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Cloth masks provide inferior protection vs. medical masks, suggests evidence review
according to an evidence review published Jan. 11 in Annals of Family Medicine.
Nevertheless, cloth masks may provide some degree of protection, filtration studies indicate. If clinicians use cloth masks, they should take into account the fit, material, and number of layers, the review authors wrote.
And if cloth masks are used as a last resort, such as during shortages of personal protective equipment (PPE), additional measures may help, such as pairing cloth masks with plastic face shields.
“We recommend frequent cloth mask changes to reduce the risk of moisture retention and washing according to hospital laundry standards to decrease the risk of ineffective cleaning,” review author Ariel Kiyomi Daoud, a researcher at the University of Colorado at Denver, Aurora, and colleagues wrote.
The investigators identified and analyzed nine studies related to cloth masks’ ability to prevent respiratory viral infections among health care clinicians. The studies generally were not specific to SARS-CoV-2. They focused on four nonrandomized trials, three laboratory efficacy studies, one single-case experiment, and one randomized controlled trial.
Filtration and fit
“Seven publications addressed the filtration efficacy of commercial cloth masks or materials used to create homemade masks ... in a laboratory setting,” the researchers wrote. These studies found that cloth materials prevent some level of penetration, but generally have “lesser filtration efficiency and greater variability than medical masks” do.
One study found that the materials with the greatest filtration efficacy – vacuum bags and tea towels – had low airflow, which limits their use.
Two studies found that additional layers may increase the viral filtration efficacy of cloth masks.
Several studies that assessed mask fit and airflow found that cloth masks “have worse fit and a greater level of particle leakage, compared to medical masks,” the authors reported. Most studies did not examine cloth masks’ ability to protect wearers from respiratory droplets or contact, which the World Health Organization consider the primary means of SARS-CoV-2 spread, with aerosols playing a smaller role. “Thus, we must interpret these results with caution in the context of COVID-19,” the authors wrote. “For a primary care clinician without access to medical masks, our qualitative synthesis of the literature suggests that it is better to wear a cloth mask than no mask,” as long as other protective measures are considered along with cloth mask use.
Generally consistent guidance
Agencies and researchers have shared similar recommendations about the use of cloth masks in health care settings.
“Health care workers are at the frontline and they need to be protected,” said Abrar Ahmad Chughtai, MBBS, MPH, PhD, an epidemiologist at University of New South Wales, Sydney, in an interview. “Many studies show that respirators are more effective, compared to medical masks, and medical masks are more effective, compared to cloth masks. So ideally, all frontline health care workers should use respirators. If respirators are not available, then medical masks should be used. Cloth masks are not as effective as medical masks and ideally should not be used in health care settings.”
Dr. Chughtai has written about cloth masks for protection against SARS-CoV-2 and was an investigator for a 2015 randomized trial that compared medical masks and cloth masks in health care workers.
In that trial, which was considered in the review, greater rates of influenza-like illness occurred in the cloth mask arm, compared with the medical mask arm.
“Studies show that three or more layers of cloth may reduce the spread of droplets and aerosols from the wearers,” Dr. Chughtai said. “So, cloth masks may be used in community settings to prevent spread of infections from the sick, particularly asymptomatic, people.”
In addition, cloth masks “may be used by health care workers as a last resort, if no other option is available,” he said. In that case, they should have at least three layers, fit to the face, and be washed regularly.
Not considered PPE
According to routine infection prevention and control recommendations for health care personnel from the Centers for Disease Control and Prevention, face masks – often referred to as surgical masks or procedure masks – should be worn by workers “at all times while they are in the healthcare facility, including in break rooms or other spaces where they might encounter coworkers.”
Unlike cloth masks, face masks offer “protection for the wearer against exposure to splashes and sprays of infectious material from others,” as well as source control, the agency says. Health care personnel “should remove their respirator or face mask, perform hand hygiene, and put on their cloth mask when leaving the facility at the end of their shift,” according to the CDC.
“Cloth masks are NOT PPE and should not be worn for the care of patients with suspected or confirmed COVID-19 or other situations where use of a respirator or face mask is recommended,” the agency notes.
When respirators or face masks are unavailable, health care personnel “might use cloth masks as a last resort for care of patients with suspected or confirmed diagnosis for which face mask or respirator use is normally recommended,” according to CDC guidance.
In that scenario, cloth masks “should ideally be used in combination with a face shield that covers the entire front (that extends to the chin or below) and sides of the face,” the CDC says.
Limited data for comparisons
A Dec. 29, 2020, update in Annals of Internal Medicine about masks for prevention of respiratory virus infections highlighted two recent studies in the United States that reported on mask use in health care settings. A study of more than 16,000 health care workers and first responders found that those who used an N95 or surgical mask all of the time were less likely to have SARS-CoV-2 antibodies, compared with workers who did not wear masks all the time. The adjusted odds ratio with consistent N95 use was 0.83, and the aOR with consistent surgical mask use was 0.86.
In the second study, which included more than 20,000 asymptomatic health care workers, risk for infection was reduced with any mask use versus no mask use (OR, 0.58). An N95 mask was associated with decreased risk versus a surgical mask (OR, 0.76). The studies had methodological limitations, however, and “evidence for various comparisons about mask use in health care settings and risk for SARS-CoV-2 remains insufficient,” the authors of the update wrote.
The Annals of Family Medicine review authors had no relevant disclosures. Dr. Chughtai has tested filtration of 3M masks and worked with CleanSpace Technology to research fit testing of respirators, and the 2015 randomized trial was funded by an Australian Research Council Linkage Grant with 3M as a partner on the grant. The Dec. 29, 2020, update was of a review that originally was supported by grants from the Agency for Healthcare Research Quality.
SOURCE: Daoud AK et al. Ann Fam Med. 2020 Jan 11. doi: 10.1370/afm.2640.
according to an evidence review published Jan. 11 in Annals of Family Medicine.
Nevertheless, cloth masks may provide some degree of protection, filtration studies indicate. If clinicians use cloth masks, they should take into account the fit, material, and number of layers, the review authors wrote.
And if cloth masks are used as a last resort, such as during shortages of personal protective equipment (PPE), additional measures may help, such as pairing cloth masks with plastic face shields.
“We recommend frequent cloth mask changes to reduce the risk of moisture retention and washing according to hospital laundry standards to decrease the risk of ineffective cleaning,” review author Ariel Kiyomi Daoud, a researcher at the University of Colorado at Denver, Aurora, and colleagues wrote.
The investigators identified and analyzed nine studies related to cloth masks’ ability to prevent respiratory viral infections among health care clinicians. The studies generally were not specific to SARS-CoV-2. They focused on four nonrandomized trials, three laboratory efficacy studies, one single-case experiment, and one randomized controlled trial.
Filtration and fit
“Seven publications addressed the filtration efficacy of commercial cloth masks or materials used to create homemade masks ... in a laboratory setting,” the researchers wrote. These studies found that cloth materials prevent some level of penetration, but generally have “lesser filtration efficiency and greater variability than medical masks” do.
One study found that the materials with the greatest filtration efficacy – vacuum bags and tea towels – had low airflow, which limits their use.
Two studies found that additional layers may increase the viral filtration efficacy of cloth masks.
Several studies that assessed mask fit and airflow found that cloth masks “have worse fit and a greater level of particle leakage, compared to medical masks,” the authors reported. Most studies did not examine cloth masks’ ability to protect wearers from respiratory droplets or contact, which the World Health Organization consider the primary means of SARS-CoV-2 spread, with aerosols playing a smaller role. “Thus, we must interpret these results with caution in the context of COVID-19,” the authors wrote. “For a primary care clinician without access to medical masks, our qualitative synthesis of the literature suggests that it is better to wear a cloth mask than no mask,” as long as other protective measures are considered along with cloth mask use.
Generally consistent guidance
Agencies and researchers have shared similar recommendations about the use of cloth masks in health care settings.
“Health care workers are at the frontline and they need to be protected,” said Abrar Ahmad Chughtai, MBBS, MPH, PhD, an epidemiologist at University of New South Wales, Sydney, in an interview. “Many studies show that respirators are more effective, compared to medical masks, and medical masks are more effective, compared to cloth masks. So ideally, all frontline health care workers should use respirators. If respirators are not available, then medical masks should be used. Cloth masks are not as effective as medical masks and ideally should not be used in health care settings.”
Dr. Chughtai has written about cloth masks for protection against SARS-CoV-2 and was an investigator for a 2015 randomized trial that compared medical masks and cloth masks in health care workers.
In that trial, which was considered in the review, greater rates of influenza-like illness occurred in the cloth mask arm, compared with the medical mask arm.
“Studies show that three or more layers of cloth may reduce the spread of droplets and aerosols from the wearers,” Dr. Chughtai said. “So, cloth masks may be used in community settings to prevent spread of infections from the sick, particularly asymptomatic, people.”
In addition, cloth masks “may be used by health care workers as a last resort, if no other option is available,” he said. In that case, they should have at least three layers, fit to the face, and be washed regularly.
Not considered PPE
According to routine infection prevention and control recommendations for health care personnel from the Centers for Disease Control and Prevention, face masks – often referred to as surgical masks or procedure masks – should be worn by workers “at all times while they are in the healthcare facility, including in break rooms or other spaces where they might encounter coworkers.”
Unlike cloth masks, face masks offer “protection for the wearer against exposure to splashes and sprays of infectious material from others,” as well as source control, the agency says. Health care personnel “should remove their respirator or face mask, perform hand hygiene, and put on their cloth mask when leaving the facility at the end of their shift,” according to the CDC.
“Cloth masks are NOT PPE and should not be worn for the care of patients with suspected or confirmed COVID-19 or other situations where use of a respirator or face mask is recommended,” the agency notes.
When respirators or face masks are unavailable, health care personnel “might use cloth masks as a last resort for care of patients with suspected or confirmed diagnosis for which face mask or respirator use is normally recommended,” according to CDC guidance.
In that scenario, cloth masks “should ideally be used in combination with a face shield that covers the entire front (that extends to the chin or below) and sides of the face,” the CDC says.
Limited data for comparisons
A Dec. 29, 2020, update in Annals of Internal Medicine about masks for prevention of respiratory virus infections highlighted two recent studies in the United States that reported on mask use in health care settings. A study of more than 16,000 health care workers and first responders found that those who used an N95 or surgical mask all of the time were less likely to have SARS-CoV-2 antibodies, compared with workers who did not wear masks all the time. The adjusted odds ratio with consistent N95 use was 0.83, and the aOR with consistent surgical mask use was 0.86.
In the second study, which included more than 20,000 asymptomatic health care workers, risk for infection was reduced with any mask use versus no mask use (OR, 0.58). An N95 mask was associated with decreased risk versus a surgical mask (OR, 0.76). The studies had methodological limitations, however, and “evidence for various comparisons about mask use in health care settings and risk for SARS-CoV-2 remains insufficient,” the authors of the update wrote.
The Annals of Family Medicine review authors had no relevant disclosures. Dr. Chughtai has tested filtration of 3M masks and worked with CleanSpace Technology to research fit testing of respirators, and the 2015 randomized trial was funded by an Australian Research Council Linkage Grant with 3M as a partner on the grant. The Dec. 29, 2020, update was of a review that originally was supported by grants from the Agency for Healthcare Research Quality.
SOURCE: Daoud AK et al. Ann Fam Med. 2020 Jan 11. doi: 10.1370/afm.2640.
according to an evidence review published Jan. 11 in Annals of Family Medicine.
Nevertheless, cloth masks may provide some degree of protection, filtration studies indicate. If clinicians use cloth masks, they should take into account the fit, material, and number of layers, the review authors wrote.
And if cloth masks are used as a last resort, such as during shortages of personal protective equipment (PPE), additional measures may help, such as pairing cloth masks with plastic face shields.
“We recommend frequent cloth mask changes to reduce the risk of moisture retention and washing according to hospital laundry standards to decrease the risk of ineffective cleaning,” review author Ariel Kiyomi Daoud, a researcher at the University of Colorado at Denver, Aurora, and colleagues wrote.
The investigators identified and analyzed nine studies related to cloth masks’ ability to prevent respiratory viral infections among health care clinicians. The studies generally were not specific to SARS-CoV-2. They focused on four nonrandomized trials, three laboratory efficacy studies, one single-case experiment, and one randomized controlled trial.
Filtration and fit
“Seven publications addressed the filtration efficacy of commercial cloth masks or materials used to create homemade masks ... in a laboratory setting,” the researchers wrote. These studies found that cloth materials prevent some level of penetration, but generally have “lesser filtration efficiency and greater variability than medical masks” do.
One study found that the materials with the greatest filtration efficacy – vacuum bags and tea towels – had low airflow, which limits their use.
Two studies found that additional layers may increase the viral filtration efficacy of cloth masks.
Several studies that assessed mask fit and airflow found that cloth masks “have worse fit and a greater level of particle leakage, compared to medical masks,” the authors reported. Most studies did not examine cloth masks’ ability to protect wearers from respiratory droplets or contact, which the World Health Organization consider the primary means of SARS-CoV-2 spread, with aerosols playing a smaller role. “Thus, we must interpret these results with caution in the context of COVID-19,” the authors wrote. “For a primary care clinician without access to medical masks, our qualitative synthesis of the literature suggests that it is better to wear a cloth mask than no mask,” as long as other protective measures are considered along with cloth mask use.
Generally consistent guidance
Agencies and researchers have shared similar recommendations about the use of cloth masks in health care settings.
“Health care workers are at the frontline and they need to be protected,” said Abrar Ahmad Chughtai, MBBS, MPH, PhD, an epidemiologist at University of New South Wales, Sydney, in an interview. “Many studies show that respirators are more effective, compared to medical masks, and medical masks are more effective, compared to cloth masks. So ideally, all frontline health care workers should use respirators. If respirators are not available, then medical masks should be used. Cloth masks are not as effective as medical masks and ideally should not be used in health care settings.”
Dr. Chughtai has written about cloth masks for protection against SARS-CoV-2 and was an investigator for a 2015 randomized trial that compared medical masks and cloth masks in health care workers.
In that trial, which was considered in the review, greater rates of influenza-like illness occurred in the cloth mask arm, compared with the medical mask arm.
“Studies show that three or more layers of cloth may reduce the spread of droplets and aerosols from the wearers,” Dr. Chughtai said. “So, cloth masks may be used in community settings to prevent spread of infections from the sick, particularly asymptomatic, people.”
In addition, cloth masks “may be used by health care workers as a last resort, if no other option is available,” he said. In that case, they should have at least three layers, fit to the face, and be washed regularly.
Not considered PPE
According to routine infection prevention and control recommendations for health care personnel from the Centers for Disease Control and Prevention, face masks – often referred to as surgical masks or procedure masks – should be worn by workers “at all times while they are in the healthcare facility, including in break rooms or other spaces where they might encounter coworkers.”
Unlike cloth masks, face masks offer “protection for the wearer against exposure to splashes and sprays of infectious material from others,” as well as source control, the agency says. Health care personnel “should remove their respirator or face mask, perform hand hygiene, and put on their cloth mask when leaving the facility at the end of their shift,” according to the CDC.
“Cloth masks are NOT PPE and should not be worn for the care of patients with suspected or confirmed COVID-19 or other situations where use of a respirator or face mask is recommended,” the agency notes.
When respirators or face masks are unavailable, health care personnel “might use cloth masks as a last resort for care of patients with suspected or confirmed diagnosis for which face mask or respirator use is normally recommended,” according to CDC guidance.
In that scenario, cloth masks “should ideally be used in combination with a face shield that covers the entire front (that extends to the chin or below) and sides of the face,” the CDC says.
Limited data for comparisons
A Dec. 29, 2020, update in Annals of Internal Medicine about masks for prevention of respiratory virus infections highlighted two recent studies in the United States that reported on mask use in health care settings. A study of more than 16,000 health care workers and first responders found that those who used an N95 or surgical mask all of the time were less likely to have SARS-CoV-2 antibodies, compared with workers who did not wear masks all the time. The adjusted odds ratio with consistent N95 use was 0.83, and the aOR with consistent surgical mask use was 0.86.
In the second study, which included more than 20,000 asymptomatic health care workers, risk for infection was reduced with any mask use versus no mask use (OR, 0.58). An N95 mask was associated with decreased risk versus a surgical mask (OR, 0.76). The studies had methodological limitations, however, and “evidence for various comparisons about mask use in health care settings and risk for SARS-CoV-2 remains insufficient,” the authors of the update wrote.
The Annals of Family Medicine review authors had no relevant disclosures. Dr. Chughtai has tested filtration of 3M masks and worked with CleanSpace Technology to research fit testing of respirators, and the 2015 randomized trial was funded by an Australian Research Council Linkage Grant with 3M as a partner on the grant. The Dec. 29, 2020, update was of a review that originally was supported by grants from the Agency for Healthcare Research Quality.
SOURCE: Daoud AK et al. Ann Fam Med. 2020 Jan 11. doi: 10.1370/afm.2640.
FROM ANNALS OF FAMILY MEDICINE
Feds authorize $3 billion to boost vaccine rollout
The CDC will send $3 billion to the states to boost a lagging national COVID-19 vaccination program.
The Department of Health and Human Services announced the new funding as only 30% of the more than 22 million doses of vaccine distributed in the U.S. has been injected into Americans’ arms.
Along with the $3 billion, HHS said another $19 billion is headed to states and jurisdictions to boost COVID-19 testing programs. The amount each state will receive will be determined by population.
The news comes days after President-elect Joe Biden said he planned to release all available doses of vaccine after he takes office on Jan. 20. The Trump administration has been holding back millions of doses to ensure supply of vaccine to provide the necessary second dose for those who received the first shot.
“This funding is another timely investment that will strengthen our nation’s efforts to stop the COVID-19 pandemic in America,” CDC Director Robert Redfield, MD, said in a statement. “Particularly now, it is crucial that states and communities have the resources they need to conduct testing, and to distribute and administer safe, high-quality COVID-19 vaccines safely and equitably.”
Federal officials and public health experts, however, expressed concerns this weekend about Biden’s plan.
Outgoing Trump administration officials and others said they worry that doing so will leave providers without enough second doses for people getting the two-shot vaccines.
If Biden releases all available doses and the vaccine-making process has an issue, they said, that could pose a supply risk.
“We have product that is going through QC right now – quality control – for sterility, identity check that we have tens and tens of millions of product. We always will. But batches fail. Sterility fails ... and then you don’t have a product for that second dose,” Alex Azar, secretary of health and human services, told the American Hospital Association on Jan. 8, according to CNN.
“And frankly, talking about that or encouraging that can really undermine a critical public health need, which is that people come back for their second vaccine,” he said.
One of the main roadblocks in the vaccine rollout has been administering the doses that have already been distributed. The U.S. has shipped 22.1 million doses, and 6.6 million first shots have been given, according to the latest CDC data updated Jan. 8. Mr. Azar and other federal health officials have encouraged states to use their current supply and expand vaccine access to more priority groups.
“We would be delighted to learn that jurisdictions have actually administered many more doses than they are presently reporting,” a spokesman for the U.S. Department of Health and Human Services told CNN. “We are encouraging jurisdictions to expand their priority groups as needed to ensure no vaccine is sitting on the shelf after having been delivered to the jurisdiction-directed locations.”
Releasing more vaccines for first doses could create ethical concerns as well, since people getting vaccines expect to get a second dose in the proper amount of time, according to The Week. Biden’s transition team said on Jan. 8 that he won’t delay the second dose but, instead, plans to ramp up production to stay on track.
To do this well, the federal government should create a coordinated vaccine strategy that sets expectations for an around-the-clock operation and help state and local vaccination programs meet their goals, Leana Wen, MD, a professor at George Washington University, wrote in an editorial for The Washington Post.
“The Biden team’s urgency around vaccinations is commendable,” she added in a Twitter post on Jan. 11. “I’d like to see a guarantee that every 1st dose given will be followed with a timely 2nd dose. Otherwise, there are ethical concerns that could add to vaccine hesitancy.”
Biden has pledged that 100 million doses will be administered in his first 100 days in office. He has grown frustrated as concerns grow that his administration could fall short of the promise, according to Politico. His coronavirus response team has noted several challenges, including what they say is a lack of long-term planning by the Trump administration and an initial refusal to share key information.
“We’re uncovering new information each day, and we’re unearthing – of course – more work to be done,” Vivek Murthy, MD, Biden’s nominee for surgeon general, told Politico.
The team has uncovered staffing shortages, technology problems, and issues with health care insurance coverage. The incoming Biden team has developed several initiatives, such as mobile vaccination units and new federal sites to give shots. It could take weeks to get the vaccine rollout on track, the news outlet reported.
“Will this be challenging? Absolutely,” Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases and Biden’s incoming chief medical adviser on the coronavirus, told Politico. “This is an unprecedented effort to vaccinate the entire country over a period of time that’s fighting against people dying at record numbers. To say it’s not a challenge would be unrealistic. Do I think it can be done? Yes.”
A version of this article first appeared on WebMD.com.
The CDC will send $3 billion to the states to boost a lagging national COVID-19 vaccination program.
The Department of Health and Human Services announced the new funding as only 30% of the more than 22 million doses of vaccine distributed in the U.S. has been injected into Americans’ arms.
Along with the $3 billion, HHS said another $19 billion is headed to states and jurisdictions to boost COVID-19 testing programs. The amount each state will receive will be determined by population.
The news comes days after President-elect Joe Biden said he planned to release all available doses of vaccine after he takes office on Jan. 20. The Trump administration has been holding back millions of doses to ensure supply of vaccine to provide the necessary second dose for those who received the first shot.
“This funding is another timely investment that will strengthen our nation’s efforts to stop the COVID-19 pandemic in America,” CDC Director Robert Redfield, MD, said in a statement. “Particularly now, it is crucial that states and communities have the resources they need to conduct testing, and to distribute and administer safe, high-quality COVID-19 vaccines safely and equitably.”
Federal officials and public health experts, however, expressed concerns this weekend about Biden’s plan.
Outgoing Trump administration officials and others said they worry that doing so will leave providers without enough second doses for people getting the two-shot vaccines.
If Biden releases all available doses and the vaccine-making process has an issue, they said, that could pose a supply risk.
“We have product that is going through QC right now – quality control – for sterility, identity check that we have tens and tens of millions of product. We always will. But batches fail. Sterility fails ... and then you don’t have a product for that second dose,” Alex Azar, secretary of health and human services, told the American Hospital Association on Jan. 8, according to CNN.
“And frankly, talking about that or encouraging that can really undermine a critical public health need, which is that people come back for their second vaccine,” he said.
One of the main roadblocks in the vaccine rollout has been administering the doses that have already been distributed. The U.S. has shipped 22.1 million doses, and 6.6 million first shots have been given, according to the latest CDC data updated Jan. 8. Mr. Azar and other federal health officials have encouraged states to use their current supply and expand vaccine access to more priority groups.
“We would be delighted to learn that jurisdictions have actually administered many more doses than they are presently reporting,” a spokesman for the U.S. Department of Health and Human Services told CNN. “We are encouraging jurisdictions to expand their priority groups as needed to ensure no vaccine is sitting on the shelf after having been delivered to the jurisdiction-directed locations.”
Releasing more vaccines for first doses could create ethical concerns as well, since people getting vaccines expect to get a second dose in the proper amount of time, according to The Week. Biden’s transition team said on Jan. 8 that he won’t delay the second dose but, instead, plans to ramp up production to stay on track.
To do this well, the federal government should create a coordinated vaccine strategy that sets expectations for an around-the-clock operation and help state and local vaccination programs meet their goals, Leana Wen, MD, a professor at George Washington University, wrote in an editorial for The Washington Post.
“The Biden team’s urgency around vaccinations is commendable,” she added in a Twitter post on Jan. 11. “I’d like to see a guarantee that every 1st dose given will be followed with a timely 2nd dose. Otherwise, there are ethical concerns that could add to vaccine hesitancy.”
Biden has pledged that 100 million doses will be administered in his first 100 days in office. He has grown frustrated as concerns grow that his administration could fall short of the promise, according to Politico. His coronavirus response team has noted several challenges, including what they say is a lack of long-term planning by the Trump administration and an initial refusal to share key information.
“We’re uncovering new information each day, and we’re unearthing – of course – more work to be done,” Vivek Murthy, MD, Biden’s nominee for surgeon general, told Politico.
The team has uncovered staffing shortages, technology problems, and issues with health care insurance coverage. The incoming Biden team has developed several initiatives, such as mobile vaccination units and new federal sites to give shots. It could take weeks to get the vaccine rollout on track, the news outlet reported.
“Will this be challenging? Absolutely,” Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases and Biden’s incoming chief medical adviser on the coronavirus, told Politico. “This is an unprecedented effort to vaccinate the entire country over a period of time that’s fighting against people dying at record numbers. To say it’s not a challenge would be unrealistic. Do I think it can be done? Yes.”
A version of this article first appeared on WebMD.com.
The CDC will send $3 billion to the states to boost a lagging national COVID-19 vaccination program.
The Department of Health and Human Services announced the new funding as only 30% of the more than 22 million doses of vaccine distributed in the U.S. has been injected into Americans’ arms.
Along with the $3 billion, HHS said another $19 billion is headed to states and jurisdictions to boost COVID-19 testing programs. The amount each state will receive will be determined by population.
The news comes days after President-elect Joe Biden said he planned to release all available doses of vaccine after he takes office on Jan. 20. The Trump administration has been holding back millions of doses to ensure supply of vaccine to provide the necessary second dose for those who received the first shot.
“This funding is another timely investment that will strengthen our nation’s efforts to stop the COVID-19 pandemic in America,” CDC Director Robert Redfield, MD, said in a statement. “Particularly now, it is crucial that states and communities have the resources they need to conduct testing, and to distribute and administer safe, high-quality COVID-19 vaccines safely and equitably.”
Federal officials and public health experts, however, expressed concerns this weekend about Biden’s plan.
Outgoing Trump administration officials and others said they worry that doing so will leave providers without enough second doses for people getting the two-shot vaccines.
If Biden releases all available doses and the vaccine-making process has an issue, they said, that could pose a supply risk.
“We have product that is going through QC right now – quality control – for sterility, identity check that we have tens and tens of millions of product. We always will. But batches fail. Sterility fails ... and then you don’t have a product for that second dose,” Alex Azar, secretary of health and human services, told the American Hospital Association on Jan. 8, according to CNN.
“And frankly, talking about that or encouraging that can really undermine a critical public health need, which is that people come back for their second vaccine,” he said.
One of the main roadblocks in the vaccine rollout has been administering the doses that have already been distributed. The U.S. has shipped 22.1 million doses, and 6.6 million first shots have been given, according to the latest CDC data updated Jan. 8. Mr. Azar and other federal health officials have encouraged states to use their current supply and expand vaccine access to more priority groups.
“We would be delighted to learn that jurisdictions have actually administered many more doses than they are presently reporting,” a spokesman for the U.S. Department of Health and Human Services told CNN. “We are encouraging jurisdictions to expand their priority groups as needed to ensure no vaccine is sitting on the shelf after having been delivered to the jurisdiction-directed locations.”
Releasing more vaccines for first doses could create ethical concerns as well, since people getting vaccines expect to get a second dose in the proper amount of time, according to The Week. Biden’s transition team said on Jan. 8 that he won’t delay the second dose but, instead, plans to ramp up production to stay on track.
To do this well, the federal government should create a coordinated vaccine strategy that sets expectations for an around-the-clock operation and help state and local vaccination programs meet their goals, Leana Wen, MD, a professor at George Washington University, wrote in an editorial for The Washington Post.
“The Biden team’s urgency around vaccinations is commendable,” she added in a Twitter post on Jan. 11. “I’d like to see a guarantee that every 1st dose given will be followed with a timely 2nd dose. Otherwise, there are ethical concerns that could add to vaccine hesitancy.”
Biden has pledged that 100 million doses will be administered in his first 100 days in office. He has grown frustrated as concerns grow that his administration could fall short of the promise, according to Politico. His coronavirus response team has noted several challenges, including what they say is a lack of long-term planning by the Trump administration and an initial refusal to share key information.
“We’re uncovering new information each day, and we’re unearthing – of course – more work to be done,” Vivek Murthy, MD, Biden’s nominee for surgeon general, told Politico.
The team has uncovered staffing shortages, technology problems, and issues with health care insurance coverage. The incoming Biden team has developed several initiatives, such as mobile vaccination units and new federal sites to give shots. It could take weeks to get the vaccine rollout on track, the news outlet reported.
“Will this be challenging? Absolutely,” Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases and Biden’s incoming chief medical adviser on the coronavirus, told Politico. “This is an unprecedented effort to vaccinate the entire country over a period of time that’s fighting against people dying at record numbers. To say it’s not a challenge would be unrealistic. Do I think it can be done? Yes.”
A version of this article first appeared on WebMD.com.
Risk of HPV-related oropharyngeal cancer linked to number of oral sex partners
Having oral sex with more than 10 previous partners was associated with a 4.3 times’ greater likelihood of developing human papillomavirus (HPV)–related oropharyngeal cancer, according to new findings.
The study also found that having more partners in a shorter period (i.e., greater oral sex intensity) and starting oral sex at a younger age were associated with higher odds of having HPV-related cancer of the mouth and throat.
The new study, published online on Jan. 11 in Cancer, confirms previous findings and adds more nuance, say the researchers.
Previous studies have demonstrated that oral sex is a strong risk factor for HPV-related oropharyngeal cancer, which has increased in incidence in recent decades, particularly cancer of the base of the tongue and palatine and lingual tonsils.
“Our research adds more nuance in our understanding of how people acquire oral HPV infection and HPV-related oropharyngeal cancer,” said study author Gypsyamber D’Souza, PhD, professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health, Baltimore. “It suggests that risk of infection is not only from the number of oral sexual partners but that the timing and type of partner also influence risk.”
The results of the study do not change the clinical care or screening of patients, Dr. D’Souza noted, but the study does add context for patients and providers in understanding, “Why did I get HPV-oropharyngeal cancer?” she said.
“We know that people who develop HPV-oropharyngeal cancer have a wide range of sexual histories, but we do not suggest sexual history be used for screening, as many patients have low-risk sexual histories,” she said. “By chance, it only takes one partner who is infected to acquire the infection, while others who have had many partners by chance do not get exposed, or who are exposed but clear the infection.”
Reinforces the need for vaccination
Approached for comment, Joseph Califano, MD, physician-in-chief at the Moores Cancer Center and director of the Head and Neck Cancer Center at the University of California, San Diego, noted that similar data have been published before. The novelty here is in the timing and intensity of oral sex. “It’s not new data, but it certainly reinforces what we knew,” he said in an interview.
These new data are not going to change monitoring, he suggested. “It’s not going to change how we screen, because we don’t do population-based screening for oropharyngeal cancer,” Dr. Califano said.
“It does underline the fact that vaccination is really the key to preventing HPV-mediated cancers,” he said.
He pointed out that some data show lower rates of high-risk oral HPV shedding by children who have been appropriately vaccinated.
“This paper really highlights the fact we need to get people vaccinated early, before sexual debut,” he said. “In this case, sexual debut doesn’t necessarily mean intercourse but oral sex, and that’s a different concept of when sex starts.”
These new data “reinforce the fact that early exposure is what we need to focus on,” he said.
Details of the new findings
The current study by Dr. D’Souza and colleagues included 163 patients with HPV-related oropharyngeal cancer who were enrolled in the Papillomavirus Role in Oral Cancer Viral Etiology (PROVE) study. These patients were compared with 345 matched control persons.
All participants completed a behavioral survey and provided a blood sample. For the patients with cancer, a tumor sample was obtained.
The majority of participants were male (85% and 82%), were aged 50-69 years, were currently married or living with a partner, and identified as heterosexual. Case patients were more likely to report a history of sexually transmitted infection than were control participants (P = .003).
Case patients were more likely to have ever performed oral sex compared to control persons (98.8% vs 90.4%; P < .001) and to have performed oral sex at the time of their sexual debut (33.3% of case patients vs 21.4% of control persons; P = .004; odds ratio [OR], 1.8).
Significantly more case patients than control persons reported starting oral sex before they were 18 years old (37.4% of cases vs. 22.6% of controls; P < .001; OR, 3.1), and they had a greater number of lifetime oral sex partners (44.8% of cases and 19.1% of controls reported having more than 10 partners; P < .001; OR, 4.3).
Intensity of oral sexual exposure, which the authors measured by number of partners per 10 years, was also significantly higher among cases than controls (30.8% vs 11.1%; P < .001; OR, 5.6).
After adjustment for confounders (such as the lifetime number of oral sex partners and tobacco use), ever performing oral sex (adjusted odds ratio [aOR], 4.4), early age of first oral sex encounter (20 years: aOR, 1.8), and oral sex intensity (aOR, 2.8) all remained significantly associated with increased odds of HPV-oropharyngeal cancer.
The type of sexual partner, such as partners who were older (OR, 1.7) and having a partner who engaged in extramarital sex (OR, 1.6), were also associated with increased odds of developing HPV-oropharyngeal cancer. In addition, seropositivity for antibodies to HPV16 E6 (OR, 286) and any HPV16 E protein (E1, E2, E6, E7; OR, 163) were also associated with increased odds of developing the disease.
The study was supported by the National Institute of Dental and Craniofacial Research and the National Institute on Deafness and Other Communication Disorders. Dr. D’Souza and Dr. Califano have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Having oral sex with more than 10 previous partners was associated with a 4.3 times’ greater likelihood of developing human papillomavirus (HPV)–related oropharyngeal cancer, according to new findings.
The study also found that having more partners in a shorter period (i.e., greater oral sex intensity) and starting oral sex at a younger age were associated with higher odds of having HPV-related cancer of the mouth and throat.
The new study, published online on Jan. 11 in Cancer, confirms previous findings and adds more nuance, say the researchers.
Previous studies have demonstrated that oral sex is a strong risk factor for HPV-related oropharyngeal cancer, which has increased in incidence in recent decades, particularly cancer of the base of the tongue and palatine and lingual tonsils.
“Our research adds more nuance in our understanding of how people acquire oral HPV infection and HPV-related oropharyngeal cancer,” said study author Gypsyamber D’Souza, PhD, professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health, Baltimore. “It suggests that risk of infection is not only from the number of oral sexual partners but that the timing and type of partner also influence risk.”
The results of the study do not change the clinical care or screening of patients, Dr. D’Souza noted, but the study does add context for patients and providers in understanding, “Why did I get HPV-oropharyngeal cancer?” she said.
“We know that people who develop HPV-oropharyngeal cancer have a wide range of sexual histories, but we do not suggest sexual history be used for screening, as many patients have low-risk sexual histories,” she said. “By chance, it only takes one partner who is infected to acquire the infection, while others who have had many partners by chance do not get exposed, or who are exposed but clear the infection.”
Reinforces the need for vaccination
Approached for comment, Joseph Califano, MD, physician-in-chief at the Moores Cancer Center and director of the Head and Neck Cancer Center at the University of California, San Diego, noted that similar data have been published before. The novelty here is in the timing and intensity of oral sex. “It’s not new data, but it certainly reinforces what we knew,” he said in an interview.
These new data are not going to change monitoring, he suggested. “It’s not going to change how we screen, because we don’t do population-based screening for oropharyngeal cancer,” Dr. Califano said.
“It does underline the fact that vaccination is really the key to preventing HPV-mediated cancers,” he said.
He pointed out that some data show lower rates of high-risk oral HPV shedding by children who have been appropriately vaccinated.
“This paper really highlights the fact we need to get people vaccinated early, before sexual debut,” he said. “In this case, sexual debut doesn’t necessarily mean intercourse but oral sex, and that’s a different concept of when sex starts.”
These new data “reinforce the fact that early exposure is what we need to focus on,” he said.
Details of the new findings
The current study by Dr. D’Souza and colleagues included 163 patients with HPV-related oropharyngeal cancer who were enrolled in the Papillomavirus Role in Oral Cancer Viral Etiology (PROVE) study. These patients were compared with 345 matched control persons.
All participants completed a behavioral survey and provided a blood sample. For the patients with cancer, a tumor sample was obtained.
The majority of participants were male (85% and 82%), were aged 50-69 years, were currently married or living with a partner, and identified as heterosexual. Case patients were more likely to report a history of sexually transmitted infection than were control participants (P = .003).
Case patients were more likely to have ever performed oral sex compared to control persons (98.8% vs 90.4%; P < .001) and to have performed oral sex at the time of their sexual debut (33.3% of case patients vs 21.4% of control persons; P = .004; odds ratio [OR], 1.8).
Significantly more case patients than control persons reported starting oral sex before they were 18 years old (37.4% of cases vs. 22.6% of controls; P < .001; OR, 3.1), and they had a greater number of lifetime oral sex partners (44.8% of cases and 19.1% of controls reported having more than 10 partners; P < .001; OR, 4.3).
Intensity of oral sexual exposure, which the authors measured by number of partners per 10 years, was also significantly higher among cases than controls (30.8% vs 11.1%; P < .001; OR, 5.6).
After adjustment for confounders (such as the lifetime number of oral sex partners and tobacco use), ever performing oral sex (adjusted odds ratio [aOR], 4.4), early age of first oral sex encounter (20 years: aOR, 1.8), and oral sex intensity (aOR, 2.8) all remained significantly associated with increased odds of HPV-oropharyngeal cancer.
The type of sexual partner, such as partners who were older (OR, 1.7) and having a partner who engaged in extramarital sex (OR, 1.6), were also associated with increased odds of developing HPV-oropharyngeal cancer. In addition, seropositivity for antibodies to HPV16 E6 (OR, 286) and any HPV16 E protein (E1, E2, E6, E7; OR, 163) were also associated with increased odds of developing the disease.
The study was supported by the National Institute of Dental and Craniofacial Research and the National Institute on Deafness and Other Communication Disorders. Dr. D’Souza and Dr. Califano have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Having oral sex with more than 10 previous partners was associated with a 4.3 times’ greater likelihood of developing human papillomavirus (HPV)–related oropharyngeal cancer, according to new findings.
The study also found that having more partners in a shorter period (i.e., greater oral sex intensity) and starting oral sex at a younger age were associated with higher odds of having HPV-related cancer of the mouth and throat.
The new study, published online on Jan. 11 in Cancer, confirms previous findings and adds more nuance, say the researchers.
Previous studies have demonstrated that oral sex is a strong risk factor for HPV-related oropharyngeal cancer, which has increased in incidence in recent decades, particularly cancer of the base of the tongue and palatine and lingual tonsils.
“Our research adds more nuance in our understanding of how people acquire oral HPV infection and HPV-related oropharyngeal cancer,” said study author Gypsyamber D’Souza, PhD, professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health, Baltimore. “It suggests that risk of infection is not only from the number of oral sexual partners but that the timing and type of partner also influence risk.”
The results of the study do not change the clinical care or screening of patients, Dr. D’Souza noted, but the study does add context for patients and providers in understanding, “Why did I get HPV-oropharyngeal cancer?” she said.
“We know that people who develop HPV-oropharyngeal cancer have a wide range of sexual histories, but we do not suggest sexual history be used for screening, as many patients have low-risk sexual histories,” she said. “By chance, it only takes one partner who is infected to acquire the infection, while others who have had many partners by chance do not get exposed, or who are exposed but clear the infection.”
Reinforces the need for vaccination
Approached for comment, Joseph Califano, MD, physician-in-chief at the Moores Cancer Center and director of the Head and Neck Cancer Center at the University of California, San Diego, noted that similar data have been published before. The novelty here is in the timing and intensity of oral sex. “It’s not new data, but it certainly reinforces what we knew,” he said in an interview.
These new data are not going to change monitoring, he suggested. “It’s not going to change how we screen, because we don’t do population-based screening for oropharyngeal cancer,” Dr. Califano said.
“It does underline the fact that vaccination is really the key to preventing HPV-mediated cancers,” he said.
He pointed out that some data show lower rates of high-risk oral HPV shedding by children who have been appropriately vaccinated.
“This paper really highlights the fact we need to get people vaccinated early, before sexual debut,” he said. “In this case, sexual debut doesn’t necessarily mean intercourse but oral sex, and that’s a different concept of when sex starts.”
These new data “reinforce the fact that early exposure is what we need to focus on,” he said.
Details of the new findings
The current study by Dr. D’Souza and colleagues included 163 patients with HPV-related oropharyngeal cancer who were enrolled in the Papillomavirus Role in Oral Cancer Viral Etiology (PROVE) study. These patients were compared with 345 matched control persons.
All participants completed a behavioral survey and provided a blood sample. For the patients with cancer, a tumor sample was obtained.
The majority of participants were male (85% and 82%), were aged 50-69 years, were currently married or living with a partner, and identified as heterosexual. Case patients were more likely to report a history of sexually transmitted infection than were control participants (P = .003).
Case patients were more likely to have ever performed oral sex compared to control persons (98.8% vs 90.4%; P < .001) and to have performed oral sex at the time of their sexual debut (33.3% of case patients vs 21.4% of control persons; P = .004; odds ratio [OR], 1.8).
Significantly more case patients than control persons reported starting oral sex before they were 18 years old (37.4% of cases vs. 22.6% of controls; P < .001; OR, 3.1), and they had a greater number of lifetime oral sex partners (44.8% of cases and 19.1% of controls reported having more than 10 partners; P < .001; OR, 4.3).
Intensity of oral sexual exposure, which the authors measured by number of partners per 10 years, was also significantly higher among cases than controls (30.8% vs 11.1%; P < .001; OR, 5.6).
After adjustment for confounders (such as the lifetime number of oral sex partners and tobacco use), ever performing oral sex (adjusted odds ratio [aOR], 4.4), early age of first oral sex encounter (20 years: aOR, 1.8), and oral sex intensity (aOR, 2.8) all remained significantly associated with increased odds of HPV-oropharyngeal cancer.
The type of sexual partner, such as partners who were older (OR, 1.7) and having a partner who engaged in extramarital sex (OR, 1.6), were also associated with increased odds of developing HPV-oropharyngeal cancer. In addition, seropositivity for antibodies to HPV16 E6 (OR, 286) and any HPV16 E protein (E1, E2, E6, E7; OR, 163) were also associated with increased odds of developing the disease.
The study was supported by the National Institute of Dental and Craniofacial Research and the National Institute on Deafness and Other Communication Disorders. Dr. D’Souza and Dr. Califano have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Physicians react: Doctors worry about patients reading their clinical notes
Patients will soon be able to read the notes that physicians make during an episode of care, as well as information about diagnostic testing and imaging results, tests for STDs, fetal ultrasounds, and cancer biopsies. This open access is raising concerns among physicians.
As part of the 21st Century Cures Act, patients have the right to see their medical notes. Known as Open Notes, the policy will go into effect on April 5, 2021. The Department of Health & Human Services recently changed the original start date, which was to be Nov. 2, 2020.
The mandate has some physicians worrying about potential legal risks and possible violation of doctor-patient confidentiality. When asked to share their views on the new Open Notes mandate, many physicians expressed their concerns but also cited some of the positive effects that could come from this.
Potentially more legal woes for physicians?
A key concern raised by one physician commenter is that patients could misunderstand legitimate medical terminology or even put a physician in legal crosshairs. For example, a medical term such as “spontaneous abortion” could be misconstrued by patients. A physician might write notes with the idea that a patient is reading them and thus might alter those notes in a way that creates legal trouble.
“This layers another level of censorship and legal liability onto physicians, who in attempting to be [politically correct], may omit critical information or have to use euphemisms in order to avoid conflict,” one physician said.
She also questioned whether notes might now have to be run through legal counsel before being posted to avoid potential liability.
Another doctor questioned how physicians would be able to document patients suspected of faking injuries for pain medication, for example. Could such documentation lead to lawsuits for the doctor?
As one physician noted, some patients “are drug seekers. Some refuse to aid in their own care. Some are malingerers. Not documenting that is bad medicine.”
The possibility of violating doctor-patient confidentiality laws, particularly for teenagers, could be another negative effect of Open Notes, said one physician.
“Won’t this violate the statutes that teenagers have the right to confidential evaluations?” the commenter mused. “If charts are to be immediately available, then STDs and pregnancies they weren’t ready to talk about will now be suddenly known by their parents.”
One doctor has already faced this issue. “I already ran into this problem once,” he noted. “Now I warn those on their parents’ insurance before I start the visit. I have literally had a patient state, ‘well then we are done,’ and leave without being seen due to it.”
Another physician questioned the possibility of having to write notes differently than they do now, especially if the patients have lower reading comprehension abilities.
One physician who uses Open Notes said he receives patient requests for changes that have little to do with the actual diagnosis and relate to ancillary issues. He highlighted patients who “don’t want psych diagnosis in their chart or are concerned a diagnosis will raise their insurance premium, so they ask me to delete it.”
Will Open Notes erode patient communication?
One physician questioned whether it would lead to patients being less open and forthcoming about their medical concerns with doctors.
“The main problem I see is the patient not telling me the whole story, or worse, telling me the story, and then asking me not to document it (as many have done in the past) because they don’t want their spouse, family, etc. to read the notes and they have already given their permission for them to do so, for a variety of reasons,” he commented. “This includes topics of STDs, infidelity, depression, suicidal thoughts, and other symptoms the patient doesn’t want their family to read about.”
Some physicians envision positive developments
Many physicians are unconcerned by the new mandate. “I see some potential good in this, such as improving doctor-patient communication and more scrupulous charting,” one physician said.
A doctor working in the U.S. federal health care system noted that open access has been a part of that system for decades.
“Since health care providers work in this unveiled setting for their entire career, they usually know how to write appropriate clinical notes and what information needs to be included in them,” he wrote. “Now it’s time for the rest of the medical community to catch up to a reality that we have worked within for decades now.
“The world did not end, malpractice complaints did not increase, and physician/patient relationships were not damaged. Living in the information age, archaic practices like private notes were surely going to end at some point.”
One doctor who has been using Open Notes has had experiences in which the patient noted an error in the medical chart that needed correcting. “I have had one patient correct me on a timeline in the HPI which was helpful and I made the requested correction in that instance,” he said.
Another physician agreed. “I’ve had patients add or correct valuable information I’ve missed. Good probably outweighs the bad if we set limits on behaviors expressed by the personality disordered group. The majority of people don’t seem to care and still ask me ‘what would you do’ or ‘tell me what to do.’ It’s all about patient/physician trust.”
Another talked about how Open Notes should have little or no impact. “Here’s a novel concept – talking to our patients,” he commented. “There is nothing in every one of my chart notes that has not already been discussed with my patients and I dictate (speech to text) my findings and plan in front of them. So, if they are reviewing my office notes, it will only serve to reinforce what we have already discussed.”
“I don’t intend to change anything,” he added. “Chances are if they were to see a test result before I have a chance to discuss it with them, they will have already ‘Googled’ its meaning and we can have more meaningful interaction if they have a basic understanding of the test.”
“I understand that this is anxiety provoking, but in general I think it is appropriate for patients to have access to their notes,” said another physician. “If physicians write lousy notes that say they did things they didn’t do, that fail to actually state a diagnosis and a plan (and they often do), that is the doc’s problem, not the patient’s.”
A version of this article first appeared on Medscape.com.
Patients will soon be able to read the notes that physicians make during an episode of care, as well as information about diagnostic testing and imaging results, tests for STDs, fetal ultrasounds, and cancer biopsies. This open access is raising concerns among physicians.
As part of the 21st Century Cures Act, patients have the right to see their medical notes. Known as Open Notes, the policy will go into effect on April 5, 2021. The Department of Health & Human Services recently changed the original start date, which was to be Nov. 2, 2020.
The mandate has some physicians worrying about potential legal risks and possible violation of doctor-patient confidentiality. When asked to share their views on the new Open Notes mandate, many physicians expressed their concerns but also cited some of the positive effects that could come from this.
Potentially more legal woes for physicians?
A key concern raised by one physician commenter is that patients could misunderstand legitimate medical terminology or even put a physician in legal crosshairs. For example, a medical term such as “spontaneous abortion” could be misconstrued by patients. A physician might write notes with the idea that a patient is reading them and thus might alter those notes in a way that creates legal trouble.
“This layers another level of censorship and legal liability onto physicians, who in attempting to be [politically correct], may omit critical information or have to use euphemisms in order to avoid conflict,” one physician said.
She also questioned whether notes might now have to be run through legal counsel before being posted to avoid potential liability.
Another doctor questioned how physicians would be able to document patients suspected of faking injuries for pain medication, for example. Could such documentation lead to lawsuits for the doctor?
As one physician noted, some patients “are drug seekers. Some refuse to aid in their own care. Some are malingerers. Not documenting that is bad medicine.”
The possibility of violating doctor-patient confidentiality laws, particularly for teenagers, could be another negative effect of Open Notes, said one physician.
“Won’t this violate the statutes that teenagers have the right to confidential evaluations?” the commenter mused. “If charts are to be immediately available, then STDs and pregnancies they weren’t ready to talk about will now be suddenly known by their parents.”
One doctor has already faced this issue. “I already ran into this problem once,” he noted. “Now I warn those on their parents’ insurance before I start the visit. I have literally had a patient state, ‘well then we are done,’ and leave without being seen due to it.”
Another physician questioned the possibility of having to write notes differently than they do now, especially if the patients have lower reading comprehension abilities.
One physician who uses Open Notes said he receives patient requests for changes that have little to do with the actual diagnosis and relate to ancillary issues. He highlighted patients who “don’t want psych diagnosis in their chart or are concerned a diagnosis will raise their insurance premium, so they ask me to delete it.”
Will Open Notes erode patient communication?
One physician questioned whether it would lead to patients being less open and forthcoming about their medical concerns with doctors.
“The main problem I see is the patient not telling me the whole story, or worse, telling me the story, and then asking me not to document it (as many have done in the past) because they don’t want their spouse, family, etc. to read the notes and they have already given their permission for them to do so, for a variety of reasons,” he commented. “This includes topics of STDs, infidelity, depression, suicidal thoughts, and other symptoms the patient doesn’t want their family to read about.”
Some physicians envision positive developments
Many physicians are unconcerned by the new mandate. “I see some potential good in this, such as improving doctor-patient communication and more scrupulous charting,” one physician said.
A doctor working in the U.S. federal health care system noted that open access has been a part of that system for decades.
“Since health care providers work in this unveiled setting for their entire career, they usually know how to write appropriate clinical notes and what information needs to be included in them,” he wrote. “Now it’s time for the rest of the medical community to catch up to a reality that we have worked within for decades now.
“The world did not end, malpractice complaints did not increase, and physician/patient relationships were not damaged. Living in the information age, archaic practices like private notes were surely going to end at some point.”
One doctor who has been using Open Notes has had experiences in which the patient noted an error in the medical chart that needed correcting. “I have had one patient correct me on a timeline in the HPI which was helpful and I made the requested correction in that instance,” he said.
Another physician agreed. “I’ve had patients add or correct valuable information I’ve missed. Good probably outweighs the bad if we set limits on behaviors expressed by the personality disordered group. The majority of people don’t seem to care and still ask me ‘what would you do’ or ‘tell me what to do.’ It’s all about patient/physician trust.”
Another talked about how Open Notes should have little or no impact. “Here’s a novel concept – talking to our patients,” he commented. “There is nothing in every one of my chart notes that has not already been discussed with my patients and I dictate (speech to text) my findings and plan in front of them. So, if they are reviewing my office notes, it will only serve to reinforce what we have already discussed.”
“I don’t intend to change anything,” he added. “Chances are if they were to see a test result before I have a chance to discuss it with them, they will have already ‘Googled’ its meaning and we can have more meaningful interaction if they have a basic understanding of the test.”
“I understand that this is anxiety provoking, but in general I think it is appropriate for patients to have access to their notes,” said another physician. “If physicians write lousy notes that say they did things they didn’t do, that fail to actually state a diagnosis and a plan (and they often do), that is the doc’s problem, not the patient’s.”
A version of this article first appeared on Medscape.com.
Patients will soon be able to read the notes that physicians make during an episode of care, as well as information about diagnostic testing and imaging results, tests for STDs, fetal ultrasounds, and cancer biopsies. This open access is raising concerns among physicians.
As part of the 21st Century Cures Act, patients have the right to see their medical notes. Known as Open Notes, the policy will go into effect on April 5, 2021. The Department of Health & Human Services recently changed the original start date, which was to be Nov. 2, 2020.
The mandate has some physicians worrying about potential legal risks and possible violation of doctor-patient confidentiality. When asked to share their views on the new Open Notes mandate, many physicians expressed their concerns but also cited some of the positive effects that could come from this.
Potentially more legal woes for physicians?
A key concern raised by one physician commenter is that patients could misunderstand legitimate medical terminology or even put a physician in legal crosshairs. For example, a medical term such as “spontaneous abortion” could be misconstrued by patients. A physician might write notes with the idea that a patient is reading them and thus might alter those notes in a way that creates legal trouble.
“This layers another level of censorship and legal liability onto physicians, who in attempting to be [politically correct], may omit critical information or have to use euphemisms in order to avoid conflict,” one physician said.
She also questioned whether notes might now have to be run through legal counsel before being posted to avoid potential liability.
Another doctor questioned how physicians would be able to document patients suspected of faking injuries for pain medication, for example. Could such documentation lead to lawsuits for the doctor?
As one physician noted, some patients “are drug seekers. Some refuse to aid in their own care. Some are malingerers. Not documenting that is bad medicine.”
The possibility of violating doctor-patient confidentiality laws, particularly for teenagers, could be another negative effect of Open Notes, said one physician.
“Won’t this violate the statutes that teenagers have the right to confidential evaluations?” the commenter mused. “If charts are to be immediately available, then STDs and pregnancies they weren’t ready to talk about will now be suddenly known by their parents.”
One doctor has already faced this issue. “I already ran into this problem once,” he noted. “Now I warn those on their parents’ insurance before I start the visit. I have literally had a patient state, ‘well then we are done,’ and leave without being seen due to it.”
Another physician questioned the possibility of having to write notes differently than they do now, especially if the patients have lower reading comprehension abilities.
One physician who uses Open Notes said he receives patient requests for changes that have little to do with the actual diagnosis and relate to ancillary issues. He highlighted patients who “don’t want psych diagnosis in their chart or are concerned a diagnosis will raise their insurance premium, so they ask me to delete it.”
Will Open Notes erode patient communication?
One physician questioned whether it would lead to patients being less open and forthcoming about their medical concerns with doctors.
“The main problem I see is the patient not telling me the whole story, or worse, telling me the story, and then asking me not to document it (as many have done in the past) because they don’t want their spouse, family, etc. to read the notes and they have already given their permission for them to do so, for a variety of reasons,” he commented. “This includes topics of STDs, infidelity, depression, suicidal thoughts, and other symptoms the patient doesn’t want their family to read about.”
Some physicians envision positive developments
Many physicians are unconcerned by the new mandate. “I see some potential good in this, such as improving doctor-patient communication and more scrupulous charting,” one physician said.
A doctor working in the U.S. federal health care system noted that open access has been a part of that system for decades.
“Since health care providers work in this unveiled setting for their entire career, they usually know how to write appropriate clinical notes and what information needs to be included in them,” he wrote. “Now it’s time for the rest of the medical community to catch up to a reality that we have worked within for decades now.
“The world did not end, malpractice complaints did not increase, and physician/patient relationships were not damaged. Living in the information age, archaic practices like private notes were surely going to end at some point.”
One doctor who has been using Open Notes has had experiences in which the patient noted an error in the medical chart that needed correcting. “I have had one patient correct me on a timeline in the HPI which was helpful and I made the requested correction in that instance,” he said.
Another physician agreed. “I’ve had patients add or correct valuable information I’ve missed. Good probably outweighs the bad if we set limits on behaviors expressed by the personality disordered group. The majority of people don’t seem to care and still ask me ‘what would you do’ or ‘tell me what to do.’ It’s all about patient/physician trust.”
Another talked about how Open Notes should have little or no impact. “Here’s a novel concept – talking to our patients,” he commented. “There is nothing in every one of my chart notes that has not already been discussed with my patients and I dictate (speech to text) my findings and plan in front of them. So, if they are reviewing my office notes, it will only serve to reinforce what we have already discussed.”
“I don’t intend to change anything,” he added. “Chances are if they were to see a test result before I have a chance to discuss it with them, they will have already ‘Googled’ its meaning and we can have more meaningful interaction if they have a basic understanding of the test.”
“I understand that this is anxiety provoking, but in general I think it is appropriate for patients to have access to their notes,” said another physician. “If physicians write lousy notes that say they did things they didn’t do, that fail to actually state a diagnosis and a plan (and they often do), that is the doc’s problem, not the patient’s.”
A version of this article first appeared on Medscape.com.
Over half of COVID-19 transmission may occur via asymptomatic people
As COVID-19 cases surge and vaccinations lag, health authorities continue to seek additional ways to mitigate the spread of the novel coronavirus.
Now, a modeling study estimates that more than half of transmissions come from pre-, never-, and asymptomatic individuals, indicating that symptom-based screening will have little effect on spread.
The Centers for Disease Control and Prevention study, published online Jan. 7 in JAMA Network Open, concludes that for optimal control, protective measures such as masking and social distancing should be supplemented with strategic testing of potentially exposed but asymptomatic individuals .
“In the absence of effective and widespread use of therapeutics or vaccines that can shorten or eliminate infectivity, successful control of SARS-CoV-2 cannot rely solely on identifying and isolating symptomatic cases; even if implemented effectively, this strategy would be insufficient,” CDC biologist Michael J. Johansson, PhD, and colleagues warn. “Multiple measures that effectively address transmission risk in the absence of symptoms are imperative to control SARS-CoV-2.”
According to the authors, the effectiveness of some current transmission prevention efforts has been disputed and subject to mixed messaging. Therefore, they decided to model the proportion of COVID-19 infections that are likely the result of individuals who show no symptoms and may be unknowingly infecting others.
“Unfortunately, there continues to be some skepticism about the value of community-wide mitigation efforts for preventing transmission such as masking, distancing, and hand hygiene, particularly for people without symptoms,” corresponding author Jay C. Butler, MD, said in an interview. “So we wanted to have a base assumption about how much transmission occurs from asymptomatic people to underscore the importance of mitigation measures and of creating immunity through vaccine delivery.”
Such a yardstick is especially germane in the context of the new, more transmissible variant. “It really puts [things] in a bigger box and underscores, boldfaces, and italicizes the need to change people’s behaviors and the importance of mitigation,” Dr. Butler said. It also highlights the advisability of targeted strategic testing in congregate settings, schools, and universities, which is already underway.
The analysis
Based on data from several COVID-19 studies from last year, the CDC’s analytical model assumes at baseline that infectiousness peaks at the median point of symptom onset, and that 30% of infected individuals never develop symptoms but are nevertheless 75% as infectious as those who develop overt symptoms.
The investigators then model multiple scenarios of transmission based pre- and never-symptomatic individuals, assuming different incubation and infectious periods, and varying numbers of days from point of infection to symptom onset.
When combined, the models predicts that 59% of all transmission would come from asymptomatic transmission – 35% from presymptomatic individuals and 24% from never-symptomatic individuals.
The findings complement those of an earlier CDC analysis, according to the authors.
The overall proportion of transmission from presymptomatic and never-symptomatic individuals is key to identifying mitigation measures that may be able to control SARS-CoV-2, the authors stated.
For example, they explain, if the infection reproduction number (R) in a particular setting is 2.0, a reduction in transmission of at least 50% is needed in order to reduce R to below 1.0. “Given that in some settings R is likely much greater than 2 and more than half of transmissions may come from individuals who are asymptomatic at the time of transmission, effective control must mitigate transmission risk from people without symptoms,” they wrote.
The authors acknowledge that the study applies a simplistic model to a complex and evolving phenomenon, and that the exact proportions of presymptomatic and never-symptomatic transmission and the incubation periods are not known. They also note symptoms and transmissions appear to vary across different population groups, with older individuals more likely than younger persons to experience symptoms, according to previous studies.
“Assume that everyone is potentially infected”
Other experts agree that expanded testing of asymptomatic individuals is important. “Screening for fever and isolation of symptomatic individuals is a common-sense approach to help prevent spread, but these measures are by no means adequate since it’s been clearly documented that individuals who are either asymptomatic or presymptomatic can still spread the virus,” said Brett Williams, MD, an infectious disease specialist and assistant professor of medicine at Rush University in Chicago.
“As we saw with the White House Rose Garden superspreader outbreak, testing does not reliably exclude infection either because the tested individual has not yet become positive or the test is falsely negative,” Dr. Williams, who was not involved in the CDC study, said in an interview. He further noted that when prevalence is as high as it currently is in the United States, the rate of false negatives will be high because a large proportion of those screened will be unknowingly infected.
At his center, all visitors and staff are screened with a temperature probe on entry, and since the earliest days of the pandemic, universal masking has been required. “Nationally there have been many instances of hospital break room outbreaks because of staff eating lunch together, and these outbreaks also demonstrate the incompleteness of symptomatic isolation,” Dr. Williams said.
For his part, virologist Frank Esper, MD, a pediatric infectious disease specialist at the Cleveland Clinic, said that while it’s been understood for some time that many infected people will not exhibit symptoms, “the question that remains is just how infectious are they?”
Dr. Esper’s takeaway from the modeling study is not so much that we need more screening of possibly exposed but asymptomatic people, but rather testing symptomatic people and tracing their contacts is not enough.
“We need to continue to assume that everyone is potentially infected whether they know it or not. And even though we have ramped up our testing to a much greater capacity than in the first wave, we need to continue to wear masks and socially distance because just identifying people who are sick and isolating or quarantining them is not going to be enough to contain the pandemic.”
And although assumption-based modeling is helpful, it cannot tell us “how many asymptomatic people are actually infected,” said Dr. Esper, who was not involved in the CDC study.
Dr. Esper also pointed out that the study estimates are based on data from early Chinese studies, but the virus has since changed. The new, more transmissible strain in the United States and elsewhere may involve not only more infections but also a longer presymptomatic stage. “So the CDC study may actually undershoot asymptomatic infections,” he said.
He also agreed with the authors that when it comes to infection, not all humans are equal. “Older people tend to be more symptomatic and become symptomatic more quickly so the asymptomatic rate is not the same across board from young people age 20 to older people.”
The bottom line, said David. A. Hirschwerk, MD, an infectious disease specialist at Northwell Health in Manhasset, N.Y., is that these data support the maintenance of protective measures we’ve been taking over the past months. “They support the concept that asymptomatic people are a significant source of transmission and that we need to adhere to mask wearing and social distancing, particularly indoors,” Dr. Hirschwerk, who was not involved in the analysis, said in an interview. “More testing would be better but it has to be fast and it has to be efficient, and there are a lot of challenges to overcome.”
The study was done as part of the CDC’s coronavirus disease 2019 response and was supported solely by federal base and response funding. The authors and commentators have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
As COVID-19 cases surge and vaccinations lag, health authorities continue to seek additional ways to mitigate the spread of the novel coronavirus.
Now, a modeling study estimates that more than half of transmissions come from pre-, never-, and asymptomatic individuals, indicating that symptom-based screening will have little effect on spread.
The Centers for Disease Control and Prevention study, published online Jan. 7 in JAMA Network Open, concludes that for optimal control, protective measures such as masking and social distancing should be supplemented with strategic testing of potentially exposed but asymptomatic individuals .
“In the absence of effective and widespread use of therapeutics or vaccines that can shorten or eliminate infectivity, successful control of SARS-CoV-2 cannot rely solely on identifying and isolating symptomatic cases; even if implemented effectively, this strategy would be insufficient,” CDC biologist Michael J. Johansson, PhD, and colleagues warn. “Multiple measures that effectively address transmission risk in the absence of symptoms are imperative to control SARS-CoV-2.”
According to the authors, the effectiveness of some current transmission prevention efforts has been disputed and subject to mixed messaging. Therefore, they decided to model the proportion of COVID-19 infections that are likely the result of individuals who show no symptoms and may be unknowingly infecting others.
“Unfortunately, there continues to be some skepticism about the value of community-wide mitigation efforts for preventing transmission such as masking, distancing, and hand hygiene, particularly for people without symptoms,” corresponding author Jay C. Butler, MD, said in an interview. “So we wanted to have a base assumption about how much transmission occurs from asymptomatic people to underscore the importance of mitigation measures and of creating immunity through vaccine delivery.”
Such a yardstick is especially germane in the context of the new, more transmissible variant. “It really puts [things] in a bigger box and underscores, boldfaces, and italicizes the need to change people’s behaviors and the importance of mitigation,” Dr. Butler said. It also highlights the advisability of targeted strategic testing in congregate settings, schools, and universities, which is already underway.
The analysis
Based on data from several COVID-19 studies from last year, the CDC’s analytical model assumes at baseline that infectiousness peaks at the median point of symptom onset, and that 30% of infected individuals never develop symptoms but are nevertheless 75% as infectious as those who develop overt symptoms.
The investigators then model multiple scenarios of transmission based pre- and never-symptomatic individuals, assuming different incubation and infectious periods, and varying numbers of days from point of infection to symptom onset.
When combined, the models predicts that 59% of all transmission would come from asymptomatic transmission – 35% from presymptomatic individuals and 24% from never-symptomatic individuals.
The findings complement those of an earlier CDC analysis, according to the authors.
The overall proportion of transmission from presymptomatic and never-symptomatic individuals is key to identifying mitigation measures that may be able to control SARS-CoV-2, the authors stated.
For example, they explain, if the infection reproduction number (R) in a particular setting is 2.0, a reduction in transmission of at least 50% is needed in order to reduce R to below 1.0. “Given that in some settings R is likely much greater than 2 and more than half of transmissions may come from individuals who are asymptomatic at the time of transmission, effective control must mitigate transmission risk from people without symptoms,” they wrote.
The authors acknowledge that the study applies a simplistic model to a complex and evolving phenomenon, and that the exact proportions of presymptomatic and never-symptomatic transmission and the incubation periods are not known. They also note symptoms and transmissions appear to vary across different population groups, with older individuals more likely than younger persons to experience symptoms, according to previous studies.
“Assume that everyone is potentially infected”
Other experts agree that expanded testing of asymptomatic individuals is important. “Screening for fever and isolation of symptomatic individuals is a common-sense approach to help prevent spread, but these measures are by no means adequate since it’s been clearly documented that individuals who are either asymptomatic or presymptomatic can still spread the virus,” said Brett Williams, MD, an infectious disease specialist and assistant professor of medicine at Rush University in Chicago.
“As we saw with the White House Rose Garden superspreader outbreak, testing does not reliably exclude infection either because the tested individual has not yet become positive or the test is falsely negative,” Dr. Williams, who was not involved in the CDC study, said in an interview. He further noted that when prevalence is as high as it currently is in the United States, the rate of false negatives will be high because a large proportion of those screened will be unknowingly infected.
At his center, all visitors and staff are screened with a temperature probe on entry, and since the earliest days of the pandemic, universal masking has been required. “Nationally there have been many instances of hospital break room outbreaks because of staff eating lunch together, and these outbreaks also demonstrate the incompleteness of symptomatic isolation,” Dr. Williams said.
For his part, virologist Frank Esper, MD, a pediatric infectious disease specialist at the Cleveland Clinic, said that while it’s been understood for some time that many infected people will not exhibit symptoms, “the question that remains is just how infectious are they?”
Dr. Esper’s takeaway from the modeling study is not so much that we need more screening of possibly exposed but asymptomatic people, but rather testing symptomatic people and tracing their contacts is not enough.
“We need to continue to assume that everyone is potentially infected whether they know it or not. And even though we have ramped up our testing to a much greater capacity than in the first wave, we need to continue to wear masks and socially distance because just identifying people who are sick and isolating or quarantining them is not going to be enough to contain the pandemic.”
And although assumption-based modeling is helpful, it cannot tell us “how many asymptomatic people are actually infected,” said Dr. Esper, who was not involved in the CDC study.
Dr. Esper also pointed out that the study estimates are based on data from early Chinese studies, but the virus has since changed. The new, more transmissible strain in the United States and elsewhere may involve not only more infections but also a longer presymptomatic stage. “So the CDC study may actually undershoot asymptomatic infections,” he said.
He also agreed with the authors that when it comes to infection, not all humans are equal. “Older people tend to be more symptomatic and become symptomatic more quickly so the asymptomatic rate is not the same across board from young people age 20 to older people.”
The bottom line, said David. A. Hirschwerk, MD, an infectious disease specialist at Northwell Health in Manhasset, N.Y., is that these data support the maintenance of protective measures we’ve been taking over the past months. “They support the concept that asymptomatic people are a significant source of transmission and that we need to adhere to mask wearing and social distancing, particularly indoors,” Dr. Hirschwerk, who was not involved in the analysis, said in an interview. “More testing would be better but it has to be fast and it has to be efficient, and there are a lot of challenges to overcome.”
The study was done as part of the CDC’s coronavirus disease 2019 response and was supported solely by federal base and response funding. The authors and commentators have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
As COVID-19 cases surge and vaccinations lag, health authorities continue to seek additional ways to mitigate the spread of the novel coronavirus.
Now, a modeling study estimates that more than half of transmissions come from pre-, never-, and asymptomatic individuals, indicating that symptom-based screening will have little effect on spread.
The Centers for Disease Control and Prevention study, published online Jan. 7 in JAMA Network Open, concludes that for optimal control, protective measures such as masking and social distancing should be supplemented with strategic testing of potentially exposed but asymptomatic individuals .
“In the absence of effective and widespread use of therapeutics or vaccines that can shorten or eliminate infectivity, successful control of SARS-CoV-2 cannot rely solely on identifying and isolating symptomatic cases; even if implemented effectively, this strategy would be insufficient,” CDC biologist Michael J. Johansson, PhD, and colleagues warn. “Multiple measures that effectively address transmission risk in the absence of symptoms are imperative to control SARS-CoV-2.”
According to the authors, the effectiveness of some current transmission prevention efforts has been disputed and subject to mixed messaging. Therefore, they decided to model the proportion of COVID-19 infections that are likely the result of individuals who show no symptoms and may be unknowingly infecting others.
“Unfortunately, there continues to be some skepticism about the value of community-wide mitigation efforts for preventing transmission such as masking, distancing, and hand hygiene, particularly for people without symptoms,” corresponding author Jay C. Butler, MD, said in an interview. “So we wanted to have a base assumption about how much transmission occurs from asymptomatic people to underscore the importance of mitigation measures and of creating immunity through vaccine delivery.”
Such a yardstick is especially germane in the context of the new, more transmissible variant. “It really puts [things] in a bigger box and underscores, boldfaces, and italicizes the need to change people’s behaviors and the importance of mitigation,” Dr. Butler said. It also highlights the advisability of targeted strategic testing in congregate settings, schools, and universities, which is already underway.
The analysis
Based on data from several COVID-19 studies from last year, the CDC’s analytical model assumes at baseline that infectiousness peaks at the median point of symptom onset, and that 30% of infected individuals never develop symptoms but are nevertheless 75% as infectious as those who develop overt symptoms.
The investigators then model multiple scenarios of transmission based pre- and never-symptomatic individuals, assuming different incubation and infectious periods, and varying numbers of days from point of infection to symptom onset.
When combined, the models predicts that 59% of all transmission would come from asymptomatic transmission – 35% from presymptomatic individuals and 24% from never-symptomatic individuals.
The findings complement those of an earlier CDC analysis, according to the authors.
The overall proportion of transmission from presymptomatic and never-symptomatic individuals is key to identifying mitigation measures that may be able to control SARS-CoV-2, the authors stated.
For example, they explain, if the infection reproduction number (R) in a particular setting is 2.0, a reduction in transmission of at least 50% is needed in order to reduce R to below 1.0. “Given that in some settings R is likely much greater than 2 and more than half of transmissions may come from individuals who are asymptomatic at the time of transmission, effective control must mitigate transmission risk from people without symptoms,” they wrote.
The authors acknowledge that the study applies a simplistic model to a complex and evolving phenomenon, and that the exact proportions of presymptomatic and never-symptomatic transmission and the incubation periods are not known. They also note symptoms and transmissions appear to vary across different population groups, with older individuals more likely than younger persons to experience symptoms, according to previous studies.
“Assume that everyone is potentially infected”
Other experts agree that expanded testing of asymptomatic individuals is important. “Screening for fever and isolation of symptomatic individuals is a common-sense approach to help prevent spread, but these measures are by no means adequate since it’s been clearly documented that individuals who are either asymptomatic or presymptomatic can still spread the virus,” said Brett Williams, MD, an infectious disease specialist and assistant professor of medicine at Rush University in Chicago.
“As we saw with the White House Rose Garden superspreader outbreak, testing does not reliably exclude infection either because the tested individual has not yet become positive or the test is falsely negative,” Dr. Williams, who was not involved in the CDC study, said in an interview. He further noted that when prevalence is as high as it currently is in the United States, the rate of false negatives will be high because a large proportion of those screened will be unknowingly infected.
At his center, all visitors and staff are screened with a temperature probe on entry, and since the earliest days of the pandemic, universal masking has been required. “Nationally there have been many instances of hospital break room outbreaks because of staff eating lunch together, and these outbreaks also demonstrate the incompleteness of symptomatic isolation,” Dr. Williams said.
For his part, virologist Frank Esper, MD, a pediatric infectious disease specialist at the Cleveland Clinic, said that while it’s been understood for some time that many infected people will not exhibit symptoms, “the question that remains is just how infectious are they?”
Dr. Esper’s takeaway from the modeling study is not so much that we need more screening of possibly exposed but asymptomatic people, but rather testing symptomatic people and tracing their contacts is not enough.
“We need to continue to assume that everyone is potentially infected whether they know it or not. And even though we have ramped up our testing to a much greater capacity than in the first wave, we need to continue to wear masks and socially distance because just identifying people who are sick and isolating or quarantining them is not going to be enough to contain the pandemic.”
And although assumption-based modeling is helpful, it cannot tell us “how many asymptomatic people are actually infected,” said Dr. Esper, who was not involved in the CDC study.
Dr. Esper also pointed out that the study estimates are based on data from early Chinese studies, but the virus has since changed. The new, more transmissible strain in the United States and elsewhere may involve not only more infections but also a longer presymptomatic stage. “So the CDC study may actually undershoot asymptomatic infections,” he said.
He also agreed with the authors that when it comes to infection, not all humans are equal. “Older people tend to be more symptomatic and become symptomatic more quickly so the asymptomatic rate is not the same across board from young people age 20 to older people.”
The bottom line, said David. A. Hirschwerk, MD, an infectious disease specialist at Northwell Health in Manhasset, N.Y., is that these data support the maintenance of protective measures we’ve been taking over the past months. “They support the concept that asymptomatic people are a significant source of transmission and that we need to adhere to mask wearing and social distancing, particularly indoors,” Dr. Hirschwerk, who was not involved in the analysis, said in an interview. “More testing would be better but it has to be fast and it has to be efficient, and there are a lot of challenges to overcome.”
The study was done as part of the CDC’s coronavirus disease 2019 response and was supported solely by federal base and response funding. The authors and commentators have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Outpatient penicillin allergy testing found safe in pregnancy
Successful outpatient penicillin allergy testing with a low incidence of anaphylaxis during pregnancy demonstrates the feasibility of performing allergy testing in the outpatient setting, reported Nerlyne Desravines, MD, of the University of North Carolina, Chapel Hill, and colleagues.
In a prospective cohort study of 74 pregnant patients with previous self reports of penicillin allergy, Dr. Desravines and colleagues sought to determine the feasibility, acceptability, and safety of performing penicillin allergy testing in an outpatient setting. Patients included in the study were aged 18-55 years with gestational age between 14 and 36 weeks and planned delivery within the University of North Carolina heath care system receiving care between March 2019 and March 2020.
Of the 74 women enrolled to participate, 24 failed to present for testing, including some citing scheduling conflicts or fear of adverse reactions. Only 46 of the remaining 50 successfully completed testing; 4 patients were scheduled for testing but unable to participate because of COVID-19 restrictions.
Insurance status may affect participation in testing
Those who had public insurance were less likely to complete testing; those who completed testing were significantly more likely to be married and carry private insurance.
Fully 52% of the 46 women who completed testing were in the second trimester. The majority (85%) experienced their initial penicillin allergy reaction more than 10 years earlier.
Ultimately, 43 of the 46 women (93%) received a negative test result despite previous self reports of severe allergic reaction. Two of the three confirmed with penicillin allergy failed the 10% oral drug challenge; the other tested positive for penicillin G on intradermal testing. The two women who were found to have severe penicillin allergy experienced coughing, chest tightening, and skin and oropharynx pruritus within 30 minutes after their 10% amoxicillin drug challenge; they also experienced vomiting at 1 and 2 hours post ingestion. Following intramuscular injection of epinephrine, oral cetirizine with periodic vital sign measures, and albuterol updraft in one patient with a history of well controlled asthma, symptom resolution was achieved and both women were discharged without the need for further care.
The systemic reactions observed in just 4% of the study population is lower than normally reported in the general population, suggesting that the study sample size may underestimate the actual prevalence of systemic reactions, the authors noted. “The primary factor in safely conducting allergy testing in pregnancy is an outpatient facility that is appropriately outfitted with trained personnel and medications for possible serious reactions,” they added.
Noteworthy is the allergy testing protocol used by Dr. Desravines and colleagues in this study. Their graded oral drug challenge has not been used in previous studies of outpatient penicillin testing in pregnancy. Two of the three participants with positive test results had penicillin allergy confirmed following reaction to the first step (10% dose) of oral challenge to amoxicillin.
Prevalence of systemic reactions may be higher than expected
The authors cited ease of implementation in an obstetrics or allergy clinic as a strength of the study. One limitation is the observed rate of systemic reaction. The wide confidence interval observed indicates the rates of anaphylaxis may actually be as high as 15%, suggested the authors. The small sample size also limits the safety analysis for rare outcomes such as death.
Patient-reported barriers included time commitment for the testing visit. Rural women or those receiving prenatal care from health departments or community health centers were not able to be enrolled. Only one Spanish-speaking woman participated despite availability of bilingual staff and interpreters.
Such outpatient testing for those at greatest risk offers the opportunity to mitigate emerging drug resistance and should ideally take place preconception or at the time of initial allergic reaction, the authors advised. As emphasized in the latest Committee Opinion issued by the American College of Obstetricians and Gynecologists, obstetricians have a real opportunity to counsel patients preconception and postpartum regarding the benefits of penicillin allergy testing.
In a separate interview, Angela Martin, MD, assistant professor, maternal-fetal medicine, at University of Kansas, Kansas City, noted the large clinical implications of this study given that more than 90% of women undergoing allergy testing following self-reported penicillin allergy had a negative test result. “By performing allergy testing on appropriate candidates, as these authors have done, clinicians can treat infections and implement group B streptococcus prophylaxis with the narrowest spectrum antibiotic. This has potential to combat antibiotic resistance and may protect patients from harms caused by unnecessary broad-spectrum antibiotic use during pregnancy and beyond,” said Dr. Martin.
“It should be mentioned that 2 out of the 46 women tested (4%) had an anaphylactic reaction. This highlights the need to perform allergy testing in a qualified center capable of managing acute anaphylactic reactions should they occur,” she advised.
Dr. Desravines and colleagues, as well as Dr. Martin, had no conflicts of interest and no relevant financial disclosures.
SOURCE: Obstet Gynecol. 2021;137:56-61. doi: 10.1097/AOG.0000000000004213.
Successful outpatient penicillin allergy testing with a low incidence of anaphylaxis during pregnancy demonstrates the feasibility of performing allergy testing in the outpatient setting, reported Nerlyne Desravines, MD, of the University of North Carolina, Chapel Hill, and colleagues.
In a prospective cohort study of 74 pregnant patients with previous self reports of penicillin allergy, Dr. Desravines and colleagues sought to determine the feasibility, acceptability, and safety of performing penicillin allergy testing in an outpatient setting. Patients included in the study were aged 18-55 years with gestational age between 14 and 36 weeks and planned delivery within the University of North Carolina heath care system receiving care between March 2019 and March 2020.
Of the 74 women enrolled to participate, 24 failed to present for testing, including some citing scheduling conflicts or fear of adverse reactions. Only 46 of the remaining 50 successfully completed testing; 4 patients were scheduled for testing but unable to participate because of COVID-19 restrictions.
Insurance status may affect participation in testing
Those who had public insurance were less likely to complete testing; those who completed testing were significantly more likely to be married and carry private insurance.
Fully 52% of the 46 women who completed testing were in the second trimester. The majority (85%) experienced their initial penicillin allergy reaction more than 10 years earlier.
Ultimately, 43 of the 46 women (93%) received a negative test result despite previous self reports of severe allergic reaction. Two of the three confirmed with penicillin allergy failed the 10% oral drug challenge; the other tested positive for penicillin G on intradermal testing. The two women who were found to have severe penicillin allergy experienced coughing, chest tightening, and skin and oropharynx pruritus within 30 minutes after their 10% amoxicillin drug challenge; they also experienced vomiting at 1 and 2 hours post ingestion. Following intramuscular injection of epinephrine, oral cetirizine with periodic vital sign measures, and albuterol updraft in one patient with a history of well controlled asthma, symptom resolution was achieved and both women were discharged without the need for further care.
The systemic reactions observed in just 4% of the study population is lower than normally reported in the general population, suggesting that the study sample size may underestimate the actual prevalence of systemic reactions, the authors noted. “The primary factor in safely conducting allergy testing in pregnancy is an outpatient facility that is appropriately outfitted with trained personnel and medications for possible serious reactions,” they added.
Noteworthy is the allergy testing protocol used by Dr. Desravines and colleagues in this study. Their graded oral drug challenge has not been used in previous studies of outpatient penicillin testing in pregnancy. Two of the three participants with positive test results had penicillin allergy confirmed following reaction to the first step (10% dose) of oral challenge to amoxicillin.
Prevalence of systemic reactions may be higher than expected
The authors cited ease of implementation in an obstetrics or allergy clinic as a strength of the study. One limitation is the observed rate of systemic reaction. The wide confidence interval observed indicates the rates of anaphylaxis may actually be as high as 15%, suggested the authors. The small sample size also limits the safety analysis for rare outcomes such as death.
Patient-reported barriers included time commitment for the testing visit. Rural women or those receiving prenatal care from health departments or community health centers were not able to be enrolled. Only one Spanish-speaking woman participated despite availability of bilingual staff and interpreters.
Such outpatient testing for those at greatest risk offers the opportunity to mitigate emerging drug resistance and should ideally take place preconception or at the time of initial allergic reaction, the authors advised. As emphasized in the latest Committee Opinion issued by the American College of Obstetricians and Gynecologists, obstetricians have a real opportunity to counsel patients preconception and postpartum regarding the benefits of penicillin allergy testing.
In a separate interview, Angela Martin, MD, assistant professor, maternal-fetal medicine, at University of Kansas, Kansas City, noted the large clinical implications of this study given that more than 90% of women undergoing allergy testing following self-reported penicillin allergy had a negative test result. “By performing allergy testing on appropriate candidates, as these authors have done, clinicians can treat infections and implement group B streptococcus prophylaxis with the narrowest spectrum antibiotic. This has potential to combat antibiotic resistance and may protect patients from harms caused by unnecessary broad-spectrum antibiotic use during pregnancy and beyond,” said Dr. Martin.
“It should be mentioned that 2 out of the 46 women tested (4%) had an anaphylactic reaction. This highlights the need to perform allergy testing in a qualified center capable of managing acute anaphylactic reactions should they occur,” she advised.
Dr. Desravines and colleagues, as well as Dr. Martin, had no conflicts of interest and no relevant financial disclosures.
SOURCE: Obstet Gynecol. 2021;137:56-61. doi: 10.1097/AOG.0000000000004213.
Successful outpatient penicillin allergy testing with a low incidence of anaphylaxis during pregnancy demonstrates the feasibility of performing allergy testing in the outpatient setting, reported Nerlyne Desravines, MD, of the University of North Carolina, Chapel Hill, and colleagues.
In a prospective cohort study of 74 pregnant patients with previous self reports of penicillin allergy, Dr. Desravines and colleagues sought to determine the feasibility, acceptability, and safety of performing penicillin allergy testing in an outpatient setting. Patients included in the study were aged 18-55 years with gestational age between 14 and 36 weeks and planned delivery within the University of North Carolina heath care system receiving care between March 2019 and March 2020.
Of the 74 women enrolled to participate, 24 failed to present for testing, including some citing scheduling conflicts or fear of adverse reactions. Only 46 of the remaining 50 successfully completed testing; 4 patients were scheduled for testing but unable to participate because of COVID-19 restrictions.
Insurance status may affect participation in testing
Those who had public insurance were less likely to complete testing; those who completed testing were significantly more likely to be married and carry private insurance.
Fully 52% of the 46 women who completed testing were in the second trimester. The majority (85%) experienced their initial penicillin allergy reaction more than 10 years earlier.
Ultimately, 43 of the 46 women (93%) received a negative test result despite previous self reports of severe allergic reaction. Two of the three confirmed with penicillin allergy failed the 10% oral drug challenge; the other tested positive for penicillin G on intradermal testing. The two women who were found to have severe penicillin allergy experienced coughing, chest tightening, and skin and oropharynx pruritus within 30 minutes after their 10% amoxicillin drug challenge; they also experienced vomiting at 1 and 2 hours post ingestion. Following intramuscular injection of epinephrine, oral cetirizine with periodic vital sign measures, and albuterol updraft in one patient with a history of well controlled asthma, symptom resolution was achieved and both women were discharged without the need for further care.
The systemic reactions observed in just 4% of the study population is lower than normally reported in the general population, suggesting that the study sample size may underestimate the actual prevalence of systemic reactions, the authors noted. “The primary factor in safely conducting allergy testing in pregnancy is an outpatient facility that is appropriately outfitted with trained personnel and medications for possible serious reactions,” they added.
Noteworthy is the allergy testing protocol used by Dr. Desravines and colleagues in this study. Their graded oral drug challenge has not been used in previous studies of outpatient penicillin testing in pregnancy. Two of the three participants with positive test results had penicillin allergy confirmed following reaction to the first step (10% dose) of oral challenge to amoxicillin.
Prevalence of systemic reactions may be higher than expected
The authors cited ease of implementation in an obstetrics or allergy clinic as a strength of the study. One limitation is the observed rate of systemic reaction. The wide confidence interval observed indicates the rates of anaphylaxis may actually be as high as 15%, suggested the authors. The small sample size also limits the safety analysis for rare outcomes such as death.
Patient-reported barriers included time commitment for the testing visit. Rural women or those receiving prenatal care from health departments or community health centers were not able to be enrolled. Only one Spanish-speaking woman participated despite availability of bilingual staff and interpreters.
Such outpatient testing for those at greatest risk offers the opportunity to mitigate emerging drug resistance and should ideally take place preconception or at the time of initial allergic reaction, the authors advised. As emphasized in the latest Committee Opinion issued by the American College of Obstetricians and Gynecologists, obstetricians have a real opportunity to counsel patients preconception and postpartum regarding the benefits of penicillin allergy testing.
In a separate interview, Angela Martin, MD, assistant professor, maternal-fetal medicine, at University of Kansas, Kansas City, noted the large clinical implications of this study given that more than 90% of women undergoing allergy testing following self-reported penicillin allergy had a negative test result. “By performing allergy testing on appropriate candidates, as these authors have done, clinicians can treat infections and implement group B streptococcus prophylaxis with the narrowest spectrum antibiotic. This has potential to combat antibiotic resistance and may protect patients from harms caused by unnecessary broad-spectrum antibiotic use during pregnancy and beyond,” said Dr. Martin.
“It should be mentioned that 2 out of the 46 women tested (4%) had an anaphylactic reaction. This highlights the need to perform allergy testing in a qualified center capable of managing acute anaphylactic reactions should they occur,” she advised.
Dr. Desravines and colleagues, as well as Dr. Martin, had no conflicts of interest and no relevant financial disclosures.
SOURCE: Obstet Gynecol. 2021;137:56-61. doi: 10.1097/AOG.0000000000004213.
FROM OBSTETRICS & GYNECOLOGY
Sentinel node biopsy cuts surgery time over lymphadenectomy
Sentinel node biopsy shortens operative time by 13% and may play a role in reducing recovery time and length of hospital stay, reported David L. Tait, MD, of the Levine Cancer Institute, Charlotte, N.C., and colleagues.
In an effort to compare the immediate perioperative outcomes for narcotic usage and use of hospital resources for patients having sentinel node dissection, Dr. Tait and his colleagues conducted a retrospective study of 241 consecutive cases of minimally invasive surgery performed between Jan. 1, 2018, and Aug. 31, 2019, on endometrial cancer patients.
A total of 156 (65%) patients received nodal dissection, including 93 (60%) who received sentinel node biopsy and 63 (40%) who underwent a full lymphadenectomy in accordance with pathological criteria established at the time of surgery. The authors noted no differences between the sentinel group and the lymphadenectomy group in terms of age, body mass index, estimated blood loss, use of a preoperative enhanced recovery after surgery (ERAS) program, tobacco use, or ethanol use. They also found no difference in primary outcome of intravenous narcotics dispensed in surgery, recovery, or total dose.
Sentinel node biopsy offers several advantages
Dr. Tate and colleagues noted that a significantly shorter surgery time, by 27 minutes, on average, was not unexpected with the sentinel node biopsy technique. With lymphadenectomy, surgical procedure and recovery times were longer (214.2 minutes vs. 185.2 minutes and 157.6 minutes vs. 125.2 minutes, respectively) than sentinel biopsy, a difference the researchers could not explain given the similar use of narcotics between the two procedures. Lymphadenectomy also resulted in longer hospital stay than sentinel biopsy (23.5 hours vs. 15.5 hours), with same-day discharge significantly less frequent (16% vs. 50%).
The differences in operative time, recovery time, and hospital stay “are important with respect to improving the efficiency of the operating room, which has become even more important in the era of the COVID-19 pandemic,” the authors noted. They also found noteworthy that recovery and hospital stay are longer after full lymphadenectomy even though there was no difference in overall narcotic administration. Although this suggests surgeon and staff bias, other factors that were not accounted for in the study include distance from hospital, social situation, and functional status.
Change in practice patterns over time and the introduction of a universal ERAS program during the study period were noted as possible limitations. It was also noted that the study did not collect data on functional status or long-term outcome of patients.
The authors did note that using the sentinel node technique was advantageous because it was performed on all patients regardless of risk factors for extra uterine spread since the injection must be performed before hysterectomy. What makes this so beneficial is the potential it offers for detecting nodal metastasis in low-risk patients who may not have otherwise qualified for dissection, said Dr. Tait and colleagues.
In a separate interview, Justin Chura, MD, director of gynecologic oncology and robotic surgery at the Cancer Treatment Centers of America in Philadelphia, observed that “sentinel lymph node [SLN] mapping has been around since the late 1970s. It is most validated in melanoma and breast cancers but has also seen application for gynecological cancers including vulva, cervix, and endometrium. More than 5 years ago, the Society of Gynecologic Oncology issued a clinical practice statement regarding the role of sentinel lymph node mapping for endometrial cancer. An SLN algorithm has been part of [National Comprehensive Cancer Network] guidelines for a similar time frame. The technique faced a lot of skepticism and criticism in the breast cancer literature until randomized studies demonstrated that full axillary adenopathy did not confer a survival benefit. For endometrial cancer, it is unlikely that we will have as robust data, so we often look to retrospective studies such as the one presented by Tait et al.
“The study utilized a data set that was originally collected to assess the impact of an ERAS protocol. So, it is important to note that the data set was not collected with the intent of evaluating SLN mapping versus full lymphadenectomy. This explains why pathological data regarding lymph node yield and final surgicopathologic staging are absent,” he said.
Adoption of sentinel node biopsy is gaining popularity
“Overall, SLN mapping is safe (from a surgical standpoint) and may decrease perioperative morbidity,” Dr. Chura said. “The adoption of SLN mapping also appears to be increasing. Some gyn oncologists (including myself) are even performing SLN mapping on patients with endometrial intraepithelial neoplasia given the risk of malignancy being identified on final pathology.
“The current study provides more of a glimpse into the practice patterns of the authors’ institution where ‘full lymphadenectomy was very dependent upon the surgeon (P < .001)’ than it demonstrates one technique is better than the other. The ultimate question is how we define ‘better?’ Survival? Less morbidity? Improved accuracy of nodal metastasis? Shorter length of stay?” Dr. Chura said.Dr. Tait and colleagues as well as Dr. Chura had no conflicts of interest and no relevant financial disclosures.
SOURCE: Tate DL et al. J Minim Invasive Gynecol. 2020 Dec 19. doi: 10.1016/jmig.2020.12.019.
Sentinel node biopsy shortens operative time by 13% and may play a role in reducing recovery time and length of hospital stay, reported David L. Tait, MD, of the Levine Cancer Institute, Charlotte, N.C., and colleagues.
In an effort to compare the immediate perioperative outcomes for narcotic usage and use of hospital resources for patients having sentinel node dissection, Dr. Tait and his colleagues conducted a retrospective study of 241 consecutive cases of minimally invasive surgery performed between Jan. 1, 2018, and Aug. 31, 2019, on endometrial cancer patients.
A total of 156 (65%) patients received nodal dissection, including 93 (60%) who received sentinel node biopsy and 63 (40%) who underwent a full lymphadenectomy in accordance with pathological criteria established at the time of surgery. The authors noted no differences between the sentinel group and the lymphadenectomy group in terms of age, body mass index, estimated blood loss, use of a preoperative enhanced recovery after surgery (ERAS) program, tobacco use, or ethanol use. They also found no difference in primary outcome of intravenous narcotics dispensed in surgery, recovery, or total dose.
Sentinel node biopsy offers several advantages
Dr. Tate and colleagues noted that a significantly shorter surgery time, by 27 minutes, on average, was not unexpected with the sentinel node biopsy technique. With lymphadenectomy, surgical procedure and recovery times were longer (214.2 minutes vs. 185.2 minutes and 157.6 minutes vs. 125.2 minutes, respectively) than sentinel biopsy, a difference the researchers could not explain given the similar use of narcotics between the two procedures. Lymphadenectomy also resulted in longer hospital stay than sentinel biopsy (23.5 hours vs. 15.5 hours), with same-day discharge significantly less frequent (16% vs. 50%).
The differences in operative time, recovery time, and hospital stay “are important with respect to improving the efficiency of the operating room, which has become even more important in the era of the COVID-19 pandemic,” the authors noted. They also found noteworthy that recovery and hospital stay are longer after full lymphadenectomy even though there was no difference in overall narcotic administration. Although this suggests surgeon and staff bias, other factors that were not accounted for in the study include distance from hospital, social situation, and functional status.
Change in practice patterns over time and the introduction of a universal ERAS program during the study period were noted as possible limitations. It was also noted that the study did not collect data on functional status or long-term outcome of patients.
The authors did note that using the sentinel node technique was advantageous because it was performed on all patients regardless of risk factors for extra uterine spread since the injection must be performed before hysterectomy. What makes this so beneficial is the potential it offers for detecting nodal metastasis in low-risk patients who may not have otherwise qualified for dissection, said Dr. Tait and colleagues.
In a separate interview, Justin Chura, MD, director of gynecologic oncology and robotic surgery at the Cancer Treatment Centers of America in Philadelphia, observed that “sentinel lymph node [SLN] mapping has been around since the late 1970s. It is most validated in melanoma and breast cancers but has also seen application for gynecological cancers including vulva, cervix, and endometrium. More than 5 years ago, the Society of Gynecologic Oncology issued a clinical practice statement regarding the role of sentinel lymph node mapping for endometrial cancer. An SLN algorithm has been part of [National Comprehensive Cancer Network] guidelines for a similar time frame. The technique faced a lot of skepticism and criticism in the breast cancer literature until randomized studies demonstrated that full axillary adenopathy did not confer a survival benefit. For endometrial cancer, it is unlikely that we will have as robust data, so we often look to retrospective studies such as the one presented by Tait et al.
“The study utilized a data set that was originally collected to assess the impact of an ERAS protocol. So, it is important to note that the data set was not collected with the intent of evaluating SLN mapping versus full lymphadenectomy. This explains why pathological data regarding lymph node yield and final surgicopathologic staging are absent,” he said.
Adoption of sentinel node biopsy is gaining popularity
“Overall, SLN mapping is safe (from a surgical standpoint) and may decrease perioperative morbidity,” Dr. Chura said. “The adoption of SLN mapping also appears to be increasing. Some gyn oncologists (including myself) are even performing SLN mapping on patients with endometrial intraepithelial neoplasia given the risk of malignancy being identified on final pathology.
“The current study provides more of a glimpse into the practice patterns of the authors’ institution where ‘full lymphadenectomy was very dependent upon the surgeon (P < .001)’ than it demonstrates one technique is better than the other. The ultimate question is how we define ‘better?’ Survival? Less morbidity? Improved accuracy of nodal metastasis? Shorter length of stay?” Dr. Chura said.Dr. Tait and colleagues as well as Dr. Chura had no conflicts of interest and no relevant financial disclosures.
SOURCE: Tate DL et al. J Minim Invasive Gynecol. 2020 Dec 19. doi: 10.1016/jmig.2020.12.019.
Sentinel node biopsy shortens operative time by 13% and may play a role in reducing recovery time and length of hospital stay, reported David L. Tait, MD, of the Levine Cancer Institute, Charlotte, N.C., and colleagues.
In an effort to compare the immediate perioperative outcomes for narcotic usage and use of hospital resources for patients having sentinel node dissection, Dr. Tait and his colleagues conducted a retrospective study of 241 consecutive cases of minimally invasive surgery performed between Jan. 1, 2018, and Aug. 31, 2019, on endometrial cancer patients.
A total of 156 (65%) patients received nodal dissection, including 93 (60%) who received sentinel node biopsy and 63 (40%) who underwent a full lymphadenectomy in accordance with pathological criteria established at the time of surgery. The authors noted no differences between the sentinel group and the lymphadenectomy group in terms of age, body mass index, estimated blood loss, use of a preoperative enhanced recovery after surgery (ERAS) program, tobacco use, or ethanol use. They also found no difference in primary outcome of intravenous narcotics dispensed in surgery, recovery, or total dose.
Sentinel node biopsy offers several advantages
Dr. Tate and colleagues noted that a significantly shorter surgery time, by 27 minutes, on average, was not unexpected with the sentinel node biopsy technique. With lymphadenectomy, surgical procedure and recovery times were longer (214.2 minutes vs. 185.2 minutes and 157.6 minutes vs. 125.2 minutes, respectively) than sentinel biopsy, a difference the researchers could not explain given the similar use of narcotics between the two procedures. Lymphadenectomy also resulted in longer hospital stay than sentinel biopsy (23.5 hours vs. 15.5 hours), with same-day discharge significantly less frequent (16% vs. 50%).
The differences in operative time, recovery time, and hospital stay “are important with respect to improving the efficiency of the operating room, which has become even more important in the era of the COVID-19 pandemic,” the authors noted. They also found noteworthy that recovery and hospital stay are longer after full lymphadenectomy even though there was no difference in overall narcotic administration. Although this suggests surgeon and staff bias, other factors that were not accounted for in the study include distance from hospital, social situation, and functional status.
Change in practice patterns over time and the introduction of a universal ERAS program during the study period were noted as possible limitations. It was also noted that the study did not collect data on functional status or long-term outcome of patients.
The authors did note that using the sentinel node technique was advantageous because it was performed on all patients regardless of risk factors for extra uterine spread since the injection must be performed before hysterectomy. What makes this so beneficial is the potential it offers for detecting nodal metastasis in low-risk patients who may not have otherwise qualified for dissection, said Dr. Tait and colleagues.
In a separate interview, Justin Chura, MD, director of gynecologic oncology and robotic surgery at the Cancer Treatment Centers of America in Philadelphia, observed that “sentinel lymph node [SLN] mapping has been around since the late 1970s. It is most validated in melanoma and breast cancers but has also seen application for gynecological cancers including vulva, cervix, and endometrium. More than 5 years ago, the Society of Gynecologic Oncology issued a clinical practice statement regarding the role of sentinel lymph node mapping for endometrial cancer. An SLN algorithm has been part of [National Comprehensive Cancer Network] guidelines for a similar time frame. The technique faced a lot of skepticism and criticism in the breast cancer literature until randomized studies demonstrated that full axillary adenopathy did not confer a survival benefit. For endometrial cancer, it is unlikely that we will have as robust data, so we often look to retrospective studies such as the one presented by Tait et al.
“The study utilized a data set that was originally collected to assess the impact of an ERAS protocol. So, it is important to note that the data set was not collected with the intent of evaluating SLN mapping versus full lymphadenectomy. This explains why pathological data regarding lymph node yield and final surgicopathologic staging are absent,” he said.
Adoption of sentinel node biopsy is gaining popularity
“Overall, SLN mapping is safe (from a surgical standpoint) and may decrease perioperative morbidity,” Dr. Chura said. “The adoption of SLN mapping also appears to be increasing. Some gyn oncologists (including myself) are even performing SLN mapping on patients with endometrial intraepithelial neoplasia given the risk of malignancy being identified on final pathology.
“The current study provides more of a glimpse into the practice patterns of the authors’ institution where ‘full lymphadenectomy was very dependent upon the surgeon (P < .001)’ than it demonstrates one technique is better than the other. The ultimate question is how we define ‘better?’ Survival? Less morbidity? Improved accuracy of nodal metastasis? Shorter length of stay?” Dr. Chura said.Dr. Tait and colleagues as well as Dr. Chura had no conflicts of interest and no relevant financial disclosures.
SOURCE: Tate DL et al. J Minim Invasive Gynecol. 2020 Dec 19. doi: 10.1016/jmig.2020.12.019.
FROM THE JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY
Anaphylaxis cases after COVID-19 vaccine rising but still rare: CDC
Health care providers should be ready to treat rare cases of anaphylaxis following administration of COVID-19 vaccines, federal medical officials have urged. The officials also stressed the importance of continuing vaccinations, despite reports of the rare side effect.
There have been 29 cases of anaphylaxis to date following administration of a COVID-19 vaccine, officials from the Centers for Disease Control and Prevention said in a call with reporters on Jan. 6.
The severe allergic reaction, which appears to be rare, can happen with either the Pfizer-BioNTech vaccine or the rival Moderna product. The Food and Drug Administration granted emergency use authorizations for these two vaccines in December.
Even with the cases seen to date, the COVID-19 vaccines remain a “good value proposition,” Nancy Messonnier, MD, director of the CDC’s National Center for Immunization, said in the call.
There have been about 11.1 cases of anaphylaxis per million doses with the Pfizer-BioNTech COVID-19 vaccine, which is higher than the estimated 1.3 cases per million doses with influenza vaccines, she said. But the low risk of anaphylaxis must be balanced against the threat of COVID-19, which currently claims about 2,000 lives a day in the United States, she said. In addition, many people are reporting long-term complications with COVID-19 even if they recover.
Kept in context, the data on anaphylaxis should not scare people away from getting a COVID-19 vaccine, she added.
“Their risk from COVID and poor outcomes is still more than the risk of a severe outcome from the vaccine,” Dr. Messonnier said. “And fortunately, we know how to treat anaphylaxis.”
Dr. Messonnier urged health care workers administering COVID-19 vaccines to be prepared.
“Anybody administering vaccines needs not just to have the EpiPen available, but frankly, to know how to use it,” Dr. Messonnier said.
MMWR details
The CDC on Jan. 6 also provided an update on anaphylaxis in Morbidity and Mortality Weekly Report (MMWR).
The information included in the report was based on cases reported with the Pfizer-BioNTech vaccine – the first to get emergency use authorization from the FDA. On the call with reporters, CDC officials confirmed there have been additional reports since then and anaphylaxis has been reported with both the Pfizer-BioNTech and Moderna vaccines. CDC officials said they could not give a breakdown of how many cases were linked to each of these products at this time.
Between Dec. 14 and 23, 2020, monitoring by the Vaccine Adverse Event Reporting System detected 21 cases of anaphylaxis after administration of a reported 1,893,360 first doses of the Pfizer-BioNTech COVID-19 vaccine. Most reactions – 71% – occurred within 15 minutes of vaccination.
A version of this article first appeared on Medscape.com.
Health care providers should be ready to treat rare cases of anaphylaxis following administration of COVID-19 vaccines, federal medical officials have urged. The officials also stressed the importance of continuing vaccinations, despite reports of the rare side effect.
There have been 29 cases of anaphylaxis to date following administration of a COVID-19 vaccine, officials from the Centers for Disease Control and Prevention said in a call with reporters on Jan. 6.
The severe allergic reaction, which appears to be rare, can happen with either the Pfizer-BioNTech vaccine or the rival Moderna product. The Food and Drug Administration granted emergency use authorizations for these two vaccines in December.
Even with the cases seen to date, the COVID-19 vaccines remain a “good value proposition,” Nancy Messonnier, MD, director of the CDC’s National Center for Immunization, said in the call.
There have been about 11.1 cases of anaphylaxis per million doses with the Pfizer-BioNTech COVID-19 vaccine, which is higher than the estimated 1.3 cases per million doses with influenza vaccines, she said. But the low risk of anaphylaxis must be balanced against the threat of COVID-19, which currently claims about 2,000 lives a day in the United States, she said. In addition, many people are reporting long-term complications with COVID-19 even if they recover.
Kept in context, the data on anaphylaxis should not scare people away from getting a COVID-19 vaccine, she added.
“Their risk from COVID and poor outcomes is still more than the risk of a severe outcome from the vaccine,” Dr. Messonnier said. “And fortunately, we know how to treat anaphylaxis.”
Dr. Messonnier urged health care workers administering COVID-19 vaccines to be prepared.
“Anybody administering vaccines needs not just to have the EpiPen available, but frankly, to know how to use it,” Dr. Messonnier said.
MMWR details
The CDC on Jan. 6 also provided an update on anaphylaxis in Morbidity and Mortality Weekly Report (MMWR).
The information included in the report was based on cases reported with the Pfizer-BioNTech vaccine – the first to get emergency use authorization from the FDA. On the call with reporters, CDC officials confirmed there have been additional reports since then and anaphylaxis has been reported with both the Pfizer-BioNTech and Moderna vaccines. CDC officials said they could not give a breakdown of how many cases were linked to each of these products at this time.
Between Dec. 14 and 23, 2020, monitoring by the Vaccine Adverse Event Reporting System detected 21 cases of anaphylaxis after administration of a reported 1,893,360 first doses of the Pfizer-BioNTech COVID-19 vaccine. Most reactions – 71% – occurred within 15 minutes of vaccination.
A version of this article first appeared on Medscape.com.
Health care providers should be ready to treat rare cases of anaphylaxis following administration of COVID-19 vaccines, federal medical officials have urged. The officials also stressed the importance of continuing vaccinations, despite reports of the rare side effect.
There have been 29 cases of anaphylaxis to date following administration of a COVID-19 vaccine, officials from the Centers for Disease Control and Prevention said in a call with reporters on Jan. 6.
The severe allergic reaction, which appears to be rare, can happen with either the Pfizer-BioNTech vaccine or the rival Moderna product. The Food and Drug Administration granted emergency use authorizations for these two vaccines in December.
Even with the cases seen to date, the COVID-19 vaccines remain a “good value proposition,” Nancy Messonnier, MD, director of the CDC’s National Center for Immunization, said in the call.
There have been about 11.1 cases of anaphylaxis per million doses with the Pfizer-BioNTech COVID-19 vaccine, which is higher than the estimated 1.3 cases per million doses with influenza vaccines, she said. But the low risk of anaphylaxis must be balanced against the threat of COVID-19, which currently claims about 2,000 lives a day in the United States, she said. In addition, many people are reporting long-term complications with COVID-19 even if they recover.
Kept in context, the data on anaphylaxis should not scare people away from getting a COVID-19 vaccine, she added.
“Their risk from COVID and poor outcomes is still more than the risk of a severe outcome from the vaccine,” Dr. Messonnier said. “And fortunately, we know how to treat anaphylaxis.”
Dr. Messonnier urged health care workers administering COVID-19 vaccines to be prepared.
“Anybody administering vaccines needs not just to have the EpiPen available, but frankly, to know how to use it,” Dr. Messonnier said.
MMWR details
The CDC on Jan. 6 also provided an update on anaphylaxis in Morbidity and Mortality Weekly Report (MMWR).
The information included in the report was based on cases reported with the Pfizer-BioNTech vaccine – the first to get emergency use authorization from the FDA. On the call with reporters, CDC officials confirmed there have been additional reports since then and anaphylaxis has been reported with both the Pfizer-BioNTech and Moderna vaccines. CDC officials said they could not give a breakdown of how many cases were linked to each of these products at this time.
Between Dec. 14 and 23, 2020, monitoring by the Vaccine Adverse Event Reporting System detected 21 cases of anaphylaxis after administration of a reported 1,893,360 first doses of the Pfizer-BioNTech COVID-19 vaccine. Most reactions – 71% – occurred within 15 minutes of vaccination.
A version of this article first appeared on Medscape.com.
Guidance issued on COVID vaccine use in patients with dermal fillers
outlining the potential risk and clinical relevance.
The association is not surprising, since other vaccines, including the influenza vaccine, have also been associated with inflammatory reactions in patients with dermal fillers. A warning about inflammatory events from these and other immunologic triggers should be part of routine informed consent, according to Sue Ellen Cox, MD, a coauthor of the guidance and the ASDS president-elect.
“Patients who have had dermal filler should not be discouraged from receiving the vaccine, and those who have received the vaccine should not be discouraged from receiving dermal filler,” Dr. Cox, who practices in Chapel Hill, N.C., said in an interview.
The only available data to assess the risk came from the trial of the Moderna vaccine. Of a total of 15,184 participants who received at least one dose of mRNA-1273, three developed facial or lip swelling that was presumably related to dermal filler. In the placebo group, there were no comparable inflammatory events.
“This is a very small number, but there is no reliable information about the number of patients in either group who had dermal filler, so we do not know the denominator,” Dr. Cox said.
In all three cases, the swelling at the site of dermal filler was observed within 2 days of the vaccination. None were considered a serious adverse event and all resolved. The filler had been administered 2 weeks prior to vaccination in one case, 6 months prior in a second, and time of administration was unknown in the third.
The resolution of the inflammatory reactions associated with the SARS-CoV-2 vaccine is similar to those related to dermal fillers following other immunologic triggers, which not only include other vaccines, but viral or bacterial illnesses and dental procedures. Typically, they are readily controlled with oral corticosteroids, but also typically resolve even in the absence of treatment, according to Dr. Cox.
“The good news is that these will go away,” Dr. Cox said.
The ASDS guidance is meant to alert clinicians and patients to the potential association between inflammatory events and SARS-CoV-2 vaccination in patients with dermal filler, but Dr. Cox said that it will ultimately have very little effect on her own practice. She already employs an informed consent that includes language warning about the potential risk of local reactions to immunological triggers that include vaccines. SARS-CoV-2 vaccination can now be added to examples of potential triggers, but it does not change the importance of informing patients of such triggers, Dr. Cox explained.
Asked if patients should be informed specifically about the association between dermal filler inflammatory reactions and SARS-CoV-2 vaccine, the current ASDS president and first author of the guidance, Mathew Avram, MD, JD, suggested that they should. Although he emphasized that the side effect is clearly rare, he believes it deserves attention.
“We wanted dermatologists and other physicians to be aware of the potential. We focused on the available data but specifically decided not to provide any treatment recommendations at this time,” he said in an interview.
As new data become available, the Soft-Tissue Fillers Guideline Task Force of the ASDS, which provided the guidance, will continue to monitor the relationship between SARS-CoV-2 vaccinations and dermal filler reactions, including other SARS-CoV-2 vaccines and the relative risks for hyaluronic acid and non–hyaluronic acid types of fillers.
“Our guidance was based only on the trial data, but there will soon be tens of millions of patients exposed to several different SARS-CoV-2 vaccines. We may learn things we do not know now, and we plan to communicate to our membership and others any new information as events unfold,” said Dr. Avram, who is director of dermatologic surgery, Massachusetts General Hospital, Boston,
Based on her own expertise in the field, Dr. Cox suggested that administration of SARS-CoV-2 vaccine and administration of dermal filler should be separated by at least 2 weeks regardless of which comes first. Her recommendation is not based on controlled data, but she considers this a prudent interval even if it has not been tested in a controlled study.
The full ASDS guidance is scheduled to appear in an upcoming issue of Dermatologic Surgery.
As new data become available, the Soft-tissue Fillers Guideline Task Force of the ASDS, which provided the guidance, will continue to monitor the relationship between SARS-CoV-2 vaccinations and dermal filler reactions, including other types of vaccines and the relative risks for hyaluronic acid and non–hyaluronic acid types of fillers.
This article was updated 1/7/21.
outlining the potential risk and clinical relevance.
The association is not surprising, since other vaccines, including the influenza vaccine, have also been associated with inflammatory reactions in patients with dermal fillers. A warning about inflammatory events from these and other immunologic triggers should be part of routine informed consent, according to Sue Ellen Cox, MD, a coauthor of the guidance and the ASDS president-elect.
“Patients who have had dermal filler should not be discouraged from receiving the vaccine, and those who have received the vaccine should not be discouraged from receiving dermal filler,” Dr. Cox, who practices in Chapel Hill, N.C., said in an interview.
The only available data to assess the risk came from the trial of the Moderna vaccine. Of a total of 15,184 participants who received at least one dose of mRNA-1273, three developed facial or lip swelling that was presumably related to dermal filler. In the placebo group, there were no comparable inflammatory events.
“This is a very small number, but there is no reliable information about the number of patients in either group who had dermal filler, so we do not know the denominator,” Dr. Cox said.
In all three cases, the swelling at the site of dermal filler was observed within 2 days of the vaccination. None were considered a serious adverse event and all resolved. The filler had been administered 2 weeks prior to vaccination in one case, 6 months prior in a second, and time of administration was unknown in the third.
The resolution of the inflammatory reactions associated with the SARS-CoV-2 vaccine is similar to those related to dermal fillers following other immunologic triggers, which not only include other vaccines, but viral or bacterial illnesses and dental procedures. Typically, they are readily controlled with oral corticosteroids, but also typically resolve even in the absence of treatment, according to Dr. Cox.
“The good news is that these will go away,” Dr. Cox said.
The ASDS guidance is meant to alert clinicians and patients to the potential association between inflammatory events and SARS-CoV-2 vaccination in patients with dermal filler, but Dr. Cox said that it will ultimately have very little effect on her own practice. She already employs an informed consent that includes language warning about the potential risk of local reactions to immunological triggers that include vaccines. SARS-CoV-2 vaccination can now be added to examples of potential triggers, but it does not change the importance of informing patients of such triggers, Dr. Cox explained.
Asked if patients should be informed specifically about the association between dermal filler inflammatory reactions and SARS-CoV-2 vaccine, the current ASDS president and first author of the guidance, Mathew Avram, MD, JD, suggested that they should. Although he emphasized that the side effect is clearly rare, he believes it deserves attention.
“We wanted dermatologists and other physicians to be aware of the potential. We focused on the available data but specifically decided not to provide any treatment recommendations at this time,” he said in an interview.
As new data become available, the Soft-Tissue Fillers Guideline Task Force of the ASDS, which provided the guidance, will continue to monitor the relationship between SARS-CoV-2 vaccinations and dermal filler reactions, including other SARS-CoV-2 vaccines and the relative risks for hyaluronic acid and non–hyaluronic acid types of fillers.
“Our guidance was based only on the trial data, but there will soon be tens of millions of patients exposed to several different SARS-CoV-2 vaccines. We may learn things we do not know now, and we plan to communicate to our membership and others any new information as events unfold,” said Dr. Avram, who is director of dermatologic surgery, Massachusetts General Hospital, Boston,
Based on her own expertise in the field, Dr. Cox suggested that administration of SARS-CoV-2 vaccine and administration of dermal filler should be separated by at least 2 weeks regardless of which comes first. Her recommendation is not based on controlled data, but she considers this a prudent interval even if it has not been tested in a controlled study.
The full ASDS guidance is scheduled to appear in an upcoming issue of Dermatologic Surgery.
As new data become available, the Soft-tissue Fillers Guideline Task Force of the ASDS, which provided the guidance, will continue to monitor the relationship between SARS-CoV-2 vaccinations and dermal filler reactions, including other types of vaccines and the relative risks for hyaluronic acid and non–hyaluronic acid types of fillers.
This article was updated 1/7/21.
outlining the potential risk and clinical relevance.
The association is not surprising, since other vaccines, including the influenza vaccine, have also been associated with inflammatory reactions in patients with dermal fillers. A warning about inflammatory events from these and other immunologic triggers should be part of routine informed consent, according to Sue Ellen Cox, MD, a coauthor of the guidance and the ASDS president-elect.
“Patients who have had dermal filler should not be discouraged from receiving the vaccine, and those who have received the vaccine should not be discouraged from receiving dermal filler,” Dr. Cox, who practices in Chapel Hill, N.C., said in an interview.
The only available data to assess the risk came from the trial of the Moderna vaccine. Of a total of 15,184 participants who received at least one dose of mRNA-1273, three developed facial or lip swelling that was presumably related to dermal filler. In the placebo group, there were no comparable inflammatory events.
“This is a very small number, but there is no reliable information about the number of patients in either group who had dermal filler, so we do not know the denominator,” Dr. Cox said.
In all three cases, the swelling at the site of dermal filler was observed within 2 days of the vaccination. None were considered a serious adverse event and all resolved. The filler had been administered 2 weeks prior to vaccination in one case, 6 months prior in a second, and time of administration was unknown in the third.
The resolution of the inflammatory reactions associated with the SARS-CoV-2 vaccine is similar to those related to dermal fillers following other immunologic triggers, which not only include other vaccines, but viral or bacterial illnesses and dental procedures. Typically, they are readily controlled with oral corticosteroids, but also typically resolve even in the absence of treatment, according to Dr. Cox.
“The good news is that these will go away,” Dr. Cox said.
The ASDS guidance is meant to alert clinicians and patients to the potential association between inflammatory events and SARS-CoV-2 vaccination in patients with dermal filler, but Dr. Cox said that it will ultimately have very little effect on her own practice. She already employs an informed consent that includes language warning about the potential risk of local reactions to immunological triggers that include vaccines. SARS-CoV-2 vaccination can now be added to examples of potential triggers, but it does not change the importance of informing patients of such triggers, Dr. Cox explained.
Asked if patients should be informed specifically about the association between dermal filler inflammatory reactions and SARS-CoV-2 vaccine, the current ASDS president and first author of the guidance, Mathew Avram, MD, JD, suggested that they should. Although he emphasized that the side effect is clearly rare, he believes it deserves attention.
“We wanted dermatologists and other physicians to be aware of the potential. We focused on the available data but specifically decided not to provide any treatment recommendations at this time,” he said in an interview.
As new data become available, the Soft-Tissue Fillers Guideline Task Force of the ASDS, which provided the guidance, will continue to monitor the relationship between SARS-CoV-2 vaccinations and dermal filler reactions, including other SARS-CoV-2 vaccines and the relative risks for hyaluronic acid and non–hyaluronic acid types of fillers.
“Our guidance was based only on the trial data, but there will soon be tens of millions of patients exposed to several different SARS-CoV-2 vaccines. We may learn things we do not know now, and we plan to communicate to our membership and others any new information as events unfold,” said Dr. Avram, who is director of dermatologic surgery, Massachusetts General Hospital, Boston,
Based on her own expertise in the field, Dr. Cox suggested that administration of SARS-CoV-2 vaccine and administration of dermal filler should be separated by at least 2 weeks regardless of which comes first. Her recommendation is not based on controlled data, but she considers this a prudent interval even if it has not been tested in a controlled study.
The full ASDS guidance is scheduled to appear in an upcoming issue of Dermatologic Surgery.
As new data become available, the Soft-tissue Fillers Guideline Task Force of the ASDS, which provided the guidance, will continue to monitor the relationship between SARS-CoV-2 vaccinations and dermal filler reactions, including other types of vaccines and the relative risks for hyaluronic acid and non–hyaluronic acid types of fillers.
This article was updated 1/7/21.
Higher dose maximizes effects of magnesium sulfate for obese women
Obese women may benefit from a higher dose of magnesium sulfate to protect against preeclampsia, based on data from a randomized trial.
Pharmacokinetic models have shown that, “in women who received a 4-g intravenous loading dose followed by a 2-g/h IV maintenance dose, obese women took approximately twice as long as women of mean body weight in the sample to achieve these previously accepted therapeutic serum magnesium concentrations,” which suggests the need for alternate dosing based on body mass index, wrote Kathleen F. Brookfield, MD, of Oregon Health & Science University, Portland, and colleagues.
In a study published in Obstetrics & Gynecology, the researchers randomized 37 women aged 15-45 years with a BMI of 35 kg/m2 or higher who were at least 32 weeks’ gestation to receive the standard Zuspan regimen of magnesium sulfate (4 g intravenous loading dose, followed by a 1-g/hour infusion) or to higher dosing (6 g IV loading dose, followed by a 2-g/hour infusion).
Higher dose increases effectiveness
Serum magnesium concentrations were measured at baseline, and after administration of magnesium sulfate at 1 hour, 4 hours, and delivery; the primary outcome was the proportion of women with subtherapeutic serum magnesium concentrations (less than 4.8 mg/dL) 4 hours after administration.
After 4 hours, the average magnesium sulfate concentrations were significantly higher for women in the high-dose group vs. the standard group (4.41 mg/dL vs. 3.53 mg/dL). In addition, 100% of women in the standard group had subtherapeutic serum magnesium concentrations compared with 63% of the high-dose group.
No significant differences in maternal side effects or neonatal outcomes occurred between the groups. However, rates of nausea and flushing were higher in the higher dose group, compared with the standard group (10.5% vs. 5.5% and 5.2% vs. 0%, respectively).
The study findings were limited by several factors including the lack of statistical power to evaluate clinical outcomes and lack of generalizability to extremely obese patients, as well as to settings in which the higher-dose regimen is already the standard treatment, the researchers noted. However, the results were strengthened by the use of prospective pharmacokinetic data to determine dosing.
The researchers also noted that the study was not powered to examine preeclampsia as an outcome “and there is no evidence to date to suggest women in the United States with higher BMIs are more likely to experience eclampsia,” they said. “Therefore, we caution against universally applying the study findings to obese women without also considering the potential for increased toxicity with higher dosing regimens,” they added.
Current results may not affect practice
The study objectives are unclear, as they do not change the dosing for magnesium sulfate already in use, said Baha M. Sibai, MD, of the University of Texas Health Science Center at Houston, in an interview.
Dr. Sibai said he was not surprised by the findings. “This information has been known for almost 30 years as to serum levels with different dosing irrespective of BMI,” he said. Based on current evidence, Dr. Sibai advised clinicians “not to change your practice, since there are no therapeutic levels for preventing seizures.” In fact, “the largest trial that included 10,000 women showed no difference in the rate of eclampsia between 4 grams loading with 1 g/hour [magnesium sulfate] and 6 g loading and 2 g/hour,” he explained.
Future research should focus on different outcomes, said Dr. Sibai. “The outcome should be eclampsia and not serum levels. This requires studying over 6,000 women,” he emphasized.
The study was supported by the National Institutes of Health Loan Repayment Program and a Mission Support Award from Oregon Health & Science University to Dr. Brookfield and by the Oregon Clinical & Translational Research Institute grant. Dr. Brookfield also disclosed funding from the World Health Organization. Dr. Sibai had no financial conflicts to disclose.
SOURCE: Brookfield KF et al. Obstet Gynecol. 2020 Dec. doi: 10.1097/AOG.0000000000004137.
Obese women may benefit from a higher dose of magnesium sulfate to protect against preeclampsia, based on data from a randomized trial.
Pharmacokinetic models have shown that, “in women who received a 4-g intravenous loading dose followed by a 2-g/h IV maintenance dose, obese women took approximately twice as long as women of mean body weight in the sample to achieve these previously accepted therapeutic serum magnesium concentrations,” which suggests the need for alternate dosing based on body mass index, wrote Kathleen F. Brookfield, MD, of Oregon Health & Science University, Portland, and colleagues.
In a study published in Obstetrics & Gynecology, the researchers randomized 37 women aged 15-45 years with a BMI of 35 kg/m2 or higher who were at least 32 weeks’ gestation to receive the standard Zuspan regimen of magnesium sulfate (4 g intravenous loading dose, followed by a 1-g/hour infusion) or to higher dosing (6 g IV loading dose, followed by a 2-g/hour infusion).
Higher dose increases effectiveness
Serum magnesium concentrations were measured at baseline, and after administration of magnesium sulfate at 1 hour, 4 hours, and delivery; the primary outcome was the proportion of women with subtherapeutic serum magnesium concentrations (less than 4.8 mg/dL) 4 hours after administration.
After 4 hours, the average magnesium sulfate concentrations were significantly higher for women in the high-dose group vs. the standard group (4.41 mg/dL vs. 3.53 mg/dL). In addition, 100% of women in the standard group had subtherapeutic serum magnesium concentrations compared with 63% of the high-dose group.
No significant differences in maternal side effects or neonatal outcomes occurred between the groups. However, rates of nausea and flushing were higher in the higher dose group, compared with the standard group (10.5% vs. 5.5% and 5.2% vs. 0%, respectively).
The study findings were limited by several factors including the lack of statistical power to evaluate clinical outcomes and lack of generalizability to extremely obese patients, as well as to settings in which the higher-dose regimen is already the standard treatment, the researchers noted. However, the results were strengthened by the use of prospective pharmacokinetic data to determine dosing.
The researchers also noted that the study was not powered to examine preeclampsia as an outcome “and there is no evidence to date to suggest women in the United States with higher BMIs are more likely to experience eclampsia,” they said. “Therefore, we caution against universally applying the study findings to obese women without also considering the potential for increased toxicity with higher dosing regimens,” they added.
Current results may not affect practice
The study objectives are unclear, as they do not change the dosing for magnesium sulfate already in use, said Baha M. Sibai, MD, of the University of Texas Health Science Center at Houston, in an interview.
Dr. Sibai said he was not surprised by the findings. “This information has been known for almost 30 years as to serum levels with different dosing irrespective of BMI,” he said. Based on current evidence, Dr. Sibai advised clinicians “not to change your practice, since there are no therapeutic levels for preventing seizures.” In fact, “the largest trial that included 10,000 women showed no difference in the rate of eclampsia between 4 grams loading with 1 g/hour [magnesium sulfate] and 6 g loading and 2 g/hour,” he explained.
Future research should focus on different outcomes, said Dr. Sibai. “The outcome should be eclampsia and not serum levels. This requires studying over 6,000 women,” he emphasized.
The study was supported by the National Institutes of Health Loan Repayment Program and a Mission Support Award from Oregon Health & Science University to Dr. Brookfield and by the Oregon Clinical & Translational Research Institute grant. Dr. Brookfield also disclosed funding from the World Health Organization. Dr. Sibai had no financial conflicts to disclose.
SOURCE: Brookfield KF et al. Obstet Gynecol. 2020 Dec. doi: 10.1097/AOG.0000000000004137.
Obese women may benefit from a higher dose of magnesium sulfate to protect against preeclampsia, based on data from a randomized trial.
Pharmacokinetic models have shown that, “in women who received a 4-g intravenous loading dose followed by a 2-g/h IV maintenance dose, obese women took approximately twice as long as women of mean body weight in the sample to achieve these previously accepted therapeutic serum magnesium concentrations,” which suggests the need for alternate dosing based on body mass index, wrote Kathleen F. Brookfield, MD, of Oregon Health & Science University, Portland, and colleagues.
In a study published in Obstetrics & Gynecology, the researchers randomized 37 women aged 15-45 years with a BMI of 35 kg/m2 or higher who were at least 32 weeks’ gestation to receive the standard Zuspan regimen of magnesium sulfate (4 g intravenous loading dose, followed by a 1-g/hour infusion) or to higher dosing (6 g IV loading dose, followed by a 2-g/hour infusion).
Higher dose increases effectiveness
Serum magnesium concentrations were measured at baseline, and after administration of magnesium sulfate at 1 hour, 4 hours, and delivery; the primary outcome was the proportion of women with subtherapeutic serum magnesium concentrations (less than 4.8 mg/dL) 4 hours after administration.
After 4 hours, the average magnesium sulfate concentrations were significantly higher for women in the high-dose group vs. the standard group (4.41 mg/dL vs. 3.53 mg/dL). In addition, 100% of women in the standard group had subtherapeutic serum magnesium concentrations compared with 63% of the high-dose group.
No significant differences in maternal side effects or neonatal outcomes occurred between the groups. However, rates of nausea and flushing were higher in the higher dose group, compared with the standard group (10.5% vs. 5.5% and 5.2% vs. 0%, respectively).
The study findings were limited by several factors including the lack of statistical power to evaluate clinical outcomes and lack of generalizability to extremely obese patients, as well as to settings in which the higher-dose regimen is already the standard treatment, the researchers noted. However, the results were strengthened by the use of prospective pharmacokinetic data to determine dosing.
The researchers also noted that the study was not powered to examine preeclampsia as an outcome “and there is no evidence to date to suggest women in the United States with higher BMIs are more likely to experience eclampsia,” they said. “Therefore, we caution against universally applying the study findings to obese women without also considering the potential for increased toxicity with higher dosing regimens,” they added.
Current results may not affect practice
The study objectives are unclear, as they do not change the dosing for magnesium sulfate already in use, said Baha M. Sibai, MD, of the University of Texas Health Science Center at Houston, in an interview.
Dr. Sibai said he was not surprised by the findings. “This information has been known for almost 30 years as to serum levels with different dosing irrespective of BMI,” he said. Based on current evidence, Dr. Sibai advised clinicians “not to change your practice, since there are no therapeutic levels for preventing seizures.” In fact, “the largest trial that included 10,000 women showed no difference in the rate of eclampsia between 4 grams loading with 1 g/hour [magnesium sulfate] and 6 g loading and 2 g/hour,” he explained.
Future research should focus on different outcomes, said Dr. Sibai. “The outcome should be eclampsia and not serum levels. This requires studying over 6,000 women,” he emphasized.
The study was supported by the National Institutes of Health Loan Repayment Program and a Mission Support Award from Oregon Health & Science University to Dr. Brookfield and by the Oregon Clinical & Translational Research Institute grant. Dr. Brookfield also disclosed funding from the World Health Organization. Dr. Sibai had no financial conflicts to disclose.
SOURCE: Brookfield KF et al. Obstet Gynecol. 2020 Dec. doi: 10.1097/AOG.0000000000004137.
FROM OBSTETRICS & GYNECOLOGY