MDedge Pediatrics

As COVID-19 cases mounted in Texas in late June, a local Houston news station shadowed Joseph Varon, MD, making rounds in the intensive care unit at United Memorial Medical Center in Houston. An unseen newscaster tells viewers that Varon credits his success against COVID-19 so far to an experimental and “controversial” drug protocol consisting of vitamins, steroids, and blood thinners.

“This is war. There’s no time to double-blind anything,” Varon tells the camera. “This is working. And if it’s working, I’m going to keep on doing it.”

Varon is one of 10 physicians behind the protocol known as MATH+, which in media interviews and congressional testimony they say has worked to treat COVID-19 patients and save lives in their intensive care units across the country. But response to the protocol among other critical care physicians is mixed, with several physicians, in interviews with Medscape Medical News, urging caution because the benefits and relative risks of the combined medications have not been tested in randomized control trials.

From the earliest days of the pandemic, there’s been tension between the need for rigorous scientific study to understand a novel disease, which takes time, and the need to treat seriously ill patients immediately. Some treatments, like hydroxychloroquine, were promoted without randomized clinical trial data and then later were shown to be ineffective or even potentially harmful when tested.

“This pandemic has shown us there’s lots of ideas out there and they need to be tested and a theoretical basis is insufficient,” says Daniel Kaul, MD, a professor of infectious disease at the University of Michigan in Ann Arbor. The ups and downs with hydroxychloroquine offer a sobering example, he says. “I would argue we have an ethical obligation to do randomized controlled trials to see if our treatments work.”
 

Creating MATH+

MATH+ stands for methylprednisolone, ascorbic acid, thiamine, and heparin. The “+” holds a place for additional therapies like vitamin D, zinc, and melatonin. The protocol originated as a variation of the “HAT therapy,” a combination of hydrocortisone, ascorbic acid, and thiamine, which critical care specialist Paul Marik, MD, created for treating critically ill patients with sepsis.

Over a few weeks, the protocol evolved as Marik, chief of the division of pulmonary and critical care medicine at Eastern Virginia Medical School in Norfolk, emailed with a small group of colleagues about treatments and their observations of SARS-CoV-2 in action, swapping in methylprednisolone and adding the anticoagulant heparin.

When Marik and colleagues created the protocol in early March, many healthcare organizations like the World Health Organization (WHO) were advising against steroids for COVID-19 patients. The MATH+ physicians decided they needed to spread a different message, and began publicizing the protocol with a website and a small communications team.

Marik says they tried to get their protocol in front of healthcare organizations – including the WHO, the Centers for Disease Control and Prevention, and the National Institutes of Health – but received no response. Marik went on Newt Gingrich’s podcast to discuss the protocol in the hopes it would make its way to the White House.

Senator Ron Johnson of Wisconsin saw the protocol and invited Pierre Kory, MD, MPA, who practices in Johnson’s home state, to testify remotely in front of the Senate Homeland Security Committee. Kory is a pulmonary critical care specialist about to start a new job at Aurora St. Luke’s Medical Center in Milwaukee.

In his testimony, Kory shared his positive experience using the protocol to treat patients and expressed his dismay that national healthcare organizations came out against the use of corticosteroids for COVID-19 from the early days of the pandemic based on what he called a “tragic error in analysis of medical data.” Although an analysis by national organizations suggested corticosteroids might be dangerous in COVID-19 patients, one of his colleagues came to the opposite conclusion, he said. But these organizations advised supportive care only, and against steroids. “We think that is a fatal and tragic flaw,” Kory said.

“The problem with the protocol early on was that it was heresy,” says Kory, referring to the protocol’s inclusion of corticosteroids before official treatment guidelines. During the height of the pandemic in New York this spring, Kory spent 5 weeks working in the ICU at Mount Sinai Beth Israel in Manhattan. Seeing patients flounder on supportive care, Kory says he used MATH+ successfully during his time in New York, using escalating and pulse doses of corticosteroids to stabilize rapidly deteriorating patients.

The website’s home page initially included an invitation for visitors to donate money to support “getting word of this effective treatment protocol out to physicians and hospitals around the world.” After Medscape Medical News brought up the donation prompt in questions, the physicians decided to remove all calls for donations from the website and social media, communications representative Betsy Ashton said. “Critics are misinterpreting this as some kind of fund-raising operation, when that could hardly be the case,” Ashton said in an email. “They are horrified that anyone would impugn their motives.”

Donations paid for the website designer, webmaster, and her work, Ashton said, and the physicians now have donors who will support publicizing the protocol without online calls for donations. “We have no commercial or vested interest,” Marik said. “I’m not going to make a single cent out of this and it’s obviously very time-consuming.”
 

The basis for the protocol

The protocol is based on common sense, an understanding of scientific literature, and an understanding of COVID-19, Marik says. The website includes links to past research trials and observational studies examining ascorbic acid and thiamine in critically ill patients and early looks at anticoagulants in COVID-19 patients.

They chose methylprednisolone as their corticosteroid based on the expertise of group member G. Umberto Meduri, MD, professor of medicine at the University of Tennessee Health Science Center in Memphis, Tennessee, who had found the steroid effective in treating acute respiratory distress syndrome. On the MATH+ website, the physicians link to multiple observational studies posted on preprint servers in April and May that suggest methylprednisolone helped COVID-19 patients.

“What’s happened with time is all the elements have been validated by scientific studies, which makes this so cool,” says Marik. The RECOVERY Trial results in particular validated the push to use corticosteroids in COVID-19 patients, he says. But that study used a different steroid, dexamethasone, in much smaller doses than what MATH+ recommends. Revised guidance from the Infectious Diseases Society of America recommends dexamethasone for severely ill patients, but says methylprednisolone and prednisone can be used as substitutes at equivalent doses.

Marik and Kory say that mortality rates for COVID-19 patients at their respective hospitals decreased after they began using the protocol. The physicians have been collecting observational data on their patients, but have not yet published any, and do not plan to conduct a randomized trial.

Several physicians who were not involved in the creation of the protocol say the evidence the physicians cite is not robust enough to warrant the promotion of MATH+ and call for randomized controlled trials. Coming up with a protocol is fine, says Kaul, but “you have to do the hard work of doing a randomized control trial to determine if those drugs given in those combinations work or not.”

“When I looked at it, I thought it was actually not very evidence based,” says Michelle Gong, MD, chief of the Division of Critical Care Medicine at Montefiore Health System in New York City. “It is not something I would recommend for my doctors to do outside of a clinical trial.”

The protocol authors push back against the necessity and feasibility of randomized control trials.

There is no time for a randomized control trial right now, says Jose Iglesias, DO, associate professor at Hackensack Meridian School of Medicine at Seton Hall and critical care specialist at Community Medical Center and Jersey Shore University Medical Center in New Jersey. “Time is limited. We’re busy bedside clinicians taking care of patients, and patients who are dying.”

Marik argues there is not equipoise: It wouldn’t be ethical to randomize patients in a placebo group when the physicians are confident the steroids will help. And the protocol is personalized for each patient, making the standardization required for a randomized control trial incredibly difficult, he says. He also cites “the people who are unwilling to accept our results and just think it’s too good to be true.”

Hugh Cassiere, MD, director of critical care medicine at Northwell Health’s North Shore University Hospital in Manhasset, New York, said he finds it “very disturbing that this is being propagated.” In the context of a pandemic in which physicians from other specialties are helping out colleagues in ICUs and might follow the protocol uncritically, he worries, “this could potentially lead to harm.”

“I understand the intention; everybody wants to do something, these patients are so sick and the crisis so sharp that we all want to do something to make patients better,” Gong said. “But as physicians taking care of patients we need to make sure we separate the noise from the evidence.”
 

Peer review

The physicians who reviewed MATH+ for Medscape Medical News differed on which parts of the protocol they support and which parts they would change.

Dexamethasone should be the corticosteroid of choice over methylprednisolone, says Cassiere, because it has now been proven effective in the randomized RECOVERY Trial, which also tested dosing and a timetable for treatment.

But Sam Parnia, MD, PhD, associate professor of medicine and director of critical care and resuscitation research at NYU Langone, thinks methylprednisolone may be effective, and that even higher doses over longer periods of time may stave off recurring pneumonia, based on his experience using the steroid to treat COVID-19 patients in New York.

“What I really like about this protocol is, these guys are very smart, they recommend the need to treat multiple different things at the same time,” says Parnia. COVID-19 is a complex condition, he notes: If physicians are only focused on solving one problem, like hypoxia, patients could still be dying from blood clots.

Despite general concerns about the protocol, Cassiere says he was excited about the inclusion of heparin. Given the extreme levels of clotting seen in COVID-19 patients, he would have included specific D-dimer levels to guide treatment and explored antiplatelet therapies like aspirin. Gong, however, cautioned that she had seen her patients on anticoagulants develop gastrointestinal bleeding, and reiterated the need for clinical evidence. (At least one clinical trial is currently testing the risks and benefits of heparin as an antithrombotic therapy for COVID-19 patients.)

Perhaps the most divisive part of the protocol is the inclusion of ascorbic acid. “That’s the civil war,” says Kory. “It’s the most polarizing medicine.” The authors of the MATH+ protocol were close colleagues before COVID-19 in part because of a mutual research interest in ascorbic acid, he says. Other physicians, including Cassiere, are extremely skeptical that ascorbic acid has any effect, citing recently published studies in the Journal of the American Medical Association that found ascorbic acid ineffective for treating sepsis.

The MATH+ creators say they are working on a literature review of the research behind the protocol, and they plan to write up the observational impacts of the protocol. Marik says he’s not optimistic about getting the findings published in a high-impact journal given the observational nature of the research; the relatively small number of patients treated at hospitals using the protocol (140 patients at Marik’s hospital in Virginia and 180 at Varon’s in Houston, according to Marik); and the vast number of COVID-19 papers being submitted to scientific journals right now.

“This is not a remedy with expensive designer drugs,” Marik said. “No one has any interest in treating patients with cheap, safe, readily available drugs.”

“I hope they’re right if they’re saying this combination of medicines dramatically decreases mortality,” says Taison Bell, MD, director of the medical intensive care unit and assistant professor of medicine at UVA Health in Charlottesville, Virginia.

But physicians have hurt patients in the past with medications they hoped would work, he says. “We have to make sure we’re balancing the risk and the harm with that benefit, and the only way to protect patients from those biases is by doing a randomized controlled trial.”

This article first appeared on Medscape.com.

As COVID-19 cases mounted in Texas in late June, a local Houston news station shadowed Joseph Varon, MD, making rounds in the intensive care unit at United Memorial Medical Center in Houston. An unseen newscaster tells viewers that Varon credits his success against COVID-19 so far to an experimental and “controversial” drug protocol consisting of vitamins, steroids, and blood thinners.

“This is war. There’s no time to double-blind anything,” Varon tells the camera. “This is working. And if it’s working, I’m going to keep on doing it.”

Varon is one of 10 physicians behind the protocol known as MATH+, which in media interviews and congressional testimony they say has worked to treat COVID-19 patients and save lives in their intensive care units across the country. But response to the protocol among other critical care physicians is mixed, with several physicians, in interviews with Medscape Medical News, urging caution because the benefits and relative risks of the combined medications have not been tested in randomized control trials.

From the earliest days of the pandemic, there’s been tension between the need for rigorous scientific study to understand a novel disease, which takes time, and the need to treat seriously ill patients immediately. Some treatments, like hydroxychloroquine, were promoted without randomized clinical trial data and then later were shown to be ineffective or even potentially harmful when tested.

“This pandemic has shown us there’s lots of ideas out there and they need to be tested and a theoretical basis is insufficient,” says Daniel Kaul, MD, a professor of infectious disease at the University of Michigan in Ann Arbor. The ups and downs with hydroxychloroquine offer a sobering example, he says. “I would argue we have an ethical obligation to do randomized controlled trials to see if our treatments work.”
 

Creating MATH+

MATH+ stands for methylprednisolone, ascorbic acid, thiamine, and heparin. The “+” holds a place for additional therapies like vitamin D, zinc, and melatonin. The protocol originated as a variation of the “HAT therapy,” a combination of hydrocortisone, ascorbic acid, and thiamine, which critical care specialist Paul Marik, MD, created for treating critically ill patients with sepsis.

Over a few weeks, the protocol evolved as Marik, chief of the division of pulmonary and critical care medicine at Eastern Virginia Medical School in Norfolk, emailed with a small group of colleagues about treatments and their observations of SARS-CoV-2 in action, swapping in methylprednisolone and adding the anticoagulant heparin.

When Marik and colleagues created the protocol in early March, many healthcare organizations like the World Health Organization (WHO) were advising against steroids for COVID-19 patients. The MATH+ physicians decided they needed to spread a different message, and began publicizing the protocol with a website and a small communications team.

Marik says they tried to get their protocol in front of healthcare organizations – including the WHO, the Centers for Disease Control and Prevention, and the National Institutes of Health – but received no response. Marik went on Newt Gingrich’s podcast to discuss the protocol in the hopes it would make its way to the White House.

Senator Ron Johnson of Wisconsin saw the protocol and invited Pierre Kory, MD, MPA, who practices in Johnson’s home state, to testify remotely in front of the Senate Homeland Security Committee. Kory is a pulmonary critical care specialist about to start a new job at Aurora St. Luke’s Medical Center in Milwaukee.

In his testimony, Kory shared his positive experience using the protocol to treat patients and expressed his dismay that national healthcare organizations came out against the use of corticosteroids for COVID-19 from the early days of the pandemic based on what he called a “tragic error in analysis of medical data.” Although an analysis by national organizations suggested corticosteroids might be dangerous in COVID-19 patients, one of his colleagues came to the opposite conclusion, he said. But these organizations advised supportive care only, and against steroids. “We think that is a fatal and tragic flaw,” Kory said.

“The problem with the protocol early on was that it was heresy,” says Kory, referring to the protocol’s inclusion of corticosteroids before official treatment guidelines. During the height of the pandemic in New York this spring, Kory spent 5 weeks working in the ICU at Mount Sinai Beth Israel in Manhattan. Seeing patients flounder on supportive care, Kory says he used MATH+ successfully during his time in New York, using escalating and pulse doses of corticosteroids to stabilize rapidly deteriorating patients.

The website’s home page initially included an invitation for visitors to donate money to support “getting word of this effective treatment protocol out to physicians and hospitals around the world.” After Medscape Medical News brought up the donation prompt in questions, the physicians decided to remove all calls for donations from the website and social media, communications representative Betsy Ashton said. “Critics are misinterpreting this as some kind of fund-raising operation, when that could hardly be the case,” Ashton said in an email. “They are horrified that anyone would impugn their motives.”

Donations paid for the website designer, webmaster, and her work, Ashton said, and the physicians now have donors who will support publicizing the protocol without online calls for donations. “We have no commercial or vested interest,” Marik said. “I’m not going to make a single cent out of this and it’s obviously very time-consuming.”
 

The basis for the protocol

The protocol is based on common sense, an understanding of scientific literature, and an understanding of COVID-19, Marik says. The website includes links to past research trials and observational studies examining ascorbic acid and thiamine in critically ill patients and early looks at anticoagulants in COVID-19 patients.

They chose methylprednisolone as their corticosteroid based on the expertise of group member G. Umberto Meduri, MD, professor of medicine at the University of Tennessee Health Science Center in Memphis, Tennessee, who had found the steroid effective in treating acute respiratory distress syndrome. On the MATH+ website, the physicians link to multiple observational studies posted on preprint servers in April and May that suggest methylprednisolone helped COVID-19 patients.

“What’s happened with time is all the elements have been validated by scientific studies, which makes this so cool,” says Marik. The RECOVERY Trial results in particular validated the push to use corticosteroids in COVID-19 patients, he says. But that study used a different steroid, dexamethasone, in much smaller doses than what MATH+ recommends. Revised guidance from the Infectious Diseases Society of America recommends dexamethasone for severely ill patients, but says methylprednisolone and prednisone can be used as substitutes at equivalent doses.

Marik and Kory say that mortality rates for COVID-19 patients at their respective hospitals decreased after they began using the protocol. The physicians have been collecting observational data on their patients, but have not yet published any, and do not plan to conduct a randomized trial.

Several physicians who were not involved in the creation of the protocol say the evidence the physicians cite is not robust enough to warrant the promotion of MATH+ and call for randomized controlled trials. Coming up with a protocol is fine, says Kaul, but “you have to do the hard work of doing a randomized control trial to determine if those drugs given in those combinations work or not.”

“When I looked at it, I thought it was actually not very evidence based,” says Michelle Gong, MD, chief of the Division of Critical Care Medicine at Montefiore Health System in New York City. “It is not something I would recommend for my doctors to do outside of a clinical trial.”

The protocol authors push back against the necessity and feasibility of randomized control trials.

There is no time for a randomized control trial right now, says Jose Iglesias, DO, associate professor at Hackensack Meridian School of Medicine at Seton Hall and critical care specialist at Community Medical Center and Jersey Shore University Medical Center in New Jersey. “Time is limited. We’re busy bedside clinicians taking care of patients, and patients who are dying.”

Marik argues there is not equipoise: It wouldn’t be ethical to randomize patients in a placebo group when the physicians are confident the steroids will help. And the protocol is personalized for each patient, making the standardization required for a randomized control trial incredibly difficult, he says. He also cites “the people who are unwilling to accept our results and just think it’s too good to be true.”

Hugh Cassiere, MD, director of critical care medicine at Northwell Health’s North Shore University Hospital in Manhasset, New York, said he finds it “very disturbing that this is being propagated.” In the context of a pandemic in which physicians from other specialties are helping out colleagues in ICUs and might follow the protocol uncritically, he worries, “this could potentially lead to harm.”

“I understand the intention; everybody wants to do something, these patients are so sick and the crisis so sharp that we all want to do something to make patients better,” Gong said. “But as physicians taking care of patients we need to make sure we separate the noise from the evidence.”
 

Peer review

The physicians who reviewed MATH+ for Medscape Medical News differed on which parts of the protocol they support and which parts they would change.

Dexamethasone should be the corticosteroid of choice over methylprednisolone, says Cassiere, because it has now been proven effective in the randomized RECOVERY Trial, which also tested dosing and a timetable for treatment.

But Sam Parnia, MD, PhD, associate professor of medicine and director of critical care and resuscitation research at NYU Langone, thinks methylprednisolone may be effective, and that even higher doses over longer periods of time may stave off recurring pneumonia, based on his experience using the steroid to treat COVID-19 patients in New York.

“What I really like about this protocol is, these guys are very smart, they recommend the need to treat multiple different things at the same time,” says Parnia. COVID-19 is a complex condition, he notes: If physicians are only focused on solving one problem, like hypoxia, patients could still be dying from blood clots.

Despite general concerns about the protocol, Cassiere says he was excited about the inclusion of heparin. Given the extreme levels of clotting seen in COVID-19 patients, he would have included specific D-dimer levels to guide treatment and explored antiplatelet therapies like aspirin. Gong, however, cautioned that she had seen her patients on anticoagulants develop gastrointestinal bleeding, and reiterated the need for clinical evidence. (At least one clinical trial is currently testing the risks and benefits of heparin as an antithrombotic therapy for COVID-19 patients.)

Perhaps the most divisive part of the protocol is the inclusion of ascorbic acid. “That’s the civil war,” says Kory. “It’s the most polarizing medicine.” The authors of the MATH+ protocol were close colleagues before COVID-19 in part because of a mutual research interest in ascorbic acid, he says. Other physicians, including Cassiere, are extremely skeptical that ascorbic acid has any effect, citing recently published studies in the Journal of the American Medical Association that found ascorbic acid ineffective for treating sepsis.

The MATH+ creators say they are working on a literature review of the research behind the protocol, and they plan to write up the observational impacts of the protocol. Marik says he’s not optimistic about getting the findings published in a high-impact journal given the observational nature of the research; the relatively small number of patients treated at hospitals using the protocol (140 patients at Marik’s hospital in Virginia and 180 at Varon’s in Houston, according to Marik); and the vast number of COVID-19 papers being submitted to scientific journals right now.

“This is not a remedy with expensive designer drugs,” Marik said. “No one has any interest in treating patients with cheap, safe, readily available drugs.”

“I hope they’re right if they’re saying this combination of medicines dramatically decreases mortality,” says Taison Bell, MD, director of the medical intensive care unit and assistant professor of medicine at UVA Health in Charlottesville, Virginia.

But physicians have hurt patients in the past with medications they hoped would work, he says. “We have to make sure we’re balancing the risk and the harm with that benefit, and the only way to protect patients from those biases is by doing a randomized controlled trial.”

This article first appeared on Medscape.com.

As COVID-19 cases mounted in Texas in late June, a local Houston news station shadowed Joseph Varon, MD, making rounds in the intensive care unit at United Memorial Medical Center in Houston. An unseen newscaster tells viewers that Varon credits his success against COVID-19 so far to an experimental and “controversial” drug protocol consisting of vitamins, steroids, and blood thinners.

“This is war. There’s no time to double-blind anything,” Varon tells the camera. “This is working. And if it’s working, I’m going to keep on doing it.”

Varon is one of 10 physicians behind the protocol known as MATH+, which in media interviews and congressional testimony they say has worked to treat COVID-19 patients and save lives in their intensive care units across the country. But response to the protocol among other critical care physicians is mixed, with several physicians, in interviews with Medscape Medical News, urging caution because the benefits and relative risks of the combined medications have not been tested in randomized control trials.

From the earliest days of the pandemic, there’s been tension between the need for rigorous scientific study to understand a novel disease, which takes time, and the need to treat seriously ill patients immediately. Some treatments, like hydroxychloroquine, were promoted without randomized clinical trial data and then later were shown to be ineffective or even potentially harmful when tested.

“This pandemic has shown us there’s lots of ideas out there and they need to be tested and a theoretical basis is insufficient,” says Daniel Kaul, MD, a professor of infectious disease at the University of Michigan in Ann Arbor. The ups and downs with hydroxychloroquine offer a sobering example, he says. “I would argue we have an ethical obligation to do randomized controlled trials to see if our treatments work.”
 

Creating MATH+

MATH+ stands for methylprednisolone, ascorbic acid, thiamine, and heparin. The “+” holds a place for additional therapies like vitamin D, zinc, and melatonin. The protocol originated as a variation of the “HAT therapy,” a combination of hydrocortisone, ascorbic acid, and thiamine, which critical care specialist Paul Marik, MD, created for treating critically ill patients with sepsis.

Over a few weeks, the protocol evolved as Marik, chief of the division of pulmonary and critical care medicine at Eastern Virginia Medical School in Norfolk, emailed with a small group of colleagues about treatments and their observations of SARS-CoV-2 in action, swapping in methylprednisolone and adding the anticoagulant heparin.

When Marik and colleagues created the protocol in early March, many healthcare organizations like the World Health Organization (WHO) were advising against steroids for COVID-19 patients. The MATH+ physicians decided they needed to spread a different message, and began publicizing the protocol with a website and a small communications team.

Marik says they tried to get their protocol in front of healthcare organizations – including the WHO, the Centers for Disease Control and Prevention, and the National Institutes of Health – but received no response. Marik went on Newt Gingrich’s podcast to discuss the protocol in the hopes it would make its way to the White House.

Senator Ron Johnson of Wisconsin saw the protocol and invited Pierre Kory, MD, MPA, who practices in Johnson’s home state, to testify remotely in front of the Senate Homeland Security Committee. Kory is a pulmonary critical care specialist about to start a new job at Aurora St. Luke’s Medical Center in Milwaukee.

In his testimony, Kory shared his positive experience using the protocol to treat patients and expressed his dismay that national healthcare organizations came out against the use of corticosteroids for COVID-19 from the early days of the pandemic based on what he called a “tragic error in analysis of medical data.” Although an analysis by national organizations suggested corticosteroids might be dangerous in COVID-19 patients, one of his colleagues came to the opposite conclusion, he said. But these organizations advised supportive care only, and against steroids. “We think that is a fatal and tragic flaw,” Kory said.

“The problem with the protocol early on was that it was heresy,” says Kory, referring to the protocol’s inclusion of corticosteroids before official treatment guidelines. During the height of the pandemic in New York this spring, Kory spent 5 weeks working in the ICU at Mount Sinai Beth Israel in Manhattan. Seeing patients flounder on supportive care, Kory says he used MATH+ successfully during his time in New York, using escalating and pulse doses of corticosteroids to stabilize rapidly deteriorating patients.

The website’s home page initially included an invitation for visitors to donate money to support “getting word of this effective treatment protocol out to physicians and hospitals around the world.” After Medscape Medical News brought up the donation prompt in questions, the physicians decided to remove all calls for donations from the website and social media, communications representative Betsy Ashton said. “Critics are misinterpreting this as some kind of fund-raising operation, when that could hardly be the case,” Ashton said in an email. “They are horrified that anyone would impugn their motives.”

Donations paid for the website designer, webmaster, and her work, Ashton said, and the physicians now have donors who will support publicizing the protocol without online calls for donations. “We have no commercial or vested interest,” Marik said. “I’m not going to make a single cent out of this and it’s obviously very time-consuming.”
 

The basis for the protocol

The protocol is based on common sense, an understanding of scientific literature, and an understanding of COVID-19, Marik says. The website includes links to past research trials and observational studies examining ascorbic acid and thiamine in critically ill patients and early looks at anticoagulants in COVID-19 patients.

They chose methylprednisolone as their corticosteroid based on the expertise of group member G. Umberto Meduri, MD, professor of medicine at the University of Tennessee Health Science Center in Memphis, Tennessee, who had found the steroid effective in treating acute respiratory distress syndrome. On the MATH+ website, the physicians link to multiple observational studies posted on preprint servers in April and May that suggest methylprednisolone helped COVID-19 patients.

“What’s happened with time is all the elements have been validated by scientific studies, which makes this so cool,” says Marik. The RECOVERY Trial results in particular validated the push to use corticosteroids in COVID-19 patients, he says. But that study used a different steroid, dexamethasone, in much smaller doses than what MATH+ recommends. Revised guidance from the Infectious Diseases Society of America recommends dexamethasone for severely ill patients, but says methylprednisolone and prednisone can be used as substitutes at equivalent doses.

Marik and Kory say that mortality rates for COVID-19 patients at their respective hospitals decreased after they began using the protocol. The physicians have been collecting observational data on their patients, but have not yet published any, and do not plan to conduct a randomized trial.

Several physicians who were not involved in the creation of the protocol say the evidence the physicians cite is not robust enough to warrant the promotion of MATH+ and call for randomized controlled trials. Coming up with a protocol is fine, says Kaul, but “you have to do the hard work of doing a randomized control trial to determine if those drugs given in those combinations work or not.”

“When I looked at it, I thought it was actually not very evidence based,” says Michelle Gong, MD, chief of the Division of Critical Care Medicine at Montefiore Health System in New York City. “It is not something I would recommend for my doctors to do outside of a clinical trial.”

The protocol authors push back against the necessity and feasibility of randomized control trials.

There is no time for a randomized control trial right now, says Jose Iglesias, DO, associate professor at Hackensack Meridian School of Medicine at Seton Hall and critical care specialist at Community Medical Center and Jersey Shore University Medical Center in New Jersey. “Time is limited. We’re busy bedside clinicians taking care of patients, and patients who are dying.”

Marik argues there is not equipoise: It wouldn’t be ethical to randomize patients in a placebo group when the physicians are confident the steroids will help. And the protocol is personalized for each patient, making the standardization required for a randomized control trial incredibly difficult, he says. He also cites “the people who are unwilling to accept our results and just think it’s too good to be true.”

Hugh Cassiere, MD, director of critical care medicine at Northwell Health’s North Shore University Hospital in Manhasset, New York, said he finds it “very disturbing that this is being propagated.” In the context of a pandemic in which physicians from other specialties are helping out colleagues in ICUs and might follow the protocol uncritically, he worries, “this could potentially lead to harm.”

“I understand the intention; everybody wants to do something, these patients are so sick and the crisis so sharp that we all want to do something to make patients better,” Gong said. “But as physicians taking care of patients we need to make sure we separate the noise from the evidence.”
 

Peer review

The physicians who reviewed MATH+ for Medscape Medical News differed on which parts of the protocol they support and which parts they would change.

Dexamethasone should be the corticosteroid of choice over methylprednisolone, says Cassiere, because it has now been proven effective in the randomized RECOVERY Trial, which also tested dosing and a timetable for treatment.

But Sam Parnia, MD, PhD, associate professor of medicine and director of critical care and resuscitation research at NYU Langone, thinks methylprednisolone may be effective, and that even higher doses over longer periods of time may stave off recurring pneumonia, based on his experience using the steroid to treat COVID-19 patients in New York.

“What I really like about this protocol is, these guys are very smart, they recommend the need to treat multiple different things at the same time,” says Parnia. COVID-19 is a complex condition, he notes: If physicians are only focused on solving one problem, like hypoxia, patients could still be dying from blood clots.

Despite general concerns about the protocol, Cassiere says he was excited about the inclusion of heparin. Given the extreme levels of clotting seen in COVID-19 patients, he would have included specific D-dimer levels to guide treatment and explored antiplatelet therapies like aspirin. Gong, however, cautioned that she had seen her patients on anticoagulants develop gastrointestinal bleeding, and reiterated the need for clinical evidence. (At least one clinical trial is currently testing the risks and benefits of heparin as an antithrombotic therapy for COVID-19 patients.)

Perhaps the most divisive part of the protocol is the inclusion of ascorbic acid. “That’s the civil war,” says Kory. “It’s the most polarizing medicine.” The authors of the MATH+ protocol were close colleagues before COVID-19 in part because of a mutual research interest in ascorbic acid, he says. Other physicians, including Cassiere, are extremely skeptical that ascorbic acid has any effect, citing recently published studies in the Journal of the American Medical Association that found ascorbic acid ineffective for treating sepsis.

The MATH+ creators say they are working on a literature review of the research behind the protocol, and they plan to write up the observational impacts of the protocol. Marik says he’s not optimistic about getting the findings published in a high-impact journal given the observational nature of the research; the relatively small number of patients treated at hospitals using the protocol (140 patients at Marik’s hospital in Virginia and 180 at Varon’s in Houston, according to Marik); and the vast number of COVID-19 papers being submitted to scientific journals right now.

“This is not a remedy with expensive designer drugs,” Marik said. “No one has any interest in treating patients with cheap, safe, readily available drugs.”

“I hope they’re right if they’re saying this combination of medicines dramatically decreases mortality,” says Taison Bell, MD, director of the medical intensive care unit and assistant professor of medicine at UVA Health in Charlottesville, Virginia.

But physicians have hurt patients in the past with medications they hoped would work, he says. “We have to make sure we’re balancing the risk and the harm with that benefit, and the only way to protect patients from those biases is by doing a randomized controlled trial.”

This article first appeared on Medscape.com.

A trio of international expert recommendations mainly agree on essentials for the diagnosis and treatment of polycystic ovary syndrome in adolescents, but some confusion persists, according to Robert L. Rosenfield, MD, of the University of California, San Francisco.

In a commentary published in the Journal of Pediatric & Adolescent Gynecology, Dr. Rosenfield, who convened one of the three conferences at which guidance was developed, noted that the three recommendations – published by the Pediatric Endocrine Society, the International Consortium of Paediatric Endocrinology, and the International PCOS Network in 2015, 2017, and 2018, respectively – “are fairly dense” and reviews have suggested a lack of agreement. His comments offer perspective and practice suggestions that follow the consensus of the recommendations.

“All the documents agree on the core diagnostic criteria for adolescent PCOS: otherwise unexplained evidence of ovulatory dysfunction, as indicated by menstrual abnormalities based on stage-appropriate standards, and evidence of an androgen excess disorder,” Dr. Rosenfield said.

The main differences among the recommendations from the three groups reflect tension between the value of an early diagnosis and the liabilities of a mistaken diagnosis in the context of attitudes about adolescent contraception. “These are issues not likely to be resolved easily, yet they are matters for every physician to consider in management of each case,” he said.

Dr. Rosenfield emphasized that clinicians must consider PCOS “in the general context of all causes of adolescent menstrual disturbances,” when evaluating a girl within 1-2 years of menarche who presents with a menstrual abnormality, hirsutism, and/or acne that has been resistant to topical treatment.

A key point on which the recommendations differ is whether further assessment is needed if the menstrual abnormality has persisted for 1 year (the 2018 recommendations) or 2 years (the 2015 and 2017 recommendations), Dr. Rosenfield explained. “What the conferees struggled with is differentiating how long after menarche a menstrual abnormality should persist to avoid confusing PCOS with normal immaturity of the menstrual cycle,” known as physiologic adolescent anovulation (PAA). “The degree of certainty is improved only modestly by waiting 2 years rather than 1 year to make a diagnosis.”

However, the three documents agree that girls suspected of having PCOS within the first 1-2 years after menarche should be evaluated at that time, and followed with a diagnosis of “at risk for PCOS” if the early test results are consistent with a PCOS diagnosis, he said.

Another point of difference among the groups is the extent to which hirsutism and acne represent clinical evidence of hyperandrogenism that justifies testing for biochemical hyperandrogenism, Dr. Rosenfield said.

“All three sets of adolescent PCOS recommendations agree that investigation for biochemical hyperandrogenism be initiated by measuring serum total and/or free testosterone by specialty assays with well-defined reference ranges,” he said.

However, “documentation of biochemical hyperandrogenism has been problematic because standard platform assays of testosterone give grossly inaccurate results.”

As for the management of PCOS in teens, “different perspectives about pharmacologic treatment [reflect] the multicultural views about adolescent contraception,” said Dr. Rosenfield. Guidelines in the United States favor estrogen-progestin combined oral contraceptives as first-line therapy, while the international guidelines support contraceptives if contraception also is desired; otherwise the 2017 guidelines recommend metformin as a first-line treatment.

“Agreement is uniform that healthy lifestyle management is first-line therapy for management of the associated obesity and metabolic disturbances, i.e., prior to and/or in conjunction with metformin therapy,” he noted.

In general, Dr. Rosenfield acknowledged that front-line clinicians cannot easily evaluate all early postmenarcheal girls for abnormal menstrual cycles. Instead, he advocated a “middle ground” approach between early diagnosis and potentially labeling a girl with a false positive diagnosis.

Postmenarcheal girls who are amenorrheic for 2 months could be assessed for signs of PCOS or pregnancy, and whether she is generally in good health, he said. “However, for example, if she remains amenorrheic for more than 90 days or if two successive periods are more than 2 months apart, laboratory screening would be reasonable.”

PCOS is “a diagnosis of exclusion for which referral to a specialist is advisable” to rule out other conditions such as non-classic congenital adrenal hyperplasia, hyperprolactinemia, endogenous Cushing syndrome, thyroid dysfunction, and virilizing tumors, said Dr. Rosenfield.

However, PCOS accounts for most cases of adolescent hyperandrogenism. The symptomatic treatment of early postmenarcheal girls at risk of PCOS is recommended to manage menstrual abnormality, hirsutism, acne, or obesity, and these girls should be reassessed by the time they finish high school after a 3-month treatment withdrawal period, he emphasized.

Dr. Rosenfield had no relevant financial conflicts to disclose.

SOURCE: Rosenfield RL. J Pediatr Adolesc Gynecol. 2020 June 29. doi: 10.1016/j.jpag.2020.06.017.

A trio of international expert recommendations mainly agree on essentials for the diagnosis and treatment of polycystic ovary syndrome in adolescents, but some confusion persists, according to Robert L. Rosenfield, MD, of the University of California, San Francisco.

In a commentary published in the Journal of Pediatric & Adolescent Gynecology, Dr. Rosenfield, who convened one of the three conferences at which guidance was developed, noted that the three recommendations – published by the Pediatric Endocrine Society, the International Consortium of Paediatric Endocrinology, and the International PCOS Network in 2015, 2017, and 2018, respectively – “are fairly dense” and reviews have suggested a lack of agreement. His comments offer perspective and practice suggestions that follow the consensus of the recommendations.

“All the documents agree on the core diagnostic criteria for adolescent PCOS: otherwise unexplained evidence of ovulatory dysfunction, as indicated by menstrual abnormalities based on stage-appropriate standards, and evidence of an androgen excess disorder,” Dr. Rosenfield said.

The main differences among the recommendations from the three groups reflect tension between the value of an early diagnosis and the liabilities of a mistaken diagnosis in the context of attitudes about adolescent contraception. “These are issues not likely to be resolved easily, yet they are matters for every physician to consider in management of each case,” he said.

Dr. Rosenfield emphasized that clinicians must consider PCOS “in the general context of all causes of adolescent menstrual disturbances,” when evaluating a girl within 1-2 years of menarche who presents with a menstrual abnormality, hirsutism, and/or acne that has been resistant to topical treatment.

A key point on which the recommendations differ is whether further assessment is needed if the menstrual abnormality has persisted for 1 year (the 2018 recommendations) or 2 years (the 2015 and 2017 recommendations), Dr. Rosenfield explained. “What the conferees struggled with is differentiating how long after menarche a menstrual abnormality should persist to avoid confusing PCOS with normal immaturity of the menstrual cycle,” known as physiologic adolescent anovulation (PAA). “The degree of certainty is improved only modestly by waiting 2 years rather than 1 year to make a diagnosis.”

However, the three documents agree that girls suspected of having PCOS within the first 1-2 years after menarche should be evaluated at that time, and followed with a diagnosis of “at risk for PCOS” if the early test results are consistent with a PCOS diagnosis, he said.

Another point of difference among the groups is the extent to which hirsutism and acne represent clinical evidence of hyperandrogenism that justifies testing for biochemical hyperandrogenism, Dr. Rosenfield said.

“All three sets of adolescent PCOS recommendations agree that investigation for biochemical hyperandrogenism be initiated by measuring serum total and/or free testosterone by specialty assays with well-defined reference ranges,” he said.

However, “documentation of biochemical hyperandrogenism has been problematic because standard platform assays of testosterone give grossly inaccurate results.”

As for the management of PCOS in teens, “different perspectives about pharmacologic treatment [reflect] the multicultural views about adolescent contraception,” said Dr. Rosenfield. Guidelines in the United States favor estrogen-progestin combined oral contraceptives as first-line therapy, while the international guidelines support contraceptives if contraception also is desired; otherwise the 2017 guidelines recommend metformin as a first-line treatment.

“Agreement is uniform that healthy lifestyle management is first-line therapy for management of the associated obesity and metabolic disturbances, i.e., prior to and/or in conjunction with metformin therapy,” he noted.

In general, Dr. Rosenfield acknowledged that front-line clinicians cannot easily evaluate all early postmenarcheal girls for abnormal menstrual cycles. Instead, he advocated a “middle ground” approach between early diagnosis and potentially labeling a girl with a false positive diagnosis.

Postmenarcheal girls who are amenorrheic for 2 months could be assessed for signs of PCOS or pregnancy, and whether she is generally in good health, he said. “However, for example, if she remains amenorrheic for more than 90 days or if two successive periods are more than 2 months apart, laboratory screening would be reasonable.”

PCOS is “a diagnosis of exclusion for which referral to a specialist is advisable” to rule out other conditions such as non-classic congenital adrenal hyperplasia, hyperprolactinemia, endogenous Cushing syndrome, thyroid dysfunction, and virilizing tumors, said Dr. Rosenfield.

However, PCOS accounts for most cases of adolescent hyperandrogenism. The symptomatic treatment of early postmenarcheal girls at risk of PCOS is recommended to manage menstrual abnormality, hirsutism, acne, or obesity, and these girls should be reassessed by the time they finish high school after a 3-month treatment withdrawal period, he emphasized.

Dr. Rosenfield had no relevant financial conflicts to disclose.

SOURCE: Rosenfield RL. J Pediatr Adolesc Gynecol. 2020 June 29. doi: 10.1016/j.jpag.2020.06.017.

A trio of international expert recommendations mainly agree on essentials for the diagnosis and treatment of polycystic ovary syndrome in adolescents, but some confusion persists, according to Robert L. Rosenfield, MD, of the University of California, San Francisco.

In a commentary published in the Journal of Pediatric & Adolescent Gynecology, Dr. Rosenfield, who convened one of the three conferences at which guidance was developed, noted that the three recommendations – published by the Pediatric Endocrine Society, the International Consortium of Paediatric Endocrinology, and the International PCOS Network in 2015, 2017, and 2018, respectively – “are fairly dense” and reviews have suggested a lack of agreement. His comments offer perspective and practice suggestions that follow the consensus of the recommendations.

“All the documents agree on the core diagnostic criteria for adolescent PCOS: otherwise unexplained evidence of ovulatory dysfunction, as indicated by menstrual abnormalities based on stage-appropriate standards, and evidence of an androgen excess disorder,” Dr. Rosenfield said.

The main differences among the recommendations from the three groups reflect tension between the value of an early diagnosis and the liabilities of a mistaken diagnosis in the context of attitudes about adolescent contraception. “These are issues not likely to be resolved easily, yet they are matters for every physician to consider in management of each case,” he said.

Dr. Rosenfield emphasized that clinicians must consider PCOS “in the general context of all causes of adolescent menstrual disturbances,” when evaluating a girl within 1-2 years of menarche who presents with a menstrual abnormality, hirsutism, and/or acne that has been resistant to topical treatment.

A key point on which the recommendations differ is whether further assessment is needed if the menstrual abnormality has persisted for 1 year (the 2018 recommendations) or 2 years (the 2015 and 2017 recommendations), Dr. Rosenfield explained. “What the conferees struggled with is differentiating how long after menarche a menstrual abnormality should persist to avoid confusing PCOS with normal immaturity of the menstrual cycle,” known as physiologic adolescent anovulation (PAA). “The degree of certainty is improved only modestly by waiting 2 years rather than 1 year to make a diagnosis.”

However, the three documents agree that girls suspected of having PCOS within the first 1-2 years after menarche should be evaluated at that time, and followed with a diagnosis of “at risk for PCOS” if the early test results are consistent with a PCOS diagnosis, he said.

Another point of difference among the groups is the extent to which hirsutism and acne represent clinical evidence of hyperandrogenism that justifies testing for biochemical hyperandrogenism, Dr. Rosenfield said.

“All three sets of adolescent PCOS recommendations agree that investigation for biochemical hyperandrogenism be initiated by measuring serum total and/or free testosterone by specialty assays with well-defined reference ranges,” he said.

However, “documentation of biochemical hyperandrogenism has been problematic because standard platform assays of testosterone give grossly inaccurate results.”

As for the management of PCOS in teens, “different perspectives about pharmacologic treatment [reflect] the multicultural views about adolescent contraception,” said Dr. Rosenfield. Guidelines in the United States favor estrogen-progestin combined oral contraceptives as first-line therapy, while the international guidelines support contraceptives if contraception also is desired; otherwise the 2017 guidelines recommend metformin as a first-line treatment.

“Agreement is uniform that healthy lifestyle management is first-line therapy for management of the associated obesity and metabolic disturbances, i.e., prior to and/or in conjunction with metformin therapy,” he noted.

In general, Dr. Rosenfield acknowledged that front-line clinicians cannot easily evaluate all early postmenarcheal girls for abnormal menstrual cycles. Instead, he advocated a “middle ground” approach between early diagnosis and potentially labeling a girl with a false positive diagnosis.

Postmenarcheal girls who are amenorrheic for 2 months could be assessed for signs of PCOS or pregnancy, and whether she is generally in good health, he said. “However, for example, if she remains amenorrheic for more than 90 days or if two successive periods are more than 2 months apart, laboratory screening would be reasonable.”

PCOS is “a diagnosis of exclusion for which referral to a specialist is advisable” to rule out other conditions such as non-classic congenital adrenal hyperplasia, hyperprolactinemia, endogenous Cushing syndrome, thyroid dysfunction, and virilizing tumors, said Dr. Rosenfield.

However, PCOS accounts for most cases of adolescent hyperandrogenism. The symptomatic treatment of early postmenarcheal girls at risk of PCOS is recommended to manage menstrual abnormality, hirsutism, acne, or obesity, and these girls should be reassessed by the time they finish high school after a 3-month treatment withdrawal period, he emphasized.

Dr. Rosenfield had no relevant financial conflicts to disclose.

SOURCE: Rosenfield RL. J Pediatr Adolesc Gynecol. 2020 June 29. doi: 10.1016/j.jpag.2020.06.017.

The conventional treatment mainstays for pemphigus are problematic during the COVID-19 pandemic, and a shift in disease management strategy is in order, Dedee F. Murrell, MD, said at the virtual annual meeting of the American Academy of Dermatology.

Together with physicians from the Mayo Clinic, Alexandria (Egypt) University, and Tehran (Iran) University, she recently published updated expert guidance for treatment of this severe, potentially fatal mucocutaneous autoimmune blistering disease, in a letter to the editor in the Journal of the American Academy of Dermatology. She presented some of the key recommendations at AAD 2020.

First off, rituximab (Rituxan), the only Food and Drug Administration–approved medication for moderate to severe pemphigus vulgaris and a biologic considered first-line therapy prepandemic, is ill-advised during the COVID-19 era. Its mechanism of benefit is through B-cell depletion. This is an irreversible effect, and reconstitution of B-cell immunity takes 6-12 months. The absence of this immunologic protection for such a long time poses potentially serious problems for pemphigus patients who become infected with SARS-CoV-2.

Also, the opportunity to administer intravenous infusions of the biologic becomes unpredictable during pandemic surges, when limitations on nonemergent medical care may be necessary, noted Dr. Murrell, professor of dermatology at the University of New South Wales and head of dermatology at St. George University Hospital, both in Sydney.

“We have taken the approach of postponing rituximab infusions temporarily, with the aim of delaying peak patient immunosuppression during peak COVID-19 incidence to reduce the risk of adverse outcomes,” Dr. Murrell and coauthors wrote in the letter (J Am Acad Dermatol. 2020 Jun;82[6]:e235-6).

The other traditional go-to therapy for pemphigus is corticosteroids. They’re effective, fast acting, and relatively inexpensive. But their nonselective immunosuppressive action boosts infection risk in general, and more specifically it increases the risk of developing severe forms of COVID-19 should a patient become infected with SARS-CoV-2.

“A basic therapeutic principle with particular importance during the pandemic is that glucocorticoids and steroid-sparing immunosuppressive agents, such as azathioprine and mycophenolate mofetil, should be tapered to the lowest effective dose. In active COVID-19 infection, immunosuppressive steroid-sparing medications should be discontinued when possible, although glucocorticoid cessation often cannot be considered due to risk for adrenal insufficiency,” the authors continued.

“Effective as adjuvant treatment in both pemphigus and COVID-19,intravenous immunoglobulin supports immunity and therefore may be useful in this setting,” they wrote. It’s not immunosuppressive, and, they noted, there’s good-quality evidence from a Japanese randomized, double-blind, controlled trial that a 5-day course of intravenous immunoglobulin is effective therapy for pemphigus (J Am Acad Dermatol. 2009 Apr;60[4]:595-603).

Moreover, intravenous immunoglobulin is also reportedly effective in severe COVID-19 (Open Forum Infect Dis. 2020 Mar 21. doi: 10.1093/ofid/ofaa102.).

Another option is to consider enrolling a patient with moderate or severe pemphigus vulgaris or foliaceus in the ongoing pivotal phase 3, international, double-blind, placebo-controlled PEGASUS trial of rilzabrutinib, a promising oral reversible Bruton tyrosine kinase inhibitor. The medication has a short half-life and a self-limited immunomodulatory effect. Moreover, the trial is set up for remote patient visits on an outpatient basis via teledermatology, so the 65-week study can continue despite the pandemic. Both newly diagnosed and relapsing patients are eligible for the trial, headed by Dr. Murrell. At AAD 2020 she reported encouraging results from a phase 2b trial of rilzabrutinib.

She is a consultant to Principia Biopharma, sponsor of the PEGASUS trial, and has received institutional research grants from numerous pharmaceutical companies.

[email protected]

The conventional treatment mainstays for pemphigus are problematic during the COVID-19 pandemic, and a shift in disease management strategy is in order, Dedee F. Murrell, MD, said at the virtual annual meeting of the American Academy of Dermatology.

Together with physicians from the Mayo Clinic, Alexandria (Egypt) University, and Tehran (Iran) University, she recently published updated expert guidance for treatment of this severe, potentially fatal mucocutaneous autoimmune blistering disease, in a letter to the editor in the Journal of the American Academy of Dermatology. She presented some of the key recommendations at AAD 2020.

First off, rituximab (Rituxan), the only Food and Drug Administration–approved medication for moderate to severe pemphigus vulgaris and a biologic considered first-line therapy prepandemic, is ill-advised during the COVID-19 era. Its mechanism of benefit is through B-cell depletion. This is an irreversible effect, and reconstitution of B-cell immunity takes 6-12 months. The absence of this immunologic protection for such a long time poses potentially serious problems for pemphigus patients who become infected with SARS-CoV-2.

Also, the opportunity to administer intravenous infusions of the biologic becomes unpredictable during pandemic surges, when limitations on nonemergent medical care may be necessary, noted Dr. Murrell, professor of dermatology at the University of New South Wales and head of dermatology at St. George University Hospital, both in Sydney.

“We have taken the approach of postponing rituximab infusions temporarily, with the aim of delaying peak patient immunosuppression during peak COVID-19 incidence to reduce the risk of adverse outcomes,” Dr. Murrell and coauthors wrote in the letter (J Am Acad Dermatol. 2020 Jun;82[6]:e235-6).

The other traditional go-to therapy for pemphigus is corticosteroids. They’re effective, fast acting, and relatively inexpensive. But their nonselective immunosuppressive action boosts infection risk in general, and more specifically it increases the risk of developing severe forms of COVID-19 should a patient become infected with SARS-CoV-2.

“A basic therapeutic principle with particular importance during the pandemic is that glucocorticoids and steroid-sparing immunosuppressive agents, such as azathioprine and mycophenolate mofetil, should be tapered to the lowest effective dose. In active COVID-19 infection, immunosuppressive steroid-sparing medications should be discontinued when possible, although glucocorticoid cessation often cannot be considered due to risk for adrenal insufficiency,” the authors continued.

“Effective as adjuvant treatment in both pemphigus and COVID-19,intravenous immunoglobulin supports immunity and therefore may be useful in this setting,” they wrote. It’s not immunosuppressive, and, they noted, there’s good-quality evidence from a Japanese randomized, double-blind, controlled trial that a 5-day course of intravenous immunoglobulin is effective therapy for pemphigus (J Am Acad Dermatol. 2009 Apr;60[4]:595-603).

Moreover, intravenous immunoglobulin is also reportedly effective in severe COVID-19 (Open Forum Infect Dis. 2020 Mar 21. doi: 10.1093/ofid/ofaa102.).

Another option is to consider enrolling a patient with moderate or severe pemphigus vulgaris or foliaceus in the ongoing pivotal phase 3, international, double-blind, placebo-controlled PEGASUS trial of rilzabrutinib, a promising oral reversible Bruton tyrosine kinase inhibitor. The medication has a short half-life and a self-limited immunomodulatory effect. Moreover, the trial is set up for remote patient visits on an outpatient basis via teledermatology, so the 65-week study can continue despite the pandemic. Both newly diagnosed and relapsing patients are eligible for the trial, headed by Dr. Murrell. At AAD 2020 she reported encouraging results from a phase 2b trial of rilzabrutinib.

She is a consultant to Principia Biopharma, sponsor of the PEGASUS trial, and has received institutional research grants from numerous pharmaceutical companies.

[email protected]

The conventional treatment mainstays for pemphigus are problematic during the COVID-19 pandemic, and a shift in disease management strategy is in order, Dedee F. Murrell, MD, said at the virtual annual meeting of the American Academy of Dermatology.

Together with physicians from the Mayo Clinic, Alexandria (Egypt) University, and Tehran (Iran) University, she recently published updated expert guidance for treatment of this severe, potentially fatal mucocutaneous autoimmune blistering disease, in a letter to the editor in the Journal of the American Academy of Dermatology. She presented some of the key recommendations at AAD 2020.

First off, rituximab (Rituxan), the only Food and Drug Administration–approved medication for moderate to severe pemphigus vulgaris and a biologic considered first-line therapy prepandemic, is ill-advised during the COVID-19 era. Its mechanism of benefit is through B-cell depletion. This is an irreversible effect, and reconstitution of B-cell immunity takes 6-12 months. The absence of this immunologic protection for such a long time poses potentially serious problems for pemphigus patients who become infected with SARS-CoV-2.

Also, the opportunity to administer intravenous infusions of the biologic becomes unpredictable during pandemic surges, when limitations on nonemergent medical care may be necessary, noted Dr. Murrell, professor of dermatology at the University of New South Wales and head of dermatology at St. George University Hospital, both in Sydney.

“We have taken the approach of postponing rituximab infusions temporarily, with the aim of delaying peak patient immunosuppression during peak COVID-19 incidence to reduce the risk of adverse outcomes,” Dr. Murrell and coauthors wrote in the letter (J Am Acad Dermatol. 2020 Jun;82[6]:e235-6).

The other traditional go-to therapy for pemphigus is corticosteroids. They’re effective, fast acting, and relatively inexpensive. But their nonselective immunosuppressive action boosts infection risk in general, and more specifically it increases the risk of developing severe forms of COVID-19 should a patient become infected with SARS-CoV-2.

“A basic therapeutic principle with particular importance during the pandemic is that glucocorticoids and steroid-sparing immunosuppressive agents, such as azathioprine and mycophenolate mofetil, should be tapered to the lowest effective dose. In active COVID-19 infection, immunosuppressive steroid-sparing medications should be discontinued when possible, although glucocorticoid cessation often cannot be considered due to risk for adrenal insufficiency,” the authors continued.

“Effective as adjuvant treatment in both pemphigus and COVID-19,intravenous immunoglobulin supports immunity and therefore may be useful in this setting,” they wrote. It’s not immunosuppressive, and, they noted, there’s good-quality evidence from a Japanese randomized, double-blind, controlled trial that a 5-day course of intravenous immunoglobulin is effective therapy for pemphigus (J Am Acad Dermatol. 2009 Apr;60[4]:595-603).

Moreover, intravenous immunoglobulin is also reportedly effective in severe COVID-19 (Open Forum Infect Dis. 2020 Mar 21. doi: 10.1093/ofid/ofaa102.).

Another option is to consider enrolling a patient with moderate or severe pemphigus vulgaris or foliaceus in the ongoing pivotal phase 3, international, double-blind, placebo-controlled PEGASUS trial of rilzabrutinib, a promising oral reversible Bruton tyrosine kinase inhibitor. The medication has a short half-life and a self-limited immunomodulatory effect. Moreover, the trial is set up for remote patient visits on an outpatient basis via teledermatology, so the 65-week study can continue despite the pandemic. Both newly diagnosed and relapsing patients are eligible for the trial, headed by Dr. Murrell. At AAD 2020 she reported encouraging results from a phase 2b trial of rilzabrutinib.

She is a consultant to Principia Biopharma, sponsor of the PEGASUS trial, and has received institutional research grants from numerous pharmaceutical companies.

[email protected]

In 2015, I proposed virtual care for the division of adolescent medicine, to the administration of our Midwestern children and adolescent hospital; they gladly listened and accepted a copy of the resources I provided. Virtual care was acknowledged to be the future direction of our and other organizations.

AJ_Watt/E+

Four years later, virtual visits were introduced in the pediatric urgent care, but with little usability as families were slow to adopt this new form of medicine. Fast forward to the COVID-19 crisis in March 2020, and virtual medicine was the only option to meet the needs of patients and to stop the economic consequences. Unfortunately, the expedited rollout at our and many other hospitals may have resulted in limited program development and a lack of shared best practices.

Since March 2020, both patients and medical providers have accepted virtual care, but we now have an opportunity to review some of the limitations to offering virtual care. Work in primary care centers may see limitations using virtual medicine to meet the needs of all patients. Take into consideration the ability to offer confidential care. Confidential care has been a challenge virtually. For example, while completing a virtual visit with a 19-year-old female, it was apparent she was not alone and when asked a benign question the commotion in the background told the real story. The young woman began to laugh and said, “That was my dad running out of the room.” Despite requesting that parents leave the call, they can be heard within earshot of the caller.

Innovation is essential, and televisits are evolving, using tools such as sticky notes embedded in the computer (virtual note cards to ask confidential questions). On a televisit, written words appear backwards on the video, requiring written questions to be mirror images. When asking questions meant to be confidential, we have used note cards with a question mark. Verbal directions asking the adolescent to give a thumbs up or down to answer the question are required to maintain privacy from others in the room. If the patient responds thumbs up, this leads to additional questions with note cards. Although not ideal, this process gets to the answers, and the adolescent can disclose confidential information without concern about being overheard. Child abuse and neglect professionals have found similar challenges talking to caregivers or children as they are uncertain if others in the home are out of the screen but listening to the questions or prompting responses.

Obtaining vitals may be restricted and picking up hypertension or changes in weight has been limited to face to face visits. To continue to provide virtual care will require screening stations. I foresee a kiosk at the grocery or drugstore with a computer and the ability to obtain vitals or portions of an exam such as heart and lung evaluations. Patients could go at their convenience and the results could be sent to their providers. Technology already exists to use a cell phone to take photos of a toddler’s sore ear drum, and to obtain basic pulse oximetry and ECG, but these have a cost and may be available only to those able to afford these tools.

Billing issues have developed when patients go to a lab on the same day as a virtual visit. Completing a virtual visit for a sore throat thought to be streptococcal pharyngitis should not be finalized without access to a streptococcal throat swab. Until families have home kits to evaluate for strep throat, the families must bring the patient to a clinic or lab to obtain a pharyngeal culture. Furthermore, insurance reimbursement standards will need to be set for ongoing virtual health to become a sustainable option.

Workflows have been disrupted by balancing face to face visits with virtual visits. Unless the virtual visit has been set up for the medical team to access immediately, there are delays accessing the virtual platform, resulting in unnecessary gaps in care. Arranging schedules to separate face to face visits from virtual visits offers more efficiency. Creating a block of virtual visits separated from face-to-face visits or assigning providers to virtual-only schedules may be the best option for an efficient clinic flow. Telemedicine visit templates may need to be created as virtual visits become standard practice.

At present, virtual visits can only be offered to English-speaking patients. The inability to offer translators limits access to a small number of patients. Given COVID-19’s impact on the underserved communities, having a safe resource to reach these patients has been limited, leaving face-to-face visits as their only option. Requiring a face-to-face visit during peak illness has placed patients at risk. They have refused health care as opposed to exposure to the illness in health care settings.

We have innovative opportunities to create a new health care system. Despite the initial struggles with the adoption of virtual care, patients and providers have begun embracing the technology. Best practices and shared resources will be required to have a successful system before brick and mortar organizations can be reduced or insurance companies create their own health care systems which can branch across state lines.
 

Ms. Thew is the medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee. She said she had no relevant financial disclosures. Email her at [email protected].

The article was updated 7/17/2020.

In 2015, I proposed virtual care for the division of adolescent medicine, to the administration of our Midwestern children and adolescent hospital; they gladly listened and accepted a copy of the resources I provided. Virtual care was acknowledged to be the future direction of our and other organizations.

AJ_Watt/E+

Four years later, virtual visits were introduced in the pediatric urgent care, but with little usability as families were slow to adopt this new form of medicine. Fast forward to the COVID-19 crisis in March 2020, and virtual medicine was the only option to meet the needs of patients and to stop the economic consequences. Unfortunately, the expedited rollout at our and many other hospitals may have resulted in limited program development and a lack of shared best practices.

Since March 2020, both patients and medical providers have accepted virtual care, but we now have an opportunity to review some of the limitations to offering virtual care. Work in primary care centers may see limitations using virtual medicine to meet the needs of all patients. Take into consideration the ability to offer confidential care. Confidential care has been a challenge virtually. For example, while completing a virtual visit with a 19-year-old female, it was apparent she was not alone and when asked a benign question the commotion in the background told the real story. The young woman began to laugh and said, “That was my dad running out of the room.” Despite requesting that parents leave the call, they can be heard within earshot of the caller.

Innovation is essential, and televisits are evolving, using tools such as sticky notes embedded in the computer (virtual note cards to ask confidential questions). On a televisit, written words appear backwards on the video, requiring written questions to be mirror images. When asking questions meant to be confidential, we have used note cards with a question mark. Verbal directions asking the adolescent to give a thumbs up or down to answer the question are required to maintain privacy from others in the room. If the patient responds thumbs up, this leads to additional questions with note cards. Although not ideal, this process gets to the answers, and the adolescent can disclose confidential information without concern about being overheard. Child abuse and neglect professionals have found similar challenges talking to caregivers or children as they are uncertain if others in the home are out of the screen but listening to the questions or prompting responses.

Obtaining vitals may be restricted and picking up hypertension or changes in weight has been limited to face to face visits. To continue to provide virtual care will require screening stations. I foresee a kiosk at the grocery or drugstore with a computer and the ability to obtain vitals or portions of an exam such as heart and lung evaluations. Patients could go at their convenience and the results could be sent to their providers. Technology already exists to use a cell phone to take photos of a toddler’s sore ear drum, and to obtain basic pulse oximetry and ECG, but these have a cost and may be available only to those able to afford these tools.

Billing issues have developed when patients go to a lab on the same day as a virtual visit. Completing a virtual visit for a sore throat thought to be streptococcal pharyngitis should not be finalized without access to a streptococcal throat swab. Until families have home kits to evaluate for strep throat, the families must bring the patient to a clinic or lab to obtain a pharyngeal culture. Furthermore, insurance reimbursement standards will need to be set for ongoing virtual health to become a sustainable option.

Workflows have been disrupted by balancing face to face visits with virtual visits. Unless the virtual visit has been set up for the medical team to access immediately, there are delays accessing the virtual platform, resulting in unnecessary gaps in care. Arranging schedules to separate face to face visits from virtual visits offers more efficiency. Creating a block of virtual visits separated from face-to-face visits or assigning providers to virtual-only schedules may be the best option for an efficient clinic flow. Telemedicine visit templates may need to be created as virtual visits become standard practice.

At present, virtual visits can only be offered to English-speaking patients. The inability to offer translators limits access to a small number of patients. Given COVID-19’s impact on the underserved communities, having a safe resource to reach these patients has been limited, leaving face-to-face visits as their only option. Requiring a face-to-face visit during peak illness has placed patients at risk. They have refused health care as opposed to exposure to the illness in health care settings.

We have innovative opportunities to create a new health care system. Despite the initial struggles with the adoption of virtual care, patients and providers have begun embracing the technology. Best practices and shared resources will be required to have a successful system before brick and mortar organizations can be reduced or insurance companies create their own health care systems which can branch across state lines.
 

Ms. Thew is the medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee. She said she had no relevant financial disclosures. Email her at [email protected].

The article was updated 7/17/2020.

In 2015, I proposed virtual care for the division of adolescent medicine, to the administration of our Midwestern children and adolescent hospital; they gladly listened and accepted a copy of the resources I provided. Virtual care was acknowledged to be the future direction of our and other organizations.

AJ_Watt/E+

Four years later, virtual visits were introduced in the pediatric urgent care, but with little usability as families were slow to adopt this new form of medicine. Fast forward to the COVID-19 crisis in March 2020, and virtual medicine was the only option to meet the needs of patients and to stop the economic consequences. Unfortunately, the expedited rollout at our and many other hospitals may have resulted in limited program development and a lack of shared best practices.

Since March 2020, both patients and medical providers have accepted virtual care, but we now have an opportunity to review some of the limitations to offering virtual care. Work in primary care centers may see limitations using virtual medicine to meet the needs of all patients. Take into consideration the ability to offer confidential care. Confidential care has been a challenge virtually. For example, while completing a virtual visit with a 19-year-old female, it was apparent she was not alone and when asked a benign question the commotion in the background told the real story. The young woman began to laugh and said, “That was my dad running out of the room.” Despite requesting that parents leave the call, they can be heard within earshot of the caller.

Innovation is essential, and televisits are evolving, using tools such as sticky notes embedded in the computer (virtual note cards to ask confidential questions). On a televisit, written words appear backwards on the video, requiring written questions to be mirror images. When asking questions meant to be confidential, we have used note cards with a question mark. Verbal directions asking the adolescent to give a thumbs up or down to answer the question are required to maintain privacy from others in the room. If the patient responds thumbs up, this leads to additional questions with note cards. Although not ideal, this process gets to the answers, and the adolescent can disclose confidential information without concern about being overheard. Child abuse and neglect professionals have found similar challenges talking to caregivers or children as they are uncertain if others in the home are out of the screen but listening to the questions or prompting responses.

Obtaining vitals may be restricted and picking up hypertension or changes in weight has been limited to face to face visits. To continue to provide virtual care will require screening stations. I foresee a kiosk at the grocery or drugstore with a computer and the ability to obtain vitals or portions of an exam such as heart and lung evaluations. Patients could go at their convenience and the results could be sent to their providers. Technology already exists to use a cell phone to take photos of a toddler’s sore ear drum, and to obtain basic pulse oximetry and ECG, but these have a cost and may be available only to those able to afford these tools.

Billing issues have developed when patients go to a lab on the same day as a virtual visit. Completing a virtual visit for a sore throat thought to be streptococcal pharyngitis should not be finalized without access to a streptococcal throat swab. Until families have home kits to evaluate for strep throat, the families must bring the patient to a clinic or lab to obtain a pharyngeal culture. Furthermore, insurance reimbursement standards will need to be set for ongoing virtual health to become a sustainable option.

Workflows have been disrupted by balancing face to face visits with virtual visits. Unless the virtual visit has been set up for the medical team to access immediately, there are delays accessing the virtual platform, resulting in unnecessary gaps in care. Arranging schedules to separate face to face visits from virtual visits offers more efficiency. Creating a block of virtual visits separated from face-to-face visits or assigning providers to virtual-only schedules may be the best option for an efficient clinic flow. Telemedicine visit templates may need to be created as virtual visits become standard practice.

At present, virtual visits can only be offered to English-speaking patients. The inability to offer translators limits access to a small number of patients. Given COVID-19’s impact on the underserved communities, having a safe resource to reach these patients has been limited, leaving face-to-face visits as their only option. Requiring a face-to-face visit during peak illness has placed patients at risk. They have refused health care as opposed to exposure to the illness in health care settings.

We have innovative opportunities to create a new health care system. Despite the initial struggles with the adoption of virtual care, patients and providers have begun embracing the technology. Best practices and shared resources will be required to have a successful system before brick and mortar organizations can be reduced or insurance companies create their own health care systems which can branch across state lines.
 

Ms. Thew is the medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee. She said she had no relevant financial disclosures. Email her at [email protected].

The article was updated 7/17/2020.

Microcephaly may be the hallmark of congenital Zika virus syndrome, but neurologic abnormalities also are common in normocephalic children exposed to the virus in utero, according to data from a large pediatric referral center in Rio de Janeiro.

CDC/ Cynthia Goldsmith

The retrospective analysis demonstrated that there is a “spectrum of clinical manifestations” in children with congenital Zika virus syndrome, including those who “had initially been perceived as developing normally based on [head circumference],” Jessica S. Cranston, a medical student at the University of California, Los Angeles, and associates wrote in JAMA Network Open.

Previous studies have described the poor clinical outcomes in Zika virus–exposed infants with microcephaly, but the current analysis evaluated head circumference (HC) as a continuous variable and stratified outcomes according to the presence or absence of microcephaly, they explained.

In the cohort of 215 children referred to Instituto Fernandes Figueira who had laboratory-confirmed antenatal Zika virus exposure, 53 had microcephaly (cephalic perimeter z score of less than –2 standard deviations) and 162 were normocephalic, the investigators said.

The children were evaluated monthly for the first 6 months of life and then every 3 months. Neurodevelopmental evaluation with the Bayley Scales of Infant and Toddler Development, Third Edition, between 6 months and 3 years of age showed that all of those with microcephaly had abnormal neuromotor findings. All but two of the children with microcephaly had abnormal neuroimaging results, and 38 (72%) had failure to thrive, they reported.

Among the children with normocephaly at birth, 68% had abnormal neurologic findings, including hyperreflexia (27%), abnormal tone (39%), and other congenital neuromotor signs (42%). Results of neuroimaging results, primarily in the form of transfontanelle ultrasonography, were abnormal in 29% of children with normocephaly.

“Infants with a larger birth HC, within the normocephalic range (±2 SDs), had higher overall neurodevelopmental scores on the Bayley-III assessment,” Sarah B. Mulkey, MD, PhD, said in an invited commentary, “whereas infants with a smaller birth HC within the normocephalic range had lower scores in the domains of cognitive and language functions.”

If HC measurements could be combined with early neurologic data such as the results of neuroimaging or a neurological exam, she suggested, it might provide “a practical tool to help determine risk for adverse clinical outcomes in a [Zika virus–]exposed infant at birth that can be widely used in a variety of follow-up settings.”

In nutritional assessments performed for 143 children with normocephaly, 51% had failure to thrive “because of neurologic repercussions leading to poor feeding,” Ms. Cranston and associates wrote, adding that 15 of the 73 (21%) infants with normocephaly and failure to thrive developed secondary microcephaly.

Altogether, 17 of the 162 (10.5%) children with normocephaly developed microcephaly during the follow-up, with the reverse – microcephaly resolving in infants who were microcephalic at birth – occurring in 4 of the 53 (7.5%) affected infants, indicating that “head circumference was not static,” they said.

“The trajectory of head growth is critical,” said Dr. Mulkey of the Prenatal Pediatrics Institute at Children’s National Hospital in Washington. “The neurologic outcome of a child who develops postnatal microcephaly would be very concerning compared with an infant who is born with normocephaly and maintains a steady HC percentile over time.”

HC is just one piece of the puzzle, however, since children with Zika virus syndrome may exhibit “a variety of manifestations and outcomes.” This lack of certainty suggests that “careful monitoring and evaluation of children with suspected exposure is essential for ensuring early detection of possible disabilities and referral to interventional services,” the investigators wrote.

The findings of this study “are both highly statistically significant and clinically significant,”said Kevin T. Powell, MD, PhD, a pediatric hospitalist and clinical ethics consultant living in St. Louis who was not associated with the study.

“While outcomes at birth are dichotomized into those with and without microcephaly, the developmental outcomes measured at 3 years of age are on a spectrum. ... Those with microcephaly tend to be more severely affected, but many infants with small but normal-sized heads are also mild to moderately impacted. The flip side is that 64% of infected babies ended up with average or better development” based on Bayley-III evaluations, said Dr. Powell, who is a member of the Pediatric News editorial advisory board.

The study was funded by grants from the National Institute of Allergy and Infectious Diseases, the National Eye Institute, and the Thrasher Foundation and by awards from Brazil’s National Council of Scientific and Technological Development; Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro. Individual investigators received fees and grants from these and other organizations.

Dr. Mulkey received a contract from the Centers for Disease Control and Prevention for technical expertise for Zika virus studies and received support for Zika studies from the Thrasher Research Fund. Dr. Powell had no relevant financial disclosures.

[email protected]

SOURCE: Cranston JS et al. JAMA Netw Open. 2020 July 7;3(7):e209303.

Microcephaly may be the hallmark of congenital Zika virus syndrome, but neurologic abnormalities also are common in normocephalic children exposed to the virus in utero, according to data from a large pediatric referral center in Rio de Janeiro.

CDC/ Cynthia Goldsmith

The retrospective analysis demonstrated that there is a “spectrum of clinical manifestations” in children with congenital Zika virus syndrome, including those who “had initially been perceived as developing normally based on [head circumference],” Jessica S. Cranston, a medical student at the University of California, Los Angeles, and associates wrote in JAMA Network Open.

Previous studies have described the poor clinical outcomes in Zika virus–exposed infants with microcephaly, but the current analysis evaluated head circumference (HC) as a continuous variable and stratified outcomes according to the presence or absence of microcephaly, they explained.

In the cohort of 215 children referred to Instituto Fernandes Figueira who had laboratory-confirmed antenatal Zika virus exposure, 53 had microcephaly (cephalic perimeter z score of less than –2 standard deviations) and 162 were normocephalic, the investigators said.

The children were evaluated monthly for the first 6 months of life and then every 3 months. Neurodevelopmental evaluation with the Bayley Scales of Infant and Toddler Development, Third Edition, between 6 months and 3 years of age showed that all of those with microcephaly had abnormal neuromotor findings. All but two of the children with microcephaly had abnormal neuroimaging results, and 38 (72%) had failure to thrive, they reported.

Among the children with normocephaly at birth, 68% had abnormal neurologic findings, including hyperreflexia (27%), abnormal tone (39%), and other congenital neuromotor signs (42%). Results of neuroimaging results, primarily in the form of transfontanelle ultrasonography, were abnormal in 29% of children with normocephaly.

“Infants with a larger birth HC, within the normocephalic range (±2 SDs), had higher overall neurodevelopmental scores on the Bayley-III assessment,” Sarah B. Mulkey, MD, PhD, said in an invited commentary, “whereas infants with a smaller birth HC within the normocephalic range had lower scores in the domains of cognitive and language functions.”

If HC measurements could be combined with early neurologic data such as the results of neuroimaging or a neurological exam, she suggested, it might provide “a practical tool to help determine risk for adverse clinical outcomes in a [Zika virus–]exposed infant at birth that can be widely used in a variety of follow-up settings.”

In nutritional assessments performed for 143 children with normocephaly, 51% had failure to thrive “because of neurologic repercussions leading to poor feeding,” Ms. Cranston and associates wrote, adding that 15 of the 73 (21%) infants with normocephaly and failure to thrive developed secondary microcephaly.

Altogether, 17 of the 162 (10.5%) children with normocephaly developed microcephaly during the follow-up, with the reverse – microcephaly resolving in infants who were microcephalic at birth – occurring in 4 of the 53 (7.5%) affected infants, indicating that “head circumference was not static,” they said.

“The trajectory of head growth is critical,” said Dr. Mulkey of the Prenatal Pediatrics Institute at Children’s National Hospital in Washington. “The neurologic outcome of a child who develops postnatal microcephaly would be very concerning compared with an infant who is born with normocephaly and maintains a steady HC percentile over time.”

HC is just one piece of the puzzle, however, since children with Zika virus syndrome may exhibit “a variety of manifestations and outcomes.” This lack of certainty suggests that “careful monitoring and evaluation of children with suspected exposure is essential for ensuring early detection of possible disabilities and referral to interventional services,” the investigators wrote.

The findings of this study “are both highly statistically significant and clinically significant,”said Kevin T. Powell, MD, PhD, a pediatric hospitalist and clinical ethics consultant living in St. Louis who was not associated with the study.

“While outcomes at birth are dichotomized into those with and without microcephaly, the developmental outcomes measured at 3 years of age are on a spectrum. ... Those with microcephaly tend to be more severely affected, but many infants with small but normal-sized heads are also mild to moderately impacted. The flip side is that 64% of infected babies ended up with average or better development” based on Bayley-III evaluations, said Dr. Powell, who is a member of the Pediatric News editorial advisory board.

The study was funded by grants from the National Institute of Allergy and Infectious Diseases, the National Eye Institute, and the Thrasher Foundation and by awards from Brazil’s National Council of Scientific and Technological Development; Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro. Individual investigators received fees and grants from these and other organizations.

Dr. Mulkey received a contract from the Centers for Disease Control and Prevention for technical expertise for Zika virus studies and received support for Zika studies from the Thrasher Research Fund. Dr. Powell had no relevant financial disclosures.

[email protected]

SOURCE: Cranston JS et al. JAMA Netw Open. 2020 July 7;3(7):e209303.

Microcephaly may be the hallmark of congenital Zika virus syndrome, but neurologic abnormalities also are common in normocephalic children exposed to the virus in utero, according to data from a large pediatric referral center in Rio de Janeiro.

CDC/ Cynthia Goldsmith

The retrospective analysis demonstrated that there is a “spectrum of clinical manifestations” in children with congenital Zika virus syndrome, including those who “had initially been perceived as developing normally based on [head circumference],” Jessica S. Cranston, a medical student at the University of California, Los Angeles, and associates wrote in JAMA Network Open.

Previous studies have described the poor clinical outcomes in Zika virus–exposed infants with microcephaly, but the current analysis evaluated head circumference (HC) as a continuous variable and stratified outcomes according to the presence or absence of microcephaly, they explained.

In the cohort of 215 children referred to Instituto Fernandes Figueira who had laboratory-confirmed antenatal Zika virus exposure, 53 had microcephaly (cephalic perimeter z score of less than –2 standard deviations) and 162 were normocephalic, the investigators said.

The children were evaluated monthly for the first 6 months of life and then every 3 months. Neurodevelopmental evaluation with the Bayley Scales of Infant and Toddler Development, Third Edition, between 6 months and 3 years of age showed that all of those with microcephaly had abnormal neuromotor findings. All but two of the children with microcephaly had abnormal neuroimaging results, and 38 (72%) had failure to thrive, they reported.

Among the children with normocephaly at birth, 68% had abnormal neurologic findings, including hyperreflexia (27%), abnormal tone (39%), and other congenital neuromotor signs (42%). Results of neuroimaging results, primarily in the form of transfontanelle ultrasonography, were abnormal in 29% of children with normocephaly.

“Infants with a larger birth HC, within the normocephalic range (±2 SDs), had higher overall neurodevelopmental scores on the Bayley-III assessment,” Sarah B. Mulkey, MD, PhD, said in an invited commentary, “whereas infants with a smaller birth HC within the normocephalic range had lower scores in the domains of cognitive and language functions.”

If HC measurements could be combined with early neurologic data such as the results of neuroimaging or a neurological exam, she suggested, it might provide “a practical tool to help determine risk for adverse clinical outcomes in a [Zika virus–]exposed infant at birth that can be widely used in a variety of follow-up settings.”

In nutritional assessments performed for 143 children with normocephaly, 51% had failure to thrive “because of neurologic repercussions leading to poor feeding,” Ms. Cranston and associates wrote, adding that 15 of the 73 (21%) infants with normocephaly and failure to thrive developed secondary microcephaly.

Altogether, 17 of the 162 (10.5%) children with normocephaly developed microcephaly during the follow-up, with the reverse – microcephaly resolving in infants who were microcephalic at birth – occurring in 4 of the 53 (7.5%) affected infants, indicating that “head circumference was not static,” they said.

“The trajectory of head growth is critical,” said Dr. Mulkey of the Prenatal Pediatrics Institute at Children’s National Hospital in Washington. “The neurologic outcome of a child who develops postnatal microcephaly would be very concerning compared with an infant who is born with normocephaly and maintains a steady HC percentile over time.”

HC is just one piece of the puzzle, however, since children with Zika virus syndrome may exhibit “a variety of manifestations and outcomes.” This lack of certainty suggests that “careful monitoring and evaluation of children with suspected exposure is essential for ensuring early detection of possible disabilities and referral to interventional services,” the investigators wrote.

The findings of this study “are both highly statistically significant and clinically significant,”said Kevin T. Powell, MD, PhD, a pediatric hospitalist and clinical ethics consultant living in St. Louis who was not associated with the study.

“While outcomes at birth are dichotomized into those with and without microcephaly, the developmental outcomes measured at 3 years of age are on a spectrum. ... Those with microcephaly tend to be more severely affected, but many infants with small but normal-sized heads are also mild to moderately impacted. The flip side is that 64% of infected babies ended up with average or better development” based on Bayley-III evaluations, said Dr. Powell, who is a member of the Pediatric News editorial advisory board.

The study was funded by grants from the National Institute of Allergy and Infectious Diseases, the National Eye Institute, and the Thrasher Foundation and by awards from Brazil’s National Council of Scientific and Technological Development; Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro. Individual investigators received fees and grants from these and other organizations.

Dr. Mulkey received a contract from the Centers for Disease Control and Prevention for technical expertise for Zika virus studies and received support for Zika studies from the Thrasher Research Fund. Dr. Powell had no relevant financial disclosures.

[email protected]

SOURCE: Cranston JS et al. JAMA Netw Open. 2020 July 7;3(7):e209303.

Contact dermatitis is an eczematous, pruritic eruption caused by direct contact with a substance and an irritant or allergic reaction. While it may not be contagious or life-threatening, contact dermatitis may be tremendously uncomfortable and impactful. Contact dermatitis may occur from exposure to chemicals in soaps, shampoos, cosmetics, metals, plants and topical products, and medications. The hallmark of contact dermatitis is localized eczematous reactions on the portion of the body that has been directly exposed to the reaction-causing substance. Signs and symptoms of contact dermatitis include significant pruritus and acute eczematous changes, including vesicles and papules – often with oozing and crusting.

Irritant contact dermatitis is the most common type, which occurs when a substance damages the skin’s outer protective layer and does not require prior exposure or sensitization. Allergic contact dermatitis (ACD) can develop after exposure and sensitization, with an external allergen triggering an acute inflammatory response.¹ Common causes of ACD include nickel, cobalt, gold, chromium, poison ivy/oak/sumac, cosmetics/personal care products that contain formaldehyde, fragrances, topical medications (anesthetics, antibiotics, corticosteroids), baby wipes, sunscreens, latex materials, protective equipment, soap/cleansers, resins, and acrylics. Among children, nickel sulfate, ammonium persulfate, gold sodium thiosulfate, thimerosal, and toluene-2,5-diamine are the most common sensitizers. Rarely, ACD can be triggered by something that enters the body through foods, flavorings, medicine, or medical or dental procedures (systemic contact dermatitis).

An Id reaction, or autoeczematization, is a generalized acute cutaneous reaction to a variety of stimuli, including infectious and inflammatory skin conditions such as contact dermatitis, stasis dermatitis, or other eczematous dermatitis.³ Id reactions usually are preceded by a preexisting dermatitis. Lesions are, by definition, at a site distant from the primary infection or dermatitis. They often are distributed symmetrically. Papular or papular-vesicular lesions of the extremities and or trunk are common in children.

Our patient had evidence of a localized periocular contact dermatitis reaction that preceded the symmetric papular, eczematous eruption consistent with an id reaction. Our patient was prescribed hydrocortisone 2.5 % ointment for the eyes and triamcinolone 0.1% ointment for the rash on the body, which resulted in significant improvement.

Rosacea is a chronic and relapsing inflammatory skin disorder that primarily involves the central face. Common clinical features include facial erythema, telangiectasias, and inflammatory papules or pustules. Ocular involvement may occur in the presence or absence of cutaneous manifestations. Patients may report the presence of ocular foreign body sensation, burning, photophobia, blurred vision, redness, and tearing. Ocular disease is usually bilateral and is not proportional to the severity of the skin disease.⁴ Common skin findings are blepharitis, lid margin telangiectasia, tear abnormalities, meibomian gland inflammation, frequent chalazion, bilateral hordeolum, conjunctivitis, and, rarely, corneal ulcers and vascularization. Our patient initially did have bilateral hordeolum in what may seem to be ocular rosacea. However, given the use of a recent topical antibiotic with subsequent eczematous rash of the eyelids and then resulting distant rash on the body 1week later made the rash likely allergic contact dermatitis with id reaction.

Seborrheic dermatitis is a chronic, relapsing, and usually mild form of dermatitis that occurs in infants and in adults. The severity may vary from minimal, asymptomatic scaliness of the scalp (dandruff) to more widespread involvement. It is usually characterized by well-demarcated, erythematous plaques with greasy-looking, yellowish scales distributed on areas rich in sebaceous glands, such as the scalp, the external ear, the center of the face, the upper part of the trunk, and the intertriginous areas.

Psoriasis typically affects the outside of the elbows, knees, or scalp, although it can appear on any location. It tends to go through cycles, flaring for a few weeks or months, then subsiding for a while or going into remission. Ocular involvement is a well known manifestation of psoriasis.⁵ Psoriatic lesions of the eyelid are rare, even in the erythrodermic variant of the disease. Occasionally, pustular psoriasis may involve the eyelids, with typical psoriatic lesions visible on the skin and lid margin. The reason for the relative sparing of the eyelid skin in patients with psoriasis is unknown. Other manifestations include meibomian gland dysfunction, decreased tear film break-up time, a nonspecific conjunctivitis, and corneal disease secondary to lid disease such as trichiasis.

Gianotti-Crosti syndrome (GCS), also known as papular acrodermatitis, papular acrodermatitis of childhood, and infantile papular acrodermatitis, is a self-limited skin disorder that most often occurs in young children. Viral infections are common GCS precipitating factors . GCS typically manifests as a symmetric, papular eruption, often with larger (3- to 10-mm) flat topped papulovesicles. Classic sites of involvement include the cheeks, buttocks, and extensor surfaces of the forearms and legs. GCS may be pruritic or asymptomatic, and papules typically resolve spontaneously within 2 months. Occasionally, GCS persists for longer periods. The eyelid lesions and localized pattern, with the absence of larger symmetric papules of the buttocks and legs, was not consistent with papular acrodermatitis of childhood.
 

Dr. Bhatti is a research fellow in pediatric dermatology at Rady Children’s Hospital and the University of California, San Diego. Dr. Eichenfield is chief of pediatric and adolescent dermatology at Rady Children’s Hospital–San Diego. He is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego. They had no conflicts of interest to disclose. Email them at [email protected].

References

1. J Am Acad Dermatol 2016 Jun; 74(6):1043-54.

2. Pediatr Dermatol 2016 Jul; 33(4):399-404.

3. Evans M & Bronson D. (2019) Id Reaction (Autoeczematization). Retrieved from emedicine.medscape.com/article/1049760-overview.

4. Curr Opin Ophthalmol. 2004 Dec;15(6):499-502.

5. Clin Dermatol. Mar-Apr 2016;34(2):146-50.

Contact dermatitis is an eczematous, pruritic eruption caused by direct contact with a substance and an irritant or allergic reaction. While it may not be contagious or life-threatening, contact dermatitis may be tremendously uncomfortable and impactful. Contact dermatitis may occur from exposure to chemicals in soaps, shampoos, cosmetics, metals, plants and topical products, and medications. The hallmark of contact dermatitis is localized eczematous reactions on the portion of the body that has been directly exposed to the reaction-causing substance. Signs and symptoms of contact dermatitis include significant pruritus and acute eczematous changes, including vesicles and papules – often with oozing and crusting.

Irritant contact dermatitis is the most common type, which occurs when a substance damages the skin’s outer protective layer and does not require prior exposure or sensitization. Allergic contact dermatitis (ACD) can develop after exposure and sensitization, with an external allergen triggering an acute inflammatory response.¹ Common causes of ACD include nickel, cobalt, gold, chromium, poison ivy/oak/sumac, cosmetics/personal care products that contain formaldehyde, fragrances, topical medications (anesthetics, antibiotics, corticosteroids), baby wipes, sunscreens, latex materials, protective equipment, soap/cleansers, resins, and acrylics. Among children, nickel sulfate, ammonium persulfate, gold sodium thiosulfate, thimerosal, and toluene-2,5-diamine are the most common sensitizers. Rarely, ACD can be triggered by something that enters the body through foods, flavorings, medicine, or medical or dental procedures (systemic contact dermatitis).

An Id reaction, or autoeczematization, is a generalized acute cutaneous reaction to a variety of stimuli, including infectious and inflammatory skin conditions such as contact dermatitis, stasis dermatitis, or other eczematous dermatitis.³ Id reactions usually are preceded by a preexisting dermatitis. Lesions are, by definition, at a site distant from the primary infection or dermatitis. They often are distributed symmetrically. Papular or papular-vesicular lesions of the extremities and or trunk are common in children.

Our patient had evidence of a localized periocular contact dermatitis reaction that preceded the symmetric papular, eczematous eruption consistent with an id reaction. Our patient was prescribed hydrocortisone 2.5 % ointment for the eyes and triamcinolone 0.1% ointment for the rash on the body, which resulted in significant improvement.

Rosacea is a chronic and relapsing inflammatory skin disorder that primarily involves the central face. Common clinical features include facial erythema, telangiectasias, and inflammatory papules or pustules. Ocular involvement may occur in the presence or absence of cutaneous manifestations. Patients may report the presence of ocular foreign body sensation, burning, photophobia, blurred vision, redness, and tearing. Ocular disease is usually bilateral and is not proportional to the severity of the skin disease.⁴ Common skin findings are blepharitis, lid margin telangiectasia, tear abnormalities, meibomian gland inflammation, frequent chalazion, bilateral hordeolum, conjunctivitis, and, rarely, corneal ulcers and vascularization. Our patient initially did have bilateral hordeolum in what may seem to be ocular rosacea. However, given the use of a recent topical antibiotic with subsequent eczematous rash of the eyelids and then resulting distant rash on the body 1week later made the rash likely allergic contact dermatitis with id reaction.

Seborrheic dermatitis is a chronic, relapsing, and usually mild form of dermatitis that occurs in infants and in adults. The severity may vary from minimal, asymptomatic scaliness of the scalp (dandruff) to more widespread involvement. It is usually characterized by well-demarcated, erythematous plaques with greasy-looking, yellowish scales distributed on areas rich in sebaceous glands, such as the scalp, the external ear, the center of the face, the upper part of the trunk, and the intertriginous areas.

Psoriasis typically affects the outside of the elbows, knees, or scalp, although it can appear on any location. It tends to go through cycles, flaring for a few weeks or months, then subsiding for a while or going into remission. Ocular involvement is a well known manifestation of psoriasis.⁵ Psoriatic lesions of the eyelid are rare, even in the erythrodermic variant of the disease. Occasionally, pustular psoriasis may involve the eyelids, with typical psoriatic lesions visible on the skin and lid margin. The reason for the relative sparing of the eyelid skin in patients with psoriasis is unknown. Other manifestations include meibomian gland dysfunction, decreased tear film break-up time, a nonspecific conjunctivitis, and corneal disease secondary to lid disease such as trichiasis.

Gianotti-Crosti syndrome (GCS), also known as papular acrodermatitis, papular acrodermatitis of childhood, and infantile papular acrodermatitis, is a self-limited skin disorder that most often occurs in young children. Viral infections are common GCS precipitating factors . GCS typically manifests as a symmetric, papular eruption, often with larger (3- to 10-mm) flat topped papulovesicles. Classic sites of involvement include the cheeks, buttocks, and extensor surfaces of the forearms and legs. GCS may be pruritic or asymptomatic, and papules typically resolve spontaneously within 2 months. Occasionally, GCS persists for longer periods. The eyelid lesions and localized pattern, with the absence of larger symmetric papules of the buttocks and legs, was not consistent with papular acrodermatitis of childhood.
 

Dr. Bhatti is a research fellow in pediatric dermatology at Rady Children’s Hospital and the University of California, San Diego. Dr. Eichenfield is chief of pediatric and adolescent dermatology at Rady Children’s Hospital–San Diego. He is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego. They had no conflicts of interest to disclose. Email them at [email protected].

References

1. J Am Acad Dermatol 2016 Jun; 74(6):1043-54.

2. Pediatr Dermatol 2016 Jul; 33(4):399-404.

3. Evans M & Bronson D. (2019) Id Reaction (Autoeczematization). Retrieved from emedicine.medscape.com/article/1049760-overview.

4. Curr Opin Ophthalmol. 2004 Dec;15(6):499-502.

5. Clin Dermatol. Mar-Apr 2016;34(2):146-50.

Contact dermatitis is an eczematous, pruritic eruption caused by direct contact with a substance and an irritant or allergic reaction. While it may not be contagious or life-threatening, contact dermatitis may be tremendously uncomfortable and impactful. Contact dermatitis may occur from exposure to chemicals in soaps, shampoos, cosmetics, metals, plants and topical products, and medications. The hallmark of contact dermatitis is localized eczematous reactions on the portion of the body that has been directly exposed to the reaction-causing substance. Signs and symptoms of contact dermatitis include significant pruritus and acute eczematous changes, including vesicles and papules – often with oozing and crusting.

Irritant contact dermatitis is the most common type, which occurs when a substance damages the skin’s outer protective layer and does not require prior exposure or sensitization. Allergic contact dermatitis (ACD) can develop after exposure and sensitization, with an external allergen triggering an acute inflammatory response.¹ Common causes of ACD include nickel, cobalt, gold, chromium, poison ivy/oak/sumac, cosmetics/personal care products that contain formaldehyde, fragrances, topical medications (anesthetics, antibiotics, corticosteroids), baby wipes, sunscreens, latex materials, protective equipment, soap/cleansers, resins, and acrylics. Among children, nickel sulfate, ammonium persulfate, gold sodium thiosulfate, thimerosal, and toluene-2,5-diamine are the most common sensitizers. Rarely, ACD can be triggered by something that enters the body through foods, flavorings, medicine, or medical or dental procedures (systemic contact dermatitis).

An Id reaction, or autoeczematization, is a generalized acute cutaneous reaction to a variety of stimuli, including infectious and inflammatory skin conditions such as contact dermatitis, stasis dermatitis, or other eczematous dermatitis.³ Id reactions usually are preceded by a preexisting dermatitis. Lesions are, by definition, at a site distant from the primary infection or dermatitis. They often are distributed symmetrically. Papular or papular-vesicular lesions of the extremities and or trunk are common in children.

Our patient had evidence of a localized periocular contact dermatitis reaction that preceded the symmetric papular, eczematous eruption consistent with an id reaction. Our patient was prescribed hydrocortisone 2.5 % ointment for the eyes and triamcinolone 0.1% ointment for the rash on the body, which resulted in significant improvement.

Rosacea is a chronic and relapsing inflammatory skin disorder that primarily involves the central face. Common clinical features include facial erythema, telangiectasias, and inflammatory papules or pustules. Ocular involvement may occur in the presence or absence of cutaneous manifestations. Patients may report the presence of ocular foreign body sensation, burning, photophobia, blurred vision, redness, and tearing. Ocular disease is usually bilateral and is not proportional to the severity of the skin disease.⁴ Common skin findings are blepharitis, lid margin telangiectasia, tear abnormalities, meibomian gland inflammation, frequent chalazion, bilateral hordeolum, conjunctivitis, and, rarely, corneal ulcers and vascularization. Our patient initially did have bilateral hordeolum in what may seem to be ocular rosacea. However, given the use of a recent topical antibiotic with subsequent eczematous rash of the eyelids and then resulting distant rash on the body 1week later made the rash likely allergic contact dermatitis with id reaction.

Seborrheic dermatitis is a chronic, relapsing, and usually mild form of dermatitis that occurs in infants and in adults. The severity may vary from minimal, asymptomatic scaliness of the scalp (dandruff) to more widespread involvement. It is usually characterized by well-demarcated, erythematous plaques with greasy-looking, yellowish scales distributed on areas rich in sebaceous glands, such as the scalp, the external ear, the center of the face, the upper part of the trunk, and the intertriginous areas.

Psoriasis typically affects the outside of the elbows, knees, or scalp, although it can appear on any location. It tends to go through cycles, flaring for a few weeks or months, then subsiding for a while or going into remission. Ocular involvement is a well known manifestation of psoriasis.⁵ Psoriatic lesions of the eyelid are rare, even in the erythrodermic variant of the disease. Occasionally, pustular psoriasis may involve the eyelids, with typical psoriatic lesions visible on the skin and lid margin. The reason for the relative sparing of the eyelid skin in patients with psoriasis is unknown. Other manifestations include meibomian gland dysfunction, decreased tear film break-up time, a nonspecific conjunctivitis, and corneal disease secondary to lid disease such as trichiasis.

Gianotti-Crosti syndrome (GCS), also known as papular acrodermatitis, papular acrodermatitis of childhood, and infantile papular acrodermatitis, is a self-limited skin disorder that most often occurs in young children. Viral infections are common GCS precipitating factors . GCS typically manifests as a symmetric, papular eruption, often with larger (3- to 10-mm) flat topped papulovesicles. Classic sites of involvement include the cheeks, buttocks, and extensor surfaces of the forearms and legs. GCS may be pruritic or asymptomatic, and papules typically resolve spontaneously within 2 months. Occasionally, GCS persists for longer periods. The eyelid lesions and localized pattern, with the absence of larger symmetric papules of the buttocks and legs, was not consistent with papular acrodermatitis of childhood.
 

Dr. Bhatti is a research fellow in pediatric dermatology at Rady Children’s Hospital and the University of California, San Diego. Dr. Eichenfield is chief of pediatric and adolescent dermatology at Rady Children’s Hospital–San Diego. He is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego. They had no conflicts of interest to disclose. Email them at [email protected].

References

1. J Am Acad Dermatol 2016 Jun; 74(6):1043-54.

2. Pediatr Dermatol 2016 Jul; 33(4):399-404.

3. Evans M & Bronson D. (2019) Id Reaction (Autoeczematization). Retrieved from emedicine.medscape.com/article/1049760-overview.

4. Curr Opin Ophthalmol. 2004 Dec;15(6):499-502.

5. Clin Dermatol. Mar-Apr 2016;34(2):146-50.

A sense of safety and stability, both emotional and physical, is crucial in promoting the healthy development of youth. Between the global pandemic, need for social distancing, economic downturn, and increased awareness of racial disparities, for many this sense of stability has been rattled.

Ryan McVay/ThinkStock

School closures have led to a loss of social interaction, challenges to continued academic growth, and, for some students, lack of access to nutrition and increased food insecurity. For students with learning or mental health challenges, closures may have eliminated or significantly reduced desperately needed supports received in school.¹ While these trying circumstances have been difficult for many, the transition back to school in the fall also may be challenging because of the uncertainty about what this will look like and possible change in routine. Some students or their families may have anxiety about returning, either because of a history of adverse experiences at school such as bullying, or because of fears about exposure for themselves or others to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

The past several months also brought about greater awareness of systemic racial disparities, whether as reflected in health care, education, or the criminal justice system. According to the Centers for Disease Control and Prevention data, Latinx and African-American individuals in the United States have had a threefold greater chance of contracting SARS-CoV-2 and have a twofold greater risk of death, compared with white people in the same communities.² Other social determinants of health – economic stability, education, social factors such as incarceration and discrimination, and neighborhood factors including access to healthy food – play a role in this vulnerability.

The pandemic has resulted in a need for social distancing, and as a result, isolation. Children and teens exposed to the news may have anxiety about what they see or hear. Additional pressures in the family can include economic uncertainty, loss of employment for the primary wage earner of the household, or stress related to family members being first responders.

Any one of these factors is a potentially significant stressor, so how do we best support youth to help them survive and hopefully thrive during this time?
 

• It is important to establish a sense of routine; this can help create a sense of stability and safety. Recognizing that circumstances are not the same as they were 5 or 6 months ago, encouraging structure should not come at the cost of preserving connection.
• Note positive behavior and choices made by children and make sure they know it was observed.
• Many children have experienced increased screen time with the lack of structure of the traditional school day or summer camp and extracurricular activities. Limiting screen time and being mindful of its potential impact on mood is prudent.
• Self-care for parents and guardians is important. This is clearly a marathon and not a sprint; parents’ caring for themselves will place them in a better position to support their children. This time is stressful for the adults of the household, let alone children who are learning self-regulation skills.
• Listen to children’s or teens’ concerns and share information in developmentally appropriate ways. It is okay to not have all of the answers.
• Balance fostering a sense of gratitude with not invalidating a child’s or teen’s experience. Showing empathy during this time is vital. While there may be other soccer seasons, it is normal to experience grief about the loss of experiences during this time.
• Parents and guardians know their children best, so it is prudent for them to be mindful of concerning changes such as an increase in sadness, anxiety, or irritability that negatively impacts daily functioning such as sleeping, eating, or relationships with family and friends.
• Promote social interactions with appropriate safeguards in place. Unfortunately, the number of SARS-CoV-2 infections is increasing in multiple states, and there is the potential to return to some of the previous restrictions. However, encouraging social interaction while following local guidelines and with cautions such as limiting the number of people present, meeting outside, or considering interacting with others who are similarly social distancing can help foster social connection and development.
• Maintain connection digitally when in-person contact is not an option.³ Social groups, places of worship, and other activities have been agile in developing virtual communities. Communication by voice and/or video is thought to be more powerful than by written communication (text, email) alone.⁴ However, it is important to consider those who may have limited to no access to electronic methods.
• Encourage open communication with children about diversity and bias, and consider how our interactions with others may affect our children’s perspectives.⁵
• As providers, it is crucial that we address structural and institutional systems that negatively impact the health, safety, and access to care including our Black, indigenous, and people of color (BIPOC) and lesbian, gay, bisexual, transgender/transsexual, queer/questioning, intersex, and allied/asexual/aromantic/agender (LGBTQIA) patients.

Dr. Strange is an assistant professor in the department of psychiatry at the University of Vermont Medical Center and University of Vermont Robert Larner College of Medicine, both in Burlington. She works with children and adolescents. Dr. Strange has no relevant financial disclosures. Email her at [email protected].

Online resources for parents and families

• Child Mind Institute: Coping With the Coronavirus Crisis: Supporting Your Kids.
• American Psychological Association: Talking with children about discrimination.
• Common Sense Media: Help with determining appropriateness of media for children.

Hotlines

• National Suicide Prevention Hotline: 1-800-273-8255
• GLBT National Hotline: 888-843-4564
• The California Peer-Run Warm Line: 1-855-845-7415
• Trevor Project: 866-488-7386 or text TREVOR to 1-202-304-1200
• Trans Lifeline: 877-565-8860
• Crisis Text Line: Text HOME to 741741

References

1. JAMA Pediatr. 2020 Apr 14. doi: 10.1001/jamapediatrics.2020.1456.

2. CDC: COVID-19 in Racial and Ethnic Minority Groups.

3. JAMA. 2020 Mar 23. doi: 10.1001/jama.2020.4469.

4. JAMA Intern Med. 2020 Apr 10. doi: 10.1001/jamainternmed.2020.1562.

5. American Psychological Association: Talking with children about discrimination.

A sense of safety and stability, both emotional and physical, is crucial in promoting the healthy development of youth. Between the global pandemic, need for social distancing, economic downturn, and increased awareness of racial disparities, for many this sense of stability has been rattled.

Ryan McVay/ThinkStock

School closures have led to a loss of social interaction, challenges to continued academic growth, and, for some students, lack of access to nutrition and increased food insecurity. For students with learning or mental health challenges, closures may have eliminated or significantly reduced desperately needed supports received in school.¹ While these trying circumstances have been difficult for many, the transition back to school in the fall also may be challenging because of the uncertainty about what this will look like and possible change in routine. Some students or their families may have anxiety about returning, either because of a history of adverse experiences at school such as bullying, or because of fears about exposure for themselves or others to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

The past several months also brought about greater awareness of systemic racial disparities, whether as reflected in health care, education, or the criminal justice system. According to the Centers for Disease Control and Prevention data, Latinx and African-American individuals in the United States have had a threefold greater chance of contracting SARS-CoV-2 and have a twofold greater risk of death, compared with white people in the same communities.² Other social determinants of health – economic stability, education, social factors such as incarceration and discrimination, and neighborhood factors including access to healthy food – play a role in this vulnerability.

The pandemic has resulted in a need for social distancing, and as a result, isolation. Children and teens exposed to the news may have anxiety about what they see or hear. Additional pressures in the family can include economic uncertainty, loss of employment for the primary wage earner of the household, or stress related to family members being first responders.

Any one of these factors is a potentially significant stressor, so how do we best support youth to help them survive and hopefully thrive during this time?
 

• It is important to establish a sense of routine; this can help create a sense of stability and safety. Recognizing that circumstances are not the same as they were 5 or 6 months ago, encouraging structure should not come at the cost of preserving connection.
• Note positive behavior and choices made by children and make sure they know it was observed.
• Many children have experienced increased screen time with the lack of structure of the traditional school day or summer camp and extracurricular activities. Limiting screen time and being mindful of its potential impact on mood is prudent.
• Self-care for parents and guardians is important. This is clearly a marathon and not a sprint; parents’ caring for themselves will place them in a better position to support their children. This time is stressful for the adults of the household, let alone children who are learning self-regulation skills.
• Listen to children’s or teens’ concerns and share information in developmentally appropriate ways. It is okay to not have all of the answers.
• Balance fostering a sense of gratitude with not invalidating a child’s or teen’s experience. Showing empathy during this time is vital. While there may be other soccer seasons, it is normal to experience grief about the loss of experiences during this time.
• Parents and guardians know their children best, so it is prudent for them to be mindful of concerning changes such as an increase in sadness, anxiety, or irritability that negatively impacts daily functioning such as sleeping, eating, or relationships with family and friends.
• Promote social interactions with appropriate safeguards in place. Unfortunately, the number of SARS-CoV-2 infections is increasing in multiple states, and there is the potential to return to some of the previous restrictions. However, encouraging social interaction while following local guidelines and with cautions such as limiting the number of people present, meeting outside, or considering interacting with others who are similarly social distancing can help foster social connection and development.
• Maintain connection digitally when in-person contact is not an option.³ Social groups, places of worship, and other activities have been agile in developing virtual communities. Communication by voice and/or video is thought to be more powerful than by written communication (text, email) alone.⁴ However, it is important to consider those who may have limited to no access to electronic methods.
• Encourage open communication with children about diversity and bias, and consider how our interactions with others may affect our children’s perspectives.⁵
• As providers, it is crucial that we address structural and institutional systems that negatively impact the health, safety, and access to care including our Black, indigenous, and people of color (BIPOC) and lesbian, gay, bisexual, transgender/transsexual, queer/questioning, intersex, and allied/asexual/aromantic/agender (LGBTQIA) patients.

Dr. Strange is an assistant professor in the department of psychiatry at the University of Vermont Medical Center and University of Vermont Robert Larner College of Medicine, both in Burlington. She works with children and adolescents. Dr. Strange has no relevant financial disclosures. Email her at [email protected].

Online resources for parents and families

• Child Mind Institute: Coping With the Coronavirus Crisis: Supporting Your Kids.
• American Psychological Association: Talking with children about discrimination.
• Common Sense Media: Help with determining appropriateness of media for children.

Hotlines

• National Suicide Prevention Hotline: 1-800-273-8255
• GLBT National Hotline: 888-843-4564
• The California Peer-Run Warm Line: 1-855-845-7415
• Trevor Project: 866-488-7386 or text TREVOR to 1-202-304-1200
• Trans Lifeline: 877-565-8860
• Crisis Text Line: Text HOME to 741741

References

1. JAMA Pediatr. 2020 Apr 14. doi: 10.1001/jamapediatrics.2020.1456.

2. CDC: COVID-19 in Racial and Ethnic Minority Groups.

3. JAMA. 2020 Mar 23. doi: 10.1001/jama.2020.4469.

4. JAMA Intern Med. 2020 Apr 10. doi: 10.1001/jamainternmed.2020.1562.

5. American Psychological Association: Talking with children about discrimination.

A sense of safety and stability, both emotional and physical, is crucial in promoting the healthy development of youth. Between the global pandemic, need for social distancing, economic downturn, and increased awareness of racial disparities, for many this sense of stability has been rattled.

Ryan McVay/ThinkStock

School closures have led to a loss of social interaction, challenges to continued academic growth, and, for some students, lack of access to nutrition and increased food insecurity. For students with learning or mental health challenges, closures may have eliminated or significantly reduced desperately needed supports received in school.¹ While these trying circumstances have been difficult for many, the transition back to school in the fall also may be challenging because of the uncertainty about what this will look like and possible change in routine. Some students or their families may have anxiety about returning, either because of a history of adverse experiences at school such as bullying, or because of fears about exposure for themselves or others to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

The past several months also brought about greater awareness of systemic racial disparities, whether as reflected in health care, education, or the criminal justice system. According to the Centers for Disease Control and Prevention data, Latinx and African-American individuals in the United States have had a threefold greater chance of contracting SARS-CoV-2 and have a twofold greater risk of death, compared with white people in the same communities.² Other social determinants of health – economic stability, education, social factors such as incarceration and discrimination, and neighborhood factors including access to healthy food – play a role in this vulnerability.

The pandemic has resulted in a need for social distancing, and as a result, isolation. Children and teens exposed to the news may have anxiety about what they see or hear. Additional pressures in the family can include economic uncertainty, loss of employment for the primary wage earner of the household, or stress related to family members being first responders.

Any one of these factors is a potentially significant stressor, so how do we best support youth to help them survive and hopefully thrive during this time?
 

• It is important to establish a sense of routine; this can help create a sense of stability and safety. Recognizing that circumstances are not the same as they were 5 or 6 months ago, encouraging structure should not come at the cost of preserving connection.
• Note positive behavior and choices made by children and make sure they know it was observed.
• Many children have experienced increased screen time with the lack of structure of the traditional school day or summer camp and extracurricular activities. Limiting screen time and being mindful of its potential impact on mood is prudent.
• Self-care for parents and guardians is important. This is clearly a marathon and not a sprint; parents’ caring for themselves will place them in a better position to support their children. This time is stressful for the adults of the household, let alone children who are learning self-regulation skills.
• Listen to children’s or teens’ concerns and share information in developmentally appropriate ways. It is okay to not have all of the answers.
• Balance fostering a sense of gratitude with not invalidating a child’s or teen’s experience. Showing empathy during this time is vital. While there may be other soccer seasons, it is normal to experience grief about the loss of experiences during this time.
• Parents and guardians know their children best, so it is prudent for them to be mindful of concerning changes such as an increase in sadness, anxiety, or irritability that negatively impacts daily functioning such as sleeping, eating, or relationships with family and friends.
• Promote social interactions with appropriate safeguards in place. Unfortunately, the number of SARS-CoV-2 infections is increasing in multiple states, and there is the potential to return to some of the previous restrictions. However, encouraging social interaction while following local guidelines and with cautions such as limiting the number of people present, meeting outside, or considering interacting with others who are similarly social distancing can help foster social connection and development.
• Maintain connection digitally when in-person contact is not an option.³ Social groups, places of worship, and other activities have been agile in developing virtual communities. Communication by voice and/or video is thought to be more powerful than by written communication (text, email) alone.⁴ However, it is important to consider those who may have limited to no access to electronic methods.
• Encourage open communication with children about diversity and bias, and consider how our interactions with others may affect our children’s perspectives.⁵
• As providers, it is crucial that we address structural and institutional systems that negatively impact the health, safety, and access to care including our Black, indigenous, and people of color (BIPOC) and lesbian, gay, bisexual, transgender/transsexual, queer/questioning, intersex, and allied/asexual/aromantic/agender (LGBTQIA) patients.

Dr. Strange is an assistant professor in the department of psychiatry at the University of Vermont Medical Center and University of Vermont Robert Larner College of Medicine, both in Burlington. She works with children and adolescents. Dr. Strange has no relevant financial disclosures. Email her at [email protected].

Online resources for parents and families

• Child Mind Institute: Coping With the Coronavirus Crisis: Supporting Your Kids.
• American Psychological Association: Talking with children about discrimination.
• Common Sense Media: Help with determining appropriateness of media for children.

Hotlines

• National Suicide Prevention Hotline: 1-800-273-8255
• GLBT National Hotline: 888-843-4564
• The California Peer-Run Warm Line: 1-855-845-7415
• Trevor Project: 866-488-7386 or text TREVOR to 1-202-304-1200
• Trans Lifeline: 877-565-8860
• Crisis Text Line: Text HOME to 741741

References

1. JAMA Pediatr. 2020 Apr 14. doi: 10.1001/jamapediatrics.2020.1456.

2. CDC: COVID-19 in Racial and Ethnic Minority Groups.

3. JAMA. 2020 Mar 23. doi: 10.1001/jama.2020.4469.

4. JAMA Intern Med. 2020 Apr 10. doi: 10.1001/jamainternmed.2020.1562.

5. American Psychological Association: Talking with children about discrimination.

Starting July 1, 2021, residents and fellows will be allowed a minimum 6 weeks away for medical leave or caregiving once during training, without having to use vacation or sick leave and without having to extend their training, the American Board of Medical Specialties has announced.

The “ABMS Policy on Parental, Caregiver and Family Leave” announced July 13 was developed after a report from the Accreditation Council for Graduate Medical Education’s Council of Review Committee Residents in June 2019.

Richard E. Hawkins, MD, ABMS President and CEO, said in a statement that “the growing shifts in viewpoints regarding work-life balance and parental roles had a great influence in the creation of this policy, which fosters an environment that supports our trainees’ ability to care not only for patients, but also for themselves and their families.”

Specifically, the time can be taken for birth and care of a newborn, adopting a child, or becoming a foster parent; care of a child, spouse, or parent with a serious health condition; or the trainee’s own serious health condition. The policy applies to member boards with training programs of at least 2 years.

Boards must communicate when a leave will require an official extension to avoid disruptions to a physician’s career trajectory, a delay in starting a fellowship, or moving into a salaried position.

Work/life balance was by far the biggest challenge reported in the Medscape Residents Lifestyle & Happiness Report 2019.

Several member boards had already implemented policies that offered more flexibility without unduly delaying board certification; now ABMS is extending that to all boards.

ABMS says member boards may limit the maximum time away in a single year or level of training and directed member boards to “make reasonable testing accommodations” – for example, by allowing candidates to take an exam provided the candidate completes all training requirements by a certain date.

Kristy Rialon, MD, an author of the ACGME report and assistant professor of surgery at Baylor College of Medicine and the Texas Children’s Hospital, both in Houston, noted the significance of the change in a news release.

“By virtue of their ages, residents and fellows – male and female – often find themselves having and raising children, as well as serving as family members’ caregivers,” Dr. Rialon said. “By adopting more realistic and compassionate approaches, the ABMS member boards will significantly improve the quality of life for residents and fellows. This also will support our female physicians, helping to narrow the gender gap in their career advancement by allowing for greater leave flexibility.”

A Medscape survey published July 15 said work-life balance was the No. 1 concern of female physicians, far outpacing pay.

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

Starting July 1, 2021, residents and fellows will be allowed a minimum 6 weeks away for medical leave or caregiving once during training, without having to use vacation or sick leave and without having to extend their training, the American Board of Medical Specialties has announced.

The “ABMS Policy on Parental, Caregiver and Family Leave” announced July 13 was developed after a report from the Accreditation Council for Graduate Medical Education’s Council of Review Committee Residents in June 2019.

Richard E. Hawkins, MD, ABMS President and CEO, said in a statement that “the growing shifts in viewpoints regarding work-life balance and parental roles had a great influence in the creation of this policy, which fosters an environment that supports our trainees’ ability to care not only for patients, but also for themselves and their families.”

Specifically, the time can be taken for birth and care of a newborn, adopting a child, or becoming a foster parent; care of a child, spouse, or parent with a serious health condition; or the trainee’s own serious health condition. The policy applies to member boards with training programs of at least 2 years.

Boards must communicate when a leave will require an official extension to avoid disruptions to a physician’s career trajectory, a delay in starting a fellowship, or moving into a salaried position.

Work/life balance was by far the biggest challenge reported in the Medscape Residents Lifestyle & Happiness Report 2019.

Several member boards had already implemented policies that offered more flexibility without unduly delaying board certification; now ABMS is extending that to all boards.

ABMS says member boards may limit the maximum time away in a single year or level of training and directed member boards to “make reasonable testing accommodations” – for example, by allowing candidates to take an exam provided the candidate completes all training requirements by a certain date.

Kristy Rialon, MD, an author of the ACGME report and assistant professor of surgery at Baylor College of Medicine and the Texas Children’s Hospital, both in Houston, noted the significance of the change in a news release.

“By virtue of their ages, residents and fellows – male and female – often find themselves having and raising children, as well as serving as family members’ caregivers,” Dr. Rialon said. “By adopting more realistic and compassionate approaches, the ABMS member boards will significantly improve the quality of life for residents and fellows. This also will support our female physicians, helping to narrow the gender gap in their career advancement by allowing for greater leave flexibility.”

A Medscape survey published July 15 said work-life balance was the No. 1 concern of female physicians, far outpacing pay.

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

Starting July 1, 2021, residents and fellows will be allowed a minimum 6 weeks away for medical leave or caregiving once during training, without having to use vacation or sick leave and without having to extend their training, the American Board of Medical Specialties has announced.

The “ABMS Policy on Parental, Caregiver and Family Leave” announced July 13 was developed after a report from the Accreditation Council for Graduate Medical Education’s Council of Review Committee Residents in June 2019.

Richard E. Hawkins, MD, ABMS President and CEO, said in a statement that “the growing shifts in viewpoints regarding work-life balance and parental roles had a great influence in the creation of this policy, which fosters an environment that supports our trainees’ ability to care not only for patients, but also for themselves and their families.”

Specifically, the time can be taken for birth and care of a newborn, adopting a child, or becoming a foster parent; care of a child, spouse, or parent with a serious health condition; or the trainee’s own serious health condition. The policy applies to member boards with training programs of at least 2 years.

Boards must communicate when a leave will require an official extension to avoid disruptions to a physician’s career trajectory, a delay in starting a fellowship, or moving into a salaried position.

Work/life balance was by far the biggest challenge reported in the Medscape Residents Lifestyle & Happiness Report 2019.

Several member boards had already implemented policies that offered more flexibility without unduly delaying board certification; now ABMS is extending that to all boards.

ABMS says member boards may limit the maximum time away in a single year or level of training and directed member boards to “make reasonable testing accommodations” – for example, by allowing candidates to take an exam provided the candidate completes all training requirements by a certain date.

Kristy Rialon, MD, an author of the ACGME report and assistant professor of surgery at Baylor College of Medicine and the Texas Children’s Hospital, both in Houston, noted the significance of the change in a news release.

“By virtue of their ages, residents and fellows – male and female – often find themselves having and raising children, as well as serving as family members’ caregivers,” Dr. Rialon said. “By adopting more realistic and compassionate approaches, the ABMS member boards will significantly improve the quality of life for residents and fellows. This also will support our female physicians, helping to narrow the gender gap in their career advancement by allowing for greater leave flexibility.”

A Medscape survey published July 15 said work-life balance was the No. 1 concern of female physicians, far outpacing pay.

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

With the COVID-19 pandemic, we are experiencing a once-in-a-100-year event. Dr. Steven A. Schulz, who is serving children on the front line in upstate New York, and I outline some of the challenges primary care pediatricians have been facing and solutions that have succeeded.

Reduction in direct patient care and its consequences

Geber86/E+

Because of the unknowns of COVID-19, many parents have not wanted to bring their children to a medical office because of fear of contracting SARS-CoV-2. At the same time, pediatricians have restricted in-person visits to prevent spread of SARS-CoV-2 and to help flatten the curve of infection. Use of pediatric medical professional services, compared with last year, dropped by 52% in March 2020 and by 58% in April, according to FAIR Health, a nonprofit organization that manages a database of 31 million claims. This is resulting in decreased immunization rates, which increases concern for secondary spikes of other preventable illnesses; for example, data from the Centers for Disease Control and Prevention showed that, from mid-March to mid-April 2020, physicians in the Vaccines for Children program ordered 2.5 million fewer doses of vaccines and 250,000 fewer doses of measles-containing vaccines, compared with the same period in 2019. Fewer children are being seen for well visits, which means opportunities are lost for adequate monitoring of growth, development, physical wellness, and social determinants of health.

This is occurring at a time when families have been experiencing increased stress in terms of finances, social isolation, finding adequate child care, and serving as parent, teacher, and breadwinner. An increase in injuries is occurring because of inadequate parental supervision because many parents have been distracted while working from home. An increase in cases of severe abuse is occurring because schools, child care providers, physicians, and other mandated reporters in the community have decreased interaction with children. Children’s Hospital Colorado in Colorado Springs saw a 118% increase in the number of trauma cases in its ED between January and April 2020. Some of these were accidental injuries caused by falls or bicycle accidents, but there was a 200% increase in nonaccidental trauma, which was associated with a steep fall in calls to the state’s child abuse hotline. Academic gains are being lost, and there has been worry for a prolonged “summer slide” risk, especially for children living in poverty and children with developmental disabilities.

The COVID-19 pandemic also is affecting physicians and staff. As frontline personnel, we are at risk to contract the virus, and news media reminds us of severe illness and deaths among health care workers. The pandemic is affecting financial viability; estimated revenue of pediatric offices fell by 45% in March 2020 and 48% in April, compared with the previous year, according to FAIR Health. Nurses and staff have been furloughed. Practices have had to apply for grants and Paycheck Protection Program funds while extending credit lines.
 

Limited testing capability for SARS-CoV-2

Testing for SARS-CoV-2 has been variably available. There have been problems with false positive and especially false negative results (BMJ. 2020 May 12. doi: 10.1136/bmj.m1808).The best specimen collection method has yet to be determined. Blood testing for antibody has been touted, but it remains unclear if there is clinical benefit because a positive result offers no guarantee of immunity, and immunity may quickly wane. Perhaps widespread primary care office–based testing will be in place by the fall, with hope for future reliable point of care results.

Evolving knowledge regarding SARS-CoV-2 and MIS-C

It initially was thought that children were relatively spared from serious illness caused by COVID-19. Then reports of cases of newly identified multisystem inflammatory syndrome of children occurred. It has been unclear how children contribute to the spread of COVID-19 illness, although emerging evidence indicates it is lower than adult transmission. What will happen when children return to school and daycare in the fall?

The challenges have led to creative solutions for how to deliver care.
 

Adapting to telehealth to provide care

At least for the short term, HIPAA regulations have been relaxed to allow for video visits using platforms such as FaceTime, Skype, Zoom, Doximity, and Doxy.me. Some of these platforms are HIPAA compliant and will be long-term solutions; however, electronic medical record portals allowing for video visits are the more secure option, according to HIPAA.

It has been a learning experience to see what can be accomplished with a video visit. Taking a history and visual examination of injuries and rashes has been possible. Addressing mental health concerns through the video exchange generally has been effective.

However, video visits change the provider-patient interpersonal dynamic and offer only visual exam capabilities, compared with an in-person visit. We cannot look in ears, palpate a liver and spleen, touch and examine a joint or bone, or feel a rash. Video visits also are dependent on the quality of patient Internet access, sufficient data plans, and mutual capabilities to address the inevitable technological glitches on the provider’s end as well. Expanding information technology infrastructure ability and added licensure costs have occurred. Practices and health systems have been working with insurance companies to ensure telephone and video visits are reimbursed on a comparable level to in-office visits.
 

A new type of office visit and developing appropriate safety plans

As understanding of SARS-CoV-2 transmission evolved, office work flows have been modified. Patients must be universally screened prior to arrival during appointment scheduling for well and illness visits. Patients aged older than 2 years and caregivers must wear masks on entering the facility. In many practices, patients are scheduled during specific sick or well visit time slots throughout the day. Waiting rooms chairs need to be spaced for 6-foot social distancing, and cars in the parking lot often serve as waiting rooms until staff can meet patients at the door and take them to the exam room. Alternate entrances, car-side exams, and drive-by and/or tent testing facilities often have become part of the new normal everyday practice. Creating virtual visit time blocks in provider’s schedules has allowed for decreased office congestion. Patients often are checked out from their room, as opposed to waiting in a line at a check out desk. Nurse triage protocols also have been adapted and enhanced to meet needs and concerns.

With the need for summer physicals and many regions opening up, a gradual return toward baseline has been evolving, although some of the twists of a “new normal” will stay in place. The new normal has been for providers and staff to wear surgical masks and face shields; sometimes N95 masks, gloves, and gowns have been needed. Cleaning rooms and equipment between patient visits has become a major, new time-consuming task. Acquiring and maintaining adequate supplies has been a challenge.
 

Summary

The American Academy of Pediatrics, CDC, and state and local health departments have been providing informative and regular updates, webinars, and best practices guidelines. Pediatricians, community organizations, schools, and mental health professionals have been collaborating, overcoming hurdles, and working together to help mitigate the effects of the pandemic on children, their families, and our communities. Continued education, cooperation, and adaptation will be needed in the months ahead. If there is a silver lining to this pandemic experience, it may be that families have grown closer together as they sheltered in place (and we have grown closer to our own families as well). One day perhaps a child who lived through this pandemic might be asked what it was like, and their recollection might be that it was a wonderful time because their parents stayed home all the time, took care of them, taught them their school work, and took lots of long family walks.

Dr. Schulz is pediatric medical director, Rochester (N.Y.) Regional Health. Dr. Pichichero is a specialist in pediatric infectious diseases and director of the Research Institute at Rochester (N.Y.) General Hospital. Dr. Schulz and Dr. Pichichero said they have no relevant financial disclosures. Email them at [email protected].

This article was updated 7/16/2020.

With the COVID-19 pandemic, we are experiencing a once-in-a-100-year event. Dr. Steven A. Schulz, who is serving children on the front line in upstate New York, and I outline some of the challenges primary care pediatricians have been facing and solutions that have succeeded.

Reduction in direct patient care and its consequences

Geber86/E+

Because of the unknowns of COVID-19, many parents have not wanted to bring their children to a medical office because of fear of contracting SARS-CoV-2. At the same time, pediatricians have restricted in-person visits to prevent spread of SARS-CoV-2 and to help flatten the curve of infection. Use of pediatric medical professional services, compared with last year, dropped by 52% in March 2020 and by 58% in April, according to FAIR Health, a nonprofit organization that manages a database of 31 million claims. This is resulting in decreased immunization rates, which increases concern for secondary spikes of other preventable illnesses; for example, data from the Centers for Disease Control and Prevention showed that, from mid-March to mid-April 2020, physicians in the Vaccines for Children program ordered 2.5 million fewer doses of vaccines and 250,000 fewer doses of measles-containing vaccines, compared with the same period in 2019. Fewer children are being seen for well visits, which means opportunities are lost for adequate monitoring of growth, development, physical wellness, and social determinants of health.

This is occurring at a time when families have been experiencing increased stress in terms of finances, social isolation, finding adequate child care, and serving as parent, teacher, and breadwinner. An increase in injuries is occurring because of inadequate parental supervision because many parents have been distracted while working from home. An increase in cases of severe abuse is occurring because schools, child care providers, physicians, and other mandated reporters in the community have decreased interaction with children. Children’s Hospital Colorado in Colorado Springs saw a 118% increase in the number of trauma cases in its ED between January and April 2020. Some of these were accidental injuries caused by falls or bicycle accidents, but there was a 200% increase in nonaccidental trauma, which was associated with a steep fall in calls to the state’s child abuse hotline. Academic gains are being lost, and there has been worry for a prolonged “summer slide” risk, especially for children living in poverty and children with developmental disabilities.

The COVID-19 pandemic also is affecting physicians and staff. As frontline personnel, we are at risk to contract the virus, and news media reminds us of severe illness and deaths among health care workers. The pandemic is affecting financial viability; estimated revenue of pediatric offices fell by 45% in March 2020 and 48% in April, compared with the previous year, according to FAIR Health. Nurses and staff have been furloughed. Practices have had to apply for grants and Paycheck Protection Program funds while extending credit lines.
 

Limited testing capability for SARS-CoV-2

Testing for SARS-CoV-2 has been variably available. There have been problems with false positive and especially false negative results (BMJ. 2020 May 12. doi: 10.1136/bmj.m1808).The best specimen collection method has yet to be determined. Blood testing for antibody has been touted, but it remains unclear if there is clinical benefit because a positive result offers no guarantee of immunity, and immunity may quickly wane. Perhaps widespread primary care office–based testing will be in place by the fall, with hope for future reliable point of care results.

Evolving knowledge regarding SARS-CoV-2 and MIS-C

It initially was thought that children were relatively spared from serious illness caused by COVID-19. Then reports of cases of newly identified multisystem inflammatory syndrome of children occurred. It has been unclear how children contribute to the spread of COVID-19 illness, although emerging evidence indicates it is lower than adult transmission. What will happen when children return to school and daycare in the fall?

The challenges have led to creative solutions for how to deliver care.
 

Adapting to telehealth to provide care

At least for the short term, HIPAA regulations have been relaxed to allow for video visits using platforms such as FaceTime, Skype, Zoom, Doximity, and Doxy.me. Some of these platforms are HIPAA compliant and will be long-term solutions; however, electronic medical record portals allowing for video visits are the more secure option, according to HIPAA.

It has been a learning experience to see what can be accomplished with a video visit. Taking a history and visual examination of injuries and rashes has been possible. Addressing mental health concerns through the video exchange generally has been effective.

However, video visits change the provider-patient interpersonal dynamic and offer only visual exam capabilities, compared with an in-person visit. We cannot look in ears, palpate a liver and spleen, touch and examine a joint or bone, or feel a rash. Video visits also are dependent on the quality of patient Internet access, sufficient data plans, and mutual capabilities to address the inevitable technological glitches on the provider’s end as well. Expanding information technology infrastructure ability and added licensure costs have occurred. Practices and health systems have been working with insurance companies to ensure telephone and video visits are reimbursed on a comparable level to in-office visits.
 

A new type of office visit and developing appropriate safety plans

As understanding of SARS-CoV-2 transmission evolved, office work flows have been modified. Patients must be universally screened prior to arrival during appointment scheduling for well and illness visits. Patients aged older than 2 years and caregivers must wear masks on entering the facility. In many practices, patients are scheduled during specific sick or well visit time slots throughout the day. Waiting rooms chairs need to be spaced for 6-foot social distancing, and cars in the parking lot often serve as waiting rooms until staff can meet patients at the door and take them to the exam room. Alternate entrances, car-side exams, and drive-by and/or tent testing facilities often have become part of the new normal everyday practice. Creating virtual visit time blocks in provider’s schedules has allowed for decreased office congestion. Patients often are checked out from their room, as opposed to waiting in a line at a check out desk. Nurse triage protocols also have been adapted and enhanced to meet needs and concerns.

With the need for summer physicals and many regions opening up, a gradual return toward baseline has been evolving, although some of the twists of a “new normal” will stay in place. The new normal has been for providers and staff to wear surgical masks and face shields; sometimes N95 masks, gloves, and gowns have been needed. Cleaning rooms and equipment between patient visits has become a major, new time-consuming task. Acquiring and maintaining adequate supplies has been a challenge.
 

Summary

The American Academy of Pediatrics, CDC, and state and local health departments have been providing informative and regular updates, webinars, and best practices guidelines. Pediatricians, community organizations, schools, and mental health professionals have been collaborating, overcoming hurdles, and working together to help mitigate the effects of the pandemic on children, their families, and our communities. Continued education, cooperation, and adaptation will be needed in the months ahead. If there is a silver lining to this pandemic experience, it may be that families have grown closer together as they sheltered in place (and we have grown closer to our own families as well). One day perhaps a child who lived through this pandemic might be asked what it was like, and their recollection might be that it was a wonderful time because their parents stayed home all the time, took care of them, taught them their school work, and took lots of long family walks.

Dr. Schulz is pediatric medical director, Rochester (N.Y.) Regional Health. Dr. Pichichero is a specialist in pediatric infectious diseases and director of the Research Institute at Rochester (N.Y.) General Hospital. Dr. Schulz and Dr. Pichichero said they have no relevant financial disclosures. Email them at [email protected].

This article was updated 7/16/2020.

With the COVID-19 pandemic, we are experiencing a once-in-a-100-year event. Dr. Steven A. Schulz, who is serving children on the front line in upstate New York, and I outline some of the challenges primary care pediatricians have been facing and solutions that have succeeded.

Reduction in direct patient care and its consequences

Geber86/E+

Because of the unknowns of COVID-19, many parents have not wanted to bring their children to a medical office because of fear of contracting SARS-CoV-2. At the same time, pediatricians have restricted in-person visits to prevent spread of SARS-CoV-2 and to help flatten the curve of infection. Use of pediatric medical professional services, compared with last year, dropped by 52% in March 2020 and by 58% in April, according to FAIR Health, a nonprofit organization that manages a database of 31 million claims. This is resulting in decreased immunization rates, which increases concern for secondary spikes of other preventable illnesses; for example, data from the Centers for Disease Control and Prevention showed that, from mid-March to mid-April 2020, physicians in the Vaccines for Children program ordered 2.5 million fewer doses of vaccines and 250,000 fewer doses of measles-containing vaccines, compared with the same period in 2019. Fewer children are being seen for well visits, which means opportunities are lost for adequate monitoring of growth, development, physical wellness, and social determinants of health.

This is occurring at a time when families have been experiencing increased stress in terms of finances, social isolation, finding adequate child care, and serving as parent, teacher, and breadwinner. An increase in injuries is occurring because of inadequate parental supervision because many parents have been distracted while working from home. An increase in cases of severe abuse is occurring because schools, child care providers, physicians, and other mandated reporters in the community have decreased interaction with children. Children’s Hospital Colorado in Colorado Springs saw a 118% increase in the number of trauma cases in its ED between January and April 2020. Some of these were accidental injuries caused by falls or bicycle accidents, but there was a 200% increase in nonaccidental trauma, which was associated with a steep fall in calls to the state’s child abuse hotline. Academic gains are being lost, and there has been worry for a prolonged “summer slide” risk, especially for children living in poverty and children with developmental disabilities.

The COVID-19 pandemic also is affecting physicians and staff. As frontline personnel, we are at risk to contract the virus, and news media reminds us of severe illness and deaths among health care workers. The pandemic is affecting financial viability; estimated revenue of pediatric offices fell by 45% in March 2020 and 48% in April, compared with the previous year, according to FAIR Health. Nurses and staff have been furloughed. Practices have had to apply for grants and Paycheck Protection Program funds while extending credit lines.
 

Limited testing capability for SARS-CoV-2

Testing for SARS-CoV-2 has been variably available. There have been problems with false positive and especially false negative results (BMJ. 2020 May 12. doi: 10.1136/bmj.m1808).The best specimen collection method has yet to be determined. Blood testing for antibody has been touted, but it remains unclear if there is clinical benefit because a positive result offers no guarantee of immunity, and immunity may quickly wane. Perhaps widespread primary care office–based testing will be in place by the fall, with hope for future reliable point of care results.

Evolving knowledge regarding SARS-CoV-2 and MIS-C

It initially was thought that children were relatively spared from serious illness caused by COVID-19. Then reports of cases of newly identified multisystem inflammatory syndrome of children occurred. It has been unclear how children contribute to the spread of COVID-19 illness, although emerging evidence indicates it is lower than adult transmission. What will happen when children return to school and daycare in the fall?

The challenges have led to creative solutions for how to deliver care.
 

Adapting to telehealth to provide care

At least for the short term, HIPAA regulations have been relaxed to allow for video visits using platforms such as FaceTime, Skype, Zoom, Doximity, and Doxy.me. Some of these platforms are HIPAA compliant and will be long-term solutions; however, electronic medical record portals allowing for video visits are the more secure option, according to HIPAA.

It has been a learning experience to see what can be accomplished with a video visit. Taking a history and visual examination of injuries and rashes has been possible. Addressing mental health concerns through the video exchange generally has been effective.

However, video visits change the provider-patient interpersonal dynamic and offer only visual exam capabilities, compared with an in-person visit. We cannot look in ears, palpate a liver and spleen, touch and examine a joint or bone, or feel a rash. Video visits also are dependent on the quality of patient Internet access, sufficient data plans, and mutual capabilities to address the inevitable technological glitches on the provider’s end as well. Expanding information technology infrastructure ability and added licensure costs have occurred. Practices and health systems have been working with insurance companies to ensure telephone and video visits are reimbursed on a comparable level to in-office visits.
 

A new type of office visit and developing appropriate safety plans

As understanding of SARS-CoV-2 transmission evolved, office work flows have been modified. Patients must be universally screened prior to arrival during appointment scheduling for well and illness visits. Patients aged older than 2 years and caregivers must wear masks on entering the facility. In many practices, patients are scheduled during specific sick or well visit time slots throughout the day. Waiting rooms chairs need to be spaced for 6-foot social distancing, and cars in the parking lot often serve as waiting rooms until staff can meet patients at the door and take them to the exam room. Alternate entrances, car-side exams, and drive-by and/or tent testing facilities often have become part of the new normal everyday practice. Creating virtual visit time blocks in provider’s schedules has allowed for decreased office congestion. Patients often are checked out from their room, as opposed to waiting in a line at a check out desk. Nurse triage protocols also have been adapted and enhanced to meet needs and concerns.

With the need for summer physicals and many regions opening up, a gradual return toward baseline has been evolving, although some of the twists of a “new normal” will stay in place. The new normal has been for providers and staff to wear surgical masks and face shields; sometimes N95 masks, gloves, and gowns have been needed. Cleaning rooms and equipment between patient visits has become a major, new time-consuming task. Acquiring and maintaining adequate supplies has been a challenge.
 

Summary

The American Academy of Pediatrics, CDC, and state and local health departments have been providing informative and regular updates, webinars, and best practices guidelines. Pediatricians, community organizations, schools, and mental health professionals have been collaborating, overcoming hurdles, and working together to help mitigate the effects of the pandemic on children, their families, and our communities. Continued education, cooperation, and adaptation will be needed in the months ahead. If there is a silver lining to this pandemic experience, it may be that families have grown closer together as they sheltered in place (and we have grown closer to our own families as well). One day perhaps a child who lived through this pandemic might be asked what it was like, and their recollection might be that it was a wonderful time because their parents stayed home all the time, took care of them, taught them their school work, and took lots of long family walks.

Dr. Schulz is pediatric medical director, Rochester (N.Y.) Regional Health. Dr. Pichichero is a specialist in pediatric infectious diseases and director of the Research Institute at Rochester (N.Y.) General Hospital. Dr. Schulz and Dr. Pichichero said they have no relevant financial disclosures. Email them at [email protected].

This article was updated 7/16/2020.

Pediatric News welcomes Margaret Thew, DNP, FNP-BC, to the editorial advisory board.

Ms. Thew is the medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee, in addition to working casually among Children’s Wisconsin pediatric urgent cares within the city of Milwaukee and surrounding suburbs. She has published articles on Nexplanon complications and management of the malnourished state of the eating disorder patient. She currently is involved in a longitudinal study on the health and nutrition of high school endurance runners. Ms. Thew has presented her research both nationally and internationally. Her most recent podium presentation was given at the International Conference for Eating Disorders May 2020 on her research working with high school endurance athletes.

Ms. Thew serves on several committees within Children’s Wisconsin including chair of the domestic violence committee and adjunct on the electronic health record provider committee. She is leading a quality improvement project on adolescent confidential care and the judicious use of the adolescent sensitive note. In addition, she is active within her state nursing organizations; she sits on the Wisconsin Nursing Association board as the advanced practice registered nurse director at large.

Ms. Thew was selected and graduated from the exclusive Duke Johnson & Johnson Nurse Leadership Fellowship in 2016 and was selected as the keynote speaker at graduation by her peers. She was asked to speak to this year’s cohort on her accomplishments as a leader at their virtual graduation April 2020.

Ms. Thew received her Doctor of Nursing Practice, Executive Nurse Leadership May 2020 from Concordia University Wisconsin, and her master’s degree in nursing specializing in family practice from the University of Wisconsin–Milwaukee in December 1997. She is presently enrolled in the nurse educator certificate program at Concordia University Wisconsin. She has worked in the department of adolescent medicine specializing in eating disorders and adolescent gynecology for 6 years and was named the medical director in October 2019. In addition to her work in adolescent medicine, she has an extensive history working as a nurse practitioner in pediatric hematology, oncology, and primary care.

Pediatric News welcomes Margaret Thew, DNP, FNP-BC, to the editorial advisory board.

Ms. Thew is the medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee, in addition to working casually among Children’s Wisconsin pediatric urgent cares within the city of Milwaukee and surrounding suburbs. She has published articles on Nexplanon complications and management of the malnourished state of the eating disorder patient. She currently is involved in a longitudinal study on the health and nutrition of high school endurance runners. Ms. Thew has presented her research both nationally and internationally. Her most recent podium presentation was given at the International Conference for Eating Disorders May 2020 on her research working with high school endurance athletes.

Ms. Thew serves on several committees within Children’s Wisconsin including chair of the domestic violence committee and adjunct on the electronic health record provider committee. She is leading a quality improvement project on adolescent confidential care and the judicious use of the adolescent sensitive note. In addition, she is active within her state nursing organizations; she sits on the Wisconsin Nursing Association board as the advanced practice registered nurse director at large.

Ms. Thew was selected and graduated from the exclusive Duke Johnson & Johnson Nurse Leadership Fellowship in 2016 and was selected as the keynote speaker at graduation by her peers. She was asked to speak to this year’s cohort on her accomplishments as a leader at their virtual graduation April 2020.

Ms. Thew received her Doctor of Nursing Practice, Executive Nurse Leadership May 2020 from Concordia University Wisconsin, and her master’s degree in nursing specializing in family practice from the University of Wisconsin–Milwaukee in December 1997. She is presently enrolled in the nurse educator certificate program at Concordia University Wisconsin. She has worked in the department of adolescent medicine specializing in eating disorders and adolescent gynecology for 6 years and was named the medical director in October 2019. In addition to her work in adolescent medicine, she has an extensive history working as a nurse practitioner in pediatric hematology, oncology, and primary care.

Pediatric News welcomes Margaret Thew, DNP, FNP-BC, to the editorial advisory board.

Ms. Thew is the medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee, in addition to working casually among Children’s Wisconsin pediatric urgent cares within the city of Milwaukee and surrounding suburbs. She has published articles on Nexplanon complications and management of the malnourished state of the eating disorder patient. She currently is involved in a longitudinal study on the health and nutrition of high school endurance runners. Ms. Thew has presented her research both nationally and internationally. Her most recent podium presentation was given at the International Conference for Eating Disorders May 2020 on her research working with high school endurance athletes.

Ms. Thew serves on several committees within Children’s Wisconsin including chair of the domestic violence committee and adjunct on the electronic health record provider committee. She is leading a quality improvement project on adolescent confidential care and the judicious use of the adolescent sensitive note. In addition, she is active within her state nursing organizations; she sits on the Wisconsin Nursing Association board as the advanced practice registered nurse director at large.

Ms. Thew was selected and graduated from the exclusive Duke Johnson & Johnson Nurse Leadership Fellowship in 2016 and was selected as the keynote speaker at graduation by her peers. She was asked to speak to this year’s cohort on her accomplishments as a leader at their virtual graduation April 2020.

Ms. Thew received her Doctor of Nursing Practice, Executive Nurse Leadership May 2020 from Concordia University Wisconsin, and her master’s degree in nursing specializing in family practice from the University of Wisconsin–Milwaukee in December 1997. She is presently enrolled in the nurse educator certificate program at Concordia University Wisconsin. She has worked in the department of adolescent medicine specializing in eating disorders and adolescent gynecology for 6 years and was named the medical director in October 2019. In addition to her work in adolescent medicine, she has an extensive history working as a nurse practitioner in pediatric hematology, oncology, and primary care.