPV status.

Experts urge HPV, cervical cancer screening for women living with HIV

“HPV is a common virus that can lead to cervical dysplasia and cervical cancer,” cautioned Clara Paik, MD, professor and clinic medical director of obstetrics and gynecology at UC Davis Health, Sacramento.

“HPV can also be associated with adverse pregnancy outcomes, including preterm birth and premature membrane rupture,” she said in an interview. “It is important to know the prevalence of HPV infection in pregnant women living with HIV in order to assess if this specific population is at higher risk for adverse pregnancy outcomes.”

Dr. Paik, who was not involved in the study, would like these results to lead to better HPV screening in pregnant women living with HIV.

“The study’s strengths include the large number of women studied when all the research studies were pooled,” she said. “A weakness is that, if individual studies had limitations, a systematic review based on weaker studies may not necessarily yield results that are conclusive.”

Linda Eckert, MD, professor of obstetrics and gynecology at the University of Washington, Seattle, said that the study highlights the importance of including cervical cancer screening in antepartum care, especially in areas of high HIV prevalence.

“Women living with HIV have a sixfold increased rate of developing cervical cancer compared to women without HIV,” she added, citing a 2020 analysis in The Lancet Global Health that estimated global cervical cancer risk among women living with HIV.

“This [new] study allows us to definitively say that pregnant women living with HIV have higher rates of HPV than do pregnant women without HIV,” noted Dr. Eckert, who was not involved in either study. “And HPV type 16 – the HPV type most associated with developing cervical cancer – was the most common high-risk HPV type found in these patients.”
 

HPV vaccination recommended

The World Health Organization’s call to eliminate cervical cancer has generated interest and funding for cervical cancer screening of women with HIV, Dr. Eckert said. “WHO recommends that women living with HIV who are 25 years of age and above be screened for cervical cancer annually.”

The authors urged that women living with HIV not only be screened for HPV but that they also be vaccinated against HPV.

“We know that HPV vaccination is unprecedented in its ability to prevent HPV infections when it is received prior to acquiring HPV infection,” Dr. Eckert said, “but currently data showing that HPV vaccination would treat HPV16 in pregnant women already infected with HPV16 are lacking.

“This study points to the need for a trial to investigate HPV vaccination in pregnant women living with HIV who have the high-risk HPV types,” she suggested.

Dr. Eckert contributed to the American College of Obstetricians and Gynecologists’ 2020 Human Papillomavirus Vaccination Committee Opinion. One study coauthor reported financial relationships with Merck. Dr. McClymont, the other coauthors, as well as Dr. Paik and Dr. Eckert reported no relevant financial relationships.

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

Nick Burwick, MD, discusses important takeaways that he gathered from the AVAHO 2022 meeting in San Diego. In keeping with this year's theme of self-care in cancer care, the keynote speaker, 'Patient Lee' Tomlinson, made a big impact on Dr Burwick with a motivational message about practicing compassion for not only your patients, but also for yourself. This theme continued with Dr Fay Hlubocky's presentation on resources available for self-care.

Dr Burwick also appreciated the multidisciplinary aspects of this year's AVAHO meeting that showcased the range of VA Whole Health options, the implementation of the Schwartz Rounds, and a diverse group of cancer care providers.

Nick Burwick, MD, discusses important takeaways that he gathered from the AVAHO 2022 meeting in San Diego. In keeping with this year's theme of self-care in cancer care, the keynote speaker, 'Patient Lee' Tomlinson, made a big impact on Dr Burwick with a motivational message about practicing compassion for not only your patients, but also for yourself. This theme continued with Dr Fay Hlubocky's presentation on resources available for self-care.

Dr Burwick also appreciated the multidisciplinary aspects of this year's AVAHO meeting that showcased the range of VA Whole Health options, the implementation of the Schwartz Rounds, and a diverse group of cancer care providers.

Nick Burwick, MD, discusses important takeaways that he gathered from the AVAHO 2022 meeting in San Diego. In keeping with this year's theme of self-care in cancer care, the keynote speaker, 'Patient Lee' Tomlinson, made a big impact on Dr Burwick with a motivational message about practicing compassion for not only your patients, but also for yourself. This theme continued with Dr Fay Hlubocky's presentation on resources available for self-care.

Dr Burwick also appreciated the multidisciplinary aspects of this year's AVAHO meeting that showcased the range of VA Whole Health options, the implementation of the Schwartz Rounds, and a diverse group of cancer care providers.

Bernadette Heron, PharmD, summarizes the offerings at the AVAHO 2022 meeting, from the standard sharing of updates across disciplines and specialties to the more specific focus on the role of self-care in cancer care.

Importantly, Dr Heron underscores the connection between the concept of self-care and the implements required for its realization in the clinical setting, resulting in an assortment of tools that practitioners can draw on as they continue the conversation that drives the evolution of cancer care. 

Bernadette Heron, PharmD, summarizes the offerings at the AVAHO 2022 meeting, from the standard sharing of updates across disciplines and specialties to the more specific focus on the role of self-care in cancer care.

Importantly, Dr Heron underscores the connection between the concept of self-care and the implements required for its realization in the clinical setting, resulting in an assortment of tools that practitioners can draw on as they continue the conversation that drives the evolution of cancer care. 

Bernadette Heron, PharmD, summarizes the offerings at the AVAHO 2022 meeting, from the standard sharing of updates across disciplines and specialties to the more specific focus on the role of self-care in cancer care.

Importantly, Dr Heron underscores the connection between the concept of self-care and the implements required for its realization in the clinical setting, resulting in an assortment of tools that practitioners can draw on as they continue the conversation that drives the evolution of cancer care. 

Lauren Cliffel, MSW, describes how the AVAHO 2022 meeting and the main theme of "Self-care in Cancer Care" reestablished the feelings of joy and compassion that led her to choose a career as a cancer care provider in the first place. 

The inclusive character of even the larger sessions this year is noted, in which all interdisciplinary contributors to cancer care were addressed as central to the delivery of an informed and effective care of patients and, importantly, how this care is enhanced by a restored sense of purpose among all those engaged in the specialty of oncology.

Lauren Cliffel, MSW, describes how the AVAHO 2022 meeting and the main theme of "Self-care in Cancer Care" reestablished the feelings of joy and compassion that led her to choose a career as a cancer care provider in the first place. 

The inclusive character of even the larger sessions this year is noted, in which all interdisciplinary contributors to cancer care were addressed as central to the delivery of an informed and effective care of patients and, importantly, how this care is enhanced by a restored sense of purpose among all those engaged in the specialty of oncology.

Lauren Cliffel, MSW, describes how the AVAHO 2022 meeting and the main theme of "Self-care in Cancer Care" reestablished the feelings of joy and compassion that led her to choose a career as a cancer care provider in the first place. 

The inclusive character of even the larger sessions this year is noted, in which all interdisciplinary contributors to cancer care were addressed as central to the delivery of an informed and effective care of patients and, importantly, how this care is enhanced by a restored sense of purpose among all those engaged in the specialty of oncology.

Bronchiectasis Section

Antibiotics in non–cystic fibrosis bronchiectasis: new perspectives

The clearest benefit of antibiotics in managing non-cystic fibrosis bronchiectasis is for treatment of exacerbations and for chronic azithromycin use. There is a paucity of high-quality evidence for prophylactic antibiotics, though guidelines support this practice, particularly for adults with three or more exacerbations a year. A recent Cochrane database review (Spencer, et al. Cochrane Database Syst Rev. 2022;1[1]:CD013254) examined eight RCTs, with interventions ranging from 16 to 48 weeks, involving 2,180 adults and found little net benefit for prophylactic cycled antibiotics (fluoroquinolones, beta-lactams, and aminoglycosides) in terms of outcomes viz time-to-first-exacerbation and duration of exacerbations, but more than doubled the risk of emerging resistance.

Clinical equipoise exists regarding the duration of antibiotics during exacerbations. Guidelines favor 14 days. A recent RCT (Pallavi, et al. Eur Respir J. 2021;58:2004388) examined the feasibility of bacterial load-guided therapy in 47 participants with bronchiectasis requiring IV antibiotics.

Patients were randomized to either 14 days of antibiotics or treatment guided by bacterial load (BLGG). The 88% of participants in the BLGG group were able to stop antibiotics by day 8, and potentially 81% of participants in the 14-day group could have stopped antibiotics at day 8. Median time to next exacerbation was much longer – 60 days (18-110 days) in the in BLGG group vs 27.5 days (12.5-60 days) in the 14-day group vs (P = .0034). A larger multicenter RCT may clarify the benefits of this approach to shortening duration of antibiotic therapy in patients with bronchiectasis exacerbations.

O’Neil Green, MBBS, FCCP
Member-at-Large

Bronchiectasis Section

Antibiotics in non–cystic fibrosis bronchiectasis: new perspectives

The clearest benefit of antibiotics in managing non-cystic fibrosis bronchiectasis is for treatment of exacerbations and for chronic azithromycin use. There is a paucity of high-quality evidence for prophylactic antibiotics, though guidelines support this practice, particularly for adults with three or more exacerbations a year. A recent Cochrane database review (Spencer, et al. Cochrane Database Syst Rev. 2022;1[1]:CD013254) examined eight RCTs, with interventions ranging from 16 to 48 weeks, involving 2,180 adults and found little net benefit for prophylactic cycled antibiotics (fluoroquinolones, beta-lactams, and aminoglycosides) in terms of outcomes viz time-to-first-exacerbation and duration of exacerbations, but more than doubled the risk of emerging resistance.

Clinical equipoise exists regarding the duration of antibiotics during exacerbations. Guidelines favor 14 days. A recent RCT (Pallavi, et al. Eur Respir J. 2021;58:2004388) examined the feasibility of bacterial load-guided therapy in 47 participants with bronchiectasis requiring IV antibiotics.

Patients were randomized to either 14 days of antibiotics or treatment guided by bacterial load (BLGG). The 88% of participants in the BLGG group were able to stop antibiotics by day 8, and potentially 81% of participants in the 14-day group could have stopped antibiotics at day 8. Median time to next exacerbation was much longer – 60 days (18-110 days) in the in BLGG group vs 27.5 days (12.5-60 days) in the 14-day group vs (P = .0034). A larger multicenter RCT may clarify the benefits of this approach to shortening duration of antibiotic therapy in patients with bronchiectasis exacerbations.

O’Neil Green, MBBS, FCCP
Member-at-Large

Bronchiectasis Section

Antibiotics in non–cystic fibrosis bronchiectasis: new perspectives

The clearest benefit of antibiotics in managing non-cystic fibrosis bronchiectasis is for treatment of exacerbations and for chronic azithromycin use. There is a paucity of high-quality evidence for prophylactic antibiotics, though guidelines support this practice, particularly for adults with three or more exacerbations a year. A recent Cochrane database review (Spencer, et al. Cochrane Database Syst Rev. 2022;1[1]:CD013254) examined eight RCTs, with interventions ranging from 16 to 48 weeks, involving 2,180 adults and found little net benefit for prophylactic cycled antibiotics (fluoroquinolones, beta-lactams, and aminoglycosides) in terms of outcomes viz time-to-first-exacerbation and duration of exacerbations, but more than doubled the risk of emerging resistance.

Clinical equipoise exists regarding the duration of antibiotics during exacerbations. Guidelines favor 14 days. A recent RCT (Pallavi, et al. Eur Respir J. 2021;58:2004388) examined the feasibility of bacterial load-guided therapy in 47 participants with bronchiectasis requiring IV antibiotics.

Patients were randomized to either 14 days of antibiotics or treatment guided by bacterial load (BLGG). The 88% of participants in the BLGG group were able to stop antibiotics by day 8, and potentially 81% of participants in the 14-day group could have stopped antibiotics at day 8. Median time to next exacerbation was much longer – 60 days (18-110 days) in the in BLGG group vs 27.5 days (12.5-60 days) in the 14-day group vs (P = .0034). A larger multicenter RCT may clarify the benefits of this approach to shortening duration of antibiotic therapy in patients with bronchiectasis exacerbations.

O’Neil Green, MBBS, FCCP
Member-at-Large

Intensive care telemedicine was first described in 1982 after implementation in a seven-bed, inner-city ICU using 19-inch television screens connected with intensivists at the University Hospitals of Cleveland (Grundy, et al. Crit Care Med. 1982;10[7]:471). After this proof-of-concept report, however, ICU telemedicine gained little traction for nearly 20 years, until Johns Hopkins Hospital established a continuously monitored ICU telemedicine service in a nonintensivist staffed surgical ICU. Their pre/post analysis suggested a 64% decrease in severity-adjusted ICU mortality and greater than 30% decrease in ICU length of stay, ICU complications, and costs (Rosenfeld, et al. Crit Care Med. 2000;28[12]:3925).

Along with better and less costly telemedicine technology, rapid adoption of electronic medical records, and a nationwide intensivist shortage, this and other evidence for the service’s clinical and cost effectiveness has spurred explosive growth in ICU telemedicine in the succeeding 2 decades, with at least 18% of hospitals and 28% of ICU beds supported by ICU telemedicine by 2018 (Ofoma, et al. Crit Care Explor. 2021;4[3]:e0468).

Importantly, what “ICU telemedicine” represents varies substantially across hospitals and even across ICUs within systems. Two-way audiovisual technology is the defining feature, and at a minimum, programs provide intensivists and/or nurses who respond to consultation requests. Commonly, telemedicine clinicians directly connect with patients; monitor labs, hemodynamics, and alarms; and proactively contact on-site clinicians with recommendations or place orders directly into the electronic health record depending on whether the clinician acts as the patients’ primary, co-managing, or consultant provider. A centralized hub and spoke model with telemedicine personnel located at a single, remote center is the most common and best studied ICU telemedicine design. Additional staffing may include respiratory therapists, pharmacists, and advanced practice clinicians in coverage models that range from 24/7 to nocturnal and can also differ in whether patients are monitored continuously or on an as needed basis, triggered by alarms or clinician/nursing concerns.

On-demand services may extend to support for teams responding to medical emergencies inside and sometimes outside the ICU. Another equally important role that ICU telemedicine can provide is helping ensure facilities adhere to ICU quality metrics, such as ventilator bundles, DVT prophylaxis, and daily SAT/SBT.

Unsurprisingly, integrating ICU telemedicine into an existing system is very costly and complex, requiring substantial and thoughtful process redesign to maximize fiscal and clinical return on investment. One vendor of proprietary telemedicine technology, Philips eICU, estimates an implementation cost of $50,000 to $100,000 per bed with annual overhead, software maintenance, and IT staffing of ~20% of implementation costs in addition to clinician staffing of $1-2 million per 100 beds. However, some (but not all) evidence suggests that ICU telemedicine programs pay for themselves over time. An influential report from Sentara Healthcare, an early adopter of ICU telemedicine, described equipment costs of more than $1 million for a total of 103 critical care beds but attributed savings of $460,000 per month to decreased length of stay (Coustasse, et al. The Permanente Journal. 2014;18[4]:76).

Cost savings are great, of course, but ICU telemedicine’s potential to improve clinical outcomes is the real priority. While Sentara’s early report included a 27% decrease in ICU mortality after telemedicine adoption, a 2011 meta-analysis of 13 studies, including 35 ICUs and over 40,000 patients, suggested decreased ICU mortality and LOS with a statistically significant effect on overall hospital mortality and LOS (Young, et al. Arch Intern Med. 2011;171[6]:498). This highlights the Achilles heel of ICU telemedicine evidence: the pretest/posttest studies that dominate this field and likely contribute substantially to the inconsistencies in the evidence base.

In the absence of risk adjustment and control groups, many studies observed postimplementation changes that may reflect trends in patient mix or the effects of unrelated practice changes rather than the causal influence of ICU telemedicine. In fact, in studies using more robust methods, ICU telemedicine’s effect size has been smaller or nonexistent. For example, in 2016, Kahn and colleagues used CMS data to evaluate 132 ICU telemedicine programs using 389 matched controlled hospitals. There was a slight reduction in 90-day mortality (OR=0.96, CI 0.94-0.98) with only 12% showing a statistically significant reduction in mortality. Interestingly, hospitals in urban areas demonstrated greater benefit than rural facilities (Kahn, et al. Medical Care. 2016;54[3]:319).

The heterogeneity of the studied programs (e.g., primary vs consultative role, on-demand vs proactive involvement) and recipient ICUs (e.g., rural vs tertiary care facility, presence of bedside intensivists) further hinders a clear answer to the key question: Would ICU telemedicine benefit my hospital? Fortunately, some recent, well-designed studies have attempted to understand which attributes of ICU telemedicine programs provide results and which ICUs will see the most benefit. In a cohort of 118,990 patients across 56 ICUs, four interventions were associated with lower mortality and reduced LOS: (1) evaluation of patients within 1 hour of ICU admission, (2) frequent leadership review of performance data, (3) ICU best practice compliance, and (4) prompt response to alerts (Lilly, et al. Chest. 2014;145[3]:500). Kahn and colleagues have also investigated this issue, conducting an in-depth ethnographic evaluation of 10 hospitals identified in their 2016 study to have positive, neutral, or negative outcomes after ICU telemedicine implementation (Kahn, et al. Am J Respir Crit Care Med. 2019;199[8]:970). They found that successful programs:

(1) provided consistent services matched to recipient needs;

(2) provided services both proactively and reactively without being obtrusive;

(3) embedded routine engagements unobtrusively into usual routines;

(4) had engaged leadership who set clear expectations and mediated conflicts; and

(5) had bedside clinicians who valued and sought out telemedicine participation in care.

The authors concluded that, “the true value of ICU telemedicine lies not in whether the technology exists but in how it is applied.” However, another recent analysis also suggested that, rather than telemedicine or recipient ICU design, targeting underperforming recipient ICU performance may be the key determinant of whether ICU telemedicine implementation improves outcomes (Fusaro, et al. Crit Care Med. 2019; 47[4]:501). While the finding may reflect regression to the mean, the idea that ICUs with above-expected mortality derive greater benefit from ICU telemedicine support than already well-performing ICUs is certainly logical.

As COVID-19 strained health care systems across the country, we and others found ways to use ICU telemedicine to preserve optimal care delivery for critically ill patients. Our program at Intermountain Healthcare – already supporting 17 ICUs within our 24-hospital health system, as well as 10 external ICUs with experienced critical care physicians, nurses, respiratory therapists, and pharmacists – took on increased responsibility for ICU load balancing and interhospital transfers.

Leveraging telemedicine services also helped community ICUs care for sicker, more complex patients than usual and aided nonintensivist physicians called upon to manage critically ill patients in ad hoc ICUs at referral hospitals. While the pandemic certainly stressed ICU staff, we suspect that telemedicine’s ability to balance caseloads and distribute clinical tasks helped mitigate these stresses. At age 40, ICU telemedicine is both mature and still growing, with continued expansion of bed coverage and the range of services available. Looking ahead, as we confront a national shortage of intensivists, ICU telemedicine likely represents a cost effective and efficient strategy to maintain critical care capacity with the potential to ensure low-cost, high-quality care for all, regardless of location.
 

Dr. Graham and Dr. Peltan are with the Division of Pulmonary & Critical Care Medicine, Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City, Utah; and Dr. Peltan is also with the Division of Pulmonary & Critical Care Medicine, Department of Medicine, Intermountain Medical Center, Murray, Utah.

Intensive care telemedicine was first described in 1982 after implementation in a seven-bed, inner-city ICU using 19-inch television screens connected with intensivists at the University Hospitals of Cleveland (Grundy, et al. Crit Care Med. 1982;10[7]:471). After this proof-of-concept report, however, ICU telemedicine gained little traction for nearly 20 years, until Johns Hopkins Hospital established a continuously monitored ICU telemedicine service in a nonintensivist staffed surgical ICU. Their pre/post analysis suggested a 64% decrease in severity-adjusted ICU mortality and greater than 30% decrease in ICU length of stay, ICU complications, and costs (Rosenfeld, et al. Crit Care Med. 2000;28[12]:3925).

Along with better and less costly telemedicine technology, rapid adoption of electronic medical records, and a nationwide intensivist shortage, this and other evidence for the service’s clinical and cost effectiveness has spurred explosive growth in ICU telemedicine in the succeeding 2 decades, with at least 18% of hospitals and 28% of ICU beds supported by ICU telemedicine by 2018 (Ofoma, et al. Crit Care Explor. 2021;4[3]:e0468).

Importantly, what “ICU telemedicine” represents varies substantially across hospitals and even across ICUs within systems. Two-way audiovisual technology is the defining feature, and at a minimum, programs provide intensivists and/or nurses who respond to consultation requests. Commonly, telemedicine clinicians directly connect with patients; monitor labs, hemodynamics, and alarms; and proactively contact on-site clinicians with recommendations or place orders directly into the electronic health record depending on whether the clinician acts as the patients’ primary, co-managing, or consultant provider. A centralized hub and spoke model with telemedicine personnel located at a single, remote center is the most common and best studied ICU telemedicine design. Additional staffing may include respiratory therapists, pharmacists, and advanced practice clinicians in coverage models that range from 24/7 to nocturnal and can also differ in whether patients are monitored continuously or on an as needed basis, triggered by alarms or clinician/nursing concerns.

On-demand services may extend to support for teams responding to medical emergencies inside and sometimes outside the ICU. Another equally important role that ICU telemedicine can provide is helping ensure facilities adhere to ICU quality metrics, such as ventilator bundles, DVT prophylaxis, and daily SAT/SBT.

Unsurprisingly, integrating ICU telemedicine into an existing system is very costly and complex, requiring substantial and thoughtful process redesign to maximize fiscal and clinical return on investment. One vendor of proprietary telemedicine technology, Philips eICU, estimates an implementation cost of $50,000 to $100,000 per bed with annual overhead, software maintenance, and IT staffing of ~20% of implementation costs in addition to clinician staffing of $1-2 million per 100 beds. However, some (but not all) evidence suggests that ICU telemedicine programs pay for themselves over time. An influential report from Sentara Healthcare, an early adopter of ICU telemedicine, described equipment costs of more than $1 million for a total of 103 critical care beds but attributed savings of $460,000 per month to decreased length of stay (Coustasse, et al. The Permanente Journal. 2014;18[4]:76).

Cost savings are great, of course, but ICU telemedicine’s potential to improve clinical outcomes is the real priority. While Sentara’s early report included a 27% decrease in ICU mortality after telemedicine adoption, a 2011 meta-analysis of 13 studies, including 35 ICUs and over 40,000 patients, suggested decreased ICU mortality and LOS with a statistically significant effect on overall hospital mortality and LOS (Young, et al. Arch Intern Med. 2011;171[6]:498). This highlights the Achilles heel of ICU telemedicine evidence: the pretest/posttest studies that dominate this field and likely contribute substantially to the inconsistencies in the evidence base.

In the absence of risk adjustment and control groups, many studies observed postimplementation changes that may reflect trends in patient mix or the effects of unrelated practice changes rather than the causal influence of ICU telemedicine. In fact, in studies using more robust methods, ICU telemedicine’s effect size has been smaller or nonexistent. For example, in 2016, Kahn and colleagues used CMS data to evaluate 132 ICU telemedicine programs using 389 matched controlled hospitals. There was a slight reduction in 90-day mortality (OR=0.96, CI 0.94-0.98) with only 12% showing a statistically significant reduction in mortality. Interestingly, hospitals in urban areas demonstrated greater benefit than rural facilities (Kahn, et al. Medical Care. 2016;54[3]:319).

The heterogeneity of the studied programs (e.g., primary vs consultative role, on-demand vs proactive involvement) and recipient ICUs (e.g., rural vs tertiary care facility, presence of bedside intensivists) further hinders a clear answer to the key question: Would ICU telemedicine benefit my hospital? Fortunately, some recent, well-designed studies have attempted to understand which attributes of ICU telemedicine programs provide results and which ICUs will see the most benefit. In a cohort of 118,990 patients across 56 ICUs, four interventions were associated with lower mortality and reduced LOS: (1) evaluation of patients within 1 hour of ICU admission, (2) frequent leadership review of performance data, (3) ICU best practice compliance, and (4) prompt response to alerts (Lilly, et al. Chest. 2014;145[3]:500). Kahn and colleagues have also investigated this issue, conducting an in-depth ethnographic evaluation of 10 hospitals identified in their 2016 study to have positive, neutral, or negative outcomes after ICU telemedicine implementation (Kahn, et al. Am J Respir Crit Care Med. 2019;199[8]:970). They found that successful programs:

(1) provided consistent services matched to recipient needs;

(2) provided services both proactively and reactively without being obtrusive;

(3) embedded routine engagements unobtrusively into usual routines;

(4) had engaged leadership who set clear expectations and mediated conflicts; and

(5) had bedside clinicians who valued and sought out telemedicine participation in care.

The authors concluded that, “the true value of ICU telemedicine lies not in whether the technology exists but in how it is applied.” However, another recent analysis also suggested that, rather than telemedicine or recipient ICU design, targeting underperforming recipient ICU performance may be the key determinant of whether ICU telemedicine implementation improves outcomes (Fusaro, et al. Crit Care Med. 2019; 47[4]:501). While the finding may reflect regression to the mean, the idea that ICUs with above-expected mortality derive greater benefit from ICU telemedicine support than already well-performing ICUs is certainly logical.

As COVID-19 strained health care systems across the country, we and others found ways to use ICU telemedicine to preserve optimal care delivery for critically ill patients. Our program at Intermountain Healthcare – already supporting 17 ICUs within our 24-hospital health system, as well as 10 external ICUs with experienced critical care physicians, nurses, respiratory therapists, and pharmacists – took on increased responsibility for ICU load balancing and interhospital transfers.

Leveraging telemedicine services also helped community ICUs care for sicker, more complex patients than usual and aided nonintensivist physicians called upon to manage critically ill patients in ad hoc ICUs at referral hospitals. While the pandemic certainly stressed ICU staff, we suspect that telemedicine’s ability to balance caseloads and distribute clinical tasks helped mitigate these stresses. At age 40, ICU telemedicine is both mature and still growing, with continued expansion of bed coverage and the range of services available. Looking ahead, as we confront a national shortage of intensivists, ICU telemedicine likely represents a cost effective and efficient strategy to maintain critical care capacity with the potential to ensure low-cost, high-quality care for all, regardless of location.
 

Dr. Graham and Dr. Peltan are with the Division of Pulmonary & Critical Care Medicine, Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City, Utah; and Dr. Peltan is also with the Division of Pulmonary & Critical Care Medicine, Department of Medicine, Intermountain Medical Center, Murray, Utah.

Intensive care telemedicine was first described in 1982 after implementation in a seven-bed, inner-city ICU using 19-inch television screens connected with intensivists at the University Hospitals of Cleveland (Grundy, et al. Crit Care Med. 1982;10[7]:471). After this proof-of-concept report, however, ICU telemedicine gained little traction for nearly 20 years, until Johns Hopkins Hospital established a continuously monitored ICU telemedicine service in a nonintensivist staffed surgical ICU. Their pre/post analysis suggested a 64% decrease in severity-adjusted ICU mortality and greater than 30% decrease in ICU length of stay, ICU complications, and costs (Rosenfeld, et al. Crit Care Med. 2000;28[12]:3925).

Along with better and less costly telemedicine technology, rapid adoption of electronic medical records, and a nationwide intensivist shortage, this and other evidence for the service’s clinical and cost effectiveness has spurred explosive growth in ICU telemedicine in the succeeding 2 decades, with at least 18% of hospitals and 28% of ICU beds supported by ICU telemedicine by 2018 (Ofoma, et al. Crit Care Explor. 2021;4[3]:e0468).

Importantly, what “ICU telemedicine” represents varies substantially across hospitals and even across ICUs within systems. Two-way audiovisual technology is the defining feature, and at a minimum, programs provide intensivists and/or nurses who respond to consultation requests. Commonly, telemedicine clinicians directly connect with patients; monitor labs, hemodynamics, and alarms; and proactively contact on-site clinicians with recommendations or place orders directly into the electronic health record depending on whether the clinician acts as the patients’ primary, co-managing, or consultant provider. A centralized hub and spoke model with telemedicine personnel located at a single, remote center is the most common and best studied ICU telemedicine design. Additional staffing may include respiratory therapists, pharmacists, and advanced practice clinicians in coverage models that range from 24/7 to nocturnal and can also differ in whether patients are monitored continuously or on an as needed basis, triggered by alarms or clinician/nursing concerns.

On-demand services may extend to support for teams responding to medical emergencies inside and sometimes outside the ICU. Another equally important role that ICU telemedicine can provide is helping ensure facilities adhere to ICU quality metrics, such as ventilator bundles, DVT prophylaxis, and daily SAT/SBT.

Unsurprisingly, integrating ICU telemedicine into an existing system is very costly and complex, requiring substantial and thoughtful process redesign to maximize fiscal and clinical return on investment. One vendor of proprietary telemedicine technology, Philips eICU, estimates an implementation cost of $50,000 to $100,000 per bed with annual overhead, software maintenance, and IT staffing of ~20% of implementation costs in addition to clinician staffing of $1-2 million per 100 beds. However, some (but not all) evidence suggests that ICU telemedicine programs pay for themselves over time. An influential report from Sentara Healthcare, an early adopter of ICU telemedicine, described equipment costs of more than $1 million for a total of 103 critical care beds but attributed savings of $460,000 per month to decreased length of stay (Coustasse, et al. The Permanente Journal. 2014;18[4]:76).

Cost savings are great, of course, but ICU telemedicine’s potential to improve clinical outcomes is the real priority. While Sentara’s early report included a 27% decrease in ICU mortality after telemedicine adoption, a 2011 meta-analysis of 13 studies, including 35 ICUs and over 40,000 patients, suggested decreased ICU mortality and LOS with a statistically significant effect on overall hospital mortality and LOS (Young, et al. Arch Intern Med. 2011;171[6]:498). This highlights the Achilles heel of ICU telemedicine evidence: the pretest/posttest studies that dominate this field and likely contribute substantially to the inconsistencies in the evidence base.

In the absence of risk adjustment and control groups, many studies observed postimplementation changes that may reflect trends in patient mix or the effects of unrelated practice changes rather than the causal influence of ICU telemedicine. In fact, in studies using more robust methods, ICU telemedicine’s effect size has been smaller or nonexistent. For example, in 2016, Kahn and colleagues used CMS data to evaluate 132 ICU telemedicine programs using 389 matched controlled hospitals. There was a slight reduction in 90-day mortality (OR=0.96, CI 0.94-0.98) with only 12% showing a statistically significant reduction in mortality. Interestingly, hospitals in urban areas demonstrated greater benefit than rural facilities (Kahn, et al. Medical Care. 2016;54[3]:319).

The heterogeneity of the studied programs (e.g., primary vs consultative role, on-demand vs proactive involvement) and recipient ICUs (e.g., rural vs tertiary care facility, presence of bedside intensivists) further hinders a clear answer to the key question: Would ICU telemedicine benefit my hospital? Fortunately, some recent, well-designed studies have attempted to understand which attributes of ICU telemedicine programs provide results and which ICUs will see the most benefit. In a cohort of 118,990 patients across 56 ICUs, four interventions were associated with lower mortality and reduced LOS: (1) evaluation of patients within 1 hour of ICU admission, (2) frequent leadership review of performance data, (3) ICU best practice compliance, and (4) prompt response to alerts (Lilly, et al. Chest. 2014;145[3]:500). Kahn and colleagues have also investigated this issue, conducting an in-depth ethnographic evaluation of 10 hospitals identified in their 2016 study to have positive, neutral, or negative outcomes after ICU telemedicine implementation (Kahn, et al. Am J Respir Crit Care Med. 2019;199[8]:970). They found that successful programs:

(1) provided consistent services matched to recipient needs;

(2) provided services both proactively and reactively without being obtrusive;

(3) embedded routine engagements unobtrusively into usual routines;

(4) had engaged leadership who set clear expectations and mediated conflicts; and

(5) had bedside clinicians who valued and sought out telemedicine participation in care.

The authors concluded that, “the true value of ICU telemedicine lies not in whether the technology exists but in how it is applied.” However, another recent analysis also suggested that, rather than telemedicine or recipient ICU design, targeting underperforming recipient ICU performance may be the key determinant of whether ICU telemedicine implementation improves outcomes (Fusaro, et al. Crit Care Med. 2019; 47[4]:501). While the finding may reflect regression to the mean, the idea that ICUs with above-expected mortality derive greater benefit from ICU telemedicine support than already well-performing ICUs is certainly logical.

As COVID-19 strained health care systems across the country, we and others found ways to use ICU telemedicine to preserve optimal care delivery for critically ill patients. Our program at Intermountain Healthcare – already supporting 17 ICUs within our 24-hospital health system, as well as 10 external ICUs with experienced critical care physicians, nurses, respiratory therapists, and pharmacists – took on increased responsibility for ICU load balancing and interhospital transfers.

Leveraging telemedicine services also helped community ICUs care for sicker, more complex patients than usual and aided nonintensivist physicians called upon to manage critically ill patients in ad hoc ICUs at referral hospitals. While the pandemic certainly stressed ICU staff, we suspect that telemedicine’s ability to balance caseloads and distribute clinical tasks helped mitigate these stresses. At age 40, ICU telemedicine is both mature and still growing, with continued expansion of bed coverage and the range of services available. Looking ahead, as we confront a national shortage of intensivists, ICU telemedicine likely represents a cost effective and efficient strategy to maintain critical care capacity with the potential to ensure low-cost, high-quality care for all, regardless of location.
 

Dr. Graham and Dr. Peltan are with the Division of Pulmonary & Critical Care Medicine, Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City, Utah; and Dr. Peltan is also with the Division of Pulmonary & Critical Care Medicine, Department of Medicine, Intermountain Medical Center, Murray, Utah.

The CHEST Board of Regents (BOR) convened a hybrid meeting in Atlanta prior to the pulmonary board review course. Hopefully, many of you had the opportunity to participate in that excellent learning experience. The function of the BOR is to provide direction and oversight for the organization’s strategy and goals, including the development of the many programs that are so expertly crafted by our talented staff, with contributions from our volunteers. The BOR has adopted organizational goals and metrics around our four key pillars, including: education, people, products, and growth. Our EVP/CEO, Dr. Robert Musacchio, opened the meeting with a review of the organization’s mid-year progress toward achieving these annual goals. Despite the current economic turmoil and need for flexibility in our COVID landscape, CHEST is on track to meet or exceed the majority of the stated goals. The team continues efforts to achieve our key metrics related to increasing learners, members, and growth in revenue – we anticipate the upcoming annual meeting will only bolster our progress.

Every BOR meeting includes a report from the Finance Committee, which is thoroughly reviewed by the BOR. CHEST investments have fared no better than the rest of the country, but our investment advisors assure us that things will improve.

Similar updates were given by the President of the CHEST Foundation, Dr. Ian Nathanson, who noted that the Foundation will be celebrating its 25th anniversary during CHEST 2022. I would like to personally encourage you to donate and make this year the best year of fundraising. We are eager to bolster our community and patients after the long journey through COVID. Every donation enables more investment in creating access to the profession and in piloting programs across our communities that improve access to care. Thank you to those who have already contributed.

The morning session was completed with excellent presentations by the Chief Learning Officer/Education SVP, Richard Schuch and Publisher/Communications SVP, Nicki Augustyn. Rich provided an update on the education strategy and how it will change to keep up with the ever-changing needs of learners. He also made the observation that CHEST cannot do this alone, and partnering with companies to assist in new methods of content delivery will be important for the future of the organization. Nicki presented data regarding the current membership structure, as well as the effect of the pandemic on membership over the last 2 years.

In the afternoon session, the BOR and staff spent over 2 hours on the topic of advocacy. CHEST has become more active in the area of advocacy for both patients and the medical profession, specifically in the areas of pulmonary, critical care, and sleep medicine. The Health Policy and Advocacy Committee (HPAC) currently has workgroups working in five different areas, including: oxygen, pulmonary rehabilitation, coding and billing, noninvasive ventilation, and tobacco and vaping. However, CHEST is often asked to sign on to or support the advocacy efforts of other organizations, including other medical societies, patient groups, and industry groups. At times, the decision to support or not support is easy. While there is a process to make that decision, this session helped better define the process and started to create some norms around when CHEST itself should lead its own statement on a particular issue.

The BOR will meet a total of six times this year, either remotely or in person, to make certain that CHEST continues to fulfill its mission “to champion the prevention, diagnosis, and treatment of chest diseases through education, communication, and research.”

The CHEST Board of Regents (BOR) convened a hybrid meeting in Atlanta prior to the pulmonary board review course. Hopefully, many of you had the opportunity to participate in that excellent learning experience. The function of the BOR is to provide direction and oversight for the organization’s strategy and goals, including the development of the many programs that are so expertly crafted by our talented staff, with contributions from our volunteers. The BOR has adopted organizational goals and metrics around our four key pillars, including: education, people, products, and growth. Our EVP/CEO, Dr. Robert Musacchio, opened the meeting with a review of the organization’s mid-year progress toward achieving these annual goals. Despite the current economic turmoil and need for flexibility in our COVID landscape, CHEST is on track to meet or exceed the majority of the stated goals. The team continues efforts to achieve our key metrics related to increasing learners, members, and growth in revenue – we anticipate the upcoming annual meeting will only bolster our progress.

Every BOR meeting includes a report from the Finance Committee, which is thoroughly reviewed by the BOR. CHEST investments have fared no better than the rest of the country, but our investment advisors assure us that things will improve.

Similar updates were given by the President of the CHEST Foundation, Dr. Ian Nathanson, who noted that the Foundation will be celebrating its 25th anniversary during CHEST 2022. I would like to personally encourage you to donate and make this year the best year of fundraising. We are eager to bolster our community and patients after the long journey through COVID. Every donation enables more investment in creating access to the profession and in piloting programs across our communities that improve access to care. Thank you to those who have already contributed.

The morning session was completed with excellent presentations by the Chief Learning Officer/Education SVP, Richard Schuch and Publisher/Communications SVP, Nicki Augustyn. Rich provided an update on the education strategy and how it will change to keep up with the ever-changing needs of learners. He also made the observation that CHEST cannot do this alone, and partnering with companies to assist in new methods of content delivery will be important for the future of the organization. Nicki presented data regarding the current membership structure, as well as the effect of the pandemic on membership over the last 2 years.

In the afternoon session, the BOR and staff spent over 2 hours on the topic of advocacy. CHEST has become more active in the area of advocacy for both patients and the medical profession, specifically in the areas of pulmonary, critical care, and sleep medicine. The Health Policy and Advocacy Committee (HPAC) currently has workgroups working in five different areas, including: oxygen, pulmonary rehabilitation, coding and billing, noninvasive ventilation, and tobacco and vaping. However, CHEST is often asked to sign on to or support the advocacy efforts of other organizations, including other medical societies, patient groups, and industry groups. At times, the decision to support or not support is easy. While there is a process to make that decision, this session helped better define the process and started to create some norms around when CHEST itself should lead its own statement on a particular issue.

The BOR will meet a total of six times this year, either remotely or in person, to make certain that CHEST continues to fulfill its mission “to champion the prevention, diagnosis, and treatment of chest diseases through education, communication, and research.”

The CHEST Board of Regents (BOR) convened a hybrid meeting in Atlanta prior to the pulmonary board review course. Hopefully, many of you had the opportunity to participate in that excellent learning experience. The function of the BOR is to provide direction and oversight for the organization’s strategy and goals, including the development of the many programs that are so expertly crafted by our talented staff, with contributions from our volunteers. The BOR has adopted organizational goals and metrics around our four key pillars, including: education, people, products, and growth. Our EVP/CEO, Dr. Robert Musacchio, opened the meeting with a review of the organization’s mid-year progress toward achieving these annual goals. Despite the current economic turmoil and need for flexibility in our COVID landscape, CHEST is on track to meet or exceed the majority of the stated goals. The team continues efforts to achieve our key metrics related to increasing learners, members, and growth in revenue – we anticipate the upcoming annual meeting will only bolster our progress.

Every BOR meeting includes a report from the Finance Committee, which is thoroughly reviewed by the BOR. CHEST investments have fared no better than the rest of the country, but our investment advisors assure us that things will improve.

Similar updates were given by the President of the CHEST Foundation, Dr. Ian Nathanson, who noted that the Foundation will be celebrating its 25th anniversary during CHEST 2022. I would like to personally encourage you to donate and make this year the best year of fundraising. We are eager to bolster our community and patients after the long journey through COVID. Every donation enables more investment in creating access to the profession and in piloting programs across our communities that improve access to care. Thank you to those who have already contributed.

The morning session was completed with excellent presentations by the Chief Learning Officer/Education SVP, Richard Schuch and Publisher/Communications SVP, Nicki Augustyn. Rich provided an update on the education strategy and how it will change to keep up with the ever-changing needs of learners. He also made the observation that CHEST cannot do this alone, and partnering with companies to assist in new methods of content delivery will be important for the future of the organization. Nicki presented data regarding the current membership structure, as well as the effect of the pandemic on membership over the last 2 years.

In the afternoon session, the BOR and staff spent over 2 hours on the topic of advocacy. CHEST has become more active in the area of advocacy for both patients and the medical profession, specifically in the areas of pulmonary, critical care, and sleep medicine. The Health Policy and Advocacy Committee (HPAC) currently has workgroups working in five different areas, including: oxygen, pulmonary rehabilitation, coding and billing, noninvasive ventilation, and tobacco and vaping. However, CHEST is often asked to sign on to or support the advocacy efforts of other organizations, including other medical societies, patient groups, and industry groups. At times, the decision to support or not support is easy. While there is a process to make that decision, this session helped better define the process and started to create some norms around when CHEST itself should lead its own statement on a particular issue.

The BOR will meet a total of six times this year, either remotely or in person, to make certain that CHEST continues to fulfill its mission “to champion the prevention, diagnosis, and treatment of chest diseases through education, communication, and research.”