The Hospitalist

Attendees at HM20 Virtual can expect some changes when it comes to how hospitalists should refer to and manage pneumonia, according to Joanna M. Bonsall, MD, PhD, SFHM, chief of hospital medicine at Grady Memorial Hospital and associate professor of medicine at Emory University, both in Atlanta.

Last year, the American Thoracic Society and the Infectious Diseases Society of America updated their clinical guidelines on community-acquired pneumonia (CAP) for the first time since 2007. The guidelines were published in the Oct. 1, 2019 issue of the American Journal of Respiratory and Critical Care Medicine.

CAP is one of the most common reasons for hospitalization in the United States, and it is estimated that CAP comprises over 4.5 million outpatient and ED visits each year, according to the National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey in 2009-2010. It is also the most common cause of death from infection disease, according to the Centers for Disease Control and Prevention.

Dr. Bonsall will present “Updates in Pneumonia” at HM20 Virtual, the virtual annual meeting of the Society of Hospital Medicine; a live question-and-answer session will be held online Aug. 20. In her session, Dr. Bonsall said she plans to cover the new ATS/IDSA guidelines for CAP, which will include what initial testing to order, which empiric antibiotics to use, and how to manage patients at risk for resistant organisms, formerly known as health care–associated pneumonia (HCAP). Dr. Bonsall also will outline the evidence for use of steroids, especially in cases of severe pneumonia, and review the 2016 ATS/IDSA guidelines for hospital-acquired pneumonia with a focus on antibiotic selection.

One major change for 2019: The ATS/IDSA CAP guideline authors issued a strong recommendation to abandon use of the term HCAP as a “distinct clinical entity” when considering antibiotics for patients with CAP. In addition, methicillin-resistant Staphylococcus aureus and Pseudomonas aeruginosa should only be empirically covered in patients with CAP if they present with locally validated risk factors for either pathogen, according to the guidelines.

“Order pretreatment testing based on severity of illness as well as risk factors for drug-resistant pathogens,” Dr. Bonsall said. Hospitalists also should avoid using procalcitonin levels as a benchmark for whether a patient should be started on antibiotics. Once the recommended antibiotic treatment has been initiated, attendees should use culture results to narrow down the possibilities, especially in cases of drug-resistant pathogens.

The ATS/IDSA guidelines also state that corticosteroids should not be routinely used for patients with nonsevere CAP, but attendees should also be aware of the limitations and interpretations of the evidence, Dr. Bonsall said. Avoiding routine corticosteroid use in patients with severe CAP or in patients with severe influenza pneumonia carries a conditional recommendation with a moderate and low quality of evidence, respectively. In general, cases of CAP should be treated for no more than 5 days, or 3 days of treatment after the patient becomes clinically stable.

Attendees at HM20 Virtual should walk away from the session knowing what testing is necessary and what testing is unnecessary, and how to reduce antibiotic exposure for both broad spectrum use and duration. “At the end of the session, you should feel comfortable using both the CAP and HAP guidelines,” Dr. Bonsall said.

Dr. Bonsall reported no relevant financial disclosures.

Updates in Pneumonia

Live Q&A: Thursday, Aug. 20, 2:15 p.m to 3:15 p.m.

Attendees at HM20 Virtual can expect some changes when it comes to how hospitalists should refer to and manage pneumonia, according to Joanna M. Bonsall, MD, PhD, SFHM, chief of hospital medicine at Grady Memorial Hospital and associate professor of medicine at Emory University, both in Atlanta.

Last year, the American Thoracic Society and the Infectious Diseases Society of America updated their clinical guidelines on community-acquired pneumonia (CAP) for the first time since 2007. The guidelines were published in the Oct. 1, 2019 issue of the American Journal of Respiratory and Critical Care Medicine.

CAP is one of the most common reasons for hospitalization in the United States, and it is estimated that CAP comprises over 4.5 million outpatient and ED visits each year, according to the National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey in 2009-2010. It is also the most common cause of death from infection disease, according to the Centers for Disease Control and Prevention.

Dr. Bonsall will present “Updates in Pneumonia” at HM20 Virtual, the virtual annual meeting of the Society of Hospital Medicine; a live question-and-answer session will be held online Aug. 20. In her session, Dr. Bonsall said she plans to cover the new ATS/IDSA guidelines for CAP, which will include what initial testing to order, which empiric antibiotics to use, and how to manage patients at risk for resistant organisms, formerly known as health care–associated pneumonia (HCAP). Dr. Bonsall also will outline the evidence for use of steroids, especially in cases of severe pneumonia, and review the 2016 ATS/IDSA guidelines for hospital-acquired pneumonia with a focus on antibiotic selection.

One major change for 2019: The ATS/IDSA CAP guideline authors issued a strong recommendation to abandon use of the term HCAP as a “distinct clinical entity” when considering antibiotics for patients with CAP. In addition, methicillin-resistant Staphylococcus aureus and Pseudomonas aeruginosa should only be empirically covered in patients with CAP if they present with locally validated risk factors for either pathogen, according to the guidelines.

“Order pretreatment testing based on severity of illness as well as risk factors for drug-resistant pathogens,” Dr. Bonsall said. Hospitalists also should avoid using procalcitonin levels as a benchmark for whether a patient should be started on antibiotics. Once the recommended antibiotic treatment has been initiated, attendees should use culture results to narrow down the possibilities, especially in cases of drug-resistant pathogens.

The ATS/IDSA guidelines also state that corticosteroids should not be routinely used for patients with nonsevere CAP, but attendees should also be aware of the limitations and interpretations of the evidence, Dr. Bonsall said. Avoiding routine corticosteroid use in patients with severe CAP or in patients with severe influenza pneumonia carries a conditional recommendation with a moderate and low quality of evidence, respectively. In general, cases of CAP should be treated for no more than 5 days, or 3 days of treatment after the patient becomes clinically stable.

Attendees at HM20 Virtual should walk away from the session knowing what testing is necessary and what testing is unnecessary, and how to reduce antibiotic exposure for both broad spectrum use and duration. “At the end of the session, you should feel comfortable using both the CAP and HAP guidelines,” Dr. Bonsall said.

Dr. Bonsall reported no relevant financial disclosures.

Updates in Pneumonia

Live Q&A: Thursday, Aug. 20, 2:15 p.m to 3:15 p.m.

Attendees at HM20 Virtual can expect some changes when it comes to how hospitalists should refer to and manage pneumonia, according to Joanna M. Bonsall, MD, PhD, SFHM, chief of hospital medicine at Grady Memorial Hospital and associate professor of medicine at Emory University, both in Atlanta.

Last year, the American Thoracic Society and the Infectious Diseases Society of America updated their clinical guidelines on community-acquired pneumonia (CAP) for the first time since 2007. The guidelines were published in the Oct. 1, 2019 issue of the American Journal of Respiratory and Critical Care Medicine.

CAP is one of the most common reasons for hospitalization in the United States, and it is estimated that CAP comprises over 4.5 million outpatient and ED visits each year, according to the National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey in 2009-2010. It is also the most common cause of death from infection disease, according to the Centers for Disease Control and Prevention.

Dr. Bonsall will present “Updates in Pneumonia” at HM20 Virtual, the virtual annual meeting of the Society of Hospital Medicine; a live question-and-answer session will be held online Aug. 20. In her session, Dr. Bonsall said she plans to cover the new ATS/IDSA guidelines for CAP, which will include what initial testing to order, which empiric antibiotics to use, and how to manage patients at risk for resistant organisms, formerly known as health care–associated pneumonia (HCAP). Dr. Bonsall also will outline the evidence for use of steroids, especially in cases of severe pneumonia, and review the 2016 ATS/IDSA guidelines for hospital-acquired pneumonia with a focus on antibiotic selection.

One major change for 2019: The ATS/IDSA CAP guideline authors issued a strong recommendation to abandon use of the term HCAP as a “distinct clinical entity” when considering antibiotics for patients with CAP. In addition, methicillin-resistant Staphylococcus aureus and Pseudomonas aeruginosa should only be empirically covered in patients with CAP if they present with locally validated risk factors for either pathogen, according to the guidelines.

“Order pretreatment testing based on severity of illness as well as risk factors for drug-resistant pathogens,” Dr. Bonsall said. Hospitalists also should avoid using procalcitonin levels as a benchmark for whether a patient should be started on antibiotics. Once the recommended antibiotic treatment has been initiated, attendees should use culture results to narrow down the possibilities, especially in cases of drug-resistant pathogens.

The ATS/IDSA guidelines also state that corticosteroids should not be routinely used for patients with nonsevere CAP, but attendees should also be aware of the limitations and interpretations of the evidence, Dr. Bonsall said. Avoiding routine corticosteroid use in patients with severe CAP or in patients with severe influenza pneumonia carries a conditional recommendation with a moderate and low quality of evidence, respectively. In general, cases of CAP should be treated for no more than 5 days, or 3 days of treatment after the patient becomes clinically stable.

Attendees at HM20 Virtual should walk away from the session knowing what testing is necessary and what testing is unnecessary, and how to reduce antibiotic exposure for both broad spectrum use and duration. “At the end of the session, you should feel comfortable using both the CAP and HAP guidelines,” Dr. Bonsall said.

Dr. Bonsall reported no relevant financial disclosures.

Updates in Pneumonia

Live Q&A: Thursday, Aug. 20, 2:15 p.m to 3:15 p.m.

Sepsis is the number one killer in U.S. hospitals. About one in three patient deaths in a hospital are attributable to sepsis, according to the Centers for Disease Control and Prevention, and it is the leading cause of readmission for U.S. hospitals as well.

Patricia Kritek MD, EdM, of the division of pulmonary, critical care, and sleep medicine at the University of Washington, Seattle, hopes to bring attendees up to speed on sepsis with her presentation, “Put SIRS on the SOFA and Let’s get Septic! Update in Sepsis” at HM20 Virtual.

Each year, approximately 1.7 million American adults develop sepsis, and nearly 270,000 Americans will die from sepsis annually. Although sepsis disproportionately affects young children, older adults, patients with chronic diseases, and those with a weak immune system, the disease can affect anyone.

With that reputation, sepsis is on the forefront of hospitalists’ minds. Hospitalists are traditionally well versed in current sepsis guidelines, but time to treatment is paramount, and it can be difficult to stay up to date on the latest studies in the field. In addition, some newer, controversial treatments have emerged recently, and there is currently a debate regarding the efficacy of these treatments in the care of patients with sepsis.

The title of Dr. Kritek’s presentation hints at the theme: Hospitalists may have learned the systemic inflammatory response syndrome (SIRS) criteria for diagnosing sepsis, but the Sequential Organ Failure Assessment (SOFA) Score developed by the Third International Consensus Definitions for Sepsis and Septic Shock – previously known as the sepsis-related organ failure assessment score – has been the new method since 2016 to assess the clinical outcomes of patients with sepsis.

The quick SOFA score (qSOFA), developed by the Society of Critical Care and European Society of Intensive Care Medicine in 2016 guidelines, further helps hospitalists and other hospital physicians identify those patients at highest risk of mortality from sepsis outside an intensive care unit setting.

Dr. Kritek, who is a board-certified critical care medicine physician, has previously presented this talk at the Society for Hospital Medicine Annual Conference in the past. This year the presentation will include a number of studies that examine what role vitamin C, thiamine, and glucocorticoids have in treating patients with sepsis, she said. For example, it is thought that parenteral administration of vitamin C could raise plasma levels and reduce multiorgan failure. Thiamine could be useful in sepsis treatment because of its role in glucose metabolism and lactate production, while glucocorticoids could help improve the mortality rate of patients with sepsis.

While Dr. Kritek said she is not going to be advocating for the benefit of vitamin C and thiamine during the session, “this is an area of ongoing debate, and we will walk through the most recent data to try to make sense of it,” she said.

Dr. Kritek noted that the role of balanced crystalloids in resuscitation will be discussed versus when to use saline, as well as the potential of new vasopressors for the treatment of septic shock.

“Our goal will be to integrate the most recent literature into day-to-day practice,” Dr. Kritek said.Dr. Kritek reports no conflicts of interest.

“Put SIRS on the SOFA and Let’s get Septic! Update in Sepsis”

Sepsis is the number one killer in U.S. hospitals. About one in three patient deaths in a hospital are attributable to sepsis, according to the Centers for Disease Control and Prevention, and it is the leading cause of readmission for U.S. hospitals as well.

Patricia Kritek MD, EdM, of the division of pulmonary, critical care, and sleep medicine at the University of Washington, Seattle, hopes to bring attendees up to speed on sepsis with her presentation, “Put SIRS on the SOFA and Let’s get Septic! Update in Sepsis” at HM20 Virtual.

Each year, approximately 1.7 million American adults develop sepsis, and nearly 270,000 Americans will die from sepsis annually. Although sepsis disproportionately affects young children, older adults, patients with chronic diseases, and those with a weak immune system, the disease can affect anyone.

With that reputation, sepsis is on the forefront of hospitalists’ minds. Hospitalists are traditionally well versed in current sepsis guidelines, but time to treatment is paramount, and it can be difficult to stay up to date on the latest studies in the field. In addition, some newer, controversial treatments have emerged recently, and there is currently a debate regarding the efficacy of these treatments in the care of patients with sepsis.

The title of Dr. Kritek’s presentation hints at the theme: Hospitalists may have learned the systemic inflammatory response syndrome (SIRS) criteria for diagnosing sepsis, but the Sequential Organ Failure Assessment (SOFA) Score developed by the Third International Consensus Definitions for Sepsis and Septic Shock – previously known as the sepsis-related organ failure assessment score – has been the new method since 2016 to assess the clinical outcomes of patients with sepsis.

The quick SOFA score (qSOFA), developed by the Society of Critical Care and European Society of Intensive Care Medicine in 2016 guidelines, further helps hospitalists and other hospital physicians identify those patients at highest risk of mortality from sepsis outside an intensive care unit setting.

Dr. Kritek, who is a board-certified critical care medicine physician, has previously presented this talk at the Society for Hospital Medicine Annual Conference in the past. This year the presentation will include a number of studies that examine what role vitamin C, thiamine, and glucocorticoids have in treating patients with sepsis, she said. For example, it is thought that parenteral administration of vitamin C could raise plasma levels and reduce multiorgan failure. Thiamine could be useful in sepsis treatment because of its role in glucose metabolism and lactate production, while glucocorticoids could help improve the mortality rate of patients with sepsis.

While Dr. Kritek said she is not going to be advocating for the benefit of vitamin C and thiamine during the session, “this is an area of ongoing debate, and we will walk through the most recent data to try to make sense of it,” she said.

Dr. Kritek noted that the role of balanced crystalloids in resuscitation will be discussed versus when to use saline, as well as the potential of new vasopressors for the treatment of septic shock.

“Our goal will be to integrate the most recent literature into day-to-day practice,” Dr. Kritek said.Dr. Kritek reports no conflicts of interest.

“Put SIRS on the SOFA and Let’s get Septic! Update in Sepsis”

Sepsis is the number one killer in U.S. hospitals. About one in three patient deaths in a hospital are attributable to sepsis, according to the Centers for Disease Control and Prevention, and it is the leading cause of readmission for U.S. hospitals as well.

Patricia Kritek MD, EdM, of the division of pulmonary, critical care, and sleep medicine at the University of Washington, Seattle, hopes to bring attendees up to speed on sepsis with her presentation, “Put SIRS on the SOFA and Let’s get Septic! Update in Sepsis” at HM20 Virtual.

Each year, approximately 1.7 million American adults develop sepsis, and nearly 270,000 Americans will die from sepsis annually. Although sepsis disproportionately affects young children, older adults, patients with chronic diseases, and those with a weak immune system, the disease can affect anyone.

With that reputation, sepsis is on the forefront of hospitalists’ minds. Hospitalists are traditionally well versed in current sepsis guidelines, but time to treatment is paramount, and it can be difficult to stay up to date on the latest studies in the field. In addition, some newer, controversial treatments have emerged recently, and there is currently a debate regarding the efficacy of these treatments in the care of patients with sepsis.

The title of Dr. Kritek’s presentation hints at the theme: Hospitalists may have learned the systemic inflammatory response syndrome (SIRS) criteria for diagnosing sepsis, but the Sequential Organ Failure Assessment (SOFA) Score developed by the Third International Consensus Definitions for Sepsis and Septic Shock – previously known as the sepsis-related organ failure assessment score – has been the new method since 2016 to assess the clinical outcomes of patients with sepsis.

The quick SOFA score (qSOFA), developed by the Society of Critical Care and European Society of Intensive Care Medicine in 2016 guidelines, further helps hospitalists and other hospital physicians identify those patients at highest risk of mortality from sepsis outside an intensive care unit setting.

Dr. Kritek, who is a board-certified critical care medicine physician, has previously presented this talk at the Society for Hospital Medicine Annual Conference in the past. This year the presentation will include a number of studies that examine what role vitamin C, thiamine, and glucocorticoids have in treating patients with sepsis, she said. For example, it is thought that parenteral administration of vitamin C could raise plasma levels and reduce multiorgan failure. Thiamine could be useful in sepsis treatment because of its role in glucose metabolism and lactate production, while glucocorticoids could help improve the mortality rate of patients with sepsis.

While Dr. Kritek said she is not going to be advocating for the benefit of vitamin C and thiamine during the session, “this is an area of ongoing debate, and we will walk through the most recent data to try to make sense of it,” she said.

Dr. Kritek noted that the role of balanced crystalloids in resuscitation will be discussed versus when to use saline, as well as the potential of new vasopressors for the treatment of septic shock.

“Our goal will be to integrate the most recent literature into day-to-day practice,” Dr. Kritek said.Dr. Kritek reports no conflicts of interest.

“Put SIRS on the SOFA and Let’s get Septic! Update in Sepsis”

The absence of in-person school has harmed children in ways beyond loss of academic learning, according to Josh Sharfstein, MD, vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health, Baltimore. In addition to learning, school is a place where many children receive breakfast and lunch every day, as well as support services and the benefits of being in a safe and secure environment, Dr. Sharfstein said in a press briefing sponsored by Johns Hopkins University.

However, although it is an important priority for children to return to school, “we are in the midst of a pandemic that poses real risk,” he said.

In the press briefing, several experts shared ideas and considerations for safely reopening K-12 schools in the fall of 2020.

Data from other countries where schools have reopened, notably Austria and Denmark, have been reassuring about the lack of transmission of SARS-CoV-2 among children in a school setting, said Jennifer Nuzzo, DrPH, an epidemiologist at the Johns Hopkins Center for Health Security. However, other countries where schools have reopened successfully have reported low levels of viral transmission locally, and a responsible strategy for school reopening in the United States should follow a similar plan, she said. In areas where transmission and infection rates are increasing “it may not be safe to reopen,” but in areas where rates are declining or stable, schools could potentially reopen if they follow safety measures.

Dr. Nuzzo suggested that schools should prioritize students who will benefit most from in-person learning, such as younger children and those with special needs. Considerations include protocols for handwashing and sanitation, and maintaining physical distance by creative use of outdoor classrooms (weather permitting) or other spaces within school buildings. Transportation to and from school also will be an issue to address, she noted.

None of the strategies being considered will completely eliminate risk of SARS-CoV-2 infection in school settings, so allowing parents and students to opt out and choose distance learning will be important as well, said Dr. Nuzzo. In addition, schools may need to consider alternative roles for teachers and staff who don’t feel comfortable being in contact with students and fellow staff members. “All of these things are going to be hard,” Dr. Nuzzo acknowledged. “Hard should not be a deterrent,” to reopening schools, but “we acknowledge the resources that schools will need in order to do this.”

At present, all 50 states and the District of Columbia have released some type of plan for reopening schools, said Megan Collins, MD, MPH, codirector the Johns Hopkins Consortium for School-Based Health Solutions.

Dr. Collins and colleagues have developed a school reopening tracker, which is “a national snapshot of current reopening plans that have been released,” she said. The tracker is being updated continuously as plans evolve. The eSchool+ K-12 School Reopening Tracker identifies 12 reopening categories that states could potentially address in the plans. These categories are divided into Operational and Ethics/Equity. The operational categories include:

• Core academics
• SARS-CoV-2 protection
• Before and after school programs
• School access and transportation
• Student health services
• Food and nutrition.

Ethics/equity categories include the following:

• Parent choice
• Teacher and staff choice
• Children of poverty and systemic disadvantage
• Children with special needs/English as second language/gifted and twice exceptional
• Privacy
• Engagement and transparency.

As of July 15, 2020, 16 states (Arizona, Colorado, Connecticut, Georgia, Maryland, Minnesota, New Mexico, North Carolina, North Dakota, Ohio, Rhode Island, Tennessee, Texas, Virginia, Washington, and Wisconsin) had addressed all 12 categories in their reopening plans, Dr. Collins said.

School reopening plans must take equity issues into account, said Annette Anderson, PhD, of the Johns Hopkins University School of Education.

Specifically, developing learning plans for special education students and others at the most risk for learning loss will be essential. “The digital divide has become a digital canyon” in some areas, Dr. Anderson noted, and schools need to rethink eligibility and work to provide access to devices for online learning for all students.

In addition, schools need to convince parents that schools are safe. She recommended that schools consider inviting parents and families to visit buildings in advance of reopening so they can see the safety measures, such as space between desks, cleaning stations, and other protective strategies.

The message to pediatricians and health care professionals when counseling families about returning individual children to school is to consider the risk to the child and the family directly in the context of the local plans, Dr. Sharfstein said during a question and answer session. “One school system’s plan is one school system’s plan,” he said, and added that families who are concerned about the risk should have an online option. However, “if you see a thoughtful approach” to reopening, with safety steps taken and parents informed, with protocols such as keeping small groups of children together to reduce transmission, “it is a pretty good trade-off,” and that is why the American Academy of Pediatrics currently favors children returning to school, he said.

The briefing participants had no relevant financial conflicts to disclose.

The absence of in-person school has harmed children in ways beyond loss of academic learning, according to Josh Sharfstein, MD, vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health, Baltimore. In addition to learning, school is a place where many children receive breakfast and lunch every day, as well as support services and the benefits of being in a safe and secure environment, Dr. Sharfstein said in a press briefing sponsored by Johns Hopkins University.

However, although it is an important priority for children to return to school, “we are in the midst of a pandemic that poses real risk,” he said.

In the press briefing, several experts shared ideas and considerations for safely reopening K-12 schools in the fall of 2020.

Data from other countries where schools have reopened, notably Austria and Denmark, have been reassuring about the lack of transmission of SARS-CoV-2 among children in a school setting, said Jennifer Nuzzo, DrPH, an epidemiologist at the Johns Hopkins Center for Health Security. However, other countries where schools have reopened successfully have reported low levels of viral transmission locally, and a responsible strategy for school reopening in the United States should follow a similar plan, she said. In areas where transmission and infection rates are increasing “it may not be safe to reopen,” but in areas where rates are declining or stable, schools could potentially reopen if they follow safety measures.

Dr. Nuzzo suggested that schools should prioritize students who will benefit most from in-person learning, such as younger children and those with special needs. Considerations include protocols for handwashing and sanitation, and maintaining physical distance by creative use of outdoor classrooms (weather permitting) or other spaces within school buildings. Transportation to and from school also will be an issue to address, she noted.

None of the strategies being considered will completely eliminate risk of SARS-CoV-2 infection in school settings, so allowing parents and students to opt out and choose distance learning will be important as well, said Dr. Nuzzo. In addition, schools may need to consider alternative roles for teachers and staff who don’t feel comfortable being in contact with students and fellow staff members. “All of these things are going to be hard,” Dr. Nuzzo acknowledged. “Hard should not be a deterrent,” to reopening schools, but “we acknowledge the resources that schools will need in order to do this.”

At present, all 50 states and the District of Columbia have released some type of plan for reopening schools, said Megan Collins, MD, MPH, codirector the Johns Hopkins Consortium for School-Based Health Solutions.

Dr. Collins and colleagues have developed a school reopening tracker, which is “a national snapshot of current reopening plans that have been released,” she said. The tracker is being updated continuously as plans evolve. The eSchool+ K-12 School Reopening Tracker identifies 12 reopening categories that states could potentially address in the plans. These categories are divided into Operational and Ethics/Equity. The operational categories include:

• Core academics
• SARS-CoV-2 protection
• Before and after school programs
• School access and transportation
• Student health services
• Food and nutrition.

Ethics/equity categories include the following:

• Parent choice
• Teacher and staff choice
• Children of poverty and systemic disadvantage
• Children with special needs/English as second language/gifted and twice exceptional
• Privacy
• Engagement and transparency.

As of July 15, 2020, 16 states (Arizona, Colorado, Connecticut, Georgia, Maryland, Minnesota, New Mexico, North Carolina, North Dakota, Ohio, Rhode Island, Tennessee, Texas, Virginia, Washington, and Wisconsin) had addressed all 12 categories in their reopening plans, Dr. Collins said.

School reopening plans must take equity issues into account, said Annette Anderson, PhD, of the Johns Hopkins University School of Education.

Specifically, developing learning plans for special education students and others at the most risk for learning loss will be essential. “The digital divide has become a digital canyon” in some areas, Dr. Anderson noted, and schools need to rethink eligibility and work to provide access to devices for online learning for all students.

In addition, schools need to convince parents that schools are safe. She recommended that schools consider inviting parents and families to visit buildings in advance of reopening so they can see the safety measures, such as space between desks, cleaning stations, and other protective strategies.

The message to pediatricians and health care professionals when counseling families about returning individual children to school is to consider the risk to the child and the family directly in the context of the local plans, Dr. Sharfstein said during a question and answer session. “One school system’s plan is one school system’s plan,” he said, and added that families who are concerned about the risk should have an online option. However, “if you see a thoughtful approach” to reopening, with safety steps taken and parents informed, with protocols such as keeping small groups of children together to reduce transmission, “it is a pretty good trade-off,” and that is why the American Academy of Pediatrics currently favors children returning to school, he said.

The briefing participants had no relevant financial conflicts to disclose.

The absence of in-person school has harmed children in ways beyond loss of academic learning, according to Josh Sharfstein, MD, vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health, Baltimore. In addition to learning, school is a place where many children receive breakfast and lunch every day, as well as support services and the benefits of being in a safe and secure environment, Dr. Sharfstein said in a press briefing sponsored by Johns Hopkins University.

However, although it is an important priority for children to return to school, “we are in the midst of a pandemic that poses real risk,” he said.

In the press briefing, several experts shared ideas and considerations for safely reopening K-12 schools in the fall of 2020.

Data from other countries where schools have reopened, notably Austria and Denmark, have been reassuring about the lack of transmission of SARS-CoV-2 among children in a school setting, said Jennifer Nuzzo, DrPH, an epidemiologist at the Johns Hopkins Center for Health Security. However, other countries where schools have reopened successfully have reported low levels of viral transmission locally, and a responsible strategy for school reopening in the United States should follow a similar plan, she said. In areas where transmission and infection rates are increasing “it may not be safe to reopen,” but in areas where rates are declining or stable, schools could potentially reopen if they follow safety measures.

Dr. Nuzzo suggested that schools should prioritize students who will benefit most from in-person learning, such as younger children and those with special needs. Considerations include protocols for handwashing and sanitation, and maintaining physical distance by creative use of outdoor classrooms (weather permitting) or other spaces within school buildings. Transportation to and from school also will be an issue to address, she noted.

None of the strategies being considered will completely eliminate risk of SARS-CoV-2 infection in school settings, so allowing parents and students to opt out and choose distance learning will be important as well, said Dr. Nuzzo. In addition, schools may need to consider alternative roles for teachers and staff who don’t feel comfortable being in contact with students and fellow staff members. “All of these things are going to be hard,” Dr. Nuzzo acknowledged. “Hard should not be a deterrent,” to reopening schools, but “we acknowledge the resources that schools will need in order to do this.”

At present, all 50 states and the District of Columbia have released some type of plan for reopening schools, said Megan Collins, MD, MPH, codirector the Johns Hopkins Consortium for School-Based Health Solutions.

Dr. Collins and colleagues have developed a school reopening tracker, which is “a national snapshot of current reopening plans that have been released,” she said. The tracker is being updated continuously as plans evolve. The eSchool+ K-12 School Reopening Tracker identifies 12 reopening categories that states could potentially address in the plans. These categories are divided into Operational and Ethics/Equity. The operational categories include:

• Core academics
• SARS-CoV-2 protection
• Before and after school programs
• School access and transportation
• Student health services
• Food and nutrition.

Ethics/equity categories include the following:

• Parent choice
• Teacher and staff choice
• Children of poverty and systemic disadvantage
• Children with special needs/English as second language/gifted and twice exceptional
• Privacy
• Engagement and transparency.

As of July 15, 2020, 16 states (Arizona, Colorado, Connecticut, Georgia, Maryland, Minnesota, New Mexico, North Carolina, North Dakota, Ohio, Rhode Island, Tennessee, Texas, Virginia, Washington, and Wisconsin) had addressed all 12 categories in their reopening plans, Dr. Collins said.

School reopening plans must take equity issues into account, said Annette Anderson, PhD, of the Johns Hopkins University School of Education.

Specifically, developing learning plans for special education students and others at the most risk for learning loss will be essential. “The digital divide has become a digital canyon” in some areas, Dr. Anderson noted, and schools need to rethink eligibility and work to provide access to devices for online learning for all students.

In addition, schools need to convince parents that schools are safe. She recommended that schools consider inviting parents and families to visit buildings in advance of reopening so they can see the safety measures, such as space between desks, cleaning stations, and other protective strategies.

The message to pediatricians and health care professionals when counseling families about returning individual children to school is to consider the risk to the child and the family directly in the context of the local plans, Dr. Sharfstein said during a question and answer session. “One school system’s plan is one school system’s plan,” he said, and added that families who are concerned about the risk should have an online option. However, “if you see a thoughtful approach” to reopening, with safety steps taken and parents informed, with protocols such as keeping small groups of children together to reduce transmission, “it is a pretty good trade-off,” and that is why the American Academy of Pediatrics currently favors children returning to school, he said.

The briefing participants had no relevant financial conflicts to disclose.

Israel Shippy doesn’t remember much about having COVID-19 – or the unusual autoimmune disease it triggered – other than being groggy and uncomfortable for a bunch of days. He’s a 5-year-old boy and would much rather talk about cartoons or the ideas for inventions that constantly pop into his head.

“Hold your horses, I think I know what I’m gonna make,” he said, holding up a finger in the middle of a conversation. “I’m gonna make something that lights up and attaches to things with glue, so if you don’t have a flashlight, you can just use it!”

In New York, at least 237 kids, including Israel, appear to have Multisystem Inflammatory Syndrome in Children (MIS-C). And state officials continue to track the syndrome, but the Centers for Disease Control and Prevention did not respond to repeated requests for information on how many children nationwide have been diagnosed so far with MIS-C.

A study published June 29 in the New England Journal of Medicine reported on 186 patients in 26 states who had been diagnosed with MIS-C. A researcher writing in the same issue added reports from other countries, finding that about 1,000 children worldwide have been diagnosed with MIS-C.
 

Tracking the long-term health effects of MIS-C

Israel is friendly and energetic, but he’s also really good at sitting still. During a recent checkup at the Children’s Hospital at Montefiore, New York, he had no complaints about all the stickers and wires a health aide attached to him for an EKG. And when Marc Foca, MD, an infectious disease specialist, came by to listen to his heart and lungs, and prod his abdomen, Israel barely seemed to notice.

There were still some tests pending, but overall, Dr. Foca said, “Israel looks like a totally healthy 5-year-old.”

“Stay safe!” Israel called out, as Dr. Foca left. It’s his new sign-off, instead of goodbye. His mother, Janelle Moholland, explained Israel came up with it himself. And she’s also hoping that, after a harrowing couple of weeks in early May, Israel himself will “stay safe.”

That’s why they’ve been returning to Montefiore for the periodic checkups, even though Israel seems to have recovered fully from both COVID-19 and MIS-C.

MIS-C is relatively rare, and it apparently responds well to treatment, but it is new enough – and mysterious enough – that doctors here want to make sure the children who recover don’t experience any related health complications in the future.

“We’ve seen these kids get really sick, and get better and recover and go home, yet we don’t know what the long-term outcomes are,” said Nadine Choueiter, MD, a pediatric cardiologist at Montefiore. “So that’s why we will be seeing them.”

When Israel first got sick at the end of April, his illness didn’t exactly look like COVID-19. He had persistent high fevers, with his temperature reaching 104° F – but no problems breathing. He wasn’t eating. He was barely drinking. He wasn’t using the bathroom. He had abdominal pains. His eyes were red.

They went to the ED a couple of times and visited an urgent care center, but the doctors sent them home without testing him for the coronavirus. Ms. Moholland, 29, said she felt powerless.

“There was nothing I could do but make him comfortable,” she said. “I literally had to just trust in a higher power and just hope that He would come through for us. It taught me a lot about patience and faith.”

As Israel grew sicker, and they still had no answers, Ms. Moholland grew frustrated. “I wish his pediatrician and [the ED and urgent care staff] had done what they were supposed to do and given him a test” when Israel first got sick, Ms. Moholland said. “What harm would it have done? He suffered for about 10 or 11 days that could have been avoided.”

In a later interview, she talked with NPR about how COVID-19 has disproportionately affected the African American community because of a combination of underlying health conditions and lack of access to good health care. She said she felt she, too, had fallen victim to those disparities.

“It affects me, personally, because I am African American, but you just never know,” she said. “It’s hard. We’re living in uncertain times – very uncertain times.”

Finally, the Children’s Hospital at Montefiore admitted Israel – and the test she’d been trying to get for days confirmed he had the virus.

“I was literally in tears, like begging them not to discharge me because I knew he was not fine,” she recalled.

Israel was in shock, and by the time he got to the hospital, doctors were on the lookout for MIS-C, so they recognized his symptoms – which were distinct from most people with COVID-19.

Doctors gave Israel fluids and intravenous immunoglobulin, a substance obtained from donated human plasma, which is used to treat deficiencies in the immune system.

Immunoglobulin has been effective in children like Israel because MIS-C appears to be caused by an immune overreaction to the initial coronavirus infection, according to Dr. Choueiter.

“The immune system starts attacking the body itself, including the arteries of the heart,” she said.

In some MIS-C cases – though not Israel’s – the attack occurs in the coronary arteries, inflaming and dilating them. That also happens in a different syndrome affecting children, Kawasaki disease. About 5% of Kawasaki patients experience aneurysms – which can fatally rupture blood vessels – after the initial condition subsides.

Dr. Choueiter and colleagues want to make sure MIS-C patients don’t face similar risks. So far, they’re cautiously optimistic.

“We have not seen any new decrease in heart function or any new coronary artery dilations,” she said. “When we check their blood, their inflammatory markers are back to normal. For the parents, the child is back to baseline, and it’s as if this illness is a nightmare that’s long gone.”
 

For a Pennsylvania teen, the MIS-C diagnosis came much later

Not every child who develops MIS-C tests positive for the coronavirus, though many will test positive for antibodies to the coronavirus, indicating they had been infected previously. That was the case with Andrew Lis, a boy from Pennsylvania who was the first MIS-C patient seen at the Nemours/Alfred I. duPont Hospital for Children in Wilmington, Del.

Andrew had been a healthy 14-year-old boy before he got sick. He and his twin brother love sports and video games. He said the first symptom was a bad headache. He developed a fever the next day, then constipation and intense stomach pain.

“It was terrible,” Andrew said. “It was unbearable. I couldn’t really move a lot.”

His mother, Ingrid Lis, said they were thinking appendicitis, not coronavirus, at first. In fact, she hesitated to take Andrew to the hospital, for fear of exposing him to the virus. But after Andrew stopped eating because of his headache and stomach discomfort, “I knew I couldn’t keep him home anymore,” Mrs. Lis said.

Andrew was admitted to the hospital April 12, but that was before reports of the mysterious syndrome had started trickling out of Europe.

Over about 5 days in the pediatric ICU, Andrew’s condition deteriorated rapidly, as doctors struggled to figure out what was wrong. Puzzled, they tried treatments for scarlet fever, strep throat, and toxic shock syndrome. Andrew’s body broke out in rashes, then his heart began failing and he was put on a ventilator. Andrew’s father, Ed Lis, said doctors told the family to brace for the worst: “We’ve got a healthy kid who a few days ago was just having these sort of strange symptoms. And now they’re telling us that we could lose him.”

Though Andrew’s symptoms were atypical for Kawasaki disease, doctors decided to give him the standard treatment for that condition – administering intravenous immunoglobulin, the same treatment Israel Shippy received.

“Within the 24 hours of the infusion, he was a different person,” Mrs. Lis said. Andrew was removed from the ventilator, and his appetite eventually returned. “That’s when we knew that we had turned that corner.”

It wasn’t until after Andrew’s discharge that his doctors learned about MIS-C from colleagues in Europe. They recommended the whole family be tested for antibodies to the coronavirus. Although Andrew tested positive, the rest of the family – both parents, Andrew’s twin brother and two older siblings – all tested negative. Andrew’s mother is still not sure how he was exposed since the family had been observing a strict lockdown since mid-March. Both she and her husband were working remotely from home, and she says they all wore masks and were conscientious about hand-washing when they ventured out for groceries. She thinks Andrew must have been exposed at least a month before his illness began.

And she’s puzzled why the rest of her close-knit family wasn’t infected as well. “We are a Latino family,” Mrs. Lis said. “We are very used to being together, clustering in the same room.” Even when Andrew was sick, she says, all six of them huddled in his bedroom to comfort him.

Meanwhile, Andrew has made a quick recovery. Not long after his discharge in April, he turned 15 and resumed an exercise routine involving running, push-ups, and sit-ups. A few weeks later, an ECG showed Andrew’s heart was “perfect,” Mr. Lis said. Still, doctors have asked Andrew to follow up with a cardiologist every 3 months.
 

An eye on the long-term effects

The medical team at Montefiore is tracking the 40 children they have already treated and discharged. With kids showing few symptoms in the immediate aftermath, Dr. Choueiter hopes the long-term trajectory after MIS-C will be similar to what happens after Kawasaki disease.

“Usually children who have had coronary artery dilations [from Kawasaki disease] that have resolved within the first 6 weeks of the illness do well long-term,” said Dr. Choueiter, who runs the Kawasaki disease program at Montefiore.

The Montefiore team is asking patients affected by MIS-C to return for a checkup 1 week after discharge, then after 1 month, 3 months, 6 months, and a year. They will be evaluated by pediatric cardiologists, hematologists, rheumatologists and infectious disease specialists.

Montefiore and other children’s hospitals around the country are sharing information. Dr. Choueiter wants to establish an even longer-term monitoring program for MIS-C, comparable with registries that exist for other diseases.

Ms. Moholland is glad the hospital is being vigilant.

“The uncertainty of not knowing whether it could come back in his future is a little unsettling,” she said. “But I am hopeful.”

This story is part of a partnership that includes WNYC, NPR, and Kaiser Health News. A version of this article originally appeared on Kaiser Health News.

Israel Shippy doesn’t remember much about having COVID-19 – or the unusual autoimmune disease it triggered – other than being groggy and uncomfortable for a bunch of days. He’s a 5-year-old boy and would much rather talk about cartoons or the ideas for inventions that constantly pop into his head.

“Hold your horses, I think I know what I’m gonna make,” he said, holding up a finger in the middle of a conversation. “I’m gonna make something that lights up and attaches to things with glue, so if you don’t have a flashlight, you can just use it!”

In New York, at least 237 kids, including Israel, appear to have Multisystem Inflammatory Syndrome in Children (MIS-C). And state officials continue to track the syndrome, but the Centers for Disease Control and Prevention did not respond to repeated requests for information on how many children nationwide have been diagnosed so far with MIS-C.

A study published June 29 in the New England Journal of Medicine reported on 186 patients in 26 states who had been diagnosed with MIS-C. A researcher writing in the same issue added reports from other countries, finding that about 1,000 children worldwide have been diagnosed with MIS-C.
 

Tracking the long-term health effects of MIS-C

Israel is friendly and energetic, but he’s also really good at sitting still. During a recent checkup at the Children’s Hospital at Montefiore, New York, he had no complaints about all the stickers and wires a health aide attached to him for an EKG. And when Marc Foca, MD, an infectious disease specialist, came by to listen to his heart and lungs, and prod his abdomen, Israel barely seemed to notice.

There were still some tests pending, but overall, Dr. Foca said, “Israel looks like a totally healthy 5-year-old.”

“Stay safe!” Israel called out, as Dr. Foca left. It’s his new sign-off, instead of goodbye. His mother, Janelle Moholland, explained Israel came up with it himself. And she’s also hoping that, after a harrowing couple of weeks in early May, Israel himself will “stay safe.”

That’s why they’ve been returning to Montefiore for the periodic checkups, even though Israel seems to have recovered fully from both COVID-19 and MIS-C.

MIS-C is relatively rare, and it apparently responds well to treatment, but it is new enough – and mysterious enough – that doctors here want to make sure the children who recover don’t experience any related health complications in the future.

“We’ve seen these kids get really sick, and get better and recover and go home, yet we don’t know what the long-term outcomes are,” said Nadine Choueiter, MD, a pediatric cardiologist at Montefiore. “So that’s why we will be seeing them.”

When Israel first got sick at the end of April, his illness didn’t exactly look like COVID-19. He had persistent high fevers, with his temperature reaching 104° F – but no problems breathing. He wasn’t eating. He was barely drinking. He wasn’t using the bathroom. He had abdominal pains. His eyes were red.

They went to the ED a couple of times and visited an urgent care center, but the doctors sent them home without testing him for the coronavirus. Ms. Moholland, 29, said she felt powerless.

“There was nothing I could do but make him comfortable,” she said. “I literally had to just trust in a higher power and just hope that He would come through for us. It taught me a lot about patience and faith.”

As Israel grew sicker, and they still had no answers, Ms. Moholland grew frustrated. “I wish his pediatrician and [the ED and urgent care staff] had done what they were supposed to do and given him a test” when Israel first got sick, Ms. Moholland said. “What harm would it have done? He suffered for about 10 or 11 days that could have been avoided.”

In a later interview, she talked with NPR about how COVID-19 has disproportionately affected the African American community because of a combination of underlying health conditions and lack of access to good health care. She said she felt she, too, had fallen victim to those disparities.

“It affects me, personally, because I am African American, but you just never know,” she said. “It’s hard. We’re living in uncertain times – very uncertain times.”

Finally, the Children’s Hospital at Montefiore admitted Israel – and the test she’d been trying to get for days confirmed he had the virus.

“I was literally in tears, like begging them not to discharge me because I knew he was not fine,” she recalled.

Israel was in shock, and by the time he got to the hospital, doctors were on the lookout for MIS-C, so they recognized his symptoms – which were distinct from most people with COVID-19.

Doctors gave Israel fluids and intravenous immunoglobulin, a substance obtained from donated human plasma, which is used to treat deficiencies in the immune system.

Immunoglobulin has been effective in children like Israel because MIS-C appears to be caused by an immune overreaction to the initial coronavirus infection, according to Dr. Choueiter.

“The immune system starts attacking the body itself, including the arteries of the heart,” she said.

In some MIS-C cases – though not Israel’s – the attack occurs in the coronary arteries, inflaming and dilating them. That also happens in a different syndrome affecting children, Kawasaki disease. About 5% of Kawasaki patients experience aneurysms – which can fatally rupture blood vessels – after the initial condition subsides.

Dr. Choueiter and colleagues want to make sure MIS-C patients don’t face similar risks. So far, they’re cautiously optimistic.

“We have not seen any new decrease in heart function or any new coronary artery dilations,” she said. “When we check their blood, their inflammatory markers are back to normal. For the parents, the child is back to baseline, and it’s as if this illness is a nightmare that’s long gone.”
 

For a Pennsylvania teen, the MIS-C diagnosis came much later

Not every child who develops MIS-C tests positive for the coronavirus, though many will test positive for antibodies to the coronavirus, indicating they had been infected previously. That was the case with Andrew Lis, a boy from Pennsylvania who was the first MIS-C patient seen at the Nemours/Alfred I. duPont Hospital for Children in Wilmington, Del.

Andrew had been a healthy 14-year-old boy before he got sick. He and his twin brother love sports and video games. He said the first symptom was a bad headache. He developed a fever the next day, then constipation and intense stomach pain.

“It was terrible,” Andrew said. “It was unbearable. I couldn’t really move a lot.”

His mother, Ingrid Lis, said they were thinking appendicitis, not coronavirus, at first. In fact, she hesitated to take Andrew to the hospital, for fear of exposing him to the virus. But after Andrew stopped eating because of his headache and stomach discomfort, “I knew I couldn’t keep him home anymore,” Mrs. Lis said.

Andrew was admitted to the hospital April 12, but that was before reports of the mysterious syndrome had started trickling out of Europe.

Over about 5 days in the pediatric ICU, Andrew’s condition deteriorated rapidly, as doctors struggled to figure out what was wrong. Puzzled, they tried treatments for scarlet fever, strep throat, and toxic shock syndrome. Andrew’s body broke out in rashes, then his heart began failing and he was put on a ventilator. Andrew’s father, Ed Lis, said doctors told the family to brace for the worst: “We’ve got a healthy kid who a few days ago was just having these sort of strange symptoms. And now they’re telling us that we could lose him.”

Though Andrew’s symptoms were atypical for Kawasaki disease, doctors decided to give him the standard treatment for that condition – administering intravenous immunoglobulin, the same treatment Israel Shippy received.

“Within the 24 hours of the infusion, he was a different person,” Mrs. Lis said. Andrew was removed from the ventilator, and his appetite eventually returned. “That’s when we knew that we had turned that corner.”

It wasn’t until after Andrew’s discharge that his doctors learned about MIS-C from colleagues in Europe. They recommended the whole family be tested for antibodies to the coronavirus. Although Andrew tested positive, the rest of the family – both parents, Andrew’s twin brother and two older siblings – all tested negative. Andrew’s mother is still not sure how he was exposed since the family had been observing a strict lockdown since mid-March. Both she and her husband were working remotely from home, and she says they all wore masks and were conscientious about hand-washing when they ventured out for groceries. She thinks Andrew must have been exposed at least a month before his illness began.

And she’s puzzled why the rest of her close-knit family wasn’t infected as well. “We are a Latino family,” Mrs. Lis said. “We are very used to being together, clustering in the same room.” Even when Andrew was sick, she says, all six of them huddled in his bedroom to comfort him.

Meanwhile, Andrew has made a quick recovery. Not long after his discharge in April, he turned 15 and resumed an exercise routine involving running, push-ups, and sit-ups. A few weeks later, an ECG showed Andrew’s heart was “perfect,” Mr. Lis said. Still, doctors have asked Andrew to follow up with a cardiologist every 3 months.
 

An eye on the long-term effects

The medical team at Montefiore is tracking the 40 children they have already treated and discharged. With kids showing few symptoms in the immediate aftermath, Dr. Choueiter hopes the long-term trajectory after MIS-C will be similar to what happens after Kawasaki disease.

“Usually children who have had coronary artery dilations [from Kawasaki disease] that have resolved within the first 6 weeks of the illness do well long-term,” said Dr. Choueiter, who runs the Kawasaki disease program at Montefiore.

The Montefiore team is asking patients affected by MIS-C to return for a checkup 1 week after discharge, then after 1 month, 3 months, 6 months, and a year. They will be evaluated by pediatric cardiologists, hematologists, rheumatologists and infectious disease specialists.

Montefiore and other children’s hospitals around the country are sharing information. Dr. Choueiter wants to establish an even longer-term monitoring program for MIS-C, comparable with registries that exist for other diseases.

Ms. Moholland is glad the hospital is being vigilant.

“The uncertainty of not knowing whether it could come back in his future is a little unsettling,” she said. “But I am hopeful.”

This story is part of a partnership that includes WNYC, NPR, and Kaiser Health News. A version of this article originally appeared on Kaiser Health News.

Israel Shippy doesn’t remember much about having COVID-19 – or the unusual autoimmune disease it triggered – other than being groggy and uncomfortable for a bunch of days. He’s a 5-year-old boy and would much rather talk about cartoons or the ideas for inventions that constantly pop into his head.

“Hold your horses, I think I know what I’m gonna make,” he said, holding up a finger in the middle of a conversation. “I’m gonna make something that lights up and attaches to things with glue, so if you don’t have a flashlight, you can just use it!”

In New York, at least 237 kids, including Israel, appear to have Multisystem Inflammatory Syndrome in Children (MIS-C). And state officials continue to track the syndrome, but the Centers for Disease Control and Prevention did not respond to repeated requests for information on how many children nationwide have been diagnosed so far with MIS-C.

A study published June 29 in the New England Journal of Medicine reported on 186 patients in 26 states who had been diagnosed with MIS-C. A researcher writing in the same issue added reports from other countries, finding that about 1,000 children worldwide have been diagnosed with MIS-C.
 

Tracking the long-term health effects of MIS-C

Israel is friendly and energetic, but he’s also really good at sitting still. During a recent checkup at the Children’s Hospital at Montefiore, New York, he had no complaints about all the stickers and wires a health aide attached to him for an EKG. And when Marc Foca, MD, an infectious disease specialist, came by to listen to his heart and lungs, and prod his abdomen, Israel barely seemed to notice.

There were still some tests pending, but overall, Dr. Foca said, “Israel looks like a totally healthy 5-year-old.”

“Stay safe!” Israel called out, as Dr. Foca left. It’s his new sign-off, instead of goodbye. His mother, Janelle Moholland, explained Israel came up with it himself. And she’s also hoping that, after a harrowing couple of weeks in early May, Israel himself will “stay safe.”

That’s why they’ve been returning to Montefiore for the periodic checkups, even though Israel seems to have recovered fully from both COVID-19 and MIS-C.

MIS-C is relatively rare, and it apparently responds well to treatment, but it is new enough – and mysterious enough – that doctors here want to make sure the children who recover don’t experience any related health complications in the future.

“We’ve seen these kids get really sick, and get better and recover and go home, yet we don’t know what the long-term outcomes are,” said Nadine Choueiter, MD, a pediatric cardiologist at Montefiore. “So that’s why we will be seeing them.”

When Israel first got sick at the end of April, his illness didn’t exactly look like COVID-19. He had persistent high fevers, with his temperature reaching 104° F – but no problems breathing. He wasn’t eating. He was barely drinking. He wasn’t using the bathroom. He had abdominal pains. His eyes were red.

They went to the ED a couple of times and visited an urgent care center, but the doctors sent them home without testing him for the coronavirus. Ms. Moholland, 29, said she felt powerless.

“There was nothing I could do but make him comfortable,” she said. “I literally had to just trust in a higher power and just hope that He would come through for us. It taught me a lot about patience and faith.”

As Israel grew sicker, and they still had no answers, Ms. Moholland grew frustrated. “I wish his pediatrician and [the ED and urgent care staff] had done what they were supposed to do and given him a test” when Israel first got sick, Ms. Moholland said. “What harm would it have done? He suffered for about 10 or 11 days that could have been avoided.”

In a later interview, she talked with NPR about how COVID-19 has disproportionately affected the African American community because of a combination of underlying health conditions and lack of access to good health care. She said she felt she, too, had fallen victim to those disparities.

“It affects me, personally, because I am African American, but you just never know,” she said. “It’s hard. We’re living in uncertain times – very uncertain times.”

Finally, the Children’s Hospital at Montefiore admitted Israel – and the test she’d been trying to get for days confirmed he had the virus.

“I was literally in tears, like begging them not to discharge me because I knew he was not fine,” she recalled.

Israel was in shock, and by the time he got to the hospital, doctors were on the lookout for MIS-C, so they recognized his symptoms – which were distinct from most people with COVID-19.

Doctors gave Israel fluids and intravenous immunoglobulin, a substance obtained from donated human plasma, which is used to treat deficiencies in the immune system.

Immunoglobulin has been effective in children like Israel because MIS-C appears to be caused by an immune overreaction to the initial coronavirus infection, according to Dr. Choueiter.

“The immune system starts attacking the body itself, including the arteries of the heart,” she said.

In some MIS-C cases – though not Israel’s – the attack occurs in the coronary arteries, inflaming and dilating them. That also happens in a different syndrome affecting children, Kawasaki disease. About 5% of Kawasaki patients experience aneurysms – which can fatally rupture blood vessels – after the initial condition subsides.

Dr. Choueiter and colleagues want to make sure MIS-C patients don’t face similar risks. So far, they’re cautiously optimistic.

“We have not seen any new decrease in heart function or any new coronary artery dilations,” she said. “When we check their blood, their inflammatory markers are back to normal. For the parents, the child is back to baseline, and it’s as if this illness is a nightmare that’s long gone.”
 

For a Pennsylvania teen, the MIS-C diagnosis came much later

Not every child who develops MIS-C tests positive for the coronavirus, though many will test positive for antibodies to the coronavirus, indicating they had been infected previously. That was the case with Andrew Lis, a boy from Pennsylvania who was the first MIS-C patient seen at the Nemours/Alfred I. duPont Hospital for Children in Wilmington, Del.

Andrew had been a healthy 14-year-old boy before he got sick. He and his twin brother love sports and video games. He said the first symptom was a bad headache. He developed a fever the next day, then constipation and intense stomach pain.

“It was terrible,” Andrew said. “It was unbearable. I couldn’t really move a lot.”

His mother, Ingrid Lis, said they were thinking appendicitis, not coronavirus, at first. In fact, she hesitated to take Andrew to the hospital, for fear of exposing him to the virus. But after Andrew stopped eating because of his headache and stomach discomfort, “I knew I couldn’t keep him home anymore,” Mrs. Lis said.

Andrew was admitted to the hospital April 12, but that was before reports of the mysterious syndrome had started trickling out of Europe.

Over about 5 days in the pediatric ICU, Andrew’s condition deteriorated rapidly, as doctors struggled to figure out what was wrong. Puzzled, they tried treatments for scarlet fever, strep throat, and toxic shock syndrome. Andrew’s body broke out in rashes, then his heart began failing and he was put on a ventilator. Andrew’s father, Ed Lis, said doctors told the family to brace for the worst: “We’ve got a healthy kid who a few days ago was just having these sort of strange symptoms. And now they’re telling us that we could lose him.”

Though Andrew’s symptoms were atypical for Kawasaki disease, doctors decided to give him the standard treatment for that condition – administering intravenous immunoglobulin, the same treatment Israel Shippy received.

“Within the 24 hours of the infusion, he was a different person,” Mrs. Lis said. Andrew was removed from the ventilator, and his appetite eventually returned. “That’s when we knew that we had turned that corner.”

It wasn’t until after Andrew’s discharge that his doctors learned about MIS-C from colleagues in Europe. They recommended the whole family be tested for antibodies to the coronavirus. Although Andrew tested positive, the rest of the family – both parents, Andrew’s twin brother and two older siblings – all tested negative. Andrew’s mother is still not sure how he was exposed since the family had been observing a strict lockdown since mid-March. Both she and her husband were working remotely from home, and she says they all wore masks and were conscientious about hand-washing when they ventured out for groceries. She thinks Andrew must have been exposed at least a month before his illness began.

And she’s puzzled why the rest of her close-knit family wasn’t infected as well. “We are a Latino family,” Mrs. Lis said. “We are very used to being together, clustering in the same room.” Even when Andrew was sick, she says, all six of them huddled in his bedroom to comfort him.

Meanwhile, Andrew has made a quick recovery. Not long after his discharge in April, he turned 15 and resumed an exercise routine involving running, push-ups, and sit-ups. A few weeks later, an ECG showed Andrew’s heart was “perfect,” Mr. Lis said. Still, doctors have asked Andrew to follow up with a cardiologist every 3 months.
 

An eye on the long-term effects

The medical team at Montefiore is tracking the 40 children they have already treated and discharged. With kids showing few symptoms in the immediate aftermath, Dr. Choueiter hopes the long-term trajectory after MIS-C will be similar to what happens after Kawasaki disease.

“Usually children who have had coronary artery dilations [from Kawasaki disease] that have resolved within the first 6 weeks of the illness do well long-term,” said Dr. Choueiter, who runs the Kawasaki disease program at Montefiore.

The Montefiore team is asking patients affected by MIS-C to return for a checkup 1 week after discharge, then after 1 month, 3 months, 6 months, and a year. They will be evaluated by pediatric cardiologists, hematologists, rheumatologists and infectious disease specialists.

Montefiore and other children’s hospitals around the country are sharing information. Dr. Choueiter wants to establish an even longer-term monitoring program for MIS-C, comparable with registries that exist for other diseases.

Ms. Moholland is glad the hospital is being vigilant.

“The uncertainty of not knowing whether it could come back in his future is a little unsettling,” she said. “But I am hopeful.”

This story is part of a partnership that includes WNYC, NPR, and Kaiser Health News. A version of this article originally appeared on Kaiser Health News.

The incidence of stillbirth has increased since the COVID-19 pandemic began, according to a comparative study of pregnancy outcomes in a London hospital.

“The increase in stillbirths may have resulted from indirect effects such as reluctance to attend hospital when needed (e.g., with reduced fetal movements), fear of contracting infection, or not wanting to add to the National Health Service burden,” Asma Khalil, MD, of St George’s University of London and coauthors reported in JAMA.

To further assess reported changes in stillbirth and preterm delivery rates during the pandemic, the researchers began a retrospective study of pregnancy outcomes at St George’s University Hospital in London. They compared two periods: from Oct. 1, 2019, to Jan. 31, 2020 as the pre–COVID-19 period and from Feb. 1, 2020, to June 14, 2020 as the pandemic period. The median age of the mother at time of birth in both periods was 33 years. The prepandemic period had 1,681 births, and the pandemic period had 1,718 births.

Although there were found to be fewer nulliparous women and fewer women with hypertension in the pandemic period, the incidence of stillbirth in that period was significantly higher (n = 16 [9 per 1,000 births]) than in the prepandemic period (n = 4 [2 per 1,000 births]) (difference, 7 per 1,000 births; 95% confidence interval, 1.83-12.0; P = .01). The pandemic rate remained higher when late terminations for fetal abnormality were excluded (difference 6 per 1,000 births; 95% CI 1.54-10.1; P = .01).

None of the pregnant women who experienced stillbirth had COVID-19 symptoms, and none of the postmortems or placental exams indicated infection. There were no significant differences between the two periods in regard to births before 37 weeks’ gestation, births after 34 weeks’ gestation, neonatal unit admission, or cesarean delivery.

“It’s very important to highlight the effects of the pandemic on pregnant patients, even if they’re not infected with COVID-19,” Shannon Clark, MD, of the University of Texas Medical Branch in Galveston said in an interview.

She noted several COVID-related considerations that could have contributed to this increase: the reluctance of both low-risk and high-risk patients to enter a hospital setting during a pandemic, along with safety-centered changes made in antenatal services and care, which includes a reduced number of ultrasounds and screening exams.

“Checking a patient’s blood pressure, checking their weight changes, checking how the baby is growing,” she said. “They’re all simple things that just can’t be done via telemedicine.”

“We’ve thought a lot about the potential effects of getting COVID in pregnancy,” she added, “but it’s just as important to think about what might happen to those who don’t have it and are considered low risk otherwise.”

The study authors noted its limitations, including it being retrospective, analyzing a short time frame, and focusing on a single medical center. It also didn’t factor in the causes of the stillbirths, nor were the time periods precisely comparable, although they did add that “there is no seasonality to stillbirths in the UK.”

One doctor reported receiving grants outside of the submitted work. No other potential conflicts of interest were noted. Dr. Clark said she had no relevant financial disclosures.

SOURCE: Khalil A et al. JAMA. 2020 Jul. doi: 10.1001/jama.2020.12746.

The incidence of stillbirth has increased since the COVID-19 pandemic began, according to a comparative study of pregnancy outcomes in a London hospital.

“The increase in stillbirths may have resulted from indirect effects such as reluctance to attend hospital when needed (e.g., with reduced fetal movements), fear of contracting infection, or not wanting to add to the National Health Service burden,” Asma Khalil, MD, of St George’s University of London and coauthors reported in JAMA.

To further assess reported changes in stillbirth and preterm delivery rates during the pandemic, the researchers began a retrospective study of pregnancy outcomes at St George’s University Hospital in London. They compared two periods: from Oct. 1, 2019, to Jan. 31, 2020 as the pre–COVID-19 period and from Feb. 1, 2020, to June 14, 2020 as the pandemic period. The median age of the mother at time of birth in both periods was 33 years. The prepandemic period had 1,681 births, and the pandemic period had 1,718 births.

Although there were found to be fewer nulliparous women and fewer women with hypertension in the pandemic period, the incidence of stillbirth in that period was significantly higher (n = 16 [9 per 1,000 births]) than in the prepandemic period (n = 4 [2 per 1,000 births]) (difference, 7 per 1,000 births; 95% confidence interval, 1.83-12.0; P = .01). The pandemic rate remained higher when late terminations for fetal abnormality were excluded (difference 6 per 1,000 births; 95% CI 1.54-10.1; P = .01).

None of the pregnant women who experienced stillbirth had COVID-19 symptoms, and none of the postmortems or placental exams indicated infection. There were no significant differences between the two periods in regard to births before 37 weeks’ gestation, births after 34 weeks’ gestation, neonatal unit admission, or cesarean delivery.

“It’s very important to highlight the effects of the pandemic on pregnant patients, even if they’re not infected with COVID-19,” Shannon Clark, MD, of the University of Texas Medical Branch in Galveston said in an interview.

She noted several COVID-related considerations that could have contributed to this increase: the reluctance of both low-risk and high-risk patients to enter a hospital setting during a pandemic, along with safety-centered changes made in antenatal services and care, which includes a reduced number of ultrasounds and screening exams.

“Checking a patient’s blood pressure, checking their weight changes, checking how the baby is growing,” she said. “They’re all simple things that just can’t be done via telemedicine.”

“We’ve thought a lot about the potential effects of getting COVID in pregnancy,” she added, “but it’s just as important to think about what might happen to those who don’t have it and are considered low risk otherwise.”

The study authors noted its limitations, including it being retrospective, analyzing a short time frame, and focusing on a single medical center. It also didn’t factor in the causes of the stillbirths, nor were the time periods precisely comparable, although they did add that “there is no seasonality to stillbirths in the UK.”

One doctor reported receiving grants outside of the submitted work. No other potential conflicts of interest were noted. Dr. Clark said she had no relevant financial disclosures.

SOURCE: Khalil A et al. JAMA. 2020 Jul. doi: 10.1001/jama.2020.12746.

The incidence of stillbirth has increased since the COVID-19 pandemic began, according to a comparative study of pregnancy outcomes in a London hospital.

“The increase in stillbirths may have resulted from indirect effects such as reluctance to attend hospital when needed (e.g., with reduced fetal movements), fear of contracting infection, or not wanting to add to the National Health Service burden,” Asma Khalil, MD, of St George’s University of London and coauthors reported in JAMA.

To further assess reported changes in stillbirth and preterm delivery rates during the pandemic, the researchers began a retrospective study of pregnancy outcomes at St George’s University Hospital in London. They compared two periods: from Oct. 1, 2019, to Jan. 31, 2020 as the pre–COVID-19 period and from Feb. 1, 2020, to June 14, 2020 as the pandemic period. The median age of the mother at time of birth in both periods was 33 years. The prepandemic period had 1,681 births, and the pandemic period had 1,718 births.

Although there were found to be fewer nulliparous women and fewer women with hypertension in the pandemic period, the incidence of stillbirth in that period was significantly higher (n = 16 [9 per 1,000 births]) than in the prepandemic period (n = 4 [2 per 1,000 births]) (difference, 7 per 1,000 births; 95% confidence interval, 1.83-12.0; P = .01). The pandemic rate remained higher when late terminations for fetal abnormality were excluded (difference 6 per 1,000 births; 95% CI 1.54-10.1; P = .01).

None of the pregnant women who experienced stillbirth had COVID-19 symptoms, and none of the postmortems or placental exams indicated infection. There were no significant differences between the two periods in regard to births before 37 weeks’ gestation, births after 34 weeks’ gestation, neonatal unit admission, or cesarean delivery.

“It’s very important to highlight the effects of the pandemic on pregnant patients, even if they’re not infected with COVID-19,” Shannon Clark, MD, of the University of Texas Medical Branch in Galveston said in an interview.

She noted several COVID-related considerations that could have contributed to this increase: the reluctance of both low-risk and high-risk patients to enter a hospital setting during a pandemic, along with safety-centered changes made in antenatal services and care, which includes a reduced number of ultrasounds and screening exams.

“Checking a patient’s blood pressure, checking their weight changes, checking how the baby is growing,” she said. “They’re all simple things that just can’t be done via telemedicine.”

“We’ve thought a lot about the potential effects of getting COVID in pregnancy,” she added, “but it’s just as important to think about what might happen to those who don’t have it and are considered low risk otherwise.”

The study authors noted its limitations, including it being retrospective, analyzing a short time frame, and focusing on a single medical center. It also didn’t factor in the causes of the stillbirths, nor were the time periods precisely comparable, although they did add that “there is no seasonality to stillbirths in the UK.”

One doctor reported receiving grants outside of the submitted work. No other potential conflicts of interest were noted. Dr. Clark said she had no relevant financial disclosures.

SOURCE: Khalil A et al. JAMA. 2020 Jul. doi: 10.1001/jama.2020.12746.

“Don’t let the gown get you down,” was the advice a 26-year-old gentleman with leukemia offered in a study investigating the psychosocial impact of hospital gowns on patients and providers.¹ Patients were found to be resigned to their “uncomfortable,” “expos[ing],” “nightmare-[ish]” “uniform,” afraid to even ask to wear more dignifying attire for fear of seeming difficult to providers and potentially harming the therapeutic relationship; one 64-year-old woman with terminal cancer detailed, “I have my own pajamas at home, but I don’t bring them because you can’t wear them here … [wearing a gown] is really not fun, but hey, this is what [providers] have to do, so it’s what you have to do.”^1-3

Research has consistently shown that patients are vulnerable to dehumanization and loss of identity in the hospital, often exacerbated by wearing the standard hospital gown.^3-8 Case in point, a mixed-methods study revealed that hospital gowns may lead to an increased sense of exposure, discomfort, disempowerment, and embarrassment for patients during a period of potential vulnerability while undergoing medical intervention.⁸

Hospital gowns strip autonomy from individuals humbly coming to the hospital for help. The gown has become a linchpin of change, initiating the dehumanizing process of “person” to “patient.” One of the main problems with the hospital gown is its exposing nature, often made light of on the wards with the joke, “Do you know who invented the hospital gown?…See-more Hiney!” The joke continued in two Super Bowl LIII commercials for a large academic health care system and insurance provider in Pennsylvania, depicting a construction worker and businessman clad in hospital gowns, mooning their less-than-pleased coworkers, to inform patients of expanded insurance coverage, i.e., “completely covered.” Hospital gowns are also a source of comedic fodder on sitcoms, including “It’s Always Sunny in Philadelphia,” “Man with a Plan,” and “Carol’s Second Act.”

It is common knowledge that hospital gowns are flawed, but very little has been done to change them. Little is known about the origin of hospital gowns, and like their design, their history has many gaps. PubMed, Google, and Wikipedia yield no fruitful insight into the evolution of the hospital gown, and perhaps the best way to understand the hospital gown over time is to watch depictions of patients in television sitcoms, dramas, and movies, ranging from the days of black-and-white into the modern era, and view artistic depictions of hospitals across eras. Case in point, depictions of fourteenth century hospital wards in art show that all patients wore night shirts, under which they also wore some type of underclothing.⁹ By the end of the 1800s and beginning of the 1900s, pajamas for men became more common as hospital attire.⁹ Although it is not known who originally invented the traditional hospital gown, the original gown was designed around a century ago with an open back for use on patients admitted the night prior to surgery, who were sedated prior to transfer to the anesthetic room while half-asleep.¹⁰

In general, the most common reason that hospitals began to provide, require, or offer clothing to patients was to reduce infection and improve hygiene, as clothing can be ruined by leakage of bodily fluids from various examinations, treatments, and procedures.⁹ In addition, in certain settings, lifesaving measures require access to the naked body to allow equipment, like a defibrillator, to be connected to the patient; a gown can theoretically be removed quickly.⁹ For some reason along the way, the simple, open-backed “johnny” gown of the early 20th century became standard of care with minimal meaningful modifications in the last hundred years. One possible explanation for the persistence of the “johnny” gown is that in past eras of medicine, patients in gowns were expected to be bedbound for recovery, keeping their bare bottom under wraps, and this norm became the status quo. Today, ambulation is encouraged in patients as part of venous thromboembolism (VTE) prophylaxis but the gown design has fallen behind.

Modern medicine emphasizes, values, and even advertises evidence-based medicine, patient-centered care, and high-quality care, yet the hospital gown stands as a stark contrast to this pledge to move forward as beacons of change. Hospital gowns have fallen outside of the scope of evidence-based research.¹¹ One may ask why the gown remains decades behind modern medicine, and it appears that this apathy stems from (1) accepting “medical tradition” and choosing to overlook the flaws of the current hospital gown, and (2) believing that changing the hospital gown would cost money, affronting an institution’s almighty bottom-line. Still, several institutions have attempted change, including Hackensack University Medical Center partnering with Cynthia Rowley and Nicole Miller (1999), Cleveland Clinic partnering with Diane von Furstenberg (2010), and Henry Ford Health System of Detroit’s “Model G” gown (2016).^12-15

In spite of these efforts to revamp the hospital gown at academic medical centers, change has been neither long lasting nor widely disseminated. Traci Lamar, a professor at the North Carolina State University College of Textiles reasoned that, “There are number of pressures in the hospital environment that influence what they purchase and when they purchase. Cost management, inventory management, storage space. ... There’s more value coming with the apparel item if it also becomes something that replaces or enhances other equipment that’s used in the hospital environment. Like a gown that can also keep an eye on your blood pressure or measure your heart rate.”¹⁵

The hospital gown remains a poor attempt at proper attire for human beings, with the most similar evolutionary relative being a hairdresser’s cape. Taken a step further, functionally the hospital gown is most similar to a prison uniform. Although this may seem bold and sensational, one must stop and think about it, considering the parallels. When individuals are admitted to the hospital, they exchange their clothing for a hospital gown, so that they can be easily identified as a “patient” and remain safe in the hospital. When individuals are sentenced to prison, they exchange their clothing for a uniform, so that they can be easily identified as a “prisoner” and remain safe in jail. The problem is, more time, money, and effort has gone into designing prisoners’ garments, who expect a loss of autonomy, than designing patients’ garments, who should never expect a loss of autonomy.

Prison uniforms are designed with safety in mind, ensuring the absence of potential ligatures or improvised weapons. The United Nations even passed an amendment to its Standard Minimum Rules for the Treatment of Prisoners in 2015, prohibiting humiliating clothing and requiring every prisoner who is “not allowed to wear his or her own clothing” to “be provided with an outfit of clothing suitable for the climate and adequate to keep him or her in good health.”¹⁶ They also stipulated that prisoners’ clothing could not be degrading or humiliating and was mandated to “be clean and kept in proper condition”.¹⁶ Even more compelling, a physician was bequeathed the task of inspecting, and advising the prison director on “the suitability and cleanliness of the prisoners’ clothing and bedding.”¹⁶ However, there are no standard minimum rules for hospital patients’ clothing. Hospital gowns have been described as “threadbare,” “one-size-fits-none,” “stained,” and “drafty,” antithetical to both hygiene and the hospital climate – far from “proper condition” (See Figure 1).¹

Where are the standard minimum rules for hospital gowns? Patients have admittedly wondered, “What happened to the person who wore this gown before I did?” or worse, “Who died in this gown?” Even more, the current hospital gown can unintentionally put a patient in harms’ way, posing a fall risk for patients with petite frames overwhelmed by the bulk of the gown and also inhibiting fast access to the chest for placement of defibrillation pads in a code. Ironically, prison uniforms have the main things patients have requested: bottoms, modesty, multiple sizes, and … color!^1-3

Although jailhouse orange or stripes are unlikely to be high fashion in the hospital, it is important to consider that, through indifference about the current hospital gown, institutions are teaching that it is acceptable for patients to wear this dehumanizing garment analogous to a prison uniform, except less colorful and more exposing. The hospital gown has persisted under the myth of medical tradition, masking the fact that there is neither evidence for the current hospital gown design nor data to support its functional success for patients or providers.^3,12,14 Silence speaks volumes, and patients are taught to expect and accept a loss of dignity without questioning this archaic aspect of medical culture. Patients, nurses, and physicians do not challenge the status quo because the hospital gown “is the way it has always been done.” Perceived added-cost and medical tradition have further perpetuated the current open-backed hospital gown because meaningful change would require money.

With that said, “double gowning,” the method hospitals have used to combat lunar eclipses in the hallways and provide a semblance of dignity to patients, is already costing hospitals more money, costs that can be reduced by creating an evidence-based, patient-guided, provider-approved design. As Mike Forbes, the product designer and licensing associate for the Model G gown, argued, “By using two, you’re purchasing two gowns because one doesn’t do the job, which costs money. … If you’re washing twice as many gowns as you need, you’re spending twice as much money as you need on laundry.”¹⁷

Thus, improvements can be made without breaking the bank and may even save hospitals money in the long run. For instance, a hospital administrator can order more colors or styles of hospital gowns and bottoms to give patients a choice of what they would prefer to wear: a small piece of autonomy in an environment where minimal autonomy exists. A physician or nurse can not only permit, but also encourage, a patient to wear his or her own attire within reason, for example, a loose-fitting t-shirt and sweatpants from home or pajama pants under a hospital gown. More complex solutions could include a community design contest for a medical center’s new hospital gown print, or even bolder, a community design contest for a medical center’s new inpatient attire. Above all, patients need to know that hospitals and providers care about what patients wear in the hospital. As a terminally ill patient suggested, “maybe all administrators and office staff should have to spend one day in a gown. …They advertise this: ‘We always put the patient first.’ Okay, so then I guess you have to put your money where your mouth is.”³

This new decade offers the opportunity to give patients a sense of dignity back and make concerted, evidence-based efforts towards meaningful and sustainable change in patient attire, be it purchasing more colorful and modest gown options in the present or total redesign in the future. The financial cost may seem burdensome, but the reward would be immensely bountiful. It is time to stop making hospital gown–clad patients’ exposed bottoms the butt of the joke, and the only way to change the punchline is to change the hospital gown. Patients deserve more than the bare minimum and a bare bottom, so hospitals must consider putting their money where their mouth is.

Dr. Lucas is based in the department of pediatrics, University of Pittsburgh Medical Center Children’s Hospital of Pittsburgh. She has a provisional utility patent pending for a novel patient gown. You can contact her at [email protected]. Dr. Dellasega is based in the department of humanities, Penn State University, Hershey.

References

1. Lucas C et al. “Don’t let the gown get you down: How patients and providers perceive hospital gowns.” Abstract published at Hospital Medicine 2019, Mar 24-27, National Harbor, Md., Abstract 322.

2. Lucas C and Dellasega C. “You don’t have to be dying to do comfort measures: Patients’ and physicians’ perceptions of inpatient attire.” Abstract published at ACP Internal Medicine 2019, Apr 11-13, Philadelphia, Abstract.

3. Lucas C and Dellasega C. Finding common threads: How patients, physicians, and nurses perceive the patient gown. Patient Exp J. 2020;7(1):51-64.

4. Detsky A and Krumholtz H. Reducing the trauma of hospitalization. JAMA. 2014;311(21):2169-70.

5. Krumholz H. Post-hospital syndrome – an acquired, transient condition of generalized risk. N Engl J Med. 2013;368(2):100-2.

6. Wellbery C and Chan M. White coat, patient gown. Med Humanit. 2014;40(2):90-6.

7. McDonald E et al. Inpatient attire: An opportunity to improve the patient experience. JAMA Intern Med. 2014;174(11):1865-67.

8. Cogan N et al. Mixed methods study exploring the impact of the hospital gown on recovery and wellbeing: Implications for policy and practice. Lancet. 2019. doi: 10.1016/S0140-6736(19)32829-6.

9. Bergbom I, Pettersson M, and Mattsson E. Patient clothing – practical solution or means of imposing anonymity? J Hosp Med Manage. 2017;3(22):1-6.

10. Who invented the hospital gown? Interweave Healthcare. Accessed Mar 30, 2020.

11. Gordon L and Guttmann S. A user-centered approach to the redesign of the patient hospital gown. Fashion Practice. 2013;5(1):137-51. doi: 10.2752/175693813X13559997788961.

12. Limbong A. “Can a Patient Gown Makeover Move Hospitals to Embrace Change?” NPR. 2018 Feb 11. Accessed Mar 26, 2020.

13. Schiro A. “Patterns: Hospital Style.” New York Times. 1999 June 29. Accessed Mar 26, 2020.

14. Luthra S. “Hospital Gowns Get a Makeover.” The Atlantic. 2015 Apr 4. Accessed Mar 26, 2020.

15. Tien E. “Hospital Gowns Get a Life.” New York Times. 1998 Oct 18. Accessed Mar 26, 2020.

16. McCall-Smith K. United Nations Standard Minimum Rules for the Treatment of Prisoners (Nelson Mandela Rules). Int Leg Materials. 2016;55(6),1180-205.

17. Green C. “Updated hospital gowns a good investment, execs say, restore ‘dignity.’ ” Healthcare Finance. 2015 Aug 3. Accessed Apr 1, 2020.

“Don’t let the gown get you down,” was the advice a 26-year-old gentleman with leukemia offered in a study investigating the psychosocial impact of hospital gowns on patients and providers.¹ Patients were found to be resigned to their “uncomfortable,” “expos[ing],” “nightmare-[ish]” “uniform,” afraid to even ask to wear more dignifying attire for fear of seeming difficult to providers and potentially harming the therapeutic relationship; one 64-year-old woman with terminal cancer detailed, “I have my own pajamas at home, but I don’t bring them because you can’t wear them here … [wearing a gown] is really not fun, but hey, this is what [providers] have to do, so it’s what you have to do.”^1-3

Research has consistently shown that patients are vulnerable to dehumanization and loss of identity in the hospital, often exacerbated by wearing the standard hospital gown.^3-8 Case in point, a mixed-methods study revealed that hospital gowns may lead to an increased sense of exposure, discomfort, disempowerment, and embarrassment for patients during a period of potential vulnerability while undergoing medical intervention.⁸

Hospital gowns strip autonomy from individuals humbly coming to the hospital for help. The gown has become a linchpin of change, initiating the dehumanizing process of “person” to “patient.” One of the main problems with the hospital gown is its exposing nature, often made light of on the wards with the joke, “Do you know who invented the hospital gown?…See-more Hiney!” The joke continued in two Super Bowl LIII commercials for a large academic health care system and insurance provider in Pennsylvania, depicting a construction worker and businessman clad in hospital gowns, mooning their less-than-pleased coworkers, to inform patients of expanded insurance coverage, i.e., “completely covered.” Hospital gowns are also a source of comedic fodder on sitcoms, including “It’s Always Sunny in Philadelphia,” “Man with a Plan,” and “Carol’s Second Act.”

It is common knowledge that hospital gowns are flawed, but very little has been done to change them. Little is known about the origin of hospital gowns, and like their design, their history has many gaps. PubMed, Google, and Wikipedia yield no fruitful insight into the evolution of the hospital gown, and perhaps the best way to understand the hospital gown over time is to watch depictions of patients in television sitcoms, dramas, and movies, ranging from the days of black-and-white into the modern era, and view artistic depictions of hospitals across eras. Case in point, depictions of fourteenth century hospital wards in art show that all patients wore night shirts, under which they also wore some type of underclothing.⁹ By the end of the 1800s and beginning of the 1900s, pajamas for men became more common as hospital attire.⁹ Although it is not known who originally invented the traditional hospital gown, the original gown was designed around a century ago with an open back for use on patients admitted the night prior to surgery, who were sedated prior to transfer to the anesthetic room while half-asleep.¹⁰

In general, the most common reason that hospitals began to provide, require, or offer clothing to patients was to reduce infection and improve hygiene, as clothing can be ruined by leakage of bodily fluids from various examinations, treatments, and procedures.⁹ In addition, in certain settings, lifesaving measures require access to the naked body to allow equipment, like a defibrillator, to be connected to the patient; a gown can theoretically be removed quickly.⁹ For some reason along the way, the simple, open-backed “johnny” gown of the early 20th century became standard of care with minimal meaningful modifications in the last hundred years. One possible explanation for the persistence of the “johnny” gown is that in past eras of medicine, patients in gowns were expected to be bedbound for recovery, keeping their bare bottom under wraps, and this norm became the status quo. Today, ambulation is encouraged in patients as part of venous thromboembolism (VTE) prophylaxis but the gown design has fallen behind.

Modern medicine emphasizes, values, and even advertises evidence-based medicine, patient-centered care, and high-quality care, yet the hospital gown stands as a stark contrast to this pledge to move forward as beacons of change. Hospital gowns have fallen outside of the scope of evidence-based research.¹¹ One may ask why the gown remains decades behind modern medicine, and it appears that this apathy stems from (1) accepting “medical tradition” and choosing to overlook the flaws of the current hospital gown, and (2) believing that changing the hospital gown would cost money, affronting an institution’s almighty bottom-line. Still, several institutions have attempted change, including Hackensack University Medical Center partnering with Cynthia Rowley and Nicole Miller (1999), Cleveland Clinic partnering with Diane von Furstenberg (2010), and Henry Ford Health System of Detroit’s “Model G” gown (2016).^12-15

In spite of these efforts to revamp the hospital gown at academic medical centers, change has been neither long lasting nor widely disseminated. Traci Lamar, a professor at the North Carolina State University College of Textiles reasoned that, “There are number of pressures in the hospital environment that influence what they purchase and when they purchase. Cost management, inventory management, storage space. ... There’s more value coming with the apparel item if it also becomes something that replaces or enhances other equipment that’s used in the hospital environment. Like a gown that can also keep an eye on your blood pressure or measure your heart rate.”¹⁵

The hospital gown remains a poor attempt at proper attire for human beings, with the most similar evolutionary relative being a hairdresser’s cape. Taken a step further, functionally the hospital gown is most similar to a prison uniform. Although this may seem bold and sensational, one must stop and think about it, considering the parallels. When individuals are admitted to the hospital, they exchange their clothing for a hospital gown, so that they can be easily identified as a “patient” and remain safe in the hospital. When individuals are sentenced to prison, they exchange their clothing for a uniform, so that they can be easily identified as a “prisoner” and remain safe in jail. The problem is, more time, money, and effort has gone into designing prisoners’ garments, who expect a loss of autonomy, than designing patients’ garments, who should never expect a loss of autonomy.

Prison uniforms are designed with safety in mind, ensuring the absence of potential ligatures or improvised weapons. The United Nations even passed an amendment to its Standard Minimum Rules for the Treatment of Prisoners in 2015, prohibiting humiliating clothing and requiring every prisoner who is “not allowed to wear his or her own clothing” to “be provided with an outfit of clothing suitable for the climate and adequate to keep him or her in good health.”¹⁶ They also stipulated that prisoners’ clothing could not be degrading or humiliating and was mandated to “be clean and kept in proper condition”.¹⁶ Even more compelling, a physician was bequeathed the task of inspecting, and advising the prison director on “the suitability and cleanliness of the prisoners’ clothing and bedding.”¹⁶ However, there are no standard minimum rules for hospital patients’ clothing. Hospital gowns have been described as “threadbare,” “one-size-fits-none,” “stained,” and “drafty,” antithetical to both hygiene and the hospital climate – far from “proper condition” (See Figure 1).¹

Where are the standard minimum rules for hospital gowns? Patients have admittedly wondered, “What happened to the person who wore this gown before I did?” or worse, “Who died in this gown?” Even more, the current hospital gown can unintentionally put a patient in harms’ way, posing a fall risk for patients with petite frames overwhelmed by the bulk of the gown and also inhibiting fast access to the chest for placement of defibrillation pads in a code. Ironically, prison uniforms have the main things patients have requested: bottoms, modesty, multiple sizes, and … color!^1-3

Although jailhouse orange or stripes are unlikely to be high fashion in the hospital, it is important to consider that, through indifference about the current hospital gown, institutions are teaching that it is acceptable for patients to wear this dehumanizing garment analogous to a prison uniform, except less colorful and more exposing. The hospital gown has persisted under the myth of medical tradition, masking the fact that there is neither evidence for the current hospital gown design nor data to support its functional success for patients or providers.^3,12,14 Silence speaks volumes, and patients are taught to expect and accept a loss of dignity without questioning this archaic aspect of medical culture. Patients, nurses, and physicians do not challenge the status quo because the hospital gown “is the way it has always been done.” Perceived added-cost and medical tradition have further perpetuated the current open-backed hospital gown because meaningful change would require money.

With that said, “double gowning,” the method hospitals have used to combat lunar eclipses in the hallways and provide a semblance of dignity to patients, is already costing hospitals more money, costs that can be reduced by creating an evidence-based, patient-guided, provider-approved design. As Mike Forbes, the product designer and licensing associate for the Model G gown, argued, “By using two, you’re purchasing two gowns because one doesn’t do the job, which costs money. … If you’re washing twice as many gowns as you need, you’re spending twice as much money as you need on laundry.”¹⁷

Thus, improvements can be made without breaking the bank and may even save hospitals money in the long run. For instance, a hospital administrator can order more colors or styles of hospital gowns and bottoms to give patients a choice of what they would prefer to wear: a small piece of autonomy in an environment where minimal autonomy exists. A physician or nurse can not only permit, but also encourage, a patient to wear his or her own attire within reason, for example, a loose-fitting t-shirt and sweatpants from home or pajama pants under a hospital gown. More complex solutions could include a community design contest for a medical center’s new hospital gown print, or even bolder, a community design contest for a medical center’s new inpatient attire. Above all, patients need to know that hospitals and providers care about what patients wear in the hospital. As a terminally ill patient suggested, “maybe all administrators and office staff should have to spend one day in a gown. …They advertise this: ‘We always put the patient first.’ Okay, so then I guess you have to put your money where your mouth is.”³

This new decade offers the opportunity to give patients a sense of dignity back and make concerted, evidence-based efforts towards meaningful and sustainable change in patient attire, be it purchasing more colorful and modest gown options in the present or total redesign in the future. The financial cost may seem burdensome, but the reward would be immensely bountiful. It is time to stop making hospital gown–clad patients’ exposed bottoms the butt of the joke, and the only way to change the punchline is to change the hospital gown. Patients deserve more than the bare minimum and a bare bottom, so hospitals must consider putting their money where their mouth is.

Dr. Lucas is based in the department of pediatrics, University of Pittsburgh Medical Center Children’s Hospital of Pittsburgh. She has a provisional utility patent pending for a novel patient gown. You can contact her at [email protected]. Dr. Dellasega is based in the department of humanities, Penn State University, Hershey.

References

1. Lucas C et al. “Don’t let the gown get you down: How patients and providers perceive hospital gowns.” Abstract published at Hospital Medicine 2019, Mar 24-27, National Harbor, Md., Abstract 322.

2. Lucas C and Dellasega C. “You don’t have to be dying to do comfort measures: Patients’ and physicians’ perceptions of inpatient attire.” Abstract published at ACP Internal Medicine 2019, Apr 11-13, Philadelphia, Abstract.

3. Lucas C and Dellasega C. Finding common threads: How patients, physicians, and nurses perceive the patient gown. Patient Exp J. 2020;7(1):51-64.

4. Detsky A and Krumholtz H. Reducing the trauma of hospitalization. JAMA. 2014;311(21):2169-70.

5. Krumholz H. Post-hospital syndrome – an acquired, transient condition of generalized risk. N Engl J Med. 2013;368(2):100-2.

6. Wellbery C and Chan M. White coat, patient gown. Med Humanit. 2014;40(2):90-6.

7. McDonald E et al. Inpatient attire: An opportunity to improve the patient experience. JAMA Intern Med. 2014;174(11):1865-67.

8. Cogan N et al. Mixed methods study exploring the impact of the hospital gown on recovery and wellbeing: Implications for policy and practice. Lancet. 2019. doi: 10.1016/S0140-6736(19)32829-6.

9. Bergbom I, Pettersson M, and Mattsson E. Patient clothing – practical solution or means of imposing anonymity? J Hosp Med Manage. 2017;3(22):1-6.

10. Who invented the hospital gown? Interweave Healthcare. Accessed Mar 30, 2020.

11. Gordon L and Guttmann S. A user-centered approach to the redesign of the patient hospital gown. Fashion Practice. 2013;5(1):137-51. doi: 10.2752/175693813X13559997788961.

12. Limbong A. “Can a Patient Gown Makeover Move Hospitals to Embrace Change?” NPR. 2018 Feb 11. Accessed Mar 26, 2020.

13. Schiro A. “Patterns: Hospital Style.” New York Times. 1999 June 29. Accessed Mar 26, 2020.

14. Luthra S. “Hospital Gowns Get a Makeover.” The Atlantic. 2015 Apr 4. Accessed Mar 26, 2020.

15. Tien E. “Hospital Gowns Get a Life.” New York Times. 1998 Oct 18. Accessed Mar 26, 2020.

16. McCall-Smith K. United Nations Standard Minimum Rules for the Treatment of Prisoners (Nelson Mandela Rules). Int Leg Materials. 2016;55(6),1180-205.

17. Green C. “Updated hospital gowns a good investment, execs say, restore ‘dignity.’ ” Healthcare Finance. 2015 Aug 3. Accessed Apr 1, 2020.

“Don’t let the gown get you down,” was the advice a 26-year-old gentleman with leukemia offered in a study investigating the psychosocial impact of hospital gowns on patients and providers.¹ Patients were found to be resigned to their “uncomfortable,” “expos[ing],” “nightmare-[ish]” “uniform,” afraid to even ask to wear more dignifying attire for fear of seeming difficult to providers and potentially harming the therapeutic relationship; one 64-year-old woman with terminal cancer detailed, “I have my own pajamas at home, but I don’t bring them because you can’t wear them here … [wearing a gown] is really not fun, but hey, this is what [providers] have to do, so it’s what you have to do.”^1-3

Research has consistently shown that patients are vulnerable to dehumanization and loss of identity in the hospital, often exacerbated by wearing the standard hospital gown.^3-8 Case in point, a mixed-methods study revealed that hospital gowns may lead to an increased sense of exposure, discomfort, disempowerment, and embarrassment for patients during a period of potential vulnerability while undergoing medical intervention.⁸

Hospital gowns strip autonomy from individuals humbly coming to the hospital for help. The gown has become a linchpin of change, initiating the dehumanizing process of “person” to “patient.” One of the main problems with the hospital gown is its exposing nature, often made light of on the wards with the joke, “Do you know who invented the hospital gown?…See-more Hiney!” The joke continued in two Super Bowl LIII commercials for a large academic health care system and insurance provider in Pennsylvania, depicting a construction worker and businessman clad in hospital gowns, mooning their less-than-pleased coworkers, to inform patients of expanded insurance coverage, i.e., “completely covered.” Hospital gowns are also a source of comedic fodder on sitcoms, including “It’s Always Sunny in Philadelphia,” “Man with a Plan,” and “Carol’s Second Act.”

It is common knowledge that hospital gowns are flawed, but very little has been done to change them. Little is known about the origin of hospital gowns, and like their design, their history has many gaps. PubMed, Google, and Wikipedia yield no fruitful insight into the evolution of the hospital gown, and perhaps the best way to understand the hospital gown over time is to watch depictions of patients in television sitcoms, dramas, and movies, ranging from the days of black-and-white into the modern era, and view artistic depictions of hospitals across eras. Case in point, depictions of fourteenth century hospital wards in art show that all patients wore night shirts, under which they also wore some type of underclothing.⁹ By the end of the 1800s and beginning of the 1900s, pajamas for men became more common as hospital attire.⁹ Although it is not known who originally invented the traditional hospital gown, the original gown was designed around a century ago with an open back for use on patients admitted the night prior to surgery, who were sedated prior to transfer to the anesthetic room while half-asleep.¹⁰

In general, the most common reason that hospitals began to provide, require, or offer clothing to patients was to reduce infection and improve hygiene, as clothing can be ruined by leakage of bodily fluids from various examinations, treatments, and procedures.⁹ In addition, in certain settings, lifesaving measures require access to the naked body to allow equipment, like a defibrillator, to be connected to the patient; a gown can theoretically be removed quickly.⁹ For some reason along the way, the simple, open-backed “johnny” gown of the early 20th century became standard of care with minimal meaningful modifications in the last hundred years. One possible explanation for the persistence of the “johnny” gown is that in past eras of medicine, patients in gowns were expected to be bedbound for recovery, keeping their bare bottom under wraps, and this norm became the status quo. Today, ambulation is encouraged in patients as part of venous thromboembolism (VTE) prophylaxis but the gown design has fallen behind.

Modern medicine emphasizes, values, and even advertises evidence-based medicine, patient-centered care, and high-quality care, yet the hospital gown stands as a stark contrast to this pledge to move forward as beacons of change. Hospital gowns have fallen outside of the scope of evidence-based research.¹¹ One may ask why the gown remains decades behind modern medicine, and it appears that this apathy stems from (1) accepting “medical tradition” and choosing to overlook the flaws of the current hospital gown, and (2) believing that changing the hospital gown would cost money, affronting an institution’s almighty bottom-line. Still, several institutions have attempted change, including Hackensack University Medical Center partnering with Cynthia Rowley and Nicole Miller (1999), Cleveland Clinic partnering with Diane von Furstenberg (2010), and Henry Ford Health System of Detroit’s “Model G” gown (2016).^12-15

In spite of these efforts to revamp the hospital gown at academic medical centers, change has been neither long lasting nor widely disseminated. Traci Lamar, a professor at the North Carolina State University College of Textiles reasoned that, “There are number of pressures in the hospital environment that influence what they purchase and when they purchase. Cost management, inventory management, storage space. ... There’s more value coming with the apparel item if it also becomes something that replaces or enhances other equipment that’s used in the hospital environment. Like a gown that can also keep an eye on your blood pressure or measure your heart rate.”¹⁵

The hospital gown remains a poor attempt at proper attire for human beings, with the most similar evolutionary relative being a hairdresser’s cape. Taken a step further, functionally the hospital gown is most similar to a prison uniform. Although this may seem bold and sensational, one must stop and think about it, considering the parallels. When individuals are admitted to the hospital, they exchange their clothing for a hospital gown, so that they can be easily identified as a “patient” and remain safe in the hospital. When individuals are sentenced to prison, they exchange their clothing for a uniform, so that they can be easily identified as a “prisoner” and remain safe in jail. The problem is, more time, money, and effort has gone into designing prisoners’ garments, who expect a loss of autonomy, than designing patients’ garments, who should never expect a loss of autonomy.

Prison uniforms are designed with safety in mind, ensuring the absence of potential ligatures or improvised weapons. The United Nations even passed an amendment to its Standard Minimum Rules for the Treatment of Prisoners in 2015, prohibiting humiliating clothing and requiring every prisoner who is “not allowed to wear his or her own clothing” to “be provided with an outfit of clothing suitable for the climate and adequate to keep him or her in good health.”¹⁶ They also stipulated that prisoners’ clothing could not be degrading or humiliating and was mandated to “be clean and kept in proper condition”.¹⁶ Even more compelling, a physician was bequeathed the task of inspecting, and advising the prison director on “the suitability and cleanliness of the prisoners’ clothing and bedding.”¹⁶ However, there are no standard minimum rules for hospital patients’ clothing. Hospital gowns have been described as “threadbare,” “one-size-fits-none,” “stained,” and “drafty,” antithetical to both hygiene and the hospital climate – far from “proper condition” (See Figure 1).¹

Where are the standard minimum rules for hospital gowns? Patients have admittedly wondered, “What happened to the person who wore this gown before I did?” or worse, “Who died in this gown?” Even more, the current hospital gown can unintentionally put a patient in harms’ way, posing a fall risk for patients with petite frames overwhelmed by the bulk of the gown and also inhibiting fast access to the chest for placement of defibrillation pads in a code. Ironically, prison uniforms have the main things patients have requested: bottoms, modesty, multiple sizes, and … color!^1-3

Although jailhouse orange or stripes are unlikely to be high fashion in the hospital, it is important to consider that, through indifference about the current hospital gown, institutions are teaching that it is acceptable for patients to wear this dehumanizing garment analogous to a prison uniform, except less colorful and more exposing. The hospital gown has persisted under the myth of medical tradition, masking the fact that there is neither evidence for the current hospital gown design nor data to support its functional success for patients or providers.^3,12,14 Silence speaks volumes, and patients are taught to expect and accept a loss of dignity without questioning this archaic aspect of medical culture. Patients, nurses, and physicians do not challenge the status quo because the hospital gown “is the way it has always been done.” Perceived added-cost and medical tradition have further perpetuated the current open-backed hospital gown because meaningful change would require money.

With that said, “double gowning,” the method hospitals have used to combat lunar eclipses in the hallways and provide a semblance of dignity to patients, is already costing hospitals more money, costs that can be reduced by creating an evidence-based, patient-guided, provider-approved design. As Mike Forbes, the product designer and licensing associate for the Model G gown, argued, “By using two, you’re purchasing two gowns because one doesn’t do the job, which costs money. … If you’re washing twice as many gowns as you need, you’re spending twice as much money as you need on laundry.”¹⁷

Thus, improvements can be made without breaking the bank and may even save hospitals money in the long run. For instance, a hospital administrator can order more colors or styles of hospital gowns and bottoms to give patients a choice of what they would prefer to wear: a small piece of autonomy in an environment where minimal autonomy exists. A physician or nurse can not only permit, but also encourage, a patient to wear his or her own attire within reason, for example, a loose-fitting t-shirt and sweatpants from home or pajama pants under a hospital gown. More complex solutions could include a community design contest for a medical center’s new hospital gown print, or even bolder, a community design contest for a medical center’s new inpatient attire. Above all, patients need to know that hospitals and providers care about what patients wear in the hospital. As a terminally ill patient suggested, “maybe all administrators and office staff should have to spend one day in a gown. …They advertise this: ‘We always put the patient first.’ Okay, so then I guess you have to put your money where your mouth is.”³

This new decade offers the opportunity to give patients a sense of dignity back and make concerted, evidence-based efforts towards meaningful and sustainable change in patient attire, be it purchasing more colorful and modest gown options in the present or total redesign in the future. The financial cost may seem burdensome, but the reward would be immensely bountiful. It is time to stop making hospital gown–clad patients’ exposed bottoms the butt of the joke, and the only way to change the punchline is to change the hospital gown. Patients deserve more than the bare minimum and a bare bottom, so hospitals must consider putting their money where their mouth is.

Dr. Lucas is based in the department of pediatrics, University of Pittsburgh Medical Center Children’s Hospital of Pittsburgh. She has a provisional utility patent pending for a novel patient gown. You can contact her at [email protected]. Dr. Dellasega is based in the department of humanities, Penn State University, Hershey.

References

1. Lucas C et al. “Don’t let the gown get you down: How patients and providers perceive hospital gowns.” Abstract published at Hospital Medicine 2019, Mar 24-27, National Harbor, Md., Abstract 322.

2. Lucas C and Dellasega C. “You don’t have to be dying to do comfort measures: Patients’ and physicians’ perceptions of inpatient attire.” Abstract published at ACP Internal Medicine 2019, Apr 11-13, Philadelphia, Abstract.

3. Lucas C and Dellasega C. Finding common threads: How patients, physicians, and nurses perceive the patient gown. Patient Exp J. 2020;7(1):51-64.

4. Detsky A and Krumholtz H. Reducing the trauma of hospitalization. JAMA. 2014;311(21):2169-70.

5. Krumholz H. Post-hospital syndrome – an acquired, transient condition of generalized risk. N Engl J Med. 2013;368(2):100-2.

6. Wellbery C and Chan M. White coat, patient gown. Med Humanit. 2014;40(2):90-6.

7. McDonald E et al. Inpatient attire: An opportunity to improve the patient experience. JAMA Intern Med. 2014;174(11):1865-67.

8. Cogan N et al. Mixed methods study exploring the impact of the hospital gown on recovery and wellbeing: Implications for policy and practice. Lancet. 2019. doi: 10.1016/S0140-6736(19)32829-6.

9. Bergbom I, Pettersson M, and Mattsson E. Patient clothing – practical solution or means of imposing anonymity? J Hosp Med Manage. 2017;3(22):1-6.

10. Who invented the hospital gown? Interweave Healthcare. Accessed Mar 30, 2020.

11. Gordon L and Guttmann S. A user-centered approach to the redesign of the patient hospital gown. Fashion Practice. 2013;5(1):137-51. doi: 10.2752/175693813X13559997788961.

12. Limbong A. “Can a Patient Gown Makeover Move Hospitals to Embrace Change?” NPR. 2018 Feb 11. Accessed Mar 26, 2020.

13. Schiro A. “Patterns: Hospital Style.” New York Times. 1999 June 29. Accessed Mar 26, 2020.

14. Luthra S. “Hospital Gowns Get a Makeover.” The Atlantic. 2015 Apr 4. Accessed Mar 26, 2020.

15. Tien E. “Hospital Gowns Get a Life.” New York Times. 1998 Oct 18. Accessed Mar 26, 2020.

16. McCall-Smith K. United Nations Standard Minimum Rules for the Treatment of Prisoners (Nelson Mandela Rules). Int Leg Materials. 2016;55(6),1180-205.

17. Green C. “Updated hospital gowns a good investment, execs say, restore ‘dignity.’ ” Healthcare Finance. 2015 Aug 3. Accessed Apr 1, 2020.

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.

Beta-blockers taken for hypertension may predispose women to worse outcomes, compared with men, when they later present with acute coronary syndromes (ACS), a registry study suggests.

In the analysis of more than 13,000 patients with ACS and no history of cardiovascular (CV) disease, the women who had taken beta-blockers for hypertension showed about a one-third increased risk for heart failure (HF) at the time of their ACS presentation.

The difference between women and men was especially pronounced among patients with ST-segment elevation MI, compared with those with non-STEMI.

No such relationship between sex and risk for HF with ACS was observed among the larger portion of the cohort that had not previously been treated with beta-blockers, according to a report published July 13 in Hypertension, with lead author Raffaele Bugiardini, MD, University of Bologna (Italy).

Mortality at 30 days was sharply higher for patients with than without HF at their ACS presentation, by more than 600% for women and more than 800% for men.

“Our study provides robust evidence of an interaction between sex and beta-blocker therapy and suggests an increased risk of HF among women presenting with incident myocardial infarction,” Dr. Bugiardini said in an interview.

Given their novelty, “our findings raise strong concern about the appropriate role of beta-blockers in the therapy of hypertension in women with no prior history of cardiovascular diseases. Beta-blocker use may be an acute precipitant of heart failure in women presenting with incident ACS as first manifestation of coronary heart disease.” Dr. Bugiardini and colleagues wrote.

“There is one main implication for clinical practice. Discontinuing a beta-blocker in an otherwise healthy woman with hypertension and no prior CV disease is not harmful and could be wise,” Dr. Bugiardini said. “Blood pressure in women may be regulated in a safer way, such as using other medications and, of course, through diet and exercise.”

Rationale for the study

Men and women “differ with respect to the risk, causes, and prognosis of HF,” Dr. Bugiardini and colleagues wrote, and current guidelines “do not differentiate between the use of beta-blockers in men and in women.”

However, they proposed, “because prior trials and meta-analyses enrolled nearly five men for every woman, any differences in the effect of beta-blockers among women would have been concealed by the effect of beta-blocker therapy among men.”

The current study looked at data from October 2010 to July 2018 in the ISACS ARCHIVES, ISACS-TC, and the EMMACE-3X registries, covering 13,764 patients from 12 European countries who had a history of hypertension and presented with confirmed ACS.

Of the combined cohort, 2,590 (19%) had been treated with beta-blockers prior to their ACS presentation. They were similar to those without a history of beta-blocker use with respect to baseline features and use of other medications in an adjusted analysis.

In the group with prior beta-blocker use, 21.3% of the women and 16.7% of the men had HF of Killip class 2 or higher, a 4.6% absolute difference that worked out to a relative risk of 1.35 (95% confidence interval, 1.10-1.65).

The corresponding rates for women and men without prior beta-blocker use were 17.2% and 16.1%, respectively, for an absolute difference of only 1.1% and an RR of1.09 (95% CI, 0.97-1.21).

The interaction between sex and beta-blocker therapy for the HF outcome was significant (P < .034). An analysis that excluded patients in cardiogenic shock at their ACS presentation produced similar results.

In an analysis only of patients with STEMI, the RR for HF in women versus men was 1.44 (95% CI, 1.12-1.84) among those with a history of beta-blocker use, and 1.11 (95% CI, 0.98-1.26) among those who hadn’t used the drugs. The interaction between sex and beta-blocker use was significant (P = .033).

No such significant interaction was seen for the subgroup with non-STEMI as their index ACS (P = .14).

Heart failure at ACS was the most powerful observed predictor of 30-day mortality in women and in men in multivariate analysis; the odds ratios were 7.54 (95% CI, 5.78-9.83) and 9.62 (95% CI, 7.67-12.07), respectively.

“Our study underscores the importance of sex analyses in clinical research studies, which may provide further actionable data,” Dr. Bugiardini stated. “Failure to include both sexes in therapeutic studies is a missed opportunity to uncover underlying sex-specific risks. The adverse effect of beta-blocker therapy in women with hypertension is a sex-specific risk.”

Not just a male disease

Part of the study’s conclusions are “really not that surprising, because we have known for a long time that women who have an MI are much more likely to develop HF than men, and we also know that HF raises mortality after MI,” Ileana L. Pina, MD, MPH, Wayne State University, Detroit, said in an interview.

But what surprised her was that women taking beta-blockers were at greater risk for HF. “This association needs to be proven in a prospective study and confirmed in another dataset,” said Dr. Pina, who was not involved with the current study. “The most important message is to remember that HF is not just a ‘male’ disease and to pay attention to the symptoms of women and not discount or relegate them to anxiety or gastric problems.”

The study was observational, Dr. Bugiardini noted, so “the results may have some variance and need confirmation. However, a sex-stratified, randomized, controlled trial of beta-blocker therapy in patients with hypertension but no prior history of coronary heart disease or HF may not be considered ethical, since it would be designed to confirm risk … and not benefit.”

“Further observational studies may give confirmation,” he added. “In the meantime, the Food and Drug Administration should alert health care professionals of the adverse events associated with beta-blocker use in women with hypertension and no prior history of CV disease, [because] prescribing beta-blockers to a woman with hypertension means exposing her to unnecessary risk.”

Dr. Bugiardini and the other authors had no disclosures. Dr. Pina reported no relevant financial relationships.

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

Beta-blockers taken for hypertension may predispose women to worse outcomes, compared with men, when they later present with acute coronary syndromes (ACS), a registry study suggests.

In the analysis of more than 13,000 patients with ACS and no history of cardiovascular (CV) disease, the women who had taken beta-blockers for hypertension showed about a one-third increased risk for heart failure (HF) at the time of their ACS presentation.

The difference between women and men was especially pronounced among patients with ST-segment elevation MI, compared with those with non-STEMI.

No such relationship between sex and risk for HF with ACS was observed among the larger portion of the cohort that had not previously been treated with beta-blockers, according to a report published July 13 in Hypertension, with lead author Raffaele Bugiardini, MD, University of Bologna (Italy).

Mortality at 30 days was sharply higher for patients with than without HF at their ACS presentation, by more than 600% for women and more than 800% for men.

“Our study provides robust evidence of an interaction between sex and beta-blocker therapy and suggests an increased risk of HF among women presenting with incident myocardial infarction,” Dr. Bugiardini said in an interview.

Given their novelty, “our findings raise strong concern about the appropriate role of beta-blockers in the therapy of hypertension in women with no prior history of cardiovascular diseases. Beta-blocker use may be an acute precipitant of heart failure in women presenting with incident ACS as first manifestation of coronary heart disease.” Dr. Bugiardini and colleagues wrote.

“There is one main implication for clinical practice. Discontinuing a beta-blocker in an otherwise healthy woman with hypertension and no prior CV disease is not harmful and could be wise,” Dr. Bugiardini said. “Blood pressure in women may be regulated in a safer way, such as using other medications and, of course, through diet and exercise.”

Rationale for the study

Men and women “differ with respect to the risk, causes, and prognosis of HF,” Dr. Bugiardini and colleagues wrote, and current guidelines “do not differentiate between the use of beta-blockers in men and in women.”

However, they proposed, “because prior trials and meta-analyses enrolled nearly five men for every woman, any differences in the effect of beta-blockers among women would have been concealed by the effect of beta-blocker therapy among men.”

The current study looked at data from October 2010 to July 2018 in the ISACS ARCHIVES, ISACS-TC, and the EMMACE-3X registries, covering 13,764 patients from 12 European countries who had a history of hypertension and presented with confirmed ACS.

Of the combined cohort, 2,590 (19%) had been treated with beta-blockers prior to their ACS presentation. They were similar to those without a history of beta-blocker use with respect to baseline features and use of other medications in an adjusted analysis.

In the group with prior beta-blocker use, 21.3% of the women and 16.7% of the men had HF of Killip class 2 or higher, a 4.6% absolute difference that worked out to a relative risk of 1.35 (95% confidence interval, 1.10-1.65).

The corresponding rates for women and men without prior beta-blocker use were 17.2% and 16.1%, respectively, for an absolute difference of only 1.1% and an RR of1.09 (95% CI, 0.97-1.21).

The interaction between sex and beta-blocker therapy for the HF outcome was significant (P < .034). An analysis that excluded patients in cardiogenic shock at their ACS presentation produced similar results.

In an analysis only of patients with STEMI, the RR for HF in women versus men was 1.44 (95% CI, 1.12-1.84) among those with a history of beta-blocker use, and 1.11 (95% CI, 0.98-1.26) among those who hadn’t used the drugs. The interaction between sex and beta-blocker use was significant (P = .033).

No such significant interaction was seen for the subgroup with non-STEMI as their index ACS (P = .14).

Heart failure at ACS was the most powerful observed predictor of 30-day mortality in women and in men in multivariate analysis; the odds ratios were 7.54 (95% CI, 5.78-9.83) and 9.62 (95% CI, 7.67-12.07), respectively.

“Our study underscores the importance of sex analyses in clinical research studies, which may provide further actionable data,” Dr. Bugiardini stated. “Failure to include both sexes in therapeutic studies is a missed opportunity to uncover underlying sex-specific risks. The adverse effect of beta-blocker therapy in women with hypertension is a sex-specific risk.”

Not just a male disease

Part of the study’s conclusions are “really not that surprising, because we have known for a long time that women who have an MI are much more likely to develop HF than men, and we also know that HF raises mortality after MI,” Ileana L. Pina, MD, MPH, Wayne State University, Detroit, said in an interview.

But what surprised her was that women taking beta-blockers were at greater risk for HF. “This association needs to be proven in a prospective study and confirmed in another dataset,” said Dr. Pina, who was not involved with the current study. “The most important message is to remember that HF is not just a ‘male’ disease and to pay attention to the symptoms of women and not discount or relegate them to anxiety or gastric problems.”

The study was observational, Dr. Bugiardini noted, so “the results may have some variance and need confirmation. However, a sex-stratified, randomized, controlled trial of beta-blocker therapy in patients with hypertension but no prior history of coronary heart disease or HF may not be considered ethical, since it would be designed to confirm risk … and not benefit.”

“Further observational studies may give confirmation,” he added. “In the meantime, the Food and Drug Administration should alert health care professionals of the adverse events associated with beta-blocker use in women with hypertension and no prior history of CV disease, [because] prescribing beta-blockers to a woman with hypertension means exposing her to unnecessary risk.”

Dr. Bugiardini and the other authors had no disclosures. Dr. Pina reported no relevant financial relationships.

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

Beta-blockers taken for hypertension may predispose women to worse outcomes, compared with men, when they later present with acute coronary syndromes (ACS), a registry study suggests.

In the analysis of more than 13,000 patients with ACS and no history of cardiovascular (CV) disease, the women who had taken beta-blockers for hypertension showed about a one-third increased risk for heart failure (HF) at the time of their ACS presentation.

The difference between women and men was especially pronounced among patients with ST-segment elevation MI, compared with those with non-STEMI.

No such relationship between sex and risk for HF with ACS was observed among the larger portion of the cohort that had not previously been treated with beta-blockers, according to a report published July 13 in Hypertension, with lead author Raffaele Bugiardini, MD, University of Bologna (Italy).

Mortality at 30 days was sharply higher for patients with than without HF at their ACS presentation, by more than 600% for women and more than 800% for men.

“Our study provides robust evidence of an interaction between sex and beta-blocker therapy and suggests an increased risk of HF among women presenting with incident myocardial infarction,” Dr. Bugiardini said in an interview.

Given their novelty, “our findings raise strong concern about the appropriate role of beta-blockers in the therapy of hypertension in women with no prior history of cardiovascular diseases. Beta-blocker use may be an acute precipitant of heart failure in women presenting with incident ACS as first manifestation of coronary heart disease.” Dr. Bugiardini and colleagues wrote.

“There is one main implication for clinical practice. Discontinuing a beta-blocker in an otherwise healthy woman with hypertension and no prior CV disease is not harmful and could be wise,” Dr. Bugiardini said. “Blood pressure in women may be regulated in a safer way, such as using other medications and, of course, through diet and exercise.”

Rationale for the study

Men and women “differ with respect to the risk, causes, and prognosis of HF,” Dr. Bugiardini and colleagues wrote, and current guidelines “do not differentiate between the use of beta-blockers in men and in women.”

However, they proposed, “because prior trials and meta-analyses enrolled nearly five men for every woman, any differences in the effect of beta-blockers among women would have been concealed by the effect of beta-blocker therapy among men.”

The current study looked at data from October 2010 to July 2018 in the ISACS ARCHIVES, ISACS-TC, and the EMMACE-3X registries, covering 13,764 patients from 12 European countries who had a history of hypertension and presented with confirmed ACS.

Of the combined cohort, 2,590 (19%) had been treated with beta-blockers prior to their ACS presentation. They were similar to those without a history of beta-blocker use with respect to baseline features and use of other medications in an adjusted analysis.

In the group with prior beta-blocker use, 21.3% of the women and 16.7% of the men had HF of Killip class 2 or higher, a 4.6% absolute difference that worked out to a relative risk of 1.35 (95% confidence interval, 1.10-1.65).

The corresponding rates for women and men without prior beta-blocker use were 17.2% and 16.1%, respectively, for an absolute difference of only 1.1% and an RR of1.09 (95% CI, 0.97-1.21).

The interaction between sex and beta-blocker therapy for the HF outcome was significant (P < .034). An analysis that excluded patients in cardiogenic shock at their ACS presentation produced similar results.

In an analysis only of patients with STEMI, the RR for HF in women versus men was 1.44 (95% CI, 1.12-1.84) among those with a history of beta-blocker use, and 1.11 (95% CI, 0.98-1.26) among those who hadn’t used the drugs. The interaction between sex and beta-blocker use was significant (P = .033).

No such significant interaction was seen for the subgroup with non-STEMI as their index ACS (P = .14).

Heart failure at ACS was the most powerful observed predictor of 30-day mortality in women and in men in multivariate analysis; the odds ratios were 7.54 (95% CI, 5.78-9.83) and 9.62 (95% CI, 7.67-12.07), respectively.

“Our study underscores the importance of sex analyses in clinical research studies, which may provide further actionable data,” Dr. Bugiardini stated. “Failure to include both sexes in therapeutic studies is a missed opportunity to uncover underlying sex-specific risks. The adverse effect of beta-blocker therapy in women with hypertension is a sex-specific risk.”

Not just a male disease

Part of the study’s conclusions are “really not that surprising, because we have known for a long time that women who have an MI are much more likely to develop HF than men, and we also know that HF raises mortality after MI,” Ileana L. Pina, MD, MPH, Wayne State University, Detroit, said in an interview.

But what surprised her was that women taking beta-blockers were at greater risk for HF. “This association needs to be proven in a prospective study and confirmed in another dataset,” said Dr. Pina, who was not involved with the current study. “The most important message is to remember that HF is not just a ‘male’ disease and to pay attention to the symptoms of women and not discount or relegate them to anxiety or gastric problems.”

The study was observational, Dr. Bugiardini noted, so “the results may have some variance and need confirmation. However, a sex-stratified, randomized, controlled trial of beta-blocker therapy in patients with hypertension but no prior history of coronary heart disease or HF may not be considered ethical, since it would be designed to confirm risk … and not benefit.”

“Further observational studies may give confirmation,” he added. “In the meantime, the Food and Drug Administration should alert health care professionals of the adverse events associated with beta-blocker use in women with hypertension and no prior history of CV disease, [because] prescribing beta-blockers to a woman with hypertension means exposing her to unnecessary risk.”

Dr. Bugiardini and the other authors had no disclosures. Dr. Pina reported no relevant financial relationships.

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

People who use proton pump inhibitors (PPIs) may be more likely to get COVID-19, researchers say.

In light of this finding, physicians should consider which patients truly need these powerful acid-lowering drugs, said Brennan Spiegel, MD, MSHS, AGAF, professor of medicine and public health at Cedars Sinai Medical Center in Los Angeles, Calif.

“All it means is that we’re going to have a conversation with our patients,” he said in an interview. “We don’t normally have that conversation because we don’t live in an environment with a high risk of enteric infection. But now we’re in a pandemic.”

The study by Dr. Spiegel and his colleagues was published online on July 7 in the American Journal of Gastroenterology.

Use of PPIs has skyrocketed over the past 2 decades. For ambulatory care visits, their use increased from 1.6% in 1998 to 7.6% in 2015. The increase raised questions about overprescription.

Although studies have not borne out many of the other concerns raised about adverse reactions, they have shown that the drugs increase the risk for enteric infections, including infections by SARS-CoV-1, a virus that is related to the COVID-19 virus, SARS-CoV-2, Dr. Spiegel said.

SARS-CoV-2 uses the angiotensin-converting enzyme–2 receptor to invade enterocytes. Dr. Spiegel theorized that an increase in stomach pH above 3 as a result of use of PPIs might allow the virus to enter the GI tract more easily, leading to enteritis, colitis, and systemic spread to other organs, including the lungs. “There is a reason we have acid in our stomachs,” Dr. Spiegel said.

To see how PPI use relates to COVID-19 infections, Dr. Spiegel and his colleagues surveyed online a nationally representative sample of Americans between May 3 and June 24, 2020, as part of a larger survey on gastroenterologic health.

Participants answered questions about gastrointestinal symptoms, current use of PPIs, and COVID-19 test results. They also answered questions about histamine-2 receptor agonists (H₂RAs), also known as H₂ blockers, which are used to treat some of the same conditions as PPIs but that do not reduce stomach acid as much.

The surveying firm, Cint, contacted 264,058 people. Of the 86,602 eligible participants who completed the survey, 53,130 said they had experienced abdominal discomfort, acid reflux, heartburn, or regurgitation. These survey participants were subsequently asked about PPI and H₂RA use.

Of these, 6.4% reported testing positive for SARS-CoV-2. The researchers adjusted for age, sex, race/ethnicity, education, marital status, household income, body mass index, smoking, alcohol consumption, U.S. region, insurance status, and the presence of irritable bowel syndrome, celiac disease, gastroesophageal reflux disease, liver cirrhosis, Crohn’s disease, ulcerative colitis, diabetes, and HIV/AIDS.

After adjusting for these factors, the researchers found that those who took PPIs up to once a day were twice as likely to have had a positive COVID-19 test result than those who did not take the drugs (odds ratio, 2.15; 95% confidence interval, 1.90-2.44).

Those who took PPIs twice a day were almost four times as likely to have tested positive for the disease (OR, 3.67; 95% CI, 2.93-4.60).

By contrast, those taking H₂RA drugs once daily were 15% less likely to report a positive COVID-19 test result (OR, 0.85; 95% CI, 0.74-0.99). Research is currently underway to determine whether H₂RAs might protect against the disease for reasons unrelated to pH balance.

Dr. Spiegel cautioned that the current data show only an association between PPI use and COVID-19 positivity; it cannot prove cause and effect.

Nevertheless, Dr. Spiegel said the findings should encourage physicians to prescribe PPIs only when clearly indicated. “If somebody is not yet on a PPI and you’re considering whether to start them on a PPI, it’s a good idea to consider H₂ blockers,” he said.

People who need a daily dose of a PPI to control a severe condition can safely continue doing so, but such patients should take care to follow standard public health recommendations for avoiding exposure to the virus. These recommendations include wearing a mask, maintaining social distance, and washing hands frequently.

“People who are older, comorbid, or smokers – if they get infected, it could be severe,” he said. “[For] someone like that, it’s reasonable to ask, do we really need to be on twice-daily PPIs? There is good evidence that they are no better off than if they are taking once-daily doses.”

Brian Lacy, MD, PhD, a professor of medicine at the Mayo Clinic in Jacksonville, Fla., agreed that the study should prompt physicians to take a second look at their patients’ PPI prescriptions. “My view is that PPIs are frequently overused, and maybe this is one more piece of data that, if someone is on PPIs, maybe they don’t need to be on this medication.”

On the other hand, the drugs are important for treating conditions such as erosive esophagitis and healing ulcers, he said. The overall risk of contracting COVID-19 is low, so even this finding of a 3.7-fold increased risk should not lead patients or providers to stop taking or prescribing PPIs.

The study also lends support to the idea that the gastrointestinal tract could be involved in SARS-CoV-2 transmission, and it supports warnings about aerosols emitted from flushing toilets and through exhalation, Dr. Spiegel said. There is less evidence of the virus being transmitted through food. “It may not be fecal-oral; it may be fecal-respiratory,” he said.

The study was part of a larger project funded by Ironwood Pharmaceuticals. Dr. Spiegel reported relationships with Alnylam Pharmaceuticals, Arena Pharmaceuticals, Ironwood Pharmaceuticals, Salix Pharmaceuticals, Shire Pharmaceuticals, Synergy Pharmaceuticals, and Takeda Pharmaceuticals. Dr. Lacy has disclosed no relevant financial relationships.

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

People who use proton pump inhibitors (PPIs) may be more likely to get COVID-19, researchers say.

In light of this finding, physicians should consider which patients truly need these powerful acid-lowering drugs, said Brennan Spiegel, MD, MSHS, AGAF, professor of medicine and public health at Cedars Sinai Medical Center in Los Angeles, Calif.

“All it means is that we’re going to have a conversation with our patients,” he said in an interview. “We don’t normally have that conversation because we don’t live in an environment with a high risk of enteric infection. But now we’re in a pandemic.”

The study by Dr. Spiegel and his colleagues was published online on July 7 in the American Journal of Gastroenterology.

Use of PPIs has skyrocketed over the past 2 decades. For ambulatory care visits, their use increased from 1.6% in 1998 to 7.6% in 2015. The increase raised questions about overprescription.

Although studies have not borne out many of the other concerns raised about adverse reactions, they have shown that the drugs increase the risk for enteric infections, including infections by SARS-CoV-1, a virus that is related to the COVID-19 virus, SARS-CoV-2, Dr. Spiegel said.

SARS-CoV-2 uses the angiotensin-converting enzyme–2 receptor to invade enterocytes. Dr. Spiegel theorized that an increase in stomach pH above 3 as a result of use of PPIs might allow the virus to enter the GI tract more easily, leading to enteritis, colitis, and systemic spread to other organs, including the lungs. “There is a reason we have acid in our stomachs,” Dr. Spiegel said.

To see how PPI use relates to COVID-19 infections, Dr. Spiegel and his colleagues surveyed online a nationally representative sample of Americans between May 3 and June 24, 2020, as part of a larger survey on gastroenterologic health.

Participants answered questions about gastrointestinal symptoms, current use of PPIs, and COVID-19 test results. They also answered questions about histamine-2 receptor agonists (H₂RAs), also known as H₂ blockers, which are used to treat some of the same conditions as PPIs but that do not reduce stomach acid as much.

The surveying firm, Cint, contacted 264,058 people. Of the 86,602 eligible participants who completed the survey, 53,130 said they had experienced abdominal discomfort, acid reflux, heartburn, or regurgitation. These survey participants were subsequently asked about PPI and H₂RA use.

Of these, 6.4% reported testing positive for SARS-CoV-2. The researchers adjusted for age, sex, race/ethnicity, education, marital status, household income, body mass index, smoking, alcohol consumption, U.S. region, insurance status, and the presence of irritable bowel syndrome, celiac disease, gastroesophageal reflux disease, liver cirrhosis, Crohn’s disease, ulcerative colitis, diabetes, and HIV/AIDS.

After adjusting for these factors, the researchers found that those who took PPIs up to once a day were twice as likely to have had a positive COVID-19 test result than those who did not take the drugs (odds ratio, 2.15; 95% confidence interval, 1.90-2.44).

Those who took PPIs twice a day were almost four times as likely to have tested positive for the disease (OR, 3.67; 95% CI, 2.93-4.60).

By contrast, those taking H₂RA drugs once daily were 15% less likely to report a positive COVID-19 test result (OR, 0.85; 95% CI, 0.74-0.99). Research is currently underway to determine whether H₂RAs might protect against the disease for reasons unrelated to pH balance.

Dr. Spiegel cautioned that the current data show only an association between PPI use and COVID-19 positivity; it cannot prove cause and effect.

Nevertheless, Dr. Spiegel said the findings should encourage physicians to prescribe PPIs only when clearly indicated. “If somebody is not yet on a PPI and you’re considering whether to start them on a PPI, it’s a good idea to consider H₂ blockers,” he said.

People who need a daily dose of a PPI to control a severe condition can safely continue doing so, but such patients should take care to follow standard public health recommendations for avoiding exposure to the virus. These recommendations include wearing a mask, maintaining social distance, and washing hands frequently.

“People who are older, comorbid, or smokers – if they get infected, it could be severe,” he said. “[For] someone like that, it’s reasonable to ask, do we really need to be on twice-daily PPIs? There is good evidence that they are no better off than if they are taking once-daily doses.”

Brian Lacy, MD, PhD, a professor of medicine at the Mayo Clinic in Jacksonville, Fla., agreed that the study should prompt physicians to take a second look at their patients’ PPI prescriptions. “My view is that PPIs are frequently overused, and maybe this is one more piece of data that, if someone is on PPIs, maybe they don’t need to be on this medication.”

On the other hand, the drugs are important for treating conditions such as erosive esophagitis and healing ulcers, he said. The overall risk of contracting COVID-19 is low, so even this finding of a 3.7-fold increased risk should not lead patients or providers to stop taking or prescribing PPIs.

The study also lends support to the idea that the gastrointestinal tract could be involved in SARS-CoV-2 transmission, and it supports warnings about aerosols emitted from flushing toilets and through exhalation, Dr. Spiegel said. There is less evidence of the virus being transmitted through food. “It may not be fecal-oral; it may be fecal-respiratory,” he said.

The study was part of a larger project funded by Ironwood Pharmaceuticals. Dr. Spiegel reported relationships with Alnylam Pharmaceuticals, Arena Pharmaceuticals, Ironwood Pharmaceuticals, Salix Pharmaceuticals, Shire Pharmaceuticals, Synergy Pharmaceuticals, and Takeda Pharmaceuticals. Dr. Lacy has disclosed no relevant financial relationships.

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

People who use proton pump inhibitors (PPIs) may be more likely to get COVID-19, researchers say.

In light of this finding, physicians should consider which patients truly need these powerful acid-lowering drugs, said Brennan Spiegel, MD, MSHS, AGAF, professor of medicine and public health at Cedars Sinai Medical Center in Los Angeles, Calif.

“All it means is that we’re going to have a conversation with our patients,” he said in an interview. “We don’t normally have that conversation because we don’t live in an environment with a high risk of enteric infection. But now we’re in a pandemic.”

The study by Dr. Spiegel and his colleagues was published online on July 7 in the American Journal of Gastroenterology.

Use of PPIs has skyrocketed over the past 2 decades. For ambulatory care visits, their use increased from 1.6% in 1998 to 7.6% in 2015. The increase raised questions about overprescription.

Although studies have not borne out many of the other concerns raised about adverse reactions, they have shown that the drugs increase the risk for enteric infections, including infections by SARS-CoV-1, a virus that is related to the COVID-19 virus, SARS-CoV-2, Dr. Spiegel said.

SARS-CoV-2 uses the angiotensin-converting enzyme–2 receptor to invade enterocytes. Dr. Spiegel theorized that an increase in stomach pH above 3 as a result of use of PPIs might allow the virus to enter the GI tract more easily, leading to enteritis, colitis, and systemic spread to other organs, including the lungs. “There is a reason we have acid in our stomachs,” Dr. Spiegel said.

To see how PPI use relates to COVID-19 infections, Dr. Spiegel and his colleagues surveyed online a nationally representative sample of Americans between May 3 and June 24, 2020, as part of a larger survey on gastroenterologic health.

Participants answered questions about gastrointestinal symptoms, current use of PPIs, and COVID-19 test results. They also answered questions about histamine-2 receptor agonists (H₂RAs), also known as H₂ blockers, which are used to treat some of the same conditions as PPIs but that do not reduce stomach acid as much.

The surveying firm, Cint, contacted 264,058 people. Of the 86,602 eligible participants who completed the survey, 53,130 said they had experienced abdominal discomfort, acid reflux, heartburn, or regurgitation. These survey participants were subsequently asked about PPI and H₂RA use.

Of these, 6.4% reported testing positive for SARS-CoV-2. The researchers adjusted for age, sex, race/ethnicity, education, marital status, household income, body mass index, smoking, alcohol consumption, U.S. region, insurance status, and the presence of irritable bowel syndrome, celiac disease, gastroesophageal reflux disease, liver cirrhosis, Crohn’s disease, ulcerative colitis, diabetes, and HIV/AIDS.

After adjusting for these factors, the researchers found that those who took PPIs up to once a day were twice as likely to have had a positive COVID-19 test result than those who did not take the drugs (odds ratio, 2.15; 95% confidence interval, 1.90-2.44).

Those who took PPIs twice a day were almost four times as likely to have tested positive for the disease (OR, 3.67; 95% CI, 2.93-4.60).

By contrast, those taking H₂RA drugs once daily were 15% less likely to report a positive COVID-19 test result (OR, 0.85; 95% CI, 0.74-0.99). Research is currently underway to determine whether H₂RAs might protect against the disease for reasons unrelated to pH balance.

Dr. Spiegel cautioned that the current data show only an association between PPI use and COVID-19 positivity; it cannot prove cause and effect.

Nevertheless, Dr. Spiegel said the findings should encourage physicians to prescribe PPIs only when clearly indicated. “If somebody is not yet on a PPI and you’re considering whether to start them on a PPI, it’s a good idea to consider H₂ blockers,” he said.

People who need a daily dose of a PPI to control a severe condition can safely continue doing so, but such patients should take care to follow standard public health recommendations for avoiding exposure to the virus. These recommendations include wearing a mask, maintaining social distance, and washing hands frequently.

“People who are older, comorbid, or smokers – if they get infected, it could be severe,” he said. “[For] someone like that, it’s reasonable to ask, do we really need to be on twice-daily PPIs? There is good evidence that they are no better off than if they are taking once-daily doses.”

Brian Lacy, MD, PhD, a professor of medicine at the Mayo Clinic in Jacksonville, Fla., agreed that the study should prompt physicians to take a second look at their patients’ PPI prescriptions. “My view is that PPIs are frequently overused, and maybe this is one more piece of data that, if someone is on PPIs, maybe they don’t need to be on this medication.”

On the other hand, the drugs are important for treating conditions such as erosive esophagitis and healing ulcers, he said. The overall risk of contracting COVID-19 is low, so even this finding of a 3.7-fold increased risk should not lead patients or providers to stop taking or prescribing PPIs.

The study also lends support to the idea that the gastrointestinal tract could be involved in SARS-CoV-2 transmission, and it supports warnings about aerosols emitted from flushing toilets and through exhalation, Dr. Spiegel said. There is less evidence of the virus being transmitted through food. “It may not be fecal-oral; it may be fecal-respiratory,” he said.

The study was part of a larger project funded by Ironwood Pharmaceuticals. Dr. Spiegel reported relationships with Alnylam Pharmaceuticals, Arena Pharmaceuticals, Ironwood Pharmaceuticals, Salix Pharmaceuticals, Shire Pharmaceuticals, Synergy Pharmaceuticals, and Takeda Pharmaceuticals. Dr. Lacy has disclosed no relevant financial relationships.

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

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.

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