Hematology News

For reasons unknown, about one in six people who recovered from COVID-19 subsequently retested positive at least 2 weeks later, researchers reported in a study in Italy.

Sore throat and rhinitis were the only symptoms associated with a positive result. “Patients who continued to have respiratory symptoms, especially, were more likely to have a new positive test result,” lead author Francesco Landi, MD, PhD, said in an interview.

“This suggests the persistence of respiratory symptoms should not be underestimated and should be adequately assessed in all patients considered recovered from COVID-19,” he said.

“The study results are interesting,” Akiko Iwasaki, PhD, an immunobiologist at Yale University and the Howard Hughes Medical Institute, both in New Haven, Conn.,, said in an interview. “There are other reports of RNA detection postdischarge, but this study ... found that only two symptoms out of many – sore throat and rhinitis – were higher in those with PCR [polymerase chain reaction]-positive status.”

The study was published online Sept. 18 in the American Journal of Preventive Medicine.

The findings could carry important implications for people who continue to be symptomatic. “It is reasonable to be cautious and avoid close contact with others, wear a face mask, and possibly undergo an additional nasopharyngeal swab,” said Dr. Landi, associate professor of internal medicine at Catholic University of the Sacred Heart in Rome.

“One of most interesting findings is that persistent symptoms do not correlate with PCR positivity, suggesting that symptoms are in many cases not due to ongoing viral replication,” Jonathan Karn, PhD, professor and chair of the department of molecular biology and microbiology at Case Western Reserve University, Cleveland, said in an interview.

“The key technical problem, which they have discussed, is that a viral RNA signal in the PCR assay does not necessarily mean that infectious virus is present,” Dr. Karn said. He added that new comprehensive viral RNA analyses would be needed to answer this question.
 

Official COVID-19 recovery

To identify risk factors and COVID-19 survivors more likely to retest positive, Dr. Landi and members of the Gemelli Against COVID-19 Post-Acute Care Study Group evaluated 131 people after hospital discharge.

All participants met World Health Organization criteria for release from isolation, including two negative test results at least 24 hours apart, and were studied between April 21 and May 21. Mean age was 56 and 39% were women. Only a slightly higher mean body mass index of 27.6 kg/m² in the positive group versus 25.9 in the negative group, was significant.

Although 51% of survivors reported fatigue, 44% had dyspnea, and 17% were coughing, the rates did not differ significantly between groups. In contrast, 18% of positive survivors and 4% of negative survivors had a sore throat (P = .04), and 27% versus 12%, respectively, reported rhinitis (P = .05).

People returned for follow-up visits a mean 17 days after the second negative swab test.
 

Asymptomatic COVID-19 carriers

“These findings indicate that a noteworthy rate of recovered patients with COVID-19 could still be asymptomatic carriers of the virus,” the researchers noted in the paper. “Even in the absence of specific guidelines, the 22 patients who tested positive for COVID-19 again were suggested to quarantine for a second time.”

No family member or close contact of the positive survivors reported SARS-CoV-2 infection. All patients continued to wear masks and observe social distancing recommendations, which makes it “very difficult to affirm whether these patients were really contagious,” the researchers noted.
 

Next steps

Evaluating all COVID-19 survivors to identify any who retest positive “will be a crucial contribution to a better understanding of both the natural history of COVID-19 as well as the public health implications of viral shedding,” the authors wrote.

One study limitation is that the reverse transcriptase–PCR test reveals genetic sequences specific to COVID-19. “It is important to underline that this is not a viral culture and cannot determine whether the virus is viable and transmissible,” the researchers noted.

“In this respect, we are trying to better understand if the persistence of long-time positive [reverse transcriptase]–PCR test for COVID-19 is really correlated to a potential contagiousness,” they added.

Dr. Landi and colleagues said their findings should be considered preliminary, and larger data samples are warranted to validate the results.

Dr. Landi and Dr. Karn disclosed no relevant financial relationships. Dr. Iwasaki disclosed a research grant from Condair, a 5% or greater equity interest in RIGImmune, and income of $250 or more from PureTec.

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

For reasons unknown, about one in six people who recovered from COVID-19 subsequently retested positive at least 2 weeks later, researchers reported in a study in Italy.

Sore throat and rhinitis were the only symptoms associated with a positive result. “Patients who continued to have respiratory symptoms, especially, were more likely to have a new positive test result,” lead author Francesco Landi, MD, PhD, said in an interview.

“This suggests the persistence of respiratory symptoms should not be underestimated and should be adequately assessed in all patients considered recovered from COVID-19,” he said.

“The study results are interesting,” Akiko Iwasaki, PhD, an immunobiologist at Yale University and the Howard Hughes Medical Institute, both in New Haven, Conn.,, said in an interview. “There are other reports of RNA detection postdischarge, but this study ... found that only two symptoms out of many – sore throat and rhinitis – were higher in those with PCR [polymerase chain reaction]-positive status.”

The study was published online Sept. 18 in the American Journal of Preventive Medicine.

The findings could carry important implications for people who continue to be symptomatic. “It is reasonable to be cautious and avoid close contact with others, wear a face mask, and possibly undergo an additional nasopharyngeal swab,” said Dr. Landi, associate professor of internal medicine at Catholic University of the Sacred Heart in Rome.

“One of most interesting findings is that persistent symptoms do not correlate with PCR positivity, suggesting that symptoms are in many cases not due to ongoing viral replication,” Jonathan Karn, PhD, professor and chair of the department of molecular biology and microbiology at Case Western Reserve University, Cleveland, said in an interview.

“The key technical problem, which they have discussed, is that a viral RNA signal in the PCR assay does not necessarily mean that infectious virus is present,” Dr. Karn said. He added that new comprehensive viral RNA analyses would be needed to answer this question.
 

Official COVID-19 recovery

To identify risk factors and COVID-19 survivors more likely to retest positive, Dr. Landi and members of the Gemelli Against COVID-19 Post-Acute Care Study Group evaluated 131 people after hospital discharge.

All participants met World Health Organization criteria for release from isolation, including two negative test results at least 24 hours apart, and were studied between April 21 and May 21. Mean age was 56 and 39% were women. Only a slightly higher mean body mass index of 27.6 kg/m² in the positive group versus 25.9 in the negative group, was significant.

Although 51% of survivors reported fatigue, 44% had dyspnea, and 17% were coughing, the rates did not differ significantly between groups. In contrast, 18% of positive survivors and 4% of negative survivors had a sore throat (P = .04), and 27% versus 12%, respectively, reported rhinitis (P = .05).

People returned for follow-up visits a mean 17 days after the second negative swab test.
 

Asymptomatic COVID-19 carriers

“These findings indicate that a noteworthy rate of recovered patients with COVID-19 could still be asymptomatic carriers of the virus,” the researchers noted in the paper. “Even in the absence of specific guidelines, the 22 patients who tested positive for COVID-19 again were suggested to quarantine for a second time.”

No family member or close contact of the positive survivors reported SARS-CoV-2 infection. All patients continued to wear masks and observe social distancing recommendations, which makes it “very difficult to affirm whether these patients were really contagious,” the researchers noted.
 

Next steps

Evaluating all COVID-19 survivors to identify any who retest positive “will be a crucial contribution to a better understanding of both the natural history of COVID-19 as well as the public health implications of viral shedding,” the authors wrote.

One study limitation is that the reverse transcriptase–PCR test reveals genetic sequences specific to COVID-19. “It is important to underline that this is not a viral culture and cannot determine whether the virus is viable and transmissible,” the researchers noted.

“In this respect, we are trying to better understand if the persistence of long-time positive [reverse transcriptase]–PCR test for COVID-19 is really correlated to a potential contagiousness,” they added.

Dr. Landi and colleagues said their findings should be considered preliminary, and larger data samples are warranted to validate the results.

Dr. Landi and Dr. Karn disclosed no relevant financial relationships. Dr. Iwasaki disclosed a research grant from Condair, a 5% or greater equity interest in RIGImmune, and income of $250 or more from PureTec.

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

For reasons unknown, about one in six people who recovered from COVID-19 subsequently retested positive at least 2 weeks later, researchers reported in a study in Italy.

Sore throat and rhinitis were the only symptoms associated with a positive result. “Patients who continued to have respiratory symptoms, especially, were more likely to have a new positive test result,” lead author Francesco Landi, MD, PhD, said in an interview.

“This suggests the persistence of respiratory symptoms should not be underestimated and should be adequately assessed in all patients considered recovered from COVID-19,” he said.

“The study results are interesting,” Akiko Iwasaki, PhD, an immunobiologist at Yale University and the Howard Hughes Medical Institute, both in New Haven, Conn.,, said in an interview. “There are other reports of RNA detection postdischarge, but this study ... found that only two symptoms out of many – sore throat and rhinitis – were higher in those with PCR [polymerase chain reaction]-positive status.”

The study was published online Sept. 18 in the American Journal of Preventive Medicine.

The findings could carry important implications for people who continue to be symptomatic. “It is reasonable to be cautious and avoid close contact with others, wear a face mask, and possibly undergo an additional nasopharyngeal swab,” said Dr. Landi, associate professor of internal medicine at Catholic University of the Sacred Heart in Rome.

“One of most interesting findings is that persistent symptoms do not correlate with PCR positivity, suggesting that symptoms are in many cases not due to ongoing viral replication,” Jonathan Karn, PhD, professor and chair of the department of molecular biology and microbiology at Case Western Reserve University, Cleveland, said in an interview.

“The key technical problem, which they have discussed, is that a viral RNA signal in the PCR assay does not necessarily mean that infectious virus is present,” Dr. Karn said. He added that new comprehensive viral RNA analyses would be needed to answer this question.
 

Official COVID-19 recovery

To identify risk factors and COVID-19 survivors more likely to retest positive, Dr. Landi and members of the Gemelli Against COVID-19 Post-Acute Care Study Group evaluated 131 people after hospital discharge.

All participants met World Health Organization criteria for release from isolation, including two negative test results at least 24 hours apart, and were studied between April 21 and May 21. Mean age was 56 and 39% were women. Only a slightly higher mean body mass index of 27.6 kg/m² in the positive group versus 25.9 in the negative group, was significant.

Although 51% of survivors reported fatigue, 44% had dyspnea, and 17% were coughing, the rates did not differ significantly between groups. In contrast, 18% of positive survivors and 4% of negative survivors had a sore throat (P = .04), and 27% versus 12%, respectively, reported rhinitis (P = .05).

People returned for follow-up visits a mean 17 days after the second negative swab test.
 

Asymptomatic COVID-19 carriers

“These findings indicate that a noteworthy rate of recovered patients with COVID-19 could still be asymptomatic carriers of the virus,” the researchers noted in the paper. “Even in the absence of specific guidelines, the 22 patients who tested positive for COVID-19 again were suggested to quarantine for a second time.”

No family member or close contact of the positive survivors reported SARS-CoV-2 infection. All patients continued to wear masks and observe social distancing recommendations, which makes it “very difficult to affirm whether these patients were really contagious,” the researchers noted.
 

Next steps

Evaluating all COVID-19 survivors to identify any who retest positive “will be a crucial contribution to a better understanding of both the natural history of COVID-19 as well as the public health implications of viral shedding,” the authors wrote.

One study limitation is that the reverse transcriptase–PCR test reveals genetic sequences specific to COVID-19. “It is important to underline that this is not a viral culture and cannot determine whether the virus is viable and transmissible,” the researchers noted.

“In this respect, we are trying to better understand if the persistence of long-time positive [reverse transcriptase]–PCR test for COVID-19 is really correlated to a potential contagiousness,” they added.

Dr. Landi and colleagues said their findings should be considered preliminary, and larger data samples are warranted to validate the results.

Dr. Landi and Dr. Karn disclosed no relevant financial relationships. Dr. Iwasaki disclosed a research grant from Condair, a 5% or greater equity interest in RIGImmune, and income of $250 or more from PureTec.

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

Federal advisers who will help determine which Americans get the first COVID vaccines took an in-depth look Oct. 30 at the challenges they face in selecting priority groups.

The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) will face two key decisions once a COVID vaccine wins clearance from the US Food and Drug Administration (FDA).

ACIP will need to decide whether to recommend its use in adults (the age group in which vaccines are currently being tested). The group will also need to offer direction on which groups should get priority in vaccine allocation, inasmuch as early supplies will not be sufficient to vaccinate everyone.

At the Oct. 30 meeting, CDC’s Kathleen Dooling, MD, MPH, suggested that ACIP plan on tackling these issues as two separate questions when it comes time to weigh in on an approved vaccine. Although there was no formal vote among ACIP members at the meeting, Dooling’s proposal for tackling a future recommendation in a two-part fashion drew positive feedback.

ACIP member Katherine A. Poehling, MD, MPH, suggested that the panel and CDC be ready to reexamine the situation frequently regarding COVID vaccination. “Perhaps we could think about reviewing data on a monthly basis and updating the recommendation, so that we can account for the concerns and balance both the benefits and the [potential] harm,” Poehling said.

Dooling agreed. “Both the vaccine recommendation and allocation will be revisited in what is a very dynamic situation,” Dooling replied to Poehling. “So all new evidence will be brought to ACIP, and certainly the allocation as vaccine distribution proceeds will need to be adjusted accordingly.”
 

Ethics and limited evidence

During the meeting, ACIP members repeatedly expressed discomfort with the prospect of having to weigh in on widespread use of COVID vaccines on the basis of limited evidence.

Within months, FDA may opt for a special clearance, known as an emergency use authorization (EUA), for one or more of the experimental COVID vaccines now in advanced testing. Many of FDA’s past EUA clearances were granted for test kits. For those EUA approvals, the agency considered risks of false results but not longer-term, direct harm to patients from these products.

With a COVID vaccine, there will be strong pressure to distribute doses as quickly as possible with the hope of curbing the pandemic, which has already led to more than 229,000 deaths in the United States alone and has disrupted lives and economies around the world. But questions will persist about the possibility of serious complications from these vaccines, ACIP members noted.

“My personal struggle is the ethical side and how to balance these two,” said ACIP member Robert L. Atmar, MD, of Baylor College of Medicine, Houston, Texas, who noted that he expects his fellow panelists to share this concern.

Currently, four experimental COVID vaccines likely to be used in the United States have advanced to phase 3 testing. Pfizer Inc and BioNtech have enrolled more than 42,000 participants in a test of their candidate, BNT162b2 vaccine, and rival Moderna has enrolled about 30,000 participants in a test of its mRNA-1273 vaccine, CDC staff said.

The other two advanced COVID vaccine candidates have overcome recent hurdles. AstraZeneca Plc on Oct. 23 announced that FDA had removed a hold on the testing of its AZD1222 vaccine candidate; the trial will enroll approximately 30,000 people. Johnson & Johnson’s Janssen unit also announced that day the lifting of a safety pause for its Ad26.COV2.S vaccine; the phase 3 trial for that vaccine will enroll approximately 60,000 volunteers. Federal agencies, states, and territories have developed plans for future distribution of COVID vaccines, CDC staff said in briefing materials for today’s ACIP meeting.

Several ACIP members raised many of the same concerns that members of an FDA advisory committee raised at a meeting earlier in October. ACIP and FDA advisers honed in on the FDA’s decision to set a median follow-up duration of 2 months in phase 3 trials in connection with expected EUA applications for COVID-19 vaccines.

“I struggle with following people for 2 months after their second vaccination as a time point to start making final decisions about safety,” said ACIP member Sharon E. Frey, MD, a professor at St. Louis University School of Medicine, St. Louis, Missouri. “I just want to put that out there.”
 

Medical front line, then who?

There is consensus that healthcare workers be in the first stage ― Phase 1 ― of distribution. That recommendation was made in a report from the National Academies of Sciences, Engineering, and Medicine (NASEM). Phase 1A would include first responders; Phase 1B might include people of all ages who have two or more comorbidities that put them at significantly higher risk for COVID-19 or death, as well as older adults living in congregate or overcrowded settings, the NASEM report said.

A presentation from the CDC’s Matthew Biggerstaff, ScD, MPH, underscored challenges in distributing what are expected to be limited initial supplies of COVID vaccines.

Biggerstaff showed several scenarios the CDC’s Data, Analytics, and Modeling Task Force had studied. The initial allocation of vaccines would be for healthcare workers, followed by what the CDC called Phase 1B.

Choices for a rollout may include next giving COVID vaccines to people at high risk, such as persons who have one or more chronic medical conditions, including heart disease, diabetes, kidney disease, or obesity. Other options for the rollout could be to vaccinate people aged 65 years and older or essential workers whose employment puts them in contact with the public, thus raising the risk of contracting the virus.

The CDC’s research found that the greatest impact in preventing death was to initially vaccinate adults aged 65 and older in Phase 1B. The agency staff described this approach as likely to result in an about “1 to 11% increase in averted deaths across the scenarios.”

Initially vaccinating essential workers or high-risk adults in Phase 1B would avert the most infections. The agency staff described this approach as yielding about “1 to 5% increase in averted infections across the scenarios,” Biggerstaff said during his presentation.

The following are other findings of the CDC staff:

The earlier the vaccine rollout relative to increasing transmission, the greater the averted percentage and differences between the strategies.

Differences were not substantial in some scenarios.

The need to continue efforts to slow the spread of COVID-19 should be emphasized.

Adverse effects

ACIP members also heard about strategies for tracking potential side effects of future vaccines. A presentation by Tom Shimabukuro, MD, MPH, MBA, from the CDC’s COVID-19 Vaccine Task Force/Vaccine Safety Team, included details about a new smartphone-based active surveillance program for COVID-19 vaccine safety.

Known as v-safe, this system would use Web-based survey monitoring and incorporate text messaging. It would conduct electronic health checks on vaccine recipients, which would occur daily during the first week post vaccination and weekly thereafter for 6 weeks from the time of vaccination.

Clinicians “can play an important role in helping CDC enroll patients in v-safe at the time of vaccination,” Shimabukuro noted in his presentation. This would add another task, though, for clinicians, the CDC staff noted.
 

Pregnancy and breastfeeding are special concerns

Of special concern with the rollout of a COVID vaccine are recommendations regarding pregnancy and breastfeeding. Women constitute about 75% of the healthcare workforce, CDC staff noted.

At the time the initial ACIP COVID vaccination recommendations are made, there could be approximately 330,000 healthcare personnel who are pregnant or who have recently given birth. Available data indicate potentially increased risks for severe maternal illness and preterm birth associated with SARS-CoV-2 infection, said CDC’s Megan Wallace, DrPH, MPH, in a presentation for the Friday meeting.

In an Oct. 27 letter to ACIP, Chair Jose Romero, the American College of Obstetricians and Gynecologists (ACOG), urged the panel to ensure that pregnant women and new mothers in the healthcare workforce have priority access to a COVID vaccine. Pregnant and lactating women were “noticeably and alarmingly absent from the NASEM vaccine allocation plan for COVID-19,” wrote Christopher M. Zahn, MD, vice president for practice activities at ACOG, in the letter to Romero.

“ACOG urges ACIP to incorporate pregnant and lactating women clearly and explicitly into its COVID-19 vaccine allocation and prioritization framework,” Zahn wrote. “Should an Emergency Use Authorization be executed for one or more COVID-19 vaccines and provide a permissive recommendation for pregnant and lactating women, pregnant health care workers, pregnant first responders, and pregnant individuals with underlying conditions should be prioritized for vaccination alongside their non-pregnant peers.”

This article first appeared on Medscape.com.

Federal advisers who will help determine which Americans get the first COVID vaccines took an in-depth look Oct. 30 at the challenges they face in selecting priority groups.

The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) will face two key decisions once a COVID vaccine wins clearance from the US Food and Drug Administration (FDA).

ACIP will need to decide whether to recommend its use in adults (the age group in which vaccines are currently being tested). The group will also need to offer direction on which groups should get priority in vaccine allocation, inasmuch as early supplies will not be sufficient to vaccinate everyone.

At the Oct. 30 meeting, CDC’s Kathleen Dooling, MD, MPH, suggested that ACIP plan on tackling these issues as two separate questions when it comes time to weigh in on an approved vaccine. Although there was no formal vote among ACIP members at the meeting, Dooling’s proposal for tackling a future recommendation in a two-part fashion drew positive feedback.

ACIP member Katherine A. Poehling, MD, MPH, suggested that the panel and CDC be ready to reexamine the situation frequently regarding COVID vaccination. “Perhaps we could think about reviewing data on a monthly basis and updating the recommendation, so that we can account for the concerns and balance both the benefits and the [potential] harm,” Poehling said.

Dooling agreed. “Both the vaccine recommendation and allocation will be revisited in what is a very dynamic situation,” Dooling replied to Poehling. “So all new evidence will be brought to ACIP, and certainly the allocation as vaccine distribution proceeds will need to be adjusted accordingly.”
 

Ethics and limited evidence

During the meeting, ACIP members repeatedly expressed discomfort with the prospect of having to weigh in on widespread use of COVID vaccines on the basis of limited evidence.

Within months, FDA may opt for a special clearance, known as an emergency use authorization (EUA), for one or more of the experimental COVID vaccines now in advanced testing. Many of FDA’s past EUA clearances were granted for test kits. For those EUA approvals, the agency considered risks of false results but not longer-term, direct harm to patients from these products.

With a COVID vaccine, there will be strong pressure to distribute doses as quickly as possible with the hope of curbing the pandemic, which has already led to more than 229,000 deaths in the United States alone and has disrupted lives and economies around the world. But questions will persist about the possibility of serious complications from these vaccines, ACIP members noted.

“My personal struggle is the ethical side and how to balance these two,” said ACIP member Robert L. Atmar, MD, of Baylor College of Medicine, Houston, Texas, who noted that he expects his fellow panelists to share this concern.

Currently, four experimental COVID vaccines likely to be used in the United States have advanced to phase 3 testing. Pfizer Inc and BioNtech have enrolled more than 42,000 participants in a test of their candidate, BNT162b2 vaccine, and rival Moderna has enrolled about 30,000 participants in a test of its mRNA-1273 vaccine, CDC staff said.

The other two advanced COVID vaccine candidates have overcome recent hurdles. AstraZeneca Plc on Oct. 23 announced that FDA had removed a hold on the testing of its AZD1222 vaccine candidate; the trial will enroll approximately 30,000 people. Johnson & Johnson’s Janssen unit also announced that day the lifting of a safety pause for its Ad26.COV2.S vaccine; the phase 3 trial for that vaccine will enroll approximately 60,000 volunteers. Federal agencies, states, and territories have developed plans for future distribution of COVID vaccines, CDC staff said in briefing materials for today’s ACIP meeting.

Several ACIP members raised many of the same concerns that members of an FDA advisory committee raised at a meeting earlier in October. ACIP and FDA advisers honed in on the FDA’s decision to set a median follow-up duration of 2 months in phase 3 trials in connection with expected EUA applications for COVID-19 vaccines.

“I struggle with following people for 2 months after their second vaccination as a time point to start making final decisions about safety,” said ACIP member Sharon E. Frey, MD, a professor at St. Louis University School of Medicine, St. Louis, Missouri. “I just want to put that out there.”
 

Medical front line, then who?

There is consensus that healthcare workers be in the first stage ― Phase 1 ― of distribution. That recommendation was made in a report from the National Academies of Sciences, Engineering, and Medicine (NASEM). Phase 1A would include first responders; Phase 1B might include people of all ages who have two or more comorbidities that put them at significantly higher risk for COVID-19 or death, as well as older adults living in congregate or overcrowded settings, the NASEM report said.

A presentation from the CDC’s Matthew Biggerstaff, ScD, MPH, underscored challenges in distributing what are expected to be limited initial supplies of COVID vaccines.

Biggerstaff showed several scenarios the CDC’s Data, Analytics, and Modeling Task Force had studied. The initial allocation of vaccines would be for healthcare workers, followed by what the CDC called Phase 1B.

Choices for a rollout may include next giving COVID vaccines to people at high risk, such as persons who have one or more chronic medical conditions, including heart disease, diabetes, kidney disease, or obesity. Other options for the rollout could be to vaccinate people aged 65 years and older or essential workers whose employment puts them in contact with the public, thus raising the risk of contracting the virus.

The CDC’s research found that the greatest impact in preventing death was to initially vaccinate adults aged 65 and older in Phase 1B. The agency staff described this approach as likely to result in an about “1 to 11% increase in averted deaths across the scenarios.”

Initially vaccinating essential workers or high-risk adults in Phase 1B would avert the most infections. The agency staff described this approach as yielding about “1 to 5% increase in averted infections across the scenarios,” Biggerstaff said during his presentation.

The following are other findings of the CDC staff:

The earlier the vaccine rollout relative to increasing transmission, the greater the averted percentage and differences between the strategies.

Differences were not substantial in some scenarios.

The need to continue efforts to slow the spread of COVID-19 should be emphasized.

Adverse effects

ACIP members also heard about strategies for tracking potential side effects of future vaccines. A presentation by Tom Shimabukuro, MD, MPH, MBA, from the CDC’s COVID-19 Vaccine Task Force/Vaccine Safety Team, included details about a new smartphone-based active surveillance program for COVID-19 vaccine safety.

Known as v-safe, this system would use Web-based survey monitoring and incorporate text messaging. It would conduct electronic health checks on vaccine recipients, which would occur daily during the first week post vaccination and weekly thereafter for 6 weeks from the time of vaccination.

Clinicians “can play an important role in helping CDC enroll patients in v-safe at the time of vaccination,” Shimabukuro noted in his presentation. This would add another task, though, for clinicians, the CDC staff noted.
 

Pregnancy and breastfeeding are special concerns

Of special concern with the rollout of a COVID vaccine are recommendations regarding pregnancy and breastfeeding. Women constitute about 75% of the healthcare workforce, CDC staff noted.

At the time the initial ACIP COVID vaccination recommendations are made, there could be approximately 330,000 healthcare personnel who are pregnant or who have recently given birth. Available data indicate potentially increased risks for severe maternal illness and preterm birth associated with SARS-CoV-2 infection, said CDC’s Megan Wallace, DrPH, MPH, in a presentation for the Friday meeting.

In an Oct. 27 letter to ACIP, Chair Jose Romero, the American College of Obstetricians and Gynecologists (ACOG), urged the panel to ensure that pregnant women and new mothers in the healthcare workforce have priority access to a COVID vaccine. Pregnant and lactating women were “noticeably and alarmingly absent from the NASEM vaccine allocation plan for COVID-19,” wrote Christopher M. Zahn, MD, vice president for practice activities at ACOG, in the letter to Romero.

“ACOG urges ACIP to incorporate pregnant and lactating women clearly and explicitly into its COVID-19 vaccine allocation and prioritization framework,” Zahn wrote. “Should an Emergency Use Authorization be executed for one or more COVID-19 vaccines and provide a permissive recommendation for pregnant and lactating women, pregnant health care workers, pregnant first responders, and pregnant individuals with underlying conditions should be prioritized for vaccination alongside their non-pregnant peers.”

This article first appeared on Medscape.com.

Federal advisers who will help determine which Americans get the first COVID vaccines took an in-depth look Oct. 30 at the challenges they face in selecting priority groups.

The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) will face two key decisions once a COVID vaccine wins clearance from the US Food and Drug Administration (FDA).

ACIP will need to decide whether to recommend its use in adults (the age group in which vaccines are currently being tested). The group will also need to offer direction on which groups should get priority in vaccine allocation, inasmuch as early supplies will not be sufficient to vaccinate everyone.

At the Oct. 30 meeting, CDC’s Kathleen Dooling, MD, MPH, suggested that ACIP plan on tackling these issues as two separate questions when it comes time to weigh in on an approved vaccine. Although there was no formal vote among ACIP members at the meeting, Dooling’s proposal for tackling a future recommendation in a two-part fashion drew positive feedback.

ACIP member Katherine A. Poehling, MD, MPH, suggested that the panel and CDC be ready to reexamine the situation frequently regarding COVID vaccination. “Perhaps we could think about reviewing data on a monthly basis and updating the recommendation, so that we can account for the concerns and balance both the benefits and the [potential] harm,” Poehling said.

Dooling agreed. “Both the vaccine recommendation and allocation will be revisited in what is a very dynamic situation,” Dooling replied to Poehling. “So all new evidence will be brought to ACIP, and certainly the allocation as vaccine distribution proceeds will need to be adjusted accordingly.”
 

Ethics and limited evidence

During the meeting, ACIP members repeatedly expressed discomfort with the prospect of having to weigh in on widespread use of COVID vaccines on the basis of limited evidence.

Within months, FDA may opt for a special clearance, known as an emergency use authorization (EUA), for one or more of the experimental COVID vaccines now in advanced testing. Many of FDA’s past EUA clearances were granted for test kits. For those EUA approvals, the agency considered risks of false results but not longer-term, direct harm to patients from these products.

With a COVID vaccine, there will be strong pressure to distribute doses as quickly as possible with the hope of curbing the pandemic, which has already led to more than 229,000 deaths in the United States alone and has disrupted lives and economies around the world. But questions will persist about the possibility of serious complications from these vaccines, ACIP members noted.

“My personal struggle is the ethical side and how to balance these two,” said ACIP member Robert L. Atmar, MD, of Baylor College of Medicine, Houston, Texas, who noted that he expects his fellow panelists to share this concern.

Currently, four experimental COVID vaccines likely to be used in the United States have advanced to phase 3 testing. Pfizer Inc and BioNtech have enrolled more than 42,000 participants in a test of their candidate, BNT162b2 vaccine, and rival Moderna has enrolled about 30,000 participants in a test of its mRNA-1273 vaccine, CDC staff said.

The other two advanced COVID vaccine candidates have overcome recent hurdles. AstraZeneca Plc on Oct. 23 announced that FDA had removed a hold on the testing of its AZD1222 vaccine candidate; the trial will enroll approximately 30,000 people. Johnson & Johnson’s Janssen unit also announced that day the lifting of a safety pause for its Ad26.COV2.S vaccine; the phase 3 trial for that vaccine will enroll approximately 60,000 volunteers. Federal agencies, states, and territories have developed plans for future distribution of COVID vaccines, CDC staff said in briefing materials for today’s ACIP meeting.

Several ACIP members raised many of the same concerns that members of an FDA advisory committee raised at a meeting earlier in October. ACIP and FDA advisers honed in on the FDA’s decision to set a median follow-up duration of 2 months in phase 3 trials in connection with expected EUA applications for COVID-19 vaccines.

“I struggle with following people for 2 months after their second vaccination as a time point to start making final decisions about safety,” said ACIP member Sharon E. Frey, MD, a professor at St. Louis University School of Medicine, St. Louis, Missouri. “I just want to put that out there.”
 

Medical front line, then who?

There is consensus that healthcare workers be in the first stage ― Phase 1 ― of distribution. That recommendation was made in a report from the National Academies of Sciences, Engineering, and Medicine (NASEM). Phase 1A would include first responders; Phase 1B might include people of all ages who have two or more comorbidities that put them at significantly higher risk for COVID-19 or death, as well as older adults living in congregate or overcrowded settings, the NASEM report said.

A presentation from the CDC’s Matthew Biggerstaff, ScD, MPH, underscored challenges in distributing what are expected to be limited initial supplies of COVID vaccines.

Biggerstaff showed several scenarios the CDC’s Data, Analytics, and Modeling Task Force had studied. The initial allocation of vaccines would be for healthcare workers, followed by what the CDC called Phase 1B.

Choices for a rollout may include next giving COVID vaccines to people at high risk, such as persons who have one or more chronic medical conditions, including heart disease, diabetes, kidney disease, or obesity. Other options for the rollout could be to vaccinate people aged 65 years and older or essential workers whose employment puts them in contact with the public, thus raising the risk of contracting the virus.

The CDC’s research found that the greatest impact in preventing death was to initially vaccinate adults aged 65 and older in Phase 1B. The agency staff described this approach as likely to result in an about “1 to 11% increase in averted deaths across the scenarios.”

Initially vaccinating essential workers or high-risk adults in Phase 1B would avert the most infections. The agency staff described this approach as yielding about “1 to 5% increase in averted infections across the scenarios,” Biggerstaff said during his presentation.

The following are other findings of the CDC staff:

The earlier the vaccine rollout relative to increasing transmission, the greater the averted percentage and differences between the strategies.

Differences were not substantial in some scenarios.

The need to continue efforts to slow the spread of COVID-19 should be emphasized.

Adverse effects

ACIP members also heard about strategies for tracking potential side effects of future vaccines. A presentation by Tom Shimabukuro, MD, MPH, MBA, from the CDC’s COVID-19 Vaccine Task Force/Vaccine Safety Team, included details about a new smartphone-based active surveillance program for COVID-19 vaccine safety.

Known as v-safe, this system would use Web-based survey monitoring and incorporate text messaging. It would conduct electronic health checks on vaccine recipients, which would occur daily during the first week post vaccination and weekly thereafter for 6 weeks from the time of vaccination.

Clinicians “can play an important role in helping CDC enroll patients in v-safe at the time of vaccination,” Shimabukuro noted in his presentation. This would add another task, though, for clinicians, the CDC staff noted.
 

Pregnancy and breastfeeding are special concerns

Of special concern with the rollout of a COVID vaccine are recommendations regarding pregnancy and breastfeeding. Women constitute about 75% of the healthcare workforce, CDC staff noted.

At the time the initial ACIP COVID vaccination recommendations are made, there could be approximately 330,000 healthcare personnel who are pregnant or who have recently given birth. Available data indicate potentially increased risks for severe maternal illness and preterm birth associated with SARS-CoV-2 infection, said CDC’s Megan Wallace, DrPH, MPH, in a presentation for the Friday meeting.

In an Oct. 27 letter to ACIP, Chair Jose Romero, the American College of Obstetricians and Gynecologists (ACOG), urged the panel to ensure that pregnant women and new mothers in the healthcare workforce have priority access to a COVID vaccine. Pregnant and lactating women were “noticeably and alarmingly absent from the NASEM vaccine allocation plan for COVID-19,” wrote Christopher M. Zahn, MD, vice president for practice activities at ACOG, in the letter to Romero.

“ACOG urges ACIP to incorporate pregnant and lactating women clearly and explicitly into its COVID-19 vaccine allocation and prioritization framework,” Zahn wrote. “Should an Emergency Use Authorization be executed for one or more COVID-19 vaccines and provide a permissive recommendation for pregnant and lactating women, pregnant health care workers, pregnant first responders, and pregnant individuals with underlying conditions should be prioritized for vaccination alongside their non-pregnant peers.”

This article first appeared on Medscape.com.

Dr. G, a New York surgeon, was only a couple years into practice when he faced his first lawsuit.

After undergoing liposuction surgery on the area of her calf and ankle, a patient claimed she had developed a severe allergic reaction, characterized by small areas of necrosis on the lower extremities, said Dr. G, who asked to remain anonymous. However, the alleged injury seemed suspicious, said Dr. G, considering that 3 weeks after the surgery, the area had shown a successful result with minimal swelling.

Six months into the suit, Dr. G received a shocking phone call. It was the patient’s estranged husband, who revealed that his wife was having an affair with another man, a physician. In recorded phone calls, the patient and her paramour had discussed causing an injury near the patient’s calf in an attempt to sue and get rich, the husband relayed. Dr. G immediately contacted his insurance carrier with the news, but his attorney said the information would not be admissible in court. Instead, the insurer settled with the patient, who received about $125,000.

At the time, Dr. G did not have a consent-to-settle clause in his contract, so the insurer was able to settle without his approval.

In legal practice, a frivolous claim is defined as one that lacks a supporting legal argument or any factual basis. A claim issued with the intent of disturbing, annoying, or harassing the opposing party can also be described as legally frivolous, said Michael Stinson, vice president of government relations and public policy for the Medical Professional Liability Association (MPL Association), a trade association for medical liability insurers.

However, when most physicians refer to “frivolous claims,” they often mean a claim in which there is no attributable negligence. Such suits represent a second category of claims – nonmeritorious lawsuits.

“I think people intermix nonmeritorious and frivolous all the time,” Mr. Stinson said. “In the vast majority of nonmeritorious claims, the patient has suffered an adverse outcome, it’s just that it wasn’t the result of negligence, whereas with a frivolous lawsuit, they really haven’t suffered any damage, so they’ve got no business filing a lawsuit on any level.”

A third type of so-called frivolous suit is that of a fraudulent or fake claim, in which, as Dr. G experienced, a patient causes a self-injury or lies about a condition to craft a false claim against a physician.

If a patient files a claim that the patient knows is false, the patient commits fraud and may be subject to counterclaims for malicious prosecution or abuse of process, said Jeffrey Segal, MD, JD, a neurosurgeon and health law attorney. Further, the patient would be testifying under oath, and such testimony can be considered perjury, a criminal offense with criminal penalties.

Sadly, Dr. G was the target of another frivolous lawsuit years later. In that suit, a patient claimed the surgeon had left a piece of sponge in her breast cavity during surgery. The case was dismissed when medical records proved the patient knew that the foreign body resulted from an unrelated procedure she had undergone years earlier.

“There is so much abuse in the court system,” Dr. G said. “You really don’t think stuff like that will happen to you, especially if you honor the profession. It’s unfortunate. It’s left a very bitter taste in my mouth.”

Frivolous claims have long been a subject of debate. Tort reform advocates often contend that such claims are pervasive. They cite them as key reasons for high health care costs and say that they have led to the rise of defensive medicine. Plaintiffs’ attorneys counter that the rate of frivolous claims is widely exaggerated and argue that the pursuit of frivolous claims would be “bad business” for legal firms. The debate begs the question: Do frivolous cases still exist, and if so, how common are they?

“I have never seen a frivolous malpractice claim,” says Malcolm P. McConnell III, JD, a Richmond, Va., medical malpractice attorney and chair of the Medical Malpractice Legislative Subcommittee for the Virginia Trial Lawyers Association. “I cannot say that such things never happen, but any lawyer bringing such a thing is foolish, because there is no reward for it.”
 

Are shotgun lawsuits frivolous?

To many physicians, being dragged into a lawsuit over a complaint or medical outcome in which they were not involved is frivolous, said Stanislaw Stawicki, MD, a trauma surgeon and researcher based in Bethlehem, Pa. Dr. Stawicki was named in a lawsuit along with a long list of medical staff who interacted in some way with the plaintiff. Dr. Stawicki himself saw the patient once and made a note in the chart but had nothing to do with the patient’s surgery or with any critical decisions regarding his care, he said.

“Nothing really prepares you for seeing your name on a legal complaint,” Dr. Stawicki said. “It’s traumatic. I had to block out entire days to give depositions, which were really kind of pointless. Questions like, ‘Is this really your name? Where did you train? Were you there that morning?’ Stuff that was really not consequential to the fact that someone had surgery a month earlier and had some sort of complication.”

Dr. Stawicki was eventually dropped from the claim, but not before a nearly year-long ordeal of legal proceedings, meetings, and paperwork.

It is common practice for plaintiffs’ attorneys to add codefendants in the early stages of a claim, said David M. Studdert, ScD, a leading health law researcher and a professor of law at Stanford (Calif.) Law School. Defendants are gradually dismissed as the case moves forward and details of the incident become clearer, he said.

“Plaintiffs’ attorneys have strong incentives to try and choose claims that will be successful,” Dr. Studdert said. “However, in the early point in the process, neither the patient nor the attorney may have a good idea what has actually happened with care. So sometimes, filing a lawsuit may be the only way to begin the process of opening up that information.”

A study by Dr. Studdert in which medical malpractice claims, errors, and compensation payments were analyzed found that, out of 1,452 claims, about one-third (37%) did not involve errors.

“Many physicians might call those frivolous lawsuits, but in fact, most of those don’t go on to receive compensation,” he said. “We suspect that in many instances, those claims are simply dropped once it becomes apparent that there wasn’t error involved.

“They can still be burdensome, anxiety provoking, and time consuming for physicians who are named in those suits, so I don’t want to suggest that claims that don’t involve errors are not a problem,” said Dr. Studdert. “However, I think it’s wrong to assume, as many people do when they use the term ‘frivolous lawsuit,’ that this is really an extortionary effort by a plaintiffs’ attorney to try to get money out of a hospital or a physician for care that was really unproblematic.”
 

Certain ‘frivolous’ cases more common than others

Nonmeritorious claims still occur relatively frequently today, according to data from the Medical Professional Liability Association’s Data Sharing Project. Of about 18,000 liability claims reported from 2016 to 2018, 65% were dropped, withdrawn, or dismissed. Of the 6% of claims that went before a jury, more than 85% resulted in a verdict for the defendant, the researchers found.

“Basically, any claim that does not result in a payment because the underlying claim of negligence on the part of a health professional had been demonstrated, proven, or adjudicated false is one we would describe as nonmeritorious,” Mr. Stinson said.

The MPL Association does not track cases that meet the legal definition of frivolous, said Mr. Stinson, and they “don’t see truly frivolous lawsuits very often.”

Malpractice claims are risky, expensive, and aggressively defended, says Mr. McConnell, the plaintiffs’ attorney. Mr. McConnell, who has been practicing for 30 years, said his own claim selection process is very rigorous and that he cannot afford to pursue claims that aren’t well supported by science and medicine.

“Pursuing frivolous cases would bankrupt me and ruin my reputation,” he said. “A lawyer I know once said he would write a check for $10,000 to anyone who could show him a lawyer who makes a living pursuing frivolous medical malpractice cases. It’s a fair challenge. The economics and the practices of liability carriers and defense lawyers make frivolous cases a dead end for plaintiff lawyers.”

Most medical malpractice cases are taken on a contingency fee basis, Mr. McConnell noted, meaning that the plaintiff’s lawyer is not paid unless the claim is successful.

“This means that the plaintiff’s lawyer is risking 2 years of intensive labor on a case which may yield no fee at all,” he said. “Obviously, any reasonable lawyer is going to want to minimize that risk. The only way to minimize that risk is for the case to be solid, not weak, and certainly not frivolous.”

But Dr. Segal, the health law attorney, says that plenty of frivolous liability claims are levied each year, with attorneys willing to pursue them.

It’s true that seasoned plaintiffs’ attorneys generally screen for merit and damages, Dr. Segal said, but in some instances, attorneys who are not trained in malpractice law accept frivolous claims and take them forward. In some cases, they are slip-and-fall accident attorneys accustomed to receiving modest amounts from insurance companies quickly, said Dr. Segal, founder of Medical Justice, a company that helps deter frivolous lawsuits against physicians.

“If we lived in a perfectly rational universe where plaintiffs’ attorneys screened cases well and only took the meritorious cases forward, we would see less frivolous cases filed, but that’s not the universe I live in,” Dr. Segal said. “There are well over a million attorneys in this country, and some are hungrier than others. The attorneys may frequently get burned in the end, and maybe that attorney won’t move another malpractice case forward, but there’s always someone else willing to take their place.”

Medical Justice has twice run a Most Frivolous Lawsuit Contest on its website, one in 2008 and one in late 2018. The first contest drew 30 entries, and the second garnered nearly 40 submissions, primarily from physicians who were defendants in the cases, according to Dr. Segal. (Dr. G’s lawsuit was highlighted in the most recent contest.)

In one case, an emergency physician was drawn into litigation by the family of a deceased patient. The patient experienced sudden cardiac arrythmia at home, and paramedics were unable to intubate her or establish IV access. She was transferred to the hospital, where resuscitation efforts continued, but she remained in asystole and was pronounced dead after 15 minutes.

At the hospital, blood tests were conducted. They showed that her serum potassium concentration was elevated to about 12 mEq/L, Dr. Segal said. The family initiated a claim in which they accused the emergency physician of failure to diagnose hyperkalemia. They alleged that had the hyperkalemia been discovered sooner, the patient’s death could have been prevented.

“If you had no other facts about this, you would wonder how a person with potassium that high would even be alive,” Dr. Segal said. “But what they were looking at was the body decomposing and all the potassium in the cells being released into the bloodstream. It wasn’t the cause of the problem, it was an effect of the problem. She really was dead on arrival, and she was probably dead at home.”

The case was eventually dropped.

Although the outcome for the patient was tragic, says Dr. Segal, the case is one of many types of frivolous claims that exist today.

“Yes, frivolous cases are out there,” he said.
 

Fraudulent claims uncommon

As for fraudulent medical liability claims, legal experts say they’re rare. J. Richard Moore, JD, an Indianapolis-based medical liability defense attorney, said he’s never personally encountered a medical malpractice claim in which he believed a plaintiff caused an injury or an illness and attempted to blame it on a physician.

However, Mr. Moore has defended many claims in which the illness or condition the plaintiff claimed was caused or was made worse through medical negligence was actually a preexisting condition or a preexisting condition that worsened and was not related to any medical negligence, Mr. Moore said.

“Although I have often felt in such cases that the plaintiff really knew that the condition was not affected by any alleged medical negligence, I would not put that in the ‘fraudulent claim’ category because it can be very difficult to establish a person’s subjective state of mind,” he said. “Usually in those cases, the plaintiff just denies memory of previous medical records or claims that the previous doctor who treated him or her for the same condition ‘got it wrong.’ In those cases, it is generally left to the jury whether to believe the plaintiff or not.”

Mr. Stinson also says he has not come across a truly fraudulent medical liability case. He noted that such a claim might be similar to a person falsely claiming a soft-tissue injury following an alleged slip-and-fall accident.

“Clearly, a fraudulent claim could be viewed as riskier from the plaintiff’s perspective because they could face criminal prosecution for insurance fraud, whereas if a claim is merely frivolous, they probably only run the risk of court-issued fine, if even that. That may be why we don’t often see fraudulent MPL claims.”
 

Ways to prevent or fight frivolous lawsuits

Since Dr. Stawicki’s legal nightmare as a resident, rules have tightened in Pennsylvania, and it is now more difficult to file frivolous claims, he said.

Pennsylvania is one of at least 28 states that require a certificate of merit in order for a medical liability claim to move forward. The provisions generally state that an appropriately licensed professional must supply a written statement attesting that the care the patient received failed to meet acceptable professional standards and that such conduct was a cause in the alleged harm.

“There is now a much greater burden of proof regarding what can proceed,” Dr. Stawicki said. “I’ve been involved in a couple cases that did not proceed because there was no certificate of merit.”

Although these reforms may help, not all merit rules are created equal. Some states require that the expert who signs the affidavit be knowledgeable in the relevant issues involved in the action. Other states have looser requirements. In one of the cases featured in Medical Justice’s Most Frivolous Lawsuit Contest, a podiatrist signed a supporting declaration for a claim related to obstetric care.

For physicians facing a frivolous claim, fighting it out in court depends on a number of factors. Without a consent-to-settle clause in the contract, an insurer can make the final decision on whether to defend or settle a case.

Resolving a malpractice claim is generally a business decision for the insurer, Dr. Studdert said.

“When the claim is for a relatively low amount of money, the costs of moving forward to defend that claim may be much more than the costs of simply settling it would be,” he said. “On the other hand, liability insurers and their lawyers are repeat players here, as are the plaintiffs’ attorneys. They don’t want to incentivize plaintiffs’ attorneys to bring questionable claims, and if they settle quickly, that may do so.”

Mr. Stinson, of the MPL Association, said a truly frivolous claim – one with no legal basis – is highly unlikely to be settled, “especially by MPL Association members who go beyond having a purely financial interest in their insureds to also focus on their professional reputation/integrity.” MPL Association members insure nearly 2 million health care professionals globally, including 2,500 hospitals and more than two-thirds of America’s physicians who are in private practice.

Physicians should make sure they know what is and what is not included in their policy, Dr. Segal said.

“The broker should sit down with the doctor, ideally before initial purchase or renewal, and explain in clear terms what the carrier’s obligations are and what the physician’s obligations are,” he said. “Know what type of protection is being purchased and what conditions might trigger a surprising and unhappy outcome.”
 

Should I countersue?

For truly frivolous claims, physicians have the legal right to sue for damages caused by the unfounded complaint.

Perhaps the most well-known case of a successful malpractice countersuit is that of Louisville neurosurgeon John Guarnaschelli, MD, who in 2000 won $72,000 in damages against a plaintiffs’ attorney for malicious prosecution.

The physician’s countersuit followed the dismissal of a negligence claim against Dr. Guarnaschelli by a patient who contracted meningitis. The plaintiffs’ attorney had made little effort to gather evidence to connect Dr. Guarnaschelli to the patient’s injuries and had consulted only one other physician, a client of his, before filing the lawsuit, according to a summary of the case in the American Bar Association Journal.

Malicious prosecution is the most common legal theory of recovery for physicians in countersuits, according to a review of successful countersuits by doctors. Dr. Stawicki is a coauthor of that review. Other legal theories that physicians can raise include abuse of process, negligence, defamation, invasion of privacy, and infliction of emotional distress. Of the 13 cases evaluated in the article by Dr. Stawicki and colleagues, damages awarded to physicians ranged from about $13,000 to $125,000.

Although some doctors have success, pursuing a counterclaim can be a difficult feat, said Benjamin Braslow, MD, a trauma surgeon and professor of clinical surgery at the University of Pennsylvania in Philadelphia.

“The main takeaways were it’s an uphill battle often met with not only resistance but diminishing returns to countersue,” said Dr. Braslow, a coauthor of the countersuits analysis. “You have to meet very specific criteria regarding leveling the suit, and it may end up being a costly, time-consuming battle.”

To prove malicious prosecution, for example, a physician must show that a claim was instituted without probable cause, that the suing party acted maliciously in instituting the action, and that the doctor was damaged by the action, among other essential elements.

As for Dr. G, the surgeon, he now has a contract with a consent-to-settle clause and has taken other legal precautions since his lawsuits. He requires that his patients sign an agreement that any negligence claims they levy go to arbitration. If an arbitrator finds in the patient’s favor, the case may proceed to court, he said. However, he requires another agreement such that if patients lose in court, they are responsible for his legal fees.

“I’m just more careful,” he said. “I ask all my staff in the office to use their judgment, however superficial, if they feel something is wrong with an individual to tell me so. I’d rather send them away than operate on them and have it result in a lawsuit.”
 

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

Dr. G, a New York surgeon, was only a couple years into practice when he faced his first lawsuit.

After undergoing liposuction surgery on the area of her calf and ankle, a patient claimed she had developed a severe allergic reaction, characterized by small areas of necrosis on the lower extremities, said Dr. G, who asked to remain anonymous. However, the alleged injury seemed suspicious, said Dr. G, considering that 3 weeks after the surgery, the area had shown a successful result with minimal swelling.

Six months into the suit, Dr. G received a shocking phone call. It was the patient’s estranged husband, who revealed that his wife was having an affair with another man, a physician. In recorded phone calls, the patient and her paramour had discussed causing an injury near the patient’s calf in an attempt to sue and get rich, the husband relayed. Dr. G immediately contacted his insurance carrier with the news, but his attorney said the information would not be admissible in court. Instead, the insurer settled with the patient, who received about $125,000.

At the time, Dr. G did not have a consent-to-settle clause in his contract, so the insurer was able to settle without his approval.

In legal practice, a frivolous claim is defined as one that lacks a supporting legal argument or any factual basis. A claim issued with the intent of disturbing, annoying, or harassing the opposing party can also be described as legally frivolous, said Michael Stinson, vice president of government relations and public policy for the Medical Professional Liability Association (MPL Association), a trade association for medical liability insurers.

However, when most physicians refer to “frivolous claims,” they often mean a claim in which there is no attributable negligence. Such suits represent a second category of claims – nonmeritorious lawsuits.

“I think people intermix nonmeritorious and frivolous all the time,” Mr. Stinson said. “In the vast majority of nonmeritorious claims, the patient has suffered an adverse outcome, it’s just that it wasn’t the result of negligence, whereas with a frivolous lawsuit, they really haven’t suffered any damage, so they’ve got no business filing a lawsuit on any level.”

A third type of so-called frivolous suit is that of a fraudulent or fake claim, in which, as Dr. G experienced, a patient causes a self-injury or lies about a condition to craft a false claim against a physician.

If a patient files a claim that the patient knows is false, the patient commits fraud and may be subject to counterclaims for malicious prosecution or abuse of process, said Jeffrey Segal, MD, JD, a neurosurgeon and health law attorney. Further, the patient would be testifying under oath, and such testimony can be considered perjury, a criminal offense with criminal penalties.

Sadly, Dr. G was the target of another frivolous lawsuit years later. In that suit, a patient claimed the surgeon had left a piece of sponge in her breast cavity during surgery. The case was dismissed when medical records proved the patient knew that the foreign body resulted from an unrelated procedure she had undergone years earlier.

“There is so much abuse in the court system,” Dr. G said. “You really don’t think stuff like that will happen to you, especially if you honor the profession. It’s unfortunate. It’s left a very bitter taste in my mouth.”

Frivolous claims have long been a subject of debate. Tort reform advocates often contend that such claims are pervasive. They cite them as key reasons for high health care costs and say that they have led to the rise of defensive medicine. Plaintiffs’ attorneys counter that the rate of frivolous claims is widely exaggerated and argue that the pursuit of frivolous claims would be “bad business” for legal firms. The debate begs the question: Do frivolous cases still exist, and if so, how common are they?

“I have never seen a frivolous malpractice claim,” says Malcolm P. McConnell III, JD, a Richmond, Va., medical malpractice attorney and chair of the Medical Malpractice Legislative Subcommittee for the Virginia Trial Lawyers Association. “I cannot say that such things never happen, but any lawyer bringing such a thing is foolish, because there is no reward for it.”
 

Are shotgun lawsuits frivolous?

To many physicians, being dragged into a lawsuit over a complaint or medical outcome in which they were not involved is frivolous, said Stanislaw Stawicki, MD, a trauma surgeon and researcher based in Bethlehem, Pa. Dr. Stawicki was named in a lawsuit along with a long list of medical staff who interacted in some way with the plaintiff. Dr. Stawicki himself saw the patient once and made a note in the chart but had nothing to do with the patient’s surgery or with any critical decisions regarding his care, he said.

“Nothing really prepares you for seeing your name on a legal complaint,” Dr. Stawicki said. “It’s traumatic. I had to block out entire days to give depositions, which were really kind of pointless. Questions like, ‘Is this really your name? Where did you train? Were you there that morning?’ Stuff that was really not consequential to the fact that someone had surgery a month earlier and had some sort of complication.”

Dr. Stawicki was eventually dropped from the claim, but not before a nearly year-long ordeal of legal proceedings, meetings, and paperwork.

It is common practice for plaintiffs’ attorneys to add codefendants in the early stages of a claim, said David M. Studdert, ScD, a leading health law researcher and a professor of law at Stanford (Calif.) Law School. Defendants are gradually dismissed as the case moves forward and details of the incident become clearer, he said.

“Plaintiffs’ attorneys have strong incentives to try and choose claims that will be successful,” Dr. Studdert said. “However, in the early point in the process, neither the patient nor the attorney may have a good idea what has actually happened with care. So sometimes, filing a lawsuit may be the only way to begin the process of opening up that information.”

A study by Dr. Studdert in which medical malpractice claims, errors, and compensation payments were analyzed found that, out of 1,452 claims, about one-third (37%) did not involve errors.

“Many physicians might call those frivolous lawsuits, but in fact, most of those don’t go on to receive compensation,” he said. “We suspect that in many instances, those claims are simply dropped once it becomes apparent that there wasn’t error involved.

“They can still be burdensome, anxiety provoking, and time consuming for physicians who are named in those suits, so I don’t want to suggest that claims that don’t involve errors are not a problem,” said Dr. Studdert. “However, I think it’s wrong to assume, as many people do when they use the term ‘frivolous lawsuit,’ that this is really an extortionary effort by a plaintiffs’ attorney to try to get money out of a hospital or a physician for care that was really unproblematic.”
 

Certain ‘frivolous’ cases more common than others

Nonmeritorious claims still occur relatively frequently today, according to data from the Medical Professional Liability Association’s Data Sharing Project. Of about 18,000 liability claims reported from 2016 to 2018, 65% were dropped, withdrawn, or dismissed. Of the 6% of claims that went before a jury, more than 85% resulted in a verdict for the defendant, the researchers found.

“Basically, any claim that does not result in a payment because the underlying claim of negligence on the part of a health professional had been demonstrated, proven, or adjudicated false is one we would describe as nonmeritorious,” Mr. Stinson said.

The MPL Association does not track cases that meet the legal definition of frivolous, said Mr. Stinson, and they “don’t see truly frivolous lawsuits very often.”

Malpractice claims are risky, expensive, and aggressively defended, says Mr. McConnell, the plaintiffs’ attorney. Mr. McConnell, who has been practicing for 30 years, said his own claim selection process is very rigorous and that he cannot afford to pursue claims that aren’t well supported by science and medicine.

“Pursuing frivolous cases would bankrupt me and ruin my reputation,” he said. “A lawyer I know once said he would write a check for $10,000 to anyone who could show him a lawyer who makes a living pursuing frivolous medical malpractice cases. It’s a fair challenge. The economics and the practices of liability carriers and defense lawyers make frivolous cases a dead end for plaintiff lawyers.”

Most medical malpractice cases are taken on a contingency fee basis, Mr. McConnell noted, meaning that the plaintiff’s lawyer is not paid unless the claim is successful.

“This means that the plaintiff’s lawyer is risking 2 years of intensive labor on a case which may yield no fee at all,” he said. “Obviously, any reasonable lawyer is going to want to minimize that risk. The only way to minimize that risk is for the case to be solid, not weak, and certainly not frivolous.”

But Dr. Segal, the health law attorney, says that plenty of frivolous liability claims are levied each year, with attorneys willing to pursue them.

It’s true that seasoned plaintiffs’ attorneys generally screen for merit and damages, Dr. Segal said, but in some instances, attorneys who are not trained in malpractice law accept frivolous claims and take them forward. In some cases, they are slip-and-fall accident attorneys accustomed to receiving modest amounts from insurance companies quickly, said Dr. Segal, founder of Medical Justice, a company that helps deter frivolous lawsuits against physicians.

“If we lived in a perfectly rational universe where plaintiffs’ attorneys screened cases well and only took the meritorious cases forward, we would see less frivolous cases filed, but that’s not the universe I live in,” Dr. Segal said. “There are well over a million attorneys in this country, and some are hungrier than others. The attorneys may frequently get burned in the end, and maybe that attorney won’t move another malpractice case forward, but there’s always someone else willing to take their place.”

Medical Justice has twice run a Most Frivolous Lawsuit Contest on its website, one in 2008 and one in late 2018. The first contest drew 30 entries, and the second garnered nearly 40 submissions, primarily from physicians who were defendants in the cases, according to Dr. Segal. (Dr. G’s lawsuit was highlighted in the most recent contest.)

In one case, an emergency physician was drawn into litigation by the family of a deceased patient. The patient experienced sudden cardiac arrythmia at home, and paramedics were unable to intubate her or establish IV access. She was transferred to the hospital, where resuscitation efforts continued, but she remained in asystole and was pronounced dead after 15 minutes.

At the hospital, blood tests were conducted. They showed that her serum potassium concentration was elevated to about 12 mEq/L, Dr. Segal said. The family initiated a claim in which they accused the emergency physician of failure to diagnose hyperkalemia. They alleged that had the hyperkalemia been discovered sooner, the patient’s death could have been prevented.

“If you had no other facts about this, you would wonder how a person with potassium that high would even be alive,” Dr. Segal said. “But what they were looking at was the body decomposing and all the potassium in the cells being released into the bloodstream. It wasn’t the cause of the problem, it was an effect of the problem. She really was dead on arrival, and she was probably dead at home.”

The case was eventually dropped.

Although the outcome for the patient was tragic, says Dr. Segal, the case is one of many types of frivolous claims that exist today.

“Yes, frivolous cases are out there,” he said.
 

Fraudulent claims uncommon

As for fraudulent medical liability claims, legal experts say they’re rare. J. Richard Moore, JD, an Indianapolis-based medical liability defense attorney, said he’s never personally encountered a medical malpractice claim in which he believed a plaintiff caused an injury or an illness and attempted to blame it on a physician.

However, Mr. Moore has defended many claims in which the illness or condition the plaintiff claimed was caused or was made worse through medical negligence was actually a preexisting condition or a preexisting condition that worsened and was not related to any medical negligence, Mr. Moore said.

“Although I have often felt in such cases that the plaintiff really knew that the condition was not affected by any alleged medical negligence, I would not put that in the ‘fraudulent claim’ category because it can be very difficult to establish a person’s subjective state of mind,” he said. “Usually in those cases, the plaintiff just denies memory of previous medical records or claims that the previous doctor who treated him or her for the same condition ‘got it wrong.’ In those cases, it is generally left to the jury whether to believe the plaintiff or not.”

Mr. Stinson also says he has not come across a truly fraudulent medical liability case. He noted that such a claim might be similar to a person falsely claiming a soft-tissue injury following an alleged slip-and-fall accident.

“Clearly, a fraudulent claim could be viewed as riskier from the plaintiff’s perspective because they could face criminal prosecution for insurance fraud, whereas if a claim is merely frivolous, they probably only run the risk of court-issued fine, if even that. That may be why we don’t often see fraudulent MPL claims.”
 

Ways to prevent or fight frivolous lawsuits

Since Dr. Stawicki’s legal nightmare as a resident, rules have tightened in Pennsylvania, and it is now more difficult to file frivolous claims, he said.

Pennsylvania is one of at least 28 states that require a certificate of merit in order for a medical liability claim to move forward. The provisions generally state that an appropriately licensed professional must supply a written statement attesting that the care the patient received failed to meet acceptable professional standards and that such conduct was a cause in the alleged harm.

“There is now a much greater burden of proof regarding what can proceed,” Dr. Stawicki said. “I’ve been involved in a couple cases that did not proceed because there was no certificate of merit.”

Although these reforms may help, not all merit rules are created equal. Some states require that the expert who signs the affidavit be knowledgeable in the relevant issues involved in the action. Other states have looser requirements. In one of the cases featured in Medical Justice’s Most Frivolous Lawsuit Contest, a podiatrist signed a supporting declaration for a claim related to obstetric care.

For physicians facing a frivolous claim, fighting it out in court depends on a number of factors. Without a consent-to-settle clause in the contract, an insurer can make the final decision on whether to defend or settle a case.

Resolving a malpractice claim is generally a business decision for the insurer, Dr. Studdert said.

“When the claim is for a relatively low amount of money, the costs of moving forward to defend that claim may be much more than the costs of simply settling it would be,” he said. “On the other hand, liability insurers and their lawyers are repeat players here, as are the plaintiffs’ attorneys. They don’t want to incentivize plaintiffs’ attorneys to bring questionable claims, and if they settle quickly, that may do so.”

Mr. Stinson, of the MPL Association, said a truly frivolous claim – one with no legal basis – is highly unlikely to be settled, “especially by MPL Association members who go beyond having a purely financial interest in their insureds to also focus on their professional reputation/integrity.” MPL Association members insure nearly 2 million health care professionals globally, including 2,500 hospitals and more than two-thirds of America’s physicians who are in private practice.

Physicians should make sure they know what is and what is not included in their policy, Dr. Segal said.

“The broker should sit down with the doctor, ideally before initial purchase or renewal, and explain in clear terms what the carrier’s obligations are and what the physician’s obligations are,” he said. “Know what type of protection is being purchased and what conditions might trigger a surprising and unhappy outcome.”
 

Should I countersue?

For truly frivolous claims, physicians have the legal right to sue for damages caused by the unfounded complaint.

Perhaps the most well-known case of a successful malpractice countersuit is that of Louisville neurosurgeon John Guarnaschelli, MD, who in 2000 won $72,000 in damages against a plaintiffs’ attorney for malicious prosecution.

The physician’s countersuit followed the dismissal of a negligence claim against Dr. Guarnaschelli by a patient who contracted meningitis. The plaintiffs’ attorney had made little effort to gather evidence to connect Dr. Guarnaschelli to the patient’s injuries and had consulted only one other physician, a client of his, before filing the lawsuit, according to a summary of the case in the American Bar Association Journal.

Malicious prosecution is the most common legal theory of recovery for physicians in countersuits, according to a review of successful countersuits by doctors. Dr. Stawicki is a coauthor of that review. Other legal theories that physicians can raise include abuse of process, negligence, defamation, invasion of privacy, and infliction of emotional distress. Of the 13 cases evaluated in the article by Dr. Stawicki and colleagues, damages awarded to physicians ranged from about $13,000 to $125,000.

Although some doctors have success, pursuing a counterclaim can be a difficult feat, said Benjamin Braslow, MD, a trauma surgeon and professor of clinical surgery at the University of Pennsylvania in Philadelphia.

“The main takeaways were it’s an uphill battle often met with not only resistance but diminishing returns to countersue,” said Dr. Braslow, a coauthor of the countersuits analysis. “You have to meet very specific criteria regarding leveling the suit, and it may end up being a costly, time-consuming battle.”

To prove malicious prosecution, for example, a physician must show that a claim was instituted without probable cause, that the suing party acted maliciously in instituting the action, and that the doctor was damaged by the action, among other essential elements.

As for Dr. G, the surgeon, he now has a contract with a consent-to-settle clause and has taken other legal precautions since his lawsuits. He requires that his patients sign an agreement that any negligence claims they levy go to arbitration. If an arbitrator finds in the patient’s favor, the case may proceed to court, he said. However, he requires another agreement such that if patients lose in court, they are responsible for his legal fees.

“I’m just more careful,” he said. “I ask all my staff in the office to use their judgment, however superficial, if they feel something is wrong with an individual to tell me so. I’d rather send them away than operate on them and have it result in a lawsuit.”
 

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

Dr. G, a New York surgeon, was only a couple years into practice when he faced his first lawsuit.

After undergoing liposuction surgery on the area of her calf and ankle, a patient claimed she had developed a severe allergic reaction, characterized by small areas of necrosis on the lower extremities, said Dr. G, who asked to remain anonymous. However, the alleged injury seemed suspicious, said Dr. G, considering that 3 weeks after the surgery, the area had shown a successful result with minimal swelling.

Six months into the suit, Dr. G received a shocking phone call. It was the patient’s estranged husband, who revealed that his wife was having an affair with another man, a physician. In recorded phone calls, the patient and her paramour had discussed causing an injury near the patient’s calf in an attempt to sue and get rich, the husband relayed. Dr. G immediately contacted his insurance carrier with the news, but his attorney said the information would not be admissible in court. Instead, the insurer settled with the patient, who received about $125,000.

At the time, Dr. G did not have a consent-to-settle clause in his contract, so the insurer was able to settle without his approval.

In legal practice, a frivolous claim is defined as one that lacks a supporting legal argument or any factual basis. A claim issued with the intent of disturbing, annoying, or harassing the opposing party can also be described as legally frivolous, said Michael Stinson, vice president of government relations and public policy for the Medical Professional Liability Association (MPL Association), a trade association for medical liability insurers.

However, when most physicians refer to “frivolous claims,” they often mean a claim in which there is no attributable negligence. Such suits represent a second category of claims – nonmeritorious lawsuits.

“I think people intermix nonmeritorious and frivolous all the time,” Mr. Stinson said. “In the vast majority of nonmeritorious claims, the patient has suffered an adverse outcome, it’s just that it wasn’t the result of negligence, whereas with a frivolous lawsuit, they really haven’t suffered any damage, so they’ve got no business filing a lawsuit on any level.”

A third type of so-called frivolous suit is that of a fraudulent or fake claim, in which, as Dr. G experienced, a patient causes a self-injury or lies about a condition to craft a false claim against a physician.

If a patient files a claim that the patient knows is false, the patient commits fraud and may be subject to counterclaims for malicious prosecution or abuse of process, said Jeffrey Segal, MD, JD, a neurosurgeon and health law attorney. Further, the patient would be testifying under oath, and such testimony can be considered perjury, a criminal offense with criminal penalties.

Sadly, Dr. G was the target of another frivolous lawsuit years later. In that suit, a patient claimed the surgeon had left a piece of sponge in her breast cavity during surgery. The case was dismissed when medical records proved the patient knew that the foreign body resulted from an unrelated procedure she had undergone years earlier.

“There is so much abuse in the court system,” Dr. G said. “You really don’t think stuff like that will happen to you, especially if you honor the profession. It’s unfortunate. It’s left a very bitter taste in my mouth.”

Frivolous claims have long been a subject of debate. Tort reform advocates often contend that such claims are pervasive. They cite them as key reasons for high health care costs and say that they have led to the rise of defensive medicine. Plaintiffs’ attorneys counter that the rate of frivolous claims is widely exaggerated and argue that the pursuit of frivolous claims would be “bad business” for legal firms. The debate begs the question: Do frivolous cases still exist, and if so, how common are they?

“I have never seen a frivolous malpractice claim,” says Malcolm P. McConnell III, JD, a Richmond, Va., medical malpractice attorney and chair of the Medical Malpractice Legislative Subcommittee for the Virginia Trial Lawyers Association. “I cannot say that such things never happen, but any lawyer bringing such a thing is foolish, because there is no reward for it.”
 

Are shotgun lawsuits frivolous?

To many physicians, being dragged into a lawsuit over a complaint or medical outcome in which they were not involved is frivolous, said Stanislaw Stawicki, MD, a trauma surgeon and researcher based in Bethlehem, Pa. Dr. Stawicki was named in a lawsuit along with a long list of medical staff who interacted in some way with the plaintiff. Dr. Stawicki himself saw the patient once and made a note in the chart but had nothing to do with the patient’s surgery or with any critical decisions regarding his care, he said.

“Nothing really prepares you for seeing your name on a legal complaint,” Dr. Stawicki said. “It’s traumatic. I had to block out entire days to give depositions, which were really kind of pointless. Questions like, ‘Is this really your name? Where did you train? Were you there that morning?’ Stuff that was really not consequential to the fact that someone had surgery a month earlier and had some sort of complication.”

Dr. Stawicki was eventually dropped from the claim, but not before a nearly year-long ordeal of legal proceedings, meetings, and paperwork.

It is common practice for plaintiffs’ attorneys to add codefendants in the early stages of a claim, said David M. Studdert, ScD, a leading health law researcher and a professor of law at Stanford (Calif.) Law School. Defendants are gradually dismissed as the case moves forward and details of the incident become clearer, he said.

“Plaintiffs’ attorneys have strong incentives to try and choose claims that will be successful,” Dr. Studdert said. “However, in the early point in the process, neither the patient nor the attorney may have a good idea what has actually happened with care. So sometimes, filing a lawsuit may be the only way to begin the process of opening up that information.”

A study by Dr. Studdert in which medical malpractice claims, errors, and compensation payments were analyzed found that, out of 1,452 claims, about one-third (37%) did not involve errors.

“Many physicians might call those frivolous lawsuits, but in fact, most of those don’t go on to receive compensation,” he said. “We suspect that in many instances, those claims are simply dropped once it becomes apparent that there wasn’t error involved.

“They can still be burdensome, anxiety provoking, and time consuming for physicians who are named in those suits, so I don’t want to suggest that claims that don’t involve errors are not a problem,” said Dr. Studdert. “However, I think it’s wrong to assume, as many people do when they use the term ‘frivolous lawsuit,’ that this is really an extortionary effort by a plaintiffs’ attorney to try to get money out of a hospital or a physician for care that was really unproblematic.”
 

Certain ‘frivolous’ cases more common than others

Nonmeritorious claims still occur relatively frequently today, according to data from the Medical Professional Liability Association’s Data Sharing Project. Of about 18,000 liability claims reported from 2016 to 2018, 65% were dropped, withdrawn, or dismissed. Of the 6% of claims that went before a jury, more than 85% resulted in a verdict for the defendant, the researchers found.

“Basically, any claim that does not result in a payment because the underlying claim of negligence on the part of a health professional had been demonstrated, proven, or adjudicated false is one we would describe as nonmeritorious,” Mr. Stinson said.

The MPL Association does not track cases that meet the legal definition of frivolous, said Mr. Stinson, and they “don’t see truly frivolous lawsuits very often.”

Malpractice claims are risky, expensive, and aggressively defended, says Mr. McConnell, the plaintiffs’ attorney. Mr. McConnell, who has been practicing for 30 years, said his own claim selection process is very rigorous and that he cannot afford to pursue claims that aren’t well supported by science and medicine.

“Pursuing frivolous cases would bankrupt me and ruin my reputation,” he said. “A lawyer I know once said he would write a check for $10,000 to anyone who could show him a lawyer who makes a living pursuing frivolous medical malpractice cases. It’s a fair challenge. The economics and the practices of liability carriers and defense lawyers make frivolous cases a dead end for plaintiff lawyers.”

Most medical malpractice cases are taken on a contingency fee basis, Mr. McConnell noted, meaning that the plaintiff’s lawyer is not paid unless the claim is successful.

“This means that the plaintiff’s lawyer is risking 2 years of intensive labor on a case which may yield no fee at all,” he said. “Obviously, any reasonable lawyer is going to want to minimize that risk. The only way to minimize that risk is for the case to be solid, not weak, and certainly not frivolous.”

But Dr. Segal, the health law attorney, says that plenty of frivolous liability claims are levied each year, with attorneys willing to pursue them.

It’s true that seasoned plaintiffs’ attorneys generally screen for merit and damages, Dr. Segal said, but in some instances, attorneys who are not trained in malpractice law accept frivolous claims and take them forward. In some cases, they are slip-and-fall accident attorneys accustomed to receiving modest amounts from insurance companies quickly, said Dr. Segal, founder of Medical Justice, a company that helps deter frivolous lawsuits against physicians.

“If we lived in a perfectly rational universe where plaintiffs’ attorneys screened cases well and only took the meritorious cases forward, we would see less frivolous cases filed, but that’s not the universe I live in,” Dr. Segal said. “There are well over a million attorneys in this country, and some are hungrier than others. The attorneys may frequently get burned in the end, and maybe that attorney won’t move another malpractice case forward, but there’s always someone else willing to take their place.”

Medical Justice has twice run a Most Frivolous Lawsuit Contest on its website, one in 2008 and one in late 2018. The first contest drew 30 entries, and the second garnered nearly 40 submissions, primarily from physicians who were defendants in the cases, according to Dr. Segal. (Dr. G’s lawsuit was highlighted in the most recent contest.)

In one case, an emergency physician was drawn into litigation by the family of a deceased patient. The patient experienced sudden cardiac arrythmia at home, and paramedics were unable to intubate her or establish IV access. She was transferred to the hospital, where resuscitation efforts continued, but she remained in asystole and was pronounced dead after 15 minutes.

At the hospital, blood tests were conducted. They showed that her serum potassium concentration was elevated to about 12 mEq/L, Dr. Segal said. The family initiated a claim in which they accused the emergency physician of failure to diagnose hyperkalemia. They alleged that had the hyperkalemia been discovered sooner, the patient’s death could have been prevented.

“If you had no other facts about this, you would wonder how a person with potassium that high would even be alive,” Dr. Segal said. “But what they were looking at was the body decomposing and all the potassium in the cells being released into the bloodstream. It wasn’t the cause of the problem, it was an effect of the problem. She really was dead on arrival, and she was probably dead at home.”

The case was eventually dropped.

Although the outcome for the patient was tragic, says Dr. Segal, the case is one of many types of frivolous claims that exist today.

“Yes, frivolous cases are out there,” he said.
 

Fraudulent claims uncommon

As for fraudulent medical liability claims, legal experts say they’re rare. J. Richard Moore, JD, an Indianapolis-based medical liability defense attorney, said he’s never personally encountered a medical malpractice claim in which he believed a plaintiff caused an injury or an illness and attempted to blame it on a physician.

However, Mr. Moore has defended many claims in which the illness or condition the plaintiff claimed was caused or was made worse through medical negligence was actually a preexisting condition or a preexisting condition that worsened and was not related to any medical negligence, Mr. Moore said.

“Although I have often felt in such cases that the plaintiff really knew that the condition was not affected by any alleged medical negligence, I would not put that in the ‘fraudulent claim’ category because it can be very difficult to establish a person’s subjective state of mind,” he said. “Usually in those cases, the plaintiff just denies memory of previous medical records or claims that the previous doctor who treated him or her for the same condition ‘got it wrong.’ In those cases, it is generally left to the jury whether to believe the plaintiff or not.”

Mr. Stinson also says he has not come across a truly fraudulent medical liability case. He noted that such a claim might be similar to a person falsely claiming a soft-tissue injury following an alleged slip-and-fall accident.

“Clearly, a fraudulent claim could be viewed as riskier from the plaintiff’s perspective because they could face criminal prosecution for insurance fraud, whereas if a claim is merely frivolous, they probably only run the risk of court-issued fine, if even that. That may be why we don’t often see fraudulent MPL claims.”
 

Ways to prevent or fight frivolous lawsuits

Since Dr. Stawicki’s legal nightmare as a resident, rules have tightened in Pennsylvania, and it is now more difficult to file frivolous claims, he said.

Pennsylvania is one of at least 28 states that require a certificate of merit in order for a medical liability claim to move forward. The provisions generally state that an appropriately licensed professional must supply a written statement attesting that the care the patient received failed to meet acceptable professional standards and that such conduct was a cause in the alleged harm.

“There is now a much greater burden of proof regarding what can proceed,” Dr. Stawicki said. “I’ve been involved in a couple cases that did not proceed because there was no certificate of merit.”

Although these reforms may help, not all merit rules are created equal. Some states require that the expert who signs the affidavit be knowledgeable in the relevant issues involved in the action. Other states have looser requirements. In one of the cases featured in Medical Justice’s Most Frivolous Lawsuit Contest, a podiatrist signed a supporting declaration for a claim related to obstetric care.

For physicians facing a frivolous claim, fighting it out in court depends on a number of factors. Without a consent-to-settle clause in the contract, an insurer can make the final decision on whether to defend or settle a case.

Resolving a malpractice claim is generally a business decision for the insurer, Dr. Studdert said.

“When the claim is for a relatively low amount of money, the costs of moving forward to defend that claim may be much more than the costs of simply settling it would be,” he said. “On the other hand, liability insurers and their lawyers are repeat players here, as are the plaintiffs’ attorneys. They don’t want to incentivize plaintiffs’ attorneys to bring questionable claims, and if they settle quickly, that may do so.”

Mr. Stinson, of the MPL Association, said a truly frivolous claim – one with no legal basis – is highly unlikely to be settled, “especially by MPL Association members who go beyond having a purely financial interest in their insureds to also focus on their professional reputation/integrity.” MPL Association members insure nearly 2 million health care professionals globally, including 2,500 hospitals and more than two-thirds of America’s physicians who are in private practice.

Physicians should make sure they know what is and what is not included in their policy, Dr. Segal said.

“The broker should sit down with the doctor, ideally before initial purchase or renewal, and explain in clear terms what the carrier’s obligations are and what the physician’s obligations are,” he said. “Know what type of protection is being purchased and what conditions might trigger a surprising and unhappy outcome.”
 

Should I countersue?

For truly frivolous claims, physicians have the legal right to sue for damages caused by the unfounded complaint.

Perhaps the most well-known case of a successful malpractice countersuit is that of Louisville neurosurgeon John Guarnaschelli, MD, who in 2000 won $72,000 in damages against a plaintiffs’ attorney for malicious prosecution.

The physician’s countersuit followed the dismissal of a negligence claim against Dr. Guarnaschelli by a patient who contracted meningitis. The plaintiffs’ attorney had made little effort to gather evidence to connect Dr. Guarnaschelli to the patient’s injuries and had consulted only one other physician, a client of his, before filing the lawsuit, according to a summary of the case in the American Bar Association Journal.

Malicious prosecution is the most common legal theory of recovery for physicians in countersuits, according to a review of successful countersuits by doctors. Dr. Stawicki is a coauthor of that review. Other legal theories that physicians can raise include abuse of process, negligence, defamation, invasion of privacy, and infliction of emotional distress. Of the 13 cases evaluated in the article by Dr. Stawicki and colleagues, damages awarded to physicians ranged from about $13,000 to $125,000.

Although some doctors have success, pursuing a counterclaim can be a difficult feat, said Benjamin Braslow, MD, a trauma surgeon and professor of clinical surgery at the University of Pennsylvania in Philadelphia.

“The main takeaways were it’s an uphill battle often met with not only resistance but diminishing returns to countersue,” said Dr. Braslow, a coauthor of the countersuits analysis. “You have to meet very specific criteria regarding leveling the suit, and it may end up being a costly, time-consuming battle.”

To prove malicious prosecution, for example, a physician must show that a claim was instituted without probable cause, that the suing party acted maliciously in instituting the action, and that the doctor was damaged by the action, among other essential elements.

As for Dr. G, the surgeon, he now has a contract with a consent-to-settle clause and has taken other legal precautions since his lawsuits. He requires that his patients sign an agreement that any negligence claims they levy go to arbitration. If an arbitrator finds in the patient’s favor, the case may proceed to court, he said. However, he requires another agreement such that if patients lose in court, they are responsible for his legal fees.

“I’m just more careful,” he said. “I ask all my staff in the office to use their judgment, however superficial, if they feel something is wrong with an individual to tell me so. I’d rather send them away than operate on them and have it result in a lawsuit.”
 

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.

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.

A routine scan used to evaluate some acute stroke patients can also detect SARS-CoV-2 infection in the upper lungs, a new study shows.

“As part of the stroke evaluation workup process, we were able to diagnose COVID-19 at the same time at no extra cost or additional workload,” lead author Charles Esenwa, MD, commented to Medscape Medical News. “This is an objective way to screen for COVID-19 in the acute stroke setting,” he added.

Esenwa is an assistant professor and a stroke neurologist at the Montefiore Medical Center/Albert Einstein College of Medicine in New York City.

He explained that, during the COVID-19 surge earlier this year, assessment of patients with severe acute stroke using computed tomography angiogram (CTA) scans – used to evaluate suitability for endovascular stroke therapy – also showed findings in the upper lung consistent with viral infection in some patients.

“We then assumed that these patients had COVID-19 and took extra precautions to keep them isolated and to protect staff involved in their care. It also allowed us to triage these patients more quickly than waiting for the COVID-19 swab test and arrange the most appropriate care for them,” Esenwa said.

The researchers have now gone back and analyzed their data on acute stroke patients who underwent CTA at their institution during the COVID-19 surge. They found that the changes identified in the lungs were highly specific for diagnosing SARS-CoV-2 infection.

The study was published online on Oct. 29 in Stroke.

“Stroke patients are normally screened for COVID-19 on hospitalization, but the swab test result can take several hours or longer to come back, and it is very useful for us to know if a patient could be infected,” Esenwa noted.

“When we do a CTA, we look at the blood vessels supplying the brain, but the scan also covers the top of the lung, as it starts at the aortic arch. We don’t normally look closely at that area, but we started to notice signs of active lung infection which could have been COVID-19,” he said. “For this paper, we went back to assess how accurate this approach actually was vs. the COVID-19 PCR test.”

The researchers report on 57 patients who presented to three Montefiore Health System hospitals in the Bronx, in New York City, with acute ischemic stroke and who underwent CTA of the head and neck in March and April 2020, the peak of the COVID-19 outbreak there. The patients also underwent PCR testing for COVID-19.

Results showed that 30 patients had a positive COVID-19 test result and that 27 had a negative result. Lung findings highly or very highly suspicious for COVID-19 pneumonia were identified during the CTA scan in 20 (67%) of the COVID-19–positive patients and in two (7%) of the COVID-19–negative patients.

These findings, when used in isolation, yielded a sensitivity of 0.67 and a specificity of 0.93. They had a positive predictive value of 0.19, a negative predictive value of 0.99, and accuracy of 0.92 for the diagnosis of COVID-19.

When apical lung assessment was combined with self-reported clinical symptoms of cough or dyspnea, sensitivity for the diagnosis of COVID-19 for patients presenting to the hospital for acute ischemic stroke increased to 0.83.

“We wondered whether looking at the whole lung would have found better results, but other studies which have done this actually found similar numbers to ours, so we think actually just looking at the top of the lungs, which can be seen in a stroke CTA, may be sufficient,” Esenwa said.

He emphasized the importance of establishing whether an acute stroke patient has COVID-19. “If we had a high suspicion of COVID-19 infection, we would take more precautions during any procedures, such as thrombectomy, and make sure to keep the patient isolated afterwards. It doesn’t necessarily affect the treatment given for stroke, but it affects the safety of the patients and everyone caring for them,” he commented.

Esenwa explained that intubation – which is sometime necessary during thrombectomy – can expose everyone in the room to aerosolized droplets. “So we would take much higher safety precautions if we thought the patient was COVID-19 positive,” he said.

“Early COVID-19 diagnosis also means patients can be given supportive treatment more quickly, admitted to ICU if appropriate, and we can all keep a close eye on pulmonary issues. So having that information is important in many ways,” he added.

Esenwa advises that any medical center that evaluates acute stroke patients for thrombectomy and is experiencing a COVID-19 surge can use this technique as a screening method for COVID-19.

He pointed out that the Montefiore Health System had a very high rate of COVID-19. That part of New York City was one of the worst hit areas of the world, and the CTA approach for identifying COVID-19 has been validated only in areas with such a high local incidence of COVID. If used in an area of lower prevalence, the accuracy would likely be less.

“We don’t know if this approach would work as well at times of low COVID-19 infection, where any lung findings would be more likely to be caused by other conditions, such as pneumonia due to other causes or congestive heart failure. So there would be more false positives,” Esenwa said.

“But when COVID-19 prevalence is high, the lung findings are much more likely to be a sign of COVID-19 infection. As COVID-19 numbers are now rising for a second time, it is likely to become a useful strategy again.”

The study was approved by the Albert Einstein College of Medicine/Montefiore Medical Center Institutional Review Board and had no external funding. Esenwa has disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

A routine scan used to evaluate some acute stroke patients can also detect SARS-CoV-2 infection in the upper lungs, a new study shows.

“As part of the stroke evaluation workup process, we were able to diagnose COVID-19 at the same time at no extra cost or additional workload,” lead author Charles Esenwa, MD, commented to Medscape Medical News. “This is an objective way to screen for COVID-19 in the acute stroke setting,” he added.

Esenwa is an assistant professor and a stroke neurologist at the Montefiore Medical Center/Albert Einstein College of Medicine in New York City.

He explained that, during the COVID-19 surge earlier this year, assessment of patients with severe acute stroke using computed tomography angiogram (CTA) scans – used to evaluate suitability for endovascular stroke therapy – also showed findings in the upper lung consistent with viral infection in some patients.

“We then assumed that these patients had COVID-19 and took extra precautions to keep them isolated and to protect staff involved in their care. It also allowed us to triage these patients more quickly than waiting for the COVID-19 swab test and arrange the most appropriate care for them,” Esenwa said.

The researchers have now gone back and analyzed their data on acute stroke patients who underwent CTA at their institution during the COVID-19 surge. They found that the changes identified in the lungs were highly specific for diagnosing SARS-CoV-2 infection.

The study was published online on Oct. 29 in Stroke.

“Stroke patients are normally screened for COVID-19 on hospitalization, but the swab test result can take several hours or longer to come back, and it is very useful for us to know if a patient could be infected,” Esenwa noted.

“When we do a CTA, we look at the blood vessels supplying the brain, but the scan also covers the top of the lung, as it starts at the aortic arch. We don’t normally look closely at that area, but we started to notice signs of active lung infection which could have been COVID-19,” he said. “For this paper, we went back to assess how accurate this approach actually was vs. the COVID-19 PCR test.”

The researchers report on 57 patients who presented to three Montefiore Health System hospitals in the Bronx, in New York City, with acute ischemic stroke and who underwent CTA of the head and neck in March and April 2020, the peak of the COVID-19 outbreak there. The patients also underwent PCR testing for COVID-19.

Results showed that 30 patients had a positive COVID-19 test result and that 27 had a negative result. Lung findings highly or very highly suspicious for COVID-19 pneumonia were identified during the CTA scan in 20 (67%) of the COVID-19–positive patients and in two (7%) of the COVID-19–negative patients.

These findings, when used in isolation, yielded a sensitivity of 0.67 and a specificity of 0.93. They had a positive predictive value of 0.19, a negative predictive value of 0.99, and accuracy of 0.92 for the diagnosis of COVID-19.

When apical lung assessment was combined with self-reported clinical symptoms of cough or dyspnea, sensitivity for the diagnosis of COVID-19 for patients presenting to the hospital for acute ischemic stroke increased to 0.83.

“We wondered whether looking at the whole lung would have found better results, but other studies which have done this actually found similar numbers to ours, so we think actually just looking at the top of the lungs, which can be seen in a stroke CTA, may be sufficient,” Esenwa said.

He emphasized the importance of establishing whether an acute stroke patient has COVID-19. “If we had a high suspicion of COVID-19 infection, we would take more precautions during any procedures, such as thrombectomy, and make sure to keep the patient isolated afterwards. It doesn’t necessarily affect the treatment given for stroke, but it affects the safety of the patients and everyone caring for them,” he commented.

Esenwa explained that intubation – which is sometime necessary during thrombectomy – can expose everyone in the room to aerosolized droplets. “So we would take much higher safety precautions if we thought the patient was COVID-19 positive,” he said.

“Early COVID-19 diagnosis also means patients can be given supportive treatment more quickly, admitted to ICU if appropriate, and we can all keep a close eye on pulmonary issues. So having that information is important in many ways,” he added.

Esenwa advises that any medical center that evaluates acute stroke patients for thrombectomy and is experiencing a COVID-19 surge can use this technique as a screening method for COVID-19.

He pointed out that the Montefiore Health System had a very high rate of COVID-19. That part of New York City was one of the worst hit areas of the world, and the CTA approach for identifying COVID-19 has been validated only in areas with such a high local incidence of COVID. If used in an area of lower prevalence, the accuracy would likely be less.

“We don’t know if this approach would work as well at times of low COVID-19 infection, where any lung findings would be more likely to be caused by other conditions, such as pneumonia due to other causes or congestive heart failure. So there would be more false positives,” Esenwa said.

“But when COVID-19 prevalence is high, the lung findings are much more likely to be a sign of COVID-19 infection. As COVID-19 numbers are now rising for a second time, it is likely to become a useful strategy again.”

The study was approved by the Albert Einstein College of Medicine/Montefiore Medical Center Institutional Review Board and had no external funding. Esenwa has disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

A routine scan used to evaluate some acute stroke patients can also detect SARS-CoV-2 infection in the upper lungs, a new study shows.

“As part of the stroke evaluation workup process, we were able to diagnose COVID-19 at the same time at no extra cost or additional workload,” lead author Charles Esenwa, MD, commented to Medscape Medical News. “This is an objective way to screen for COVID-19 in the acute stroke setting,” he added.

Esenwa is an assistant professor and a stroke neurologist at the Montefiore Medical Center/Albert Einstein College of Medicine in New York City.

He explained that, during the COVID-19 surge earlier this year, assessment of patients with severe acute stroke using computed tomography angiogram (CTA) scans – used to evaluate suitability for endovascular stroke therapy – also showed findings in the upper lung consistent with viral infection in some patients.

“We then assumed that these patients had COVID-19 and took extra precautions to keep them isolated and to protect staff involved in their care. It also allowed us to triage these patients more quickly than waiting for the COVID-19 swab test and arrange the most appropriate care for them,” Esenwa said.

The researchers have now gone back and analyzed their data on acute stroke patients who underwent CTA at their institution during the COVID-19 surge. They found that the changes identified in the lungs were highly specific for diagnosing SARS-CoV-2 infection.

The study was published online on Oct. 29 in Stroke.

“Stroke patients are normally screened for COVID-19 on hospitalization, but the swab test result can take several hours or longer to come back, and it is very useful for us to know if a patient could be infected,” Esenwa noted.

“When we do a CTA, we look at the blood vessels supplying the brain, but the scan also covers the top of the lung, as it starts at the aortic arch. We don’t normally look closely at that area, but we started to notice signs of active lung infection which could have been COVID-19,” he said. “For this paper, we went back to assess how accurate this approach actually was vs. the COVID-19 PCR test.”

The researchers report on 57 patients who presented to three Montefiore Health System hospitals in the Bronx, in New York City, with acute ischemic stroke and who underwent CTA of the head and neck in March and April 2020, the peak of the COVID-19 outbreak there. The patients also underwent PCR testing for COVID-19.

Results showed that 30 patients had a positive COVID-19 test result and that 27 had a negative result. Lung findings highly or very highly suspicious for COVID-19 pneumonia were identified during the CTA scan in 20 (67%) of the COVID-19–positive patients and in two (7%) of the COVID-19–negative patients.

These findings, when used in isolation, yielded a sensitivity of 0.67 and a specificity of 0.93. They had a positive predictive value of 0.19, a negative predictive value of 0.99, and accuracy of 0.92 for the diagnosis of COVID-19.

When apical lung assessment was combined with self-reported clinical symptoms of cough or dyspnea, sensitivity for the diagnosis of COVID-19 for patients presenting to the hospital for acute ischemic stroke increased to 0.83.

“We wondered whether looking at the whole lung would have found better results, but other studies which have done this actually found similar numbers to ours, so we think actually just looking at the top of the lungs, which can be seen in a stroke CTA, may be sufficient,” Esenwa said.

He emphasized the importance of establishing whether an acute stroke patient has COVID-19. “If we had a high suspicion of COVID-19 infection, we would take more precautions during any procedures, such as thrombectomy, and make sure to keep the patient isolated afterwards. It doesn’t necessarily affect the treatment given for stroke, but it affects the safety of the patients and everyone caring for them,” he commented.

Esenwa explained that intubation – which is sometime necessary during thrombectomy – can expose everyone in the room to aerosolized droplets. “So we would take much higher safety precautions if we thought the patient was COVID-19 positive,” he said.

“Early COVID-19 diagnosis also means patients can be given supportive treatment more quickly, admitted to ICU if appropriate, and we can all keep a close eye on pulmonary issues. So having that information is important in many ways,” he added.

Esenwa advises that any medical center that evaluates acute stroke patients for thrombectomy and is experiencing a COVID-19 surge can use this technique as a screening method for COVID-19.

He pointed out that the Montefiore Health System had a very high rate of COVID-19. That part of New York City was one of the worst hit areas of the world, and the CTA approach for identifying COVID-19 has been validated only in areas with such a high local incidence of COVID. If used in an area of lower prevalence, the accuracy would likely be less.

“We don’t know if this approach would work as well at times of low COVID-19 infection, where any lung findings would be more likely to be caused by other conditions, such as pneumonia due to other causes or congestive heart failure. So there would be more false positives,” Esenwa said.

“But when COVID-19 prevalence is high, the lung findings are much more likely to be a sign of COVID-19 infection. As COVID-19 numbers are now rising for a second time, it is likely to become a useful strategy again.”

The study was approved by the Albert Einstein College of Medicine/Montefiore Medical Center Institutional Review Board and had no external funding. Esenwa has disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

A cumulative 511,000 lives could be lost from COVID-19 in the United States by the end of February 2021, a new prediction study reveals.

However, if universal mask wearing is adopted — defined as 95% of Americans complying with the protective measure — along with social distancing mandates as warranted, nearly 130,000 of those lives could be saved.

And if even 85% of Americans comply, an additional 95,800 lives would be spared before March of next year, researchers at the University of Washington Institute for Health Metrics and Evaluation (IHME) report.

The study was published online October 23 in Nature Medicine.

“The study is sound and makes the case for mandatory mask policies,” said Arthur L. Caplan, PhD, a professor of bioethics at NYU Langone Health in New York City, who frequently provides commentary for Medscape.

Without mandatory mask requirements, he added, “we will see a pandemic slaughter and an overwhelmed healthcare system and workforce.”

The IHME team evaluated COVID-19 data for cases and related deaths between February 1 and September 21. Based on this data, they predicted the likely future of SARS-CoV-2 infections on a state level from September 22, 2020, to February 2021.

An Optimistic Projection

Lead author Robert C. Reiner Jr and colleagues looked at five scenarios. For example, they calculated likely deaths associated with COVID-19 if adoption of mask and social distancing recommendations were nearly universal. They note that Singapore achieved a 95% compliance rate with masks and used this as their “best-case scenario” model.

An estimated 129,574 (range, 85,284–170,867) additional lives could be saved if 95% of Americans wore masks in public, their research reveals. This optimistic scenario includes a “plausible reference” in which any US state reaching 8 COVID-19 deaths per 1 million residents would enact 6 weeks of social distancing mandates (SDMs).

Achieving this level of mask compliance in the United States “could be sufficient to ameliorate the worst effects of epidemic resurgences in many states,” the researchers note.

In contrast, the proportion of Americans wearing masks in public as of September 22 was 49%, according to IHME data.
 

Universal mask use unlikely

“I’m not a modeling expert, but it is an interesting, and as far as I can judge, well-conducted study which looks, state by state, at what might happen in various scenarios around masking policies going forward — and in particular the effect that mandated masking might have,” Trish Greenhalgh, MD, told Medscape Medical News.  

“However, the scenario is a thought experiment. Near-universal mask use is not going to happen in the USA, nor indeed in any individual state, right now, given how emotive the issue has become,” added Greenhalgh, professor in the Nuffield Department of Primary Care Health Sciences at Oxford University, UK. She was not affiliated with the study.

“Hence, whilst I am broadly supportive of the science,” she said, “I’m not confident that this paper will be able to change policy.”
 

Other ‘What if?’ scenarios

The authors also predicted the mortality implications associated with lower adherence to masks, the presence or absence of SDMs, and what could happen if mandates continue to ease at their current rate.

For example, they considered a scenario with less-than-universal mask use in public, 85%, along with SDMs being reinstated based on the mortality rate threshold. In this instance, they found an additional 95,814 (range, 60,731–133,077) lives could be spared by February 28.

Another calculation looked at outcomes if 95% of Americans wore masks going forward without states instituting SDMs at any point. In this case, the researchers predict that 490,437 Americans would die from COVID-19 by February 2021.

A fourth analysis revealed what would happen without greater mask use if the mortality threshold triggered 6 weeks of SDMs as warranted. Under this ‘plausible reference’ calculation, a total 511,373 Americans would die from COVID-19 by the end of February.

A fifth scenario predicted potential mortality if states continue easing SDMs at the current pace. “This is an alternative scenario to the more probable situation where states are expected to respond to an impending health crisis by reinstating some SDMs,” the authors note. The predicted number of American deaths appears more dire in this calculation. The investigators predict cumulative total deaths could reach 1,053,206 (range, 759,693–1,452,397) by the end of February 2021.

The death toll would likely vary among states in this scenario. California, Florida, and Pennsylvania would like account for approximately one third of all deaths.

All the modeling scenarios considered other factors including pneumonia seasonality, mobility, testing rates, and mask use per capita.
 

“I have seen the IHME study and I agree with the broad conclusions,” Richard Stutt, PhD, of the Epidemiology and Modelling Group at the University of Cambridge, UK, told Medscape Medical News.

“Case numbers are climbing in the US, and without further intervention, there will be a significant number of deaths over the coming months,” he said.

Masks are low cost and widely available, Stutt said. “I am hopeful that even if masks are not widely adopted, we will not see as many deaths as predicted here, as these outbreaks can be significantly reduced by increased social distancing or lockdowns.”

“However this comes at a far higher economic cost than the use of masks, and still requires action,” added Stutt, who authored a study in June that modeled facemasks in combination with “lock-down” measures for managing the COVID-19 pandemic.

Modeling study results depend on the assumptions researchers make, and the IHME team rightly tested a number of different assumptions, Greenhalgh said.

“The key conclusion,” she added, “is here: ‘The implementation of SDMs as soon as individual states reach a threshold of 8 daily deaths per million could dramatically ameliorate the effects of the disease; achieving near-universal mask use could delay, or in many states, possibly prevent, this threshold from being reached and has the potential to save the most lives while minimizing damage to the economy.’ “

“This is a useful piece of information and I think is borne out by their data,” added Greenhalgh, lead author of an April study on face masks for the public during the pandemic.

You can visit the IHME website for the most current mortality projections.

Caplan, Greenhalgh, and Stutt have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A cumulative 511,000 lives could be lost from COVID-19 in the United States by the end of February 2021, a new prediction study reveals.

However, if universal mask wearing is adopted — defined as 95% of Americans complying with the protective measure — along with social distancing mandates as warranted, nearly 130,000 of those lives could be saved.

And if even 85% of Americans comply, an additional 95,800 lives would be spared before March of next year, researchers at the University of Washington Institute for Health Metrics and Evaluation (IHME) report.

The study was published online October 23 in Nature Medicine.

“The study is sound and makes the case for mandatory mask policies,” said Arthur L. Caplan, PhD, a professor of bioethics at NYU Langone Health in New York City, who frequently provides commentary for Medscape.

Without mandatory mask requirements, he added, “we will see a pandemic slaughter and an overwhelmed healthcare system and workforce.”

The IHME team evaluated COVID-19 data for cases and related deaths between February 1 and September 21. Based on this data, they predicted the likely future of SARS-CoV-2 infections on a state level from September 22, 2020, to February 2021.

An Optimistic Projection

Lead author Robert C. Reiner Jr and colleagues looked at five scenarios. For example, they calculated likely deaths associated with COVID-19 if adoption of mask and social distancing recommendations were nearly universal. They note that Singapore achieved a 95% compliance rate with masks and used this as their “best-case scenario” model.

An estimated 129,574 (range, 85,284–170,867) additional lives could be saved if 95% of Americans wore masks in public, their research reveals. This optimistic scenario includes a “plausible reference” in which any US state reaching 8 COVID-19 deaths per 1 million residents would enact 6 weeks of social distancing mandates (SDMs).

Achieving this level of mask compliance in the United States “could be sufficient to ameliorate the worst effects of epidemic resurgences in many states,” the researchers note.

In contrast, the proportion of Americans wearing masks in public as of September 22 was 49%, according to IHME data.
 

Universal mask use unlikely

“I’m not a modeling expert, but it is an interesting, and as far as I can judge, well-conducted study which looks, state by state, at what might happen in various scenarios around masking policies going forward — and in particular the effect that mandated masking might have,” Trish Greenhalgh, MD, told Medscape Medical News.  

“However, the scenario is a thought experiment. Near-universal mask use is not going to happen in the USA, nor indeed in any individual state, right now, given how emotive the issue has become,” added Greenhalgh, professor in the Nuffield Department of Primary Care Health Sciences at Oxford University, UK. She was not affiliated with the study.

“Hence, whilst I am broadly supportive of the science,” she said, “I’m not confident that this paper will be able to change policy.”
 

Other ‘What if?’ scenarios

The authors also predicted the mortality implications associated with lower adherence to masks, the presence or absence of SDMs, and what could happen if mandates continue to ease at their current rate.

For example, they considered a scenario with less-than-universal mask use in public, 85%, along with SDMs being reinstated based on the mortality rate threshold. In this instance, they found an additional 95,814 (range, 60,731–133,077) lives could be spared by February 28.

Another calculation looked at outcomes if 95% of Americans wore masks going forward without states instituting SDMs at any point. In this case, the researchers predict that 490,437 Americans would die from COVID-19 by February 2021.

A fourth analysis revealed what would happen without greater mask use if the mortality threshold triggered 6 weeks of SDMs as warranted. Under this ‘plausible reference’ calculation, a total 511,373 Americans would die from COVID-19 by the end of February.

A fifth scenario predicted potential mortality if states continue easing SDMs at the current pace. “This is an alternative scenario to the more probable situation where states are expected to respond to an impending health crisis by reinstating some SDMs,” the authors note. The predicted number of American deaths appears more dire in this calculation. The investigators predict cumulative total deaths could reach 1,053,206 (range, 759,693–1,452,397) by the end of February 2021.

The death toll would likely vary among states in this scenario. California, Florida, and Pennsylvania would like account for approximately one third of all deaths.

All the modeling scenarios considered other factors including pneumonia seasonality, mobility, testing rates, and mask use per capita.
 

“I have seen the IHME study and I agree with the broad conclusions,” Richard Stutt, PhD, of the Epidemiology and Modelling Group at the University of Cambridge, UK, told Medscape Medical News.

“Case numbers are climbing in the US, and without further intervention, there will be a significant number of deaths over the coming months,” he said.

Masks are low cost and widely available, Stutt said. “I am hopeful that even if masks are not widely adopted, we will not see as many deaths as predicted here, as these outbreaks can be significantly reduced by increased social distancing or lockdowns.”

“However this comes at a far higher economic cost than the use of masks, and still requires action,” added Stutt, who authored a study in June that modeled facemasks in combination with “lock-down” measures for managing the COVID-19 pandemic.

Modeling study results depend on the assumptions researchers make, and the IHME team rightly tested a number of different assumptions, Greenhalgh said.

“The key conclusion,” she added, “is here: ‘The implementation of SDMs as soon as individual states reach a threshold of 8 daily deaths per million could dramatically ameliorate the effects of the disease; achieving near-universal mask use could delay, or in many states, possibly prevent, this threshold from being reached and has the potential to save the most lives while minimizing damage to the economy.’ “

“This is a useful piece of information and I think is borne out by their data,” added Greenhalgh, lead author of an April study on face masks for the public during the pandemic.

You can visit the IHME website for the most current mortality projections.

Caplan, Greenhalgh, and Stutt have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A cumulative 511,000 lives could be lost from COVID-19 in the United States by the end of February 2021, a new prediction study reveals.

However, if universal mask wearing is adopted — defined as 95% of Americans complying with the protective measure — along with social distancing mandates as warranted, nearly 130,000 of those lives could be saved.

And if even 85% of Americans comply, an additional 95,800 lives would be spared before March of next year, researchers at the University of Washington Institute for Health Metrics and Evaluation (IHME) report.

The study was published online October 23 in Nature Medicine.

“The study is sound and makes the case for mandatory mask policies,” said Arthur L. Caplan, PhD, a professor of bioethics at NYU Langone Health in New York City, who frequently provides commentary for Medscape.

Without mandatory mask requirements, he added, “we will see a pandemic slaughter and an overwhelmed healthcare system and workforce.”

The IHME team evaluated COVID-19 data for cases and related deaths between February 1 and September 21. Based on this data, they predicted the likely future of SARS-CoV-2 infections on a state level from September 22, 2020, to February 2021.

An Optimistic Projection

Lead author Robert C. Reiner Jr and colleagues looked at five scenarios. For example, they calculated likely deaths associated with COVID-19 if adoption of mask and social distancing recommendations were nearly universal. They note that Singapore achieved a 95% compliance rate with masks and used this as their “best-case scenario” model.

An estimated 129,574 (range, 85,284–170,867) additional lives could be saved if 95% of Americans wore masks in public, their research reveals. This optimistic scenario includes a “plausible reference” in which any US state reaching 8 COVID-19 deaths per 1 million residents would enact 6 weeks of social distancing mandates (SDMs).

Achieving this level of mask compliance in the United States “could be sufficient to ameliorate the worst effects of epidemic resurgences in many states,” the researchers note.

In contrast, the proportion of Americans wearing masks in public as of September 22 was 49%, according to IHME data.
 

Universal mask use unlikely

“I’m not a modeling expert, but it is an interesting, and as far as I can judge, well-conducted study which looks, state by state, at what might happen in various scenarios around masking policies going forward — and in particular the effect that mandated masking might have,” Trish Greenhalgh, MD, told Medscape Medical News.  

“However, the scenario is a thought experiment. Near-universal mask use is not going to happen in the USA, nor indeed in any individual state, right now, given how emotive the issue has become,” added Greenhalgh, professor in the Nuffield Department of Primary Care Health Sciences at Oxford University, UK. She was not affiliated with the study.

“Hence, whilst I am broadly supportive of the science,” she said, “I’m not confident that this paper will be able to change policy.”
 

Other ‘What if?’ scenarios

The authors also predicted the mortality implications associated with lower adherence to masks, the presence or absence of SDMs, and what could happen if mandates continue to ease at their current rate.

For example, they considered a scenario with less-than-universal mask use in public, 85%, along with SDMs being reinstated based on the mortality rate threshold. In this instance, they found an additional 95,814 (range, 60,731–133,077) lives could be spared by February 28.

Another calculation looked at outcomes if 95% of Americans wore masks going forward without states instituting SDMs at any point. In this case, the researchers predict that 490,437 Americans would die from COVID-19 by February 2021.

A fourth analysis revealed what would happen without greater mask use if the mortality threshold triggered 6 weeks of SDMs as warranted. Under this ‘plausible reference’ calculation, a total 511,373 Americans would die from COVID-19 by the end of February.

A fifth scenario predicted potential mortality if states continue easing SDMs at the current pace. “This is an alternative scenario to the more probable situation where states are expected to respond to an impending health crisis by reinstating some SDMs,” the authors note. The predicted number of American deaths appears more dire in this calculation. The investigators predict cumulative total deaths could reach 1,053,206 (range, 759,693–1,452,397) by the end of February 2021.

The death toll would likely vary among states in this scenario. California, Florida, and Pennsylvania would like account for approximately one third of all deaths.

All the modeling scenarios considered other factors including pneumonia seasonality, mobility, testing rates, and mask use per capita.
 

“I have seen the IHME study and I agree with the broad conclusions,” Richard Stutt, PhD, of the Epidemiology and Modelling Group at the University of Cambridge, UK, told Medscape Medical News.

“Case numbers are climbing in the US, and without further intervention, there will be a significant number of deaths over the coming months,” he said.

Masks are low cost and widely available, Stutt said. “I am hopeful that even if masks are not widely adopted, we will not see as many deaths as predicted here, as these outbreaks can be significantly reduced by increased social distancing or lockdowns.”

“However this comes at a far higher economic cost than the use of masks, and still requires action,” added Stutt, who authored a study in June that modeled facemasks in combination with “lock-down” measures for managing the COVID-19 pandemic.

Modeling study results depend on the assumptions researchers make, and the IHME team rightly tested a number of different assumptions, Greenhalgh said.

“The key conclusion,” she added, “is here: ‘The implementation of SDMs as soon as individual states reach a threshold of 8 daily deaths per million could dramatically ameliorate the effects of the disease; achieving near-universal mask use could delay, or in many states, possibly prevent, this threshold from being reached and has the potential to save the most lives while minimizing damage to the economy.’ “

“This is a useful piece of information and I think is borne out by their data,” added Greenhalgh, lead author of an April study on face masks for the public during the pandemic.

You can visit the IHME website for the most current mortality projections.

Caplan, Greenhalgh, and Stutt have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.