The Hospitalist

Many student athletes who test positive for COVID-19 likely can have an uneventful return to their sports after they have rested for 2 weeks in quarantine, doctors suggest.

Canberk Sezer/Getty Images

There are reasons for caution, however, especially when a patient has symptoms that indicate possible cardiac involvement. In these cases, patients should undergo cardiac testing before a physician clears them to return to play, according to guidance from professional associations. Reports of myocarditis in college athletes who tested positive for SARS-CoV-2 but were asymptomatic are among the reasons for concern. Myocarditis may increase the risk of sudden death during exercise.

“The thing that you need to keep in mind is that this is not just a respiratory illness,” David T. Bernhardt, MD, professor of pediatrics, orthopedics, and rehabilitation at the University of Wisconsin in Madison, said in a presentation at the annual meeting of the American Academy of Pediatrics, held virtually this year. High school and college athletes have had cardiac, neurologic, hematologic, and renal problems that “can complicate their recovery and their return to sport.”

Still, children who test positive for COVID-19 tend to have mild illness and often are asymptomatic. “It is more than likely going to be safe for the majority of the student athletes who are in the elementary and middle school age to return to sport,” said Dr. Bernhardt. Given that 18-year-old college freshmen have had cardiac complications, there may be reason for more caution with high school students.
 

Limited data

The AAP has released interim guidance on returning to sports and recommends that primary care physicians clear all patients with COVID-19 before they resume training. Physicians should screen for cardiac symptoms such as chest pain, shortness of breath, fatigue, palpitations, or syncope.

Those with severe illness should be restricted from exercise and participation for 3-6 months. Primary care physicians, preferably in consultation with pediatric cardiologists, should clear athletes who experience severe illness.

“Most of the recommendations come from the fact that we simply do not know what we do not know with COVID-19,” Susannah Briskin, MD, a coauthor of the interim guidance, said in an interview. “We have to be cautious in returning individuals to play and closely monitor them as we learn more about the disease process and its effect on kids.”

Patients with severe illness could include those who were hospitalized and experienced hypotension or arrhythmias, required intubation or extracorporeal membrane oxygenation (ECMO) support, had kidney or cardiac failure, or developed multisystem inflammatory syndrome in children (MIS-C), said Dr. Briskin, a specialist in pediatric sports medicine at Case Western Reserve University, Cleveland.

“The majority of COVID-19 cases will not present like this in kids. We have no idea how common myocarditis is in kids post infection. We do know that, if anyone has chest pain, shortness of breath, excessive fatigue, syncope [passing out], or arrhythmia [feeling of their heart skipping beats], they should undergo further evaluation for myocarditis,” Dr. Briskin said.

Patients who are asymptomatic or have mild symptoms should rest for 14 days after their positive test. After their infectious period has passed, a doctor should assess for any concerning cardiac symptoms. “Anyone with prolonged fever or moderate symptoms should see their pediatrician and have an EKG performed, at a minimum, prior to return to sports,” Dr. Briskin said. “Anyone with an abnormal EKG or concerning signs or symptoms should be referred on to pediatric cardiology for a further assessment.”

Most patients who Dr. Briskin has seen have been asymptomatic or mildly symptomatic. “They have done well with a gradual return to physical activity,” she said. “We recommend a gradual return so individuals can be monitored for any signs or symptoms concerning for myocarditis. The far majority of individuals likely have an uneventful return to play.”

Mitigating risk

COVID-19 adds elements of uncertainty and complexity to the usual process of mitigating risk in sports, Dr. Bernhardt noted in his lecture. “You are dealing with an infection that we do not know a lot about,” he said. “And we are trying to mitigate risk not only for the individual who may or may not have underlying health problems, but you are also trying to mitigate risk for anybody else involved with the sport, including athletic trainers and team physicians, coaches, spectators, custodial staff, people working at a snack shack, and all the other people that can be involved in a typical sporting type of atmosphere.”

When patients do return to play after an illness, they should gradually increase the training load to avoid injury. In addition, clinicians should screen for depression and anxiety using tools such as the Four-Item Patient Health Questionnaire (PHQ-4) when they see patients. “The pandemic has been quite stressful for everybody, including our high school student athletes,” Dr. Bernhardt said. “Giving everybody a PHQ-4 when they come into clinic right now probably makes sense in terms of the stress levels that all of us are experiencing.”

If a patient screens positive, take additional history and refer for more in-depth mental health evaluation and treatment if warranted. Sharing breathing and relaxation exercises, promoting healthy behaviors, and paying attention to unhealthy strategies also may help, Dr. Bernhardt suggested.

Ultimately, determining when an athlete with COVID-19 can be medically cleared to return to play may be a challenge. There are limited data on epidemiology and clinical presentations that could help identify cardiac injury related to the disease, Dr. Bernhardt said. Guidance from the American College of Cardiology provides a framework for evaluating athletes for return to play, and pediatric cardiologists have discussed how the guidance relates to a pediatric population. Cardiac assessments may include measures of biomarkers such as troponin, B-type natriuretic peptide, and sedimentation rate, along with electrocardiograms, echocardiograms, and cardiac MRI.

Beyond return-to-play decisions, encourage the use of cloth face coverings on the sidelines and away from the playing field, and stress proper quarantining, Dr. Briskin added. Too often, she hears about children not quarantining properly. “Individuals with a known exposure should be quarantined in their house – ideally in a separate room from everyone else. ... When they come out of their room, they should wash their hands well and wear a cloth face covering. They should not be eating with other people.”

Dr. Bernhardt had no relevant disclosures.

[email protected]

Many student athletes who test positive for COVID-19 likely can have an uneventful return to their sports after they have rested for 2 weeks in quarantine, doctors suggest.

Canberk Sezer/Getty Images

There are reasons for caution, however, especially when a patient has symptoms that indicate possible cardiac involvement. In these cases, patients should undergo cardiac testing before a physician clears them to return to play, according to guidance from professional associations. Reports of myocarditis in college athletes who tested positive for SARS-CoV-2 but were asymptomatic are among the reasons for concern. Myocarditis may increase the risk of sudden death during exercise.

“The thing that you need to keep in mind is that this is not just a respiratory illness,” David T. Bernhardt, MD, professor of pediatrics, orthopedics, and rehabilitation at the University of Wisconsin in Madison, said in a presentation at the annual meeting of the American Academy of Pediatrics, held virtually this year. High school and college athletes have had cardiac, neurologic, hematologic, and renal problems that “can complicate their recovery and their return to sport.”

Still, children who test positive for COVID-19 tend to have mild illness and often are asymptomatic. “It is more than likely going to be safe for the majority of the student athletes who are in the elementary and middle school age to return to sport,” said Dr. Bernhardt. Given that 18-year-old college freshmen have had cardiac complications, there may be reason for more caution with high school students.
 

Limited data

The AAP has released interim guidance on returning to sports and recommends that primary care physicians clear all patients with COVID-19 before they resume training. Physicians should screen for cardiac symptoms such as chest pain, shortness of breath, fatigue, palpitations, or syncope.

Those with severe illness should be restricted from exercise and participation for 3-6 months. Primary care physicians, preferably in consultation with pediatric cardiologists, should clear athletes who experience severe illness.

“Most of the recommendations come from the fact that we simply do not know what we do not know with COVID-19,” Susannah Briskin, MD, a coauthor of the interim guidance, said in an interview. “We have to be cautious in returning individuals to play and closely monitor them as we learn more about the disease process and its effect on kids.”

Patients with severe illness could include those who were hospitalized and experienced hypotension or arrhythmias, required intubation or extracorporeal membrane oxygenation (ECMO) support, had kidney or cardiac failure, or developed multisystem inflammatory syndrome in children (MIS-C), said Dr. Briskin, a specialist in pediatric sports medicine at Case Western Reserve University, Cleveland.

“The majority of COVID-19 cases will not present like this in kids. We have no idea how common myocarditis is in kids post infection. We do know that, if anyone has chest pain, shortness of breath, excessive fatigue, syncope [passing out], or arrhythmia [feeling of their heart skipping beats], they should undergo further evaluation for myocarditis,” Dr. Briskin said.

Patients who are asymptomatic or have mild symptoms should rest for 14 days after their positive test. After their infectious period has passed, a doctor should assess for any concerning cardiac symptoms. “Anyone with prolonged fever or moderate symptoms should see their pediatrician and have an EKG performed, at a minimum, prior to return to sports,” Dr. Briskin said. “Anyone with an abnormal EKG or concerning signs or symptoms should be referred on to pediatric cardiology for a further assessment.”

Most patients who Dr. Briskin has seen have been asymptomatic or mildly symptomatic. “They have done well with a gradual return to physical activity,” she said. “We recommend a gradual return so individuals can be monitored for any signs or symptoms concerning for myocarditis. The far majority of individuals likely have an uneventful return to play.”

Mitigating risk

COVID-19 adds elements of uncertainty and complexity to the usual process of mitigating risk in sports, Dr. Bernhardt noted in his lecture. “You are dealing with an infection that we do not know a lot about,” he said. “And we are trying to mitigate risk not only for the individual who may or may not have underlying health problems, but you are also trying to mitigate risk for anybody else involved with the sport, including athletic trainers and team physicians, coaches, spectators, custodial staff, people working at a snack shack, and all the other people that can be involved in a typical sporting type of atmosphere.”

When patients do return to play after an illness, they should gradually increase the training load to avoid injury. In addition, clinicians should screen for depression and anxiety using tools such as the Four-Item Patient Health Questionnaire (PHQ-4) when they see patients. “The pandemic has been quite stressful for everybody, including our high school student athletes,” Dr. Bernhardt said. “Giving everybody a PHQ-4 when they come into clinic right now probably makes sense in terms of the stress levels that all of us are experiencing.”

If a patient screens positive, take additional history and refer for more in-depth mental health evaluation and treatment if warranted. Sharing breathing and relaxation exercises, promoting healthy behaviors, and paying attention to unhealthy strategies also may help, Dr. Bernhardt suggested.

Ultimately, determining when an athlete with COVID-19 can be medically cleared to return to play may be a challenge. There are limited data on epidemiology and clinical presentations that could help identify cardiac injury related to the disease, Dr. Bernhardt said. Guidance from the American College of Cardiology provides a framework for evaluating athletes for return to play, and pediatric cardiologists have discussed how the guidance relates to a pediatric population. Cardiac assessments may include measures of biomarkers such as troponin, B-type natriuretic peptide, and sedimentation rate, along with electrocardiograms, echocardiograms, and cardiac MRI.

Beyond return-to-play decisions, encourage the use of cloth face coverings on the sidelines and away from the playing field, and stress proper quarantining, Dr. Briskin added. Too often, she hears about children not quarantining properly. “Individuals with a known exposure should be quarantined in their house – ideally in a separate room from everyone else. ... When they come out of their room, they should wash their hands well and wear a cloth face covering. They should not be eating with other people.”

Dr. Bernhardt had no relevant disclosures.

[email protected]

Many student athletes who test positive for COVID-19 likely can have an uneventful return to their sports after they have rested for 2 weeks in quarantine, doctors suggest.

Canberk Sezer/Getty Images

There are reasons for caution, however, especially when a patient has symptoms that indicate possible cardiac involvement. In these cases, patients should undergo cardiac testing before a physician clears them to return to play, according to guidance from professional associations. Reports of myocarditis in college athletes who tested positive for SARS-CoV-2 but were asymptomatic are among the reasons for concern. Myocarditis may increase the risk of sudden death during exercise.

“The thing that you need to keep in mind is that this is not just a respiratory illness,” David T. Bernhardt, MD, professor of pediatrics, orthopedics, and rehabilitation at the University of Wisconsin in Madison, said in a presentation at the annual meeting of the American Academy of Pediatrics, held virtually this year. High school and college athletes have had cardiac, neurologic, hematologic, and renal problems that “can complicate their recovery and their return to sport.”

Still, children who test positive for COVID-19 tend to have mild illness and often are asymptomatic. “It is more than likely going to be safe for the majority of the student athletes who are in the elementary and middle school age to return to sport,” said Dr. Bernhardt. Given that 18-year-old college freshmen have had cardiac complications, there may be reason for more caution with high school students.
 

Limited data

The AAP has released interim guidance on returning to sports and recommends that primary care physicians clear all patients with COVID-19 before they resume training. Physicians should screen for cardiac symptoms such as chest pain, shortness of breath, fatigue, palpitations, or syncope.

Those with severe illness should be restricted from exercise and participation for 3-6 months. Primary care physicians, preferably in consultation with pediatric cardiologists, should clear athletes who experience severe illness.

“Most of the recommendations come from the fact that we simply do not know what we do not know with COVID-19,” Susannah Briskin, MD, a coauthor of the interim guidance, said in an interview. “We have to be cautious in returning individuals to play and closely monitor them as we learn more about the disease process and its effect on kids.”

Patients with severe illness could include those who were hospitalized and experienced hypotension or arrhythmias, required intubation or extracorporeal membrane oxygenation (ECMO) support, had kidney or cardiac failure, or developed multisystem inflammatory syndrome in children (MIS-C), said Dr. Briskin, a specialist in pediatric sports medicine at Case Western Reserve University, Cleveland.

“The majority of COVID-19 cases will not present like this in kids. We have no idea how common myocarditis is in kids post infection. We do know that, if anyone has chest pain, shortness of breath, excessive fatigue, syncope [passing out], or arrhythmia [feeling of their heart skipping beats], they should undergo further evaluation for myocarditis,” Dr. Briskin said.

Patients who are asymptomatic or have mild symptoms should rest for 14 days after their positive test. After their infectious period has passed, a doctor should assess for any concerning cardiac symptoms. “Anyone with prolonged fever or moderate symptoms should see their pediatrician and have an EKG performed, at a minimum, prior to return to sports,” Dr. Briskin said. “Anyone with an abnormal EKG or concerning signs or symptoms should be referred on to pediatric cardiology for a further assessment.”

Most patients who Dr. Briskin has seen have been asymptomatic or mildly symptomatic. “They have done well with a gradual return to physical activity,” she said. “We recommend a gradual return so individuals can be monitored for any signs or symptoms concerning for myocarditis. The far majority of individuals likely have an uneventful return to play.”

Mitigating risk

COVID-19 adds elements of uncertainty and complexity to the usual process of mitigating risk in sports, Dr. Bernhardt noted in his lecture. “You are dealing with an infection that we do not know a lot about,” he said. “And we are trying to mitigate risk not only for the individual who may or may not have underlying health problems, but you are also trying to mitigate risk for anybody else involved with the sport, including athletic trainers and team physicians, coaches, spectators, custodial staff, people working at a snack shack, and all the other people that can be involved in a typical sporting type of atmosphere.”

When patients do return to play after an illness, they should gradually increase the training load to avoid injury. In addition, clinicians should screen for depression and anxiety using tools such as the Four-Item Patient Health Questionnaire (PHQ-4) when they see patients. “The pandemic has been quite stressful for everybody, including our high school student athletes,” Dr. Bernhardt said. “Giving everybody a PHQ-4 when they come into clinic right now probably makes sense in terms of the stress levels that all of us are experiencing.”

If a patient screens positive, take additional history and refer for more in-depth mental health evaluation and treatment if warranted. Sharing breathing and relaxation exercises, promoting healthy behaviors, and paying attention to unhealthy strategies also may help, Dr. Bernhardt suggested.

Ultimately, determining when an athlete with COVID-19 can be medically cleared to return to play may be a challenge. There are limited data on epidemiology and clinical presentations that could help identify cardiac injury related to the disease, Dr. Bernhardt said. Guidance from the American College of Cardiology provides a framework for evaluating athletes for return to play, and pediatric cardiologists have discussed how the guidance relates to a pediatric population. Cardiac assessments may include measures of biomarkers such as troponin, B-type natriuretic peptide, and sedimentation rate, along with electrocardiograms, echocardiograms, and cardiac MRI.

Beyond return-to-play decisions, encourage the use of cloth face coverings on the sidelines and away from the playing field, and stress proper quarantining, Dr. Briskin added. Too often, she hears about children not quarantining properly. “Individuals with a known exposure should be quarantined in their house – ideally in a separate room from everyone else. ... When they come out of their room, they should wash their hands well and wear a cloth face covering. They should not be eating with other people.”

Dr. Bernhardt had no relevant disclosures.

[email protected]

Background: A previous study reported that a median of 5.6 years of intensive versus standard glucose lowering in veterans with type 2 diabetes resulted in significantly reduced risk of major cardiovascular events after 10 years of combined intervention and observational follow-up. 

Over a period of 15 years of combined intervention and posttrial follow-up, the risks of major cardiovascular events or death were not lower in the intensive-therapy group (hazard ratio for composite outcome, 0.91; 95% confidence interval, 0.78-1.06; P = .23; HR for death, 1.02; 95% CI, 0.88-1.18). The risk of major cardiovascular disease outcomes was reduced during the approximately 10-year interval of separation of the Hb A_1c curves (HR, 0.83; 95% CI, 0.70-0.99), but it did not persist after equalization of Hb A_1c levels (HR, 1.26; 95% CI, 0.90-1.75). Limitations include the observational study design, the study population of mostly older men, and reliance on administrative data for outcomes.  

Bottom line: More than 5 years of intensive glucose lowering, compared with standard therapy, did not show significantly lower risks of cardiovascular events or mortality once the glycated hemoglobin curves equalized during follow-up in years 11-15.

Citation: Reaven PD et al. Intensive glucose control in patients with type 2 diabetes – 15-year follow-up. New Engl J Med. 2019 Jun 6;380(23):2215-24.

Dr. Burke is a hospitalist at Vanderbilt University Medical Center, Nashville, Tenn.

Background: A previous study reported that a median of 5.6 years of intensive versus standard glucose lowering in veterans with type 2 diabetes resulted in significantly reduced risk of major cardiovascular events after 10 years of combined intervention and observational follow-up. 

Over a period of 15 years of combined intervention and posttrial follow-up, the risks of major cardiovascular events or death were not lower in the intensive-therapy group (hazard ratio for composite outcome, 0.91; 95% confidence interval, 0.78-1.06; P = .23; HR for death, 1.02; 95% CI, 0.88-1.18). The risk of major cardiovascular disease outcomes was reduced during the approximately 10-year interval of separation of the Hb A_1c curves (HR, 0.83; 95% CI, 0.70-0.99), but it did not persist after equalization of Hb A_1c levels (HR, 1.26; 95% CI, 0.90-1.75). Limitations include the observational study design, the study population of mostly older men, and reliance on administrative data for outcomes.  

Bottom line: More than 5 years of intensive glucose lowering, compared with standard therapy, did not show significantly lower risks of cardiovascular events or mortality once the glycated hemoglobin curves equalized during follow-up in years 11-15.

Citation: Reaven PD et al. Intensive glucose control in patients with type 2 diabetes – 15-year follow-up. New Engl J Med. 2019 Jun 6;380(23):2215-24.

Dr. Burke is a hospitalist at Vanderbilt University Medical Center, Nashville, Tenn.

Background: A previous study reported that a median of 5.6 years of intensive versus standard glucose lowering in veterans with type 2 diabetes resulted in significantly reduced risk of major cardiovascular events after 10 years of combined intervention and observational follow-up. 

Over a period of 15 years of combined intervention and posttrial follow-up, the risks of major cardiovascular events or death were not lower in the intensive-therapy group (hazard ratio for composite outcome, 0.91; 95% confidence interval, 0.78-1.06; P = .23; HR for death, 1.02; 95% CI, 0.88-1.18). The risk of major cardiovascular disease outcomes was reduced during the approximately 10-year interval of separation of the Hb A_1c curves (HR, 0.83; 95% CI, 0.70-0.99), but it did not persist after equalization of Hb A_1c levels (HR, 1.26; 95% CI, 0.90-1.75). Limitations include the observational study design, the study population of mostly older men, and reliance on administrative data for outcomes.  

Bottom line: More than 5 years of intensive glucose lowering, compared with standard therapy, did not show significantly lower risks of cardiovascular events or mortality once the glycated hemoglobin curves equalized during follow-up in years 11-15.

Citation: Reaven PD et al. Intensive glucose control in patients with type 2 diabetes – 15-year follow-up. New Engl J Med. 2019 Jun 6;380(23):2215-24.

Dr. Burke is a hospitalist at Vanderbilt University Medical Center, Nashville, Tenn.

Researchers and several medical groups on Oct. 23 pressed for changes to the US Food and Drug Administration’s (FDA) current plans for deciding how to eventually clear vaccines for COVID-19, arguing tougher standards would help bolster confidence in these critical medicines.

The FDA’s Vaccines and Related Biological Products Advisory Committee met for a wide-ranging discussion beginning around 10 am. The FDA did not ask the panel to weigh in on any particular vaccine. Instead, the FDA asked for the panel’s feedback on a series of questions, including considerations for continuing phase 3 trials if a product were to get an interim clearance known as an emergency use authorization (EUA).

Speakers at the hearing made a variety of requests, including asking for data showing COVID-19 vaccines can prevent serious illness and urging transparency about the agency’s deliberations for each product to be considered.

FDA staff are closely tracking the crop of experimental vaccines that have made it into advanced stages of testing, including products from Pfizer Inc, AstraZeneca, Johnson & Johnson, and Moderna.
 

‘Time for a reset’

Among the speakers at the public hearing was Peter Lurie, MD, who served as an FDA associate commissioner from 2014 to 2017. Now the president of the Center for Science in the Public Interest, Lurie was among the speakers who asked the agency to make its independence clear.

President Donald Trump has for months been making predictions about COVID-19 vaccine approvals that have been overly optimistic. In one example, the president, who is seeking re-election on November 3, last month spoke about being able to begin distributing a vaccine in October.

“Until now the process of developing candidate vaccines has been inappropriately politicized with an eye on the election calendar, rather than the deliberate timeframe science requires,” Lurie told the FDA advisory panel. “Now is the time for a reset. This committee has a unique opportunity to set a new tone for vaccine deliberations going forward.”

Lurie asked the panel to press the FDA to commit to hold an advisory committee meeting on requests by drugmakers for EUAs. He also asked the panel to demand that informed consent forms and minutes from institutional review board (IRB) discussions of COVID-19 vaccines trials be made public.

Also among the speakers at the public hearing was Peter Doshi, PhD, an associate professor at the University of Maryland School of Pharmacy, who argued that the current trials won’t answer the right questions about the COVID-19 vaccines.

“We could end up with approved vaccines that reduce the risk of mild infection, but do not decrease the risk of hospitalization, ICU use, or death — either at all or by a clinically relevant amount,” Doshi told the panel.

In his presentation, he reiterated points he had made previously, including in an October 21 article in the BMJ, for which he is an associate editor. Doshi also raised these concerns in a September opinion article in The New York Times, co-authored with Eric Topol, MD, director of the Scripps Research Translational Institute and editor-in-chief of Medscape.
 

Risks of a ‘rushed vaccine’

Other complaints about the FDA’s approach included criticism of a 2-month follow-up time after vaccination, which was seen as too short. ECRI, a nonprofit organization that seeks to improve the safety, quality, and cost-effectiveness of medicines, has argued that approving a weak COVID-19 vaccine might worsen the pandemic.

In an October 21 statement, ECRI noted the risk of a partially effective vaccine, which could be welcomed as a means of slowing transmission of the virus. But public response and attitudes over the past 9 months in the United States suggest that people would relax their precautions as soon as a vaccine is available.

“Resulting infections may offset the vaccine’s impact and end up increasing the mortality and morbidity burden,” ECRI said in the brief.

“The risks and consequences of a rushed vaccine could be very severe if the review is anything shy of thorough,” ECRI Chief Executive Officer Marcus Schabacker, MD, PhD, said in a statement prepared for the hearing.

This article first appeared on Medscape.com.

Researchers and several medical groups on Oct. 23 pressed for changes to the US Food and Drug Administration’s (FDA) current plans for deciding how to eventually clear vaccines for COVID-19, arguing tougher standards would help bolster confidence in these critical medicines.

The FDA’s Vaccines and Related Biological Products Advisory Committee met for a wide-ranging discussion beginning around 10 am. The FDA did not ask the panel to weigh in on any particular vaccine. Instead, the FDA asked for the panel’s feedback on a series of questions, including considerations for continuing phase 3 trials if a product were to get an interim clearance known as an emergency use authorization (EUA).

Speakers at the hearing made a variety of requests, including asking for data showing COVID-19 vaccines can prevent serious illness and urging transparency about the agency’s deliberations for each product to be considered.

FDA staff are closely tracking the crop of experimental vaccines that have made it into advanced stages of testing, including products from Pfizer Inc, AstraZeneca, Johnson & Johnson, and Moderna.
 

‘Time for a reset’

Among the speakers at the public hearing was Peter Lurie, MD, who served as an FDA associate commissioner from 2014 to 2017. Now the president of the Center for Science in the Public Interest, Lurie was among the speakers who asked the agency to make its independence clear.

President Donald Trump has for months been making predictions about COVID-19 vaccine approvals that have been overly optimistic. In one example, the president, who is seeking re-election on November 3, last month spoke about being able to begin distributing a vaccine in October.

“Until now the process of developing candidate vaccines has been inappropriately politicized with an eye on the election calendar, rather than the deliberate timeframe science requires,” Lurie told the FDA advisory panel. “Now is the time for a reset. This committee has a unique opportunity to set a new tone for vaccine deliberations going forward.”

Lurie asked the panel to press the FDA to commit to hold an advisory committee meeting on requests by drugmakers for EUAs. He also asked the panel to demand that informed consent forms and minutes from institutional review board (IRB) discussions of COVID-19 vaccines trials be made public.

Also among the speakers at the public hearing was Peter Doshi, PhD, an associate professor at the University of Maryland School of Pharmacy, who argued that the current trials won’t answer the right questions about the COVID-19 vaccines.

“We could end up with approved vaccines that reduce the risk of mild infection, but do not decrease the risk of hospitalization, ICU use, or death — either at all or by a clinically relevant amount,” Doshi told the panel.

In his presentation, he reiterated points he had made previously, including in an October 21 article in the BMJ, for which he is an associate editor. Doshi also raised these concerns in a September opinion article in The New York Times, co-authored with Eric Topol, MD, director of the Scripps Research Translational Institute and editor-in-chief of Medscape.
 

Risks of a ‘rushed vaccine’

Other complaints about the FDA’s approach included criticism of a 2-month follow-up time after vaccination, which was seen as too short. ECRI, a nonprofit organization that seeks to improve the safety, quality, and cost-effectiveness of medicines, has argued that approving a weak COVID-19 vaccine might worsen the pandemic.

In an October 21 statement, ECRI noted the risk of a partially effective vaccine, which could be welcomed as a means of slowing transmission of the virus. But public response and attitudes over the past 9 months in the United States suggest that people would relax their precautions as soon as a vaccine is available.

“Resulting infections may offset the vaccine’s impact and end up increasing the mortality and morbidity burden,” ECRI said in the brief.

“The risks and consequences of a rushed vaccine could be very severe if the review is anything shy of thorough,” ECRI Chief Executive Officer Marcus Schabacker, MD, PhD, said in a statement prepared for the hearing.

This article first appeared on Medscape.com.

Researchers and several medical groups on Oct. 23 pressed for changes to the US Food and Drug Administration’s (FDA) current plans for deciding how to eventually clear vaccines for COVID-19, arguing tougher standards would help bolster confidence in these critical medicines.

The FDA’s Vaccines and Related Biological Products Advisory Committee met for a wide-ranging discussion beginning around 10 am. The FDA did not ask the panel to weigh in on any particular vaccine. Instead, the FDA asked for the panel’s feedback on a series of questions, including considerations for continuing phase 3 trials if a product were to get an interim clearance known as an emergency use authorization (EUA).

Speakers at the hearing made a variety of requests, including asking for data showing COVID-19 vaccines can prevent serious illness and urging transparency about the agency’s deliberations for each product to be considered.

FDA staff are closely tracking the crop of experimental vaccines that have made it into advanced stages of testing, including products from Pfizer Inc, AstraZeneca, Johnson & Johnson, and Moderna.
 

‘Time for a reset’

Among the speakers at the public hearing was Peter Lurie, MD, who served as an FDA associate commissioner from 2014 to 2017. Now the president of the Center for Science in the Public Interest, Lurie was among the speakers who asked the agency to make its independence clear.

President Donald Trump has for months been making predictions about COVID-19 vaccine approvals that have been overly optimistic. In one example, the president, who is seeking re-election on November 3, last month spoke about being able to begin distributing a vaccine in October.

“Until now the process of developing candidate vaccines has been inappropriately politicized with an eye on the election calendar, rather than the deliberate timeframe science requires,” Lurie told the FDA advisory panel. “Now is the time for a reset. This committee has a unique opportunity to set a new tone for vaccine deliberations going forward.”

Lurie asked the panel to press the FDA to commit to hold an advisory committee meeting on requests by drugmakers for EUAs. He also asked the panel to demand that informed consent forms and minutes from institutional review board (IRB) discussions of COVID-19 vaccines trials be made public.

Also among the speakers at the public hearing was Peter Doshi, PhD, an associate professor at the University of Maryland School of Pharmacy, who argued that the current trials won’t answer the right questions about the COVID-19 vaccines.

“We could end up with approved vaccines that reduce the risk of mild infection, but do not decrease the risk of hospitalization, ICU use, or death — either at all or by a clinically relevant amount,” Doshi told the panel.

In his presentation, he reiterated points he had made previously, including in an October 21 article in the BMJ, for which he is an associate editor. Doshi also raised these concerns in a September opinion article in The New York Times, co-authored with Eric Topol, MD, director of the Scripps Research Translational Institute and editor-in-chief of Medscape.
 

Risks of a ‘rushed vaccine’

Other complaints about the FDA’s approach included criticism of a 2-month follow-up time after vaccination, which was seen as too short. ECRI, a nonprofit organization that seeks to improve the safety, quality, and cost-effectiveness of medicines, has argued that approving a weak COVID-19 vaccine might worsen the pandemic.

In an October 21 statement, ECRI noted the risk of a partially effective vaccine, which could be welcomed as a means of slowing transmission of the virus. But public response and attitudes over the past 9 months in the United States suggest that people would relax their precautions as soon as a vaccine is available.

“Resulting infections may offset the vaccine’s impact and end up increasing the mortality and morbidity burden,” ECRI said in the brief.

“The risks and consequences of a rushed vaccine could be very severe if the review is anything shy of thorough,” ECRI Chief Executive Officer Marcus Schabacker, MD, PhD, said in a statement prepared for the hearing.

This article first appeared on Medscape.com.

The Centers for Disease Control and Prevention updated its recommendations for likely person-to-person spread of SARS-CoV-2 to warn about the risk of multiple, brief, “close contact” encounters with others who are positive for COVID-19.

New data suggest each close encounter – coming within 6 feet of an infected person – can increase the risk for transmission, CDC director Robert Redfield, MD, said during a media briefing.

“As we get more data and understand the science of COVID, we’re going to continue to incorporate that in our recommendations,” Dr. Redfield said in response to a reporter’s question about a recent study.

Previously, the CDC cautioned against spending 15 minutes or longer in close proximity to an infected person, particularly in enclosed indoor spaces.

In a new report published online Oct. 21 in Morbidity and Mortality Weekly Report, however, investigators “determined that an individual who had a series of shorter contacts that over time added up to more than 15 minutes became infected.”
 

Beware of brief encounters?

On July 28, a 20-year-old male correctional officer in Vermont had multiple brief encounters with six transferred incarcerated or detained people while their SARS-CoV-2 test results were pending. The six were asymptomatic at the time and were housed in a quarantine unit, reported CDC researcher Julia Pringle, PhD, and colleagues.

The following day, all six inmates tested polymerase chain reaction (PCR) positive for COVID-19. The correctional officer did not spend 15 minutes or more within 6 feet of any of the inmates, according to video surveillance footage, and he continued to work.

On Aug. 4, however, he developed symptoms that included loss of smell and taste, myalgia, runny nose, cough, shortness of breath, headache, loss of appetite, and gastrointestinal symptoms. He stayed home starting the next day and tested PCR positive for COVID-19 on Aug. 11.

Further review of the surveillance video showed that the officer had numerous brief encounters of approximately 1 minute each that cumulatively exceeded 15 minutes over a 24-hour period, the researchers reported.

During all the interactions with inmates, the correctional officer wore a cloth mask, gown, and eye protection. The inmates wore masks while in their cells but did not have them on during brief cell doorway interactions or in the recreation room, according to the report.
 

No interaction is 100% safe

“We know that every activity that involves interacting with others has some degree of risk right now,” said Jay Butler, MD, CDC deputy director for infectious diseases.

“Unfortunately, we’re seeing a distressing trend here in the United States with COVID-19 cases increasing in nearly 75% of the country,” he said. “We’ve confirmed 8.1 million cases and, sadly, over 220,000 deaths since January.

“I know these are numbers, but these are also people,” Dr. Butler added.

“The pandemic is not over,” Dr. Redfield said. “Earlier this week, COVID virus cases reached over 40 million globally. Here in the United States we are approaching a critical phase.”

Four factors associated with higher risk for transmission are the proximity of each encounter, its duration, whether an interaction takes place indoors or outdoors, and the number of people encountered, Dr. Butler said.

Dr. Butler acknowledged widespread fatigue with adherence to personal protection measures, but added that social distancing, mask-wearing, and other measures are more important now than ever. He noted that more Americans will be spending time indoors with the onset of cooler weather and the upcoming holidays.
 

A note of optimism

Dr. Redfield remains optimistic about the limited availability of a vaccine or vaccines by year’s end but added that “it’s important for all of us to remain diligent in our efforts to defeat this virus.”

“There is hope on the way, in the form of safe and effective vaccines in a matter of weeks or months. To bridge to that next phase, we have to take steps to keep ourselves, our families, and our communities safe,” said Alex Azar, secretary of the Department of Health & Human Services.

“I know it’s been a difficult year for Americans, but we are going to come through this on the other side,” Dr. Redfield said.

The Centers for Disease Control and Prevention updated its recommendations for likely person-to-person spread of SARS-CoV-2 to warn about the risk of multiple, brief, “close contact” encounters with others who are positive for COVID-19.

New data suggest each close encounter – coming within 6 feet of an infected person – can increase the risk for transmission, CDC director Robert Redfield, MD, said during a media briefing.

“As we get more data and understand the science of COVID, we’re going to continue to incorporate that in our recommendations,” Dr. Redfield said in response to a reporter’s question about a recent study.

Previously, the CDC cautioned against spending 15 minutes or longer in close proximity to an infected person, particularly in enclosed indoor spaces.

In a new report published online Oct. 21 in Morbidity and Mortality Weekly Report, however, investigators “determined that an individual who had a series of shorter contacts that over time added up to more than 15 minutes became infected.”
 

Beware of brief encounters?

On July 28, a 20-year-old male correctional officer in Vermont had multiple brief encounters with six transferred incarcerated or detained people while their SARS-CoV-2 test results were pending. The six were asymptomatic at the time and were housed in a quarantine unit, reported CDC researcher Julia Pringle, PhD, and colleagues.

The following day, all six inmates tested polymerase chain reaction (PCR) positive for COVID-19. The correctional officer did not spend 15 minutes or more within 6 feet of any of the inmates, according to video surveillance footage, and he continued to work.

On Aug. 4, however, he developed symptoms that included loss of smell and taste, myalgia, runny nose, cough, shortness of breath, headache, loss of appetite, and gastrointestinal symptoms. He stayed home starting the next day and tested PCR positive for COVID-19 on Aug. 11.

Further review of the surveillance video showed that the officer had numerous brief encounters of approximately 1 minute each that cumulatively exceeded 15 minutes over a 24-hour period, the researchers reported.

During all the interactions with inmates, the correctional officer wore a cloth mask, gown, and eye protection. The inmates wore masks while in their cells but did not have them on during brief cell doorway interactions or in the recreation room, according to the report.
 

No interaction is 100% safe

“We know that every activity that involves interacting with others has some degree of risk right now,” said Jay Butler, MD, CDC deputy director for infectious diseases.

“Unfortunately, we’re seeing a distressing trend here in the United States with COVID-19 cases increasing in nearly 75% of the country,” he said. “We’ve confirmed 8.1 million cases and, sadly, over 220,000 deaths since January.

“I know these are numbers, but these are also people,” Dr. Butler added.

“The pandemic is not over,” Dr. Redfield said. “Earlier this week, COVID virus cases reached over 40 million globally. Here in the United States we are approaching a critical phase.”

Four factors associated with higher risk for transmission are the proximity of each encounter, its duration, whether an interaction takes place indoors or outdoors, and the number of people encountered, Dr. Butler said.

Dr. Butler acknowledged widespread fatigue with adherence to personal protection measures, but added that social distancing, mask-wearing, and other measures are more important now than ever. He noted that more Americans will be spending time indoors with the onset of cooler weather and the upcoming holidays.
 

A note of optimism

Dr. Redfield remains optimistic about the limited availability of a vaccine or vaccines by year’s end but added that “it’s important for all of us to remain diligent in our efforts to defeat this virus.”

“There is hope on the way, in the form of safe and effective vaccines in a matter of weeks or months. To bridge to that next phase, we have to take steps to keep ourselves, our families, and our communities safe,” said Alex Azar, secretary of the Department of Health & Human Services.

“I know it’s been a difficult year for Americans, but we are going to come through this on the other side,” Dr. Redfield said.

The Centers for Disease Control and Prevention updated its recommendations for likely person-to-person spread of SARS-CoV-2 to warn about the risk of multiple, brief, “close contact” encounters with others who are positive for COVID-19.

New data suggest each close encounter – coming within 6 feet of an infected person – can increase the risk for transmission, CDC director Robert Redfield, MD, said during a media briefing.

“As we get more data and understand the science of COVID, we’re going to continue to incorporate that in our recommendations,” Dr. Redfield said in response to a reporter’s question about a recent study.

Previously, the CDC cautioned against spending 15 minutes or longer in close proximity to an infected person, particularly in enclosed indoor spaces.

In a new report published online Oct. 21 in Morbidity and Mortality Weekly Report, however, investigators “determined that an individual who had a series of shorter contacts that over time added up to more than 15 minutes became infected.”
 

Beware of brief encounters?

On July 28, a 20-year-old male correctional officer in Vermont had multiple brief encounters with six transferred incarcerated or detained people while their SARS-CoV-2 test results were pending. The six were asymptomatic at the time and were housed in a quarantine unit, reported CDC researcher Julia Pringle, PhD, and colleagues.

The following day, all six inmates tested polymerase chain reaction (PCR) positive for COVID-19. The correctional officer did not spend 15 minutes or more within 6 feet of any of the inmates, according to video surveillance footage, and he continued to work.

On Aug. 4, however, he developed symptoms that included loss of smell and taste, myalgia, runny nose, cough, shortness of breath, headache, loss of appetite, and gastrointestinal symptoms. He stayed home starting the next day and tested PCR positive for COVID-19 on Aug. 11.

Further review of the surveillance video showed that the officer had numerous brief encounters of approximately 1 minute each that cumulatively exceeded 15 minutes over a 24-hour period, the researchers reported.

During all the interactions with inmates, the correctional officer wore a cloth mask, gown, and eye protection. The inmates wore masks while in their cells but did not have them on during brief cell doorway interactions or in the recreation room, according to the report.
 

No interaction is 100% safe

“We know that every activity that involves interacting with others has some degree of risk right now,” said Jay Butler, MD, CDC deputy director for infectious diseases.

“Unfortunately, we’re seeing a distressing trend here in the United States with COVID-19 cases increasing in nearly 75% of the country,” he said. “We’ve confirmed 8.1 million cases and, sadly, over 220,000 deaths since January.

“I know these are numbers, but these are also people,” Dr. Butler added.

“The pandemic is not over,” Dr. Redfield said. “Earlier this week, COVID virus cases reached over 40 million globally. Here in the United States we are approaching a critical phase.”

Four factors associated with higher risk for transmission are the proximity of each encounter, its duration, whether an interaction takes place indoors or outdoors, and the number of people encountered, Dr. Butler said.

Dr. Butler acknowledged widespread fatigue with adherence to personal protection measures, but added that social distancing, mask-wearing, and other measures are more important now than ever. He noted that more Americans will be spending time indoors with the onset of cooler weather and the upcoming holidays.
 

A note of optimism

Dr. Redfield remains optimistic about the limited availability of a vaccine or vaccines by year’s end but added that “it’s important for all of us to remain diligent in our efforts to defeat this virus.”

“There is hope on the way, in the form of safe and effective vaccines in a matter of weeks or months. To bridge to that next phase, we have to take steps to keep ourselves, our families, and our communities safe,” said Alex Azar, secretary of the Department of Health & Human Services.

“I know it’s been a difficult year for Americans, but we are going to come through this on the other side,” Dr. Redfield said.

Convalescent plasma may not prevent progression to severe disease or reduce mortality risk in hospitalized patients with moderate COVID-19, based on a phase 2 trial involving more than 400 patients in India.

The PLACID trial offers real-world data with “high generalizability,” according to lead author Anup Agarwal, MD, of the Indian Council of Medical Research, New Delhi, and colleagues.

“Evidence suggests that convalescent plasma collected from survivors of COVID-19 contains receptor binding domain specific antibodies with potent antiviral activity,” the investigators wrote in the BMJ. “However, effective titers of antiviral neutralizing antibodies, optimal timing for convalescent plasma treatment, optimal timing for plasma donation, and the severity class of patients who are likely to benefit from convalescent plasma remain unclear.”

According to Dr. Agarwal and colleagues, case series and observational studies have suggested that convalescent plasma may reduce viral load, hospital stay, and mortality, but randomized controlled trials to date have ended prematurely because of issues with enrollment and design, making PLACID the first randomized controlled trial of its kind to reach completion.

The open-label, multicenter study involved 464 hospitalized adults who tested positive for SARS-CoV-2 via reverse transcription polymerase chain reaction (RT-PCR). Enrollment also required a respiratory rate of more than 24 breaths/min with an oxygen saturation (SpO₂) of 93% or less on room air, or a partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO₂ /FiO₂ ) ratio between 200 and 300 mm Hg.

Patients were randomly assigned in a 1:1 ratio to receive either best standard of care (control), or best standard of care plus convalescent plasma, which was given in two doses of 200 mL, 24 hours apart. Patients were assessed via clinical examination, chest imaging, and serial laboratory testing, the latter of which included neutralizing antibody titers on days 0, 3, and 7.

The primary outcome was a 28-day composite of progression to severe disease (PaO₂/FiO₂ ratio < 100 mm Hg) and all-cause mortality. An array of secondary outcomes were also reported, including symptom resolution, total duration of respiratory support, change in oxygen requirement, and others.

In the convalescent plasma group, 19% of patients progressed to severe disease or died within 28 days, compared with 18% of those in the control group (risk ratio, 1.04; 95% confidence interval, 0.71-1.54), suggesting no statistically significant benefit from the intervention. This lack of benefit was also found in a subgroup analysis of patients with detectable titers of antibodies to SARS-CoV-2, and when progression to severe disease and all-cause mortality were analyzed independently across all patients.

Still, at day 7, patients treated with convalescent plasma were significantly more likely to have resolution of fatigue (RR, 1.21; 95% CI, 1.02-1.42) and shortness of breath (RR, 1.16; 95% CI, 1.02-1.32). And at the same time point, patients treated with convalescent plasma were 20% more likely to test negative for SARS-CoV-2 RNA (RR, 1.2; 95% CI, 1.04-1.5).

In an accompanying editorial, Elizabeth B. Pathak, PhD, of the Women’s Institute for Independent Social Enquiry, Olney, Md., suggested that the reported symptom improvements need to be viewed with skepticism.

“These results should be interpreted with caution, because the trial was not blinded, so knowledge of treatment status could have influenced the reporting of subjective symptoms by patients who survived to day 7,” Dr. Pathak wrote.

Dr. Pathak noted that convalescent plasma did appear to have an antiviral effect, based on the higher rate of negative RNA test results at day 7. She hypothesized that the lack of major corresponding clinical benefit could be explained by detrimental thrombotic processes.

“The net effect of plasma is prothrombotic,” Dr. Pathak wrote, which should raise safety concerns, since “COVID-19 is a life-threatening thrombotic disorder.”

According to Dr. Pathak, large-scale datasets may be giving a false sense of security. She cited a recent safety analysis of 20,000 U.S. patients who received convalescent plasma, in which the investigators excluded 88.2% of cardiac events and 66.3% of thrombotic events, as these were deemed unrelated to transfusion; but this decision was made by the treating physician, without independent review or a defined protocol.

Michael J. Joyner, MD, of the Mayo Clinic in Rochester, Minn., was the lead author of the above safety study, and is leading the Food and Drug Administration expanded access program for convalescent plasma in patients with COVID-19. He suggested that the study by Dr. Agarwal and colleagues was admirable, but flaws in the treatment protocol cast doubt upon the efficacy findings.

“It is very impressive that these investigators performed a large trial of convalescent plasma in the midst of a pandemic,” Dr. Joyner said. “Unfortunately it is unclear how generalizable the findings are because many of the units of plasma had either very low or no antibody titers and because the plasma was given late in the course of the disease. It has been known since at least the 1930s that antibody therapy works best when enough product is given either prophylactically or early in the course of disease.”

Dr. Joyner had a more positive interpretation of the reported symptom improvements.

“It is also interesting to note that while there was no mortality benefit, that – even with the limitations of the study – there was some evidence of improved patient physiology at 7 days,” he said. “So, at one level, [this is] a negative study, but at least [there are] some hints of efficacy given the suboptimal use case in the patients studied.”

The study was funded by the Indian Council of Medical Research, which employs several of the authors and PLACID Trial Collaborators. Dr. Pathak and Dr. Joyner reported no conflicts of interest.

SOURCE: Agarwal A et al. BMJ. 2020 Oct 23. doi: 10.1136/bmj.m3939 .

Convalescent plasma may not prevent progression to severe disease or reduce mortality risk in hospitalized patients with moderate COVID-19, based on a phase 2 trial involving more than 400 patients in India.

The PLACID trial offers real-world data with “high generalizability,” according to lead author Anup Agarwal, MD, of the Indian Council of Medical Research, New Delhi, and colleagues.

“Evidence suggests that convalescent plasma collected from survivors of COVID-19 contains receptor binding domain specific antibodies with potent antiviral activity,” the investigators wrote in the BMJ. “However, effective titers of antiviral neutralizing antibodies, optimal timing for convalescent plasma treatment, optimal timing for plasma donation, and the severity class of patients who are likely to benefit from convalescent plasma remain unclear.”

According to Dr. Agarwal and colleagues, case series and observational studies have suggested that convalescent plasma may reduce viral load, hospital stay, and mortality, but randomized controlled trials to date have ended prematurely because of issues with enrollment and design, making PLACID the first randomized controlled trial of its kind to reach completion.

The open-label, multicenter study involved 464 hospitalized adults who tested positive for SARS-CoV-2 via reverse transcription polymerase chain reaction (RT-PCR). Enrollment also required a respiratory rate of more than 24 breaths/min with an oxygen saturation (SpO₂) of 93% or less on room air, or a partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO₂ /FiO₂ ) ratio between 200 and 300 mm Hg.

Patients were randomly assigned in a 1:1 ratio to receive either best standard of care (control), or best standard of care plus convalescent plasma, which was given in two doses of 200 mL, 24 hours apart. Patients were assessed via clinical examination, chest imaging, and serial laboratory testing, the latter of which included neutralizing antibody titers on days 0, 3, and 7.

The primary outcome was a 28-day composite of progression to severe disease (PaO₂/FiO₂ ratio < 100 mm Hg) and all-cause mortality. An array of secondary outcomes were also reported, including symptom resolution, total duration of respiratory support, change in oxygen requirement, and others.

In the convalescent plasma group, 19% of patients progressed to severe disease or died within 28 days, compared with 18% of those in the control group (risk ratio, 1.04; 95% confidence interval, 0.71-1.54), suggesting no statistically significant benefit from the intervention. This lack of benefit was also found in a subgroup analysis of patients with detectable titers of antibodies to SARS-CoV-2, and when progression to severe disease and all-cause mortality were analyzed independently across all patients.

Still, at day 7, patients treated with convalescent plasma were significantly more likely to have resolution of fatigue (RR, 1.21; 95% CI, 1.02-1.42) and shortness of breath (RR, 1.16; 95% CI, 1.02-1.32). And at the same time point, patients treated with convalescent plasma were 20% more likely to test negative for SARS-CoV-2 RNA (RR, 1.2; 95% CI, 1.04-1.5).

In an accompanying editorial, Elizabeth B. Pathak, PhD, of the Women’s Institute for Independent Social Enquiry, Olney, Md., suggested that the reported symptom improvements need to be viewed with skepticism.

“These results should be interpreted with caution, because the trial was not blinded, so knowledge of treatment status could have influenced the reporting of subjective symptoms by patients who survived to day 7,” Dr. Pathak wrote.

Dr. Pathak noted that convalescent plasma did appear to have an antiviral effect, based on the higher rate of negative RNA test results at day 7. She hypothesized that the lack of major corresponding clinical benefit could be explained by detrimental thrombotic processes.

“The net effect of plasma is prothrombotic,” Dr. Pathak wrote, which should raise safety concerns, since “COVID-19 is a life-threatening thrombotic disorder.”

According to Dr. Pathak, large-scale datasets may be giving a false sense of security. She cited a recent safety analysis of 20,000 U.S. patients who received convalescent plasma, in which the investigators excluded 88.2% of cardiac events and 66.3% of thrombotic events, as these were deemed unrelated to transfusion; but this decision was made by the treating physician, without independent review or a defined protocol.

Michael J. Joyner, MD, of the Mayo Clinic in Rochester, Minn., was the lead author of the above safety study, and is leading the Food and Drug Administration expanded access program for convalescent plasma in patients with COVID-19. He suggested that the study by Dr. Agarwal and colleagues was admirable, but flaws in the treatment protocol cast doubt upon the efficacy findings.

“It is very impressive that these investigators performed a large trial of convalescent plasma in the midst of a pandemic,” Dr. Joyner said. “Unfortunately it is unclear how generalizable the findings are because many of the units of plasma had either very low or no antibody titers and because the plasma was given late in the course of the disease. It has been known since at least the 1930s that antibody therapy works best when enough product is given either prophylactically or early in the course of disease.”

Dr. Joyner had a more positive interpretation of the reported symptom improvements.

“It is also interesting to note that while there was no mortality benefit, that – even with the limitations of the study – there was some evidence of improved patient physiology at 7 days,” he said. “So, at one level, [this is] a negative study, but at least [there are] some hints of efficacy given the suboptimal use case in the patients studied.”

The study was funded by the Indian Council of Medical Research, which employs several of the authors and PLACID Trial Collaborators. Dr. Pathak and Dr. Joyner reported no conflicts of interest.

SOURCE: Agarwal A et al. BMJ. 2020 Oct 23. doi: 10.1136/bmj.m3939 .

Convalescent plasma may not prevent progression to severe disease or reduce mortality risk in hospitalized patients with moderate COVID-19, based on a phase 2 trial involving more than 400 patients in India.

The PLACID trial offers real-world data with “high generalizability,” according to lead author Anup Agarwal, MD, of the Indian Council of Medical Research, New Delhi, and colleagues.

“Evidence suggests that convalescent plasma collected from survivors of COVID-19 contains receptor binding domain specific antibodies with potent antiviral activity,” the investigators wrote in the BMJ. “However, effective titers of antiviral neutralizing antibodies, optimal timing for convalescent plasma treatment, optimal timing for plasma donation, and the severity class of patients who are likely to benefit from convalescent plasma remain unclear.”

According to Dr. Agarwal and colleagues, case series and observational studies have suggested that convalescent plasma may reduce viral load, hospital stay, and mortality, but randomized controlled trials to date have ended prematurely because of issues with enrollment and design, making PLACID the first randomized controlled trial of its kind to reach completion.

The open-label, multicenter study involved 464 hospitalized adults who tested positive for SARS-CoV-2 via reverse transcription polymerase chain reaction (RT-PCR). Enrollment also required a respiratory rate of more than 24 breaths/min with an oxygen saturation (SpO₂) of 93% or less on room air, or a partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO₂ /FiO₂ ) ratio between 200 and 300 mm Hg.

Patients were randomly assigned in a 1:1 ratio to receive either best standard of care (control), or best standard of care plus convalescent plasma, which was given in two doses of 200 mL, 24 hours apart. Patients were assessed via clinical examination, chest imaging, and serial laboratory testing, the latter of which included neutralizing antibody titers on days 0, 3, and 7.

The primary outcome was a 28-day composite of progression to severe disease (PaO₂/FiO₂ ratio < 100 mm Hg) and all-cause mortality. An array of secondary outcomes were also reported, including symptom resolution, total duration of respiratory support, change in oxygen requirement, and others.

In the convalescent plasma group, 19% of patients progressed to severe disease or died within 28 days, compared with 18% of those in the control group (risk ratio, 1.04; 95% confidence interval, 0.71-1.54), suggesting no statistically significant benefit from the intervention. This lack of benefit was also found in a subgroup analysis of patients with detectable titers of antibodies to SARS-CoV-2, and when progression to severe disease and all-cause mortality were analyzed independently across all patients.

Still, at day 7, patients treated with convalescent plasma were significantly more likely to have resolution of fatigue (RR, 1.21; 95% CI, 1.02-1.42) and shortness of breath (RR, 1.16; 95% CI, 1.02-1.32). And at the same time point, patients treated with convalescent plasma were 20% more likely to test negative for SARS-CoV-2 RNA (RR, 1.2; 95% CI, 1.04-1.5).

In an accompanying editorial, Elizabeth B. Pathak, PhD, of the Women’s Institute for Independent Social Enquiry, Olney, Md., suggested that the reported symptom improvements need to be viewed with skepticism.

“These results should be interpreted with caution, because the trial was not blinded, so knowledge of treatment status could have influenced the reporting of subjective symptoms by patients who survived to day 7,” Dr. Pathak wrote.

Dr. Pathak noted that convalescent plasma did appear to have an antiviral effect, based on the higher rate of negative RNA test results at day 7. She hypothesized that the lack of major corresponding clinical benefit could be explained by detrimental thrombotic processes.

“The net effect of plasma is prothrombotic,” Dr. Pathak wrote, which should raise safety concerns, since “COVID-19 is a life-threatening thrombotic disorder.”

According to Dr. Pathak, large-scale datasets may be giving a false sense of security. She cited a recent safety analysis of 20,000 U.S. patients who received convalescent plasma, in which the investigators excluded 88.2% of cardiac events and 66.3% of thrombotic events, as these were deemed unrelated to transfusion; but this decision was made by the treating physician, without independent review or a defined protocol.

Michael J. Joyner, MD, of the Mayo Clinic in Rochester, Minn., was the lead author of the above safety study, and is leading the Food and Drug Administration expanded access program for convalescent plasma in patients with COVID-19. He suggested that the study by Dr. Agarwal and colleagues was admirable, but flaws in the treatment protocol cast doubt upon the efficacy findings.

“It is very impressive that these investigators performed a large trial of convalescent plasma in the midst of a pandemic,” Dr. Joyner said. “Unfortunately it is unclear how generalizable the findings are because many of the units of plasma had either very low or no antibody titers and because the plasma was given late in the course of the disease. It has been known since at least the 1930s that antibody therapy works best when enough product is given either prophylactically or early in the course of disease.”

Dr. Joyner had a more positive interpretation of the reported symptom improvements.

“It is also interesting to note that while there was no mortality benefit, that – even with the limitations of the study – there was some evidence of improved patient physiology at 7 days,” he said. “So, at one level, [this is] a negative study, but at least [there are] some hints of efficacy given the suboptimal use case in the patients studied.”

The study was funded by the Indian Council of Medical Research, which employs several of the authors and PLACID Trial Collaborators. Dr. Pathak and Dr. Joyner reported no conflicts of interest.

SOURCE: Agarwal A et al. BMJ. 2020 Oct 23. doi: 10.1136/bmj.m3939 .

The U.S. Food and Drug Administration approved remdesivir (Veklury) Oct. 22 as a treatment for hospitalized COVID-19 patients aged 12 and up, making it the first and only approved treatment for COVID-19, according to a release from drug manufacturer Gilead Sciences.

The FDA’s initial Emergency Use Authorization (EUA) of the antiviral, issued in May, allowed the drug to be used only for patients with severe COVID-19, specifically, COVID-19 patients with low blood oxygen levels or who needed oxygen therapy or mechanical ventilation.

An August EUA expanded treatment to include all adult and pediatric hospitalized COVID-19 patients, regardless of the severity of their disease. The FDA also issued a new EUA for remdesivir Oct. 22 allowing treatment of hospitalized pediatric patients younger than 12 weighing at least 3.5 kg.

Today’s approval is based on three randomized controlled trials, according to Gilead.

Final trial results from one of them, the National Institute of Allergy and Infectious Disease–funded ACTT-1 trial, published earlier in October, showed that hospitalized patients with COVID-19 who received remdesivir had a shorter median recovery time than those who received a placebo – 10 days versus 15 days.

This difference and some related secondary endpoints were statistically significant in the randomized trial, but there was not a statistically significant difference in mortality between the treatment and placebo groups.

The other two trials used for the approval, the SIMPLE trials, were open-label phase 3 trials conducted in countries with a high prevalence of COVID-19 infections, according to Gilead.

The SIMPLE-Severe trial was a randomized, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing plus standard of care in 397 hospitalized adult patients with severe COVID-19. The primary endpoint was clinical status on day 14 assessed on a 7-point ordinal scale, according to Gilead.

The trial found that a 5-day or a 10-day treatment course of Veklury achieved similar clinical outcomes to the ACTT-1 trial (odds ratio, 0.75; 95% confidence interval, 0.51-1.12).

The SIMPLE-Moderate trial was a randomized, controlled, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing durations of Veklury plus standard of care, compared with standard of care alone in 600 hospitalized adult patients with moderate COVID-19, Gilead stated in its release.

The primary endpoint was clinical status on day 11 assessed on a 7-point ordinal scale.

The results showed statistically improved clinical outcomes with a 5-day treatment course of Veklury, compared with standard of care (OR, 1.65; 95% CI, 1.0-2.48; P = .017), according to Gilead.

This article first appeared on Medscape.com.

The U.S. Food and Drug Administration approved remdesivir (Veklury) Oct. 22 as a treatment for hospitalized COVID-19 patients aged 12 and up, making it the first and only approved treatment for COVID-19, according to a release from drug manufacturer Gilead Sciences.

The FDA’s initial Emergency Use Authorization (EUA) of the antiviral, issued in May, allowed the drug to be used only for patients with severe COVID-19, specifically, COVID-19 patients with low blood oxygen levels or who needed oxygen therapy or mechanical ventilation.

An August EUA expanded treatment to include all adult and pediatric hospitalized COVID-19 patients, regardless of the severity of their disease. The FDA also issued a new EUA for remdesivir Oct. 22 allowing treatment of hospitalized pediatric patients younger than 12 weighing at least 3.5 kg.

Today’s approval is based on three randomized controlled trials, according to Gilead.

Final trial results from one of them, the National Institute of Allergy and Infectious Disease–funded ACTT-1 trial, published earlier in October, showed that hospitalized patients with COVID-19 who received remdesivir had a shorter median recovery time than those who received a placebo – 10 days versus 15 days.

This difference and some related secondary endpoints were statistically significant in the randomized trial, but there was not a statistically significant difference in mortality between the treatment and placebo groups.

The other two trials used for the approval, the SIMPLE trials, were open-label phase 3 trials conducted in countries with a high prevalence of COVID-19 infections, according to Gilead.

The SIMPLE-Severe trial was a randomized, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing plus standard of care in 397 hospitalized adult patients with severe COVID-19. The primary endpoint was clinical status on day 14 assessed on a 7-point ordinal scale, according to Gilead.

The trial found that a 5-day or a 10-day treatment course of Veklury achieved similar clinical outcomes to the ACTT-1 trial (odds ratio, 0.75; 95% confidence interval, 0.51-1.12).

The SIMPLE-Moderate trial was a randomized, controlled, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing durations of Veklury plus standard of care, compared with standard of care alone in 600 hospitalized adult patients with moderate COVID-19, Gilead stated in its release.

The primary endpoint was clinical status on day 11 assessed on a 7-point ordinal scale.

The results showed statistically improved clinical outcomes with a 5-day treatment course of Veklury, compared with standard of care (OR, 1.65; 95% CI, 1.0-2.48; P = .017), according to Gilead.

This article first appeared on Medscape.com.

The U.S. Food and Drug Administration approved remdesivir (Veklury) Oct. 22 as a treatment for hospitalized COVID-19 patients aged 12 and up, making it the first and only approved treatment for COVID-19, according to a release from drug manufacturer Gilead Sciences.

The FDA’s initial Emergency Use Authorization (EUA) of the antiviral, issued in May, allowed the drug to be used only for patients with severe COVID-19, specifically, COVID-19 patients with low blood oxygen levels or who needed oxygen therapy or mechanical ventilation.

An August EUA expanded treatment to include all adult and pediatric hospitalized COVID-19 patients, regardless of the severity of their disease. The FDA also issued a new EUA for remdesivir Oct. 22 allowing treatment of hospitalized pediatric patients younger than 12 weighing at least 3.5 kg.

Today’s approval is based on three randomized controlled trials, according to Gilead.

Final trial results from one of them, the National Institute of Allergy and Infectious Disease–funded ACTT-1 trial, published earlier in October, showed that hospitalized patients with COVID-19 who received remdesivir had a shorter median recovery time than those who received a placebo – 10 days versus 15 days.

This difference and some related secondary endpoints were statistically significant in the randomized trial, but there was not a statistically significant difference in mortality between the treatment and placebo groups.

The other two trials used for the approval, the SIMPLE trials, were open-label phase 3 trials conducted in countries with a high prevalence of COVID-19 infections, according to Gilead.

The SIMPLE-Severe trial was a randomized, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing plus standard of care in 397 hospitalized adult patients with severe COVID-19. The primary endpoint was clinical status on day 14 assessed on a 7-point ordinal scale, according to Gilead.

The trial found that a 5-day or a 10-day treatment course of Veklury achieved similar clinical outcomes to the ACTT-1 trial (odds ratio, 0.75; 95% confidence interval, 0.51-1.12).

The SIMPLE-Moderate trial was a randomized, controlled, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing durations of Veklury plus standard of care, compared with standard of care alone in 600 hospitalized adult patients with moderate COVID-19, Gilead stated in its release.

The primary endpoint was clinical status on day 11 assessed on a 7-point ordinal scale.

The results showed statistically improved clinical outcomes with a 5-day treatment course of Veklury, compared with standard of care (OR, 1.65; 95% CI, 1.0-2.48; P = .017), according to Gilead.

This article first appeared on Medscape.com.

I. Finding a mentor

Case

You are a 27-year-old first-year resident who is seeking mentorship. You are halfway through the year and are thinking about your goals and future. You have a general interest in hematology/oncology but have limited experience and would like to gain more experience with clinically relevant scholarship. However, you do not know anyone in the field and are not sure who to ask for guidance.

Stage 1: Seeking the right mentor

Start first with your area of interest and then look broadly. In this case the resident is interested in heme/onc. The first place to look is on the heme/onc department website or in the faculty directory. It can be helpful to look at what the potential mentor has published recently and/or look at a version of their CV on the faculty directory or website. This can help determine how productive they are and help assess whether you share similar interests, and whether they have worked with many learners in the past.

It is also important to do some background work and ask around about potential mentors. Often resident colleagues and fellows have a good sense of current projects and which faculty work well with learners. Lastly, it is important to also look at non–heme/onc physicians as there may be internal medicine physicians or surgeons who are doing hematology or oncology research that more align with your interests.

After you have assessed whether you think this person would be a strong mentor for you, it is time to reach out. People are flattered to be asked and part of their promotion criteria is their ability to mentor. Do not assume that a potential mentor is too busy! Let him or her make that decision. Remember the worst a mentor can say is “no.” Even if they do not have time or the need for a mentee at the present time, they generally will offer some assistance or direction on who to ask.

Start with a straightforward, but pleasant email. Waiting up to 2 weeks for a response is reasonable. If after 2 weeks you have not received word, feel free to reach out again asking politely if he or she would be willing to work with you. Do not be afraid to ask bluntly for their guidance and mentorship and have a specific project or area of research that you would like their assistance with.
 

II. Optimizing the mentor/mentee relationship

Case continued

Success! Your email was received with interest by a hematologist who has done several projects, comes highly recommended by other residents, and worked with students and residents in the past. The project involves anticoagulation on the inpatient service. You are set to meet with her next month.

Stage 2: Establishing expectations and goals

Now comes the hard work in establishing an excellent mentor/mentee relationship. Before you meet with your mentor, brainstorm first. What do you want out of the relationship? A publication? Career advice? Attaining a fellowship position? You should feel empowered in knowing that you as the mentee are in the driver seat, but this relationship should be mutually beneficial. Consider basing the relationship and initial discussions on these key questions:

1. My goals

• What are my goals? It is okay not to know but be ready to communicate some information to your mentor.
• Remember to also ask your mentor what their goals are for you as well.

2. Outcome

• What type of outcome are both you and your mentor looking for from the relationship?

3. Expectations

• What mentorship expectations do you have?
• What are your mentor’s expectations of you?

Once you feel you have a sense of what you are looking for out of the relationship, it is important to communicate this with the mentor to establish congruent expectations of one another. For example, think about asking your mentor if the two of you can establish a mentor/mentee contract. This is a written document that can be found online and establishes a mutual agreement of roles, responsibilities, and expectations of one another for the relationship. It can further help to open a line for honest and consistent feedback. This can also give you a formalized endpoint and agreed upon scope for the mentoring relationship. Having a check-in preestablished in a contract reduces any potentially awkward conversations about redefining the relationship down the road. (For example, what if our case resident decides to pursue GI? It could happen.)
 

Stage 3: Establishing a common goal

After you have determined the goals and expectations of the relationship together (remember, this is a relationship), it is time to start exploring possible projects and establishing goals for those projects. Having a quality improvement or research project will determine a common goal to work towards and help establish and define the relationship.

Once you have delineated broadly what the project(s) should be, develop smaller SMART (specific, measurable, achievable, relevant, time-bound) goals to move the project forward. These goals determine stopping points for evaluation and feedback, which further establish the relationship and keep the project(s) progressing. For example, one goal could be to write the first draft of the proposal for your quality improvement project within 3 weeks.
 

Stage 4: Continued communication

With any project it is important to stay on the same page as your mentor and be clear to establish “who is doing what by when.” Do not expect accountability to be the mentor’s job. Remember that you are in the driver’s seat and that you should propose how often you need to meet and what those meetings look like by developing an agenda. You can have an open discussion and allow your mentor to help determine a reasonable timeline. Remember, the more you communicate your goals, the better your mentor will be able to address them.

One pro tip is to always exceed your mentor’s expectations – if you think you need 2 weeks to complete a task, ask for 3-4 weeks. This gives you extra padding in case of unforeseen circumstances and makes you look like a “rockstar” if you hit a deadline 1-2 weeks earlier than planned.
 

III. Ending and/or redefining the relationship

Case continued

You are now a senior resident who’s published multiple articles in the past year, and have completed an anticoagulation project for inpatients with pulmonary emboli. You look back on your experience and what stands out is the extent of your gratitude and appreciation for your incredible mentor. Not only do you feel that your mentor has guided you in your career and with your scholarship, but you feel that he or she has shaped your character and talent set. At this point your mentor is both a teacher and guide, but now also a friend. While you feel there is always more that you can learn from her, you are ready to explore new interests. How do you effectively end or redefine this relationship?

Stage 5: Redefining your mentoring relationship

First, go back to the expectations or contract established early in the relationship. The check-in is a key time in the relationship to reevaluate goals and priorities. At this point you may decide to amicably end the relationship or project, or move on to a new project with a change in your role. For example, the quality improvement project may change to research, or you as the mentee have a change in focus (e.g., change in specialty or scholarly focus).

In summary, the interaction between you and your mentor should be a relationship. And the keys to a great relationship are:

1. Establish clear expectations from the beginning. This clarifies the relationship and helps the mentee and mentor to become more successful.

2. Maintain clear and open communication throughout the relationship.3. Define your goals and discuss them with your mentor early. (Have we mentioned the importance of goals enough?) After all, your goal is the reason you started pursuing this relationship in the first place.

In clinical training having guidance can greatly enhance your experience and direct your future career in unexpected ways. We hope that using these tools will guide you towards forging a strong mentor/mentee relationship.

Dr. Zimmerberg-Helms is a resident physician at the University of New Mexico, Albuquerque. Dr. Rendon is an attending hospitalist at the University of New Mexico.

I. Finding a mentor

Case

You are a 27-year-old first-year resident who is seeking mentorship. You are halfway through the year and are thinking about your goals and future. You have a general interest in hematology/oncology but have limited experience and would like to gain more experience with clinically relevant scholarship. However, you do not know anyone in the field and are not sure who to ask for guidance.

Stage 1: Seeking the right mentor

Start first with your area of interest and then look broadly. In this case the resident is interested in heme/onc. The first place to look is on the heme/onc department website or in the faculty directory. It can be helpful to look at what the potential mentor has published recently and/or look at a version of their CV on the faculty directory or website. This can help determine how productive they are and help assess whether you share similar interests, and whether they have worked with many learners in the past.

It is also important to do some background work and ask around about potential mentors. Often resident colleagues and fellows have a good sense of current projects and which faculty work well with learners. Lastly, it is important to also look at non–heme/onc physicians as there may be internal medicine physicians or surgeons who are doing hematology or oncology research that more align with your interests.

After you have assessed whether you think this person would be a strong mentor for you, it is time to reach out. People are flattered to be asked and part of their promotion criteria is their ability to mentor. Do not assume that a potential mentor is too busy! Let him or her make that decision. Remember the worst a mentor can say is “no.” Even if they do not have time or the need for a mentee at the present time, they generally will offer some assistance or direction on who to ask.

Start with a straightforward, but pleasant email. Waiting up to 2 weeks for a response is reasonable. If after 2 weeks you have not received word, feel free to reach out again asking politely if he or she would be willing to work with you. Do not be afraid to ask bluntly for their guidance and mentorship and have a specific project or area of research that you would like their assistance with.
 

II. Optimizing the mentor/mentee relationship

Case continued

Success! Your email was received with interest by a hematologist who has done several projects, comes highly recommended by other residents, and worked with students and residents in the past. The project involves anticoagulation on the inpatient service. You are set to meet with her next month.

Stage 2: Establishing expectations and goals

Now comes the hard work in establishing an excellent mentor/mentee relationship. Before you meet with your mentor, brainstorm first. What do you want out of the relationship? A publication? Career advice? Attaining a fellowship position? You should feel empowered in knowing that you as the mentee are in the driver seat, but this relationship should be mutually beneficial. Consider basing the relationship and initial discussions on these key questions:

1. My goals

• What are my goals? It is okay not to know but be ready to communicate some information to your mentor.
• Remember to also ask your mentor what their goals are for you as well.

2. Outcome

• What type of outcome are both you and your mentor looking for from the relationship?

3. Expectations

• What mentorship expectations do you have?
• What are your mentor’s expectations of you?

Once you feel you have a sense of what you are looking for out of the relationship, it is important to communicate this with the mentor to establish congruent expectations of one another. For example, think about asking your mentor if the two of you can establish a mentor/mentee contract. This is a written document that can be found online and establishes a mutual agreement of roles, responsibilities, and expectations of one another for the relationship. It can further help to open a line for honest and consistent feedback. This can also give you a formalized endpoint and agreed upon scope for the mentoring relationship. Having a check-in preestablished in a contract reduces any potentially awkward conversations about redefining the relationship down the road. (For example, what if our case resident decides to pursue GI? It could happen.)
 

Stage 3: Establishing a common goal

After you have determined the goals and expectations of the relationship together (remember, this is a relationship), it is time to start exploring possible projects and establishing goals for those projects. Having a quality improvement or research project will determine a common goal to work towards and help establish and define the relationship.

Once you have delineated broadly what the project(s) should be, develop smaller SMART (specific, measurable, achievable, relevant, time-bound) goals to move the project forward. These goals determine stopping points for evaluation and feedback, which further establish the relationship and keep the project(s) progressing. For example, one goal could be to write the first draft of the proposal for your quality improvement project within 3 weeks.
 

Stage 4: Continued communication

With any project it is important to stay on the same page as your mentor and be clear to establish “who is doing what by when.” Do not expect accountability to be the mentor’s job. Remember that you are in the driver’s seat and that you should propose how often you need to meet and what those meetings look like by developing an agenda. You can have an open discussion and allow your mentor to help determine a reasonable timeline. Remember, the more you communicate your goals, the better your mentor will be able to address them.

One pro tip is to always exceed your mentor’s expectations – if you think you need 2 weeks to complete a task, ask for 3-4 weeks. This gives you extra padding in case of unforeseen circumstances and makes you look like a “rockstar” if you hit a deadline 1-2 weeks earlier than planned.
 

III. Ending and/or redefining the relationship

Case continued

You are now a senior resident who’s published multiple articles in the past year, and have completed an anticoagulation project for inpatients with pulmonary emboli. You look back on your experience and what stands out is the extent of your gratitude and appreciation for your incredible mentor. Not only do you feel that your mentor has guided you in your career and with your scholarship, but you feel that he or she has shaped your character and talent set. At this point your mentor is both a teacher and guide, but now also a friend. While you feel there is always more that you can learn from her, you are ready to explore new interests. How do you effectively end or redefine this relationship?

Stage 5: Redefining your mentoring relationship

First, go back to the expectations or contract established early in the relationship. The check-in is a key time in the relationship to reevaluate goals and priorities. At this point you may decide to amicably end the relationship or project, or move on to a new project with a change in your role. For example, the quality improvement project may change to research, or you as the mentee have a change in focus (e.g., change in specialty or scholarly focus).

In summary, the interaction between you and your mentor should be a relationship. And the keys to a great relationship are:

1. Establish clear expectations from the beginning. This clarifies the relationship and helps the mentee and mentor to become more successful.

2. Maintain clear and open communication throughout the relationship.3. Define your goals and discuss them with your mentor early. (Have we mentioned the importance of goals enough?) After all, your goal is the reason you started pursuing this relationship in the first place.

In clinical training having guidance can greatly enhance your experience and direct your future career in unexpected ways. We hope that using these tools will guide you towards forging a strong mentor/mentee relationship.

Dr. Zimmerberg-Helms is a resident physician at the University of New Mexico, Albuquerque. Dr. Rendon is an attending hospitalist at the University of New Mexico.

I. Finding a mentor

Case

You are a 27-year-old first-year resident who is seeking mentorship. You are halfway through the year and are thinking about your goals and future. You have a general interest in hematology/oncology but have limited experience and would like to gain more experience with clinically relevant scholarship. However, you do not know anyone in the field and are not sure who to ask for guidance.

Stage 1: Seeking the right mentor

Start first with your area of interest and then look broadly. In this case the resident is interested in heme/onc. The first place to look is on the heme/onc department website or in the faculty directory. It can be helpful to look at what the potential mentor has published recently and/or look at a version of their CV on the faculty directory or website. This can help determine how productive they are and help assess whether you share similar interests, and whether they have worked with many learners in the past.

It is also important to do some background work and ask around about potential mentors. Often resident colleagues and fellows have a good sense of current projects and which faculty work well with learners. Lastly, it is important to also look at non–heme/onc physicians as there may be internal medicine physicians or surgeons who are doing hematology or oncology research that more align with your interests.

After you have assessed whether you think this person would be a strong mentor for you, it is time to reach out. People are flattered to be asked and part of their promotion criteria is their ability to mentor. Do not assume that a potential mentor is too busy! Let him or her make that decision. Remember the worst a mentor can say is “no.” Even if they do not have time or the need for a mentee at the present time, they generally will offer some assistance or direction on who to ask.

Start with a straightforward, but pleasant email. Waiting up to 2 weeks for a response is reasonable. If after 2 weeks you have not received word, feel free to reach out again asking politely if he or she would be willing to work with you. Do not be afraid to ask bluntly for their guidance and mentorship and have a specific project or area of research that you would like their assistance with.
 

II. Optimizing the mentor/mentee relationship

Case continued

Success! Your email was received with interest by a hematologist who has done several projects, comes highly recommended by other residents, and worked with students and residents in the past. The project involves anticoagulation on the inpatient service. You are set to meet with her next month.

Stage 2: Establishing expectations and goals

Now comes the hard work in establishing an excellent mentor/mentee relationship. Before you meet with your mentor, brainstorm first. What do you want out of the relationship? A publication? Career advice? Attaining a fellowship position? You should feel empowered in knowing that you as the mentee are in the driver seat, but this relationship should be mutually beneficial. Consider basing the relationship and initial discussions on these key questions:

1. My goals

• What are my goals? It is okay not to know but be ready to communicate some information to your mentor.
• Remember to also ask your mentor what their goals are for you as well.

2. Outcome

• What type of outcome are both you and your mentor looking for from the relationship?

3. Expectations

• What mentorship expectations do you have?
• What are your mentor’s expectations of you?

Once you feel you have a sense of what you are looking for out of the relationship, it is important to communicate this with the mentor to establish congruent expectations of one another. For example, think about asking your mentor if the two of you can establish a mentor/mentee contract. This is a written document that can be found online and establishes a mutual agreement of roles, responsibilities, and expectations of one another for the relationship. It can further help to open a line for honest and consistent feedback. This can also give you a formalized endpoint and agreed upon scope for the mentoring relationship. Having a check-in preestablished in a contract reduces any potentially awkward conversations about redefining the relationship down the road. (For example, what if our case resident decides to pursue GI? It could happen.)
 

Stage 3: Establishing a common goal

After you have determined the goals and expectations of the relationship together (remember, this is a relationship), it is time to start exploring possible projects and establishing goals for those projects. Having a quality improvement or research project will determine a common goal to work towards and help establish and define the relationship.

Once you have delineated broadly what the project(s) should be, develop smaller SMART (specific, measurable, achievable, relevant, time-bound) goals to move the project forward. These goals determine stopping points for evaluation and feedback, which further establish the relationship and keep the project(s) progressing. For example, one goal could be to write the first draft of the proposal for your quality improvement project within 3 weeks.
 

Stage 4: Continued communication

With any project it is important to stay on the same page as your mentor and be clear to establish “who is doing what by when.” Do not expect accountability to be the mentor’s job. Remember that you are in the driver’s seat and that you should propose how often you need to meet and what those meetings look like by developing an agenda. You can have an open discussion and allow your mentor to help determine a reasonable timeline. Remember, the more you communicate your goals, the better your mentor will be able to address them.

One pro tip is to always exceed your mentor’s expectations – if you think you need 2 weeks to complete a task, ask for 3-4 weeks. This gives you extra padding in case of unforeseen circumstances and makes you look like a “rockstar” if you hit a deadline 1-2 weeks earlier than planned.
 

III. Ending and/or redefining the relationship

Case continued

You are now a senior resident who’s published multiple articles in the past year, and have completed an anticoagulation project for inpatients with pulmonary emboli. You look back on your experience and what stands out is the extent of your gratitude and appreciation for your incredible mentor. Not only do you feel that your mentor has guided you in your career and with your scholarship, but you feel that he or she has shaped your character and talent set. At this point your mentor is both a teacher and guide, but now also a friend. While you feel there is always more that you can learn from her, you are ready to explore new interests. How do you effectively end or redefine this relationship?

Stage 5: Redefining your mentoring relationship

First, go back to the expectations or contract established early in the relationship. The check-in is a key time in the relationship to reevaluate goals and priorities. At this point you may decide to amicably end the relationship or project, or move on to a new project with a change in your role. For example, the quality improvement project may change to research, or you as the mentee have a change in focus (e.g., change in specialty or scholarly focus).

In summary, the interaction between you and your mentor should be a relationship. And the keys to a great relationship are:

1. Establish clear expectations from the beginning. This clarifies the relationship and helps the mentee and mentor to become more successful.

2. Maintain clear and open communication throughout the relationship.3. Define your goals and discuss them with your mentor early. (Have we mentioned the importance of goals enough?) After all, your goal is the reason you started pursuing this relationship in the first place.

In clinical training having guidance can greatly enhance your experience and direct your future career in unexpected ways. We hope that using these tools will guide you towards forging a strong mentor/mentee relationship.

Dr. Zimmerberg-Helms is a resident physician at the University of New Mexico, Albuquerque. Dr. Rendon is an attending hospitalist at the University of New Mexico.

Among individuals admitted to hospitals with sepsis, statin users had a lower mortality, compared with nonstatin users, according to a recent analysis focused on a large and diverse cohort of patients in California.

Mortality hazard ratios at 30 and 90 days were lower by about 20% for statin users admitted for sepsis, compared with nonstatin users, according to results of the retrospective cohort study.

Hydrophilic and synthetic statins had more favorable mortality outcomes, compared with lipophilic and fungal-derived statins, respectively, added investigator Brannen Liang, MD, a third-year internal medicine resident at Kaiser Permanente Los Angeles Medical Center.

These findings suggest a potential benefit of statins in patients with sepsis, with certain types of statins having a greater protective effect than others, according to Dr. Liang, who presented the original research in a presentation at the annual meeting of the American College of Chest Physicians, held virtually this year.

“I think there’s potential for extending the use of statins to other indications, such as sepsis,” Dr. Liang said in an interview, though he also cautioned that the present study is hypothesis generating and more research is necessary.

Using a certain statin type over another (i.e., a hydrophilic, synthetic statin) might be a consideration for populations who are at greater risk for sepsis, such as the immunocompromised, patients with diabetes, or elderly and who also require a statin for an indication such as hyperlipidemia, he added.

While the link between statin use and sepsis mortality outcomes is not new, this study is unique in that it replicates results of earlier studies in a large and diverse real-world population, Dr. Liang said.

“Numerous studies seem to suggest that statins may play a role in attenuating the mortality of patients admitted to the hospital with sepsis, for whatever reason – whether this is due to their anti-inflammatory effects, their lipid-lowering effects, or if they truly have an antimicrobial effect, which has been studied in vitro and in animal studies,” he said in an interview.

It’s impossible to definitively conclude from retrospective studies such as this whether statins reduce sepsis-related mortality risk, but the present study at least makes the case for using certain types of statins when they are indicated in high-risk patients, said Steven Q. Simpson, MD, FCCP, professor of medicine in the division of pulmonary and critical care medicine at the University of Kansas, Kansas City.

“If you have patients at high risk for sepsis and they need a statin, you could give consideration to using a hydrophilic and synthetic statin, rather than either of the other choices,” said Dr. Simpson, CHEST president-elect and senior advisor to the Solving Sepsis initiative of the Biomedical Advanced Research and Development Authority of the Department of Health & Human Services.

The retrospective cohort study by Dr. Liang and colleagues included a total of 137,019 individuals admitted for sepsis within the Kaiser Permanente Southern California health system between 2008 and 2018. Of that group, 36,908 were taking a statin.

Overall, the mean age of patients admitted for sepsis was 66.9 years, and 50.4% were female. Nearly 50% were White, about 12% were Black, 28% were Hispanic, and 8% were Asian. A diagnosis of ischemic heart disease was reported for 43% of statin users and 23% of nonusers, while diabetes mellitus was reported for 60% of statin users and 37% of nonusers (P < .0001 for both comparisons).

Differences in mortality favored statin users, compared with nonusers, with hazard ratios of 0.79 (95% confidence interval, 0.77-0.82) at 30 days and similarly, 0.79 (95% CI, 0.77-0.81) at 90 days, Dr. Liang reported, noting that the models were adjusted for age, race, sex, and comorbidities.

Further analysis suggested a mortality advantage of lipophilic, compared with hydrophilic statins, and an advantage of fungal-derived statins over synthetic-derived statins, the investigator added.

In the comparison of lipophilic statin users and hydrophilic statin users, the 30- and 90-day mortality HRs were 1.13 (95% CI, 1.02-1.26) and 1.17 (95% CI, 1.07-1.28), respectively, the data show. For fungal-derived statin users, compared with synthetic derived statin users, 30- and 90-day mortality HRs were 1.12 (95% CI, 1.06-1.19) and 1.14 (95% CI, 1.09-1.20), respectively.

Dr. Liang and coauthors disclosed no relevant relationships with respect to the work presented at the CHEST meeting.

SOURCE: Liang B et al. CHEST 2020, Abstract A589.

Among individuals admitted to hospitals with sepsis, statin users had a lower mortality, compared with nonstatin users, according to a recent analysis focused on a large and diverse cohort of patients in California.

Mortality hazard ratios at 30 and 90 days were lower by about 20% for statin users admitted for sepsis, compared with nonstatin users, according to results of the retrospective cohort study.

Hydrophilic and synthetic statins had more favorable mortality outcomes, compared with lipophilic and fungal-derived statins, respectively, added investigator Brannen Liang, MD, a third-year internal medicine resident at Kaiser Permanente Los Angeles Medical Center.

These findings suggest a potential benefit of statins in patients with sepsis, with certain types of statins having a greater protective effect than others, according to Dr. Liang, who presented the original research in a presentation at the annual meeting of the American College of Chest Physicians, held virtually this year.

“I think there’s potential for extending the use of statins to other indications, such as sepsis,” Dr. Liang said in an interview, though he also cautioned that the present study is hypothesis generating and more research is necessary.

Using a certain statin type over another (i.e., a hydrophilic, synthetic statin) might be a consideration for populations who are at greater risk for sepsis, such as the immunocompromised, patients with diabetes, or elderly and who also require a statin for an indication such as hyperlipidemia, he added.

While the link between statin use and sepsis mortality outcomes is not new, this study is unique in that it replicates results of earlier studies in a large and diverse real-world population, Dr. Liang said.

“Numerous studies seem to suggest that statins may play a role in attenuating the mortality of patients admitted to the hospital with sepsis, for whatever reason – whether this is due to their anti-inflammatory effects, their lipid-lowering effects, or if they truly have an antimicrobial effect, which has been studied in vitro and in animal studies,” he said in an interview.

It’s impossible to definitively conclude from retrospective studies such as this whether statins reduce sepsis-related mortality risk, but the present study at least makes the case for using certain types of statins when they are indicated in high-risk patients, said Steven Q. Simpson, MD, FCCP, professor of medicine in the division of pulmonary and critical care medicine at the University of Kansas, Kansas City.

“If you have patients at high risk for sepsis and they need a statin, you could give consideration to using a hydrophilic and synthetic statin, rather than either of the other choices,” said Dr. Simpson, CHEST president-elect and senior advisor to the Solving Sepsis initiative of the Biomedical Advanced Research and Development Authority of the Department of Health & Human Services.

The retrospective cohort study by Dr. Liang and colleagues included a total of 137,019 individuals admitted for sepsis within the Kaiser Permanente Southern California health system between 2008 and 2018. Of that group, 36,908 were taking a statin.

Overall, the mean age of patients admitted for sepsis was 66.9 years, and 50.4% were female. Nearly 50% were White, about 12% were Black, 28% were Hispanic, and 8% were Asian. A diagnosis of ischemic heart disease was reported for 43% of statin users and 23% of nonusers, while diabetes mellitus was reported for 60% of statin users and 37% of nonusers (P < .0001 for both comparisons).

Differences in mortality favored statin users, compared with nonusers, with hazard ratios of 0.79 (95% confidence interval, 0.77-0.82) at 30 days and similarly, 0.79 (95% CI, 0.77-0.81) at 90 days, Dr. Liang reported, noting that the models were adjusted for age, race, sex, and comorbidities.

Further analysis suggested a mortality advantage of lipophilic, compared with hydrophilic statins, and an advantage of fungal-derived statins over synthetic-derived statins, the investigator added.

In the comparison of lipophilic statin users and hydrophilic statin users, the 30- and 90-day mortality HRs were 1.13 (95% CI, 1.02-1.26) and 1.17 (95% CI, 1.07-1.28), respectively, the data show. For fungal-derived statin users, compared with synthetic derived statin users, 30- and 90-day mortality HRs were 1.12 (95% CI, 1.06-1.19) and 1.14 (95% CI, 1.09-1.20), respectively.

Dr. Liang and coauthors disclosed no relevant relationships with respect to the work presented at the CHEST meeting.

SOURCE: Liang B et al. CHEST 2020, Abstract A589.

Among individuals admitted to hospitals with sepsis, statin users had a lower mortality, compared with nonstatin users, according to a recent analysis focused on a large and diverse cohort of patients in California.

Mortality hazard ratios at 30 and 90 days were lower by about 20% for statin users admitted for sepsis, compared with nonstatin users, according to results of the retrospective cohort study.

Hydrophilic and synthetic statins had more favorable mortality outcomes, compared with lipophilic and fungal-derived statins, respectively, added investigator Brannen Liang, MD, a third-year internal medicine resident at Kaiser Permanente Los Angeles Medical Center.

These findings suggest a potential benefit of statins in patients with sepsis, with certain types of statins having a greater protective effect than others, according to Dr. Liang, who presented the original research in a presentation at the annual meeting of the American College of Chest Physicians, held virtually this year.

“I think there’s potential for extending the use of statins to other indications, such as sepsis,” Dr. Liang said in an interview, though he also cautioned that the present study is hypothesis generating and more research is necessary.

Using a certain statin type over another (i.e., a hydrophilic, synthetic statin) might be a consideration for populations who are at greater risk for sepsis, such as the immunocompromised, patients with diabetes, or elderly and who also require a statin for an indication such as hyperlipidemia, he added.

While the link between statin use and sepsis mortality outcomes is not new, this study is unique in that it replicates results of earlier studies in a large and diverse real-world population, Dr. Liang said.

“Numerous studies seem to suggest that statins may play a role in attenuating the mortality of patients admitted to the hospital with sepsis, for whatever reason – whether this is due to their anti-inflammatory effects, their lipid-lowering effects, or if they truly have an antimicrobial effect, which has been studied in vitro and in animal studies,” he said in an interview.

It’s impossible to definitively conclude from retrospective studies such as this whether statins reduce sepsis-related mortality risk, but the present study at least makes the case for using certain types of statins when they are indicated in high-risk patients, said Steven Q. Simpson, MD, FCCP, professor of medicine in the division of pulmonary and critical care medicine at the University of Kansas, Kansas City.

“If you have patients at high risk for sepsis and they need a statin, you could give consideration to using a hydrophilic and synthetic statin, rather than either of the other choices,” said Dr. Simpson, CHEST president-elect and senior advisor to the Solving Sepsis initiative of the Biomedical Advanced Research and Development Authority of the Department of Health & Human Services.

The retrospective cohort study by Dr. Liang and colleagues included a total of 137,019 individuals admitted for sepsis within the Kaiser Permanente Southern California health system between 2008 and 2018. Of that group, 36,908 were taking a statin.

Overall, the mean age of patients admitted for sepsis was 66.9 years, and 50.4% were female. Nearly 50% were White, about 12% were Black, 28% were Hispanic, and 8% were Asian. A diagnosis of ischemic heart disease was reported for 43% of statin users and 23% of nonusers, while diabetes mellitus was reported for 60% of statin users and 37% of nonusers (P < .0001 for both comparisons).

Differences in mortality favored statin users, compared with nonusers, with hazard ratios of 0.79 (95% confidence interval, 0.77-0.82) at 30 days and similarly, 0.79 (95% CI, 0.77-0.81) at 90 days, Dr. Liang reported, noting that the models were adjusted for age, race, sex, and comorbidities.

Further analysis suggested a mortality advantage of lipophilic, compared with hydrophilic statins, and an advantage of fungal-derived statins over synthetic-derived statins, the investigator added.

In the comparison of lipophilic statin users and hydrophilic statin users, the 30- and 90-day mortality HRs were 1.13 (95% CI, 1.02-1.26) and 1.17 (95% CI, 1.07-1.28), respectively, the data show. For fungal-derived statin users, compared with synthetic derived statin users, 30- and 90-day mortality HRs were 1.12 (95% CI, 1.06-1.19) and 1.14 (95% CI, 1.09-1.20), respectively.

Dr. Liang and coauthors disclosed no relevant relationships with respect to the work presented at the CHEST meeting.

SOURCE: Liang B et al. CHEST 2020, Abstract A589.

Multiple mouthwash and oral rinse products wiped out a human coronavirus closely related to the SARS-CoV-2 virus in a laboratory comparison study.

Listerine Antiseptic led the list of most effective mouthwashes for inactivating the coronavirus. Interestingly, a 1% nasal rinse solution of Johnson’s Baby Shampoo also worked, eliminating up to 99.9% of the viral load in the in vitro experiments.

In contrast, use of a neti pot nasal solution yielded no decrease in virus levels.

The study was published in the Journal of Medical Virology.

Because the mouthwash and hydrogen peroxide oral rinses in the study are widely available and easy to use, “I would recommend the use of the rinses on top of wearing mask and social distancing. This could add a layer of protection for yourself and others,” lead study author Craig Meyers, PhD, professor of microbiology and immunology and obstetrics and gynecology, Penn State College of Medicine in Hershey, Pennsylvania, told Medscape Medical News.

Meyers and colleagues found that efficacy aligned with duration of time the cell cultures were exposed to each mouthwash or rinse product. Although it varied, the products required at least 30 seconds to kill most of the virus. Waiting 1 or 2 minutes tended to fortify results.

“This study adds to and further confirms the recently published evidence from virologists in Germany that mouthwashes can inactivate the virus that causes COVID-19 in a test tube,” Valerie O’Donnell, PhD, co-director of the Systems Immunity Research Institute of Cardiff University, Cardiff, Wales, said when asked to comment on the study.

“While this is great to see, what is still lacking is in vivo evidence, since we know the virus will be continually shed in the mouth,” O’Donnell said. “So, the question now becomes, by how much could mouthwashes reduce viral load in the oropharynx of infected people, and if so, then for how long?”

Meyers noted that studies of people positive for COVID-19 using each product would be informative. It remains unknown, for example, if swishing, gargling, and/or spitting out mouthwash would add or decrease the efficacy demonstrated in the lab.

The investigators used the human coronavirus HCoV‐229e as a surrogate for SARS-CoV-2. They noted HCoV-229e is analogous, and SARS-CoV-2 would have been more expensive, less available, and would have required biosafety level 3 laboratory conditions.
 

Listerine Antiseptic leads the way

“Surprisingly, we found that several of these common products had strong virucidal properties, inactivating from 2 log10 [or 99%] to greater than 4 log10 [or 99.99%] of infectious human coronavirus,” the researchers note.

Timing of the essence?

Meyers and colleagues also tested a nasal rinse solution of 1% baby shampoo because it is sometimes used to treat people with chronic rhinosinusitis. They found 30 seconds led to < 90% to < 99.99% effectiveness, but that, by 2 minutes, efficacy climbed to > 99.9% to > 99.99%.

“Thirty seconds for some products just was not enough time for the efficacy to be observed,” Meyers said. “Whereas, after a minute or two the active ingredient had enough time to work. Thirty seconds may be at the border to see full efficacy.” More research is needed to confirm the timing and determine which active ingredients are driving the findings.

A future trial could test the efficacy of mouthwash products to reduce the viral load in people with COVID-19. “If we are able to get funding to continue, I would like to see a small clinical trial as the next step,” Meyers said.

Meyers and O’Donnell disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Multiple mouthwash and oral rinse products wiped out a human coronavirus closely related to the SARS-CoV-2 virus in a laboratory comparison study.

Listerine Antiseptic led the list of most effective mouthwashes for inactivating the coronavirus. Interestingly, a 1% nasal rinse solution of Johnson’s Baby Shampoo also worked, eliminating up to 99.9% of the viral load in the in vitro experiments.

In contrast, use of a neti pot nasal solution yielded no decrease in virus levels.

The study was published in the Journal of Medical Virology.

Because the mouthwash and hydrogen peroxide oral rinses in the study are widely available and easy to use, “I would recommend the use of the rinses on top of wearing mask and social distancing. This could add a layer of protection for yourself and others,” lead study author Craig Meyers, PhD, professor of microbiology and immunology and obstetrics and gynecology, Penn State College of Medicine in Hershey, Pennsylvania, told Medscape Medical News.

Meyers and colleagues found that efficacy aligned with duration of time the cell cultures were exposed to each mouthwash or rinse product. Although it varied, the products required at least 30 seconds to kill most of the virus. Waiting 1 or 2 minutes tended to fortify results.

“This study adds to and further confirms the recently published evidence from virologists in Germany that mouthwashes can inactivate the virus that causes COVID-19 in a test tube,” Valerie O’Donnell, PhD, co-director of the Systems Immunity Research Institute of Cardiff University, Cardiff, Wales, said when asked to comment on the study.

“While this is great to see, what is still lacking is in vivo evidence, since we know the virus will be continually shed in the mouth,” O’Donnell said. “So, the question now becomes, by how much could mouthwashes reduce viral load in the oropharynx of infected people, and if so, then for how long?”

Meyers noted that studies of people positive for COVID-19 using each product would be informative. It remains unknown, for example, if swishing, gargling, and/or spitting out mouthwash would add or decrease the efficacy demonstrated in the lab.

The investigators used the human coronavirus HCoV‐229e as a surrogate for SARS-CoV-2. They noted HCoV-229e is analogous, and SARS-CoV-2 would have been more expensive, less available, and would have required biosafety level 3 laboratory conditions.
 

Listerine Antiseptic leads the way

“Surprisingly, we found that several of these common products had strong virucidal properties, inactivating from 2 log10 [or 99%] to greater than 4 log10 [or 99.99%] of infectious human coronavirus,” the researchers note.

Timing of the essence?

Meyers and colleagues also tested a nasal rinse solution of 1% baby shampoo because it is sometimes used to treat people with chronic rhinosinusitis. They found 30 seconds led to < 90% to < 99.99% effectiveness, but that, by 2 minutes, efficacy climbed to > 99.9% to > 99.99%.

“Thirty seconds for some products just was not enough time for the efficacy to be observed,” Meyers said. “Whereas, after a minute or two the active ingredient had enough time to work. Thirty seconds may be at the border to see full efficacy.” More research is needed to confirm the timing and determine which active ingredients are driving the findings.

A future trial could test the efficacy of mouthwash products to reduce the viral load in people with COVID-19. “If we are able to get funding to continue, I would like to see a small clinical trial as the next step,” Meyers said.

Meyers and O’Donnell disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Multiple mouthwash and oral rinse products wiped out a human coronavirus closely related to the SARS-CoV-2 virus in a laboratory comparison study.

Listerine Antiseptic led the list of most effective mouthwashes for inactivating the coronavirus. Interestingly, a 1% nasal rinse solution of Johnson’s Baby Shampoo also worked, eliminating up to 99.9% of the viral load in the in vitro experiments.

In contrast, use of a neti pot nasal solution yielded no decrease in virus levels.

The study was published in the Journal of Medical Virology.

Because the mouthwash and hydrogen peroxide oral rinses in the study are widely available and easy to use, “I would recommend the use of the rinses on top of wearing mask and social distancing. This could add a layer of protection for yourself and others,” lead study author Craig Meyers, PhD, professor of microbiology and immunology and obstetrics and gynecology, Penn State College of Medicine in Hershey, Pennsylvania, told Medscape Medical News.

Meyers and colleagues found that efficacy aligned with duration of time the cell cultures were exposed to each mouthwash or rinse product. Although it varied, the products required at least 30 seconds to kill most of the virus. Waiting 1 or 2 minutes tended to fortify results.

“This study adds to and further confirms the recently published evidence from virologists in Germany that mouthwashes can inactivate the virus that causes COVID-19 in a test tube,” Valerie O’Donnell, PhD, co-director of the Systems Immunity Research Institute of Cardiff University, Cardiff, Wales, said when asked to comment on the study.

“While this is great to see, what is still lacking is in vivo evidence, since we know the virus will be continually shed in the mouth,” O’Donnell said. “So, the question now becomes, by how much could mouthwashes reduce viral load in the oropharynx of infected people, and if so, then for how long?”

Meyers noted that studies of people positive for COVID-19 using each product would be informative. It remains unknown, for example, if swishing, gargling, and/or spitting out mouthwash would add or decrease the efficacy demonstrated in the lab.

The investigators used the human coronavirus HCoV‐229e as a surrogate for SARS-CoV-2. They noted HCoV-229e is analogous, and SARS-CoV-2 would have been more expensive, less available, and would have required biosafety level 3 laboratory conditions.
 

Listerine Antiseptic leads the way

“Surprisingly, we found that several of these common products had strong virucidal properties, inactivating from 2 log10 [or 99%] to greater than 4 log10 [or 99.99%] of infectious human coronavirus,” the researchers note.

Timing of the essence?

Meyers and colleagues also tested a nasal rinse solution of 1% baby shampoo because it is sometimes used to treat people with chronic rhinosinusitis. They found 30 seconds led to < 90% to < 99.99% effectiveness, but that, by 2 minutes, efficacy climbed to > 99.9% to > 99.99%.

“Thirty seconds for some products just was not enough time for the efficacy to be observed,” Meyers said. “Whereas, after a minute or two the active ingredient had enough time to work. Thirty seconds may be at the border to see full efficacy.” More research is needed to confirm the timing and determine which active ingredients are driving the findings.

A future trial could test the efficacy of mouthwash products to reduce the viral load in people with COVID-19. “If we are able to get funding to continue, I would like to see a small clinical trial as the next step,” Meyers said.

Meyers and O’Donnell disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Starting Nov. 2, all patients in the United States will have immediate access to clinical notes and thus will be able to read their doctors’ writings, as well as test results and reports from pathology and imaging.

FG Trade/iStock/Getty Images Plus

The 21st Century Cures Act mandates that patients have fast, electronic access to the following types of notes: consultations, discharge summaries, history, physical examination findings, imaging narratives, laboratory and pathology report narratives, and procedure and progress notes.

But this federal mandate, called “open notes” by many, is potentially confusing and frightening for patients, say some physicians. Others worry that the change will increase workload as clinicians tailor notes for patients and answer related questions.

The law means that inpatient and outpatient notes will be released immediately and that patients will have immediate access to testing and imaging results, including results from sexually transmitted disease tests, Pap tests, cancer biopsies, CT and PET scans, fetal ultrasounds, pneumonia cultures, and mammograms.

Such notes could contain sensitive information, and there is concern that patients could be shocked, confused, or annoyed by what they read, even with more run-of-the-mill notes.

Champions of open notes say that the benefits, including better provider-patient communication, greatly outweigh such risks.

“This is about convenience – a bit like online banking,” commented Charlotte Blease, PhD, resident scholar at OpenNotes, an advocacy nonprofit organization headquartered at the Beth Israel–Deaconess Medical Center in Boston. “But it’s a culture shift for doctors,” she said in an interview.

“It turns physician paternalism on its head,” said C. T. Lin, MD, chief medical information officer, UCHealth, Denver. The change requires “some letting go of old traditions” in medicine, he wrote in an August blog post, referring to the fact that a computer screen – and not a physician – may tell patients about a new health problem.

Dr. Lin summarized the experience at the University of Colorado Cancer Center, which has allowed patients to have access to oncology notes for the past 5 years: “No issues and highly appreciated by patients. We have nothing to fear but fear itself.”
 

A new audience

Other institutions have also been voluntarily implementing open notes.

UC Davis Health in Sacramento, Calif., has run an optional program for the past year. However, only about two dozen of approximately 1,000 staff physicians opted in to the program.

“This illustrates the point that it’s a new thing that physicians aren’t used to doing. They’ve traditionally written notes for the benefit of their colleagues, for billing, for their own reference,” Scott MacDonald, MD, an internist and electronic health record medical director at UC Davis Health, told this news organization.

“They’ve never –until recently – had the patient as one of the audiences for a note,” he said.

Liam Keating, MD, an otolaryngologist in Martinez, Calif., recalls that he once wrote “globus hystericus,” and the patient wanted to sue him for saying that the patient was hysterical. “I now just code ‘Globus’ (if I don’t jump straight to LPD [lateral pharyngeal diverticulum]),” he commented in response to a commentary on open notes.

Sensitive information occurs more often in certain specialties, for example, psychiatry, genetics, adolescent medicine, and oncology, experts say.

“Cancer is an area that is highly charged for patients and doctors alike,” Dr. MacDonald pointed out. When reading pathology or imaging notes, patients may learn that they have been diagnosed with cancer or that they have a recurrence “without the physician being able to contextualize it and explain things – that’s just new and scary,” he said.

California law dictates that providers cannot post cancer test results without talking with the patient first, said Dr. MacDonald, but not all states have such laws.
 

Adjustments needed – or not – with open notes

At UCHealth in Aurora, Colo., Robert Breeze, MD, vice-chair of neurosurgery, said he has adjusted his practice to accommodate open notes and to anticipate trouble spots.*

“When I order imaging or send pathology specimens, I have already discussed with the patient the possibilities, including cancer, and what we will do next. Patients deeply appreciate these discussions, before they see the results,” he commented in an institutional white paper issued in anticipation of the changes on Nov. 2.

This is called precounseling, said Trent Rosenbloom, MD, MPH, director of patient portals at Vanderbilt University Medical Center, Nashville, Tenn., which has been a pioneer in information sharing with patients. Their system does delay the release of information in the case of “complicated” results, such as from cancer biopsies, he said in an interview.

However, Christiaan Hoff, MD, PhD, a surgeon at the Medical Center Leeuwarden (the Netherlands), wonders how important it is for the physician to be present when the patient receives bad news, including news about cancer. “We may overestimate our added value in these situations,” he suggested.

“Our empathy may not outweigh” the disadvantages of the situation, and the “finer points of our explanation will often go unnoticed” by the stressed patient, he commented. Dr. Hoff was also responding to the commentary about open notes.

In that commentary, Jack West, MD, a medical oncologist at City of Hope Cancer Center, Duarte, Calif., was concerned about misunderstandings. Oncology is complex, and patients can struggle to understand their prognosis and planned treatment efficacy, especially in cases of metastatic disease, he wrote.

This concern is somewhat refuted by a study published Oct. 5 in Cancer Cell. Responses to two surveys involving 96 oncology clinicians at three U.S. centers found that almost half (44%) believed that their patients “would be confused” by open notes.

However, only 4% of the 3,418 cancer patients from the same surveys reported being confused by open notes. (A majority of participants had more than a high school education, and English was their primary language.)

“Patient and clinician views about open notes in oncology are not aligned, with patients expressing considerably more enthusiasm,” wrote the authors, led by Liz Salmi, senior strategist at OpenNotes, who has been treated for brain cancer.

“All clinicians are anxious at first,” Ms. Salmi told this news organization. “Those patients who have more serious or chronic conditions … are more likely to read their notes.”

The survey results echo the early experience reported from Sweden, where open notes was launched in 2012. “Patients have loved it from the beginning,” said Maria Haggland, PhD, of Uppsala MedTech Science Innovation Center.

However, when the scheme first launched, it was considered to be “very controversial,” and “there were a lot of complaints, from health care professionals, especially,” she added.

Over time, clinicians have embraced open notes, and the program has 7.2 million patient accounts in a country of 10 million people, she observed during an Oct. 5 webinar on open notes.
 

More work for already overworked clinicians?

An outstanding concern about open notes is that it will cause more work for health care professionals.

Traditionally, doctors have written notes using medical lexicon, including a lot of abbreviations and jargon for efficiency’s sake. Now that patients will read the notes, will clinicians have to spell out things in lay terms, alter their writing so as not to offend, and generally do more work?

William Harvey, MD, chief medical information officer, Tufts Medical Center, Boston, acknowledged that that may be the case.

In a forthcoming note to staff about the Nov. 2 start of open notes, Dr. Harvey will include a reminder to accommodate the patient as a reader. But that may or may not mean an increase in work volume, depending on the provider. “Clinical note writing is highly personal. There’s an art to it,” he said in an interview. “So it’s hard to give standard advice.”

Steven Reidbord, MD, a psychiatrist in private practice in San Francisco and a lecturer at California Pacific Medical Center, is particularly concerned about the impact of open notes on progress notes, which he calls a tool to develop strategies and make observations while working with a patient.

By watering down the language for patients, “you are trading away the technical precision and other advantages of having a professional language,” he told this news organization.

“These notes serve many masters already,” he said, referring to purposes such as utilization review and billing. “The more masters they serve, the less useful they are to get medical work done.”

Dr. MacDonald, the medical information officer, said the new law doesn’t mandate a change in writing style.

In a study published last year, researchers analyzed notes written by oncologists before and after adoption of open notes. They found that, on average, clinicians did not change their note writing. The investigators analyzed more than 100,000 clinical notes written by 35 oncologists at a single center.

Advocates for open notes emphasize that there are benefits for clinicians.

“Doctors are overworked. They’re overburdened. But empowered patients can help the doctor,” said OpenNotes’ Dr. Blease. She cited survey data that show that patients better understand their treatment plan and medication, which can cut down on physician workload.

Open notes are “what you make of it,” said Marlene Millen, MD, an internist at UC San Diego Health, which has had a pilot program for 3 years. Each day, Dr. Millen discusses a shared note with two or three patients. “I actually end all of my appointments with, ‘Don’t forget to read your note later,’ ” she told this news organization.

“I was a little afraid of this initially,” she said, but within the first 3 months of the pilot, 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.”

The persons quoted in this article have disclosed no relevant financial relationships.
 

Correction, 10/23/20: An earlier version of this article misstated the campus' location. 

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

Starting Nov. 2, all patients in the United States will have immediate access to clinical notes and thus will be able to read their doctors’ writings, as well as test results and reports from pathology and imaging.

FG Trade/iStock/Getty Images Plus

The 21st Century Cures Act mandates that patients have fast, electronic access to the following types of notes: consultations, discharge summaries, history, physical examination findings, imaging narratives, laboratory and pathology report narratives, and procedure and progress notes.

But this federal mandate, called “open notes” by many, is potentially confusing and frightening for patients, say some physicians. Others worry that the change will increase workload as clinicians tailor notes for patients and answer related questions.

The law means that inpatient and outpatient notes will be released immediately and that patients will have immediate access to testing and imaging results, including results from sexually transmitted disease tests, Pap tests, cancer biopsies, CT and PET scans, fetal ultrasounds, pneumonia cultures, and mammograms.

Such notes could contain sensitive information, and there is concern that patients could be shocked, confused, or annoyed by what they read, even with more run-of-the-mill notes.

Champions of open notes say that the benefits, including better provider-patient communication, greatly outweigh such risks.

“This is about convenience – a bit like online banking,” commented Charlotte Blease, PhD, resident scholar at OpenNotes, an advocacy nonprofit organization headquartered at the Beth Israel–Deaconess Medical Center in Boston. “But it’s a culture shift for doctors,” she said in an interview.

“It turns physician paternalism on its head,” said C. T. Lin, MD, chief medical information officer, UCHealth, Denver. The change requires “some letting go of old traditions” in medicine, he wrote in an August blog post, referring to the fact that a computer screen – and not a physician – may tell patients about a new health problem.

Dr. Lin summarized the experience at the University of Colorado Cancer Center, which has allowed patients to have access to oncology notes for the past 5 years: “No issues and highly appreciated by patients. We have nothing to fear but fear itself.”
 

A new audience

Other institutions have also been voluntarily implementing open notes.

UC Davis Health in Sacramento, Calif., has run an optional program for the past year. However, only about two dozen of approximately 1,000 staff physicians opted in to the program.

“This illustrates the point that it’s a new thing that physicians aren’t used to doing. They’ve traditionally written notes for the benefit of their colleagues, for billing, for their own reference,” Scott MacDonald, MD, an internist and electronic health record medical director at UC Davis Health, told this news organization.

“They’ve never –until recently – had the patient as one of the audiences for a note,” he said.

Liam Keating, MD, an otolaryngologist in Martinez, Calif., recalls that he once wrote “globus hystericus,” and the patient wanted to sue him for saying that the patient was hysterical. “I now just code ‘Globus’ (if I don’t jump straight to LPD [lateral pharyngeal diverticulum]),” he commented in response to a commentary on open notes.

Sensitive information occurs more often in certain specialties, for example, psychiatry, genetics, adolescent medicine, and oncology, experts say.

“Cancer is an area that is highly charged for patients and doctors alike,” Dr. MacDonald pointed out. When reading pathology or imaging notes, patients may learn that they have been diagnosed with cancer or that they have a recurrence “without the physician being able to contextualize it and explain things – that’s just new and scary,” he said.

California law dictates that providers cannot post cancer test results without talking with the patient first, said Dr. MacDonald, but not all states have such laws.
 

Adjustments needed – or not – with open notes

At UCHealth in Aurora, Colo., Robert Breeze, MD, vice-chair of neurosurgery, said he has adjusted his practice to accommodate open notes and to anticipate trouble spots.*

“When I order imaging or send pathology specimens, I have already discussed with the patient the possibilities, including cancer, and what we will do next. Patients deeply appreciate these discussions, before they see the results,” he commented in an institutional white paper issued in anticipation of the changes on Nov. 2.

This is called precounseling, said Trent Rosenbloom, MD, MPH, director of patient portals at Vanderbilt University Medical Center, Nashville, Tenn., which has been a pioneer in information sharing with patients. Their system does delay the release of information in the case of “complicated” results, such as from cancer biopsies, he said in an interview.

However, Christiaan Hoff, MD, PhD, a surgeon at the Medical Center Leeuwarden (the Netherlands), wonders how important it is for the physician to be present when the patient receives bad news, including news about cancer. “We may overestimate our added value in these situations,” he suggested.

“Our empathy may not outweigh” the disadvantages of the situation, and the “finer points of our explanation will often go unnoticed” by the stressed patient, he commented. Dr. Hoff was also responding to the commentary about open notes.

In that commentary, Jack West, MD, a medical oncologist at City of Hope Cancer Center, Duarte, Calif., was concerned about misunderstandings. Oncology is complex, and patients can struggle to understand their prognosis and planned treatment efficacy, especially in cases of metastatic disease, he wrote.

This concern is somewhat refuted by a study published Oct. 5 in Cancer Cell. Responses to two surveys involving 96 oncology clinicians at three U.S. centers found that almost half (44%) believed that their patients “would be confused” by open notes.

However, only 4% of the 3,418 cancer patients from the same surveys reported being confused by open notes. (A majority of participants had more than a high school education, and English was their primary language.)

“Patient and clinician views about open notes in oncology are not aligned, with patients expressing considerably more enthusiasm,” wrote the authors, led by Liz Salmi, senior strategist at OpenNotes, who has been treated for brain cancer.

“All clinicians are anxious at first,” Ms. Salmi told this news organization. “Those patients who have more serious or chronic conditions … are more likely to read their notes.”

The survey results echo the early experience reported from Sweden, where open notes was launched in 2012. “Patients have loved it from the beginning,” said Maria Haggland, PhD, of Uppsala MedTech Science Innovation Center.

However, when the scheme first launched, it was considered to be “very controversial,” and “there were a lot of complaints, from health care professionals, especially,” she added.

Over time, clinicians have embraced open notes, and the program has 7.2 million patient accounts in a country of 10 million people, she observed during an Oct. 5 webinar on open notes.
 

More work for already overworked clinicians?

An outstanding concern about open notes is that it will cause more work for health care professionals.

Traditionally, doctors have written notes using medical lexicon, including a lot of abbreviations and jargon for efficiency’s sake. Now that patients will read the notes, will clinicians have to spell out things in lay terms, alter their writing so as not to offend, and generally do more work?

William Harvey, MD, chief medical information officer, Tufts Medical Center, Boston, acknowledged that that may be the case.

In a forthcoming note to staff about the Nov. 2 start of open notes, Dr. Harvey will include a reminder to accommodate the patient as a reader. But that may or may not mean an increase in work volume, depending on the provider. “Clinical note writing is highly personal. There’s an art to it,” he said in an interview. “So it’s hard to give standard advice.”

Steven Reidbord, MD, a psychiatrist in private practice in San Francisco and a lecturer at California Pacific Medical Center, is particularly concerned about the impact of open notes on progress notes, which he calls a tool to develop strategies and make observations while working with a patient.

By watering down the language for patients, “you are trading away the technical precision and other advantages of having a professional language,” he told this news organization.

“These notes serve many masters already,” he said, referring to purposes such as utilization review and billing. “The more masters they serve, the less useful they are to get medical work done.”

Dr. MacDonald, the medical information officer, said the new law doesn’t mandate a change in writing style.

In a study published last year, researchers analyzed notes written by oncologists before and after adoption of open notes. They found that, on average, clinicians did not change their note writing. The investigators analyzed more than 100,000 clinical notes written by 35 oncologists at a single center.

Advocates for open notes emphasize that there are benefits for clinicians.

“Doctors are overworked. They’re overburdened. But empowered patients can help the doctor,” said OpenNotes’ Dr. Blease. She cited survey data that show that patients better understand their treatment plan and medication, which can cut down on physician workload.

Open notes are “what you make of it,” said Marlene Millen, MD, an internist at UC San Diego Health, which has had a pilot program for 3 years. Each day, Dr. Millen discusses a shared note with two or three patients. “I actually end all of my appointments with, ‘Don’t forget to read your note later,’ ” she told this news organization.

“I was a little afraid of this initially,” she said, but within the first 3 months of the pilot, 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.”

The persons quoted in this article have disclosed no relevant financial relationships.
 

Correction, 10/23/20: An earlier version of this article misstated the campus' location. 

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

Starting Nov. 2, all patients in the United States will have immediate access to clinical notes and thus will be able to read their doctors’ writings, as well as test results and reports from pathology and imaging.

FG Trade/iStock/Getty Images Plus

The 21st Century Cures Act mandates that patients have fast, electronic access to the following types of notes: consultations, discharge summaries, history, physical examination findings, imaging narratives, laboratory and pathology report narratives, and procedure and progress notes.

But this federal mandate, called “open notes” by many, is potentially confusing and frightening for patients, say some physicians. Others worry that the change will increase workload as clinicians tailor notes for patients and answer related questions.

The law means that inpatient and outpatient notes will be released immediately and that patients will have immediate access to testing and imaging results, including results from sexually transmitted disease tests, Pap tests, cancer biopsies, CT and PET scans, fetal ultrasounds, pneumonia cultures, and mammograms.

Such notes could contain sensitive information, and there is concern that patients could be shocked, confused, or annoyed by what they read, even with more run-of-the-mill notes.

Champions of open notes say that the benefits, including better provider-patient communication, greatly outweigh such risks.

“This is about convenience – a bit like online banking,” commented Charlotte Blease, PhD, resident scholar at OpenNotes, an advocacy nonprofit organization headquartered at the Beth Israel–Deaconess Medical Center in Boston. “But it’s a culture shift for doctors,” she said in an interview.

“It turns physician paternalism on its head,” said C. T. Lin, MD, chief medical information officer, UCHealth, Denver. The change requires “some letting go of old traditions” in medicine, he wrote in an August blog post, referring to the fact that a computer screen – and not a physician – may tell patients about a new health problem.

Dr. Lin summarized the experience at the University of Colorado Cancer Center, which has allowed patients to have access to oncology notes for the past 5 years: “No issues and highly appreciated by patients. We have nothing to fear but fear itself.”
 

A new audience

Other institutions have also been voluntarily implementing open notes.

UC Davis Health in Sacramento, Calif., has run an optional program for the past year. However, only about two dozen of approximately 1,000 staff physicians opted in to the program.

“This illustrates the point that it’s a new thing that physicians aren’t used to doing. They’ve traditionally written notes for the benefit of their colleagues, for billing, for their own reference,” Scott MacDonald, MD, an internist and electronic health record medical director at UC Davis Health, told this news organization.

“They’ve never –until recently – had the patient as one of the audiences for a note,” he said.

Liam Keating, MD, an otolaryngologist in Martinez, Calif., recalls that he once wrote “globus hystericus,” and the patient wanted to sue him for saying that the patient was hysterical. “I now just code ‘Globus’ (if I don’t jump straight to LPD [lateral pharyngeal diverticulum]),” he commented in response to a commentary on open notes.

Sensitive information occurs more often in certain specialties, for example, psychiatry, genetics, adolescent medicine, and oncology, experts say.

“Cancer is an area that is highly charged for patients and doctors alike,” Dr. MacDonald pointed out. When reading pathology or imaging notes, patients may learn that they have been diagnosed with cancer or that they have a recurrence “without the physician being able to contextualize it and explain things – that’s just new and scary,” he said.

California law dictates that providers cannot post cancer test results without talking with the patient first, said Dr. MacDonald, but not all states have such laws.
 

Adjustments needed – or not – with open notes

At UCHealth in Aurora, Colo., Robert Breeze, MD, vice-chair of neurosurgery, said he has adjusted his practice to accommodate open notes and to anticipate trouble spots.*

“When I order imaging or send pathology specimens, I have already discussed with the patient the possibilities, including cancer, and what we will do next. Patients deeply appreciate these discussions, before they see the results,” he commented in an institutional white paper issued in anticipation of the changes on Nov. 2.

This is called precounseling, said Trent Rosenbloom, MD, MPH, director of patient portals at Vanderbilt University Medical Center, Nashville, Tenn., which has been a pioneer in information sharing with patients. Their system does delay the release of information in the case of “complicated” results, such as from cancer biopsies, he said in an interview.

However, Christiaan Hoff, MD, PhD, a surgeon at the Medical Center Leeuwarden (the Netherlands), wonders how important it is for the physician to be present when the patient receives bad news, including news about cancer. “We may overestimate our added value in these situations,” he suggested.

“Our empathy may not outweigh” the disadvantages of the situation, and the “finer points of our explanation will often go unnoticed” by the stressed patient, he commented. Dr. Hoff was also responding to the commentary about open notes.

In that commentary, Jack West, MD, a medical oncologist at City of Hope Cancer Center, Duarte, Calif., was concerned about misunderstandings. Oncology is complex, and patients can struggle to understand their prognosis and planned treatment efficacy, especially in cases of metastatic disease, he wrote.

This concern is somewhat refuted by a study published Oct. 5 in Cancer Cell. Responses to two surveys involving 96 oncology clinicians at three U.S. centers found that almost half (44%) believed that their patients “would be confused” by open notes.

However, only 4% of the 3,418 cancer patients from the same surveys reported being confused by open notes. (A majority of participants had more than a high school education, and English was their primary language.)

“Patient and clinician views about open notes in oncology are not aligned, with patients expressing considerably more enthusiasm,” wrote the authors, led by Liz Salmi, senior strategist at OpenNotes, who has been treated for brain cancer.

“All clinicians are anxious at first,” Ms. Salmi told this news organization. “Those patients who have more serious or chronic conditions … are more likely to read their notes.”

The survey results echo the early experience reported from Sweden, where open notes was launched in 2012. “Patients have loved it from the beginning,” said Maria Haggland, PhD, of Uppsala MedTech Science Innovation Center.

However, when the scheme first launched, it was considered to be “very controversial,” and “there were a lot of complaints, from health care professionals, especially,” she added.

Over time, clinicians have embraced open notes, and the program has 7.2 million patient accounts in a country of 10 million people, she observed during an Oct. 5 webinar on open notes.
 

More work for already overworked clinicians?

An outstanding concern about open notes is that it will cause more work for health care professionals.

Traditionally, doctors have written notes using medical lexicon, including a lot of abbreviations and jargon for efficiency’s sake. Now that patients will read the notes, will clinicians have to spell out things in lay terms, alter their writing so as not to offend, and generally do more work?

William Harvey, MD, chief medical information officer, Tufts Medical Center, Boston, acknowledged that that may be the case.

In a forthcoming note to staff about the Nov. 2 start of open notes, Dr. Harvey will include a reminder to accommodate the patient as a reader. But that may or may not mean an increase in work volume, depending on the provider. “Clinical note writing is highly personal. There’s an art to it,” he said in an interview. “So it’s hard to give standard advice.”

Steven Reidbord, MD, a psychiatrist in private practice in San Francisco and a lecturer at California Pacific Medical Center, is particularly concerned about the impact of open notes on progress notes, which he calls a tool to develop strategies and make observations while working with a patient.

By watering down the language for patients, “you are trading away the technical precision and other advantages of having a professional language,” he told this news organization.

“These notes serve many masters already,” he said, referring to purposes such as utilization review and billing. “The more masters they serve, the less useful they are to get medical work done.”

Dr. MacDonald, the medical information officer, said the new law doesn’t mandate a change in writing style.

In a study published last year, researchers analyzed notes written by oncologists before and after adoption of open notes. They found that, on average, clinicians did not change their note writing. The investigators analyzed more than 100,000 clinical notes written by 35 oncologists at a single center.

Advocates for open notes emphasize that there are benefits for clinicians.

“Doctors are overworked. They’re overburdened. But empowered patients can help the doctor,” said OpenNotes’ Dr. Blease. She cited survey data that show that patients better understand their treatment plan and medication, which can cut down on physician workload.

Open notes are “what you make of it,” said Marlene Millen, MD, an internist at UC San Diego Health, which has had a pilot program for 3 years. Each day, Dr. Millen discusses a shared note with two or three patients. “I actually end all of my appointments with, ‘Don’t forget to read your note later,’ ” she told this news organization.

“I was a little afraid of this initially,” she said, but within the first 3 months of the pilot, 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.”

The persons quoted in this article have disclosed no relevant financial relationships.
 

Correction, 10/23/20: An earlier version of this article misstated the campus' location. 

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