Diana Swift

After acute SARS-CoV-2 infection, patients report lingering malnutrition, loss of appetite, and failure to regain lost weight long after other gastrointestinal and non-GI symptoms have resolved, according to the results of a new study.

In the large, multicenter retrospective study published online in Clinical Gastroenterology and Hepatology, Anam Rizvi, MD, and colleagues at Long Island Jewish Medical Center, in New Hyde Park (N.Y.), report a high prevalence of GI symptoms among patients with COVID-19.

They followed 17,462 adult patients who were hospitalized for severe COVID-19 between March 2020 and January 2021. Of these, 3,229 (18.5%) also had GI symptoms.

The median age of the patients was 66 years, and 46.9% were women. The diverse population included White (46%), Black (23%), and Hispanic (17%) patients admitted to 12 medical centers of the Northwell Health System in Manhattan, Queens, Long Island, and Staten Island. The researchers followed patients for 3 months (88.7%) and 6 months (56.5%).

The most frequent initial GI symptoms were gastroenteritis (52.5%), malnutrition (23%), GI bleeding (20.4%), and idiopathic pancreatitis (0.5%). Notably, 50.6% of those with GI manifestations reported an inability to regain lost weight at 3 months; 32.4% reported failure to regain lost weight at 6 months.

These percentages rose among patients with malnutrition, as determined by a board-certified in-hospital nutritionist; 56.4% failed to gain weight at 6 months. A median 14.7-lb weight loss persisted at the half-year mark.

In contrast to these lingering symptoms, gastroenteritis, GI bleeding, and pancreatitis all resolved by 3 months post hospitalization.

“We were somewhat shocked that the prevalence of these symptoms was so high, but it’s overall reassuring that most GI symptoms of COVID-19 resolve,” study author Arvind J. Trindade, MD, told this news organization. “In some COVID patients, we’re seeing an inability to gain weight without diarrhea or postinfectious irritable bowel syndrome.

“Patients with an inability to regain weight should consider follow-up with a nutritionist,” continued Dr. Trindade, who is the center’s director of endoscopy and an associate professor at the Feinstein Institutes for Medical Research, in Manhasset (N.Y.). His group also recommends developing malnutrition screening assessments for COVID-19 patients who recover from the acute infection.

The study was prompted by clinical observations during follow-up.

“We saw that a lot of these patients had trouble regaining weight, but we still don’t know why,” Dr. Trindade said. There were no discriminating clinical features apart from malnutrition that indicated an increased risk, and no socioeconomic or demographic characteristics. “We also looked at whether any factors predicted malnutrition, and there weren’t any that would predispose to malnutrition,” he added.

“We’re now reaching out to nonclinical investigators to see if there’s an interest in studying the underlying science behind these symptoms,” Dr. Trindade said.

His group plans to release 12-month follow-up data from the second wave of the pandemic in January 2022.

Initial GI symptoms are thought to be due to the virus’s S1 spike protein’s binding to the angiotensin-converting enzyme 2 receptors, which are abundant in GI epithelial cells. “But why patients have long-term GI sequelae is probably a whole different physiological mechanism,” Dr. Trindade said. “The thought is that there has to be some hormone or pathway that doesn’t allow them to regain weight.”

“The hospital cohort by [Dr. Rizvi] and colleagues is unique and helpful in that patients with GI symptoms are less likely to be hospitalized, and perhaps those patients who are sick enough for admission to the hospital who also have GI symptoms need specific attention paid to their appetite, weight, and nutritional status,” said Jordan M. Shapiro, MD, who commented on the study but was not involved in it.

The constellations of GI symptoms are difficult to distinguish from other postinfectious GI syndromes, such as irritable bowel syndrome and gastroparesis, added Dr. Shapiro, an assistant professor of medicine in gastroenterology and hepatology at Baylor College of Medicine, Houston. “We’re still unpacking what is and is not specific to post–COVID-19 GI symptoms. Prospective studies are necessary to further study this phenomenon.”

Last year, a small Italian study documented significant weight loss and malnutrition in a hospital cohort of 213 discharged COVID-19 patients. In that study, the duration of disease was predictive of weight loss.

The authors note several study limitations, including that the cohort was limited to hospitalized patients from New York and that the 6-month follow-up period was short.

The study received no funding. Dr. Trindade serves as a consultant to Pentax Medical. All other authors and Dr. Shapiro have disclosed no relevant financial relationships.

For the latest clinical guidance, education, research and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID.

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

After acute SARS-CoV-2 infection, patients report lingering malnutrition, loss of appetite, and failure to regain lost weight long after other gastrointestinal and non-GI symptoms have resolved, according to the results of a new study.

In the large, multicenter retrospective study published online in Clinical Gastroenterology and Hepatology, Anam Rizvi, MD, and colleagues at Long Island Jewish Medical Center, in New Hyde Park (N.Y.), report a high prevalence of GI symptoms among patients with COVID-19.

They followed 17,462 adult patients who were hospitalized for severe COVID-19 between March 2020 and January 2021. Of these, 3,229 (18.5%) also had GI symptoms.

The median age of the patients was 66 years, and 46.9% were women. The diverse population included White (46%), Black (23%), and Hispanic (17%) patients admitted to 12 medical centers of the Northwell Health System in Manhattan, Queens, Long Island, and Staten Island. The researchers followed patients for 3 months (88.7%) and 6 months (56.5%).

The most frequent initial GI symptoms were gastroenteritis (52.5%), malnutrition (23%), GI bleeding (20.4%), and idiopathic pancreatitis (0.5%). Notably, 50.6% of those with GI manifestations reported an inability to regain lost weight at 3 months; 32.4% reported failure to regain lost weight at 6 months.

These percentages rose among patients with malnutrition, as determined by a board-certified in-hospital nutritionist; 56.4% failed to gain weight at 6 months. A median 14.7-lb weight loss persisted at the half-year mark.

In contrast to these lingering symptoms, gastroenteritis, GI bleeding, and pancreatitis all resolved by 3 months post hospitalization.

“We were somewhat shocked that the prevalence of these symptoms was so high, but it’s overall reassuring that most GI symptoms of COVID-19 resolve,” study author Arvind J. Trindade, MD, told this news organization. “In some COVID patients, we’re seeing an inability to gain weight without diarrhea or postinfectious irritable bowel syndrome.

“Patients with an inability to regain weight should consider follow-up with a nutritionist,” continued Dr. Trindade, who is the center’s director of endoscopy and an associate professor at the Feinstein Institutes for Medical Research, in Manhasset (N.Y.). His group also recommends developing malnutrition screening assessments for COVID-19 patients who recover from the acute infection.

The study was prompted by clinical observations during follow-up.

“We saw that a lot of these patients had trouble regaining weight, but we still don’t know why,” Dr. Trindade said. There were no discriminating clinical features apart from malnutrition that indicated an increased risk, and no socioeconomic or demographic characteristics. “We also looked at whether any factors predicted malnutrition, and there weren’t any that would predispose to malnutrition,” he added.

“We’re now reaching out to nonclinical investigators to see if there’s an interest in studying the underlying science behind these symptoms,” Dr. Trindade said.

His group plans to release 12-month follow-up data from the second wave of the pandemic in January 2022.

Initial GI symptoms are thought to be due to the virus’s S1 spike protein’s binding to the angiotensin-converting enzyme 2 receptors, which are abundant in GI epithelial cells. “But why patients have long-term GI sequelae is probably a whole different physiological mechanism,” Dr. Trindade said. “The thought is that there has to be some hormone or pathway that doesn’t allow them to regain weight.”

“The hospital cohort by [Dr. Rizvi] and colleagues is unique and helpful in that patients with GI symptoms are less likely to be hospitalized, and perhaps those patients who are sick enough for admission to the hospital who also have GI symptoms need specific attention paid to their appetite, weight, and nutritional status,” said Jordan M. Shapiro, MD, who commented on the study but was not involved in it.

The constellations of GI symptoms are difficult to distinguish from other postinfectious GI syndromes, such as irritable bowel syndrome and gastroparesis, added Dr. Shapiro, an assistant professor of medicine in gastroenterology and hepatology at Baylor College of Medicine, Houston. “We’re still unpacking what is and is not specific to post–COVID-19 GI symptoms. Prospective studies are necessary to further study this phenomenon.”

Last year, a small Italian study documented significant weight loss and malnutrition in a hospital cohort of 213 discharged COVID-19 patients. In that study, the duration of disease was predictive of weight loss.

The authors note several study limitations, including that the cohort was limited to hospitalized patients from New York and that the 6-month follow-up period was short.

The study received no funding. Dr. Trindade serves as a consultant to Pentax Medical. All other authors and Dr. Shapiro have disclosed no relevant financial relationships.

For the latest clinical guidance, education, research and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID.

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

After acute SARS-CoV-2 infection, patients report lingering malnutrition, loss of appetite, and failure to regain lost weight long after other gastrointestinal and non-GI symptoms have resolved, according to the results of a new study.

In the large, multicenter retrospective study published online in Clinical Gastroenterology and Hepatology, Anam Rizvi, MD, and colleagues at Long Island Jewish Medical Center, in New Hyde Park (N.Y.), report a high prevalence of GI symptoms among patients with COVID-19.

They followed 17,462 adult patients who were hospitalized for severe COVID-19 between March 2020 and January 2021. Of these, 3,229 (18.5%) also had GI symptoms.

The median age of the patients was 66 years, and 46.9% were women. The diverse population included White (46%), Black (23%), and Hispanic (17%) patients admitted to 12 medical centers of the Northwell Health System in Manhattan, Queens, Long Island, and Staten Island. The researchers followed patients for 3 months (88.7%) and 6 months (56.5%).

The most frequent initial GI symptoms were gastroenteritis (52.5%), malnutrition (23%), GI bleeding (20.4%), and idiopathic pancreatitis (0.5%). Notably, 50.6% of those with GI manifestations reported an inability to regain lost weight at 3 months; 32.4% reported failure to regain lost weight at 6 months.

These percentages rose among patients with malnutrition, as determined by a board-certified in-hospital nutritionist; 56.4% failed to gain weight at 6 months. A median 14.7-lb weight loss persisted at the half-year mark.

In contrast to these lingering symptoms, gastroenteritis, GI bleeding, and pancreatitis all resolved by 3 months post hospitalization.

“We were somewhat shocked that the prevalence of these symptoms was so high, but it’s overall reassuring that most GI symptoms of COVID-19 resolve,” study author Arvind J. Trindade, MD, told this news organization. “In some COVID patients, we’re seeing an inability to gain weight without diarrhea or postinfectious irritable bowel syndrome.

“Patients with an inability to regain weight should consider follow-up with a nutritionist,” continued Dr. Trindade, who is the center’s director of endoscopy and an associate professor at the Feinstein Institutes for Medical Research, in Manhasset (N.Y.). His group also recommends developing malnutrition screening assessments for COVID-19 patients who recover from the acute infection.

The study was prompted by clinical observations during follow-up.

“We saw that a lot of these patients had trouble regaining weight, but we still don’t know why,” Dr. Trindade said. There were no discriminating clinical features apart from malnutrition that indicated an increased risk, and no socioeconomic or demographic characteristics. “We also looked at whether any factors predicted malnutrition, and there weren’t any that would predispose to malnutrition,” he added.

“We’re now reaching out to nonclinical investigators to see if there’s an interest in studying the underlying science behind these symptoms,” Dr. Trindade said.

His group plans to release 12-month follow-up data from the second wave of the pandemic in January 2022.

Initial GI symptoms are thought to be due to the virus’s S1 spike protein’s binding to the angiotensin-converting enzyme 2 receptors, which are abundant in GI epithelial cells. “But why patients have long-term GI sequelae is probably a whole different physiological mechanism,” Dr. Trindade said. “The thought is that there has to be some hormone or pathway that doesn’t allow them to regain weight.”

“The hospital cohort by [Dr. Rizvi] and colleagues is unique and helpful in that patients with GI symptoms are less likely to be hospitalized, and perhaps those patients who are sick enough for admission to the hospital who also have GI symptoms need specific attention paid to their appetite, weight, and nutritional status,” said Jordan M. Shapiro, MD, who commented on the study but was not involved in it.

The constellations of GI symptoms are difficult to distinguish from other postinfectious GI syndromes, such as irritable bowel syndrome and gastroparesis, added Dr. Shapiro, an assistant professor of medicine in gastroenterology and hepatology at Baylor College of Medicine, Houston. “We’re still unpacking what is and is not specific to post–COVID-19 GI symptoms. Prospective studies are necessary to further study this phenomenon.”

Last year, a small Italian study documented significant weight loss and malnutrition in a hospital cohort of 213 discharged COVID-19 patients. In that study, the duration of disease was predictive of weight loss.

The authors note several study limitations, including that the cohort was limited to hospitalized patients from New York and that the 6-month follow-up period was short.

The study received no funding. Dr. Trindade serves as a consultant to Pentax Medical. All other authors and Dr. Shapiro have disclosed no relevant financial relationships.

For the latest clinical guidance, education, research and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID.

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

Sickle cell disease (SCD) was associated with a greater than fourfold excess risk for COVID-19–related hospitalization and a greater than twofold risk for COVID-19–related death, according to a big-data analysis from the United Kingdom.

SCD was associated with an adjusted hazard ratio (HR) of 4.11 (95% confidence interval, 2.98-5.66) for admission to hospital and an HR of 2.55 (95% CI, 1.36-4.75) for death, report Ashley K. Clift, MBBS, a clinical research fellow at the University of Oxford, and colleagues. The results were published online July 20 in Annals of Internal Medicine.

Even those who carry just one copy of the sickle cell gene – the carrier status for sickle cell disease – appeared to be at heightened risk for these outcomes (HR for hospitalization, 1.38; 95% CI, 1.12-1.70; HR for death, 1.51; 95% CI, 1.13-2.00).

“Given the well-known ethnic patterning of sickle cell disorders, the predisposition they pose to other infections, and early evidence from smaller registries, we thought this would be an important analysis to run at the population level,” Dr. Clift said in an interview.

“Our data suggest that people living with sickle cell disorders are a group at higher risk from this infection, and this is important from a public health perspective in terms of vaccination strategies and advice on nonpharmacological interventions,” he said.

“The best course of action for managing risk in this group is vaccination,” said Enrico M. Novelli, MD, director of the adult sickle cell program at the University of Pittsburgh Medical Center. Dr. Novelli, who is also section chief of benign hematology in the university’s School of Medicine, was not involved in the study. “To date, there are no specific studies of the effect of COVID-19 vaccination in patients with SCD, but there is no reason to believe it would be less effective or more risky in this patient population,” he said.

In addition, common-sense measures, such as masking and physical distancing, particularly at large, indoor gatherings, should be encouraged, Dr. Novelli added. Keeping SCD under good control with available treatments is also important. “Any patient with SCD who contracts COVID-19 should undergo close, outpatient monitoring with pulse oxygen measurements. If sick, they should be hospitalized in a center familiar with the care of SCD patients.”

The U.K. results are in line with and expand on earlier evidence from specialist centers and registries, but the association with sickle cell trait has been unclear and is notable in these findings, Dr. Clift said.

“The finding of the association with sickle cell trait is somewhat unexpected,” pediatric hematologist/oncologist Rabi Hanna, MD, director of pediatric bone marrow transplantation at Cleveland Clinic Children’s, told this news organization. “But I would question the accuracy of the numbers, since not all people with the trait realize they have it. In other respects, the study confirms earlier hypotheses and data from single-center studies.” Dr. Hanna did not participate in the U.K. study.
 

Study details

The SCD cohort consisted of 5,059 persons with SCD and 25,682 carriers, those with just one copy of the trait. Data were drawn from the United Kingdom’s large primary-care QResearch database. Follow-up for hospitalizations was conducted from Jan. 24, 2020 to Sept. 30, 2020; follow-up for deaths was conducted from Jan. 24, 2020 to Jan. 18, 2021. Among adults with SCD, there were 40 hospitalizations and 10 deaths. Among those with sickle cell trait, there were 98 hospitalizations and 50 deaths. No children died, and only a few (<5) required hospitalization.

Previous registry research showed similarly elevated risks for severe disease and fatality among patients with SCD who were infected with SARS-CoV-2.

Because SCD affects 8 to 12 million people globally – 100,000 in the United States – the authors say their results are important for policymakers and for prioritizing vaccination. They also note that trait carriers may be underdiagnosed.

“While SCD is part of newborn screening, there may be undiagnosed older people with the trait in the general population, but it’s difficult to quantify how much this is undiagnosed,” Dr. Clift said. “But now we have these results, it’s not that surprising that sickle cell trait is also associated with increased risk, albeit to a lower extent. This could suggest an almost dose-like effect of the sickle mutations on COVID hospitalization risk.”

Neonatal screening for the most common form of SCD is currently mandatory in the United States, but the Centers for Disease Control and Prevention has no clear data on how many people are aware they are carriers, Dr. Hanna said. “The states didn’t all begin screening at the same time – some started in the 1990s, others started in the 2000s – so many young adults may be unaware they have the trait,” he said.

Dr. Clift said the multiorgan complications of SCD, such as cardiac and immune problems, may be contributing to the heightened risk in individuals infected with SARS-CoV-2. “For example, we know that people with sickle cell disease are more susceptible to other viral infections. There is also some pathophysiological overlap between SCD disease and severe COVID, such as clotting dysfunction, so that may be worth further exploration,” he said.

The overlapping clotting problems associated with both COVID-19 and SCD could increase the risk for severe venous thromboembolism. In addition, experts noted that patients with SCD often have pre-COVID endothelial damage and baseline inflammation and are very sensitive to hypoxia; as well, a sizable proportion have lung disease.

The message to patients and physicians counseling patients is twofold, said Dr. Hanna: “SCD patients are at higher risk of COVID complications, and these are preventable with vaccination.”

The study was supported by the UK Medical Research Council. Dr. Clift is supported by Cancer Research UK. Coauthor Dr. Hippisley-Cox has received fees from ClinRisk and nonfinancial support from QResearch outside of the submitted work. Dr. Hanna has disclosed no relevant financial relationships. Dr. Novelli is a consultant for Novartis.

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

Sickle cell disease (SCD) was associated with a greater than fourfold excess risk for COVID-19–related hospitalization and a greater than twofold risk for COVID-19–related death, according to a big-data analysis from the United Kingdom.

SCD was associated with an adjusted hazard ratio (HR) of 4.11 (95% confidence interval, 2.98-5.66) for admission to hospital and an HR of 2.55 (95% CI, 1.36-4.75) for death, report Ashley K. Clift, MBBS, a clinical research fellow at the University of Oxford, and colleagues. The results were published online July 20 in Annals of Internal Medicine.

Even those who carry just one copy of the sickle cell gene – the carrier status for sickle cell disease – appeared to be at heightened risk for these outcomes (HR for hospitalization, 1.38; 95% CI, 1.12-1.70; HR for death, 1.51; 95% CI, 1.13-2.00).

“Given the well-known ethnic patterning of sickle cell disorders, the predisposition they pose to other infections, and early evidence from smaller registries, we thought this would be an important analysis to run at the population level,” Dr. Clift said in an interview.

“Our data suggest that people living with sickle cell disorders are a group at higher risk from this infection, and this is important from a public health perspective in terms of vaccination strategies and advice on nonpharmacological interventions,” he said.

“The best course of action for managing risk in this group is vaccination,” said Enrico M. Novelli, MD, director of the adult sickle cell program at the University of Pittsburgh Medical Center. Dr. Novelli, who is also section chief of benign hematology in the university’s School of Medicine, was not involved in the study. “To date, there are no specific studies of the effect of COVID-19 vaccination in patients with SCD, but there is no reason to believe it would be less effective or more risky in this patient population,” he said.

In addition, common-sense measures, such as masking and physical distancing, particularly at large, indoor gatherings, should be encouraged, Dr. Novelli added. Keeping SCD under good control with available treatments is also important. “Any patient with SCD who contracts COVID-19 should undergo close, outpatient monitoring with pulse oxygen measurements. If sick, they should be hospitalized in a center familiar with the care of SCD patients.”

The U.K. results are in line with and expand on earlier evidence from specialist centers and registries, but the association with sickle cell trait has been unclear and is notable in these findings, Dr. Clift said.

“The finding of the association with sickle cell trait is somewhat unexpected,” pediatric hematologist/oncologist Rabi Hanna, MD, director of pediatric bone marrow transplantation at Cleveland Clinic Children’s, told this news organization. “But I would question the accuracy of the numbers, since not all people with the trait realize they have it. In other respects, the study confirms earlier hypotheses and data from single-center studies.” Dr. Hanna did not participate in the U.K. study.
 

Study details

The SCD cohort consisted of 5,059 persons with SCD and 25,682 carriers, those with just one copy of the trait. Data were drawn from the United Kingdom’s large primary-care QResearch database. Follow-up for hospitalizations was conducted from Jan. 24, 2020 to Sept. 30, 2020; follow-up for deaths was conducted from Jan. 24, 2020 to Jan. 18, 2021. Among adults with SCD, there were 40 hospitalizations and 10 deaths. Among those with sickle cell trait, there were 98 hospitalizations and 50 deaths. No children died, and only a few (<5) required hospitalization.

Previous registry research showed similarly elevated risks for severe disease and fatality among patients with SCD who were infected with SARS-CoV-2.

Because SCD affects 8 to 12 million people globally – 100,000 in the United States – the authors say their results are important for policymakers and for prioritizing vaccination. They also note that trait carriers may be underdiagnosed.

“While SCD is part of newborn screening, there may be undiagnosed older people with the trait in the general population, but it’s difficult to quantify how much this is undiagnosed,” Dr. Clift said. “But now we have these results, it’s not that surprising that sickle cell trait is also associated with increased risk, albeit to a lower extent. This could suggest an almost dose-like effect of the sickle mutations on COVID hospitalization risk.”

Neonatal screening for the most common form of SCD is currently mandatory in the United States, but the Centers for Disease Control and Prevention has no clear data on how many people are aware they are carriers, Dr. Hanna said. “The states didn’t all begin screening at the same time – some started in the 1990s, others started in the 2000s – so many young adults may be unaware they have the trait,” he said.

Dr. Clift said the multiorgan complications of SCD, such as cardiac and immune problems, may be contributing to the heightened risk in individuals infected with SARS-CoV-2. “For example, we know that people with sickle cell disease are more susceptible to other viral infections. There is also some pathophysiological overlap between SCD disease and severe COVID, such as clotting dysfunction, so that may be worth further exploration,” he said.

The overlapping clotting problems associated with both COVID-19 and SCD could increase the risk for severe venous thromboembolism. In addition, experts noted that patients with SCD often have pre-COVID endothelial damage and baseline inflammation and are very sensitive to hypoxia; as well, a sizable proportion have lung disease.

The message to patients and physicians counseling patients is twofold, said Dr. Hanna: “SCD patients are at higher risk of COVID complications, and these are preventable with vaccination.”

The study was supported by the UK Medical Research Council. Dr. Clift is supported by Cancer Research UK. Coauthor Dr. Hippisley-Cox has received fees from ClinRisk and nonfinancial support from QResearch outside of the submitted work. Dr. Hanna has disclosed no relevant financial relationships. Dr. Novelli is a consultant for Novartis.

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

Sickle cell disease (SCD) was associated with a greater than fourfold excess risk for COVID-19–related hospitalization and a greater than twofold risk for COVID-19–related death, according to a big-data analysis from the United Kingdom.

SCD was associated with an adjusted hazard ratio (HR) of 4.11 (95% confidence interval, 2.98-5.66) for admission to hospital and an HR of 2.55 (95% CI, 1.36-4.75) for death, report Ashley K. Clift, MBBS, a clinical research fellow at the University of Oxford, and colleagues. The results were published online July 20 in Annals of Internal Medicine.

Even those who carry just one copy of the sickle cell gene – the carrier status for sickle cell disease – appeared to be at heightened risk for these outcomes (HR for hospitalization, 1.38; 95% CI, 1.12-1.70; HR for death, 1.51; 95% CI, 1.13-2.00).

“Given the well-known ethnic patterning of sickle cell disorders, the predisposition they pose to other infections, and early evidence from smaller registries, we thought this would be an important analysis to run at the population level,” Dr. Clift said in an interview.

“Our data suggest that people living with sickle cell disorders are a group at higher risk from this infection, and this is important from a public health perspective in terms of vaccination strategies and advice on nonpharmacological interventions,” he said.

“The best course of action for managing risk in this group is vaccination,” said Enrico M. Novelli, MD, director of the adult sickle cell program at the University of Pittsburgh Medical Center. Dr. Novelli, who is also section chief of benign hematology in the university’s School of Medicine, was not involved in the study. “To date, there are no specific studies of the effect of COVID-19 vaccination in patients with SCD, but there is no reason to believe it would be less effective or more risky in this patient population,” he said.

In addition, common-sense measures, such as masking and physical distancing, particularly at large, indoor gatherings, should be encouraged, Dr. Novelli added. Keeping SCD under good control with available treatments is also important. “Any patient with SCD who contracts COVID-19 should undergo close, outpatient monitoring with pulse oxygen measurements. If sick, they should be hospitalized in a center familiar with the care of SCD patients.”

The U.K. results are in line with and expand on earlier evidence from specialist centers and registries, but the association with sickle cell trait has been unclear and is notable in these findings, Dr. Clift said.

“The finding of the association with sickle cell trait is somewhat unexpected,” pediatric hematologist/oncologist Rabi Hanna, MD, director of pediatric bone marrow transplantation at Cleveland Clinic Children’s, told this news organization. “But I would question the accuracy of the numbers, since not all people with the trait realize they have it. In other respects, the study confirms earlier hypotheses and data from single-center studies.” Dr. Hanna did not participate in the U.K. study.
 

Study details

The SCD cohort consisted of 5,059 persons with SCD and 25,682 carriers, those with just one copy of the trait. Data were drawn from the United Kingdom’s large primary-care QResearch database. Follow-up for hospitalizations was conducted from Jan. 24, 2020 to Sept. 30, 2020; follow-up for deaths was conducted from Jan. 24, 2020 to Jan. 18, 2021. Among adults with SCD, there were 40 hospitalizations and 10 deaths. Among those with sickle cell trait, there were 98 hospitalizations and 50 deaths. No children died, and only a few (<5) required hospitalization.

Previous registry research showed similarly elevated risks for severe disease and fatality among patients with SCD who were infected with SARS-CoV-2.

Because SCD affects 8 to 12 million people globally – 100,000 in the United States – the authors say their results are important for policymakers and for prioritizing vaccination. They also note that trait carriers may be underdiagnosed.

“While SCD is part of newborn screening, there may be undiagnosed older people with the trait in the general population, but it’s difficult to quantify how much this is undiagnosed,” Dr. Clift said. “But now we have these results, it’s not that surprising that sickle cell trait is also associated with increased risk, albeit to a lower extent. This could suggest an almost dose-like effect of the sickle mutations on COVID hospitalization risk.”

Neonatal screening for the most common form of SCD is currently mandatory in the United States, but the Centers for Disease Control and Prevention has no clear data on how many people are aware they are carriers, Dr. Hanna said. “The states didn’t all begin screening at the same time – some started in the 1990s, others started in the 2000s – so many young adults may be unaware they have the trait,” he said.

Dr. Clift said the multiorgan complications of SCD, such as cardiac and immune problems, may be contributing to the heightened risk in individuals infected with SARS-CoV-2. “For example, we know that people with sickle cell disease are more susceptible to other viral infections. There is also some pathophysiological overlap between SCD disease and severe COVID, such as clotting dysfunction, so that may be worth further exploration,” he said.

The overlapping clotting problems associated with both COVID-19 and SCD could increase the risk for severe venous thromboembolism. In addition, experts noted that patients with SCD often have pre-COVID endothelial damage and baseline inflammation and are very sensitive to hypoxia; as well, a sizable proportion have lung disease.

The message to patients and physicians counseling patients is twofold, said Dr. Hanna: “SCD patients are at higher risk of COVID complications, and these are preventable with vaccination.”

The study was supported by the UK Medical Research Council. Dr. Clift is supported by Cancer Research UK. Coauthor Dr. Hippisley-Cox has received fees from ClinRisk and nonfinancial support from QResearch outside of the submitted work. Dr. Hanna has disclosed no relevant financial relationships. Dr. Novelli is a consultant for Novartis.

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

After acute SARS-CoV-2 infection, patients report lingering malnutrition, loss of appetite, and failure to regain lost weight long after other gastrointestinal and non-GI symptoms have resolved, according to the results of a new study.

In the large, multicenter retrospective study published online in Clinical Gastroenterology and Hepatology, Anam Rizvi, MD, and colleagues at Long Island Jewish Medical Center, in New Hyde Park (N.Y.), report a high prevalence of GI symptoms among patients with COVID-19.

They followed 17,462 adult patients who were hospitalized for severe COVID-19 between March 2020 and January 2021. Of these, 3,229 (18.5%) also had GI symptoms.

The median age of the patients was 66 years, and 46.9% were women. The diverse population included White (46%), Black (23%), and Hispanic (17%) patients admitted to 12 medical centers of the Northwell Health System in Manhattan, Queens, Long Island, and Staten Island. The researchers followed patients for 3 months (88.7%) and 6 months (56.5%).

The most frequent initial GI symptoms were gastroenteritis (52.5%), malnutrition (23%), GI bleeding (20.4%), and idiopathic pancreatitis (0.5%). Notably, 50.6% of those with GI manifestations reported an inability to regain lost weight at 3 months; 32.4% reported failure to regain lost weight at 6 months.

These percentages rose among patients with malnutrition, as determined by a board-certified in-hospital nutritionist; 56.4% failed to gain weight at 6 months. A median 14.7-lb weight loss persisted at the half-year mark.

In contrast to these lingering symptoms, gastroenteritis, GI bleeding, and pancreatitis all resolved by 3 months post hospitalization.

“We were somewhat shocked that the prevalence of these symptoms was so high, but it’s overall reassuring that most GI symptoms of COVID-19 resolve,” study author Arvind J. Trindade, MD, told this news organization. “In some COVID patients, we’re seeing an inability to gain weight without diarrhea or postinfectious irritable bowel syndrome.

“Patients with an inability to regain weight should consider follow-up with a nutritionist,” continued Dr. Trindade, who is the center’s director of endoscopy and an associate professor at the Feinstein Institutes for Medical Research, in Manhasset (N.Y.). His group also recommends developing malnutrition screening assessments for COVID-19 patients who recover from the acute infection.

The study was prompted by clinical observations during follow-up.

“We saw that a lot of these patients had trouble regaining weight, but we still don’t know why,” Dr. Trindade said. There were no discriminating clinical features apart from malnutrition that indicated an increased risk, and no socioeconomic or demographic characteristics. “We also looked at whether any factors predicted malnutrition, and there weren’t any that would predispose to malnutrition,” he added.

“We’re now reaching out to nonclinical investigators to see if there’s an interest in studying the underlying science behind these symptoms,” Dr. Trindade said.

His group plans to release 12-month follow-up data from the second wave of the pandemic in January 2022.

Initial GI symptoms are thought to be due to the virus’s S1 spike protein’s binding to the angiotensin-converting enzyme 2 receptors, which are abundant in GI epithelial cells. “But why patients have long-term GI sequelae is probably a whole different physiological mechanism,” Dr. Trindade said. “The thought is that there has to be some hormone or pathway that doesn’t allow them to regain weight.”

“The hospital cohort by [Dr. Rizvi] and colleagues is unique and helpful in that patients with GI symptoms are less likely to be hospitalized, and perhaps those patients who are sick enough for admission to the hospital who also have GI symptoms need specific attention paid to their appetite, weight, and nutritional status,” said Jordan M. Shapiro, MD, who commented on the study but was not involved in it.

The constellations of GI symptoms are difficult to distinguish from other postinfectious GI syndromes, such as irritable bowel syndrome and gastroparesis, added Dr. Shapiro, an assistant professor of medicine in gastroenterology and hepatology at Baylor College of Medicine, Houston. “We’re still unpacking what is and is not specific to post–COVID-19 GI symptoms. Prospective studies are necessary to further study this phenomenon.”

Last year, a small Italian study documented significant weight loss and malnutrition in a hospital cohort of 213 discharged COVID-19 patients. In that study, the duration of disease was predictive of weight loss.

The authors note several study limitations, including that the cohort was limited to hospitalized patients from New York and that the 6-month follow-up period was short.

The study received no funding. Dr. Trindade serves as a consultant to Pentax Medical. All other authors and Dr. Shapiro have disclosed no relevant financial relationships.

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

After acute SARS-CoV-2 infection, patients report lingering malnutrition, loss of appetite, and failure to regain lost weight long after other gastrointestinal and non-GI symptoms have resolved, according to the results of a new study.

In the large, multicenter retrospective study published online in Clinical Gastroenterology and Hepatology, Anam Rizvi, MD, and colleagues at Long Island Jewish Medical Center, in New Hyde Park (N.Y.), report a high prevalence of GI symptoms among patients with COVID-19.

They followed 17,462 adult patients who were hospitalized for severe COVID-19 between March 2020 and January 2021. Of these, 3,229 (18.5%) also had GI symptoms.

The median age of the patients was 66 years, and 46.9% were women. The diverse population included White (46%), Black (23%), and Hispanic (17%) patients admitted to 12 medical centers of the Northwell Health System in Manhattan, Queens, Long Island, and Staten Island. The researchers followed patients for 3 months (88.7%) and 6 months (56.5%).

The most frequent initial GI symptoms were gastroenteritis (52.5%), malnutrition (23%), GI bleeding (20.4%), and idiopathic pancreatitis (0.5%). Notably, 50.6% of those with GI manifestations reported an inability to regain lost weight at 3 months; 32.4% reported failure to regain lost weight at 6 months.

These percentages rose among patients with malnutrition, as determined by a board-certified in-hospital nutritionist; 56.4% failed to gain weight at 6 months. A median 14.7-lb weight loss persisted at the half-year mark.

In contrast to these lingering symptoms, gastroenteritis, GI bleeding, and pancreatitis all resolved by 3 months post hospitalization.

“We were somewhat shocked that the prevalence of these symptoms was so high, but it’s overall reassuring that most GI symptoms of COVID-19 resolve,” study author Arvind J. Trindade, MD, told this news organization. “In some COVID patients, we’re seeing an inability to gain weight without diarrhea or postinfectious irritable bowel syndrome.

“Patients with an inability to regain weight should consider follow-up with a nutritionist,” continued Dr. Trindade, who is the center’s director of endoscopy and an associate professor at the Feinstein Institutes for Medical Research, in Manhasset (N.Y.). His group also recommends developing malnutrition screening assessments for COVID-19 patients who recover from the acute infection.

The study was prompted by clinical observations during follow-up.

“We saw that a lot of these patients had trouble regaining weight, but we still don’t know why,” Dr. Trindade said. There were no discriminating clinical features apart from malnutrition that indicated an increased risk, and no socioeconomic or demographic characteristics. “We also looked at whether any factors predicted malnutrition, and there weren’t any that would predispose to malnutrition,” he added.

“We’re now reaching out to nonclinical investigators to see if there’s an interest in studying the underlying science behind these symptoms,” Dr. Trindade said.

His group plans to release 12-month follow-up data from the second wave of the pandemic in January 2022.

Initial GI symptoms are thought to be due to the virus’s S1 spike protein’s binding to the angiotensin-converting enzyme 2 receptors, which are abundant in GI epithelial cells. “But why patients have long-term GI sequelae is probably a whole different physiological mechanism,” Dr. Trindade said. “The thought is that there has to be some hormone or pathway that doesn’t allow them to regain weight.”

“The hospital cohort by [Dr. Rizvi] and colleagues is unique and helpful in that patients with GI symptoms are less likely to be hospitalized, and perhaps those patients who are sick enough for admission to the hospital who also have GI symptoms need specific attention paid to their appetite, weight, and nutritional status,” said Jordan M. Shapiro, MD, who commented on the study but was not involved in it.

The constellations of GI symptoms are difficult to distinguish from other postinfectious GI syndromes, such as irritable bowel syndrome and gastroparesis, added Dr. Shapiro, an assistant professor of medicine in gastroenterology and hepatology at Baylor College of Medicine, Houston. “We’re still unpacking what is and is not specific to post–COVID-19 GI symptoms. Prospective studies are necessary to further study this phenomenon.”

Last year, a small Italian study documented significant weight loss and malnutrition in a hospital cohort of 213 discharged COVID-19 patients. In that study, the duration of disease was predictive of weight loss.

The authors note several study limitations, including that the cohort was limited to hospitalized patients from New York and that the 6-month follow-up period was short.

The study received no funding. Dr. Trindade serves as a consultant to Pentax Medical. All other authors and Dr. Shapiro have disclosed no relevant financial relationships.

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

After acute SARS-CoV-2 infection, patients report lingering malnutrition, loss of appetite, and failure to regain lost weight long after other gastrointestinal and non-GI symptoms have resolved, according to the results of a new study.

In the large, multicenter retrospective study published online in Clinical Gastroenterology and Hepatology, Anam Rizvi, MD, and colleagues at Long Island Jewish Medical Center, in New Hyde Park (N.Y.), report a high prevalence of GI symptoms among patients with COVID-19.

They followed 17,462 adult patients who were hospitalized for severe COVID-19 between March 2020 and January 2021. Of these, 3,229 (18.5%) also had GI symptoms.

The median age of the patients was 66 years, and 46.9% were women. The diverse population included White (46%), Black (23%), and Hispanic (17%) patients admitted to 12 medical centers of the Northwell Health System in Manhattan, Queens, Long Island, and Staten Island. The researchers followed patients for 3 months (88.7%) and 6 months (56.5%).

The most frequent initial GI symptoms were gastroenteritis (52.5%), malnutrition (23%), GI bleeding (20.4%), and idiopathic pancreatitis (0.5%). Notably, 50.6% of those with GI manifestations reported an inability to regain lost weight at 3 months; 32.4% reported failure to regain lost weight at 6 months.

These percentages rose among patients with malnutrition, as determined by a board-certified in-hospital nutritionist; 56.4% failed to gain weight at 6 months. A median 14.7-lb weight loss persisted at the half-year mark.

In contrast to these lingering symptoms, gastroenteritis, GI bleeding, and pancreatitis all resolved by 3 months post hospitalization.

“We were somewhat shocked that the prevalence of these symptoms was so high, but it’s overall reassuring that most GI symptoms of COVID-19 resolve,” study author Arvind J. Trindade, MD, told this news organization. “In some COVID patients, we’re seeing an inability to gain weight without diarrhea or postinfectious irritable bowel syndrome.

“Patients with an inability to regain weight should consider follow-up with a nutritionist,” continued Dr. Trindade, who is the center’s director of endoscopy and an associate professor at the Feinstein Institutes for Medical Research, in Manhasset (N.Y.). His group also recommends developing malnutrition screening assessments for COVID-19 patients who recover from the acute infection.

The study was prompted by clinical observations during follow-up.

“We saw that a lot of these patients had trouble regaining weight, but we still don’t know why,” Dr. Trindade said. There were no discriminating clinical features apart from malnutrition that indicated an increased risk, and no socioeconomic or demographic characteristics. “We also looked at whether any factors predicted malnutrition, and there weren’t any that would predispose to malnutrition,” he added.

“We’re now reaching out to nonclinical investigators to see if there’s an interest in studying the underlying science behind these symptoms,” Dr. Trindade said.

His group plans to release 12-month follow-up data from the second wave of the pandemic in January 2022.

Initial GI symptoms are thought to be due to the virus’s S1 spike protein’s binding to the angiotensin-converting enzyme 2 receptors, which are abundant in GI epithelial cells. “But why patients have long-term GI sequelae is probably a whole different physiological mechanism,” Dr. Trindade said. “The thought is that there has to be some hormone or pathway that doesn’t allow them to regain weight.”

“The hospital cohort by [Dr. Rizvi] and colleagues is unique and helpful in that patients with GI symptoms are less likely to be hospitalized, and perhaps those patients who are sick enough for admission to the hospital who also have GI symptoms need specific attention paid to their appetite, weight, and nutritional status,” said Jordan M. Shapiro, MD, who commented on the study but was not involved in it.

The constellations of GI symptoms are difficult to distinguish from other postinfectious GI syndromes, such as irritable bowel syndrome and gastroparesis, added Dr. Shapiro, an assistant professor of medicine in gastroenterology and hepatology at Baylor College of Medicine, Houston. “We’re still unpacking what is and is not specific to post–COVID-19 GI symptoms. Prospective studies are necessary to further study this phenomenon.”

Last year, a small Italian study documented significant weight loss and malnutrition in a hospital cohort of 213 discharged COVID-19 patients. In that study, the duration of disease was predictive of weight loss.

The authors note several study limitations, including that the cohort was limited to hospitalized patients from New York and that the 6-month follow-up period was short.

The study received no funding. Dr. Trindade serves as a consultant to Pentax Medical. All other authors and Dr. Shapiro have disclosed no relevant financial relationships.

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

In the absence of formal clinical trials, pediatricians are racing to determine the efficacy and risks of currently used therapies for the SARS-CoV-2–linked multisystem inflammatory syndrome in children (MIS-C).

That requires rapid pragmatic evaluation of therapies. Two real-world observational studies published online June 16 in The New England Journal of Medicine do that, with differing results.

In the Overcoming COVID-19 study, investigators assessed initial therapy and outcomes for patients with MIS-C using surveillance data from 58 pediatric hospitals nationwide.

The results suggest that patients with MIS-C who were younger than 21 years of age and who were initially treated with intravenous immunoglobulin (IVIG) plus glucocorticoids fared better in terms of cardiovascular function.

The study included 518 children (median age, 8.7 years) who were admitted to the hospital between March and October 2020 and who received at least one immunomodulatory therapy. In a propensity score–matched analysis, those given IVIG plus glucocorticoids (n = 103) had a lower risk for the primary outcome of cardiovascular dysfunction on or after day 2 than those given IVIG alone (n = 103), at 17% versus 31% (risk ratio, 0.56; 95% confidence interval, 0.34-0.94).

Risks for individual aspects of the study’s composite outcome were also lower with IVIG plus glucocorticoids. Left ventricular dysfunction occurred in 8% and 17%, respectively (RR, 0.46; 95% CI, 0.19-1.15). Shock requiring vasopressor use emerged in 13% and 24%, respectively (RR, 0.54; 95% CI, 0.29-1.00).

In addition, there were fewer cases in which adjunctive therapy was given on day one among those who received combination therapy than among those who received IVIG alone, at 34% versus 70% (RR, 0.49; 95% CI, 0.36-0.65), but the risk for fever was not lower on or after day two (31% and 40%, respectively; RR, 0.78; 95% CI, 0.53-1.13).

Lead author Mary Beth F. Son, MD, director of the rheumatology program at Boston Children’s Hospital, who is also associate professor of pediatrics at Harvard Medical School, stressed that the study did not assess which MIS-C patients should receive treatment. “Rather, we studied children who had been treated with one of two initial regimens and then assessed short-term outcomes,” she told this news organization.

Going forward, it will be important to study which children should receive immunomodulatory treatment, Dr. Son said. “Specifically, can the less ill children receive IVIG alone or no treatment? This is an unanswered question at the moment, which could be addressed with a randomized controlled trial.”

Future directions, she added, will include assessing long-term cardiac outcomes for patients with MIS-C as well as studying outpatient regimens, especially those that involve steroids.

Earlier this year, French investigators found better outcomes with combined corticosteroids and IVIG than with IVIG alone. They suggested that combination therapy should be the standard of care, given the present state of therapeutic knowledge.
 

Maybe not so standard

Different results emerged, however, from an international study of MIS-C that compared three, rather than two, treatment approaches. Collaborators from the Best Available Treatment Study for MIS-C (BATS) evaluated data for 614 children with suspected MIS-C between June 2020 and February 2021 in 32 countries and found no substantial differences in recovery among children whose primary treatment was IVIG alone, IVIG plus glucocorticoids, or glucocorticoids alone.

The study by Andrew J. McArdle, MB BChir, MSC, a clinical research fellow at Imperial College London, and colleagues was published June 16 in The New England Journal of Medicine.

In the BATS cohort, 246 received IVIG alone, 208 received IVIG plus glucocorticoids, and 99 received glucocorticoids alone. Twenty-two patients received other combinations, including biologics, and 39 received no immunomodulatory therapy.

Among patients who were included in the primary analysis, death occurred or inotropic or ventilatory support was employed in 56 of 180 of the patients who received IVIG plus glucocorticoids, compared with 44 of 211 patients treated with IVIG alone, for an adjusted odds ratio (aOR) of 0.77 (95% CI, 0.33-1.82). Among those who received glucocorticoids alone, 17 of 83 met the primary endpoint of death or inotropic or ventilatory support, for an aOR relative to IVIG alone of 0.54 (95% CI, 0.22-1.33).

After adjustments, the likelihood for reduced disease severity was similar in the two groups relative to IVIG alone, at 0.90 for IVIG plus glucocorticoids and 0.93 for glucocorticoids alone. Time to reduction in disease severity was also comparable across all groups.

Some of the differences between the U.S. study and the global studies could be the result of the larger size of the international cohort and possibly a difference in the strains of virus in the United States and abroad, according to S. Sexson Tejtel, MD, PhD, MPH, a pediatric cardiologist at Texas Children’s Hospital and an assistant professor at Baylor College of Medicine, Houston, Texas. “Some strains make children sicker than others, and they’re going to need more treatment,” said Dr. Sexson Tejtel, who was not involved in either study.

Dr. Sexson Tejtel also noted that the U.S. researchers did not assess outcomes among children treated with steroids alone. “It would be interesting to know what steroids alone look like in the U.S. MIS-C population,” she said in an interview.

BATS corresponding author Michael Levin, MBE, PhD, FRCPCH, an Imperial College professor of pediatrics and international child health, told this news organization that the differing results may have arisen because of the international study’s three-treatment focus, its wider spectrum of patients, and its different endpoints: Death and inotropic support on or after day 2, versus echocardiographic left ventricular dysfunction or inotropic usage.

Regardless of the differences between the two studies, neither establishes the most effective single or combination treatment, writes Roberta L. DeBiasi, MD, of the Division of Pediatric Infectious Diseases at Children’s National Hospital and Research Institute and George Washington University, Washington, in an accompanying editorial. “Specifically, neither study was powered to include an evaluation of approaches that steer away from broad immunosuppression with glucocorticoids and that focus on more targeted and titratable treatments with biologic agents, such as anakinra and infliximab,” she writes.

Dr. DeBiasi adds that long-term follow-up studies of cardiac and noncardiac outcomes in these patients will launch soon. “Meanwhile, continued collaboration across centers is essential to decreasing the short-term incidence of death and complications,” she writes.

“It will be interesting as we apply results from these studies as they come out to see how they change our practice,” Dr. Sexson Tejtel said. “And it would be good to have some randomized clinical trials.”

For Dr. Levin, the bottom line is that all three treatments are associated with recovery for a majority of children. “This is good news for clinicians who have been guessing which treatment to use,” he said. “Both studies are attempts to provide doctors with some evidence on which to base treatment decisions and are not the final answer. Our study is ongoing, and with larger numbers of patients it may give clearer answers.”

The Overcoming COVID-19 study was funded by the U.S. Centers for Disease Control and Prevention. Several coauthors have reported support from industry outside of the submitted work. BATS was funded by the European Union’s Horizons 2020 Program. The study authors have disclosed no relevant financial relationships. One coauthor’s spouse is employed by GlaxoSmithKline. Dr. DeBiasi and Dr. Sexson Tejtel have disclosed no relevant financial relationships.

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

In the absence of formal clinical trials, pediatricians are racing to determine the efficacy and risks of currently used therapies for the SARS-CoV-2–linked multisystem inflammatory syndrome in children (MIS-C).

That requires rapid pragmatic evaluation of therapies. Two real-world observational studies published online June 16 in The New England Journal of Medicine do that, with differing results.

In the Overcoming COVID-19 study, investigators assessed initial therapy and outcomes for patients with MIS-C using surveillance data from 58 pediatric hospitals nationwide.

The results suggest that patients with MIS-C who were younger than 21 years of age and who were initially treated with intravenous immunoglobulin (IVIG) plus glucocorticoids fared better in terms of cardiovascular function.

The study included 518 children (median age, 8.7 years) who were admitted to the hospital between March and October 2020 and who received at least one immunomodulatory therapy. In a propensity score–matched analysis, those given IVIG plus glucocorticoids (n = 103) had a lower risk for the primary outcome of cardiovascular dysfunction on or after day 2 than those given IVIG alone (n = 103), at 17% versus 31% (risk ratio, 0.56; 95% confidence interval, 0.34-0.94).

Risks for individual aspects of the study’s composite outcome were also lower with IVIG plus glucocorticoids. Left ventricular dysfunction occurred in 8% and 17%, respectively (RR, 0.46; 95% CI, 0.19-1.15). Shock requiring vasopressor use emerged in 13% and 24%, respectively (RR, 0.54; 95% CI, 0.29-1.00).

In addition, there were fewer cases in which adjunctive therapy was given on day one among those who received combination therapy than among those who received IVIG alone, at 34% versus 70% (RR, 0.49; 95% CI, 0.36-0.65), but the risk for fever was not lower on or after day two (31% and 40%, respectively; RR, 0.78; 95% CI, 0.53-1.13).

Lead author Mary Beth F. Son, MD, director of the rheumatology program at Boston Children’s Hospital, who is also associate professor of pediatrics at Harvard Medical School, stressed that the study did not assess which MIS-C patients should receive treatment. “Rather, we studied children who had been treated with one of two initial regimens and then assessed short-term outcomes,” she told this news organization.

Going forward, it will be important to study which children should receive immunomodulatory treatment, Dr. Son said. “Specifically, can the less ill children receive IVIG alone or no treatment? This is an unanswered question at the moment, which could be addressed with a randomized controlled trial.”

Future directions, she added, will include assessing long-term cardiac outcomes for patients with MIS-C as well as studying outpatient regimens, especially those that involve steroids.

Earlier this year, French investigators found better outcomes with combined corticosteroids and IVIG than with IVIG alone. They suggested that combination therapy should be the standard of care, given the present state of therapeutic knowledge.
 

Maybe not so standard

Different results emerged, however, from an international study of MIS-C that compared three, rather than two, treatment approaches. Collaborators from the Best Available Treatment Study for MIS-C (BATS) evaluated data for 614 children with suspected MIS-C between June 2020 and February 2021 in 32 countries and found no substantial differences in recovery among children whose primary treatment was IVIG alone, IVIG plus glucocorticoids, or glucocorticoids alone.

The study by Andrew J. McArdle, MB BChir, MSC, a clinical research fellow at Imperial College London, and colleagues was published June 16 in The New England Journal of Medicine.

In the BATS cohort, 246 received IVIG alone, 208 received IVIG plus glucocorticoids, and 99 received glucocorticoids alone. Twenty-two patients received other combinations, including biologics, and 39 received no immunomodulatory therapy.

Among patients who were included in the primary analysis, death occurred or inotropic or ventilatory support was employed in 56 of 180 of the patients who received IVIG plus glucocorticoids, compared with 44 of 211 patients treated with IVIG alone, for an adjusted odds ratio (aOR) of 0.77 (95% CI, 0.33-1.82). Among those who received glucocorticoids alone, 17 of 83 met the primary endpoint of death or inotropic or ventilatory support, for an aOR relative to IVIG alone of 0.54 (95% CI, 0.22-1.33).

After adjustments, the likelihood for reduced disease severity was similar in the two groups relative to IVIG alone, at 0.90 for IVIG plus glucocorticoids and 0.93 for glucocorticoids alone. Time to reduction in disease severity was also comparable across all groups.

Some of the differences between the U.S. study and the global studies could be the result of the larger size of the international cohort and possibly a difference in the strains of virus in the United States and abroad, according to S. Sexson Tejtel, MD, PhD, MPH, a pediatric cardiologist at Texas Children’s Hospital and an assistant professor at Baylor College of Medicine, Houston, Texas. “Some strains make children sicker than others, and they’re going to need more treatment,” said Dr. Sexson Tejtel, who was not involved in either study.

Dr. Sexson Tejtel also noted that the U.S. researchers did not assess outcomes among children treated with steroids alone. “It would be interesting to know what steroids alone look like in the U.S. MIS-C population,” she said in an interview.

BATS corresponding author Michael Levin, MBE, PhD, FRCPCH, an Imperial College professor of pediatrics and international child health, told this news organization that the differing results may have arisen because of the international study’s three-treatment focus, its wider spectrum of patients, and its different endpoints: Death and inotropic support on or after day 2, versus echocardiographic left ventricular dysfunction or inotropic usage.

Regardless of the differences between the two studies, neither establishes the most effective single or combination treatment, writes Roberta L. DeBiasi, MD, of the Division of Pediatric Infectious Diseases at Children’s National Hospital and Research Institute and George Washington University, Washington, in an accompanying editorial. “Specifically, neither study was powered to include an evaluation of approaches that steer away from broad immunosuppression with glucocorticoids and that focus on more targeted and titratable treatments with biologic agents, such as anakinra and infliximab,” she writes.

Dr. DeBiasi adds that long-term follow-up studies of cardiac and noncardiac outcomes in these patients will launch soon. “Meanwhile, continued collaboration across centers is essential to decreasing the short-term incidence of death and complications,” she writes.

“It will be interesting as we apply results from these studies as they come out to see how they change our practice,” Dr. Sexson Tejtel said. “And it would be good to have some randomized clinical trials.”

For Dr. Levin, the bottom line is that all three treatments are associated with recovery for a majority of children. “This is good news for clinicians who have been guessing which treatment to use,” he said. “Both studies are attempts to provide doctors with some evidence on which to base treatment decisions and are not the final answer. Our study is ongoing, and with larger numbers of patients it may give clearer answers.”

The Overcoming COVID-19 study was funded by the U.S. Centers for Disease Control and Prevention. Several coauthors have reported support from industry outside of the submitted work. BATS was funded by the European Union’s Horizons 2020 Program. The study authors have disclosed no relevant financial relationships. One coauthor’s spouse is employed by GlaxoSmithKline. Dr. DeBiasi and Dr. Sexson Tejtel have disclosed no relevant financial relationships.

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

In the absence of formal clinical trials, pediatricians are racing to determine the efficacy and risks of currently used therapies for the SARS-CoV-2–linked multisystem inflammatory syndrome in children (MIS-C).

That requires rapid pragmatic evaluation of therapies. Two real-world observational studies published online June 16 in The New England Journal of Medicine do that, with differing results.

In the Overcoming COVID-19 study, investigators assessed initial therapy and outcomes for patients with MIS-C using surveillance data from 58 pediatric hospitals nationwide.

The results suggest that patients with MIS-C who were younger than 21 years of age and who were initially treated with intravenous immunoglobulin (IVIG) plus glucocorticoids fared better in terms of cardiovascular function.

The study included 518 children (median age, 8.7 years) who were admitted to the hospital between March and October 2020 and who received at least one immunomodulatory therapy. In a propensity score–matched analysis, those given IVIG plus glucocorticoids (n = 103) had a lower risk for the primary outcome of cardiovascular dysfunction on or after day 2 than those given IVIG alone (n = 103), at 17% versus 31% (risk ratio, 0.56; 95% confidence interval, 0.34-0.94).

Risks for individual aspects of the study’s composite outcome were also lower with IVIG plus glucocorticoids. Left ventricular dysfunction occurred in 8% and 17%, respectively (RR, 0.46; 95% CI, 0.19-1.15). Shock requiring vasopressor use emerged in 13% and 24%, respectively (RR, 0.54; 95% CI, 0.29-1.00).

In addition, there were fewer cases in which adjunctive therapy was given on day one among those who received combination therapy than among those who received IVIG alone, at 34% versus 70% (RR, 0.49; 95% CI, 0.36-0.65), but the risk for fever was not lower on or after day two (31% and 40%, respectively; RR, 0.78; 95% CI, 0.53-1.13).

Lead author Mary Beth F. Son, MD, director of the rheumatology program at Boston Children’s Hospital, who is also associate professor of pediatrics at Harvard Medical School, stressed that the study did not assess which MIS-C patients should receive treatment. “Rather, we studied children who had been treated with one of two initial regimens and then assessed short-term outcomes,” she told this news organization.

Going forward, it will be important to study which children should receive immunomodulatory treatment, Dr. Son said. “Specifically, can the less ill children receive IVIG alone or no treatment? This is an unanswered question at the moment, which could be addressed with a randomized controlled trial.”

Future directions, she added, will include assessing long-term cardiac outcomes for patients with MIS-C as well as studying outpatient regimens, especially those that involve steroids.

Earlier this year, French investigators found better outcomes with combined corticosteroids and IVIG than with IVIG alone. They suggested that combination therapy should be the standard of care, given the present state of therapeutic knowledge.
 

Maybe not so standard

Different results emerged, however, from an international study of MIS-C that compared three, rather than two, treatment approaches. Collaborators from the Best Available Treatment Study for MIS-C (BATS) evaluated data for 614 children with suspected MIS-C between June 2020 and February 2021 in 32 countries and found no substantial differences in recovery among children whose primary treatment was IVIG alone, IVIG plus glucocorticoids, or glucocorticoids alone.

The study by Andrew J. McArdle, MB BChir, MSC, a clinical research fellow at Imperial College London, and colleagues was published June 16 in The New England Journal of Medicine.

In the BATS cohort, 246 received IVIG alone, 208 received IVIG plus glucocorticoids, and 99 received glucocorticoids alone. Twenty-two patients received other combinations, including biologics, and 39 received no immunomodulatory therapy.

Among patients who were included in the primary analysis, death occurred or inotropic or ventilatory support was employed in 56 of 180 of the patients who received IVIG plus glucocorticoids, compared with 44 of 211 patients treated with IVIG alone, for an adjusted odds ratio (aOR) of 0.77 (95% CI, 0.33-1.82). Among those who received glucocorticoids alone, 17 of 83 met the primary endpoint of death or inotropic or ventilatory support, for an aOR relative to IVIG alone of 0.54 (95% CI, 0.22-1.33).

After adjustments, the likelihood for reduced disease severity was similar in the two groups relative to IVIG alone, at 0.90 for IVIG plus glucocorticoids and 0.93 for glucocorticoids alone. Time to reduction in disease severity was also comparable across all groups.

Some of the differences between the U.S. study and the global studies could be the result of the larger size of the international cohort and possibly a difference in the strains of virus in the United States and abroad, according to S. Sexson Tejtel, MD, PhD, MPH, a pediatric cardiologist at Texas Children’s Hospital and an assistant professor at Baylor College of Medicine, Houston, Texas. “Some strains make children sicker than others, and they’re going to need more treatment,” said Dr. Sexson Tejtel, who was not involved in either study.

Dr. Sexson Tejtel also noted that the U.S. researchers did not assess outcomes among children treated with steroids alone. “It would be interesting to know what steroids alone look like in the U.S. MIS-C population,” she said in an interview.

BATS corresponding author Michael Levin, MBE, PhD, FRCPCH, an Imperial College professor of pediatrics and international child health, told this news organization that the differing results may have arisen because of the international study’s three-treatment focus, its wider spectrum of patients, and its different endpoints: Death and inotropic support on or after day 2, versus echocardiographic left ventricular dysfunction or inotropic usage.

Regardless of the differences between the two studies, neither establishes the most effective single or combination treatment, writes Roberta L. DeBiasi, MD, of the Division of Pediatric Infectious Diseases at Children’s National Hospital and Research Institute and George Washington University, Washington, in an accompanying editorial. “Specifically, neither study was powered to include an evaluation of approaches that steer away from broad immunosuppression with glucocorticoids and that focus on more targeted and titratable treatments with biologic agents, such as anakinra and infliximab,” she writes.

Dr. DeBiasi adds that long-term follow-up studies of cardiac and noncardiac outcomes in these patients will launch soon. “Meanwhile, continued collaboration across centers is essential to decreasing the short-term incidence of death and complications,” she writes.

“It will be interesting as we apply results from these studies as they come out to see how they change our practice,” Dr. Sexson Tejtel said. “And it would be good to have some randomized clinical trials.”

For Dr. Levin, the bottom line is that all three treatments are associated with recovery for a majority of children. “This is good news for clinicians who have been guessing which treatment to use,” he said. “Both studies are attempts to provide doctors with some evidence on which to base treatment decisions and are not the final answer. Our study is ongoing, and with larger numbers of patients it may give clearer answers.”

The Overcoming COVID-19 study was funded by the U.S. Centers for Disease Control and Prevention. Several coauthors have reported support from industry outside of the submitted work. BATS was funded by the European Union’s Horizons 2020 Program. The study authors have disclosed no relevant financial relationships. One coauthor’s spouse is employed by GlaxoSmithKline. Dr. DeBiasi and Dr. Sexson Tejtel have disclosed no relevant financial relationships.

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

For the eighth consecutive year, Boston Children’s Hospital has captured the no. 1 spot in the national honor roll of U.S. News & World Report’s Best Children’s Hospitals.

Released June 15, the 2021-2022 rankings, which acknowledge 50 U.S. centers for delivering exceptional care in several specialties, also give the Massachusetts hospital the top spot in 4 of 10 pediatric specialties assessed: nephrology, neurology and neurosurgery, pulmonology and lung surgery, and urology.

Children’s Hospital of Philadelphia retains second spot in the annually updated list, and Texas Children’s Hospital, in Houston, moves up a rung to third place, bumping Cincinnati Children’s Hospital Medical Center from third to fourth place. Children’s Hospital Los Angeles comes in at no. 5.

The remaining top 10 placements, in descending order, are as follows:

Children’s Hospital Colorado in Aurora; Children’s National Hospital in Washington; Nationwide Children’s Hospital in Columbus, Ohio; UPMS Children’s Hospital of Pittsburgh; and Lucile Packard Children’s Hospital Stanford (Calif.).
 

New regional rankings

This year’s edition offers something new, adding rankings within states and multiple-state rankings within seven regions to facilitate choice. “The Best Children’s Hospitals rankings have always highlighted hospitals that excel in specialized care,” said Ben Harder, chief of health analysis and managing editor at U.S. News, in a press release. “Now, this year’s new state and regional rankings can help families identify conveniently located hospitals capable of meeting their child’s needs. As the pandemic continues to affect travel, finding high-quality care close to home has never been more important.”

Across the seven regions, the top-ranked institutions are as follows:

• Mid-Atlantic – Children’s Hospital of Philadelphia.
• Midwest – Cincinnati Children’s Hospital Medical Center.
• New England – Boston Children’s Hospital.
• Pacific – Children’s Hospital Los Angeles.
• Rocky Mountains – Children’s Hospital Colorado.
• Southeast – Children’s Healthcare of Atlanta and Monroe Carell Jr. Children’s Hospital of Vanderbilt, in Nashville, Tenn.
• Southwest – Texas Children’s Hospital.

Specialties

Boston Children’s not only topped the overall list but also led in four specialties. For the other six specialties that were ranked, the top hospitals on the honor roll are as follows:

• Cancer – Children’s Hospital of Philadelphia.
• Cardiology and heart surgery – Texas Children’s Hospital.
• Diabetes and endocrinology – Children’s Hospital of Philadelphia.
• Gastroenterology and gastrointestinal surgery – Children’s Hospital Colorado.
• Neonatology – Children’s National Hospital.
• Orthopedics – Children’s Hospital of Philadelphia.

For the past 15 years, the objective of the rankings has been to offer a starting point for parents in making decisions about the best place to take very sick children for high-quality care. The editors of the rankings acknowledge that considerations of travel costs and insurance coverage are other factors to consider.
 

Helpful for families

The rankings are helpful for families, according to Joe W. St. Geme, III, MD, Children’s Hospital of Philadelphia’s physician-in-chief and chair of its department of pediatrics. “Some parents, especially those coming from outside an area, find them useful when deciding on care away from home,” he told this news organization. “Most types of pediatric care are available in the community, but sometimes a child has an unusual disease or complex disease for which local care is not available.”

Dr. St. Geme said the new regional rankings may be useful in helping parents decide where to bring a child for care that is closer to where they live.

A top ranking from U.S. News is just one indication of a hospital›s overall performance, according to Angela Lorts, MD, MBA, director of the Ventricular Assist Device Program, at Cincinnati Children’s Hospital Medical Center.

“Parents seeking care for their child should use the data to ask questions and understand the limitations,” she told this news organization. “Rankings are only based on a small subset of the children we care for. Many of the metrics may not pertain to their child and may not reflect the care they will receive.”

In her view, ranking will not give parents all the information they need about medical care and outcomes for specific conditions.
 

Hospital reaction

Hospitals can use the rankings to target improvements, says Dr. St. Geme. “These rankings can provide an opportunity for some benchmarking, to see what other institutions are doing and how they’re able to deliver care. They can serve as a source of ideas and can influence planning,” he said.

He cautioned that the data are not as complete as they could be. “A number of services are not included, and we try to keep that in mind,” he said.

Rankings may also affect recruitment, Dr. St. Geme added, because higher-ranked institutions may find it easier to attract sought-after clinicians and investigators in needed areas.

Another sphere of influence is philanthropy and fund raising. “People are much more likely to consider making both small and large donations to a high-ranked institution,” said J. Howard Smart, MD, chair of pediatrics at Sharp Rees-Stealy Medical Group and chair-elect of the physician leadership council at Sharp Mary Birch Hospital for Women and Newborns in San Diego.

Dr. St. Geme agrees. “Philanthropists are interested in making investments where they feel they’re a sure bet, and rankings may indicate a sure bet. But their impact on government funding and grant support is probably less.”

Ultimately, however, some families may not have lot of choice in where to go when their children are sick, Dr. Smart said. “And people probably don’t choose a location to live in based on nearby children’s hospitals the way they do for schools,” he said.

What about hospitals that continue to rank much lower on the 50-institution list – excellent though they must be to make it onto the honor roll. “To be on the list but not to have risen in rank in recent years might be a disappointment,” said Dr. St. Geme. “But it might also motivate a hospital to think about making internal investments in order to strengthen a particular service. And it may motivate nonranked hospitals to improve care in order to break into the list.”

Dr. Lorts points out that the annual survey process requires hospitals to track the clinical outcomes of a subset of patients, which may lead to improvement in these areas. It also requires data collection on structure and process, which drives needs assessments of select hospital areas. “But ideally, all hospitals would be tracking important outcomes, benchmarking to peer hospitals, and improving where needed without the U.S. News incentive,” she said.

This year’s data, compiled by research and consulting firm RTI International, derive from feedback on more than 1,200 questions provided by 118 responding institutions. Details on each hospital on the list and the methodology used in the analysis are available on U.S. News & World Report’s website.

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

For the eighth consecutive year, Boston Children’s Hospital has captured the no. 1 spot in the national honor roll of U.S. News & World Report’s Best Children’s Hospitals.

Released June 15, the 2021-2022 rankings, which acknowledge 50 U.S. centers for delivering exceptional care in several specialties, also give the Massachusetts hospital the top spot in 4 of 10 pediatric specialties assessed: nephrology, neurology and neurosurgery, pulmonology and lung surgery, and urology.

Children’s Hospital of Philadelphia retains second spot in the annually updated list, and Texas Children’s Hospital, in Houston, moves up a rung to third place, bumping Cincinnati Children’s Hospital Medical Center from third to fourth place. Children’s Hospital Los Angeles comes in at no. 5.

The remaining top 10 placements, in descending order, are as follows:

Children’s Hospital Colorado in Aurora; Children’s National Hospital in Washington; Nationwide Children’s Hospital in Columbus, Ohio; UPMS Children’s Hospital of Pittsburgh; and Lucile Packard Children’s Hospital Stanford (Calif.).
 

New regional rankings

This year’s edition offers something new, adding rankings within states and multiple-state rankings within seven regions to facilitate choice. “The Best Children’s Hospitals rankings have always highlighted hospitals that excel in specialized care,” said Ben Harder, chief of health analysis and managing editor at U.S. News, in a press release. “Now, this year’s new state and regional rankings can help families identify conveniently located hospitals capable of meeting their child’s needs. As the pandemic continues to affect travel, finding high-quality care close to home has never been more important.”

Across the seven regions, the top-ranked institutions are as follows:

• Mid-Atlantic – Children’s Hospital of Philadelphia.
• Midwest – Cincinnati Children’s Hospital Medical Center.
• New England – Boston Children’s Hospital.
• Pacific – Children’s Hospital Los Angeles.
• Rocky Mountains – Children’s Hospital Colorado.
• Southeast – Children’s Healthcare of Atlanta and Monroe Carell Jr. Children’s Hospital of Vanderbilt, in Nashville, Tenn.
• Southwest – Texas Children’s Hospital.

Specialties

Boston Children’s not only topped the overall list but also led in four specialties. For the other six specialties that were ranked, the top hospitals on the honor roll are as follows:

• Cancer – Children’s Hospital of Philadelphia.
• Cardiology and heart surgery – Texas Children’s Hospital.
• Diabetes and endocrinology – Children’s Hospital of Philadelphia.
• Gastroenterology and gastrointestinal surgery – Children’s Hospital Colorado.
• Neonatology – Children’s National Hospital.
• Orthopedics – Children’s Hospital of Philadelphia.

For the past 15 years, the objective of the rankings has been to offer a starting point for parents in making decisions about the best place to take very sick children for high-quality care. The editors of the rankings acknowledge that considerations of travel costs and insurance coverage are other factors to consider.
 

Helpful for families

The rankings are helpful for families, according to Joe W. St. Geme, III, MD, Children’s Hospital of Philadelphia’s physician-in-chief and chair of its department of pediatrics. “Some parents, especially those coming from outside an area, find them useful when deciding on care away from home,” he told this news organization. “Most types of pediatric care are available in the community, but sometimes a child has an unusual disease or complex disease for which local care is not available.”

Dr. St. Geme said the new regional rankings may be useful in helping parents decide where to bring a child for care that is closer to where they live.

A top ranking from U.S. News is just one indication of a hospital›s overall performance, according to Angela Lorts, MD, MBA, director of the Ventricular Assist Device Program, at Cincinnati Children’s Hospital Medical Center.

“Parents seeking care for their child should use the data to ask questions and understand the limitations,” she told this news organization. “Rankings are only based on a small subset of the children we care for. Many of the metrics may not pertain to their child and may not reflect the care they will receive.”

In her view, ranking will not give parents all the information they need about medical care and outcomes for specific conditions.
 

Hospital reaction

Hospitals can use the rankings to target improvements, says Dr. St. Geme. “These rankings can provide an opportunity for some benchmarking, to see what other institutions are doing and how they’re able to deliver care. They can serve as a source of ideas and can influence planning,” he said.

He cautioned that the data are not as complete as they could be. “A number of services are not included, and we try to keep that in mind,” he said.

Rankings may also affect recruitment, Dr. St. Geme added, because higher-ranked institutions may find it easier to attract sought-after clinicians and investigators in needed areas.

Another sphere of influence is philanthropy and fund raising. “People are much more likely to consider making both small and large donations to a high-ranked institution,” said J. Howard Smart, MD, chair of pediatrics at Sharp Rees-Stealy Medical Group and chair-elect of the physician leadership council at Sharp Mary Birch Hospital for Women and Newborns in San Diego.

Dr. St. Geme agrees. “Philanthropists are interested in making investments where they feel they’re a sure bet, and rankings may indicate a sure bet. But their impact on government funding and grant support is probably less.”

Ultimately, however, some families may not have lot of choice in where to go when their children are sick, Dr. Smart said. “And people probably don’t choose a location to live in based on nearby children’s hospitals the way they do for schools,” he said.

What about hospitals that continue to rank much lower on the 50-institution list – excellent though they must be to make it onto the honor roll. “To be on the list but not to have risen in rank in recent years might be a disappointment,” said Dr. St. Geme. “But it might also motivate a hospital to think about making internal investments in order to strengthen a particular service. And it may motivate nonranked hospitals to improve care in order to break into the list.”

Dr. Lorts points out that the annual survey process requires hospitals to track the clinical outcomes of a subset of patients, which may lead to improvement in these areas. It also requires data collection on structure and process, which drives needs assessments of select hospital areas. “But ideally, all hospitals would be tracking important outcomes, benchmarking to peer hospitals, and improving where needed without the U.S. News incentive,” she said.

This year’s data, compiled by research and consulting firm RTI International, derive from feedback on more than 1,200 questions provided by 118 responding institutions. Details on each hospital on the list and the methodology used in the analysis are available on U.S. News & World Report’s website.

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

For the eighth consecutive year, Boston Children’s Hospital has captured the no. 1 spot in the national honor roll of U.S. News & World Report’s Best Children’s Hospitals.

Released June 15, the 2021-2022 rankings, which acknowledge 50 U.S. centers for delivering exceptional care in several specialties, also give the Massachusetts hospital the top spot in 4 of 10 pediatric specialties assessed: nephrology, neurology and neurosurgery, pulmonology and lung surgery, and urology.

Children’s Hospital of Philadelphia retains second spot in the annually updated list, and Texas Children’s Hospital, in Houston, moves up a rung to third place, bumping Cincinnati Children’s Hospital Medical Center from third to fourth place. Children’s Hospital Los Angeles comes in at no. 5.

The remaining top 10 placements, in descending order, are as follows:

Children’s Hospital Colorado in Aurora; Children’s National Hospital in Washington; Nationwide Children’s Hospital in Columbus, Ohio; UPMS Children’s Hospital of Pittsburgh; and Lucile Packard Children’s Hospital Stanford (Calif.).
 

New regional rankings

This year’s edition offers something new, adding rankings within states and multiple-state rankings within seven regions to facilitate choice. “The Best Children’s Hospitals rankings have always highlighted hospitals that excel in specialized care,” said Ben Harder, chief of health analysis and managing editor at U.S. News, in a press release. “Now, this year’s new state and regional rankings can help families identify conveniently located hospitals capable of meeting their child’s needs. As the pandemic continues to affect travel, finding high-quality care close to home has never been more important.”

Across the seven regions, the top-ranked institutions are as follows:

• Mid-Atlantic – Children’s Hospital of Philadelphia.
• Midwest – Cincinnati Children’s Hospital Medical Center.
• New England – Boston Children’s Hospital.
• Pacific – Children’s Hospital Los Angeles.
• Rocky Mountains – Children’s Hospital Colorado.
• Southeast – Children’s Healthcare of Atlanta and Monroe Carell Jr. Children’s Hospital of Vanderbilt, in Nashville, Tenn.
• Southwest – Texas Children’s Hospital.

Specialties

Boston Children’s not only topped the overall list but also led in four specialties. For the other six specialties that were ranked, the top hospitals on the honor roll are as follows:

• Cancer – Children’s Hospital of Philadelphia.
• Cardiology and heart surgery – Texas Children’s Hospital.
• Diabetes and endocrinology – Children’s Hospital of Philadelphia.
• Gastroenterology and gastrointestinal surgery – Children’s Hospital Colorado.
• Neonatology – Children’s National Hospital.
• Orthopedics – Children’s Hospital of Philadelphia.

For the past 15 years, the objective of the rankings has been to offer a starting point for parents in making decisions about the best place to take very sick children for high-quality care. The editors of the rankings acknowledge that considerations of travel costs and insurance coverage are other factors to consider.
 

Helpful for families

The rankings are helpful for families, according to Joe W. St. Geme, III, MD, Children’s Hospital of Philadelphia’s physician-in-chief and chair of its department of pediatrics. “Some parents, especially those coming from outside an area, find them useful when deciding on care away from home,” he told this news organization. “Most types of pediatric care are available in the community, but sometimes a child has an unusual disease or complex disease for which local care is not available.”

Dr. St. Geme said the new regional rankings may be useful in helping parents decide where to bring a child for care that is closer to where they live.

A top ranking from U.S. News is just one indication of a hospital›s overall performance, according to Angela Lorts, MD, MBA, director of the Ventricular Assist Device Program, at Cincinnati Children’s Hospital Medical Center.

“Parents seeking care for their child should use the data to ask questions and understand the limitations,” she told this news organization. “Rankings are only based on a small subset of the children we care for. Many of the metrics may not pertain to their child and may not reflect the care they will receive.”

In her view, ranking will not give parents all the information they need about medical care and outcomes for specific conditions.
 

Hospital reaction

Hospitals can use the rankings to target improvements, says Dr. St. Geme. “These rankings can provide an opportunity for some benchmarking, to see what other institutions are doing and how they’re able to deliver care. They can serve as a source of ideas and can influence planning,” he said.

He cautioned that the data are not as complete as they could be. “A number of services are not included, and we try to keep that in mind,” he said.

Rankings may also affect recruitment, Dr. St. Geme added, because higher-ranked institutions may find it easier to attract sought-after clinicians and investigators in needed areas.

Another sphere of influence is philanthropy and fund raising. “People are much more likely to consider making both small and large donations to a high-ranked institution,” said J. Howard Smart, MD, chair of pediatrics at Sharp Rees-Stealy Medical Group and chair-elect of the physician leadership council at Sharp Mary Birch Hospital for Women and Newborns in San Diego.

Dr. St. Geme agrees. “Philanthropists are interested in making investments where they feel they’re a sure bet, and rankings may indicate a sure bet. But their impact on government funding and grant support is probably less.”

Ultimately, however, some families may not have lot of choice in where to go when their children are sick, Dr. Smart said. “And people probably don’t choose a location to live in based on nearby children’s hospitals the way they do for schools,” he said.

What about hospitals that continue to rank much lower on the 50-institution list – excellent though they must be to make it onto the honor roll. “To be on the list but not to have risen in rank in recent years might be a disappointment,” said Dr. St. Geme. “But it might also motivate a hospital to think about making internal investments in order to strengthen a particular service. And it may motivate nonranked hospitals to improve care in order to break into the list.”

Dr. Lorts points out that the annual survey process requires hospitals to track the clinical outcomes of a subset of patients, which may lead to improvement in these areas. It also requires data collection on structure and process, which drives needs assessments of select hospital areas. “But ideally, all hospitals would be tracking important outcomes, benchmarking to peer hospitals, and improving where needed without the U.S. News incentive,” she said.

This year’s data, compiled by research and consulting firm RTI International, derive from feedback on more than 1,200 questions provided by 118 responding institutions. Details on each hospital on the list and the methodology used in the analysis are available on U.S. News & World Report’s website.

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

The American Academy of Pediatrics now recommends against the routine administration of probiotics to preterm infants, particularly the most vulnerable (those whose birth weight is <1,000 g), for the treatment or prevention of necrotizing enterocolitis (NEC) and late-onset sepsis.

Although probiotics are increasingly given to preterm infants, the AAP notes that the data on their safety and efficacy are inconsistent. In addition, the supplements are not subject to approval by the Food and Drug Administration.

Therefore, the academy advises clinicians to use extreme caution in selecting preterm neonates to receive these microorganisms and recommends obtaining informed consent from parents after carefully discussing the risks. It also recommends that centers using probiotics conduct surveillance, inasmuch as probiotics can alter a center’s flora, potentially affecting all patients. Such centers should also carefully document outcomes, adverse events, and safety.

The AAP’s clinical report, published online May 24 in Pediatrics, highlights wide differences between commercially available formulations and a lack of regulatory standards in this country.

Absent FDA-approved drug labeling, these nutritional supplements cannot be marketed as treatment or prophylaxis, but that has scarcely stopped their use. “Despite lack of availability of a pharmaceutical-grade product, the number of preterm infants receiving probiotics in the United States and Canada is steadily increasing,” wrote Brenda Poindexter, MD, FAAP, chief of neonatology at Children’s Healthcare of Atlanta, and members of the AAP’s Committee on Fetus and Newborn.

Analyses of U.S. collaborative databases indicate that approximately 10% of neonates of extremely low gestational age receive a probiotic preparation in the neonatal intensive care unit (NICU). The use of these preparations varies widely across institutions.

“NEC is a devastating morbidity of prematurity, and it’s multifactorial. Some babies only given mother’s milk still get NEC, and the decision to use these products is a very nuanced one,” Dr. Poindexter said in an interview. “I suspect some people will disagree with the report, and we tried to give folks some wiggle room.”

Evidence from other countries suggests that probiotics can be protective against NEC, she added, “so not to have a reliable product in this country is very frustrating.”

Dr. Poindexter and colleagues pointed to a 2015 study that found that only 1 of 16 commercial products tested contained the exact organisms listed on their labels. One product contained none of the species listed on the label.

In light of increasing use, the AAP emphasizes the need for development of pharmaceutical-grade probiotics that would be rigorously evaluated for safety and efficacy.
 

The infant microbiome

Over the past decade, the gut microbiome has been increasingly recognized as a factor relevant to health and disease in preterm infants, the authors noted. Differences in the intestinal microbiota between full-term and preterm infants are substantial. The microbiome of preterm infants tends to include fewer bacterial species and greater proportions of potentially pathogenic strains.

Evidence of benefit from probiotics has been mixed. Some studies and pooled systematic analyses suggest a significant benefit. However, Dr. Poindexter and colleagues noted that some researchers express concerns about the study methods used, such as pooling results from trials that tested different probiotic strains or that had few infants in the highest risk category.

Whereas the potential for probiotic-related infection appears low, there does seem to be some risk for sepsis associated with colonization by a strain in a given product or from contamination with a pathogen during manufacturing, the report explains.

At least one trial found that a third of infants randomly assigned to receive placebo showed evidence of the probiotic strain.

“However, it may be difficult to distinguish the change in the infant from the change in the resident flora of the NICU,” the AAP panel wrote.

In addition, there have recently been several recalls of dietary supplement–grade probiotics for contamination, which have raised concerns. Pathogens include Salmonella, Rhizopus, and Penicillium species. Fatal gastrointestinal mucormycosis has also been reported in a preterm infant who received ABC Dophilus powder that was contaminated with the microfungus Rhizopus oryzae.

Other safety considerations, according to the authors, are the unknown longer-term effect of probiotics on preterm infants and the unknown impact of microorganisms on the microbiome over time.

Last year, the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition published a position paper with a conditional recommendation for selected probiotics to reduce NEC rates. “These guidelines would be applicable in the U.S. if we had products manufactured in a way that could guarantee that what’s on the label is in the bottle,” Dr. Poindexter said.

Asked for her perspective on the AAP clinical report, Erica Wymore, MD, assistant professor of neonatal and perinatal medicine at the University of Colorado at Denver, Aurora, called it “an excellent review of the current literature” that shows the inadequacy of data on the composition, dosage, timing, duration, and use of single-strain vs. multiple-strain probiotics to reduce NEC. Her clinical center, Children’s Hospital Colorado, does not administer probiotics to preterm babies.

Although guidelines can improve outcomes, said Dr. Wymore, who was not involved in the AAP report, improvement observed with probiotics results from more stringent care in centers that experience high NEC rates. “It’s hard to know if it’s due to the probiotics if they already have a high rate of NEC,” Dr. Wymore said.

She echoed the AAP’s position and stressed the need for extreme caution in giving these products to vulnerable infants with immature immune systems. Before that can be safely done, she said, “we need more FDA oversight of product composition [and] pharmaceutical-grade products, and more studies to determine efficacy.”

Added Dr. Poindexter: “Hopefully, this report will inform clinicians of the risks of using non–pharmaceutical-grade products and encourage industry to actually develop probiotics for neonates that we can feel comfortable using.”

The report received no external funding. Dr. Poindexter and Dr. Wymore have disclosed no relevant financial relationships.

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

The American Academy of Pediatrics now recommends against the routine administration of probiotics to preterm infants, particularly the most vulnerable (those whose birth weight is <1,000 g), for the treatment or prevention of necrotizing enterocolitis (NEC) and late-onset sepsis.

Although probiotics are increasingly given to preterm infants, the AAP notes that the data on their safety and efficacy are inconsistent. In addition, the supplements are not subject to approval by the Food and Drug Administration.

Therefore, the academy advises clinicians to use extreme caution in selecting preterm neonates to receive these microorganisms and recommends obtaining informed consent from parents after carefully discussing the risks. It also recommends that centers using probiotics conduct surveillance, inasmuch as probiotics can alter a center’s flora, potentially affecting all patients. Such centers should also carefully document outcomes, adverse events, and safety.

The AAP’s clinical report, published online May 24 in Pediatrics, highlights wide differences between commercially available formulations and a lack of regulatory standards in this country.

Absent FDA-approved drug labeling, these nutritional supplements cannot be marketed as treatment or prophylaxis, but that has scarcely stopped their use. “Despite lack of availability of a pharmaceutical-grade product, the number of preterm infants receiving probiotics in the United States and Canada is steadily increasing,” wrote Brenda Poindexter, MD, FAAP, chief of neonatology at Children’s Healthcare of Atlanta, and members of the AAP’s Committee on Fetus and Newborn.

Analyses of U.S. collaborative databases indicate that approximately 10% of neonates of extremely low gestational age receive a probiotic preparation in the neonatal intensive care unit (NICU). The use of these preparations varies widely across institutions.

“NEC is a devastating morbidity of prematurity, and it’s multifactorial. Some babies only given mother’s milk still get NEC, and the decision to use these products is a very nuanced one,” Dr. Poindexter said in an interview. “I suspect some people will disagree with the report, and we tried to give folks some wiggle room.”

Evidence from other countries suggests that probiotics can be protective against NEC, she added, “so not to have a reliable product in this country is very frustrating.”

Dr. Poindexter and colleagues pointed to a 2015 study that found that only 1 of 16 commercial products tested contained the exact organisms listed on their labels. One product contained none of the species listed on the label.

In light of increasing use, the AAP emphasizes the need for development of pharmaceutical-grade probiotics that would be rigorously evaluated for safety and efficacy.
 

The infant microbiome

Over the past decade, the gut microbiome has been increasingly recognized as a factor relevant to health and disease in preterm infants, the authors noted. Differences in the intestinal microbiota between full-term and preterm infants are substantial. The microbiome of preterm infants tends to include fewer bacterial species and greater proportions of potentially pathogenic strains.

Evidence of benefit from probiotics has been mixed. Some studies and pooled systematic analyses suggest a significant benefit. However, Dr. Poindexter and colleagues noted that some researchers express concerns about the study methods used, such as pooling results from trials that tested different probiotic strains or that had few infants in the highest risk category.

Whereas the potential for probiotic-related infection appears low, there does seem to be some risk for sepsis associated with colonization by a strain in a given product or from contamination with a pathogen during manufacturing, the report explains.

At least one trial found that a third of infants randomly assigned to receive placebo showed evidence of the probiotic strain.

“However, it may be difficult to distinguish the change in the infant from the change in the resident flora of the NICU,” the AAP panel wrote.

In addition, there have recently been several recalls of dietary supplement–grade probiotics for contamination, which have raised concerns. Pathogens include Salmonella, Rhizopus, and Penicillium species. Fatal gastrointestinal mucormycosis has also been reported in a preterm infant who received ABC Dophilus powder that was contaminated with the microfungus Rhizopus oryzae.

Other safety considerations, according to the authors, are the unknown longer-term effect of probiotics on preterm infants and the unknown impact of microorganisms on the microbiome over time.

Last year, the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition published a position paper with a conditional recommendation for selected probiotics to reduce NEC rates. “These guidelines would be applicable in the U.S. if we had products manufactured in a way that could guarantee that what’s on the label is in the bottle,” Dr. Poindexter said.

Asked for her perspective on the AAP clinical report, Erica Wymore, MD, assistant professor of neonatal and perinatal medicine at the University of Colorado at Denver, Aurora, called it “an excellent review of the current literature” that shows the inadequacy of data on the composition, dosage, timing, duration, and use of single-strain vs. multiple-strain probiotics to reduce NEC. Her clinical center, Children’s Hospital Colorado, does not administer probiotics to preterm babies.

Although guidelines can improve outcomes, said Dr. Wymore, who was not involved in the AAP report, improvement observed with probiotics results from more stringent care in centers that experience high NEC rates. “It’s hard to know if it’s due to the probiotics if they already have a high rate of NEC,” Dr. Wymore said.

She echoed the AAP’s position and stressed the need for extreme caution in giving these products to vulnerable infants with immature immune systems. Before that can be safely done, she said, “we need more FDA oversight of product composition [and] pharmaceutical-grade products, and more studies to determine efficacy.”

Added Dr. Poindexter: “Hopefully, this report will inform clinicians of the risks of using non–pharmaceutical-grade products and encourage industry to actually develop probiotics for neonates that we can feel comfortable using.”

The report received no external funding. Dr. Poindexter and Dr. Wymore have disclosed no relevant financial relationships.

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

The American Academy of Pediatrics now recommends against the routine administration of probiotics to preterm infants, particularly the most vulnerable (those whose birth weight is <1,000 g), for the treatment or prevention of necrotizing enterocolitis (NEC) and late-onset sepsis.

Although probiotics are increasingly given to preterm infants, the AAP notes that the data on their safety and efficacy are inconsistent. In addition, the supplements are not subject to approval by the Food and Drug Administration.

Therefore, the academy advises clinicians to use extreme caution in selecting preterm neonates to receive these microorganisms and recommends obtaining informed consent from parents after carefully discussing the risks. It also recommends that centers using probiotics conduct surveillance, inasmuch as probiotics can alter a center’s flora, potentially affecting all patients. Such centers should also carefully document outcomes, adverse events, and safety.

The AAP’s clinical report, published online May 24 in Pediatrics, highlights wide differences between commercially available formulations and a lack of regulatory standards in this country.

Absent FDA-approved drug labeling, these nutritional supplements cannot be marketed as treatment or prophylaxis, but that has scarcely stopped their use. “Despite lack of availability of a pharmaceutical-grade product, the number of preterm infants receiving probiotics in the United States and Canada is steadily increasing,” wrote Brenda Poindexter, MD, FAAP, chief of neonatology at Children’s Healthcare of Atlanta, and members of the AAP’s Committee on Fetus and Newborn.

Analyses of U.S. collaborative databases indicate that approximately 10% of neonates of extremely low gestational age receive a probiotic preparation in the neonatal intensive care unit (NICU). The use of these preparations varies widely across institutions.

“NEC is a devastating morbidity of prematurity, and it’s multifactorial. Some babies only given mother’s milk still get NEC, and the decision to use these products is a very nuanced one,” Dr. Poindexter said in an interview. “I suspect some people will disagree with the report, and we tried to give folks some wiggle room.”

Evidence from other countries suggests that probiotics can be protective against NEC, she added, “so not to have a reliable product in this country is very frustrating.”

Dr. Poindexter and colleagues pointed to a 2015 study that found that only 1 of 16 commercial products tested contained the exact organisms listed on their labels. One product contained none of the species listed on the label.

In light of increasing use, the AAP emphasizes the need for development of pharmaceutical-grade probiotics that would be rigorously evaluated for safety and efficacy.
 

The infant microbiome

Over the past decade, the gut microbiome has been increasingly recognized as a factor relevant to health and disease in preterm infants, the authors noted. Differences in the intestinal microbiota between full-term and preterm infants are substantial. The microbiome of preterm infants tends to include fewer bacterial species and greater proportions of potentially pathogenic strains.

Evidence of benefit from probiotics has been mixed. Some studies and pooled systematic analyses suggest a significant benefit. However, Dr. Poindexter and colleagues noted that some researchers express concerns about the study methods used, such as pooling results from trials that tested different probiotic strains or that had few infants in the highest risk category.

Whereas the potential for probiotic-related infection appears low, there does seem to be some risk for sepsis associated with colonization by a strain in a given product or from contamination with a pathogen during manufacturing, the report explains.

At least one trial found that a third of infants randomly assigned to receive placebo showed evidence of the probiotic strain.

“However, it may be difficult to distinguish the change in the infant from the change in the resident flora of the NICU,” the AAP panel wrote.

In addition, there have recently been several recalls of dietary supplement–grade probiotics for contamination, which have raised concerns. Pathogens include Salmonella, Rhizopus, and Penicillium species. Fatal gastrointestinal mucormycosis has also been reported in a preterm infant who received ABC Dophilus powder that was contaminated with the microfungus Rhizopus oryzae.

Other safety considerations, according to the authors, are the unknown longer-term effect of probiotics on preterm infants and the unknown impact of microorganisms on the microbiome over time.

Last year, the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition published a position paper with a conditional recommendation for selected probiotics to reduce NEC rates. “These guidelines would be applicable in the U.S. if we had products manufactured in a way that could guarantee that what’s on the label is in the bottle,” Dr. Poindexter said.

Asked for her perspective on the AAP clinical report, Erica Wymore, MD, assistant professor of neonatal and perinatal medicine at the University of Colorado at Denver, Aurora, called it “an excellent review of the current literature” that shows the inadequacy of data on the composition, dosage, timing, duration, and use of single-strain vs. multiple-strain probiotics to reduce NEC. Her clinical center, Children’s Hospital Colorado, does not administer probiotics to preterm babies.

Although guidelines can improve outcomes, said Dr. Wymore, who was not involved in the AAP report, improvement observed with probiotics results from more stringent care in centers that experience high NEC rates. “It’s hard to know if it’s due to the probiotics if they already have a high rate of NEC,” Dr. Wymore said.

She echoed the AAP’s position and stressed the need for extreme caution in giving these products to vulnerable infants with immature immune systems. Before that can be safely done, she said, “we need more FDA oversight of product composition [and] pharmaceutical-grade products, and more studies to determine efficacy.”

Added Dr. Poindexter: “Hopefully, this report will inform clinicians of the risks of using non–pharmaceutical-grade products and encourage industry to actually develop probiotics for neonates that we can feel comfortable using.”

The report received no external funding. Dr. Poindexter and Dr. Wymore have disclosed no relevant financial relationships.

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

A common cause of infant morbidity and hospitalization in developed countries, infant viral bronchiolitis, has long been bedeviled by treatment uncertainty beyond supportive care.

Rationales for most pharmacologic treatments continue to be debated, and clinical practice guidelines generally advise respiratory and hydration support, discouraging the use of chest radiography, albuterol, glucocorticoids, antibiotics, and epinephrine.

Despite evidence that the latter interventions are ineffective, they are still too often applied, according to two recent studies, one in Pediatrics, the other in JAMA Pediatrics.

“The pull of the therapeutic vacuum surrounding this disease has been noted in the pages of this journal for at least 50 years, with Wright and Beem writing in 1965 that ‘energies should not be frittered away by the annoyance of unnecessary or futile medications and procedures’ for the child with bronchiolitis,” said emergency physicians Matthew J. Lipshaw, MD, MS, of the Cincinnati Children’s Hospital Medical Center, and Todd A. Florin, MD, MSCE, of Ann and Robert H. Lurie Children’s Hospital of Chicago.

These remarks came in their editorial in Pediatrics wryly titled: “Don’t Just Do Something, Stand There” and published online to accompany a recent study of three network meta-analyses.

Led by Sarah A. Elliott, PhD, of the Alberta Research Centre for Health Evidence at the University of Alberta in Edmonton, this analysis amalgamated 150 randomized, controlled trials comparing a placebo or active comparator with any bronchodilator, glucocorticoid steroid, hypertonic saline solution, antibiotic, helium-oxygen therapy, or high-flow oxygen therapy. It then looked at the following outcomes in children aged 2 years and younger: hospital admission rate on day 1, hospital admission rate within 7 days, and total hospital length of stay.

Few treatments seemed more effective than nebulized placebo (0.9% saline) for short-term outcomes, the authors found. While nebulized epinephrine and nebulized hypertonic saline plus salbutamol appeared to reduce admission rates during the index ED presentation, and hypertonic saline, alone or in combination with epinephrine, seemed to reduce hospital stays, such treatment had no effect on admissions within 7 days of initial presentation. Furthermore, most benefits disappeared in higher-quality studies.

Concluding, albeit with weak evidence and low confidence, that some benefit might accrue with hypertonic saline with salbutamol to reduce admission rates on initial presentation to the ED, the authors called for well-designed studies on treatments in inpatients and outpatients.

According to Dr. Lipshaw, assistant professor of clinical pediatrics, the lack of benefit observed in superior studies limits the applicability of Dr. Elliott and colleagues’ results to immediate clinical practice. “These findings could be used, however, to target future high-quality studies toward the medications that they found might be useful,” he said in an interview.

For the present, other recent research augurs well for strategically reducing unnecessary care. In a paper published online in JAMA Pediatrics, Libby Haskell, MN, of the ED at Starship Children’s Hospital in Auckland, New Zealand, and associates reported on a cluster-randomized, controlled trial of targeted interventions.

Conducted in 2017 at 26 hospitals and with 3,727 babies in New Zealand and Australia, the study addressed drivers of non–evidence-based approaches with behavior-modifying approaches such as on-site clinical leads, stakeholder meetings, a train-the-trainer workshop, education, and audit and feedback.

The authors reported a 14.1% difference in rates of compliance during the first 24 hours of hospitalization favoring the intervention group for all five bronchiolitis guideline recommendations. The greatest change was seen in albuterol and chest radiography use, with other improvements in ED visits, inpatient consultations, and throughout hospitalization.

“These results provide clinicians and hospitals with clear implementation strategies to address unnecessary treatment of infants with bronchiolitis,” Dr. Haskell’s group wrote. Dr. Lipshaw agreed that multifaceted deimplementation packages including clinician and family education, audit and feedback, and clinical decision support have been successful. “Haskell et al. demonstrated that it is possible to successfully deimplement non–evidence-based practices for bronchiolitis with targeted inventions,” he said. “It would be wonderful to see their success replicated in the U.S.”


 

Why the slow adoption of guidelines?

The American Academy of Pediatrics issued bronchiolitis guidelines for babies to 23 months in 2014 and updated them in 2018. Why, then, has care in some centers been seemingly all over the map and counter to guidelines? “Both parents and clinicians are acting in what they believe to be the best interests of the child, and in the absence of high-value interventions, can feel the need to do something, even if that something is not supported by evidence,” Dr. Lipshaw said. 

Furthermore, with children in obvious distress, breathing fast and with difficulty, and sometimes unable to eat or drink, “we feel like we should have some way to make them feel better quicker. Unfortunately, none of the medications we have tried seem to be useful for most children, and we are left with supportive care measures such as suctioning their noses, giving them oxygen if their oxygen is low, and giving them fluids if they are dehydrated.”

Other physicians agree that taking a less-is-more approach can be challenging and even counterintuitive. “To families, seeing their child’s doctor ‘doing less’ can be frustrating,” admitted Diana S. Lee, MD, assistant professor of pediatrics at Icahn School of Medicine at Mount Sinai, New York.

Beyond that, altering practice behavior will need more than guidelines, Dr. Lee said in an interview. “Haskell et al. showed targeted behavior-change interventions improved compliance with bronchiolitis guidelines, but such change requires motivation and resources, and the sustainability of this effect over time remains to be seen.”

At Dr. Lipshaw’s institution, treatment depends on the attending physician, “but we have an emergency department care algorithm, which does not recommend any inhaled medications or steroids in accordance with the 2014 AAP guidelines,” he said.

Similarly at Mount Sinai, practitioners strive to follow the AAP guidelines, although their implementation has not been immediate, Dr. Lee said. “This is a situation where we must make the effort to choose not to do more, given current evidence.”

But Michelle Dunn, MD, an attending physician in the division of general pediatrics at the Children’s Hospital of Philadelphia, said the American practice norm already tends more to the observance than the breach of the guidelines, noting that since 2014 quality improvement efforts have been made throughout the country. “At our institution, we have effectively reduced the use of albuterol in patients with bronchiolitis and we use evidence-based therapy as much as possible, which in the case of bronchiolitis generally involves supportive management alone,” she said in an interview.

Still, Dr. Dunn added, many patients receive unnecessary diagnostic testing and ineffective therapies, with some providers facing psychological barriers to doing less. “However, with more and more evidence to support this, hopefully, physicians will become more comfortable with this.”

To that end, Dr. Lipshaw’s editorial urges physicians to “curb the rampant use of therapies repeatedly revealed to be ineffective,” citing team engagement, clear practice guidelines, and information technology as key factors in deimplementation. In the meantime, his mantra remains: “Don’t just do something, stand there.”

The study by Dr. Elliot and colleagues was supported by the Canadian Institutes of Health Research Knowledge Synthesis grant program. One coauthor is supported by a University of Ottawa Tier I Research Chair in Pediatric Emergency Medicine. Another is supported by a Tier 1 Canada Research Chair in Knowledge Synthesis and Translation and the Stollery Science Laboratory. Dr. Lipshaw and Dr. Florin disclosed no financial relationships relevant to their commentary. Dr. Haskell and colleagues were supported, variously, by the National Health and Medical Research Council of New Zealand, the Center of Research Excellence for Pediatric Emergency Medicine, the Victorian Government’s Operational Infrastructure Support Program, Cure Kids New Zealand, the Royal Children’s Hospital Foundation, and the Starship Foundation. Dr. Lee and Dr. Dunn had no competing interests to disclose with regard to their comments.

A common cause of infant morbidity and hospitalization in developed countries, infant viral bronchiolitis, has long been bedeviled by treatment uncertainty beyond supportive care.

Rationales for most pharmacologic treatments continue to be debated, and clinical practice guidelines generally advise respiratory and hydration support, discouraging the use of chest radiography, albuterol, glucocorticoids, antibiotics, and epinephrine.

Despite evidence that the latter interventions are ineffective, they are still too often applied, according to two recent studies, one in Pediatrics, the other in JAMA Pediatrics.

“The pull of the therapeutic vacuum surrounding this disease has been noted in the pages of this journal for at least 50 years, with Wright and Beem writing in 1965 that ‘energies should not be frittered away by the annoyance of unnecessary or futile medications and procedures’ for the child with bronchiolitis,” said emergency physicians Matthew J. Lipshaw, MD, MS, of the Cincinnati Children’s Hospital Medical Center, and Todd A. Florin, MD, MSCE, of Ann and Robert H. Lurie Children’s Hospital of Chicago.

These remarks came in their editorial in Pediatrics wryly titled: “Don’t Just Do Something, Stand There” and published online to accompany a recent study of three network meta-analyses.

Led by Sarah A. Elliott, PhD, of the Alberta Research Centre for Health Evidence at the University of Alberta in Edmonton, this analysis amalgamated 150 randomized, controlled trials comparing a placebo or active comparator with any bronchodilator, glucocorticoid steroid, hypertonic saline solution, antibiotic, helium-oxygen therapy, or high-flow oxygen therapy. It then looked at the following outcomes in children aged 2 years and younger: hospital admission rate on day 1, hospital admission rate within 7 days, and total hospital length of stay.

Few treatments seemed more effective than nebulized placebo (0.9% saline) for short-term outcomes, the authors found. While nebulized epinephrine and nebulized hypertonic saline plus salbutamol appeared to reduce admission rates during the index ED presentation, and hypertonic saline, alone or in combination with epinephrine, seemed to reduce hospital stays, such treatment had no effect on admissions within 7 days of initial presentation. Furthermore, most benefits disappeared in higher-quality studies.

Concluding, albeit with weak evidence and low confidence, that some benefit might accrue with hypertonic saline with salbutamol to reduce admission rates on initial presentation to the ED, the authors called for well-designed studies on treatments in inpatients and outpatients.

According to Dr. Lipshaw, assistant professor of clinical pediatrics, the lack of benefit observed in superior studies limits the applicability of Dr. Elliott and colleagues’ results to immediate clinical practice. “These findings could be used, however, to target future high-quality studies toward the medications that they found might be useful,” he said in an interview.

For the present, other recent research augurs well for strategically reducing unnecessary care. In a paper published online in JAMA Pediatrics, Libby Haskell, MN, of the ED at Starship Children’s Hospital in Auckland, New Zealand, and associates reported on a cluster-randomized, controlled trial of targeted interventions.

Conducted in 2017 at 26 hospitals and with 3,727 babies in New Zealand and Australia, the study addressed drivers of non–evidence-based approaches with behavior-modifying approaches such as on-site clinical leads, stakeholder meetings, a train-the-trainer workshop, education, and audit and feedback.

The authors reported a 14.1% difference in rates of compliance during the first 24 hours of hospitalization favoring the intervention group for all five bronchiolitis guideline recommendations. The greatest change was seen in albuterol and chest radiography use, with other improvements in ED visits, inpatient consultations, and throughout hospitalization.

“These results provide clinicians and hospitals with clear implementation strategies to address unnecessary treatment of infants with bronchiolitis,” Dr. Haskell’s group wrote. Dr. Lipshaw agreed that multifaceted deimplementation packages including clinician and family education, audit and feedback, and clinical decision support have been successful. “Haskell et al. demonstrated that it is possible to successfully deimplement non–evidence-based practices for bronchiolitis with targeted inventions,” he said. “It would be wonderful to see their success replicated in the U.S.”


 

Why the slow adoption of guidelines?

The American Academy of Pediatrics issued bronchiolitis guidelines for babies to 23 months in 2014 and updated them in 2018. Why, then, has care in some centers been seemingly all over the map and counter to guidelines? “Both parents and clinicians are acting in what they believe to be the best interests of the child, and in the absence of high-value interventions, can feel the need to do something, even if that something is not supported by evidence,” Dr. Lipshaw said. 

Furthermore, with children in obvious distress, breathing fast and with difficulty, and sometimes unable to eat or drink, “we feel like we should have some way to make them feel better quicker. Unfortunately, none of the medications we have tried seem to be useful for most children, and we are left with supportive care measures such as suctioning their noses, giving them oxygen if their oxygen is low, and giving them fluids if they are dehydrated.”

Other physicians agree that taking a less-is-more approach can be challenging and even counterintuitive. “To families, seeing their child’s doctor ‘doing less’ can be frustrating,” admitted Diana S. Lee, MD, assistant professor of pediatrics at Icahn School of Medicine at Mount Sinai, New York.

Beyond that, altering practice behavior will need more than guidelines, Dr. Lee said in an interview. “Haskell et al. showed targeted behavior-change interventions improved compliance with bronchiolitis guidelines, but such change requires motivation and resources, and the sustainability of this effect over time remains to be seen.”

At Dr. Lipshaw’s institution, treatment depends on the attending physician, “but we have an emergency department care algorithm, which does not recommend any inhaled medications or steroids in accordance with the 2014 AAP guidelines,” he said.

Similarly at Mount Sinai, practitioners strive to follow the AAP guidelines, although their implementation has not been immediate, Dr. Lee said. “This is a situation where we must make the effort to choose not to do more, given current evidence.”

But Michelle Dunn, MD, an attending physician in the division of general pediatrics at the Children’s Hospital of Philadelphia, said the American practice norm already tends more to the observance than the breach of the guidelines, noting that since 2014 quality improvement efforts have been made throughout the country. “At our institution, we have effectively reduced the use of albuterol in patients with bronchiolitis and we use evidence-based therapy as much as possible, which in the case of bronchiolitis generally involves supportive management alone,” she said in an interview.

Still, Dr. Dunn added, many patients receive unnecessary diagnostic testing and ineffective therapies, with some providers facing psychological barriers to doing less. “However, with more and more evidence to support this, hopefully, physicians will become more comfortable with this.”

To that end, Dr. Lipshaw’s editorial urges physicians to “curb the rampant use of therapies repeatedly revealed to be ineffective,” citing team engagement, clear practice guidelines, and information technology as key factors in deimplementation. In the meantime, his mantra remains: “Don’t just do something, stand there.”

The study by Dr. Elliot and colleagues was supported by the Canadian Institutes of Health Research Knowledge Synthesis grant program. One coauthor is supported by a University of Ottawa Tier I Research Chair in Pediatric Emergency Medicine. Another is supported by a Tier 1 Canada Research Chair in Knowledge Synthesis and Translation and the Stollery Science Laboratory. Dr. Lipshaw and Dr. Florin disclosed no financial relationships relevant to their commentary. Dr. Haskell and colleagues were supported, variously, by the National Health and Medical Research Council of New Zealand, the Center of Research Excellence for Pediatric Emergency Medicine, the Victorian Government’s Operational Infrastructure Support Program, Cure Kids New Zealand, the Royal Children’s Hospital Foundation, and the Starship Foundation. Dr. Lee and Dr. Dunn had no competing interests to disclose with regard to their comments.

A common cause of infant morbidity and hospitalization in developed countries, infant viral bronchiolitis, has long been bedeviled by treatment uncertainty beyond supportive care.

Rationales for most pharmacologic treatments continue to be debated, and clinical practice guidelines generally advise respiratory and hydration support, discouraging the use of chest radiography, albuterol, glucocorticoids, antibiotics, and epinephrine.

Despite evidence that the latter interventions are ineffective, they are still too often applied, according to two recent studies, one in Pediatrics, the other in JAMA Pediatrics.

“The pull of the therapeutic vacuum surrounding this disease has been noted in the pages of this journal for at least 50 years, with Wright and Beem writing in 1965 that ‘energies should not be frittered away by the annoyance of unnecessary or futile medications and procedures’ for the child with bronchiolitis,” said emergency physicians Matthew J. Lipshaw, MD, MS, of the Cincinnati Children’s Hospital Medical Center, and Todd A. Florin, MD, MSCE, of Ann and Robert H. Lurie Children’s Hospital of Chicago.

These remarks came in their editorial in Pediatrics wryly titled: “Don’t Just Do Something, Stand There” and published online to accompany a recent study of three network meta-analyses.

Led by Sarah A. Elliott, PhD, of the Alberta Research Centre for Health Evidence at the University of Alberta in Edmonton, this analysis amalgamated 150 randomized, controlled trials comparing a placebo or active comparator with any bronchodilator, glucocorticoid steroid, hypertonic saline solution, antibiotic, helium-oxygen therapy, or high-flow oxygen therapy. It then looked at the following outcomes in children aged 2 years and younger: hospital admission rate on day 1, hospital admission rate within 7 days, and total hospital length of stay.

Few treatments seemed more effective than nebulized placebo (0.9% saline) for short-term outcomes, the authors found. While nebulized epinephrine and nebulized hypertonic saline plus salbutamol appeared to reduce admission rates during the index ED presentation, and hypertonic saline, alone or in combination with epinephrine, seemed to reduce hospital stays, such treatment had no effect on admissions within 7 days of initial presentation. Furthermore, most benefits disappeared in higher-quality studies.

Concluding, albeit with weak evidence and low confidence, that some benefit might accrue with hypertonic saline with salbutamol to reduce admission rates on initial presentation to the ED, the authors called for well-designed studies on treatments in inpatients and outpatients.

According to Dr. Lipshaw, assistant professor of clinical pediatrics, the lack of benefit observed in superior studies limits the applicability of Dr. Elliott and colleagues’ results to immediate clinical practice. “These findings could be used, however, to target future high-quality studies toward the medications that they found might be useful,” he said in an interview.

For the present, other recent research augurs well for strategically reducing unnecessary care. In a paper published online in JAMA Pediatrics, Libby Haskell, MN, of the ED at Starship Children’s Hospital in Auckland, New Zealand, and associates reported on a cluster-randomized, controlled trial of targeted interventions.

Conducted in 2017 at 26 hospitals and with 3,727 babies in New Zealand and Australia, the study addressed drivers of non–evidence-based approaches with behavior-modifying approaches such as on-site clinical leads, stakeholder meetings, a train-the-trainer workshop, education, and audit and feedback.

The authors reported a 14.1% difference in rates of compliance during the first 24 hours of hospitalization favoring the intervention group for all five bronchiolitis guideline recommendations. The greatest change was seen in albuterol and chest radiography use, with other improvements in ED visits, inpatient consultations, and throughout hospitalization.

“These results provide clinicians and hospitals with clear implementation strategies to address unnecessary treatment of infants with bronchiolitis,” Dr. Haskell’s group wrote. Dr. Lipshaw agreed that multifaceted deimplementation packages including clinician and family education, audit and feedback, and clinical decision support have been successful. “Haskell et al. demonstrated that it is possible to successfully deimplement non–evidence-based practices for bronchiolitis with targeted inventions,” he said. “It would be wonderful to see their success replicated in the U.S.”


 

Why the slow adoption of guidelines?

The American Academy of Pediatrics issued bronchiolitis guidelines for babies to 23 months in 2014 and updated them in 2018. Why, then, has care in some centers been seemingly all over the map and counter to guidelines? “Both parents and clinicians are acting in what they believe to be the best interests of the child, and in the absence of high-value interventions, can feel the need to do something, even if that something is not supported by evidence,” Dr. Lipshaw said. 

Furthermore, with children in obvious distress, breathing fast and with difficulty, and sometimes unable to eat or drink, “we feel like we should have some way to make them feel better quicker. Unfortunately, none of the medications we have tried seem to be useful for most children, and we are left with supportive care measures such as suctioning their noses, giving them oxygen if their oxygen is low, and giving them fluids if they are dehydrated.”

Other physicians agree that taking a less-is-more approach can be challenging and even counterintuitive. “To families, seeing their child’s doctor ‘doing less’ can be frustrating,” admitted Diana S. Lee, MD, assistant professor of pediatrics at Icahn School of Medicine at Mount Sinai, New York.

Beyond that, altering practice behavior will need more than guidelines, Dr. Lee said in an interview. “Haskell et al. showed targeted behavior-change interventions improved compliance with bronchiolitis guidelines, but such change requires motivation and resources, and the sustainability of this effect over time remains to be seen.”

At Dr. Lipshaw’s institution, treatment depends on the attending physician, “but we have an emergency department care algorithm, which does not recommend any inhaled medications or steroids in accordance with the 2014 AAP guidelines,” he said.

Similarly at Mount Sinai, practitioners strive to follow the AAP guidelines, although their implementation has not been immediate, Dr. Lee said. “This is a situation where we must make the effort to choose not to do more, given current evidence.”

But Michelle Dunn, MD, an attending physician in the division of general pediatrics at the Children’s Hospital of Philadelphia, said the American practice norm already tends more to the observance than the breach of the guidelines, noting that since 2014 quality improvement efforts have been made throughout the country. “At our institution, we have effectively reduced the use of albuterol in patients with bronchiolitis and we use evidence-based therapy as much as possible, which in the case of bronchiolitis generally involves supportive management alone,” she said in an interview.

Still, Dr. Dunn added, many patients receive unnecessary diagnostic testing and ineffective therapies, with some providers facing psychological barriers to doing less. “However, with more and more evidence to support this, hopefully, physicians will become more comfortable with this.”

To that end, Dr. Lipshaw’s editorial urges physicians to “curb the rampant use of therapies repeatedly revealed to be ineffective,” citing team engagement, clear practice guidelines, and information technology as key factors in deimplementation. In the meantime, his mantra remains: “Don’t just do something, stand there.”

The study by Dr. Elliot and colleagues was supported by the Canadian Institutes of Health Research Knowledge Synthesis grant program. One coauthor is supported by a University of Ottawa Tier I Research Chair in Pediatric Emergency Medicine. Another is supported by a Tier 1 Canada Research Chair in Knowledge Synthesis and Translation and the Stollery Science Laboratory. Dr. Lipshaw and Dr. Florin disclosed no financial relationships relevant to their commentary. Dr. Haskell and colleagues were supported, variously, by the National Health and Medical Research Council of New Zealand, the Center of Research Excellence for Pediatric Emergency Medicine, the Victorian Government’s Operational Infrastructure Support Program, Cure Kids New Zealand, the Royal Children’s Hospital Foundation, and the Starship Foundation. Dr. Lee and Dr. Dunn had no competing interests to disclose with regard to their comments.

Delta-9-Tetrahydrocannabinol (THC), the main psychoactive component of cannabis, remains detectable in breast milk even after weeks of abstinence, new data show. The estimated half-life of THC in breast milk is 17 days, according to the study results, with a projected time to elimination of more than 6 weeks. The clinical importance of the remaining THC is up for debate, according to some experts.

“To limit THC effects on fetal brain development and promote safe breastfeeding, it is critical to emphasize marijuana abstention both early in pregnancy and post partum,” Erica M. Wymore, MD, MPH, an assistant professor of pediatrics and neonatology at the University of Colorado at Denver, Aurora, and colleagues wrote. The group published their results online March 8, 2021, in JAMA Pediatrics.

And while the study was a pharmacokinetic analysis rather than a safety investigation, Dr. Wymore said in an interview that the detectable levels of THC suggest any use is of concern and no safety thresholds have been established. “We wish we had more data on the potential effects on the neurocognitive development of children, but for now we must discourage any use in prepregnancy, pregnancy, and breastfeeding, as our national guidelines recommend.”

Therefore, the findings support current guidelines discouraging any cannabis use in mothers-to-be and breast-feeding mothers issued by national organizations, including those from the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the Academy of Breastfeeding Medicine.

Furthermore, the difficulties many mothers face in abstaining from marijuana, a commonly used drug in pregnancy, and the persistence of THC in maternal milk led the authors to question the feasibility of having women who use marijuana simply discard their breast milk until THC is cleared.

“We report challenges in abstention and prolonged excretion of THC in breast milk greater than 6 weeks among women with prenatal marijuana use,” they wrote. “These findings make the recommendations for mothers to discard breast milk until THC is undetectable unrealistic for mothers committed to breastfeeding.”

However, not all experts are equally concerned about low THC concentrations in breast milk. Neonatal pharmacologist Thomas R. Hale, PhD, a professor of pediatrics at Texas Tech University, Lubbock, said a previous study by his group showed that THC levels in maternal milk peaked within 60 minutes of a moderate dose of inhaled marijuana and fell to quite low levels over the next 4 hours. The highest concentration in maternal milk occurred shortly after the peak in plasma.

“So you can see that, just because a mom is drug screen positive, the clinical dose transferred to the infant is probably exceedingly low,” he said in an interview.

Dr. Hale also stressed that judgments about drugs in this context should weigh the risk of the drug against the risk of not breastfeeding. “All of us caution women not to use cannabis when pregnant or breastfeeding,” Dr. Hale said. “But when the decision has to be made as to whether a mom breastfeeds or not if she is drug screen positive, a lot of other factors must be analyzed to make such a decision.”
 

Study cohort

For the study, Dr. Wymore and colleagues screened 394 women who gave birth between Nov. 1, 2016, and June 30, 2019. Of those, 25 women, with a median age of 26 years, were eligible and enrolled. Inclusion criteria included known prenatal marijuana use, intention to breastfeed, and self-reported abstinence. Prenatal use primarily involved inhaling cannabis more than twice a week.

Of the 25 enrolled mothers, 12 who self-reported marijuana abstinence were in fact found to be abstinent according to the results of plasma analysis. Those who continued to use the substance were younger than the overall sample, with a median age of 21, and were less likely to have attended college (23%) than abstainers (58%).

The researchers prospectively collected data on self-reported marijuana usage and paired maternal plasma and breast milk samples several times a week. All participants had detectable THC in breast milk throughout the study. Initial median THC concentrations were 3.2 ng/mL (interquartile range, 1.2-6.8) within the first week after delivery. These increased to 5.5 ng/mL (IQR, 4.4-16.0) at 2 weeks and declined to 1.9 ng/mL (IQR, 1.1-4.3) at 6 weeks. In terms of ratio, the milk:plasma partition coefficient for THC was approximately 6:1 (IQR, 3.8:1-8.1:1).

Dr. Hale noted that, although THC was detectable in milk, the levels were exceedingly low. “This is where the risk assessment comes in. There’s a lot of hysteria in the cannabis field right now, and we’re going to need time and a lot more studies to really be able to predict any untoward complications.”

Dr. Wymore, however, countered that THC levels were low only in those who abstained and that her concerns relate not just to postpartum breast milk levels but the health effects on children of mothers’ cannabis use over the course of prepregnancy, pregnancy, and lactation. “[Dr. Hale’s] message makes it difficult for clinicians to counsel mothers since it goes against national guidelines,” she said. “We need to be consistent.”

But Dr. Wymore and other experts acknowledge the dilemma faced in that breast milk clearly offers substantial benefits for infant and child health. “The risks of an infant’s exposure to marijuana versus the benefit of breast milk must be considered,” said Amy B. Hair, MD, assistant professor of pediatrics and neonatal medicine at Baylor College of Medicine, Houston, who was not involved in the Colorado study. “And it’s unrealistic, as the study suggests, for mothers to discard breast milk for 6 weeks.”

Nevertheless, calling the findings of THC persistence after abstinence “troublesome,” Dr. Hair said the legalization of marijuana in some states gives the public the impression it’s safe to use marijuana even during pregnancy and lactation. “Research studies, however, are concerning for potential detrimental effects on brain growth and development in infants whose mothers use marijuana during pregnancy and breastfeeding,” she added.

Dr. Wymore stressed that more U.S. cannabis dispensaries must engage in rigorous point-of-sale counseling to women on the potential harms during pregnancy. This is the case in Canada, she noted, where recreational and medicinal cannabis has been legal since 2018 and more than 90% of outlets (vs. two thirds of their U.S. counterparts) advise women not to use cannabis during pregnancy or lactation, even for nausea.

“This is where many women are getting their information on cannabis,” she said. “We learned the hard way with alcohol and we don’t want to make the same mistake with marijuana.”

The study was funded by the Colorado Department of Public Health and Environment, the Children’s Hospital Colorado Research Institute, the Colorado Fetal Care Center, the Colorado Perinatal Clinical and Translational Research Center, and the Children’s Colorado Research Institute. Two study coauthors disclosed relationships with the private sector outside the submitted work. Dr. Hale and Dr. Hair have disclosed no competing interests with regard to their comments.

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

Delta-9-Tetrahydrocannabinol (THC), the main psychoactive component of cannabis, remains detectable in breast milk even after weeks of abstinence, new data show. The estimated half-life of THC in breast milk is 17 days, according to the study results, with a projected time to elimination of more than 6 weeks. The clinical importance of the remaining THC is up for debate, according to some experts.

“To limit THC effects on fetal brain development and promote safe breastfeeding, it is critical to emphasize marijuana abstention both early in pregnancy and post partum,” Erica M. Wymore, MD, MPH, an assistant professor of pediatrics and neonatology at the University of Colorado at Denver, Aurora, and colleagues wrote. The group published their results online March 8, 2021, in JAMA Pediatrics.

And while the study was a pharmacokinetic analysis rather than a safety investigation, Dr. Wymore said in an interview that the detectable levels of THC suggest any use is of concern and no safety thresholds have been established. “We wish we had more data on the potential effects on the neurocognitive development of children, but for now we must discourage any use in prepregnancy, pregnancy, and breastfeeding, as our national guidelines recommend.”

Therefore, the findings support current guidelines discouraging any cannabis use in mothers-to-be and breast-feeding mothers issued by national organizations, including those from the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the Academy of Breastfeeding Medicine.

Furthermore, the difficulties many mothers face in abstaining from marijuana, a commonly used drug in pregnancy, and the persistence of THC in maternal milk led the authors to question the feasibility of having women who use marijuana simply discard their breast milk until THC is cleared.

“We report challenges in abstention and prolonged excretion of THC in breast milk greater than 6 weeks among women with prenatal marijuana use,” they wrote. “These findings make the recommendations for mothers to discard breast milk until THC is undetectable unrealistic for mothers committed to breastfeeding.”

However, not all experts are equally concerned about low THC concentrations in breast milk. Neonatal pharmacologist Thomas R. Hale, PhD, a professor of pediatrics at Texas Tech University, Lubbock, said a previous study by his group showed that THC levels in maternal milk peaked within 60 minutes of a moderate dose of inhaled marijuana and fell to quite low levels over the next 4 hours. The highest concentration in maternal milk occurred shortly after the peak in plasma.

“So you can see that, just because a mom is drug screen positive, the clinical dose transferred to the infant is probably exceedingly low,” he said in an interview.

Dr. Hale also stressed that judgments about drugs in this context should weigh the risk of the drug against the risk of not breastfeeding. “All of us caution women not to use cannabis when pregnant or breastfeeding,” Dr. Hale said. “But when the decision has to be made as to whether a mom breastfeeds or not if she is drug screen positive, a lot of other factors must be analyzed to make such a decision.”
 

Study cohort

For the study, Dr. Wymore and colleagues screened 394 women who gave birth between Nov. 1, 2016, and June 30, 2019. Of those, 25 women, with a median age of 26 years, were eligible and enrolled. Inclusion criteria included known prenatal marijuana use, intention to breastfeed, and self-reported abstinence. Prenatal use primarily involved inhaling cannabis more than twice a week.

Of the 25 enrolled mothers, 12 who self-reported marijuana abstinence were in fact found to be abstinent according to the results of plasma analysis. Those who continued to use the substance were younger than the overall sample, with a median age of 21, and were less likely to have attended college (23%) than abstainers (58%).

The researchers prospectively collected data on self-reported marijuana usage and paired maternal plasma and breast milk samples several times a week. All participants had detectable THC in breast milk throughout the study. Initial median THC concentrations were 3.2 ng/mL (interquartile range, 1.2-6.8) within the first week after delivery. These increased to 5.5 ng/mL (IQR, 4.4-16.0) at 2 weeks and declined to 1.9 ng/mL (IQR, 1.1-4.3) at 6 weeks. In terms of ratio, the milk:plasma partition coefficient for THC was approximately 6:1 (IQR, 3.8:1-8.1:1).

Dr. Hale noted that, although THC was detectable in milk, the levels were exceedingly low. “This is where the risk assessment comes in. There’s a lot of hysteria in the cannabis field right now, and we’re going to need time and a lot more studies to really be able to predict any untoward complications.”

Dr. Wymore, however, countered that THC levels were low only in those who abstained and that her concerns relate not just to postpartum breast milk levels but the health effects on children of mothers’ cannabis use over the course of prepregnancy, pregnancy, and lactation. “[Dr. Hale’s] message makes it difficult for clinicians to counsel mothers since it goes against national guidelines,” she said. “We need to be consistent.”

But Dr. Wymore and other experts acknowledge the dilemma faced in that breast milk clearly offers substantial benefits for infant and child health. “The risks of an infant’s exposure to marijuana versus the benefit of breast milk must be considered,” said Amy B. Hair, MD, assistant professor of pediatrics and neonatal medicine at Baylor College of Medicine, Houston, who was not involved in the Colorado study. “And it’s unrealistic, as the study suggests, for mothers to discard breast milk for 6 weeks.”

Nevertheless, calling the findings of THC persistence after abstinence “troublesome,” Dr. Hair said the legalization of marijuana in some states gives the public the impression it’s safe to use marijuana even during pregnancy and lactation. “Research studies, however, are concerning for potential detrimental effects on brain growth and development in infants whose mothers use marijuana during pregnancy and breastfeeding,” she added.

Dr. Wymore stressed that more U.S. cannabis dispensaries must engage in rigorous point-of-sale counseling to women on the potential harms during pregnancy. This is the case in Canada, she noted, where recreational and medicinal cannabis has been legal since 2018 and more than 90% of outlets (vs. two thirds of their U.S. counterparts) advise women not to use cannabis during pregnancy or lactation, even for nausea.

“This is where many women are getting their information on cannabis,” she said. “We learned the hard way with alcohol and we don’t want to make the same mistake with marijuana.”

The study was funded by the Colorado Department of Public Health and Environment, the Children’s Hospital Colorado Research Institute, the Colorado Fetal Care Center, the Colorado Perinatal Clinical and Translational Research Center, and the Children’s Colorado Research Institute. Two study coauthors disclosed relationships with the private sector outside the submitted work. Dr. Hale and Dr. Hair have disclosed no competing interests with regard to their comments.

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

Delta-9-Tetrahydrocannabinol (THC), the main psychoactive component of cannabis, remains detectable in breast milk even after weeks of abstinence, new data show. The estimated half-life of THC in breast milk is 17 days, according to the study results, with a projected time to elimination of more than 6 weeks. The clinical importance of the remaining THC is up for debate, according to some experts.

“To limit THC effects on fetal brain development and promote safe breastfeeding, it is critical to emphasize marijuana abstention both early in pregnancy and post partum,” Erica M. Wymore, MD, MPH, an assistant professor of pediatrics and neonatology at the University of Colorado at Denver, Aurora, and colleagues wrote. The group published their results online March 8, 2021, in JAMA Pediatrics.

And while the study was a pharmacokinetic analysis rather than a safety investigation, Dr. Wymore said in an interview that the detectable levels of THC suggest any use is of concern and no safety thresholds have been established. “We wish we had more data on the potential effects on the neurocognitive development of children, but for now we must discourage any use in prepregnancy, pregnancy, and breastfeeding, as our national guidelines recommend.”

Therefore, the findings support current guidelines discouraging any cannabis use in mothers-to-be and breast-feeding mothers issued by national organizations, including those from the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the Academy of Breastfeeding Medicine.

Furthermore, the difficulties many mothers face in abstaining from marijuana, a commonly used drug in pregnancy, and the persistence of THC in maternal milk led the authors to question the feasibility of having women who use marijuana simply discard their breast milk until THC is cleared.

“We report challenges in abstention and prolonged excretion of THC in breast milk greater than 6 weeks among women with prenatal marijuana use,” they wrote. “These findings make the recommendations for mothers to discard breast milk until THC is undetectable unrealistic for mothers committed to breastfeeding.”

However, not all experts are equally concerned about low THC concentrations in breast milk. Neonatal pharmacologist Thomas R. Hale, PhD, a professor of pediatrics at Texas Tech University, Lubbock, said a previous study by his group showed that THC levels in maternal milk peaked within 60 minutes of a moderate dose of inhaled marijuana and fell to quite low levels over the next 4 hours. The highest concentration in maternal milk occurred shortly after the peak in plasma.

“So you can see that, just because a mom is drug screen positive, the clinical dose transferred to the infant is probably exceedingly low,” he said in an interview.

Dr. Hale also stressed that judgments about drugs in this context should weigh the risk of the drug against the risk of not breastfeeding. “All of us caution women not to use cannabis when pregnant or breastfeeding,” Dr. Hale said. “But when the decision has to be made as to whether a mom breastfeeds or not if she is drug screen positive, a lot of other factors must be analyzed to make such a decision.”
 

Study cohort

For the study, Dr. Wymore and colleagues screened 394 women who gave birth between Nov. 1, 2016, and June 30, 2019. Of those, 25 women, with a median age of 26 years, were eligible and enrolled. Inclusion criteria included known prenatal marijuana use, intention to breastfeed, and self-reported abstinence. Prenatal use primarily involved inhaling cannabis more than twice a week.

Of the 25 enrolled mothers, 12 who self-reported marijuana abstinence were in fact found to be abstinent according to the results of plasma analysis. Those who continued to use the substance were younger than the overall sample, with a median age of 21, and were less likely to have attended college (23%) than abstainers (58%).

The researchers prospectively collected data on self-reported marijuana usage and paired maternal plasma and breast milk samples several times a week. All participants had detectable THC in breast milk throughout the study. Initial median THC concentrations were 3.2 ng/mL (interquartile range, 1.2-6.8) within the first week after delivery. These increased to 5.5 ng/mL (IQR, 4.4-16.0) at 2 weeks and declined to 1.9 ng/mL (IQR, 1.1-4.3) at 6 weeks. In terms of ratio, the milk:plasma partition coefficient for THC was approximately 6:1 (IQR, 3.8:1-8.1:1).

Dr. Hale noted that, although THC was detectable in milk, the levels were exceedingly low. “This is where the risk assessment comes in. There’s a lot of hysteria in the cannabis field right now, and we’re going to need time and a lot more studies to really be able to predict any untoward complications.”

Dr. Wymore, however, countered that THC levels were low only in those who abstained and that her concerns relate not just to postpartum breast milk levels but the health effects on children of mothers’ cannabis use over the course of prepregnancy, pregnancy, and lactation. “[Dr. Hale’s] message makes it difficult for clinicians to counsel mothers since it goes against national guidelines,” she said. “We need to be consistent.”

But Dr. Wymore and other experts acknowledge the dilemma faced in that breast milk clearly offers substantial benefits for infant and child health. “The risks of an infant’s exposure to marijuana versus the benefit of breast milk must be considered,” said Amy B. Hair, MD, assistant professor of pediatrics and neonatal medicine at Baylor College of Medicine, Houston, who was not involved in the Colorado study. “And it’s unrealistic, as the study suggests, for mothers to discard breast milk for 6 weeks.”

Nevertheless, calling the findings of THC persistence after abstinence “troublesome,” Dr. Hair said the legalization of marijuana in some states gives the public the impression it’s safe to use marijuana even during pregnancy and lactation. “Research studies, however, are concerning for potential detrimental effects on brain growth and development in infants whose mothers use marijuana during pregnancy and breastfeeding,” she added.

Dr. Wymore stressed that more U.S. cannabis dispensaries must engage in rigorous point-of-sale counseling to women on the potential harms during pregnancy. This is the case in Canada, she noted, where recreational and medicinal cannabis has been legal since 2018 and more than 90% of outlets (vs. two thirds of their U.S. counterparts) advise women not to use cannabis during pregnancy or lactation, even for nausea.

“This is where many women are getting their information on cannabis,” she said. “We learned the hard way with alcohol and we don’t want to make the same mistake with marijuana.”

The study was funded by the Colorado Department of Public Health and Environment, the Children’s Hospital Colorado Research Institute, the Colorado Fetal Care Center, the Colorado Perinatal Clinical and Translational Research Center, and the Children’s Colorado Research Institute. Two study coauthors disclosed relationships with the private sector outside the submitted work. Dr. Hale and Dr. Hair have disclosed no competing interests with regard to their comments.

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

It’s bad enough that this month’s historic snowstorm left ordinary Texans scrambling for heat and resorting to melted snow for drinking, washing, and flushing. But what about hospitals, where sanitation is paramount and ample water is a sine qua non?

As pipes burst, pumps froze, and water pressure plummeted, patient care was affected as well as maintenance, food preparation, laundry, and heat. To counter the problems, several Texas hospitals stepped up to the plate with inventive responses.

In Houston, Texas’s largest city and no stranger to natural disasters, such as from Hurricanes Ike and Harvey, water pressure in the municipal supply system dropped after the Feb. 13 storm, creating a series of problems for some of Houston Methodist’s eight-hospital network. “At the worst point, two of our hospitals, Houston Methodist West and Houston Methodist Baytown, had no city water supply, one for over 48 hours and the other for 72 hours,” said Marc L. Boom, MD, MBA, Houston Methodist’s president and CEO.

Although the main hospital had a reserve supply of potable water, a supply of water for laundry, cooking, and cleaning was another matter. “We introduced significant water restrictions and had to have 6,000-gallon tankers bring in extra water,” Dr. Boom said.

One hospital in the network got creative. When it rained the day after the ice storm, the staff rigged up a rain collection system using the huge bins that move linens around the hospital to collect nonpotable water for cleaning and flushing toilets, Dr. Boom said. Another hospital was able to provide showers for staff by bringing in bathroom trailers with self-contained water supplies of the kind used at some sporting events.

And at some facilities, patients were discharged into the lobby as they could not return home with transportation, electricity, and water systems crippled. With widespread challenges continuing, even as temperatures warmed, President Biden signed a major disaster declaration Feb. 20 that will provide emergency assistance to residents and businesses in more than a third of Texas counties, including those surrounding Houston, Dallas, and Austin.

Although conditions forced the rescheduling of some nonemergent surgeries, the water shortage had no impact on COVID-19 care, except for the unavailability of showers in the case of mobile patients. “At the worst, they just had to use bucket flushing for the toilets,” Dr. Boom said.

And in an unexpected win, when a Harris County freezer for COVID-19 vaccine storage failed and threatened to spoil 8,400 precious doses, Dr. Boom’s center was able to take delivery on 1,000 doses and administer them in 3 hours at a hastily set up ad hoc immunization center. 

In all this, the lessons of the pandemic had a positive preparatory role. “2020 taught us to be agile as things change and to align our goals across different medical teams,” said Ben Saldana, MD, medical director of Houston Methodist’s emergency care centers. “And we were prepared for hurricanes, but not for snow.”
 

Increased pressure on emergency departments

As the outages continued and stress levels in the community rose, the network started seeing exacerbations of chronic conditions after the power shut-down incapacitated electrical devices running machines for heart assistance, oxygen delivery, and sleep apnea. “We started seeing food-borne illness and carbon monoxide poisoning, as well as more heart attacks, strokes, and sepsis,” Dr. Saldana said.

One serious strain on the network’s main hospital was the sudden need to accommodate large numbers of patients on dialysis, a procedure that uses a lot of water and is typically performed in small, vulnerable community facilities with limited infrastructure and no generators. “The hospitals are their backup and act as a safety net for them,” Boom said. Some hospital areas generally used for other types of conditions had to be marshaled for renal care.

Emergency rooms became pop-up dialysis centers, Dr. Saldana said. “And if the water pressure dropped, we had to cut dialysis time from the standard 4 hours to 2. That’s like putting a band-aid on patients.”

Fortunately, municipal water pressure in the Houston area has steadily risen and is almost back to normal. And according to Dr. Boom, the brutal storm may yet have a silver lining: a decline in county coronavirus cases as the storm and icy road conditions forced people to stay sequestered at home.

Further north in Austin, a number of hospitals lost municipal water pressure, creating a series of problems. Among them was St. David’s South Austin Medical Center, at which, according to reports in the Austin American-Statesman, staff members were at one point asked to use trash bags to remove waste from toilets, to refrain from showering, and to clean their hands only with sanitizer.

A statement issued by David Huffstutler, CEO of St. David’s HealthCare, acknowledged that the heating system is based on a water-fed boiler. When the building lost heat owing to lack of water, some patients had to be transferred elsewhere or discharged. The hospital distributed jugs and bottles of water for handwashing and drinking, and was working with city officials to obtain portable toilets.

Meanwhile, officials at Austin’s Dell Children’s Medical Center acknowledged in a memo that its toilets no longer had “flushing capabilities.” Other area hospitals in the Ascension Seton network were also suffering from compromised water supplies last week, according to local news reports.

Washroom facilities were affected elsewhere as well. A post on a medical association Facebook page referred to a memo ordering staff to use a single toilet in an outpatient area for bowel movements and warned them to limit their time there. No paper or other products were to be used in other toilets designated for urination.
 

‘The pandemic was the prelude to the ice storm’

Some hospitals fared better. Along the Coastal Bend, Corpus Christi Medical Center managed to maintain its electricity and water supply to ensure continuity of hospital services after the storm, according to a statement.

But back in Houston, Liz Youngblood, MBA, RN, president of Baylor St. Luke’s Medical Center, said a number of hospitals in her network experienced low water pressure after the storm.

“Fortunately, we had water conservation measures and low-water alerts in place for such emergencies,” she said. “And we rely on water tankers to help maintain enough pressure for the basics.”

Some of the challenges posed by the storm are quite similar to what St. Luke’s faced after Hurricane Harvey in 2017. “We had already made plans to address them and so we felt prepared,” Ms. Youngblood said.

And thanks to COVID-19, Texas hospitals have been operating in crisis mode for the past year. “The pandemic was the prelude to the ice storm,” said Gina Blocker, MD, a St. Luke’s ED physician, “so we had measures and teams in place. We did have some reduction in water pressure, though the pressure was still good.”

But the hospital was inundated with patients looking for shelter. “Some were just scared about what might happen to them if their heat didn’t come back on and they wanted to be where they could get care,” Dr. Blocker said. Others came in with expected storm-related injuries such as hypothermia and carbon monoxide poisoning.

According to Ms. Youngblood, little compromise in patient care was necessary except for the cancellation of some operations and vaccinations owing to the treacherous travel conditions. “But one of the biggest remaining issues is that we need plenty of blood, so we’re encouraging people to donate at their local centers.”

A version of this article first appeared on Medscape.com

It’s bad enough that this month’s historic snowstorm left ordinary Texans scrambling for heat and resorting to melted snow for drinking, washing, and flushing. But what about hospitals, where sanitation is paramount and ample water is a sine qua non?

As pipes burst, pumps froze, and water pressure plummeted, patient care was affected as well as maintenance, food preparation, laundry, and heat. To counter the problems, several Texas hospitals stepped up to the plate with inventive responses.

In Houston, Texas’s largest city and no stranger to natural disasters, such as from Hurricanes Ike and Harvey, water pressure in the municipal supply system dropped after the Feb. 13 storm, creating a series of problems for some of Houston Methodist’s eight-hospital network. “At the worst point, two of our hospitals, Houston Methodist West and Houston Methodist Baytown, had no city water supply, one for over 48 hours and the other for 72 hours,” said Marc L. Boom, MD, MBA, Houston Methodist’s president and CEO.

Although the main hospital had a reserve supply of potable water, a supply of water for laundry, cooking, and cleaning was another matter. “We introduced significant water restrictions and had to have 6,000-gallon tankers bring in extra water,” Dr. Boom said.

One hospital in the network got creative. When it rained the day after the ice storm, the staff rigged up a rain collection system using the huge bins that move linens around the hospital to collect nonpotable water for cleaning and flushing toilets, Dr. Boom said. Another hospital was able to provide showers for staff by bringing in bathroom trailers with self-contained water supplies of the kind used at some sporting events.

And at some facilities, patients were discharged into the lobby as they could not return home with transportation, electricity, and water systems crippled. With widespread challenges continuing, even as temperatures warmed, President Biden signed a major disaster declaration Feb. 20 that will provide emergency assistance to residents and businesses in more than a third of Texas counties, including those surrounding Houston, Dallas, and Austin.

Although conditions forced the rescheduling of some nonemergent surgeries, the water shortage had no impact on COVID-19 care, except for the unavailability of showers in the case of mobile patients. “At the worst, they just had to use bucket flushing for the toilets,” Dr. Boom said.

And in an unexpected win, when a Harris County freezer for COVID-19 vaccine storage failed and threatened to spoil 8,400 precious doses, Dr. Boom’s center was able to take delivery on 1,000 doses and administer them in 3 hours at a hastily set up ad hoc immunization center. 

In all this, the lessons of the pandemic had a positive preparatory role. “2020 taught us to be agile as things change and to align our goals across different medical teams,” said Ben Saldana, MD, medical director of Houston Methodist’s emergency care centers. “And we were prepared for hurricanes, but not for snow.”
 

Increased pressure on emergency departments

As the outages continued and stress levels in the community rose, the network started seeing exacerbations of chronic conditions after the power shut-down incapacitated electrical devices running machines for heart assistance, oxygen delivery, and sleep apnea. “We started seeing food-borne illness and carbon monoxide poisoning, as well as more heart attacks, strokes, and sepsis,” Dr. Saldana said.

One serious strain on the network’s main hospital was the sudden need to accommodate large numbers of patients on dialysis, a procedure that uses a lot of water and is typically performed in small, vulnerable community facilities with limited infrastructure and no generators. “The hospitals are their backup and act as a safety net for them,” Boom said. Some hospital areas generally used for other types of conditions had to be marshaled for renal care.

Emergency rooms became pop-up dialysis centers, Dr. Saldana said. “And if the water pressure dropped, we had to cut dialysis time from the standard 4 hours to 2. That’s like putting a band-aid on patients.”

Fortunately, municipal water pressure in the Houston area has steadily risen and is almost back to normal. And according to Dr. Boom, the brutal storm may yet have a silver lining: a decline in county coronavirus cases as the storm and icy road conditions forced people to stay sequestered at home.

Further north in Austin, a number of hospitals lost municipal water pressure, creating a series of problems. Among them was St. David’s South Austin Medical Center, at which, according to reports in the Austin American-Statesman, staff members were at one point asked to use trash bags to remove waste from toilets, to refrain from showering, and to clean their hands only with sanitizer.

A statement issued by David Huffstutler, CEO of St. David’s HealthCare, acknowledged that the heating system is based on a water-fed boiler. When the building lost heat owing to lack of water, some patients had to be transferred elsewhere or discharged. The hospital distributed jugs and bottles of water for handwashing and drinking, and was working with city officials to obtain portable toilets.

Meanwhile, officials at Austin’s Dell Children’s Medical Center acknowledged in a memo that its toilets no longer had “flushing capabilities.” Other area hospitals in the Ascension Seton network were also suffering from compromised water supplies last week, according to local news reports.

Washroom facilities were affected elsewhere as well. A post on a medical association Facebook page referred to a memo ordering staff to use a single toilet in an outpatient area for bowel movements and warned them to limit their time there. No paper or other products were to be used in other toilets designated for urination.
 

‘The pandemic was the prelude to the ice storm’

Some hospitals fared better. Along the Coastal Bend, Corpus Christi Medical Center managed to maintain its electricity and water supply to ensure continuity of hospital services after the storm, according to a statement.

But back in Houston, Liz Youngblood, MBA, RN, president of Baylor St. Luke’s Medical Center, said a number of hospitals in her network experienced low water pressure after the storm.

“Fortunately, we had water conservation measures and low-water alerts in place for such emergencies,” she said. “And we rely on water tankers to help maintain enough pressure for the basics.”

Some of the challenges posed by the storm are quite similar to what St. Luke’s faced after Hurricane Harvey in 2017. “We had already made plans to address them and so we felt prepared,” Ms. Youngblood said.

And thanks to COVID-19, Texas hospitals have been operating in crisis mode for the past year. “The pandemic was the prelude to the ice storm,” said Gina Blocker, MD, a St. Luke’s ED physician, “so we had measures and teams in place. We did have some reduction in water pressure, though the pressure was still good.”

But the hospital was inundated with patients looking for shelter. “Some were just scared about what might happen to them if their heat didn’t come back on and they wanted to be where they could get care,” Dr. Blocker said. Others came in with expected storm-related injuries such as hypothermia and carbon monoxide poisoning.

According to Ms. Youngblood, little compromise in patient care was necessary except for the cancellation of some operations and vaccinations owing to the treacherous travel conditions. “But one of the biggest remaining issues is that we need plenty of blood, so we’re encouraging people to donate at their local centers.”

A version of this article first appeared on Medscape.com

It’s bad enough that this month’s historic snowstorm left ordinary Texans scrambling for heat and resorting to melted snow for drinking, washing, and flushing. But what about hospitals, where sanitation is paramount and ample water is a sine qua non?

As pipes burst, pumps froze, and water pressure plummeted, patient care was affected as well as maintenance, food preparation, laundry, and heat. To counter the problems, several Texas hospitals stepped up to the plate with inventive responses.

In Houston, Texas’s largest city and no stranger to natural disasters, such as from Hurricanes Ike and Harvey, water pressure in the municipal supply system dropped after the Feb. 13 storm, creating a series of problems for some of Houston Methodist’s eight-hospital network. “At the worst point, two of our hospitals, Houston Methodist West and Houston Methodist Baytown, had no city water supply, one for over 48 hours and the other for 72 hours,” said Marc L. Boom, MD, MBA, Houston Methodist’s president and CEO.

Although the main hospital had a reserve supply of potable water, a supply of water for laundry, cooking, and cleaning was another matter. “We introduced significant water restrictions and had to have 6,000-gallon tankers bring in extra water,” Dr. Boom said.

One hospital in the network got creative. When it rained the day after the ice storm, the staff rigged up a rain collection system using the huge bins that move linens around the hospital to collect nonpotable water for cleaning and flushing toilets, Dr. Boom said. Another hospital was able to provide showers for staff by bringing in bathroom trailers with self-contained water supplies of the kind used at some sporting events.

And at some facilities, patients were discharged into the lobby as they could not return home with transportation, electricity, and water systems crippled. With widespread challenges continuing, even as temperatures warmed, President Biden signed a major disaster declaration Feb. 20 that will provide emergency assistance to residents and businesses in more than a third of Texas counties, including those surrounding Houston, Dallas, and Austin.

Although conditions forced the rescheduling of some nonemergent surgeries, the water shortage had no impact on COVID-19 care, except for the unavailability of showers in the case of mobile patients. “At the worst, they just had to use bucket flushing for the toilets,” Dr. Boom said.

And in an unexpected win, when a Harris County freezer for COVID-19 vaccine storage failed and threatened to spoil 8,400 precious doses, Dr. Boom’s center was able to take delivery on 1,000 doses and administer them in 3 hours at a hastily set up ad hoc immunization center. 

In all this, the lessons of the pandemic had a positive preparatory role. “2020 taught us to be agile as things change and to align our goals across different medical teams,” said Ben Saldana, MD, medical director of Houston Methodist’s emergency care centers. “And we were prepared for hurricanes, but not for snow.”
 

Increased pressure on emergency departments

As the outages continued and stress levels in the community rose, the network started seeing exacerbations of chronic conditions after the power shut-down incapacitated electrical devices running machines for heart assistance, oxygen delivery, and sleep apnea. “We started seeing food-borne illness and carbon monoxide poisoning, as well as more heart attacks, strokes, and sepsis,” Dr. Saldana said.

One serious strain on the network’s main hospital was the sudden need to accommodate large numbers of patients on dialysis, a procedure that uses a lot of water and is typically performed in small, vulnerable community facilities with limited infrastructure and no generators. “The hospitals are their backup and act as a safety net for them,” Boom said. Some hospital areas generally used for other types of conditions had to be marshaled for renal care.

Emergency rooms became pop-up dialysis centers, Dr. Saldana said. “And if the water pressure dropped, we had to cut dialysis time from the standard 4 hours to 2. That’s like putting a band-aid on patients.”

Fortunately, municipal water pressure in the Houston area has steadily risen and is almost back to normal. And according to Dr. Boom, the brutal storm may yet have a silver lining: a decline in county coronavirus cases as the storm and icy road conditions forced people to stay sequestered at home.

Further north in Austin, a number of hospitals lost municipal water pressure, creating a series of problems. Among them was St. David’s South Austin Medical Center, at which, according to reports in the Austin American-Statesman, staff members were at one point asked to use trash bags to remove waste from toilets, to refrain from showering, and to clean their hands only with sanitizer.

A statement issued by David Huffstutler, CEO of St. David’s HealthCare, acknowledged that the heating system is based on a water-fed boiler. When the building lost heat owing to lack of water, some patients had to be transferred elsewhere or discharged. The hospital distributed jugs and bottles of water for handwashing and drinking, and was working with city officials to obtain portable toilets.

Meanwhile, officials at Austin’s Dell Children’s Medical Center acknowledged in a memo that its toilets no longer had “flushing capabilities.” Other area hospitals in the Ascension Seton network were also suffering from compromised water supplies last week, according to local news reports.

Washroom facilities were affected elsewhere as well. A post on a medical association Facebook page referred to a memo ordering staff to use a single toilet in an outpatient area for bowel movements and warned them to limit their time there. No paper or other products were to be used in other toilets designated for urination.
 

‘The pandemic was the prelude to the ice storm’

Some hospitals fared better. Along the Coastal Bend, Corpus Christi Medical Center managed to maintain its electricity and water supply to ensure continuity of hospital services after the storm, according to a statement.

But back in Houston, Liz Youngblood, MBA, RN, president of Baylor St. Luke’s Medical Center, said a number of hospitals in her network experienced low water pressure after the storm.

“Fortunately, we had water conservation measures and low-water alerts in place for such emergencies,” she said. “And we rely on water tankers to help maintain enough pressure for the basics.”

Some of the challenges posed by the storm are quite similar to what St. Luke’s faced after Hurricane Harvey in 2017. “We had already made plans to address them and so we felt prepared,” Ms. Youngblood said.

And thanks to COVID-19, Texas hospitals have been operating in crisis mode for the past year. “The pandemic was the prelude to the ice storm,” said Gina Blocker, MD, a St. Luke’s ED physician, “so we had measures and teams in place. We did have some reduction in water pressure, though the pressure was still good.”

But the hospital was inundated with patients looking for shelter. “Some were just scared about what might happen to them if their heat didn’t come back on and they wanted to be where they could get care,” Dr. Blocker said. Others came in with expected storm-related injuries such as hypothermia and carbon monoxide poisoning.

According to Ms. Youngblood, little compromise in patient care was necessary except for the cancellation of some operations and vaccinations owing to the treacherous travel conditions. “But one of the biggest remaining issues is that we need plenty of blood, so we’re encouraging people to donate at their local centers.”

A version of this article first appeared on Medscape.com

The rate of hospital admissions in the United Kingdom for food-induced anaphylaxis more than tripled over the 20 years from 1998 to 2018, but the case fatality rate fell by more than half, researchers report in BMJ.

“Cow’s milk is increasingly identified as the culprit allergen for fatal food reactions and is now the commonest cause of fatal anaphylaxis in children,” write Alessia Baseggio Conrado, PhD, a biochemist with the National Heart and Lung Institute at Imperial College London, and colleagues. “More education is needed to highlight the specific risks posed by cow’s milk to people who are allergic to increase awareness among food businesses.”

Whereas recognition of the risks posed by nut allergies has increased, people think milk allergy is mild, says senior author Paul. J. Turner, BMBCh, PhD, an allergist/immunologist at Imperial College. “This is often true in very young children, but school-aged children who still have milk allergy tend to have a more allergic profile, often with other allergies, including asthma,” Dr. Turner told this news organization. “Also, milk is very common in our diet, and you don’t need much milk to achieve a decent dose of allergen.”

During the study period, 101,891 people were hospitalized for anaphylaxis; 30,700 cases (30%) were coded as having been triggered by food.

These food-related admissions represent an increase from 1.23 to 4.04 per 100,000 population per year, for an annual increase of 5.7% (95% confidence interval, 5.5-5.9; P < .001), the authors write.

The largest jump occurred among children younger than 15 years, for whom admissions rose from 2.1 to 9.2 per 100,000 population per year, an annual increase of 6.6% (95% CI, 6.3-7.0). The annual increases were 5.9% (95% CI, 5.6-6.2) among persons aged 15 to 59 years and 2.1% (95% CI, 1.8-3.1) among those aged 60 years and older.

The investigators used data from England, Scotland, Wales, and Northern Ireland to track temporal trends and age and sex distributions for hospital admissions for which the primary diagnosis was anaphylaxis attributable to both food and nonfood triggers. These data were compared with nationally reported fatalities.

Over the 20-year period, 152 deaths were attributed to likely food-induced anaphylaxis. During that time, the case fatality rate for confirmed fatal food anaphylaxis fell from 0.7% to 0.19% (rate ratio, 0.931; 95% CI, 0.904-0.959; P < .001) and declined to 0.30% for suspected fatal food anaphylaxis (rate ratio, 0.970; 95% CI, 0.945-0.996; P = .024).

Between 1992 and 2018, at least 46% of all anaphylactic fatalities were deemed to be triggered by peanut or tree nut. Among school-aged children, 26% of anaphylactic fatalities were attributed to cow’s milk.

Not surprisingly, during the study period, there was an increase of 336% in prescriptions for adrenaline autoinjectors. Such prescriptions increased 11% per year.

Global trend

The data extend findings Dr. Turner and colleagues reported for England and Wales in 2014 regarding the entire United Kingdom population and align with epidemiologic trends in hospital admissions for anaphylaxis in the United States and Australia.

The researchers say better recognition and management of anaphylaxis could partly explain the decrease in fatalities, but the rise in hospitalizations remains puzzling. “Whether a true increase in the prevalence of anaphylaxis has occurred (rather than a reduction in the threshold to admit patients presenting with anaphylaxis) is unclear because evidence is lacking for an increase in prevalence of food allergy in the [United Kingdom] (and elsewhere) over the same time period,” they write.

Ronna L. Campbell, MD, PhD, an emergency physician at the Mayo Clinic in Rochester, Minn., has noted similar trends in the United States. “It may be that anaphylaxis recognition and diagnosis have improved, resulting in earlier administration of epinephrine,” Dr. Campbell said in an interview. “So while cases are increasing, earlier recognition and treatment result in decreased fatalities.” She is unaware of any new guidelines recommending increased hospitalization that would explain the puzzling rise in admissions.

According to the study authors, the clinical criteria used to diagnose anaphylaxis in the United Kingdom did not change during the study period. Although national guidance recommending the hospitalization of children younger than 16 who are suspected of having anaphylaxis was introduced in 2011 and may have boosted admissions, the year-on-year rate of increase has persisted since 2014. “Therefore the increase over the past 5 years cannot be attributed to the impact of the guidance,” they write.

The study was funded by grants from the U.K. Medical Research Council and U.K. Food Standards Agency. Two coauthors have disclosed financial relationships with industry outside of the submitted work. Dr. Conrado has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com

The rate of hospital admissions in the United Kingdom for food-induced anaphylaxis more than tripled over the 20 years from 1998 to 2018, but the case fatality rate fell by more than half, researchers report in BMJ.

“Cow’s milk is increasingly identified as the culprit allergen for fatal food reactions and is now the commonest cause of fatal anaphylaxis in children,” write Alessia Baseggio Conrado, PhD, a biochemist with the National Heart and Lung Institute at Imperial College London, and colleagues. “More education is needed to highlight the specific risks posed by cow’s milk to people who are allergic to increase awareness among food businesses.”

Whereas recognition of the risks posed by nut allergies has increased, people think milk allergy is mild, says senior author Paul. J. Turner, BMBCh, PhD, an allergist/immunologist at Imperial College. “This is often true in very young children, but school-aged children who still have milk allergy tend to have a more allergic profile, often with other allergies, including asthma,” Dr. Turner told this news organization. “Also, milk is very common in our diet, and you don’t need much milk to achieve a decent dose of allergen.”

During the study period, 101,891 people were hospitalized for anaphylaxis; 30,700 cases (30%) were coded as having been triggered by food.

These food-related admissions represent an increase from 1.23 to 4.04 per 100,000 population per year, for an annual increase of 5.7% (95% confidence interval, 5.5-5.9; P < .001), the authors write.

The largest jump occurred among children younger than 15 years, for whom admissions rose from 2.1 to 9.2 per 100,000 population per year, an annual increase of 6.6% (95% CI, 6.3-7.0). The annual increases were 5.9% (95% CI, 5.6-6.2) among persons aged 15 to 59 years and 2.1% (95% CI, 1.8-3.1) among those aged 60 years and older.

The investigators used data from England, Scotland, Wales, and Northern Ireland to track temporal trends and age and sex distributions for hospital admissions for which the primary diagnosis was anaphylaxis attributable to both food and nonfood triggers. These data were compared with nationally reported fatalities.

Over the 20-year period, 152 deaths were attributed to likely food-induced anaphylaxis. During that time, the case fatality rate for confirmed fatal food anaphylaxis fell from 0.7% to 0.19% (rate ratio, 0.931; 95% CI, 0.904-0.959; P < .001) and declined to 0.30% for suspected fatal food anaphylaxis (rate ratio, 0.970; 95% CI, 0.945-0.996; P = .024).

Between 1992 and 2018, at least 46% of all anaphylactic fatalities were deemed to be triggered by peanut or tree nut. Among school-aged children, 26% of anaphylactic fatalities were attributed to cow’s milk.

Not surprisingly, during the study period, there was an increase of 336% in prescriptions for adrenaline autoinjectors. Such prescriptions increased 11% per year.

Global trend

The data extend findings Dr. Turner and colleagues reported for England and Wales in 2014 regarding the entire United Kingdom population and align with epidemiologic trends in hospital admissions for anaphylaxis in the United States and Australia.

The researchers say better recognition and management of anaphylaxis could partly explain the decrease in fatalities, but the rise in hospitalizations remains puzzling. “Whether a true increase in the prevalence of anaphylaxis has occurred (rather than a reduction in the threshold to admit patients presenting with anaphylaxis) is unclear because evidence is lacking for an increase in prevalence of food allergy in the [United Kingdom] (and elsewhere) over the same time period,” they write.

Ronna L. Campbell, MD, PhD, an emergency physician at the Mayo Clinic in Rochester, Minn., has noted similar trends in the United States. “It may be that anaphylaxis recognition and diagnosis have improved, resulting in earlier administration of epinephrine,” Dr. Campbell said in an interview. “So while cases are increasing, earlier recognition and treatment result in decreased fatalities.” She is unaware of any new guidelines recommending increased hospitalization that would explain the puzzling rise in admissions.

According to the study authors, the clinical criteria used to diagnose anaphylaxis in the United Kingdom did not change during the study period. Although national guidance recommending the hospitalization of children younger than 16 who are suspected of having anaphylaxis was introduced in 2011 and may have boosted admissions, the year-on-year rate of increase has persisted since 2014. “Therefore the increase over the past 5 years cannot be attributed to the impact of the guidance,” they write.

The study was funded by grants from the U.K. Medical Research Council and U.K. Food Standards Agency. Two coauthors have disclosed financial relationships with industry outside of the submitted work. Dr. Conrado has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com

The rate of hospital admissions in the United Kingdom for food-induced anaphylaxis more than tripled over the 20 years from 1998 to 2018, but the case fatality rate fell by more than half, researchers report in BMJ.

“Cow’s milk is increasingly identified as the culprit allergen for fatal food reactions and is now the commonest cause of fatal anaphylaxis in children,” write Alessia Baseggio Conrado, PhD, a biochemist with the National Heart and Lung Institute at Imperial College London, and colleagues. “More education is needed to highlight the specific risks posed by cow’s milk to people who are allergic to increase awareness among food businesses.”

Whereas recognition of the risks posed by nut allergies has increased, people think milk allergy is mild, says senior author Paul. J. Turner, BMBCh, PhD, an allergist/immunologist at Imperial College. “This is often true in very young children, but school-aged children who still have milk allergy tend to have a more allergic profile, often with other allergies, including asthma,” Dr. Turner told this news organization. “Also, milk is very common in our diet, and you don’t need much milk to achieve a decent dose of allergen.”

During the study period, 101,891 people were hospitalized for anaphylaxis; 30,700 cases (30%) were coded as having been triggered by food.

These food-related admissions represent an increase from 1.23 to 4.04 per 100,000 population per year, for an annual increase of 5.7% (95% confidence interval, 5.5-5.9; P < .001), the authors write.

The largest jump occurred among children younger than 15 years, for whom admissions rose from 2.1 to 9.2 per 100,000 population per year, an annual increase of 6.6% (95% CI, 6.3-7.0). The annual increases were 5.9% (95% CI, 5.6-6.2) among persons aged 15 to 59 years and 2.1% (95% CI, 1.8-3.1) among those aged 60 years and older.

The investigators used data from England, Scotland, Wales, and Northern Ireland to track temporal trends and age and sex distributions for hospital admissions for which the primary diagnosis was anaphylaxis attributable to both food and nonfood triggers. These data were compared with nationally reported fatalities.

Over the 20-year period, 152 deaths were attributed to likely food-induced anaphylaxis. During that time, the case fatality rate for confirmed fatal food anaphylaxis fell from 0.7% to 0.19% (rate ratio, 0.931; 95% CI, 0.904-0.959; P < .001) and declined to 0.30% for suspected fatal food anaphylaxis (rate ratio, 0.970; 95% CI, 0.945-0.996; P = .024).

Between 1992 and 2018, at least 46% of all anaphylactic fatalities were deemed to be triggered by peanut or tree nut. Among school-aged children, 26% of anaphylactic fatalities were attributed to cow’s milk.

Not surprisingly, during the study period, there was an increase of 336% in prescriptions for adrenaline autoinjectors. Such prescriptions increased 11% per year.

Global trend

The data extend findings Dr. Turner and colleagues reported for England and Wales in 2014 regarding the entire United Kingdom population and align with epidemiologic trends in hospital admissions for anaphylaxis in the United States and Australia.

The researchers say better recognition and management of anaphylaxis could partly explain the decrease in fatalities, but the rise in hospitalizations remains puzzling. “Whether a true increase in the prevalence of anaphylaxis has occurred (rather than a reduction in the threshold to admit patients presenting with anaphylaxis) is unclear because evidence is lacking for an increase in prevalence of food allergy in the [United Kingdom] (and elsewhere) over the same time period,” they write.

Ronna L. Campbell, MD, PhD, an emergency physician at the Mayo Clinic in Rochester, Minn., has noted similar trends in the United States. “It may be that anaphylaxis recognition and diagnosis have improved, resulting in earlier administration of epinephrine,” Dr. Campbell said in an interview. “So while cases are increasing, earlier recognition and treatment result in decreased fatalities.” She is unaware of any new guidelines recommending increased hospitalization that would explain the puzzling rise in admissions.

According to the study authors, the clinical criteria used to diagnose anaphylaxis in the United Kingdom did not change during the study period. Although national guidance recommending the hospitalization of children younger than 16 who are suspected of having anaphylaxis was introduced in 2011 and may have boosted admissions, the year-on-year rate of increase has persisted since 2014. “Therefore the increase over the past 5 years cannot be attributed to the impact of the guidance,” they write.

The study was funded by grants from the U.K. Medical Research Council and U.K. Food Standards Agency. Two coauthors have disclosed financial relationships with industry outside of the submitted work. Dr. Conrado has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com