Journal of Clinical Outcomes Management

Adding a second-generation antipsychotic to an antidepressant to treat depression carries an increased mortality risk for middle-aged adults, results of a large, observational study show.

“Our study suggests physicians should consider prescribing antipsychotics to adults with depression carefully, as the potential health risks are substantial and the benefits are quite modest and controversially debated,” lead investigator Tobias Gerhard, PhD, Center for Pharmacoepidemiology and Treatment Science, Rutgers University, New Brunswick, N.J., said in a news release.

The results, he added, “emphasize the importance of considering newer antipsychotics only after nonresponse to less risky, evidence-based treatment options has been established.”

The study was published online September 30 in PLOS ONE.
 

A last resort

Previous research has demonstrated an increased mortality risk for elderly patients with dementia who take an atypical antipsychotic, but it’s unclear whether this risk occurs among nonelderly adults who use newer antipsychotics as augmentation treatment for depression.

To investigate, Gerhard and colleagues analyzed national healthcare claims from the Medicaid program from 2001 to 2010 for 39,582 Medicaid beneficiaries (mean age, 44.5 years; 78.5% women) who had been diagnosed with depression. Patients with alternative indications for antipsychotic therapy, such as schizophrenia, psychotic depression, or bipolar disorder, were excluded.

After at least 3 months of treatment with a single antidepressant, for more than half of the patients (56.6%), treatment was augmented with an atypical antipsychotic (quetiapine, risperidone, aripiprazole or olanzapine). For the remainder (43.4%), a second antidepressant was added.

The average chlorpromazine equivalent starting dose for all atypical antipsychotics was 68 mg/d. The dose was increased to 100 mg/d during follow-up.

A total of 153 patients died during 13,328 person-years of follow-up, including 105 for whom treatment was augmented with an atypical antipsychotic and 48 for whom treatment was augmented with a second antidepressant.

Compared to those who received a second antidepressant, among those for whom an antipsychotic was added, there was a 45% increased risk of dying during follow-up (adjusted hazard ratio, 1.45; 95% CI, 1.02 – 2.06).

This equates to an absolute risk difference of 37.7 deaths per 10,000 person-years of treatment (0.38% per year) and a number needed to harm of roughly 265 per year. For higher-risk subgroups, the number needed to harm decreased substantially, the authors note. The results were robust across several sensitivity analyses.

“We don’t know the mechanisms of the increased mortality risk, but cardiac and infectious causes are leading candidates,” said Gerhard.

“Our study in nonelderly adults with depression did not identify a single predominant cause of death. However, this may be a result of both the relatively small number of deaths in our study as well as of the well-recognized concerns regarding the accuracy of cause-of-death attribution in death certificates,” Gerhard said.

“As with the potential causes of death, the pathophysiological pathways involved are not well understood but could, among others, involve adverse metabolic effects, including weight gain, diabetes, dyslipidemia, QT prolongation, sedation, and falls – all of which have been associated with at least some of the newer antipsychotics,” he added.

The researchers state that atypical antipsychotics should be considered only “after non-response to evidence-based treatment options that are less risky.”
 

Another red flag

Commenting for Medscape Medical News, Timothy Sullivan, MD, chair of psychiatry and behavioral sciences at Northwell Health’s Staten Island University Hospital in New York, said this is a “valid contribution” and represents the second large study that “raises the same concern.”

“We’ve been probably underestimating the risk in administering them, and that’s something people really need to know, because if you’re prescribing it for someone with mild to moderate depression, it may be helpful, but is it really worth the risk if you’re significantly increasing their risk of death?” said Sullivan, who wasn’t involved in the study.

Clearly, he said, this “raises a flag that we have to look at this a little more carefully and be a little clearer with patients about the risk. One could argue that we should not be so quick to add these drugs, even though they could be helpful, before we exhaust other less potentially risky options.”

Sullivan’s advice: “Do the three trials of antidepressants, look at antidepressant combinations, don’t be quick to jump to this particular option, because of the concerns. Certainly there are situations like psychotic depression where the risk of use is outweighed by the benefits, given the clinical syndrome, but for less severe forms, we probably should reformulate some of our algorithms.”

The study was supported by the National Institute of Mental Health (NIMH). Gerhard received grants from the NIMH and the National Institute on Aging during the conduct of the study; grants and personal fees from Bristol-Myers Squibb; and personal fees from Eisai, Merck, Pfizer, Lilly, and IntraCellular Therapies outside the submitted work. Sullivan has disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

Adding a second-generation antipsychotic to an antidepressant to treat depression carries an increased mortality risk for middle-aged adults, results of a large, observational study show.

“Our study suggests physicians should consider prescribing antipsychotics to adults with depression carefully, as the potential health risks are substantial and the benefits are quite modest and controversially debated,” lead investigator Tobias Gerhard, PhD, Center for Pharmacoepidemiology and Treatment Science, Rutgers University, New Brunswick, N.J., said in a news release.

The results, he added, “emphasize the importance of considering newer antipsychotics only after nonresponse to less risky, evidence-based treatment options has been established.”

The study was published online September 30 in PLOS ONE.
 

A last resort

Previous research has demonstrated an increased mortality risk for elderly patients with dementia who take an atypical antipsychotic, but it’s unclear whether this risk occurs among nonelderly adults who use newer antipsychotics as augmentation treatment for depression.

To investigate, Gerhard and colleagues analyzed national healthcare claims from the Medicaid program from 2001 to 2010 for 39,582 Medicaid beneficiaries (mean age, 44.5 years; 78.5% women) who had been diagnosed with depression. Patients with alternative indications for antipsychotic therapy, such as schizophrenia, psychotic depression, or bipolar disorder, were excluded.

After at least 3 months of treatment with a single antidepressant, for more than half of the patients (56.6%), treatment was augmented with an atypical antipsychotic (quetiapine, risperidone, aripiprazole or olanzapine). For the remainder (43.4%), a second antidepressant was added.

The average chlorpromazine equivalent starting dose for all atypical antipsychotics was 68 mg/d. The dose was increased to 100 mg/d during follow-up.

A total of 153 patients died during 13,328 person-years of follow-up, including 105 for whom treatment was augmented with an atypical antipsychotic and 48 for whom treatment was augmented with a second antidepressant.

Compared to those who received a second antidepressant, among those for whom an antipsychotic was added, there was a 45% increased risk of dying during follow-up (adjusted hazard ratio, 1.45; 95% CI, 1.02 – 2.06).

This equates to an absolute risk difference of 37.7 deaths per 10,000 person-years of treatment (0.38% per year) and a number needed to harm of roughly 265 per year. For higher-risk subgroups, the number needed to harm decreased substantially, the authors note. The results were robust across several sensitivity analyses.

“We don’t know the mechanisms of the increased mortality risk, but cardiac and infectious causes are leading candidates,” said Gerhard.

“Our study in nonelderly adults with depression did not identify a single predominant cause of death. However, this may be a result of both the relatively small number of deaths in our study as well as of the well-recognized concerns regarding the accuracy of cause-of-death attribution in death certificates,” Gerhard said.

“As with the potential causes of death, the pathophysiological pathways involved are not well understood but could, among others, involve adverse metabolic effects, including weight gain, diabetes, dyslipidemia, QT prolongation, sedation, and falls – all of which have been associated with at least some of the newer antipsychotics,” he added.

The researchers state that atypical antipsychotics should be considered only “after non-response to evidence-based treatment options that are less risky.”
 

Another red flag

Commenting for Medscape Medical News, Timothy Sullivan, MD, chair of psychiatry and behavioral sciences at Northwell Health’s Staten Island University Hospital in New York, said this is a “valid contribution” and represents the second large study that “raises the same concern.”

“We’ve been probably underestimating the risk in administering them, and that’s something people really need to know, because if you’re prescribing it for someone with mild to moderate depression, it may be helpful, but is it really worth the risk if you’re significantly increasing their risk of death?” said Sullivan, who wasn’t involved in the study.

Clearly, he said, this “raises a flag that we have to look at this a little more carefully and be a little clearer with patients about the risk. One could argue that we should not be so quick to add these drugs, even though they could be helpful, before we exhaust other less potentially risky options.”

Sullivan’s advice: “Do the three trials of antidepressants, look at antidepressant combinations, don’t be quick to jump to this particular option, because of the concerns. Certainly there are situations like psychotic depression where the risk of use is outweighed by the benefits, given the clinical syndrome, but for less severe forms, we probably should reformulate some of our algorithms.”

The study was supported by the National Institute of Mental Health (NIMH). Gerhard received grants from the NIMH and the National Institute on Aging during the conduct of the study; grants and personal fees from Bristol-Myers Squibb; and personal fees from Eisai, Merck, Pfizer, Lilly, and IntraCellular Therapies outside the submitted work. Sullivan has disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

Adding a second-generation antipsychotic to an antidepressant to treat depression carries an increased mortality risk for middle-aged adults, results of a large, observational study show.

“Our study suggests physicians should consider prescribing antipsychotics to adults with depression carefully, as the potential health risks are substantial and the benefits are quite modest and controversially debated,” lead investigator Tobias Gerhard, PhD, Center for Pharmacoepidemiology and Treatment Science, Rutgers University, New Brunswick, N.J., said in a news release.

The results, he added, “emphasize the importance of considering newer antipsychotics only after nonresponse to less risky, evidence-based treatment options has been established.”

The study was published online September 30 in PLOS ONE.
 

A last resort

Previous research has demonstrated an increased mortality risk for elderly patients with dementia who take an atypical antipsychotic, but it’s unclear whether this risk occurs among nonelderly adults who use newer antipsychotics as augmentation treatment for depression.

To investigate, Gerhard and colleagues analyzed national healthcare claims from the Medicaid program from 2001 to 2010 for 39,582 Medicaid beneficiaries (mean age, 44.5 years; 78.5% women) who had been diagnosed with depression. Patients with alternative indications for antipsychotic therapy, such as schizophrenia, psychotic depression, or bipolar disorder, were excluded.

After at least 3 months of treatment with a single antidepressant, for more than half of the patients (56.6%), treatment was augmented with an atypical antipsychotic (quetiapine, risperidone, aripiprazole or olanzapine). For the remainder (43.4%), a second antidepressant was added.

The average chlorpromazine equivalent starting dose for all atypical antipsychotics was 68 mg/d. The dose was increased to 100 mg/d during follow-up.

A total of 153 patients died during 13,328 person-years of follow-up, including 105 for whom treatment was augmented with an atypical antipsychotic and 48 for whom treatment was augmented with a second antidepressant.

Compared to those who received a second antidepressant, among those for whom an antipsychotic was added, there was a 45% increased risk of dying during follow-up (adjusted hazard ratio, 1.45; 95% CI, 1.02 – 2.06).

This equates to an absolute risk difference of 37.7 deaths per 10,000 person-years of treatment (0.38% per year) and a number needed to harm of roughly 265 per year. For higher-risk subgroups, the number needed to harm decreased substantially, the authors note. The results were robust across several sensitivity analyses.

“We don’t know the mechanisms of the increased mortality risk, but cardiac and infectious causes are leading candidates,” said Gerhard.

“Our study in nonelderly adults with depression did not identify a single predominant cause of death. However, this may be a result of both the relatively small number of deaths in our study as well as of the well-recognized concerns regarding the accuracy of cause-of-death attribution in death certificates,” Gerhard said.

“As with the potential causes of death, the pathophysiological pathways involved are not well understood but could, among others, involve adverse metabolic effects, including weight gain, diabetes, dyslipidemia, QT prolongation, sedation, and falls – all of which have been associated with at least some of the newer antipsychotics,” he added.

The researchers state that atypical antipsychotics should be considered only “after non-response to evidence-based treatment options that are less risky.”
 

Another red flag

Commenting for Medscape Medical News, Timothy Sullivan, MD, chair of psychiatry and behavioral sciences at Northwell Health’s Staten Island University Hospital in New York, said this is a “valid contribution” and represents the second large study that “raises the same concern.”

“We’ve been probably underestimating the risk in administering them, and that’s something people really need to know, because if you’re prescribing it for someone with mild to moderate depression, it may be helpful, but is it really worth the risk if you’re significantly increasing their risk of death?” said Sullivan, who wasn’t involved in the study.

Clearly, he said, this “raises a flag that we have to look at this a little more carefully and be a little clearer with patients about the risk. One could argue that we should not be so quick to add these drugs, even though they could be helpful, before we exhaust other less potentially risky options.”

Sullivan’s advice: “Do the three trials of antidepressants, look at antidepressant combinations, don’t be quick to jump to this particular option, because of the concerns. Certainly there are situations like psychotic depression where the risk of use is outweighed by the benefits, given the clinical syndrome, but for less severe forms, we probably should reformulate some of our algorithms.”

The study was supported by the National Institute of Mental Health (NIMH). Gerhard received grants from the NIMH and the National Institute on Aging during the conduct of the study; grants and personal fees from Bristol-Myers Squibb; and personal fees from Eisai, Merck, Pfizer, Lilly, and IntraCellular Therapies outside the submitted work. Sullivan has disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

The Food and Drug Administration has approved 0.5% lotion formulation of ivermectin (Sklice) as an over-the-counter treatment for head lice infestation in patients aged 6 months and older.

Ivermectin was approved as a prescription treatment for head lice in February 2012, according to an FDA press release, and is now approved as an over-the-counter treatment through an “Rx-to-OTC” switch process. The approval was granted to Arbor Pharmaceuticals.

The expanded approval for ivermectin increases access to effective care for head lice, which is estimated to affect between 6 million and 12 million children each year in the United States, according to the Centers for Disease Control and Prevention.

“The Rx-to-OTC switch process aims to promote public health by increasing consumer access to drugs that would otherwise only be available by prescription,” Theresa Michele, MD, acting director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research, said in the press release.

The FDA also noted in the press release that “Sklice, and its active ingredient ivermectin, have not been shown to be safe or effective for the treatment or prevention of COVID-19 and they are not FDA-approved for this use.”

The drug is approved only for treating head lice, and should be used on the scalp and dry hair, according to the labeling. In the wake of the approval, ivermectin will no longer be available as a prescription drug, according to the FDA, and patients currently using prescription versions should contact their health care providers.

An Rx-to-OTC switch is contingent on the manufacturer’s data showing that the drug is safe and effective when used as directed. In addition, “the manufacturer must show that consumers can understand how to use the drug safely and effectively without the supervision of a health care professional,” according to the FDA.

The Food and Drug Administration has approved 0.5% lotion formulation of ivermectin (Sklice) as an over-the-counter treatment for head lice infestation in patients aged 6 months and older.

Ivermectin was approved as a prescription treatment for head lice in February 2012, according to an FDA press release, and is now approved as an over-the-counter treatment through an “Rx-to-OTC” switch process. The approval was granted to Arbor Pharmaceuticals.

The expanded approval for ivermectin increases access to effective care for head lice, which is estimated to affect between 6 million and 12 million children each year in the United States, according to the Centers for Disease Control and Prevention.

“The Rx-to-OTC switch process aims to promote public health by increasing consumer access to drugs that would otherwise only be available by prescription,” Theresa Michele, MD, acting director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research, said in the press release.

The FDA also noted in the press release that “Sklice, and its active ingredient ivermectin, have not been shown to be safe or effective for the treatment or prevention of COVID-19 and they are not FDA-approved for this use.”

The drug is approved only for treating head lice, and should be used on the scalp and dry hair, according to the labeling. In the wake of the approval, ivermectin will no longer be available as a prescription drug, according to the FDA, and patients currently using prescription versions should contact their health care providers.

An Rx-to-OTC switch is contingent on the manufacturer’s data showing that the drug is safe and effective when used as directed. In addition, “the manufacturer must show that consumers can understand how to use the drug safely and effectively without the supervision of a health care professional,” according to the FDA.

The Food and Drug Administration has approved 0.5% lotion formulation of ivermectin (Sklice) as an over-the-counter treatment for head lice infestation in patients aged 6 months and older.

Ivermectin was approved as a prescription treatment for head lice in February 2012, according to an FDA press release, and is now approved as an over-the-counter treatment through an “Rx-to-OTC” switch process. The approval was granted to Arbor Pharmaceuticals.

The expanded approval for ivermectin increases access to effective care for head lice, which is estimated to affect between 6 million and 12 million children each year in the United States, according to the Centers for Disease Control and Prevention.

“The Rx-to-OTC switch process aims to promote public health by increasing consumer access to drugs that would otherwise only be available by prescription,” Theresa Michele, MD, acting director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research, said in the press release.

The FDA also noted in the press release that “Sklice, and its active ingredient ivermectin, have not been shown to be safe or effective for the treatment or prevention of COVID-19 and they are not FDA-approved for this use.”

The drug is approved only for treating head lice, and should be used on the scalp and dry hair, according to the labeling. In the wake of the approval, ivermectin will no longer be available as a prescription drug, according to the FDA, and patients currently using prescription versions should contact their health care providers.

An Rx-to-OTC switch is contingent on the manufacturer’s data showing that the drug is safe and effective when used as directed. In addition, “the manufacturer must show that consumers can understand how to use the drug safely and effectively without the supervision of a health care professional,” according to the FDA.

Christopher Pribula, MD, a hospitalist at Sanford Broadway Medical Center in Fargo, N.D., didn’t anticipate becoming his hospital’s resident expert on COVID-19. Having just returned from vacation in March, he agreed to cover for a colleague on what would become the special care unit. “When our hospital medicine group decided that it would be the COVID unit, I just ran with it,” he said. Dr. Pribula spent the next 18 days doing 8- to 14-hour shifts and learning as much as he could as the hospital – and the nation – wrestled with the pandemic.

“Because I was the first hospitalist, along with our infectious disease specialist, Dr. Avish Nagpal, to really engage with the virus, people came to me with their questions,” Dr. Pribula said. Working to establish protocols for the care of COVID-19 patients involved a lot of planning, from nursing protocols to discharge planning.

Dr. Pribula was part of the hospital’s incident command structure, thought about how the system could scale up for a potential surge, and worked with the North Dakota Medical Association to reach out to outlying medical centers on safety and infection control. He even drew on his prior work experience as a medical technologist doing negative-pressure containment in a cell-processing facility to help create the hospital’s negative-pressure unit in an old ICU.

“We did a lot of communication from the start. To a certain extent we were making it up as we went along, but we sat down and huddled as a team every day at 9 and 4,” he explained. “We started out with observation and retrospective research, and learned piece by piece. But that’s how science works.”

Hospitalists across the country have played leading roles in their hospitals’ and health systems’ response to the pandemic, and not just because they are on the front lines providing patient care. Their job as doctors who work full-time in the hospital makes them natural leaders in improving clinical quality and hospital administrative protocols as well as studying the latest information and educating their colleagues. Responding to the pandemic has required lots of planning, careful attention to schedules and assignments and staff stress, and working with other departments in the hospital and groups in the community, including public health authorities.
 

Where is hospital treatment for COVID-19 at today?

As knowledge has grown, Dr. Pribula said, COVID-19 treatment in the hospital has come to incorporate remdesivir, a broad-spectrum antiviral; dexamethasone, a common steroid medication; and convalescent plasma, blood products from people who have recovered from the illness. “We went from no steroids to giving steroids. We went from putting patients on ventilators to avoid acute respiratory distress syndrome (ARDS) initially to now working to avoid intubation at all costs,” he said.

“What we found is that we need to pressure-support these patients. We do proning and CPAP while we let the lungs heal. By the time they arrive at the hospital, more often than not they’re on the backside of the viral load. But now we’re dealing with the body’s inflammatory response.”

Navneet Attri, MD, a hospitalist at Sutter Santa Rosa Regional Hospital in Santa Rosa, Calif., 50 miles north of San Francisco, experienced fears and uncertainties working at a hospital that treated early COVID patients from the Grand Princess cruise ship. Early on, she wrote a post describing her experience for The Hospitalist Leader, the Society of Hospital Medicine’s blog page.

Dr. Attri said she has gone through the gamut of emotions while caring for COVID-19 patients, addressing their fears and trying to support family members who aren’t allowed to enter the hospital to be at their loved one’s side. Sometimes, patient after patient with COVID-19 becomes almost too much. But seeing a lot of them in the intervening 6 months has increased her confidence level.

Understanding of how the disease is spread has continued to evolve, with a recent return to focusing on airborne transmission, she said. Frontline workers need N95 masks and eye shields, even if all of that PPE feels like a burden. Dr. Attri said she hardly notices the PPE anymore. “Putting it on is just a habit.”

She sits on Sonoma County’s COVID-19 surge planning group, which has representatives from the three local hospitals, the public health department, and other community agencies. “I report back to my hospitalist group about the situation in the community. Because our facilities were well prepared, our hospitals have not been overwhelmed,” she said.
 

The importance of teamwork

Sunil Shah, MD, a hospitalist with Northwell Health’s Southside Hospital in Bay Shore, N.Y., is part of the massive hospital medicine team, including reassigned specialists and volunteers from across the country, deployed at Northwell hospitals in Greater New York City and Long Island during the COVID-19 surge. Northwell probably has cared for more COVID-19 patients than any other health system in the country, and at the height of the surge the intensity of hospital care was like nothing he’s ever seen. But he also expressed gratitude that doctors from other parts of the country were willing to come and help out.

Southside Hospital went almost overnight from a 200-bed acute facility to a full, 350-bed, regional COVID-19–only hospital. “On busy days, our entire hospital was like a floating ICU,” he said. “You’d hear ‘rapid response’ or ‘code blue’ over the intercom every few seconds. Normally we’d have a designated rapid response person for the day, but with COVID, everybody stepped in to help – whoever was closest,” he said.

Majid Sheikh, MD, a hospitalist at Emory University Hospital in Atlanta, also became a go-to COVID-19 expert for his group. “I didn’t specifically volunteer, but my partner and I had the first cases, and the leadership group was happy to have us there,” he explained.

“One interesting thing I learned was the concept of the ‘happy’ hypoxemic patient, who is having a significant drop in oxygen saturation without developing any obvious signs of respiratory distress,” he said. “We’d be checking the accuracy of the reading and trying to figure out if it was real.” Emory was also one of the leaders in studying anticoagulant treatments for COVID-19 patients.

“Six months later I would say we’re definitely getting better outcomes on the floor, and our COVID patients aren’t landing in the ICU as easily,” Dr. Sheikh said. “It was scary at first, and doubly scary when doctors sometimes don’t feel they can say, ‘Hey, I’m scared too,’ or ‘By the way, I really don’t know what I’m doing.’ So, we’d be trying to reassure the patients when the information was coming to us in fragments.”

But he also believes that the pandemic has afforded hospitalists the opportunity to be the clinical detectives they were trained to be, sifting through clues. “I had to think more and really pay attention clinically in a much different way. You could say it was exciting and scary at the same time,” he said.
 

A human fix in the hospital

Dr. Pribula agreed that the pandemic has been both a difficult experience and a rewarding one. “I think of the people I first admitted. If they had shown up even a month later, would they still be with us?” He believes that his group and his field are going to get to a place where they have solid treatment plans for how to provide optimal care and how to protect providers from exposure.

One of the first COVID-19 patients in Fargo had dementia and was very distressed. “She had no idea why nobody was visiting or why we wouldn’t let her out of her room,” Dr. Pribula said. “Instead of reaching for sedatives, one of our nurses went into the room and talked with her, prayed a rosary, and played two hands of cards with her and didn’t have to sedate her. That’s what people need when they’re alone and scared. It wasn’t a medical fix but a human fix.”
 

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

Christopher Pribula, MD, a hospitalist at Sanford Broadway Medical Center in Fargo, N.D., didn’t anticipate becoming his hospital’s resident expert on COVID-19. Having just returned from vacation in March, he agreed to cover for a colleague on what would become the special care unit. “When our hospital medicine group decided that it would be the COVID unit, I just ran with it,” he said. Dr. Pribula spent the next 18 days doing 8- to 14-hour shifts and learning as much as he could as the hospital – and the nation – wrestled with the pandemic.

“Because I was the first hospitalist, along with our infectious disease specialist, Dr. Avish Nagpal, to really engage with the virus, people came to me with their questions,” Dr. Pribula said. Working to establish protocols for the care of COVID-19 patients involved a lot of planning, from nursing protocols to discharge planning.

Dr. Pribula was part of the hospital’s incident command structure, thought about how the system could scale up for a potential surge, and worked with the North Dakota Medical Association to reach out to outlying medical centers on safety and infection control. He even drew on his prior work experience as a medical technologist doing negative-pressure containment in a cell-processing facility to help create the hospital’s negative-pressure unit in an old ICU.

“We did a lot of communication from the start. To a certain extent we were making it up as we went along, but we sat down and huddled as a team every day at 9 and 4,” he explained. “We started out with observation and retrospective research, and learned piece by piece. But that’s how science works.”

Hospitalists across the country have played leading roles in their hospitals’ and health systems’ response to the pandemic, and not just because they are on the front lines providing patient care. Their job as doctors who work full-time in the hospital makes them natural leaders in improving clinical quality and hospital administrative protocols as well as studying the latest information and educating their colleagues. Responding to the pandemic has required lots of planning, careful attention to schedules and assignments and staff stress, and working with other departments in the hospital and groups in the community, including public health authorities.
 

Where is hospital treatment for COVID-19 at today?

As knowledge has grown, Dr. Pribula said, COVID-19 treatment in the hospital has come to incorporate remdesivir, a broad-spectrum antiviral; dexamethasone, a common steroid medication; and convalescent plasma, blood products from people who have recovered from the illness. “We went from no steroids to giving steroids. We went from putting patients on ventilators to avoid acute respiratory distress syndrome (ARDS) initially to now working to avoid intubation at all costs,” he said.

“What we found is that we need to pressure-support these patients. We do proning and CPAP while we let the lungs heal. By the time they arrive at the hospital, more often than not they’re on the backside of the viral load. But now we’re dealing with the body’s inflammatory response.”

Navneet Attri, MD, a hospitalist at Sutter Santa Rosa Regional Hospital in Santa Rosa, Calif., 50 miles north of San Francisco, experienced fears and uncertainties working at a hospital that treated early COVID patients from the Grand Princess cruise ship. Early on, she wrote a post describing her experience for The Hospitalist Leader, the Society of Hospital Medicine’s blog page.

Dr. Attri said she has gone through the gamut of emotions while caring for COVID-19 patients, addressing their fears and trying to support family members who aren’t allowed to enter the hospital to be at their loved one’s side. Sometimes, patient after patient with COVID-19 becomes almost too much. But seeing a lot of them in the intervening 6 months has increased her confidence level.

Understanding of how the disease is spread has continued to evolve, with a recent return to focusing on airborne transmission, she said. Frontline workers need N95 masks and eye shields, even if all of that PPE feels like a burden. Dr. Attri said she hardly notices the PPE anymore. “Putting it on is just a habit.”

She sits on Sonoma County’s COVID-19 surge planning group, which has representatives from the three local hospitals, the public health department, and other community agencies. “I report back to my hospitalist group about the situation in the community. Because our facilities were well prepared, our hospitals have not been overwhelmed,” she said.
 

The importance of teamwork

Sunil Shah, MD, a hospitalist with Northwell Health’s Southside Hospital in Bay Shore, N.Y., is part of the massive hospital medicine team, including reassigned specialists and volunteers from across the country, deployed at Northwell hospitals in Greater New York City and Long Island during the COVID-19 surge. Northwell probably has cared for more COVID-19 patients than any other health system in the country, and at the height of the surge the intensity of hospital care was like nothing he’s ever seen. But he also expressed gratitude that doctors from other parts of the country were willing to come and help out.

Southside Hospital went almost overnight from a 200-bed acute facility to a full, 350-bed, regional COVID-19–only hospital. “On busy days, our entire hospital was like a floating ICU,” he said. “You’d hear ‘rapid response’ or ‘code blue’ over the intercom every few seconds. Normally we’d have a designated rapid response person for the day, but with COVID, everybody stepped in to help – whoever was closest,” he said.

Majid Sheikh, MD, a hospitalist at Emory University Hospital in Atlanta, also became a go-to COVID-19 expert for his group. “I didn’t specifically volunteer, but my partner and I had the first cases, and the leadership group was happy to have us there,” he explained.

“One interesting thing I learned was the concept of the ‘happy’ hypoxemic patient, who is having a significant drop in oxygen saturation without developing any obvious signs of respiratory distress,” he said. “We’d be checking the accuracy of the reading and trying to figure out if it was real.” Emory was also one of the leaders in studying anticoagulant treatments for COVID-19 patients.

“Six months later I would say we’re definitely getting better outcomes on the floor, and our COVID patients aren’t landing in the ICU as easily,” Dr. Sheikh said. “It was scary at first, and doubly scary when doctors sometimes don’t feel they can say, ‘Hey, I’m scared too,’ or ‘By the way, I really don’t know what I’m doing.’ So, we’d be trying to reassure the patients when the information was coming to us in fragments.”

But he also believes that the pandemic has afforded hospitalists the opportunity to be the clinical detectives they were trained to be, sifting through clues. “I had to think more and really pay attention clinically in a much different way. You could say it was exciting and scary at the same time,” he said.
 

A human fix in the hospital

Dr. Pribula agreed that the pandemic has been both a difficult experience and a rewarding one. “I think of the people I first admitted. If they had shown up even a month later, would they still be with us?” He believes that his group and his field are going to get to a place where they have solid treatment plans for how to provide optimal care and how to protect providers from exposure.

One of the first COVID-19 patients in Fargo had dementia and was very distressed. “She had no idea why nobody was visiting or why we wouldn’t let her out of her room,” Dr. Pribula said. “Instead of reaching for sedatives, one of our nurses went into the room and talked with her, prayed a rosary, and played two hands of cards with her and didn’t have to sedate her. That’s what people need when they’re alone and scared. It wasn’t a medical fix but a human fix.”
 

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

Christopher Pribula, MD, a hospitalist at Sanford Broadway Medical Center in Fargo, N.D., didn’t anticipate becoming his hospital’s resident expert on COVID-19. Having just returned from vacation in March, he agreed to cover for a colleague on what would become the special care unit. “When our hospital medicine group decided that it would be the COVID unit, I just ran with it,” he said. Dr. Pribula spent the next 18 days doing 8- to 14-hour shifts and learning as much as he could as the hospital – and the nation – wrestled with the pandemic.

“Because I was the first hospitalist, along with our infectious disease specialist, Dr. Avish Nagpal, to really engage with the virus, people came to me with their questions,” Dr. Pribula said. Working to establish protocols for the care of COVID-19 patients involved a lot of planning, from nursing protocols to discharge planning.

Dr. Pribula was part of the hospital’s incident command structure, thought about how the system could scale up for a potential surge, and worked with the North Dakota Medical Association to reach out to outlying medical centers on safety and infection control. He even drew on his prior work experience as a medical technologist doing negative-pressure containment in a cell-processing facility to help create the hospital’s negative-pressure unit in an old ICU.

“We did a lot of communication from the start. To a certain extent we were making it up as we went along, but we sat down and huddled as a team every day at 9 and 4,” he explained. “We started out with observation and retrospective research, and learned piece by piece. But that’s how science works.”

Hospitalists across the country have played leading roles in their hospitals’ and health systems’ response to the pandemic, and not just because they are on the front lines providing patient care. Their job as doctors who work full-time in the hospital makes them natural leaders in improving clinical quality and hospital administrative protocols as well as studying the latest information and educating their colleagues. Responding to the pandemic has required lots of planning, careful attention to schedules and assignments and staff stress, and working with other departments in the hospital and groups in the community, including public health authorities.
 

Where is hospital treatment for COVID-19 at today?

As knowledge has grown, Dr. Pribula said, COVID-19 treatment in the hospital has come to incorporate remdesivir, a broad-spectrum antiviral; dexamethasone, a common steroid medication; and convalescent plasma, blood products from people who have recovered from the illness. “We went from no steroids to giving steroids. We went from putting patients on ventilators to avoid acute respiratory distress syndrome (ARDS) initially to now working to avoid intubation at all costs,” he said.

“What we found is that we need to pressure-support these patients. We do proning and CPAP while we let the lungs heal. By the time they arrive at the hospital, more often than not they’re on the backside of the viral load. But now we’re dealing with the body’s inflammatory response.”

Navneet Attri, MD, a hospitalist at Sutter Santa Rosa Regional Hospital in Santa Rosa, Calif., 50 miles north of San Francisco, experienced fears and uncertainties working at a hospital that treated early COVID patients from the Grand Princess cruise ship. Early on, she wrote a post describing her experience for The Hospitalist Leader, the Society of Hospital Medicine’s blog page.

Dr. Attri said she has gone through the gamut of emotions while caring for COVID-19 patients, addressing their fears and trying to support family members who aren’t allowed to enter the hospital to be at their loved one’s side. Sometimes, patient after patient with COVID-19 becomes almost too much. But seeing a lot of them in the intervening 6 months has increased her confidence level.

Understanding of how the disease is spread has continued to evolve, with a recent return to focusing on airborne transmission, she said. Frontline workers need N95 masks and eye shields, even if all of that PPE feels like a burden. Dr. Attri said she hardly notices the PPE anymore. “Putting it on is just a habit.”

She sits on Sonoma County’s COVID-19 surge planning group, which has representatives from the three local hospitals, the public health department, and other community agencies. “I report back to my hospitalist group about the situation in the community. Because our facilities were well prepared, our hospitals have not been overwhelmed,” she said.
 

The importance of teamwork

Sunil Shah, MD, a hospitalist with Northwell Health’s Southside Hospital in Bay Shore, N.Y., is part of the massive hospital medicine team, including reassigned specialists and volunteers from across the country, deployed at Northwell hospitals in Greater New York City and Long Island during the COVID-19 surge. Northwell probably has cared for more COVID-19 patients than any other health system in the country, and at the height of the surge the intensity of hospital care was like nothing he’s ever seen. But he also expressed gratitude that doctors from other parts of the country were willing to come and help out.

Southside Hospital went almost overnight from a 200-bed acute facility to a full, 350-bed, regional COVID-19–only hospital. “On busy days, our entire hospital was like a floating ICU,” he said. “You’d hear ‘rapid response’ or ‘code blue’ over the intercom every few seconds. Normally we’d have a designated rapid response person for the day, but with COVID, everybody stepped in to help – whoever was closest,” he said.

Majid Sheikh, MD, a hospitalist at Emory University Hospital in Atlanta, also became a go-to COVID-19 expert for his group. “I didn’t specifically volunteer, but my partner and I had the first cases, and the leadership group was happy to have us there,” he explained.

“One interesting thing I learned was the concept of the ‘happy’ hypoxemic patient, who is having a significant drop in oxygen saturation without developing any obvious signs of respiratory distress,” he said. “We’d be checking the accuracy of the reading and trying to figure out if it was real.” Emory was also one of the leaders in studying anticoagulant treatments for COVID-19 patients.

“Six months later I would say we’re definitely getting better outcomes on the floor, and our COVID patients aren’t landing in the ICU as easily,” Dr. Sheikh said. “It was scary at first, and doubly scary when doctors sometimes don’t feel they can say, ‘Hey, I’m scared too,’ or ‘By the way, I really don’t know what I’m doing.’ So, we’d be trying to reassure the patients when the information was coming to us in fragments.”

But he also believes that the pandemic has afforded hospitalists the opportunity to be the clinical detectives they were trained to be, sifting through clues. “I had to think more and really pay attention clinically in a much different way. You could say it was exciting and scary at the same time,” he said.
 

A human fix in the hospital

Dr. Pribula agreed that the pandemic has been both a difficult experience and a rewarding one. “I think of the people I first admitted. If they had shown up even a month later, would they still be with us?” He believes that his group and his field are going to get to a place where they have solid treatment plans for how to provide optimal care and how to protect providers from exposure.

One of the first COVID-19 patients in Fargo had dementia and was very distressed. “She had no idea why nobody was visiting or why we wouldn’t let her out of her room,” Dr. Pribula said. “Instead of reaching for sedatives, one of our nurses went into the room and talked with her, prayed a rosary, and played two hands of cards with her and didn’t have to sedate her. That’s what people need when they’re alone and scared. It wasn’t a medical fix but a human fix.”
 

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

Like most medical students, Kaitlyn Thomas’s education was abruptly interrupted by the pandemic. Her school, an osteopathic medicine institution in the Midwest, followed guidelines issued by the American Association of Medical Colleges in March, shifting lectures online and suspending activities in which students interacted with patients. But even as Ms. Thomas’s learning opportunities dwindled for the sake of safety, the costs kept piling up.

Instead of going home to live with her family, she stayed in her apartment near school – and kept paying rent – so she could be nearby for the two licensing exams she was scheduled to take 3 months later. Both tests were canceled 9 days before she was scheduled to take them, one without any notification. This meant she had to travel to two different testing sites in two different states. All told, she said, the whole thing cost her around $2,000.

Ms. Thomas’s experience isn’t rare. Across the country, medical students find themselves paying substantial costs for a medical education now greatly altered by the pandemic. Despite restrictions on time spent in hospitals, hands-on learning, social events, and access to libraries, gyms, study spaces, and instructors, the price of tuition hasn’t dropped but has remained the same or has even risen.

In response, students have become vocal about the return on their pricey investment. “Am I just going to end up doing most of my year online, and what does that look like for my future patients?” Ms. Thomas asked. “It really doesn’t feel like a time to be limiting education.”

Medical schools and administrators are scrambling to find creative solutions for safely educating students. No matter what those solutions may be, experts say, the pandemic has drawn fresh attention to enduring questions about how the cost of medical education compares to its value. Although many are frustrated, some see the potential for COVID to open new opportunities for lasting innovation. At the very least, the pandemic has sparked conversations about what matters most in terms of producing qualified physicians.

“While this is a challenging time, we will get through it, and we will continue to educate doctors, and we will get them through to practice,” says Robert Cain, president and CEO of the American Association of Colleges of Osteopathic Medicine. Many in the midst of training still have one lingering question: Is the price future doctors are now paying still worth it?
 

COVID’s “hidden costs” for students

Tom is a third-year student at an allopathic medicine institution in the Caribbean. He asked not to be fully identified here, owing to concern about possible backlash. In March, Tom was doing clinical rotations in New York City when his training was put on hold. He returned home to Connecticut and resumed working 60-80 hours a week as a paramedic. As much as 75% of that income went to pay for the New York City apartment he was no longer living in – an apartment that cost more than $2,000 a month – and for student loans that suddenly came due when his enrollment status changed.

Tom has been able to take some online courses through his school. But he still doesn’t know whether state licensing boards will accept them, how residency programs will view them, or whether he will eventually have to retake those online classes in person. At the end of September, he was allowed to return to the hospital but was relocated to Chicago and was forced to move on short notice.

Like many students, Tom has worried that the pandemic may prevent him from acquiring crucial elements for his residency applications, things like letters of recommendation or key experiences. That could delay his next stage of training, which would mean lost future income, increasing student loan interest, and lost work experience. “This could also mean the difference between getting a residency and being able to practice medicine and not being able to practice my intended specialty,” he said. “This is the real hidden cost we may have to deal with.”

International medical students hoping to practice in the United States face additional costs. Michelle Warncke earned her bachelor’s degree in America but went to the United Kingdom for her master’s and her medical degree, which she completed in 2019. She then moved to North Carolina with her husband and saved money to take the exams she needed for residency in the states. But her scheduled Step 2 CS exam was canceled because of the pandemic. Now, like hundreds or even thousands of other students, she said she is unable to apply for residency, even as her student loans collect interest. An active Facebook group of international medical graduates includes about 1,500 people with comparable dilemmas.

The path to becoming a physician carries a well-known price tag, one that is already quite high. Now, for many, that price is substantially increasing. “The only way I can actually keep my medical credentials up to date and passable, to be able to ever get a shot at a residency in the following years,” she said, “is to move to another country and work for less pay, pay for a visa, pay for my exams, pay for my language test, and wait and hope that I might be able to as an older graduate then be able to apply for residency.”
 

Scaling back the price of med school?

Questions about the economics of medical education aren’t new, says David Asch, MD, MBA, an internal medicine physician and executive director of the Center for Health Care Innovation at the University of Pennsylvania, Philadelphia. But the changes forced by COVID could lead to innovations that may finally better balance the financial scales.

Such innovations are necessary, many say, given how medical education costs have skyrocketed over the past half century. In the 1960s, 4 years of medical school cost about $40,000 in today’s dollars, Dr. Asch and colleagues wrote in a 2020 analysis, which they conducted before the pandemic began. By 2018, the price of a medical education in the United States had ballooned to about $300,000. About 75% of students were taking out loans. Upon graduating, the average debt was $200,000.

Medical school is expensive for many tangible reasons, Dr. Asch said. Schools must pay for curriculum, faculty, technology, textbooks, lab materials, facilities, administrators, and more. But policy changes could decrease those costs.

He says one idea would be for medical schools to join forces and give students access to the same basic lectures in the early years, delivered online by top-notch instructors. Students could then participate in on-campus programs that might only require 3 years to complete instead of 4. By demonstrating what can be done via online platforms, he said, the pandemic might pave the way to permanent changes that could reduce costs.

“I’m not trying to pick on biochemistry professors and medical schools, but how many do we need in the country?” Dr. Asch asked. “We’re all watching the same episode of Seinfeld. Why can’t we all watch the same episode of the Krebs cycle?” If all 190 or so medical schools in the United States shared such preclinical courses, he says, each would require a fraction of the current cost to produce. “We could save 99.5% of the cost. So why don’t we do that?”
 

Pandemic as opportunity

Although the price of medical education has yet to decrease, schools are working to leverage the pandemic to provide increased educational value.

This generation of physicians will not only have to cope with the fallout of this pandemic, they will be the ones responsible for confronting the next pandemic as well, says Donald Brady, MD, senior associate dean for health sciences education at Vanderbilt University, Nashville, Tenn. “They will be the leaders in the future who will better be able to know how to handle it [a pandemic] because they were able to watch it and be part of it safely in the current circumstance.”

As much as possible, Vanderbilt is using the pandemic as an opportunity. As soon as it became clear that students couldn’t be involved in certain hands-on training, instructors developed a course about pandemics that included lectures on ethics, global health, systemic racism, and other topics. It also included experiential components of pandemic management, such as opportunities to work with patients through telehealth.

Students say they feel that they are getting less for their money and that they are paying for experiences that are no longer available, such as hands-on patient contact and community events. However, Dr. Brady said, schools have had to account for new expenses, including various now-required technologies and transitioning to courses online.

Some challenges can’t be solved with money alone. Medical schools across the country are working together to ensure that they are still adequately preparing students. Vanderbilt participates in an AAMC group that meets regularly and is also one of 37 institutions involved in an American Medical Association Consortium (AACOM). These groups discuss challenges, strategies, and opportunities for optimizing medical education during the pandemic.

Some institutions have come up with creative solutions. Ohio University’s Heritage College of Osteopathic Medicine, in Athens, Ohio, in collaboration with the Ohio Department of Health, launched a 4-week rotation for third-year students that focuses on public health. Harvard Medical School, Boston, was one of several schools that allowed students to graduate early in the spring. “We’re constantly talking to our colleagues and friends,” Dr. Brady said. “We learn from each other. There’s a lot of sharing going on.”

Other organizations are also working to make sure students ultimately get what they are paying for: a high-quality education. As soon as the pandemic began, the AACOM organized four working groups to address how schools could better use technology to deliver curricula and how students could participate in public health efforts, among other topics. “For the students, the part they don’t see and can’t really be aware of is all the things that happen behind the scenes,” Mr. Cain said. “People were working really hard to make sure that their education was still delivered, and delivered in a way that was going to assure a good product at the end.”

Ultimately, that product will be held to a rigid standard, said Geoffrey Young, the AAMC’s senior director for student affairs and programs. Medical schools must still meet standards of competency set by the liaison committee on medical education. Mr. Young says that even now those standards remain rigorous enough to ensure that medical students are learning what they need to know. “The core elements for competency may be slightly altered to address the realities that we’re experiencing because of COVID, but the core tenants of competencies will not change,” he said.

Even as conversations continue about what a medical education is worth, the pandemic is drawing new attention to the profession. No signs suggest that the value of tuition or a shift to more virtual offerings are scaring students away. Applications for medical schools were up 17% for the fall of 2021.

Brady expects the surge in interest to continue. “The increased focus and emphasis on public health, the increased focus and emphasis on health equity, the increased focus on the need for a more diverse physician workforce, the interest in basic science research around viruses, the interest in COVID itself – there are a lot of different elements that are setting us up for a potential boom in applications to medical school,” he said.

Beyond increasing interest, the pandemic may also finally force a reckoning on the disconnection between how schools think about costs and how students think about value, Dr. Asch said. “When students say: ‘I’m not getting as much from this,’ they’re saying, ‘you should price this according to its lower value.’ And when the medical schools are saying: ‘Oh, but it’s costing us so much more,’ they’re talking about pricing according to the cost. It’s like one group is speaking Latin and the other group is speaking Greek.” Perhaps, he said, COVID-related changes will finally get them speaking the same language.

This article first appeared on Medscape.com.

Like most medical students, Kaitlyn Thomas’s education was abruptly interrupted by the pandemic. Her school, an osteopathic medicine institution in the Midwest, followed guidelines issued by the American Association of Medical Colleges in March, shifting lectures online and suspending activities in which students interacted with patients. But even as Ms. Thomas’s learning opportunities dwindled for the sake of safety, the costs kept piling up.

Instead of going home to live with her family, she stayed in her apartment near school – and kept paying rent – so she could be nearby for the two licensing exams she was scheduled to take 3 months later. Both tests were canceled 9 days before she was scheduled to take them, one without any notification. This meant she had to travel to two different testing sites in two different states. All told, she said, the whole thing cost her around $2,000.

Ms. Thomas’s experience isn’t rare. Across the country, medical students find themselves paying substantial costs for a medical education now greatly altered by the pandemic. Despite restrictions on time spent in hospitals, hands-on learning, social events, and access to libraries, gyms, study spaces, and instructors, the price of tuition hasn’t dropped but has remained the same or has even risen.

In response, students have become vocal about the return on their pricey investment. “Am I just going to end up doing most of my year online, and what does that look like for my future patients?” Ms. Thomas asked. “It really doesn’t feel like a time to be limiting education.”

Medical schools and administrators are scrambling to find creative solutions for safely educating students. No matter what those solutions may be, experts say, the pandemic has drawn fresh attention to enduring questions about how the cost of medical education compares to its value. Although many are frustrated, some see the potential for COVID to open new opportunities for lasting innovation. At the very least, the pandemic has sparked conversations about what matters most in terms of producing qualified physicians.

“While this is a challenging time, we will get through it, and we will continue to educate doctors, and we will get them through to practice,” says Robert Cain, president and CEO of the American Association of Colleges of Osteopathic Medicine. Many in the midst of training still have one lingering question: Is the price future doctors are now paying still worth it?
 

COVID’s “hidden costs” for students

Tom is a third-year student at an allopathic medicine institution in the Caribbean. He asked not to be fully identified here, owing to concern about possible backlash. In March, Tom was doing clinical rotations in New York City when his training was put on hold. He returned home to Connecticut and resumed working 60-80 hours a week as a paramedic. As much as 75% of that income went to pay for the New York City apartment he was no longer living in – an apartment that cost more than $2,000 a month – and for student loans that suddenly came due when his enrollment status changed.

Tom has been able to take some online courses through his school. But he still doesn’t know whether state licensing boards will accept them, how residency programs will view them, or whether he will eventually have to retake those online classes in person. At the end of September, he was allowed to return to the hospital but was relocated to Chicago and was forced to move on short notice.

Like many students, Tom has worried that the pandemic may prevent him from acquiring crucial elements for his residency applications, things like letters of recommendation or key experiences. That could delay his next stage of training, which would mean lost future income, increasing student loan interest, and lost work experience. “This could also mean the difference between getting a residency and being able to practice medicine and not being able to practice my intended specialty,” he said. “This is the real hidden cost we may have to deal with.”

International medical students hoping to practice in the United States face additional costs. Michelle Warncke earned her bachelor’s degree in America but went to the United Kingdom for her master’s and her medical degree, which she completed in 2019. She then moved to North Carolina with her husband and saved money to take the exams she needed for residency in the states. But her scheduled Step 2 CS exam was canceled because of the pandemic. Now, like hundreds or even thousands of other students, she said she is unable to apply for residency, even as her student loans collect interest. An active Facebook group of international medical graduates includes about 1,500 people with comparable dilemmas.

The path to becoming a physician carries a well-known price tag, one that is already quite high. Now, for many, that price is substantially increasing. “The only way I can actually keep my medical credentials up to date and passable, to be able to ever get a shot at a residency in the following years,” she said, “is to move to another country and work for less pay, pay for a visa, pay for my exams, pay for my language test, and wait and hope that I might be able to as an older graduate then be able to apply for residency.”
 

Scaling back the price of med school?

Questions about the economics of medical education aren’t new, says David Asch, MD, MBA, an internal medicine physician and executive director of the Center for Health Care Innovation at the University of Pennsylvania, Philadelphia. But the changes forced by COVID could lead to innovations that may finally better balance the financial scales.

Such innovations are necessary, many say, given how medical education costs have skyrocketed over the past half century. In the 1960s, 4 years of medical school cost about $40,000 in today’s dollars, Dr. Asch and colleagues wrote in a 2020 analysis, which they conducted before the pandemic began. By 2018, the price of a medical education in the United States had ballooned to about $300,000. About 75% of students were taking out loans. Upon graduating, the average debt was $200,000.

Medical school is expensive for many tangible reasons, Dr. Asch said. Schools must pay for curriculum, faculty, technology, textbooks, lab materials, facilities, administrators, and more. But policy changes could decrease those costs.

He says one idea would be for medical schools to join forces and give students access to the same basic lectures in the early years, delivered online by top-notch instructors. Students could then participate in on-campus programs that might only require 3 years to complete instead of 4. By demonstrating what can be done via online platforms, he said, the pandemic might pave the way to permanent changes that could reduce costs.

“I’m not trying to pick on biochemistry professors and medical schools, but how many do we need in the country?” Dr. Asch asked. “We’re all watching the same episode of Seinfeld. Why can’t we all watch the same episode of the Krebs cycle?” If all 190 or so medical schools in the United States shared such preclinical courses, he says, each would require a fraction of the current cost to produce. “We could save 99.5% of the cost. So why don’t we do that?”
 

Pandemic as opportunity

Although the price of medical education has yet to decrease, schools are working to leverage the pandemic to provide increased educational value.

This generation of physicians will not only have to cope with the fallout of this pandemic, they will be the ones responsible for confronting the next pandemic as well, says Donald Brady, MD, senior associate dean for health sciences education at Vanderbilt University, Nashville, Tenn. “They will be the leaders in the future who will better be able to know how to handle it [a pandemic] because they were able to watch it and be part of it safely in the current circumstance.”

As much as possible, Vanderbilt is using the pandemic as an opportunity. As soon as it became clear that students couldn’t be involved in certain hands-on training, instructors developed a course about pandemics that included lectures on ethics, global health, systemic racism, and other topics. It also included experiential components of pandemic management, such as opportunities to work with patients through telehealth.

Students say they feel that they are getting less for their money and that they are paying for experiences that are no longer available, such as hands-on patient contact and community events. However, Dr. Brady said, schools have had to account for new expenses, including various now-required technologies and transitioning to courses online.

Some challenges can’t be solved with money alone. Medical schools across the country are working together to ensure that they are still adequately preparing students. Vanderbilt participates in an AAMC group that meets regularly and is also one of 37 institutions involved in an American Medical Association Consortium (AACOM). These groups discuss challenges, strategies, and opportunities for optimizing medical education during the pandemic.

Some institutions have come up with creative solutions. Ohio University’s Heritage College of Osteopathic Medicine, in Athens, Ohio, in collaboration with the Ohio Department of Health, launched a 4-week rotation for third-year students that focuses on public health. Harvard Medical School, Boston, was one of several schools that allowed students to graduate early in the spring. “We’re constantly talking to our colleagues and friends,” Dr. Brady said. “We learn from each other. There’s a lot of sharing going on.”

Other organizations are also working to make sure students ultimately get what they are paying for: a high-quality education. As soon as the pandemic began, the AACOM organized four working groups to address how schools could better use technology to deliver curricula and how students could participate in public health efforts, among other topics. “For the students, the part they don’t see and can’t really be aware of is all the things that happen behind the scenes,” Mr. Cain said. “People were working really hard to make sure that their education was still delivered, and delivered in a way that was going to assure a good product at the end.”

Ultimately, that product will be held to a rigid standard, said Geoffrey Young, the AAMC’s senior director for student affairs and programs. Medical schools must still meet standards of competency set by the liaison committee on medical education. Mr. Young says that even now those standards remain rigorous enough to ensure that medical students are learning what they need to know. “The core elements for competency may be slightly altered to address the realities that we’re experiencing because of COVID, but the core tenants of competencies will not change,” he said.

Even as conversations continue about what a medical education is worth, the pandemic is drawing new attention to the profession. No signs suggest that the value of tuition or a shift to more virtual offerings are scaring students away. Applications for medical schools were up 17% for the fall of 2021.

Brady expects the surge in interest to continue. “The increased focus and emphasis on public health, the increased focus and emphasis on health equity, the increased focus on the need for a more diverse physician workforce, the interest in basic science research around viruses, the interest in COVID itself – there are a lot of different elements that are setting us up for a potential boom in applications to medical school,” he said.

Beyond increasing interest, the pandemic may also finally force a reckoning on the disconnection between how schools think about costs and how students think about value, Dr. Asch said. “When students say: ‘I’m not getting as much from this,’ they’re saying, ‘you should price this according to its lower value.’ And when the medical schools are saying: ‘Oh, but it’s costing us so much more,’ they’re talking about pricing according to the cost. It’s like one group is speaking Latin and the other group is speaking Greek.” Perhaps, he said, COVID-related changes will finally get them speaking the same language.

This article first appeared on Medscape.com.

Like most medical students, Kaitlyn Thomas’s education was abruptly interrupted by the pandemic. Her school, an osteopathic medicine institution in the Midwest, followed guidelines issued by the American Association of Medical Colleges in March, shifting lectures online and suspending activities in which students interacted with patients. But even as Ms. Thomas’s learning opportunities dwindled for the sake of safety, the costs kept piling up.

Instead of going home to live with her family, she stayed in her apartment near school – and kept paying rent – so she could be nearby for the two licensing exams she was scheduled to take 3 months later. Both tests were canceled 9 days before she was scheduled to take them, one without any notification. This meant she had to travel to two different testing sites in two different states. All told, she said, the whole thing cost her around $2,000.

Ms. Thomas’s experience isn’t rare. Across the country, medical students find themselves paying substantial costs for a medical education now greatly altered by the pandemic. Despite restrictions on time spent in hospitals, hands-on learning, social events, and access to libraries, gyms, study spaces, and instructors, the price of tuition hasn’t dropped but has remained the same or has even risen.

In response, students have become vocal about the return on their pricey investment. “Am I just going to end up doing most of my year online, and what does that look like for my future patients?” Ms. Thomas asked. “It really doesn’t feel like a time to be limiting education.”

Medical schools and administrators are scrambling to find creative solutions for safely educating students. No matter what those solutions may be, experts say, the pandemic has drawn fresh attention to enduring questions about how the cost of medical education compares to its value. Although many are frustrated, some see the potential for COVID to open new opportunities for lasting innovation. At the very least, the pandemic has sparked conversations about what matters most in terms of producing qualified physicians.

“While this is a challenging time, we will get through it, and we will continue to educate doctors, and we will get them through to practice,” says Robert Cain, president and CEO of the American Association of Colleges of Osteopathic Medicine. Many in the midst of training still have one lingering question: Is the price future doctors are now paying still worth it?
 

COVID’s “hidden costs” for students

Tom is a third-year student at an allopathic medicine institution in the Caribbean. He asked not to be fully identified here, owing to concern about possible backlash. In March, Tom was doing clinical rotations in New York City when his training was put on hold. He returned home to Connecticut and resumed working 60-80 hours a week as a paramedic. As much as 75% of that income went to pay for the New York City apartment he was no longer living in – an apartment that cost more than $2,000 a month – and for student loans that suddenly came due when his enrollment status changed.

Tom has been able to take some online courses through his school. But he still doesn’t know whether state licensing boards will accept them, how residency programs will view them, or whether he will eventually have to retake those online classes in person. At the end of September, he was allowed to return to the hospital but was relocated to Chicago and was forced to move on short notice.

Like many students, Tom has worried that the pandemic may prevent him from acquiring crucial elements for his residency applications, things like letters of recommendation or key experiences. That could delay his next stage of training, which would mean lost future income, increasing student loan interest, and lost work experience. “This could also mean the difference between getting a residency and being able to practice medicine and not being able to practice my intended specialty,” he said. “This is the real hidden cost we may have to deal with.”

International medical students hoping to practice in the United States face additional costs. Michelle Warncke earned her bachelor’s degree in America but went to the United Kingdom for her master’s and her medical degree, which she completed in 2019. She then moved to North Carolina with her husband and saved money to take the exams she needed for residency in the states. But her scheduled Step 2 CS exam was canceled because of the pandemic. Now, like hundreds or even thousands of other students, she said she is unable to apply for residency, even as her student loans collect interest. An active Facebook group of international medical graduates includes about 1,500 people with comparable dilemmas.

The path to becoming a physician carries a well-known price tag, one that is already quite high. Now, for many, that price is substantially increasing. “The only way I can actually keep my medical credentials up to date and passable, to be able to ever get a shot at a residency in the following years,” she said, “is to move to another country and work for less pay, pay for a visa, pay for my exams, pay for my language test, and wait and hope that I might be able to as an older graduate then be able to apply for residency.”
 

Scaling back the price of med school?

Questions about the economics of medical education aren’t new, says David Asch, MD, MBA, an internal medicine physician and executive director of the Center for Health Care Innovation at the University of Pennsylvania, Philadelphia. But the changes forced by COVID could lead to innovations that may finally better balance the financial scales.

Such innovations are necessary, many say, given how medical education costs have skyrocketed over the past half century. In the 1960s, 4 years of medical school cost about $40,000 in today’s dollars, Dr. Asch and colleagues wrote in a 2020 analysis, which they conducted before the pandemic began. By 2018, the price of a medical education in the United States had ballooned to about $300,000. About 75% of students were taking out loans. Upon graduating, the average debt was $200,000.

Medical school is expensive for many tangible reasons, Dr. Asch said. Schools must pay for curriculum, faculty, technology, textbooks, lab materials, facilities, administrators, and more. But policy changes could decrease those costs.

He says one idea would be for medical schools to join forces and give students access to the same basic lectures in the early years, delivered online by top-notch instructors. Students could then participate in on-campus programs that might only require 3 years to complete instead of 4. By demonstrating what can be done via online platforms, he said, the pandemic might pave the way to permanent changes that could reduce costs.

“I’m not trying to pick on biochemistry professors and medical schools, but how many do we need in the country?” Dr. Asch asked. “We’re all watching the same episode of Seinfeld. Why can’t we all watch the same episode of the Krebs cycle?” If all 190 or so medical schools in the United States shared such preclinical courses, he says, each would require a fraction of the current cost to produce. “We could save 99.5% of the cost. So why don’t we do that?”
 

Pandemic as opportunity

Although the price of medical education has yet to decrease, schools are working to leverage the pandemic to provide increased educational value.

This generation of physicians will not only have to cope with the fallout of this pandemic, they will be the ones responsible for confronting the next pandemic as well, says Donald Brady, MD, senior associate dean for health sciences education at Vanderbilt University, Nashville, Tenn. “They will be the leaders in the future who will better be able to know how to handle it [a pandemic] because they were able to watch it and be part of it safely in the current circumstance.”

As much as possible, Vanderbilt is using the pandemic as an opportunity. As soon as it became clear that students couldn’t be involved in certain hands-on training, instructors developed a course about pandemics that included lectures on ethics, global health, systemic racism, and other topics. It also included experiential components of pandemic management, such as opportunities to work with patients through telehealth.

Students say they feel that they are getting less for their money and that they are paying for experiences that are no longer available, such as hands-on patient contact and community events. However, Dr. Brady said, schools have had to account for new expenses, including various now-required technologies and transitioning to courses online.

Some challenges can’t be solved with money alone. Medical schools across the country are working together to ensure that they are still adequately preparing students. Vanderbilt participates in an AAMC group that meets regularly and is also one of 37 institutions involved in an American Medical Association Consortium (AACOM). These groups discuss challenges, strategies, and opportunities for optimizing medical education during the pandemic.

Some institutions have come up with creative solutions. Ohio University’s Heritage College of Osteopathic Medicine, in Athens, Ohio, in collaboration with the Ohio Department of Health, launched a 4-week rotation for third-year students that focuses on public health. Harvard Medical School, Boston, was one of several schools that allowed students to graduate early in the spring. “We’re constantly talking to our colleagues and friends,” Dr. Brady said. “We learn from each other. There’s a lot of sharing going on.”

Other organizations are also working to make sure students ultimately get what they are paying for: a high-quality education. As soon as the pandemic began, the AACOM organized four working groups to address how schools could better use technology to deliver curricula and how students could participate in public health efforts, among other topics. “For the students, the part they don’t see and can’t really be aware of is all the things that happen behind the scenes,” Mr. Cain said. “People were working really hard to make sure that their education was still delivered, and delivered in a way that was going to assure a good product at the end.”

Ultimately, that product will be held to a rigid standard, said Geoffrey Young, the AAMC’s senior director for student affairs and programs. Medical schools must still meet standards of competency set by the liaison committee on medical education. Mr. Young says that even now those standards remain rigorous enough to ensure that medical students are learning what they need to know. “The core elements for competency may be slightly altered to address the realities that we’re experiencing because of COVID, but the core tenants of competencies will not change,” he said.

Even as conversations continue about what a medical education is worth, the pandemic is drawing new attention to the profession. No signs suggest that the value of tuition or a shift to more virtual offerings are scaring students away. Applications for medical schools were up 17% for the fall of 2021.

Brady expects the surge in interest to continue. “The increased focus and emphasis on public health, the increased focus and emphasis on health equity, the increased focus on the need for a more diverse physician workforce, the interest in basic science research around viruses, the interest in COVID itself – there are a lot of different elements that are setting us up for a potential boom in applications to medical school,” he said.

Beyond increasing interest, the pandemic may also finally force a reckoning on the disconnection between how schools think about costs and how students think about value, Dr. Asch said. “When students say: ‘I’m not getting as much from this,’ they’re saying, ‘you should price this according to its lower value.’ And when the medical schools are saying: ‘Oh, but it’s costing us so much more,’ they’re talking about pricing according to the cost. It’s like one group is speaking Latin and the other group is speaking Greek.” Perhaps, he said, COVID-related changes will finally get them speaking the same language.

This article first appeared on Medscape.com.

Two COVID-19 antibody treatments, one developed by Regeneron and the other by Eli Lilly, show promise in the outpatient setting in results released on Oct. 28.

Regeneron, in a randomized, double-blind trial, is assessing the effect of adding its investigational antibody cocktail REGN-COV2 to usual standard of care in comparison with adding placebo to standard of care. A descriptive analysis from the first 275 patients was previously reported. The data described on Oct. 28, which involve an additional 524 patients, show that the trial met all of the first nine endpoints.

Regeneron announced prospective results from its phase 2/3 trial showing REGN-COV2 significantly reduced viral load and patient medical visits, which included hospitalizations, visits to an emergency department, visits for urgent care, and/or physician office/telemedicine visits.

Interest in the cocktail spiked after President Donald Trump extolled its benefits after it was used in his own COVID-19 treatment earlier in October.

Trump received the highest dose of the drug, 8 g, but, according to a Regeneron news release announcing the latest findings, “results showed no significant difference in virologic or clinical efficacy between the REGN-COV2 high dose (8 grams) and low dose (2.4 grams).”

The company described further results of the industry-funded study in the release: “On the primary endpoint, the average daily change in viral load through day 7 (mean time-weighted average change from baseline) in patients with high viral load (defined as greater than107 copies/mL) was a 0.68 log10 copies/mL greater reduction with REGN-COV2 compared to placebo (combined dose groups; P < .0001). There was a 1.08 log greater reduction with REGN-COV2 treatment by day 5, which corresponds to REGN-COV2 patients having, on average, a greater than 10-fold reduction in viral load, compared to placebo.”

The treatment appears to be most effective in patients most at risk, whether because of high viral load, ineffective baseline antibody immune response, or preexisting conditions, according to the researchers.

According to the press release, these results have not been peer reviewed but have been submitted to the US Food and Drug Administration, which is reviewing a potential emergency use authorization for the treatment in high-risk adults with mild to moderate COVID-19.

Operation Warp Speed, the Trump administration’s treatment and vaccine program, contracted in July with Regeneron for up to 300,000 doses of its antibody cocktail.
 

Lilly treatment shows drop in hospitalizations, symptoms

Another treatment, also given in the outpatient setting, shows promise as well.

Patients recently diagnosed with mild to moderate COVID-19 who received Eli Lilly’s antibody treatment LY-CoV555 had fewer hospitalizations and symptoms compared with a group that received placebo, an interim analysis of a phase 2 trial indicates.

Peter Chen, MD, with the Department of Medicine, Women’s Guild Lung Institute at Cedars-Sinai Medical Center, Los Angeles, California, and colleagues found that the most profound effects were in the high-risk groups.

The interim findings of the BLAZE-1 study, which was funded by Eli Lilly, were published online October 28 in The New England Journal of Medicine.

Researchers randomly assigned 452 patients to receive an intravenous infusion of LY-CoV555 in one of three doses (700 mg, 2800 mg, or 7000 mg) or placebo.

In the interim analysis, the researchers found that for the entire population, more than 99.97% of viral RNA was eliminated.

For patients who received the 2800-mg dose, the difference from placebo in the decrease from baseline was −0.53 (95% CI, −0.98 to −0.08; P = .02), for a log viral load that was lower by a factor of 3.4. Benefit over placebo was not significant with the other doses.

At day 29, according to the investigators, the percentage of patients hospitalized with COVID-19 was 1.6% (5 of 309 patients) in the treatment group compared with 6.3% (9 of 143 patients) in the placebo group.

Data indicate that the safety profile was similar whether patients received the active treatment or placebo.

“If these results are confirmed in additional analyses in this trial, LY-CoV555 could become a useful treatment for emergency use in patients with recently diagnosed Covid-19,” the authors write.

Deborah Fuller, PhD, professor in the Department of Microbiology at the University of Washington School of Medicine in Seattle, told Medscape Medical News the findings are «exciting» but only part of the treatment solution.

“What’s remarkable about these two studies and others I’ve seen,” she said, “is how consistent they are in terms of the window of time they will be effective, and that’s because they are just targeting the virus itself. They do not have an effect on the inflammation unless they stop the replication early enough.”

The treatments are effective when they are given near the time of diagnosis, she pointed out.

“Once the virus has started that inflammatory cascade in your body, then that train has left the station and you have to deal with the inflammation,” Fuller said.

She says future treatments will likely have to include both the antiviral and anti-inflammatory properties, and physicians will have to assess what’s best, given the stage of the the patient’s disease.

The trial of REGN-COV2 is funded by Regeneron. The BLAZE-1 study is funded by Eli Lilly. Many of the authors have financial ties to Eli Lilly. Fuller has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Two COVID-19 antibody treatments, one developed by Regeneron and the other by Eli Lilly, show promise in the outpatient setting in results released on Oct. 28.

Regeneron, in a randomized, double-blind trial, is assessing the effect of adding its investigational antibody cocktail REGN-COV2 to usual standard of care in comparison with adding placebo to standard of care. A descriptive analysis from the first 275 patients was previously reported. The data described on Oct. 28, which involve an additional 524 patients, show that the trial met all of the first nine endpoints.

Regeneron announced prospective results from its phase 2/3 trial showing REGN-COV2 significantly reduced viral load and patient medical visits, which included hospitalizations, visits to an emergency department, visits for urgent care, and/or physician office/telemedicine visits.

Interest in the cocktail spiked after President Donald Trump extolled its benefits after it was used in his own COVID-19 treatment earlier in October.

Trump received the highest dose of the drug, 8 g, but, according to a Regeneron news release announcing the latest findings, “results showed no significant difference in virologic or clinical efficacy between the REGN-COV2 high dose (8 grams) and low dose (2.4 grams).”

The company described further results of the industry-funded study in the release: “On the primary endpoint, the average daily change in viral load through day 7 (mean time-weighted average change from baseline) in patients with high viral load (defined as greater than107 copies/mL) was a 0.68 log10 copies/mL greater reduction with REGN-COV2 compared to placebo (combined dose groups; P < .0001). There was a 1.08 log greater reduction with REGN-COV2 treatment by day 5, which corresponds to REGN-COV2 patients having, on average, a greater than 10-fold reduction in viral load, compared to placebo.”

The treatment appears to be most effective in patients most at risk, whether because of high viral load, ineffective baseline antibody immune response, or preexisting conditions, according to the researchers.

According to the press release, these results have not been peer reviewed but have been submitted to the US Food and Drug Administration, which is reviewing a potential emergency use authorization for the treatment in high-risk adults with mild to moderate COVID-19.

Operation Warp Speed, the Trump administration’s treatment and vaccine program, contracted in July with Regeneron for up to 300,000 doses of its antibody cocktail.
 

Lilly treatment shows drop in hospitalizations, symptoms

Another treatment, also given in the outpatient setting, shows promise as well.

Patients recently diagnosed with mild to moderate COVID-19 who received Eli Lilly’s antibody treatment LY-CoV555 had fewer hospitalizations and symptoms compared with a group that received placebo, an interim analysis of a phase 2 trial indicates.

Peter Chen, MD, with the Department of Medicine, Women’s Guild Lung Institute at Cedars-Sinai Medical Center, Los Angeles, California, and colleagues found that the most profound effects were in the high-risk groups.

The interim findings of the BLAZE-1 study, which was funded by Eli Lilly, were published online October 28 in The New England Journal of Medicine.

Researchers randomly assigned 452 patients to receive an intravenous infusion of LY-CoV555 in one of three doses (700 mg, 2800 mg, or 7000 mg) or placebo.

In the interim analysis, the researchers found that for the entire population, more than 99.97% of viral RNA was eliminated.

For patients who received the 2800-mg dose, the difference from placebo in the decrease from baseline was −0.53 (95% CI, −0.98 to −0.08; P = .02), for a log viral load that was lower by a factor of 3.4. Benefit over placebo was not significant with the other doses.

At day 29, according to the investigators, the percentage of patients hospitalized with COVID-19 was 1.6% (5 of 309 patients) in the treatment group compared with 6.3% (9 of 143 patients) in the placebo group.

Data indicate that the safety profile was similar whether patients received the active treatment or placebo.

“If these results are confirmed in additional analyses in this trial, LY-CoV555 could become a useful treatment for emergency use in patients with recently diagnosed Covid-19,” the authors write.

Deborah Fuller, PhD, professor in the Department of Microbiology at the University of Washington School of Medicine in Seattle, told Medscape Medical News the findings are «exciting» but only part of the treatment solution.

“What’s remarkable about these two studies and others I’ve seen,” she said, “is how consistent they are in terms of the window of time they will be effective, and that’s because they are just targeting the virus itself. They do not have an effect on the inflammation unless they stop the replication early enough.”

The treatments are effective when they are given near the time of diagnosis, she pointed out.

“Once the virus has started that inflammatory cascade in your body, then that train has left the station and you have to deal with the inflammation,” Fuller said.

She says future treatments will likely have to include both the antiviral and anti-inflammatory properties, and physicians will have to assess what’s best, given the stage of the the patient’s disease.

The trial of REGN-COV2 is funded by Regeneron. The BLAZE-1 study is funded by Eli Lilly. Many of the authors have financial ties to Eli Lilly. Fuller has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Two COVID-19 antibody treatments, one developed by Regeneron and the other by Eli Lilly, show promise in the outpatient setting in results released on Oct. 28.

Regeneron, in a randomized, double-blind trial, is assessing the effect of adding its investigational antibody cocktail REGN-COV2 to usual standard of care in comparison with adding placebo to standard of care. A descriptive analysis from the first 275 patients was previously reported. The data described on Oct. 28, which involve an additional 524 patients, show that the trial met all of the first nine endpoints.

Regeneron announced prospective results from its phase 2/3 trial showing REGN-COV2 significantly reduced viral load and patient medical visits, which included hospitalizations, visits to an emergency department, visits for urgent care, and/or physician office/telemedicine visits.

Interest in the cocktail spiked after President Donald Trump extolled its benefits after it was used in his own COVID-19 treatment earlier in October.

Trump received the highest dose of the drug, 8 g, but, according to a Regeneron news release announcing the latest findings, “results showed no significant difference in virologic or clinical efficacy between the REGN-COV2 high dose (8 grams) and low dose (2.4 grams).”

The company described further results of the industry-funded study in the release: “On the primary endpoint, the average daily change in viral load through day 7 (mean time-weighted average change from baseline) in patients with high viral load (defined as greater than107 copies/mL) was a 0.68 log10 copies/mL greater reduction with REGN-COV2 compared to placebo (combined dose groups; P < .0001). There was a 1.08 log greater reduction with REGN-COV2 treatment by day 5, which corresponds to REGN-COV2 patients having, on average, a greater than 10-fold reduction in viral load, compared to placebo.”

The treatment appears to be most effective in patients most at risk, whether because of high viral load, ineffective baseline antibody immune response, or preexisting conditions, according to the researchers.

According to the press release, these results have not been peer reviewed but have been submitted to the US Food and Drug Administration, which is reviewing a potential emergency use authorization for the treatment in high-risk adults with mild to moderate COVID-19.

Operation Warp Speed, the Trump administration’s treatment and vaccine program, contracted in July with Regeneron for up to 300,000 doses of its antibody cocktail.
 

Lilly treatment shows drop in hospitalizations, symptoms

Another treatment, also given in the outpatient setting, shows promise as well.

Patients recently diagnosed with mild to moderate COVID-19 who received Eli Lilly’s antibody treatment LY-CoV555 had fewer hospitalizations and symptoms compared with a group that received placebo, an interim analysis of a phase 2 trial indicates.

Peter Chen, MD, with the Department of Medicine, Women’s Guild Lung Institute at Cedars-Sinai Medical Center, Los Angeles, California, and colleagues found that the most profound effects were in the high-risk groups.

The interim findings of the BLAZE-1 study, which was funded by Eli Lilly, were published online October 28 in The New England Journal of Medicine.

Researchers randomly assigned 452 patients to receive an intravenous infusion of LY-CoV555 in one of three doses (700 mg, 2800 mg, or 7000 mg) or placebo.

In the interim analysis, the researchers found that for the entire population, more than 99.97% of viral RNA was eliminated.

For patients who received the 2800-mg dose, the difference from placebo in the decrease from baseline was −0.53 (95% CI, −0.98 to −0.08; P = .02), for a log viral load that was lower by a factor of 3.4. Benefit over placebo was not significant with the other doses.

At day 29, according to the investigators, the percentage of patients hospitalized with COVID-19 was 1.6% (5 of 309 patients) in the treatment group compared with 6.3% (9 of 143 patients) in the placebo group.

Data indicate that the safety profile was similar whether patients received the active treatment or placebo.

“If these results are confirmed in additional analyses in this trial, LY-CoV555 could become a useful treatment for emergency use in patients with recently diagnosed Covid-19,” the authors write.

Deborah Fuller, PhD, professor in the Department of Microbiology at the University of Washington School of Medicine in Seattle, told Medscape Medical News the findings are «exciting» but only part of the treatment solution.

“What’s remarkable about these two studies and others I’ve seen,” she said, “is how consistent they are in terms of the window of time they will be effective, and that’s because they are just targeting the virus itself. They do not have an effect on the inflammation unless they stop the replication early enough.”

The treatments are effective when they are given near the time of diagnosis, she pointed out.

“Once the virus has started that inflammatory cascade in your body, then that train has left the station and you have to deal with the inflammation,” Fuller said.

She says future treatments will likely have to include both the antiviral and anti-inflammatory properties, and physicians will have to assess what’s best, given the stage of the the patient’s disease.

The trial of REGN-COV2 is funded by Regeneron. The BLAZE-1 study is funded by Eli Lilly. Many of the authors have financial ties to Eli Lilly. Fuller has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A small subset of SARS-CoV-2 patients with “COVID toes” can be categorized as COVID-19 long-haulers, with skin symptoms sometimes enduring for more than 150 days, a new analysis revealed.

Evaluating data from an international registry of COVID-19 patients with dermatologic symptoms, researchers found that retiform purpura rashes are linked to severe COVID-19, with 100% of these patients requiring hospitalization and 82% experiencing acute respiratory distress syndrome (ARDS).

Meanwhile, pernio/chilblains rashes, dubbed “COVID toes,” are associated with milder disease and a 16% hospitalization rate. For all COVID-19–related skin symptoms, the average duration is 12 days.

“The skin is another organ system that we didn’t know could have long COVID” effects, said principal investigator Esther Freeman, MD, PhD, of the department of dermatology, Massachusetts General Hospital, Boston.

“The skin is really a window into how the body is working overall, so the fact that we could visually see persistent inflammation in long-hauler patients is particularly fascinating and gives us a chance to explore what’s going on,” Dr. Freeman said in an interview. “It certainly makes sense to me, knowing what we know about other organ systems, that there might be some long-lasting inflammation” in the skin as well.

The study is a result of the collaboration between the American Academy of Dermatology and the International League of Dermatological Societies, the international registry launched this past April. While the study included provider-supplied data from 990 cases spanning 39 countries, the registry now encompasses more than 1,000 patients from 41 countries, Dr. Freeman noted.

Dr. Freeman presented the data at the annual congress of the European Academy of Dermatology and Venereology.

Many studies have reported dermatologic effects of COVID-19 infection, but information was lacking about duration. The registry represents the largest dataset to date detailing these persistent skin symptoms and offers insight about how COVID-19 can affect many different organ systems even after patients recover from acute infection, Dr. Freeman said.

Eight different types of skin rashes were noted in the study group, of which 303 were lab-confirmed or suspected COVID-19 patients with skin symptoms. Of those, 224 total cases and 90 lab-confirmed cases included information on how long skin symptoms lasted. Lab tests for SARS-CoV-2 included polymerase chain reaction and serum antibody assays.

Dr. Freeman and associates defined “long-haulers” as patients with dermatologic symptoms of COVID-19 lasting 60 days or longer. These “outliers” are likely more prevalent than the registry suggests, she said, since not all providers initially reporting skin symptoms in patients updated that information over time.

“It’s important to understand that the registry is probably significantly underreporting the duration of symptoms and number of long-hauler patients,” she explained. “A registry is often a glimpse into a moment in time to these patients. To combat that, we followed up by email twice with providers to ask if patients’ symptoms were still ongoing or completed.”

Results showed a wide spectrum in average duration of symptoms among lab-confirmed COVID-19 patients, depending on specific rash. Urticaria lasted for a median of 4 days; morbilliform eruptions, 7 days; pernio/chilblains, 10 days; and papulosquamous eruptions, 20 days, with one long-hauler case lasting 70 days.

Five patients with pernio/chilblains were long-haulers, with toe symptoms enduring 60 days or longer. Only one went beyond 133 days with severe pernio and fatigue.

“The fact that we’re not necessarily seeing these long-hauler symptoms across every type of skin rash makes sense,” Dr. Freeman said. “Hives, for example, usually comes on acutely and leaves pretty rapidly. There are no reports of long-hauler hives.”

“That we’re really seeing these long-hauler symptoms in certain skin rashes really suggests that there’s a certain pathophysiology going in within that group of patients,” she added.

Dr. Freeman said not enough data have yet been generated to correlate long-standing COVID-19 skin symptoms with lasting cardiac, neurologic, or other symptoms of prolonged inflammation stemming from the virus.

Meanwhile, an EADV survey of 490 dermatologists revealed that just over one-third have seen patients presenting with skin signs of COVID-19. Moreover, 4% of dermatologists themselves tested positive for the virus.

Dr. Freeman encouraged all frontline clinicians assessing COVID-19 patients with skin symptoms to enter patients into the registry. But despite its strengths, the registry “can’t tell us what percentage of everyone who gets COVID will develop a skin finding or what percentage will be a long-hauler,” she said.

“A registry doesn’t have a denominator, so it’s like a giant case series,” she added.

“It will be very helpful going forward, as many places around the world experience second or third waves of COVID-19, to follow patients prospectively, acknowledge that patients will have symptoms lasting different amounts of time, and be aware these symptoms can occur on the skin,” she said.

Christopher Griffiths, MD, of the University of Manchester (England), praised the international registry as a valuable tool that will help clinicians better manage patients with COVID-19–related skin effects and predict prognosis.

“This has really brought the international dermatology community together, working on a focused goal relevant to all of us around the world,” Dr. Griffiths said in an interview. “It shows the power of communication and collaboration and what can be achieved in a short period of time.”

Dr. Freeman and Dr. Griffiths disclosed no relevant financial relationships.
 

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

A small subset of SARS-CoV-2 patients with “COVID toes” can be categorized as COVID-19 long-haulers, with skin symptoms sometimes enduring for more than 150 days, a new analysis revealed.

Evaluating data from an international registry of COVID-19 patients with dermatologic symptoms, researchers found that retiform purpura rashes are linked to severe COVID-19, with 100% of these patients requiring hospitalization and 82% experiencing acute respiratory distress syndrome (ARDS).

Meanwhile, pernio/chilblains rashes, dubbed “COVID toes,” are associated with milder disease and a 16% hospitalization rate. For all COVID-19–related skin symptoms, the average duration is 12 days.

“The skin is another organ system that we didn’t know could have long COVID” effects, said principal investigator Esther Freeman, MD, PhD, of the department of dermatology, Massachusetts General Hospital, Boston.

“The skin is really a window into how the body is working overall, so the fact that we could visually see persistent inflammation in long-hauler patients is particularly fascinating and gives us a chance to explore what’s going on,” Dr. Freeman said in an interview. “It certainly makes sense to me, knowing what we know about other organ systems, that there might be some long-lasting inflammation” in the skin as well.

The study is a result of the collaboration between the American Academy of Dermatology and the International League of Dermatological Societies, the international registry launched this past April. While the study included provider-supplied data from 990 cases spanning 39 countries, the registry now encompasses more than 1,000 patients from 41 countries, Dr. Freeman noted.

Dr. Freeman presented the data at the annual congress of the European Academy of Dermatology and Venereology.

Many studies have reported dermatologic effects of COVID-19 infection, but information was lacking about duration. The registry represents the largest dataset to date detailing these persistent skin symptoms and offers insight about how COVID-19 can affect many different organ systems even after patients recover from acute infection, Dr. Freeman said.

Eight different types of skin rashes were noted in the study group, of which 303 were lab-confirmed or suspected COVID-19 patients with skin symptoms. Of those, 224 total cases and 90 lab-confirmed cases included information on how long skin symptoms lasted. Lab tests for SARS-CoV-2 included polymerase chain reaction and serum antibody assays.

Dr. Freeman and associates defined “long-haulers” as patients with dermatologic symptoms of COVID-19 lasting 60 days or longer. These “outliers” are likely more prevalent than the registry suggests, she said, since not all providers initially reporting skin symptoms in patients updated that information over time.

“It’s important to understand that the registry is probably significantly underreporting the duration of symptoms and number of long-hauler patients,” she explained. “A registry is often a glimpse into a moment in time to these patients. To combat that, we followed up by email twice with providers to ask if patients’ symptoms were still ongoing or completed.”

Results showed a wide spectrum in average duration of symptoms among lab-confirmed COVID-19 patients, depending on specific rash. Urticaria lasted for a median of 4 days; morbilliform eruptions, 7 days; pernio/chilblains, 10 days; and papulosquamous eruptions, 20 days, with one long-hauler case lasting 70 days.

Five patients with pernio/chilblains were long-haulers, with toe symptoms enduring 60 days or longer. Only one went beyond 133 days with severe pernio and fatigue.

“The fact that we’re not necessarily seeing these long-hauler symptoms across every type of skin rash makes sense,” Dr. Freeman said. “Hives, for example, usually comes on acutely and leaves pretty rapidly. There are no reports of long-hauler hives.”

“That we’re really seeing these long-hauler symptoms in certain skin rashes really suggests that there’s a certain pathophysiology going in within that group of patients,” she added.

Dr. Freeman said not enough data have yet been generated to correlate long-standing COVID-19 skin symptoms with lasting cardiac, neurologic, or other symptoms of prolonged inflammation stemming from the virus.

Meanwhile, an EADV survey of 490 dermatologists revealed that just over one-third have seen patients presenting with skin signs of COVID-19. Moreover, 4% of dermatologists themselves tested positive for the virus.

Dr. Freeman encouraged all frontline clinicians assessing COVID-19 patients with skin symptoms to enter patients into the registry. But despite its strengths, the registry “can’t tell us what percentage of everyone who gets COVID will develop a skin finding or what percentage will be a long-hauler,” she said.

“A registry doesn’t have a denominator, so it’s like a giant case series,” she added.

“It will be very helpful going forward, as many places around the world experience second or third waves of COVID-19, to follow patients prospectively, acknowledge that patients will have symptoms lasting different amounts of time, and be aware these symptoms can occur on the skin,” she said.

Christopher Griffiths, MD, of the University of Manchester (England), praised the international registry as a valuable tool that will help clinicians better manage patients with COVID-19–related skin effects and predict prognosis.

“This has really brought the international dermatology community together, working on a focused goal relevant to all of us around the world,” Dr. Griffiths said in an interview. “It shows the power of communication and collaboration and what can be achieved in a short period of time.”

Dr. Freeman and Dr. Griffiths disclosed no relevant financial relationships.
 

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

A small subset of SARS-CoV-2 patients with “COVID toes” can be categorized as COVID-19 long-haulers, with skin symptoms sometimes enduring for more than 150 days, a new analysis revealed.

Evaluating data from an international registry of COVID-19 patients with dermatologic symptoms, researchers found that retiform purpura rashes are linked to severe COVID-19, with 100% of these patients requiring hospitalization and 82% experiencing acute respiratory distress syndrome (ARDS).

Meanwhile, pernio/chilblains rashes, dubbed “COVID toes,” are associated with milder disease and a 16% hospitalization rate. For all COVID-19–related skin symptoms, the average duration is 12 days.

“The skin is another organ system that we didn’t know could have long COVID” effects, said principal investigator Esther Freeman, MD, PhD, of the department of dermatology, Massachusetts General Hospital, Boston.

“The skin is really a window into how the body is working overall, so the fact that we could visually see persistent inflammation in long-hauler patients is particularly fascinating and gives us a chance to explore what’s going on,” Dr. Freeman said in an interview. “It certainly makes sense to me, knowing what we know about other organ systems, that there might be some long-lasting inflammation” in the skin as well.

The study is a result of the collaboration between the American Academy of Dermatology and the International League of Dermatological Societies, the international registry launched this past April. While the study included provider-supplied data from 990 cases spanning 39 countries, the registry now encompasses more than 1,000 patients from 41 countries, Dr. Freeman noted.

Dr. Freeman presented the data at the annual congress of the European Academy of Dermatology and Venereology.

Many studies have reported dermatologic effects of COVID-19 infection, but information was lacking about duration. The registry represents the largest dataset to date detailing these persistent skin symptoms and offers insight about how COVID-19 can affect many different organ systems even after patients recover from acute infection, Dr. Freeman said.

Eight different types of skin rashes were noted in the study group, of which 303 were lab-confirmed or suspected COVID-19 patients with skin symptoms. Of those, 224 total cases and 90 lab-confirmed cases included information on how long skin symptoms lasted. Lab tests for SARS-CoV-2 included polymerase chain reaction and serum antibody assays.

Dr. Freeman and associates defined “long-haulers” as patients with dermatologic symptoms of COVID-19 lasting 60 days or longer. These “outliers” are likely more prevalent than the registry suggests, she said, since not all providers initially reporting skin symptoms in patients updated that information over time.

“It’s important to understand that the registry is probably significantly underreporting the duration of symptoms and number of long-hauler patients,” she explained. “A registry is often a glimpse into a moment in time to these patients. To combat that, we followed up by email twice with providers to ask if patients’ symptoms were still ongoing or completed.”

Results showed a wide spectrum in average duration of symptoms among lab-confirmed COVID-19 patients, depending on specific rash. Urticaria lasted for a median of 4 days; morbilliform eruptions, 7 days; pernio/chilblains, 10 days; and papulosquamous eruptions, 20 days, with one long-hauler case lasting 70 days.

Five patients with pernio/chilblains were long-haulers, with toe symptoms enduring 60 days or longer. Only one went beyond 133 days with severe pernio and fatigue.

“The fact that we’re not necessarily seeing these long-hauler symptoms across every type of skin rash makes sense,” Dr. Freeman said. “Hives, for example, usually comes on acutely and leaves pretty rapidly. There are no reports of long-hauler hives.”

“That we’re really seeing these long-hauler symptoms in certain skin rashes really suggests that there’s a certain pathophysiology going in within that group of patients,” she added.

Dr. Freeman said not enough data have yet been generated to correlate long-standing COVID-19 skin symptoms with lasting cardiac, neurologic, or other symptoms of prolonged inflammation stemming from the virus.

Meanwhile, an EADV survey of 490 dermatologists revealed that just over one-third have seen patients presenting with skin signs of COVID-19. Moreover, 4% of dermatologists themselves tested positive for the virus.

Dr. Freeman encouraged all frontline clinicians assessing COVID-19 patients with skin symptoms to enter patients into the registry. But despite its strengths, the registry “can’t tell us what percentage of everyone who gets COVID will develop a skin finding or what percentage will be a long-hauler,” she said.

“A registry doesn’t have a denominator, so it’s like a giant case series,” she added.

“It will be very helpful going forward, as many places around the world experience second or third waves of COVID-19, to follow patients prospectively, acknowledge that patients will have symptoms lasting different amounts of time, and be aware these symptoms can occur on the skin,” she said.

Christopher Griffiths, MD, of the University of Manchester (England), praised the international registry as a valuable tool that will help clinicians better manage patients with COVID-19–related skin effects and predict prognosis.

“This has really brought the international dermatology community together, working on a focused goal relevant to all of us around the world,” Dr. Griffiths said in an interview. “It shows the power of communication and collaboration and what can be achieved in a short period of time.”

Dr. Freeman and Dr. Griffiths disclosed no relevant financial relationships.
 

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

Real-world survival outcomes for cancer patients on immune checkpoint inhibitors (ICIs) are inferior to outcomes reported in patients on clinical trials of ICIs, according to research published in JCO Clinical Cancer Informatics.

However, the research also suggests that real-world patients who receive ICIs achieve longer survival than patients on standard-of-care medications.

“Patients receiving ICIs in real-world practice may differ from those enrolled in trials in a variety of ways, including age, race, performance status, and comorbidity burden,” said study author Jerry S.H. Lee, PhD, of the University of Southern California, Los Angeles.

Dr. Lee noted that only 3%-4% of cancer patients participate in clinical trials. In fact, more than half of patients with melanoma and nearly three-quarters of those with non–small cell lung cancer (NSCLC) do not meet criteria for eligibility in clinical trials, he said.

To examine the discrepancies between real-world practice and clinical trials and to better understand which patients receive ICIs in clinical practice, Dr. Lee and colleagues conducted a retrospective analysis using electronic health record data from Veterans Administration (VA) facilities nationwide.

The researchers identified 11,888 cancer patients who were treated with ICIs. The cohort included patients who are underrepresented in pivotal clinical trials, including older, non-White, and/or higher disease-burdened patients.

The majority of patients were treated for NSCLC (51.1%), followed by melanoma (14.4%), renal cell carcinoma (RCC; 8.1%), squamous cell carcinoma of the head and neck (6.8%), urothelial cancer (6.4%), hepatocellular carcinoma (4.5%), and other less common cancer types (8.8%).
 

Overall survival by indication

In general, median overall survival (OS) in the VA cohort was inferior to median OS reported in clinical trials. However, patients treated with first-line nivolumab for melanoma and second-line pembrolizumab or nivolumab for NSCLC had similar OS in the real-world and trial data.

The researchers did not report exact OS numbers from clinical trials. However, they did report the exact numbers from the VA cohort and show OS differences between the VA cohort and clinical trials graphically.

Among patients in the VA cohort, the median OS was:

• 25.5 months in melanoma patients on first-line nivolumab
• 16.3 months in RCC patients receiving nivolumab in the second line or higher
• 14 months in RCC patients on first-line ipilimumab and nivolumab
• 10.6 months in NSCLC patients on first-line pembrolizumab
• 9.9 months in NSCLC patients receiving pembrolizumab or nivolumab in the second line or higher
• 9.1 months in NSCLC patients on first-line pembrolizumab and platinum-based chemotherapy
• 6.7 months in urothelial cancer patients receiving ICIs in the second line or higher.

A number of factors may have contributed to the shorter OS observed in the VA cohort, according to the researchers. The VA cohort is predominantly male, is older, and has a higher degree of comorbidity, compared with patients in clinical trials.

In addition, no data are available to determine the cause for discontinuation of therapy, and VA patients may have received ICIs after failing multiple lines of previous therapy, while clinical trials may limit patients to only one or two previous lines of therapy.

After stratifying VA patients by frailty status, the OS among non-frail patients was more similar to the OS reported in clinical trials.

“Real-world outcomes from the VA were more similar when adjusted for frailty, which shows the importance of patient diversity in clinical trials,” Dr. Lee said. He added that the definition of frailty among VA patients included potential injury during combat and therefore differs from a generic frailty definition.
 

ICIs vs. standard care

The researchers also found that VA patients treated with ICIs had longer OS, compared with a cohort of VA patients receiving standard-of-care therapies.

The median OS was as follows:

• In melanoma patients on first-line treatment – 39.29 months with nivolumab and 5.75 months with chemotherapy (P < .001).
• In RCC patients on first-line treatment – 14.01 months with ipilimumab plus nivolumab and 8.63 months with targeted therapy (P = .051).
• In RCC patients on second-line or greater treatment – 12.43 months with nivolumab and 8.09 months with everolimus (P < .001).
• In NSCLC patients on first-line therapy – 8.88 months with pembrolizumab and 6.38 months with a platinum doublet (P < .001).
• In NSCLC patients on first-line combination therapy – 10.59 months with pembrolizumab plus platinum chemotherapy and 6.38 months with a platinum doublet (P < .001).
• In NSCLC patients on second-line or greater therapy – 10.06 months with pembrolizumab or nivolumab and 6.41 months with docetaxel (P < .001).
• In urothelial cancer patients on second-line or greater therapy – 7.66 months with an ICI and 6.31 months with chemotherapy (P = .043).
   

Help for treatment decisions

“The real-world survival outcomes not only indicate the breadth of indications but also represent patients who tend not to be eligible for immunotherapy trials, based on their health status,” Dr. Lee said. “We hope this dataset of national-level experience provides practicing oncologists evidence to help patients and family members in the process of decision-making about therapy.”

Real-world data can also inform oncologists who face decisions on whether to prescribe or withhold ICIs and patients who face the financial burden of paying for ICIs, he said.

This dataset will be continually updated. The researchers have already added another 10,000 VA patients who have received immunotherapies in the year since the trial began.

“In a longitudinal way, we plan to examine what causes differences in outcomes and continue to find ways to extend care to veterans with a balance of high quality of life,” Dr. Lee said.

“Patients who participate in clinical trials are, on average, younger and healthier than the general population,” said Bora Youn, PhD, a senior biostatistician at Biogen in Cambridge, Mass., who was not involved in this study.

“In the case of immunotherapies, those with poor performance status and autoimmune conditions are often excluded from trials,” Dr. Youn added. “In the real world, these patients can also receive treatments, and clinicians often need to extrapolate the results from clinical trials. It is therefore important to collect real-world data to understand the effectiveness and safety of these therapies in patients with limited evidence.”

Dr. Youn led a real-world study, published in Cancer, of 1,256 Medicare recipients who were diagnosed with NSCLC and received ICI therapy.

“We found that factors associated with poor prognosis in general, such as squamous histology and failure of aggressive prior treatment, are also predictive of decreased survival among those who initiated immunotherapies. Yet, OS of older patients was relatively comparable to those observed in clinical trials,” Dr. Youn said.

“Understanding the real-world effectiveness of these treatments will help improve the evidence base, especially for those underrepresented in clinical trials. These studies can also help identify patients who are most likely to benefit from immunotherapies,” Dr. Youn added.

This study was supported by the VA Office of Research and Development Cooperative Studies Program. Dr. Lee and Dr. Youn disclosed no conflicts of interest.

SOURCE: Jennifer La et al. JCO Clinical Cancer Informatics. 2020:4:918-28.

Real-world survival outcomes for cancer patients on immune checkpoint inhibitors (ICIs) are inferior to outcomes reported in patients on clinical trials of ICIs, according to research published in JCO Clinical Cancer Informatics.

However, the research also suggests that real-world patients who receive ICIs achieve longer survival than patients on standard-of-care medications.

“Patients receiving ICIs in real-world practice may differ from those enrolled in trials in a variety of ways, including age, race, performance status, and comorbidity burden,” said study author Jerry S.H. Lee, PhD, of the University of Southern California, Los Angeles.

Dr. Lee noted that only 3%-4% of cancer patients participate in clinical trials. In fact, more than half of patients with melanoma and nearly three-quarters of those with non–small cell lung cancer (NSCLC) do not meet criteria for eligibility in clinical trials, he said.

To examine the discrepancies between real-world practice and clinical trials and to better understand which patients receive ICIs in clinical practice, Dr. Lee and colleagues conducted a retrospective analysis using electronic health record data from Veterans Administration (VA) facilities nationwide.

The researchers identified 11,888 cancer patients who were treated with ICIs. The cohort included patients who are underrepresented in pivotal clinical trials, including older, non-White, and/or higher disease-burdened patients.

The majority of patients were treated for NSCLC (51.1%), followed by melanoma (14.4%), renal cell carcinoma (RCC; 8.1%), squamous cell carcinoma of the head and neck (6.8%), urothelial cancer (6.4%), hepatocellular carcinoma (4.5%), and other less common cancer types (8.8%).
 

Overall survival by indication

In general, median overall survival (OS) in the VA cohort was inferior to median OS reported in clinical trials. However, patients treated with first-line nivolumab for melanoma and second-line pembrolizumab or nivolumab for NSCLC had similar OS in the real-world and trial data.

The researchers did not report exact OS numbers from clinical trials. However, they did report the exact numbers from the VA cohort and show OS differences between the VA cohort and clinical trials graphically.

Among patients in the VA cohort, the median OS was:

• 25.5 months in melanoma patients on first-line nivolumab
• 16.3 months in RCC patients receiving nivolumab in the second line or higher
• 14 months in RCC patients on first-line ipilimumab and nivolumab
• 10.6 months in NSCLC patients on first-line pembrolizumab
• 9.9 months in NSCLC patients receiving pembrolizumab or nivolumab in the second line or higher
• 9.1 months in NSCLC patients on first-line pembrolizumab and platinum-based chemotherapy
• 6.7 months in urothelial cancer patients receiving ICIs in the second line or higher.

A number of factors may have contributed to the shorter OS observed in the VA cohort, according to the researchers. The VA cohort is predominantly male, is older, and has a higher degree of comorbidity, compared with patients in clinical trials.

In addition, no data are available to determine the cause for discontinuation of therapy, and VA patients may have received ICIs after failing multiple lines of previous therapy, while clinical trials may limit patients to only one or two previous lines of therapy.

After stratifying VA patients by frailty status, the OS among non-frail patients was more similar to the OS reported in clinical trials.

“Real-world outcomes from the VA were more similar when adjusted for frailty, which shows the importance of patient diversity in clinical trials,” Dr. Lee said. He added that the definition of frailty among VA patients included potential injury during combat and therefore differs from a generic frailty definition.
 

ICIs vs. standard care

The researchers also found that VA patients treated with ICIs had longer OS, compared with a cohort of VA patients receiving standard-of-care therapies.

The median OS was as follows:

• In melanoma patients on first-line treatment – 39.29 months with nivolumab and 5.75 months with chemotherapy (P < .001).
• In RCC patients on first-line treatment – 14.01 months with ipilimumab plus nivolumab and 8.63 months with targeted therapy (P = .051).
• In RCC patients on second-line or greater treatment – 12.43 months with nivolumab and 8.09 months with everolimus (P < .001).
• In NSCLC patients on first-line therapy – 8.88 months with pembrolizumab and 6.38 months with a platinum doublet (P < .001).
• In NSCLC patients on first-line combination therapy – 10.59 months with pembrolizumab plus platinum chemotherapy and 6.38 months with a platinum doublet (P < .001).
• In NSCLC patients on second-line or greater therapy – 10.06 months with pembrolizumab or nivolumab and 6.41 months with docetaxel (P < .001).
• In urothelial cancer patients on second-line or greater therapy – 7.66 months with an ICI and 6.31 months with chemotherapy (P = .043).
   

Help for treatment decisions

“The real-world survival outcomes not only indicate the breadth of indications but also represent patients who tend not to be eligible for immunotherapy trials, based on their health status,” Dr. Lee said. “We hope this dataset of national-level experience provides practicing oncologists evidence to help patients and family members in the process of decision-making about therapy.”

Real-world data can also inform oncologists who face decisions on whether to prescribe or withhold ICIs and patients who face the financial burden of paying for ICIs, he said.

This dataset will be continually updated. The researchers have already added another 10,000 VA patients who have received immunotherapies in the year since the trial began.

“In a longitudinal way, we plan to examine what causes differences in outcomes and continue to find ways to extend care to veterans with a balance of high quality of life,” Dr. Lee said.

“Patients who participate in clinical trials are, on average, younger and healthier than the general population,” said Bora Youn, PhD, a senior biostatistician at Biogen in Cambridge, Mass., who was not involved in this study.

“In the case of immunotherapies, those with poor performance status and autoimmune conditions are often excluded from trials,” Dr. Youn added. “In the real world, these patients can also receive treatments, and clinicians often need to extrapolate the results from clinical trials. It is therefore important to collect real-world data to understand the effectiveness and safety of these therapies in patients with limited evidence.”

Dr. Youn led a real-world study, published in Cancer, of 1,256 Medicare recipients who were diagnosed with NSCLC and received ICI therapy.

“We found that factors associated with poor prognosis in general, such as squamous histology and failure of aggressive prior treatment, are also predictive of decreased survival among those who initiated immunotherapies. Yet, OS of older patients was relatively comparable to those observed in clinical trials,” Dr. Youn said.

“Understanding the real-world effectiveness of these treatments will help improve the evidence base, especially for those underrepresented in clinical trials. These studies can also help identify patients who are most likely to benefit from immunotherapies,” Dr. Youn added.

This study was supported by the VA Office of Research and Development Cooperative Studies Program. Dr. Lee and Dr. Youn disclosed no conflicts of interest.

SOURCE: Jennifer La et al. JCO Clinical Cancer Informatics. 2020:4:918-28.

Real-world survival outcomes for cancer patients on immune checkpoint inhibitors (ICIs) are inferior to outcomes reported in patients on clinical trials of ICIs, according to research published in JCO Clinical Cancer Informatics.

However, the research also suggests that real-world patients who receive ICIs achieve longer survival than patients on standard-of-care medications.

“Patients receiving ICIs in real-world practice may differ from those enrolled in trials in a variety of ways, including age, race, performance status, and comorbidity burden,” said study author Jerry S.H. Lee, PhD, of the University of Southern California, Los Angeles.

Dr. Lee noted that only 3%-4% of cancer patients participate in clinical trials. In fact, more than half of patients with melanoma and nearly three-quarters of those with non–small cell lung cancer (NSCLC) do not meet criteria for eligibility in clinical trials, he said.

To examine the discrepancies between real-world practice and clinical trials and to better understand which patients receive ICIs in clinical practice, Dr. Lee and colleagues conducted a retrospective analysis using electronic health record data from Veterans Administration (VA) facilities nationwide.

The researchers identified 11,888 cancer patients who were treated with ICIs. The cohort included patients who are underrepresented in pivotal clinical trials, including older, non-White, and/or higher disease-burdened patients.

The majority of patients were treated for NSCLC (51.1%), followed by melanoma (14.4%), renal cell carcinoma (RCC; 8.1%), squamous cell carcinoma of the head and neck (6.8%), urothelial cancer (6.4%), hepatocellular carcinoma (4.5%), and other less common cancer types (8.8%).
 

Overall survival by indication

In general, median overall survival (OS) in the VA cohort was inferior to median OS reported in clinical trials. However, patients treated with first-line nivolumab for melanoma and second-line pembrolizumab or nivolumab for NSCLC had similar OS in the real-world and trial data.

The researchers did not report exact OS numbers from clinical trials. However, they did report the exact numbers from the VA cohort and show OS differences between the VA cohort and clinical trials graphically.

Among patients in the VA cohort, the median OS was:

• 25.5 months in melanoma patients on first-line nivolumab
• 16.3 months in RCC patients receiving nivolumab in the second line or higher
• 14 months in RCC patients on first-line ipilimumab and nivolumab
• 10.6 months in NSCLC patients on first-line pembrolizumab
• 9.9 months in NSCLC patients receiving pembrolizumab or nivolumab in the second line or higher
• 9.1 months in NSCLC patients on first-line pembrolizumab and platinum-based chemotherapy
• 6.7 months in urothelial cancer patients receiving ICIs in the second line or higher.

A number of factors may have contributed to the shorter OS observed in the VA cohort, according to the researchers. The VA cohort is predominantly male, is older, and has a higher degree of comorbidity, compared with patients in clinical trials.

In addition, no data are available to determine the cause for discontinuation of therapy, and VA patients may have received ICIs after failing multiple lines of previous therapy, while clinical trials may limit patients to only one or two previous lines of therapy.

After stratifying VA patients by frailty status, the OS among non-frail patients was more similar to the OS reported in clinical trials.

“Real-world outcomes from the VA were more similar when adjusted for frailty, which shows the importance of patient diversity in clinical trials,” Dr. Lee said. He added that the definition of frailty among VA patients included potential injury during combat and therefore differs from a generic frailty definition.
 

ICIs vs. standard care

The researchers also found that VA patients treated with ICIs had longer OS, compared with a cohort of VA patients receiving standard-of-care therapies.

The median OS was as follows:

• In melanoma patients on first-line treatment – 39.29 months with nivolumab and 5.75 months with chemotherapy (P < .001).
• In RCC patients on first-line treatment – 14.01 months with ipilimumab plus nivolumab and 8.63 months with targeted therapy (P = .051).
• In RCC patients on second-line or greater treatment – 12.43 months with nivolumab and 8.09 months with everolimus (P < .001).
• In NSCLC patients on first-line therapy – 8.88 months with pembrolizumab and 6.38 months with a platinum doublet (P < .001).
• In NSCLC patients on first-line combination therapy – 10.59 months with pembrolizumab plus platinum chemotherapy and 6.38 months with a platinum doublet (P < .001).
• In NSCLC patients on second-line or greater therapy – 10.06 months with pembrolizumab or nivolumab and 6.41 months with docetaxel (P < .001).
• In urothelial cancer patients on second-line or greater therapy – 7.66 months with an ICI and 6.31 months with chemotherapy (P = .043).
   

Help for treatment decisions

“The real-world survival outcomes not only indicate the breadth of indications but also represent patients who tend not to be eligible for immunotherapy trials, based on their health status,” Dr. Lee said. “We hope this dataset of national-level experience provides practicing oncologists evidence to help patients and family members in the process of decision-making about therapy.”

Real-world data can also inform oncologists who face decisions on whether to prescribe or withhold ICIs and patients who face the financial burden of paying for ICIs, he said.

This dataset will be continually updated. The researchers have already added another 10,000 VA patients who have received immunotherapies in the year since the trial began.

“In a longitudinal way, we plan to examine what causes differences in outcomes and continue to find ways to extend care to veterans with a balance of high quality of life,” Dr. Lee said.

“Patients who participate in clinical trials are, on average, younger and healthier than the general population,” said Bora Youn, PhD, a senior biostatistician at Biogen in Cambridge, Mass., who was not involved in this study.

“In the case of immunotherapies, those with poor performance status and autoimmune conditions are often excluded from trials,” Dr. Youn added. “In the real world, these patients can also receive treatments, and clinicians often need to extrapolate the results from clinical trials. It is therefore important to collect real-world data to understand the effectiveness and safety of these therapies in patients with limited evidence.”

Dr. Youn led a real-world study, published in Cancer, of 1,256 Medicare recipients who were diagnosed with NSCLC and received ICI therapy.

“We found that factors associated with poor prognosis in general, such as squamous histology and failure of aggressive prior treatment, are also predictive of decreased survival among those who initiated immunotherapies. Yet, OS of older patients was relatively comparable to those observed in clinical trials,” Dr. Youn said.

“Understanding the real-world effectiveness of these treatments will help improve the evidence base, especially for those underrepresented in clinical trials. These studies can also help identify patients who are most likely to benefit from immunotherapies,” Dr. Youn added.

This study was supported by the VA Office of Research and Development Cooperative Studies Program. Dr. Lee and Dr. Youn disclosed no conflicts of interest.

SOURCE: Jennifer La et al. JCO Clinical Cancer Informatics. 2020:4:918-28.

A program in which optometrists conduct in-office diabetes screening is now being expanded based on successful pilot data.

Attila Barabas/Thinkstock

The program is sponsored by VSP Vision Care, a vision benefits company with over 40,000 network optometrists and nearly 90 million consumer members worldwide. “Optometrists are often the first to detect signs of diabetes by looking at the blood vessels in the eye during a comprehensive eye exam,” the company said in a statement.

In the pilot program, conducted from May 2019 to February 2020* in 12 VSP practices in five states, 818 patients who had come in for their annual vision exam were given the American Diabetes Association Risk Test for type 2 diabetes, and 287 identified at risk were offered an in-office fingerstick hemoglobin A1c test.

Materials were provided free to the optometrists, who were paid a professional fee to perform the HbA1c screenings.

Of the 287 eligible for the HbA1c test, 85% took it. Of those 244, 31% and 5% had levels in the prediabetes and diabetes range, respectively. None had been aware of their status previously, and 92% rated the screening as an extremely or very positive experience.

Now, VSP is expanding the pilot program for another year with two large clients in Ohio covering about 90,000 members.

“Coupled with the fact that VSP members are more likely to get their annual eye exam over their annual physical exam with their primary care physician, HbA1c screenings provided by eye doctors offer another critical way to detect the chronic condition earlier and help prevent eye disease and even vision loss caused by diabetes,” according to the statement.

In an interview, a VSP spokesperson explained that if the patient provides their primary care provider information to the optometrist, the optometrist will send a referral with exam information to that provider and also instruct the patient to make an appointment with the provider for follow-up testing and care.

The optometrist also educates the patient about the connection between eye health and overall health and provides them with a flier that gives tips on lifestyle changes they can make to help slow or prevent the progression to type 2 diabetes, the spokesperson said.

Thirty states, including Ohio, allow optometrists to perform in-office blood testing, including HbA1c screening, provided they obtain a Clinical Laboratory Improvement Amendments Certificate of Waiver. VSP is providing online training for participating optometrists on administering the HbA1c screening.

The pilot program is part of an alliance between VSP and the American Diabetes Association formed in November 2019 to raise awareness of eye health in people with diabetes and those at risk for it.

*Correction: The original article included the wrong end date for the pilot program.

A program in which optometrists conduct in-office diabetes screening is now being expanded based on successful pilot data.

Attila Barabas/Thinkstock

The program is sponsored by VSP Vision Care, a vision benefits company with over 40,000 network optometrists and nearly 90 million consumer members worldwide. “Optometrists are often the first to detect signs of diabetes by looking at the blood vessels in the eye during a comprehensive eye exam,” the company said in a statement.

In the pilot program, conducted from May 2019 to February 2020* in 12 VSP practices in five states, 818 patients who had come in for their annual vision exam were given the American Diabetes Association Risk Test for type 2 diabetes, and 287 identified at risk were offered an in-office fingerstick hemoglobin A1c test.

Materials were provided free to the optometrists, who were paid a professional fee to perform the HbA1c screenings.

Of the 287 eligible for the HbA1c test, 85% took it. Of those 244, 31% and 5% had levels in the prediabetes and diabetes range, respectively. None had been aware of their status previously, and 92% rated the screening as an extremely or very positive experience.

Now, VSP is expanding the pilot program for another year with two large clients in Ohio covering about 90,000 members.

“Coupled with the fact that VSP members are more likely to get their annual eye exam over their annual physical exam with their primary care physician, HbA1c screenings provided by eye doctors offer another critical way to detect the chronic condition earlier and help prevent eye disease and even vision loss caused by diabetes,” according to the statement.

In an interview, a VSP spokesperson explained that if the patient provides their primary care provider information to the optometrist, the optometrist will send a referral with exam information to that provider and also instruct the patient to make an appointment with the provider for follow-up testing and care.

The optometrist also educates the patient about the connection between eye health and overall health and provides them with a flier that gives tips on lifestyle changes they can make to help slow or prevent the progression to type 2 diabetes, the spokesperson said.

Thirty states, including Ohio, allow optometrists to perform in-office blood testing, including HbA1c screening, provided they obtain a Clinical Laboratory Improvement Amendments Certificate of Waiver. VSP is providing online training for participating optometrists on administering the HbA1c screening.

The pilot program is part of an alliance between VSP and the American Diabetes Association formed in November 2019 to raise awareness of eye health in people with diabetes and those at risk for it.

*Correction: The original article included the wrong end date for the pilot program.

A program in which optometrists conduct in-office diabetes screening is now being expanded based on successful pilot data.

Attila Barabas/Thinkstock

The program is sponsored by VSP Vision Care, a vision benefits company with over 40,000 network optometrists and nearly 90 million consumer members worldwide. “Optometrists are often the first to detect signs of diabetes by looking at the blood vessels in the eye during a comprehensive eye exam,” the company said in a statement.

In the pilot program, conducted from May 2019 to February 2020* in 12 VSP practices in five states, 818 patients who had come in for their annual vision exam were given the American Diabetes Association Risk Test for type 2 diabetes, and 287 identified at risk were offered an in-office fingerstick hemoglobin A1c test.

Materials were provided free to the optometrists, who were paid a professional fee to perform the HbA1c screenings.

Of the 287 eligible for the HbA1c test, 85% took it. Of those 244, 31% and 5% had levels in the prediabetes and diabetes range, respectively. None had been aware of their status previously, and 92% rated the screening as an extremely or very positive experience.

Now, VSP is expanding the pilot program for another year with two large clients in Ohio covering about 90,000 members.

“Coupled with the fact that VSP members are more likely to get their annual eye exam over their annual physical exam with their primary care physician, HbA1c screenings provided by eye doctors offer another critical way to detect the chronic condition earlier and help prevent eye disease and even vision loss caused by diabetes,” according to the statement.

In an interview, a VSP spokesperson explained that if the patient provides their primary care provider information to the optometrist, the optometrist will send a referral with exam information to that provider and also instruct the patient to make an appointment with the provider for follow-up testing and care.

The optometrist also educates the patient about the connection between eye health and overall health and provides them with a flier that gives tips on lifestyle changes they can make to help slow or prevent the progression to type 2 diabetes, the spokesperson said.

Thirty states, including Ohio, allow optometrists to perform in-office blood testing, including HbA1c screening, provided they obtain a Clinical Laboratory Improvement Amendments Certificate of Waiver. VSP is providing online training for participating optometrists on administering the HbA1c screening.

The pilot program is part of an alliance between VSP and the American Diabetes Association formed in November 2019 to raise awareness of eye health in people with diabetes and those at risk for it.

*Correction: The original article included the wrong end date for the pilot program.

Physician practices nationwide lost 32% of their revenue, on average, from February to the summer, according to a new American Medical Association survey of 3,500 physicians, conducted from mid-July to August. That period coincided with the second wave of the coronavirus pandemic in the United States.

A third of practices reported a revenue drop of 25%-49%; 15% said their volume had fallen by 50%-74%, and 4% saw a decrease of 75% or more.

Because of the pandemic, 81% of physicians were providing fewer in-person visits than in February. In-person visits dropped by 50% or more for more than one-third of physicians. The average number of in-person visits fell from 95 to 57 per week.

Physicians who responded to the survey held an average of six weekly telehealth visits before the pandemic, 29 at the height of the pandemic in the spring, and 16 the week they were surveyed. About 20% of respondents with any telehealth visits had conducted them before the pandemic, 77% at the height of the crisis, and 68% in the survey week.

Among the doctors who weren’t involved in telehealth visits before the pandemic, only 23% conducted them at the pandemic’s peak; 12% conducted them in the survey week.

Despite the telehealth increase, almost 70% of physicians were providing fewer total visits, including in-person and virtual encounters, than before the pandemic, the survey showed. About 21% saw a decrease of 25%-49%; 11%, a drop of 50%-74%; and 10%, a falloff of at least 75%. On average, total visits fell from 101 to 72 per week.
 

Other surveys more upbeat

A larger survey by Harvard University, the Commonwealth Fund, and the technology company Phreesia found that total outpatient visits in early October had rebounded to the level of March 1. This was a major turnaround from late March, when visits had plunged by nearly 60%.

According to the Harvard/Commonwealth Fund’s ongoing survey, visits started recovering in late June, although they were still off by 10%. They began rising further around Labor Day. The AMA researchers began conducting their survey in mid-June. The summertime surge in COVID-19 likely accounted for their finding that practice revenues were off by a third from the February baseline.

If so, the return to normalcy early this month may not represent the current situation as the virus sweeps across the country for a third time. In any case, even if patient visits and revenues have recovered more than the AMA data indicate, most practices will not have recovered from their losses earlier in the year.

A third survey more closely mirrors the AMA results. At the end of June, according to data from the Medical Group Management Association, revenues for the association’s members were 76% of what they had been in June 2019, and patient volume was 78% of that in the previous year.
 

Practice expenses rise

The AMA survey also found that, since February, practice spending on personal protective equipment (PPE) had increased by 57% or more, on average. About 64% of practice owners said their PPE expenditures were up from what they had been before the pandemic. For nearly 40% of practice owners, this expense had increased by 50% or more.

About 36% of the respondents said that acquiring PPE was very or extremely difficult. This was an especially big challenge for smaller practices, which do not have the purchasing power to compete with big health care systems for masks, gowns, and gloves, the AMA noted.

About 41% of doctors in practices with one to five physicians said they had difficulty getting PPE, compared with 30% of those in practices of 50 or more doctors. Only 25% of respondents in practices owned by hospitals and health systems said this was a problem.

Acquiring sufficient PPE is just one factor in the increase in practice expenses attributable to COVID-19. Still, it is indicative of the financial woes affecting physicians during the pandemic.

Nearly all respondents agreed that federal financial relief early in the pandemic was helpful and was appreciated. Among these programs was the CARES Act, which authorized the Provider Relief Fund, which accepted applications through Aug.28; the Medicare Accelerated and Advance Payment Program, which was suspended in April; and the SBA Paycheck Protection Program, which ended on Aug. 8.

To date, Congress had not approved the renewal of any these programs.

“Physician practices continue to be under significant financial stress due to reductions in patient volume and revenue, in addition to higher expenses for supplies that are scarce for some physicians,” said AMA President Susan R. Bailey, MD, in a news release on the survey’s findings. “More economic relief is needed now from Congress as some medical practices contemplate the brink of viability, particularly smaller practices that are facing a difficult road to recovery.”

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

Physician practices nationwide lost 32% of their revenue, on average, from February to the summer, according to a new American Medical Association survey of 3,500 physicians, conducted from mid-July to August. That period coincided with the second wave of the coronavirus pandemic in the United States.

A third of practices reported a revenue drop of 25%-49%; 15% said their volume had fallen by 50%-74%, and 4% saw a decrease of 75% or more.

Because of the pandemic, 81% of physicians were providing fewer in-person visits than in February. In-person visits dropped by 50% or more for more than one-third of physicians. The average number of in-person visits fell from 95 to 57 per week.

Physicians who responded to the survey held an average of six weekly telehealth visits before the pandemic, 29 at the height of the pandemic in the spring, and 16 the week they were surveyed. About 20% of respondents with any telehealth visits had conducted them before the pandemic, 77% at the height of the crisis, and 68% in the survey week.

Among the doctors who weren’t involved in telehealth visits before the pandemic, only 23% conducted them at the pandemic’s peak; 12% conducted them in the survey week.

Despite the telehealth increase, almost 70% of physicians were providing fewer total visits, including in-person and virtual encounters, than before the pandemic, the survey showed. About 21% saw a decrease of 25%-49%; 11%, a drop of 50%-74%; and 10%, a falloff of at least 75%. On average, total visits fell from 101 to 72 per week.
 

Other surveys more upbeat

A larger survey by Harvard University, the Commonwealth Fund, and the technology company Phreesia found that total outpatient visits in early October had rebounded to the level of March 1. This was a major turnaround from late March, when visits had plunged by nearly 60%.

According to the Harvard/Commonwealth Fund’s ongoing survey, visits started recovering in late June, although they were still off by 10%. They began rising further around Labor Day. The AMA researchers began conducting their survey in mid-June. The summertime surge in COVID-19 likely accounted for their finding that practice revenues were off by a third from the February baseline.

If so, the return to normalcy early this month may not represent the current situation as the virus sweeps across the country for a third time. In any case, even if patient visits and revenues have recovered more than the AMA data indicate, most practices will not have recovered from their losses earlier in the year.

A third survey more closely mirrors the AMA results. At the end of June, according to data from the Medical Group Management Association, revenues for the association’s members were 76% of what they had been in June 2019, and patient volume was 78% of that in the previous year.
 

Practice expenses rise

The AMA survey also found that, since February, practice spending on personal protective equipment (PPE) had increased by 57% or more, on average. About 64% of practice owners said their PPE expenditures were up from what they had been before the pandemic. For nearly 40% of practice owners, this expense had increased by 50% or more.

About 36% of the respondents said that acquiring PPE was very or extremely difficult. This was an especially big challenge for smaller practices, which do not have the purchasing power to compete with big health care systems for masks, gowns, and gloves, the AMA noted.

About 41% of doctors in practices with one to five physicians said they had difficulty getting PPE, compared with 30% of those in practices of 50 or more doctors. Only 25% of respondents in practices owned by hospitals and health systems said this was a problem.

Acquiring sufficient PPE is just one factor in the increase in practice expenses attributable to COVID-19. Still, it is indicative of the financial woes affecting physicians during the pandemic.

Nearly all respondents agreed that federal financial relief early in the pandemic was helpful and was appreciated. Among these programs was the CARES Act, which authorized the Provider Relief Fund, which accepted applications through Aug.28; the Medicare Accelerated and Advance Payment Program, which was suspended in April; and the SBA Paycheck Protection Program, which ended on Aug. 8.

To date, Congress had not approved the renewal of any these programs.

“Physician practices continue to be under significant financial stress due to reductions in patient volume and revenue, in addition to higher expenses for supplies that are scarce for some physicians,” said AMA President Susan R. Bailey, MD, in a news release on the survey’s findings. “More economic relief is needed now from Congress as some medical practices contemplate the brink of viability, particularly smaller practices that are facing a difficult road to recovery.”

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

Physician practices nationwide lost 32% of their revenue, on average, from February to the summer, according to a new American Medical Association survey of 3,500 physicians, conducted from mid-July to August. That period coincided with the second wave of the coronavirus pandemic in the United States.

A third of practices reported a revenue drop of 25%-49%; 15% said their volume had fallen by 50%-74%, and 4% saw a decrease of 75% or more.

Because of the pandemic, 81% of physicians were providing fewer in-person visits than in February. In-person visits dropped by 50% or more for more than one-third of physicians. The average number of in-person visits fell from 95 to 57 per week.

Physicians who responded to the survey held an average of six weekly telehealth visits before the pandemic, 29 at the height of the pandemic in the spring, and 16 the week they were surveyed. About 20% of respondents with any telehealth visits had conducted them before the pandemic, 77% at the height of the crisis, and 68% in the survey week.

Among the doctors who weren’t involved in telehealth visits before the pandemic, only 23% conducted them at the pandemic’s peak; 12% conducted them in the survey week.

Despite the telehealth increase, almost 70% of physicians were providing fewer total visits, including in-person and virtual encounters, than before the pandemic, the survey showed. About 21% saw a decrease of 25%-49%; 11%, a drop of 50%-74%; and 10%, a falloff of at least 75%. On average, total visits fell from 101 to 72 per week.
 

Other surveys more upbeat

A larger survey by Harvard University, the Commonwealth Fund, and the technology company Phreesia found that total outpatient visits in early October had rebounded to the level of March 1. This was a major turnaround from late March, when visits had plunged by nearly 60%.

According to the Harvard/Commonwealth Fund’s ongoing survey, visits started recovering in late June, although they were still off by 10%. They began rising further around Labor Day. The AMA researchers began conducting their survey in mid-June. The summertime surge in COVID-19 likely accounted for their finding that practice revenues were off by a third from the February baseline.

If so, the return to normalcy early this month may not represent the current situation as the virus sweeps across the country for a third time. In any case, even if patient visits and revenues have recovered more than the AMA data indicate, most practices will not have recovered from their losses earlier in the year.

A third survey more closely mirrors the AMA results. At the end of June, according to data from the Medical Group Management Association, revenues for the association’s members were 76% of what they had been in June 2019, and patient volume was 78% of that in the previous year.
 

Practice expenses rise

The AMA survey also found that, since February, practice spending on personal protective equipment (PPE) had increased by 57% or more, on average. About 64% of practice owners said their PPE expenditures were up from what they had been before the pandemic. For nearly 40% of practice owners, this expense had increased by 50% or more.

About 36% of the respondents said that acquiring PPE was very or extremely difficult. This was an especially big challenge for smaller practices, which do not have the purchasing power to compete with big health care systems for masks, gowns, and gloves, the AMA noted.

About 41% of doctors in practices with one to five physicians said they had difficulty getting PPE, compared with 30% of those in practices of 50 or more doctors. Only 25% of respondents in practices owned by hospitals and health systems said this was a problem.

Acquiring sufficient PPE is just one factor in the increase in practice expenses attributable to COVID-19. Still, it is indicative of the financial woes affecting physicians during the pandemic.

Nearly all respondents agreed that federal financial relief early in the pandemic was helpful and was appreciated. Among these programs was the CARES Act, which authorized the Provider Relief Fund, which accepted applications through Aug.28; the Medicare Accelerated and Advance Payment Program, which was suspended in April; and the SBA Paycheck Protection Program, which ended on Aug. 8.

To date, Congress had not approved the renewal of any these programs.

“Physician practices continue to be under significant financial stress due to reductions in patient volume and revenue, in addition to higher expenses for supplies that are scarce for some physicians,” said AMA President Susan R. Bailey, MD, in a news release on the survey’s findings. “More economic relief is needed now from Congress as some medical practices contemplate the brink of viability, particularly smaller practices that are facing a difficult road to recovery.”

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

The Department of Health & Human Services on Oct. 29 extended the deadline for health care groups to provide patients with immediate electronic access to their doctors’ clinical notes as well as test results and reports from pathology and imaging.

The mandate, called “open notes” by many, is part of the 21st Century Cures Act, and will now go into effect April 5.

The announcement comes just 4 days before the previously established Nov. 2 deadline and gives the pandemic as the reason for the delay.

“We are hearing that, while there is strong support for advancing patient access … stakeholders also must manage the needs being experienced during the current pandemic,” Don Rucker, MD, national coordinator for health information technology at HHS, said in a press statement.

“To be clear, the Office of the National Coordinator is not removing the requirements advancing patient access to their health information,” he added.
 

‘What you make of it’

Scott MacDonald, MD, electronic health record medical director at the University of California, Davis, said his organization is proceeding anyway. “UC Davis is going to start releasing notes and test results on Nov. 12,” he said in an interview.

Other organizations and practices now have more time, he said, but the law stays the same. “There’s no change to the what or why – only to the when,” Dr. MacDonald pointed out.

Vanderbilt University Medical Center in Nashville, Tenn., will take advantage of the extra time, Trent Rosenbloom, MD, MPH, director of patient portals, said in an interview.

“Given the super-short time frame we had to work under as this emerged out from dealing with COVID, we feel that we have not addressed all the potential legal-edge cases such as dealing with adolescent medicine and child abuse,” he said.

On Oct. 21, this news organization reported on the then-imminent start of the new law, which irked many readers. They cited, among other things, the likelihood of patient confusion with fast patient access to all clinical notes.

“To me, the biggest issue is that we speak a foreign language that most outside of medicine don’t speak. Our job is to explain it to the patient at a level they can understand. What will 100% happen now is that a patient will not be able to reconcile what is in the note to what they’ve been told,” Andrew White, MD, wrote in a reader comment.

But benefits of open notes outweigh the risks, say proponents, who claim that doctor-patient communication and trust actually improve with information access and that research indicates other benefits such as improved medication adherence.

Open notes are “what you make of it,” said Marlene Millen, MD, an internist at UC San Diego Health, which has had a pilot open-notes program for 3 years.

“I actually end all of my appointments with: ‘Don’t forget to read your note later,’ ” she said in an interview.

Dr. Millen feared open notes initially but, within the first 3 months of usage, about 15 patients gave her direct feedback on how much they appreciated her notes. “It seemed to really reassure them that they were getting good care.”

Dr. MacDonald and Dr. Millen disclosed no relevant financial relationships.
 

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

The Department of Health & Human Services on Oct. 29 extended the deadline for health care groups to provide patients with immediate electronic access to their doctors’ clinical notes as well as test results and reports from pathology and imaging.

The mandate, called “open notes” by many, is part of the 21st Century Cures Act, and will now go into effect April 5.

The announcement comes just 4 days before the previously established Nov. 2 deadline and gives the pandemic as the reason for the delay.

“We are hearing that, while there is strong support for advancing patient access … stakeholders also must manage the needs being experienced during the current pandemic,” Don Rucker, MD, national coordinator for health information technology at HHS, said in a press statement.

“To be clear, the Office of the National Coordinator is not removing the requirements advancing patient access to their health information,” he added.
 

‘What you make of it’

Scott MacDonald, MD, electronic health record medical director at the University of California, Davis, said his organization is proceeding anyway. “UC Davis is going to start releasing notes and test results on Nov. 12,” he said in an interview.

Other organizations and practices now have more time, he said, but the law stays the same. “There’s no change to the what or why – only to the when,” Dr. MacDonald pointed out.

Vanderbilt University Medical Center in Nashville, Tenn., will take advantage of the extra time, Trent Rosenbloom, MD, MPH, director of patient portals, said in an interview.

“Given the super-short time frame we had to work under as this emerged out from dealing with COVID, we feel that we have not addressed all the potential legal-edge cases such as dealing with adolescent medicine and child abuse,” he said.

On Oct. 21, this news organization reported on the then-imminent start of the new law, which irked many readers. They cited, among other things, the likelihood of patient confusion with fast patient access to all clinical notes.

“To me, the biggest issue is that we speak a foreign language that most outside of medicine don’t speak. Our job is to explain it to the patient at a level they can understand. What will 100% happen now is that a patient will not be able to reconcile what is in the note to what they’ve been told,” Andrew White, MD, wrote in a reader comment.

But benefits of open notes outweigh the risks, say proponents, who claim that doctor-patient communication and trust actually improve with information access and that research indicates other benefits such as improved medication adherence.

Open notes are “what you make of it,” said Marlene Millen, MD, an internist at UC San Diego Health, which has had a pilot open-notes program for 3 years.

“I actually end all of my appointments with: ‘Don’t forget to read your note later,’ ” she said in an interview.

Dr. Millen feared open notes initially but, within the first 3 months of usage, about 15 patients gave her direct feedback on how much they appreciated her notes. “It seemed to really reassure them that they were getting good care.”

Dr. MacDonald and Dr. Millen disclosed no relevant financial relationships.
 

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

The Department of Health & Human Services on Oct. 29 extended the deadline for health care groups to provide patients with immediate electronic access to their doctors’ clinical notes as well as test results and reports from pathology and imaging.

The mandate, called “open notes” by many, is part of the 21st Century Cures Act, and will now go into effect April 5.

The announcement comes just 4 days before the previously established Nov. 2 deadline and gives the pandemic as the reason for the delay.

“We are hearing that, while there is strong support for advancing patient access … stakeholders also must manage the needs being experienced during the current pandemic,” Don Rucker, MD, national coordinator for health information technology at HHS, said in a press statement.

“To be clear, the Office of the National Coordinator is not removing the requirements advancing patient access to their health information,” he added.
 

‘What you make of it’

Scott MacDonald, MD, electronic health record medical director at the University of California, Davis, said his organization is proceeding anyway. “UC Davis is going to start releasing notes and test results on Nov. 12,” he said in an interview.

Other organizations and practices now have more time, he said, but the law stays the same. “There’s no change to the what or why – only to the when,” Dr. MacDonald pointed out.

Vanderbilt University Medical Center in Nashville, Tenn., will take advantage of the extra time, Trent Rosenbloom, MD, MPH, director of patient portals, said in an interview.

“Given the super-short time frame we had to work under as this emerged out from dealing with COVID, we feel that we have not addressed all the potential legal-edge cases such as dealing with adolescent medicine and child abuse,” he said.

On Oct. 21, this news organization reported on the then-imminent start of the new law, which irked many readers. They cited, among other things, the likelihood of patient confusion with fast patient access to all clinical notes.

“To me, the biggest issue is that we speak a foreign language that most outside of medicine don’t speak. Our job is to explain it to the patient at a level they can understand. What will 100% happen now is that a patient will not be able to reconcile what is in the note to what they’ve been told,” Andrew White, MD, wrote in a reader comment.

But benefits of open notes outweigh the risks, say proponents, who claim that doctor-patient communication and trust actually improve with information access and that research indicates other benefits such as improved medication adherence.

Open notes are “what you make of it,” said Marlene Millen, MD, an internist at UC San Diego Health, which has had a pilot open-notes program for 3 years.

“I actually end all of my appointments with: ‘Don’t forget to read your note later,’ ” she said in an interview.

Dr. Millen feared open notes initially but, within the first 3 months of usage, about 15 patients gave her direct feedback on how much they appreciated her notes. “It seemed to really reassure them that they were getting good care.”

Dr. MacDonald and Dr. Millen disclosed no relevant financial relationships.
 

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