Pediatrics

New COVID-19 cases in children soared by almost 86% over the course of just 1 week, while the number of 12- to 17-year-old children who have received at least one dose of vaccine rose by 5.4%, according to two separate sources.

There were 71,726 new cases reported during the week of July 23-29, compared with 38,654 the previous week, an increase of 85.6%. Meanwhile, the increase over the past 2 weeks – from 23,551 new cases for July 16-22 to almost 72,000 – works out to almost 205%, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

Children represented 19.0% of the cases reported during the week of July 23-29, and they have made up 14.3% of all cases since the pandemic began, with the total number of cases in children now approaching 4.2 million, the AAP and CHA said in their weekly COVID report. About 22% of the U.S. population is under the age of 18 years.

As of Aug. 2, just over 9.8 million children aged 12-17 years had received at least one dose of the COVID vaccine, which was up by about 500,000, or 5.4%, from a week earlier, based on data from the Centers for Disease Control and Prevention.

Children aged 16-17 have reached a notable milestone on the journey that started with vaccine approval in December: 50.2% have gotten at least one dose and 40.3% are fully vaccinated. Among children aged 12-15 years, the proportion with at least one dose of vaccine is up to 39.5%, compared with 37.1% the previous week, while 29.0% are fully vaccinated (27.8% the week before), the CDC said on its COVID Data Tracker.

The national rates for child vaccination, however, tend to hide the disparities between states. There is a gap between Mississippi (lowest), where just 17% of children aged 12-17 years have gotten at least one dose, and Vermont (highest), which is up to 69%. Vermont also has the highest rate of vaccine completion (60%), while Alabama and Mississippi have the lowest (10%), according to a solo report from the AAP.

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New COVID-19 cases in children soared by almost 86% over the course of just 1 week, while the number of 12- to 17-year-old children who have received at least one dose of vaccine rose by 5.4%, according to two separate sources.

There were 71,726 new cases reported during the week of July 23-29, compared with 38,654 the previous week, an increase of 85.6%. Meanwhile, the increase over the past 2 weeks – from 23,551 new cases for July 16-22 to almost 72,000 – works out to almost 205%, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

Children represented 19.0% of the cases reported during the week of July 23-29, and they have made up 14.3% of all cases since the pandemic began, with the total number of cases in children now approaching 4.2 million, the AAP and CHA said in their weekly COVID report. About 22% of the U.S. population is under the age of 18 years.

As of Aug. 2, just over 9.8 million children aged 12-17 years had received at least one dose of the COVID vaccine, which was up by about 500,000, or 5.4%, from a week earlier, based on data from the Centers for Disease Control and Prevention.

Children aged 16-17 have reached a notable milestone on the journey that started with vaccine approval in December: 50.2% have gotten at least one dose and 40.3% are fully vaccinated. Among children aged 12-15 years, the proportion with at least one dose of vaccine is up to 39.5%, compared with 37.1% the previous week, while 29.0% are fully vaccinated (27.8% the week before), the CDC said on its COVID Data Tracker.

The national rates for child vaccination, however, tend to hide the disparities between states. There is a gap between Mississippi (lowest), where just 17% of children aged 12-17 years have gotten at least one dose, and Vermont (highest), which is up to 69%. Vermont also has the highest rate of vaccine completion (60%), while Alabama and Mississippi have the lowest (10%), according to a solo report from the AAP.

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New COVID-19 cases in children soared by almost 86% over the course of just 1 week, while the number of 12- to 17-year-old children who have received at least one dose of vaccine rose by 5.4%, according to two separate sources.

There were 71,726 new cases reported during the week of July 23-29, compared with 38,654 the previous week, an increase of 85.6%. Meanwhile, the increase over the past 2 weeks – from 23,551 new cases for July 16-22 to almost 72,000 – works out to almost 205%, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

Children represented 19.0% of the cases reported during the week of July 23-29, and they have made up 14.3% of all cases since the pandemic began, with the total number of cases in children now approaching 4.2 million, the AAP and CHA said in their weekly COVID report. About 22% of the U.S. population is under the age of 18 years.

As of Aug. 2, just over 9.8 million children aged 12-17 years had received at least one dose of the COVID vaccine, which was up by about 500,000, or 5.4%, from a week earlier, based on data from the Centers for Disease Control and Prevention.

Children aged 16-17 have reached a notable milestone on the journey that started with vaccine approval in December: 50.2% have gotten at least one dose and 40.3% are fully vaccinated. Among children aged 12-15 years, the proportion with at least one dose of vaccine is up to 39.5%, compared with 37.1% the previous week, while 29.0% are fully vaccinated (27.8% the week before), the CDC said on its COVID Data Tracker.

The national rates for child vaccination, however, tend to hide the disparities between states. There is a gap between Mississippi (lowest), where just 17% of children aged 12-17 years have gotten at least one dose, and Vermont (highest), which is up to 69%. Vermont also has the highest rate of vaccine completion (60%), while Alabama and Mississippi have the lowest (10%), according to a solo report from the AAP.

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More children admitted to hospitals in 2018 had acute bronchitis than any other diagnosis, according to a recent report from the Agency for Healthcare Research and Quality.

About 7% (99,000) of the 1.47 million nonmaternal, nonneonatal hospital stays in children aged 0-17 years involved a primary diagnosis of acute bronchitis in 2018, representing the leading cause of admissions in boys (154.7 stays per 100,000 population) and the second-leading diagnosis in girls (113.1 stays per 100,000), Kimberly W. McDermott, PhD, and Marc Roemer, MS, said in a statistical brief.

Depressive disorders were the most common primary diagnosis in girls, with a rate of 176.7 stays per 100,000, and the second-leading diagnosis overall, although the rate was less than half that (74.0 per 100,000) in boys. Two other respiratory conditions, asthma and pneumonia, were among the top five for both girls and boys, as was epilepsy, they reported.

The combined rate for all diagnoses was slightly higher for boys, 2,051 per 100,000, compared with 1,922 for girls, they said based on data from the National Inpatient Sample.

“Identifying the most frequent primary conditions for which patients are admitted to the hospital is important to the implementation and improvement of health care delivery, quality initiatives, and health policy,” said Dr. McDermott of IBM Watson Health and Mr. Roemer of the AHRQ.

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More children admitted to hospitals in 2018 had acute bronchitis than any other diagnosis, according to a recent report from the Agency for Healthcare Research and Quality.

About 7% (99,000) of the 1.47 million nonmaternal, nonneonatal hospital stays in children aged 0-17 years involved a primary diagnosis of acute bronchitis in 2018, representing the leading cause of admissions in boys (154.7 stays per 100,000 population) and the second-leading diagnosis in girls (113.1 stays per 100,000), Kimberly W. McDermott, PhD, and Marc Roemer, MS, said in a statistical brief.

Depressive disorders were the most common primary diagnosis in girls, with a rate of 176.7 stays per 100,000, and the second-leading diagnosis overall, although the rate was less than half that (74.0 per 100,000) in boys. Two other respiratory conditions, asthma and pneumonia, were among the top five for both girls and boys, as was epilepsy, they reported.

The combined rate for all diagnoses was slightly higher for boys, 2,051 per 100,000, compared with 1,922 for girls, they said based on data from the National Inpatient Sample.

“Identifying the most frequent primary conditions for which patients are admitted to the hospital is important to the implementation and improvement of health care delivery, quality initiatives, and health policy,” said Dr. McDermott of IBM Watson Health and Mr. Roemer of the AHRQ.

[email protected]

More children admitted to hospitals in 2018 had acute bronchitis than any other diagnosis, according to a recent report from the Agency for Healthcare Research and Quality.

About 7% (99,000) of the 1.47 million nonmaternal, nonneonatal hospital stays in children aged 0-17 years involved a primary diagnosis of acute bronchitis in 2018, representing the leading cause of admissions in boys (154.7 stays per 100,000 population) and the second-leading diagnosis in girls (113.1 stays per 100,000), Kimberly W. McDermott, PhD, and Marc Roemer, MS, said in a statistical brief.

Depressive disorders were the most common primary diagnosis in girls, with a rate of 176.7 stays per 100,000, and the second-leading diagnosis overall, although the rate was less than half that (74.0 per 100,000) in boys. Two other respiratory conditions, asthma and pneumonia, were among the top five for both girls and boys, as was epilepsy, they reported.

The combined rate for all diagnoses was slightly higher for boys, 2,051 per 100,000, compared with 1,922 for girls, they said based on data from the National Inpatient Sample.

“Identifying the most frequent primary conditions for which patients are admitted to the hospital is important to the implementation and improvement of health care delivery, quality initiatives, and health policy,” said Dr. McDermott of IBM Watson Health and Mr. Roemer of the AHRQ.

[email protected]

Newly published data show alarmingly high rates and severity of early diabetes-specific complications in individuals who develop type 2 diabetes at a young age. This suggests intervention should be early and aggressive among these youngsters, said the researchers.

AzmanJaka/E+/Getty Images

The results for the 500 young adult participants in the Treatment Options for Type 2 Diabetes in Adolescents and Youth 2 (TODAY 2) study were published online July 29 in the New England Journal of Medicine by the TODAY study group.

At follow-up – after originally participating in the TODAY trial when they were young teenagers – they had a mean age of 26.4 years.

At this time, more than two thirds had hypertension and half had dyslipidemia.

Overall, 60% had at least one diabetic microvascular complication (retinal disease, neuropathy, or diabetic kidney disease), and more than a quarter had two or more such complications.

“These data illustrate the serious personal and public health consequences of youth-onset type 2 diabetes in the transition to adulthood,” the researchers noted.
 

Don’t tread lightly just because they are young

“The fact that these youth are accumulating complications at a rapid rate and are broadly affected early in adulthood certainly suggests that aggressive therapy is needed, both for glycemic control and treatment of risk factors like hypertension and dyslipidemia,” study coauthor Philip S. Zeitler, MD, PhD, said in an interview.

“In the absence of studies specifically addressing this, we need to take a more aggressive approach than people might be inclined to, given that the age at diagnosis is young, around 14 years,” he added.

“Contrary to the inclination to be ‘gentle’ in treating them because they are kids, these data suggest that we can’t let these initial years go by without strong intervention, and we need to be prepared for polypharmacy.”

Unfortunately, as Dr. Zeitler and coauthors explained, youth-onset type 2 diabetes is characterized by a suboptimal response to currently approved diabetes medications.

New pediatric indications in the United States for drugs used to treat type 2 diabetes in adults, including the recent Food and Drug Administration approval of extended-release exenatide for children as young as 10 years of age, “helps, but only marginally,” said Dr. Zeitler, of the Clinical & Translational Research Center, Children’s Hospital Colorado, Aurora.

“In some cases, it will help get them covered by carriers, which is always good. But this is still a very limited set of medications. It doesn’t include more recently approved more potent glucagon-like peptide-1 (GLP-1) agonists, like semaglutide, and doesn’t include the sodium-glucose cotransporter 2 (SGLT2) inhibitors. Pediatricians are used to using medications off label and that is necessary here while we await further approvals,” he said.  

And he noted that most individuals with youth-onset type 2 diabetes in the United States are covered by public insurance or are uninsured, depending on which state they live in. While the two major Medicaid programs in Colorado allow full access to adult formularies, that’s not the case everywhere. Moreover, patients often face further access barriers in states without expanded Medicaid.
 

Follow-up shows all metrics worsening over time

In TODAY 2, patients participated in an observational follow-up in their usual care settings in 2011-2020. At the start, they were receiving metformin with or without insulin for diabetes, but whether this continued and whether they were treated for other risk factors was down to individual circumstances.

Participants’ median A1c increased over time, and the percentage with A1c < 6% (< 48 mmol/mol) declined from 75% at the time of TODAY entry to just 19% at the 15-year end of follow-up.

The proportion with an A1c ≤ 10% (≤ 86 mmol/mol) rose from 0% at baseline to 34% at 15 years.

At that time, nearly 50% were taking both metformin and insulin, while more than a quarter were taking no medications.

The prevalence of hypertension increased from 19.2% at baseline to 67.5% at 15 years, while dyslipidemia rose from 20.8% to 51.6%.

Kidney disease prevalence increased from 8.0% at baseline to 54.8% at 15 years. Nerve disease rose from 1.0% to 32.4%. Retinal disease jumped from 13.7% with milder nonproliferative retinopathy in 2010-2011 to 51.0% with any eye disease in 2017-2018, including 8.8% with moderate to severe retinal changes and 3.5% with macular edema.  

Overall, at the time of the last visit, 39.9% had no diabetes complications, 31.8% had one, 21.3% had two, and 7.1% had three complications.
 

Serious cardiovascular events in mid-20s

There were 17 adjudicated serious cardiovascular events, including four myocardial infarctions, six heart failure events, three diagnoses of coronary artery disease, and four strokes.

Six participants died, one each from myocardial infarction, kidney failure, and drug overdose, and three from sepsis.

Dr. Zeitler called the macrovascular events “shocking,” noting that although the numbers are small, for people in their mid-20s “they should be zero ... While we don’t yet know if the rates are the same or faster than in adults, even if they are the same, these kids are only in their late 20s, as opposed to adults experiencing these problems in their 50s, 60s, and 70s.  

“The fact that these complications are occurring when these individuals should be in the prime of their life for both family and work has huge implications,” he stressed.
 

Findings have multiple causes

The reasons for the findings are both biologic and socioeconomic, Dr. Zeitler said.

“We know already that many kids with type 2 have rapid [deterioration of] beta-cell [function], which is probably very biologic. It stands to reason that an individual who can get diabetes as an adolescent probably has more fragile beta cells in some way,” he noted.

“But we also know that many other things contribute: stress, social determinants, access to quality care and medications, access to healthy foods and physical activity, availability of family supervision given the realities of families’ economic status and jobs, etc.”

It’s also known that youth with type 2 diabetes have much more severe insulin resistance than that of adults with the condition, and that “once the kids left ... the [TODAY] study, risk factor treatment in the community was less than ideal, and a lot of kids who met criteria for treatment of their blood pressure or lipids were not being treated. This is likely at least partly sociologic and partly the general pediatric hesitancy to use medications.”

He said the TODAY team will soon have some new data to show that “glycemia during the early years makes a difference, again supporting intensive intervention early on.”

The TODAY study was supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Zeitler had no further disclosures.

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

Newly published data show alarmingly high rates and severity of early diabetes-specific complications in individuals who develop type 2 diabetes at a young age. This suggests intervention should be early and aggressive among these youngsters, said the researchers.

AzmanJaka/E+/Getty Images

The results for the 500 young adult participants in the Treatment Options for Type 2 Diabetes in Adolescents and Youth 2 (TODAY 2) study were published online July 29 in the New England Journal of Medicine by the TODAY study group.

At follow-up – after originally participating in the TODAY trial when they were young teenagers – they had a mean age of 26.4 years.

At this time, more than two thirds had hypertension and half had dyslipidemia.

Overall, 60% had at least one diabetic microvascular complication (retinal disease, neuropathy, or diabetic kidney disease), and more than a quarter had two or more such complications.

“These data illustrate the serious personal and public health consequences of youth-onset type 2 diabetes in the transition to adulthood,” the researchers noted.
 

Don’t tread lightly just because they are young

“The fact that these youth are accumulating complications at a rapid rate and are broadly affected early in adulthood certainly suggests that aggressive therapy is needed, both for glycemic control and treatment of risk factors like hypertension and dyslipidemia,” study coauthor Philip S. Zeitler, MD, PhD, said in an interview.

“In the absence of studies specifically addressing this, we need to take a more aggressive approach than people might be inclined to, given that the age at diagnosis is young, around 14 years,” he added.

“Contrary to the inclination to be ‘gentle’ in treating them because they are kids, these data suggest that we can’t let these initial years go by without strong intervention, and we need to be prepared for polypharmacy.”

Unfortunately, as Dr. Zeitler and coauthors explained, youth-onset type 2 diabetes is characterized by a suboptimal response to currently approved diabetes medications.

New pediatric indications in the United States for drugs used to treat type 2 diabetes in adults, including the recent Food and Drug Administration approval of extended-release exenatide for children as young as 10 years of age, “helps, but only marginally,” said Dr. Zeitler, of the Clinical & Translational Research Center, Children’s Hospital Colorado, Aurora.

“In some cases, it will help get them covered by carriers, which is always good. But this is still a very limited set of medications. It doesn’t include more recently approved more potent glucagon-like peptide-1 (GLP-1) agonists, like semaglutide, and doesn’t include the sodium-glucose cotransporter 2 (SGLT2) inhibitors. Pediatricians are used to using medications off label and that is necessary here while we await further approvals,” he said.  

And he noted that most individuals with youth-onset type 2 diabetes in the United States are covered by public insurance or are uninsured, depending on which state they live in. While the two major Medicaid programs in Colorado allow full access to adult formularies, that’s not the case everywhere. Moreover, patients often face further access barriers in states without expanded Medicaid.
 

Follow-up shows all metrics worsening over time

In TODAY 2, patients participated in an observational follow-up in their usual care settings in 2011-2020. At the start, they were receiving metformin with or without insulin for diabetes, but whether this continued and whether they were treated for other risk factors was down to individual circumstances.

Participants’ median A1c increased over time, and the percentage with A1c < 6% (< 48 mmol/mol) declined from 75% at the time of TODAY entry to just 19% at the 15-year end of follow-up.

The proportion with an A1c ≤ 10% (≤ 86 mmol/mol) rose from 0% at baseline to 34% at 15 years.

At that time, nearly 50% were taking both metformin and insulin, while more than a quarter were taking no medications.

The prevalence of hypertension increased from 19.2% at baseline to 67.5% at 15 years, while dyslipidemia rose from 20.8% to 51.6%.

Kidney disease prevalence increased from 8.0% at baseline to 54.8% at 15 years. Nerve disease rose from 1.0% to 32.4%. Retinal disease jumped from 13.7% with milder nonproliferative retinopathy in 2010-2011 to 51.0% with any eye disease in 2017-2018, including 8.8% with moderate to severe retinal changes and 3.5% with macular edema.  

Overall, at the time of the last visit, 39.9% had no diabetes complications, 31.8% had one, 21.3% had two, and 7.1% had three complications.
 

Serious cardiovascular events in mid-20s

There were 17 adjudicated serious cardiovascular events, including four myocardial infarctions, six heart failure events, three diagnoses of coronary artery disease, and four strokes.

Six participants died, one each from myocardial infarction, kidney failure, and drug overdose, and three from sepsis.

Dr. Zeitler called the macrovascular events “shocking,” noting that although the numbers are small, for people in their mid-20s “they should be zero ... While we don’t yet know if the rates are the same or faster than in adults, even if they are the same, these kids are only in their late 20s, as opposed to adults experiencing these problems in their 50s, 60s, and 70s.  

“The fact that these complications are occurring when these individuals should be in the prime of their life for both family and work has huge implications,” he stressed.
 

Findings have multiple causes

The reasons for the findings are both biologic and socioeconomic, Dr. Zeitler said.

“We know already that many kids with type 2 have rapid [deterioration of] beta-cell [function], which is probably very biologic. It stands to reason that an individual who can get diabetes as an adolescent probably has more fragile beta cells in some way,” he noted.

“But we also know that many other things contribute: stress, social determinants, access to quality care and medications, access to healthy foods and physical activity, availability of family supervision given the realities of families’ economic status and jobs, etc.”

It’s also known that youth with type 2 diabetes have much more severe insulin resistance than that of adults with the condition, and that “once the kids left ... the [TODAY] study, risk factor treatment in the community was less than ideal, and a lot of kids who met criteria for treatment of their blood pressure or lipids were not being treated. This is likely at least partly sociologic and partly the general pediatric hesitancy to use medications.”

He said the TODAY team will soon have some new data to show that “glycemia during the early years makes a difference, again supporting intensive intervention early on.”

The TODAY study was supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Zeitler had no further disclosures.

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

Newly published data show alarmingly high rates and severity of early diabetes-specific complications in individuals who develop type 2 diabetes at a young age. This suggests intervention should be early and aggressive among these youngsters, said the researchers.

AzmanJaka/E+/Getty Images

The results for the 500 young adult participants in the Treatment Options for Type 2 Diabetes in Adolescents and Youth 2 (TODAY 2) study were published online July 29 in the New England Journal of Medicine by the TODAY study group.

At follow-up – after originally participating in the TODAY trial when they were young teenagers – they had a mean age of 26.4 years.

At this time, more than two thirds had hypertension and half had dyslipidemia.

Overall, 60% had at least one diabetic microvascular complication (retinal disease, neuropathy, or diabetic kidney disease), and more than a quarter had two or more such complications.

“These data illustrate the serious personal and public health consequences of youth-onset type 2 diabetes in the transition to adulthood,” the researchers noted.
 

Don’t tread lightly just because they are young

“The fact that these youth are accumulating complications at a rapid rate and are broadly affected early in adulthood certainly suggests that aggressive therapy is needed, both for glycemic control and treatment of risk factors like hypertension and dyslipidemia,” study coauthor Philip S. Zeitler, MD, PhD, said in an interview.

“In the absence of studies specifically addressing this, we need to take a more aggressive approach than people might be inclined to, given that the age at diagnosis is young, around 14 years,” he added.

“Contrary to the inclination to be ‘gentle’ in treating them because they are kids, these data suggest that we can’t let these initial years go by without strong intervention, and we need to be prepared for polypharmacy.”

Unfortunately, as Dr. Zeitler and coauthors explained, youth-onset type 2 diabetes is characterized by a suboptimal response to currently approved diabetes medications.

New pediatric indications in the United States for drugs used to treat type 2 diabetes in adults, including the recent Food and Drug Administration approval of extended-release exenatide for children as young as 10 years of age, “helps, but only marginally,” said Dr. Zeitler, of the Clinical & Translational Research Center, Children’s Hospital Colorado, Aurora.

“In some cases, it will help get them covered by carriers, which is always good. But this is still a very limited set of medications. It doesn’t include more recently approved more potent glucagon-like peptide-1 (GLP-1) agonists, like semaglutide, and doesn’t include the sodium-glucose cotransporter 2 (SGLT2) inhibitors. Pediatricians are used to using medications off label and that is necessary here while we await further approvals,” he said.  

And he noted that most individuals with youth-onset type 2 diabetes in the United States are covered by public insurance or are uninsured, depending on which state they live in. While the two major Medicaid programs in Colorado allow full access to adult formularies, that’s not the case everywhere. Moreover, patients often face further access barriers in states without expanded Medicaid.
 

Follow-up shows all metrics worsening over time

In TODAY 2, patients participated in an observational follow-up in their usual care settings in 2011-2020. At the start, they were receiving metformin with or without insulin for diabetes, but whether this continued and whether they were treated for other risk factors was down to individual circumstances.

Participants’ median A1c increased over time, and the percentage with A1c < 6% (< 48 mmol/mol) declined from 75% at the time of TODAY entry to just 19% at the 15-year end of follow-up.

The proportion with an A1c ≤ 10% (≤ 86 mmol/mol) rose from 0% at baseline to 34% at 15 years.

At that time, nearly 50% were taking both metformin and insulin, while more than a quarter were taking no medications.

The prevalence of hypertension increased from 19.2% at baseline to 67.5% at 15 years, while dyslipidemia rose from 20.8% to 51.6%.

Kidney disease prevalence increased from 8.0% at baseline to 54.8% at 15 years. Nerve disease rose from 1.0% to 32.4%. Retinal disease jumped from 13.7% with milder nonproliferative retinopathy in 2010-2011 to 51.0% with any eye disease in 2017-2018, including 8.8% with moderate to severe retinal changes and 3.5% with macular edema.  

Overall, at the time of the last visit, 39.9% had no diabetes complications, 31.8% had one, 21.3% had two, and 7.1% had three complications.
 

Serious cardiovascular events in mid-20s

There were 17 adjudicated serious cardiovascular events, including four myocardial infarctions, six heart failure events, three diagnoses of coronary artery disease, and four strokes.

Six participants died, one each from myocardial infarction, kidney failure, and drug overdose, and three from sepsis.

Dr. Zeitler called the macrovascular events “shocking,” noting that although the numbers are small, for people in their mid-20s “they should be zero ... While we don’t yet know if the rates are the same or faster than in adults, even if they are the same, these kids are only in their late 20s, as opposed to adults experiencing these problems in their 50s, 60s, and 70s.  

“The fact that these complications are occurring when these individuals should be in the prime of their life for both family and work has huge implications,” he stressed.
 

Findings have multiple causes

The reasons for the findings are both biologic and socioeconomic, Dr. Zeitler said.

“We know already that many kids with type 2 have rapid [deterioration of] beta-cell [function], which is probably very biologic. It stands to reason that an individual who can get diabetes as an adolescent probably has more fragile beta cells in some way,” he noted.

“But we also know that many other things contribute: stress, social determinants, access to quality care and medications, access to healthy foods and physical activity, availability of family supervision given the realities of families’ economic status and jobs, etc.”

It’s also known that youth with type 2 diabetes have much more severe insulin resistance than that of adults with the condition, and that “once the kids left ... the [TODAY] study, risk factor treatment in the community was less than ideal, and a lot of kids who met criteria for treatment of their blood pressure or lipids were not being treated. This is likely at least partly sociologic and partly the general pediatric hesitancy to use medications.”

He said the TODAY team will soon have some new data to show that “glycemia during the early years makes a difference, again supporting intensive intervention early on.”

The TODAY study was supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Zeitler had no further disclosures.

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

Administering hyperimmune globulin to pregnant women who tested positive for cytomegalovirus did not reduce CMV infections or deaths among their fetuses or newborns, according to a randomized controlled trial published online July 28 in the New England Journal of Medicine.

Up to 40,000 infants a year have congenital CMV infections, which can lead to stillbirth, neonatal death, deafness, and cognitive and motor delay. An estimated 35%-40% of fetuses of women with a primary CMV infection will develop an infection, write Brenna Hughes, MD, an associate professor of ob/gyn and chief of the division of maternal fetal medicine at Duke University, Durham, N.C., and colleagues.

Previous trials and observational studies have shown mixed results with hyperimmune globulin for the prevention of congenital CMV infection.

“It was surprising to us that none of the outcomes in this trial were in the direction of potential benefit,” Dr. Hughes told this news organization. “However, this is why it is important to do large trials in a diverse population.”

The study cohort comprised 206,082 pregnant women who were screened for CMV infection before 23 weeks’ gestation. Of those women, 712 (0.35%) tested positive for CMV. The researchers enrolled 399 women who had tested positive and randomly assigned them to receive either a monthly infusion of CMV hyperimmune globulin (100 mg/kg) or placebo until delivery. The researchers used a composite of CMV infection or, if no testing occurred, fetal/neonatal death as the primary endpoint.

The trial was stopped early for futility when data from 394 participants revealed that 22.7% of offspring in the hyperimmune globulin group and 19.4% of those in the placebo group had had a CMV infection or had died (relative risk = 1.17; P = .42).

When individual endpoints were examined, trends were detected in favor of the placebo, but they did not reach statistical significance. The incidence of death was higher in the hyperimmune globulin group (4.9%) than in the placebo group (2.6%). The rate of preterm birth was also higher in the intervention group (12.2%) than in the group that received placebo (8.3%). The incidence of birth weight below the fifth percentile was 10.3% in the intervention group and 5.4% in the placebo group.

One woman who received hyperimmune globulin experienced a severe allergic reaction to the first infusion. Additionally, more women in the hyperimmune globulin group experienced headaches and shaking chills during infusions than did those who received placebo. There were no differences in maternal outcomes between the groups. There were no thromboembolic or ischemic events in either group.

“These findings suggest CMV hyperimmune globulin should not be used for the prevention of congenital CMV in pregnant patients with primary CMV during pregnancy,” Dr. Hughes said in an interview.

“A CMV vaccine is likely to be the most effective public health measure that we can offer, and that should be at the forefront of research investments,” she said. “But some of the other medications that work against CMV should be tested on a large scale as well,” she said. For example, a small trial in Israel showed that high-dose valacyclovir in early pregnancy decreased congenital CMV, and thus the drug merits study in a larger trial, she said.

Other experts agree that developing a vaccine should be the priority.

“The ultimate goal for preventing the brain damage and birth defects caused by congenital CMV infection is a vaccine that is as effective as the rubella vaccine has been for eliminating congenital rubella syndrome and that can be given well before pregnancy,” said Sallie Permar, MD, PhD, chair of pediatrics at Weill Cornell Medicine and pediatrician-in-chief at New York–Presbyterian/Weill Cornell Medical Center and the New York–Presbyterian Komansky Children’s Hospital in New York.

“While trials of vaccines are ongoing, there is a need to have a therapeutic option, especially for the high-risk setting of a mother acquiring the virus for the first time during pregnancy,” Dr. Permar said in an interview.

Dr. Permar was not involved in this study but is involved in follow-up studies of this cohort and is conducting research on CMV maternal vaccines. She noted the need for safe, effective antiviral treatments and for research into newer immunoglobulin products, such as monoclonal antibodies.

Both Dr. Permar and Dr. Hughes highlighted the challenge of raising awareness about the danger of CMV infections during pregnancy.

“Pregnant women, and especially those who have or work with young children, who are frequently carriers of the infection, should be informed of this risk,” Dr. Permar said. She hopes universal testing of newborns will be implemented and that it enables people to recognize the frequency and burden of these infections. She remains optimistic about a vaccine.

“After 60 years of research into a CMV vaccine, I believe we are currently in a ‘golden age’ of CMV vaccine development,” she said. She noted that Moderna is about to launch a phase 3 mRNA vaccine trial for CMV. “Moreover, immune correlates of protection against CMV have been identified from previous partially effective vaccines, and animal models have improved for preclinical studies. Therefore, I believe we will have an effective and safe vaccine against this most common congenital infection in the coming years.”

The research was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Center for Advancing Translational Sciences. Dr. Hughes has served on Merck’s scientific advisory board. Various coauthors have received personal fees from Medela and nonfinancial support from Hologic; personal fees from Moderna and VBI vaccines, and grants from Novavax. Dr. Permar consults for Pfizer, Moderna, Merck, Sanofi, and Dynavax on their CMV vaccine programs, and she has a sponsored research program with Merck and Moderna on CMV vaccines.

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

Administering hyperimmune globulin to pregnant women who tested positive for cytomegalovirus did not reduce CMV infections or deaths among their fetuses or newborns, according to a randomized controlled trial published online July 28 in the New England Journal of Medicine.

Up to 40,000 infants a year have congenital CMV infections, which can lead to stillbirth, neonatal death, deafness, and cognitive and motor delay. An estimated 35%-40% of fetuses of women with a primary CMV infection will develop an infection, write Brenna Hughes, MD, an associate professor of ob/gyn and chief of the division of maternal fetal medicine at Duke University, Durham, N.C., and colleagues.

Previous trials and observational studies have shown mixed results with hyperimmune globulin for the prevention of congenital CMV infection.

“It was surprising to us that none of the outcomes in this trial were in the direction of potential benefit,” Dr. Hughes told this news organization. “However, this is why it is important to do large trials in a diverse population.”

The study cohort comprised 206,082 pregnant women who were screened for CMV infection before 23 weeks’ gestation. Of those women, 712 (0.35%) tested positive for CMV. The researchers enrolled 399 women who had tested positive and randomly assigned them to receive either a monthly infusion of CMV hyperimmune globulin (100 mg/kg) or placebo until delivery. The researchers used a composite of CMV infection or, if no testing occurred, fetal/neonatal death as the primary endpoint.

The trial was stopped early for futility when data from 394 participants revealed that 22.7% of offspring in the hyperimmune globulin group and 19.4% of those in the placebo group had had a CMV infection or had died (relative risk = 1.17; P = .42).

When individual endpoints were examined, trends were detected in favor of the placebo, but they did not reach statistical significance. The incidence of death was higher in the hyperimmune globulin group (4.9%) than in the placebo group (2.6%). The rate of preterm birth was also higher in the intervention group (12.2%) than in the group that received placebo (8.3%). The incidence of birth weight below the fifth percentile was 10.3% in the intervention group and 5.4% in the placebo group.

One woman who received hyperimmune globulin experienced a severe allergic reaction to the first infusion. Additionally, more women in the hyperimmune globulin group experienced headaches and shaking chills during infusions than did those who received placebo. There were no differences in maternal outcomes between the groups. There were no thromboembolic or ischemic events in either group.

“These findings suggest CMV hyperimmune globulin should not be used for the prevention of congenital CMV in pregnant patients with primary CMV during pregnancy,” Dr. Hughes said in an interview.

“A CMV vaccine is likely to be the most effective public health measure that we can offer, and that should be at the forefront of research investments,” she said. “But some of the other medications that work against CMV should be tested on a large scale as well,” she said. For example, a small trial in Israel showed that high-dose valacyclovir in early pregnancy decreased congenital CMV, and thus the drug merits study in a larger trial, she said.

Other experts agree that developing a vaccine should be the priority.

“The ultimate goal for preventing the brain damage and birth defects caused by congenital CMV infection is a vaccine that is as effective as the rubella vaccine has been for eliminating congenital rubella syndrome and that can be given well before pregnancy,” said Sallie Permar, MD, PhD, chair of pediatrics at Weill Cornell Medicine and pediatrician-in-chief at New York–Presbyterian/Weill Cornell Medical Center and the New York–Presbyterian Komansky Children’s Hospital in New York.

“While trials of vaccines are ongoing, there is a need to have a therapeutic option, especially for the high-risk setting of a mother acquiring the virus for the first time during pregnancy,” Dr. Permar said in an interview.

Dr. Permar was not involved in this study but is involved in follow-up studies of this cohort and is conducting research on CMV maternal vaccines. She noted the need for safe, effective antiviral treatments and for research into newer immunoglobulin products, such as monoclonal antibodies.

Both Dr. Permar and Dr. Hughes highlighted the challenge of raising awareness about the danger of CMV infections during pregnancy.

“Pregnant women, and especially those who have or work with young children, who are frequently carriers of the infection, should be informed of this risk,” Dr. Permar said. She hopes universal testing of newborns will be implemented and that it enables people to recognize the frequency and burden of these infections. She remains optimistic about a vaccine.

“After 60 years of research into a CMV vaccine, I believe we are currently in a ‘golden age’ of CMV vaccine development,” she said. She noted that Moderna is about to launch a phase 3 mRNA vaccine trial for CMV. “Moreover, immune correlates of protection against CMV have been identified from previous partially effective vaccines, and animal models have improved for preclinical studies. Therefore, I believe we will have an effective and safe vaccine against this most common congenital infection in the coming years.”

The research was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Center for Advancing Translational Sciences. Dr. Hughes has served on Merck’s scientific advisory board. Various coauthors have received personal fees from Medela and nonfinancial support from Hologic; personal fees from Moderna and VBI vaccines, and grants from Novavax. Dr. Permar consults for Pfizer, Moderna, Merck, Sanofi, and Dynavax on their CMV vaccine programs, and she has a sponsored research program with Merck and Moderna on CMV vaccines.

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

Administering hyperimmune globulin to pregnant women who tested positive for cytomegalovirus did not reduce CMV infections or deaths among their fetuses or newborns, according to a randomized controlled trial published online July 28 in the New England Journal of Medicine.

Up to 40,000 infants a year have congenital CMV infections, which can lead to stillbirth, neonatal death, deafness, and cognitive and motor delay. An estimated 35%-40% of fetuses of women with a primary CMV infection will develop an infection, write Brenna Hughes, MD, an associate professor of ob/gyn and chief of the division of maternal fetal medicine at Duke University, Durham, N.C., and colleagues.

Previous trials and observational studies have shown mixed results with hyperimmune globulin for the prevention of congenital CMV infection.

“It was surprising to us that none of the outcomes in this trial were in the direction of potential benefit,” Dr. Hughes told this news organization. “However, this is why it is important to do large trials in a diverse population.”

The study cohort comprised 206,082 pregnant women who were screened for CMV infection before 23 weeks’ gestation. Of those women, 712 (0.35%) tested positive for CMV. The researchers enrolled 399 women who had tested positive and randomly assigned them to receive either a monthly infusion of CMV hyperimmune globulin (100 mg/kg) or placebo until delivery. The researchers used a composite of CMV infection or, if no testing occurred, fetal/neonatal death as the primary endpoint.

The trial was stopped early for futility when data from 394 participants revealed that 22.7% of offspring in the hyperimmune globulin group and 19.4% of those in the placebo group had had a CMV infection or had died (relative risk = 1.17; P = .42).

When individual endpoints were examined, trends were detected in favor of the placebo, but they did not reach statistical significance. The incidence of death was higher in the hyperimmune globulin group (4.9%) than in the placebo group (2.6%). The rate of preterm birth was also higher in the intervention group (12.2%) than in the group that received placebo (8.3%). The incidence of birth weight below the fifth percentile was 10.3% in the intervention group and 5.4% in the placebo group.

One woman who received hyperimmune globulin experienced a severe allergic reaction to the first infusion. Additionally, more women in the hyperimmune globulin group experienced headaches and shaking chills during infusions than did those who received placebo. There were no differences in maternal outcomes between the groups. There were no thromboembolic or ischemic events in either group.

“These findings suggest CMV hyperimmune globulin should not be used for the prevention of congenital CMV in pregnant patients with primary CMV during pregnancy,” Dr. Hughes said in an interview.

“A CMV vaccine is likely to be the most effective public health measure that we can offer, and that should be at the forefront of research investments,” she said. “But some of the other medications that work against CMV should be tested on a large scale as well,” she said. For example, a small trial in Israel showed that high-dose valacyclovir in early pregnancy decreased congenital CMV, and thus the drug merits study in a larger trial, she said.

Other experts agree that developing a vaccine should be the priority.

“The ultimate goal for preventing the brain damage and birth defects caused by congenital CMV infection is a vaccine that is as effective as the rubella vaccine has been for eliminating congenital rubella syndrome and that can be given well before pregnancy,” said Sallie Permar, MD, PhD, chair of pediatrics at Weill Cornell Medicine and pediatrician-in-chief at New York–Presbyterian/Weill Cornell Medical Center and the New York–Presbyterian Komansky Children’s Hospital in New York.

“While trials of vaccines are ongoing, there is a need to have a therapeutic option, especially for the high-risk setting of a mother acquiring the virus for the first time during pregnancy,” Dr. Permar said in an interview.

Dr. Permar was not involved in this study but is involved in follow-up studies of this cohort and is conducting research on CMV maternal vaccines. She noted the need for safe, effective antiviral treatments and for research into newer immunoglobulin products, such as monoclonal antibodies.

Both Dr. Permar and Dr. Hughes highlighted the challenge of raising awareness about the danger of CMV infections during pregnancy.

“Pregnant women, and especially those who have or work with young children, who are frequently carriers of the infection, should be informed of this risk,” Dr. Permar said. She hopes universal testing of newborns will be implemented and that it enables people to recognize the frequency and burden of these infections. She remains optimistic about a vaccine.

“After 60 years of research into a CMV vaccine, I believe we are currently in a ‘golden age’ of CMV vaccine development,” she said. She noted that Moderna is about to launch a phase 3 mRNA vaccine trial for CMV. “Moreover, immune correlates of protection against CMV have been identified from previous partially effective vaccines, and animal models have improved for preclinical studies. Therefore, I believe we will have an effective and safe vaccine against this most common congenital infection in the coming years.”

The research was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Center for Advancing Translational Sciences. Dr. Hughes has served on Merck’s scientific advisory board. Various coauthors have received personal fees from Medela and nonfinancial support from Hologic; personal fees from Moderna and VBI vaccines, and grants from Novavax. Dr. Permar consults for Pfizer, Moderna, Merck, Sanofi, and Dynavax on their CMV vaccine programs, and she has a sponsored research program with Merck and Moderna on CMV vaccines.

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

From the Department of Pharmaceutical and Health Economics, University of Southern California, Los Angeles, CA, (Drs. Sangha and McCombs), Department of Pediatrics, Keck School of Medicine, and Department of Clinical Pharmacy, School of Pharmacy, University of Southern California, Los Angeles, CA, (Dr. Steinberg), and Leonard Schaeffer Center for Health Policy and Economics, University of Southern California, Los Angeles, CA (Dr. McCombs).

Objective: The recommended treatment for children and adolescents under 18 years of age who have a positive test for group A Streptococcus (GAS) are antibiotics using the “test and treat” strategy to detect and treat GAS for pediatric pharyngitis. This study used paid claims data to document the extent to which real-world treatment patterns are consistent with these recommendations. We document the factors correlated with testing and treatment, then examine the effects of receiving a GAS test and being treated with an antibiotic impact the likelihood of a revisit for an acute respiratory tract infection within 28 days.

Methods: This retrospective cohort study used Optum Insight Clinformatics data for medical and pharmacy claims from 2011-2013 to identify episodes of care for children and adolescents with pharyngitis around their index visit (± 6 months). The sample population included children and adolescents under 18 years of age with a diagnosis of pharyngitis. Multivariable logistic regression analyses were used to document factors associated with receipt of GAS test and antibiotic treatment. Next, we used logistic regression models to estimate the impact of test and treat recommendation on revisit risk.

Results: There were 24 685 treatment episodes for children and adolescents diagnosed with pharyngitis. Nearly 47% of these episodes included a GAS test and 48% of tested patients were prescribed an antibiotic prescription. Failing to perform a GAS test increased the risk of a revisit within 28 days by 44%. The use of antibiotics by tested and untested patients had no impact on revisit risk.

Conclusion: While the judicious use of antibiotics is important in managing pharyngitis infections and managing complications, the use of rapid diagnostic tools was found to be the determining factor in reducing revisits for pediatric patients with pharyngitis.

Keywords: pediatrics; pharyngitis; respiratory infections; acute infections; diagnostic tests; group A Streptococcus; antibiotics; revisits.

Acute pharyngitis is a common acute respiratory tract infection (ARTI) in children. Group A β-hemolytic streptococci (GABHS) is the most common bacterial etiology for pediatric pharyngitis, accounting for 15% to 30% of cases.¹

Beyond clinical assessment, laboratory diagnostic testing generally plays a limited role in guiding appropriate antibiotic prescribing for patients with an ARTI.^2,3 Most diagnostic tests require 2 or 3 days to result, incur additional costs, and may delay treatment.⁴ While these tests do not provide clear and timely guidance on which specific antibiotic is appropriate for ARTI patients, this is not the case for patients with pharyngitis.^5,6,7 A rapid diagnostic test exists to identify pharyngitis patients with GABHS which accounts for 1 in 4 children with acute sore throat.^1,4,6 Both the American Academy of Pediatrics and the Infectious Diseases Society of America recommend antibiotic treatment for children and adolescents under 18 years of age who have a positive test for group A Streptococcus (GAS).^8,9 This “test and treat” protocol has been consistently included in the Healthcare Effectiveness Data and Information Set (HEDIS) standards over time for pediatric pharyngitis patients aged 3 to 18 years before dispensing an antibiotic.¹⁰

Sinusitis, pneumonia, and acute otitis media are considered ARTIs where antibiotic treatment is justified. Therefore, pharyngitis of unclear etiology seen with these comorbid infections may not always undergo GAS testing but move directly to the patient being prescribed antibiotics. This analysis enumerates ARTI-related comorbidities present together with the initial coded pharyngitis diagnosis to evaluate their impact on the provider’s decision to test and treat, and on revisit risk.

Antibiotic treatment for GAS patients is likely to eradicate the acute GABHS infection within 10 days. Penicillin and amoxicillin are commonly recommended because of their narrow spectrum of activity, few adverse effects, established efficacy, and modest cost. Alternative antibiotics for patients with penicillin allergy, or with polymicrobial infection seen on culture results, include a first-generation cephalosporin, clindamycin, clarithromycin (Biaxin), or azithromycin (Zithromax).^1,8,11 However, while compliance with these HEDIS guidelines has been evaluated, the outcome effects of following the HEDIS “test and treat” recommendations for children with pharyngitis have not been adequately evaluated.

These outcome evaluations have increasing importance as the latest HEDIS survey has shown testing rates in commercial Preferred Provider Organizations (PPO) falling from 86.4% in 2018 to 75.9% in 2019, the lowest rate of testing since 2009, with similar reductions under 80% for Health Maintenance Organizations (HMO).¹⁰ While health plans may execute cost-benefit analyses and algorithms to forge best practices for GAS testing in children and adolescents presenting with symptoms of pharyngitis, it is important to regard the wasteful resource utilization and additional cost of revisits that may offset any gains accrued by more focused GAS testing outside the existing clinical guidelines and HEDIS measures. This may be of particular importance in documenting infection and sparing antibiotic therapy in toddlers and younger.

The objective of this study was to investigate the correlation between testing and antibiotic use on the likelihood of a revisit for an acute respiratory tract infection within 28 days. To achieve this objective, this investigation consists of 3 sequential analyses. First, we document the factors associated with the decision to test the patient for a GABHS infection using the GAS test. Next, we document the factors associated with the decision to use an antibiotic to treat the patient as a function of having tested the patient. Finally, we investigate the impact of the testing and treatment decisions on the likelihood of a revisit within 28 days.

Methods

Study design

This was a retrospective cohort study of episodes of treatment for pediatric patients with pharyngitis. Episodes were identified using data derived from the Optum Insight Clinformatics claims database provided to the University of Southern California to facilitate the training of graduate students. These data cover commercially insured patients with both medical and pharmacy benefits. Data were retrieved from the 3-year period spanning 2011-2013. An episode of care was identified based on date of the first (index) outpatient visit for a pharyngitis diagnosis (International Classification of Diseases, Ninth Revision [ICD-9]: 462, 463, 034.0). Outpatient visits were defined by visit setting: ambulatory clinics, physician offices, emergency rooms, and urgent care facilities. Each pharyngitis treatment episode was then screened for at least a 6-month enrollment in a health insurance plan prior and subsequent to the index visit using Optum enrollment data. Finally, eligible treatment episodes were restricted to children and adolescents under 18 years of age, who had an index outpatient visit for a primary diagnosis of acute pharyngitis.

A diagnostic profile was created for each episode using the diagnoses recorded for the index visit. Up to 3 diagnoses may be recorded for any outpatient visit and the first recorded diagnosis was assumed to be the primary diagnosis for that episode. Any secondary diagnoses recorded on the index visit were used to define comorbidities present at the index visit. ARTI-related comorbidities included: acute otitis media (AOM), bronchitis, sinusitis, pneumonia, and upper respiratory infection (URI). Other comorbid medical diagnoses were documented using diagnostic data from the pre-index period. Dichotomous variables for the following categories were created: mental disorders, nervous system disorders, respiratory symptoms, fever, injury and poisoning, other, or no diseases.

Prior visits for other respiratory infections in the previous 90 days were also identified for patients based on their index visit for pharyngitis. Similarly, any subsequent visits, within 28 days of the index visit, were also recorded to measure the health outcome for analysis. Practice settings include physician offices and federally qualified health centers, state and local health clinics, outpatient hospitals facilities, emergency departments, and other outpatient settings such as walk-in retail health clinic or ambulatory centers. Providers include primary care physicians (family practice, pediatricians, internal medicine), specialty care physicians (emergency medicine, preventive medicine), nonphysician providers (nurse practitioners, physician assistants) and other providers (urgent care, acute outpatient care, ambulatory care centers). Seasons of the year were determined based on the index date of the episode to account for possible seasonality in pharyngitis treatment. Lastly, a previous visits variable was created to identify whether the child had nonpharyngitis ARTI visits in the 3 months prior to the index visit.

Demographic variables were created based on enrollment and the socioeconomic data available in the Optum socioeconomic status file. These variables include patient age, race, sex, household income, geographic location, practice setting type, provider specialty, and type of insurance. An estimate of patient household income was based on algorithms using census block groups. Income categories were informed by the federal guidelines for a family of 4. A low-income family was defined as earning less than $50 000; a middle-income family earned between $50 000 and $75 000, and a high-income family earned $75 000 and above.¹² Patient insurance type was categorized as HMO, Exclusive Provider Organization (EPO), Point of Service (POS), and PPO. Race was identified as White, Black, Hispanic, and Asian. Patient location was defined according to national census regions.

Outcomes

GAS test

The HEDIS measures for pharyngitis recommend using the GAS test to identify the bacterial etiology of the pharyngitis infection. Patients who received the test were identified based on Current Procedural Terminology (CPT) codes 87070-71, 87081, 87430, 87650-52, and 87880.¹⁰

The pharmacy administrative claims dataset was used to identify study patients who filled a prescription for an antibiotic during their pharyngitis treatment episode. Optum pharmacy data identify the medications received, specifies the date of prescription filling, National Drug Codes, and American Hospital Formulary Service (AHFS) Classification System codes for each medication. We used the AHFS Pharmacologic-Therapeutic classification of antibiotics to create dichotomous variables documenting the antibacterial used by each patient.¹³ These are categorized under antibacterial including penicillins, cephalosporins (first, second, third, fourth generation cephalosporins), macrolides (first generation and others), tetracyclines, sulfonamides, fluoroquinolones (ciprofloxacin, levofloxacin, moxifloxacin), cephamycin, carbapenems, and β-lactam antibiotics (amoxicillin, amoxicillin/clavulanate, cephalexin, cefuroxime, cefdinir).

Revisits to physician or other provider

Revisits within 28 days were used as the measure of patient outcomes related to testing and filling of an antibiotic prescription for acute pharyngitis. Revisits may also be due to a patient returning for a follow-up, alternative treatment, worsening pharyngitis, or for another ARTI. An ARTI-related revisit also increases total resources used to treat pediatric pharyngitis patients.

Statistical analysis

Logistic regression was used for all 3 analyses conducted in this study. First, we determined the patient and treating physician characteristics that impact the decision to use GAS testing for pharyngitis. Second, we identified those factors that impact the decision to use antibiotic prescriptions among children who were diagnosed with pharyngitis adding in the dichotomous variable indicating if the patient had received a GAS test. Third, we used a logit regression analysis to document if receiving a GAS test and/or an antibiotic impacted the likelihood of a revisit by comparing revisit risk. To estimate the effect of testing and/or antibiotic use, we divided patients into 4 groups based on whether the patient received a GAS test and/or an antibiotic prescription. This specification of the analysis of revisits as an outcome focuses on adherence to HEDIS “test and treat” guidelines¹⁰:

1. Patients who were not tested yet filled an antibiotic prescription. This decision was likely based on the clinician’s judgment of the patient’s signs and symptoms, and confirmational testing not performed.
2. Patients who were not tested and did not fill an antibiotic prescription. Apparently, in the clinician’s judgment the patient’s signs and symptoms were such that the infection did not warrant treatment and the clinical presentation did not necessitate the GAS test to confirm the recorded diagnosis of pharyngitis.
3. Patients who were tested and received antibiotic prescription, likely because the test was positive for GABHS.
4. Patients who were tested and did not receive antibiotic prescription.

We tested for statistically significant differences in baseline characteristics across these 4 patient groups using t tests for continuous variables and χ² tests for categorical variables. Odds ratios (OR) and CI were computed for the influential variables included the regression analyses.

We conducted a sensitivity analysis using a model specification which included the dichotomous variables for testing and for treatment, and the interaction term between these variables to assess if treatment effects varied in tested and untested patients. We also estimated this model of revisit risk using revisits within 7 days as the outcome variable.

All analyses were completed using STATA/IC 13 (StataCorp, College Station, TX).

Results

There were 24 685 treatment episodes for children diagnosed with pharyngitis. Nearly 47% of these episodes included GAS testing and 47% of the tested patients filled an antibiotic prescription. Similarly, 53% of patients were not tested and 49% of untested patients filled an antibiotic prescription. As a result, the 4 groups identified for analysis were evenly distributed: untested and no prescription (26.9%), untested and prescription (26.3%), tested and prescription (21.9%), and tested and no prescription (24.9%) (Figure).

Table 1 presents the descriptive statistics for these 4 patient groups. Note first that the rate of revisits within 28 days is under 5% across all groups. Second, the 2 tested groups have a lower revisit rate than the untested groups: the tested and treated have a revisit rate of 3.3%, and the tested and untreated have a revisit rate of 2.4%, while both the untested groups have a revisit rate of nearly 5%. These small absolute differences in revisit rates across groups were statistically significant.

Factors associated with receiving GAS test

Several factors were found to impact the decision to test (Table 2). Only 9.7% of children were reported to have any ARTI coinfection. As expected, these comorbidities resulted in a significantly lower likelihood of receiving the GAS test: AOM, bronchitis, sinusitis, pneumonia, and URI as comorbid infections had a 48%, 41%, 37%, 63%, and 13% lower likelihood of receiving the GAS test, respectively, than those with no comorbidities. Similarly, children with fever and respiratory symptoms were 35% and 45% less likely to receiving the GAS test, respectively. This is consistent with our expectation that comorbid ARTI infections will lead many providers to forgo testing.

Provider type and patient age also plays a role in receipt of the GAS test. Relative to outpatient facility providers, primary care physicians were 24% more likely and specialty physicians were 38% less likely of employing the GAS test. The child’s age played a significant role in receipt of the GAS test. Children aged 1 to 5 years and 5 to 12 years were 15% and 14% more likely to receive the test compared to children older than 12 years.

Pharyngitis patients have disproportionately higher odds of receiving a GAS test in most regions of the country compared to the Pacific region. For instance, children in the Mid-Atlantic region have 51% higher odds of receiving a GAS test while children in New England have 80% higher odds of receiving the same test.

Black children have 11% lower odds of receiving the GAS test compared to White children. Both middle-income and high-income children have 12% and 32% higher odds of receiving the test compared to low-income children. Compared to office-based visits, children visiting a clinic were twice as likely to receive a GAS test while those seen in the emergency room have 43% lower odds of receiving a GAS test. Hospital outpatient departments, which account for less than 1% of all visits, rarely used a GAS test which could be a statistical artifact due to small sample size. Lastly, insurance and season of the year had no significant impact of receipt of a GAS test.

Factors associated with receiving antibiotic prescription

Surprisingly, receiving the GAS test has a small but insignificant impact on the likelihood that the patient will receive an antibiotic prescription (Table 3) (Adjusted OR = 1.055, P = .07). After controlling for receipt of a GAS test, children with AOM and sinusitis comorbidities have an increased likelihood of being prescribed an antibiotic. Children with URI have a lower likelihood of being prescribed an antibiotic. Additionally, relative to primary care physicians, children visiting nonphysician providers for pharyngitis were more likely to be prescribed an antibiotic.

Children under 12 years of age were more likely to use an antibiotic compared to children 12 years and older. Geographically, there is some evidence of regional variation in antibiotic use as well. Children in the south Atlantic, west-south central, and southeast central regions had a significantly lower odds of being prescribed an antibiotic respectively than pharyngitis patients in the Pacific region. Black children had a 10% lower likelihood of being prescribed an antibiotic compared to White children, possibly related to their lower rate of GAS testing. Compared to office-based visits, children visiting a clinic were less likely to use an antibiotic. Household income, insurance type, and season had no significant impact on revisit risk.

Effects of GAS test and antibiotic prescriptions on likelihood of revisits

The multivariate analysis of the risk of a revisit within 28 days is presented in Table 4. Children with pharyngitis who tested and did not receive an antibiotic serve as the reference comparison group for this analysis to illustrate the impact of using the GAS test and treatment with an antibiotic. The results in Table 4 are quite clear: patients who receive the GAS test were significantly less likely to have a revisit within 28 days. Moreover, within the group of patients who were tested, those not receiving an antibiotic, presumedly because their GAS test was negative, experienced the lowest risk of a revisit. This result is consistent with the data in Table 1. Moreover, using an antibiotic had no impact on the likelihood of a revisit in patients not receiving the GAS test. This result is also consistent with Table 1.

Other results from the analysis of revisit risk may be of interest to clinicians. Pharyngitis patients with a prior episode of treatment within 90 days for an acute respiratory tract infection were more than 7 times more likely to experience a revisit within 28 days of the pharyngitis diagnosis than patients without a history of recent ARTI infections. Age is also a risk factor in likelihood of initiating a revisit. Children under 1 year and children aged 1 to 5 years were more likely to have a revisit than children aged more than 12 years. Compared to White children, Black children were 25% (P = .04) less likely to have a revisit. The care setting also has a significant impact on revisit risk. Children visiting outpatient hospital and other care settings had a significantly higher revisit risk than those visiting a physician’s office. Lastly, household income, geographic region, season, medical comorbidities, gender, and insurance type have no significant impact on revisit risk.

Sensitivity analysis

The results from the analysis of 7-day and 28-day revisit risk are summarized in Table 5. These results indicate that patients who were tested had a more significant decrease in revisit risk at 7 days (72%) than was evident at 28 days (47% reduction). Receiving an antibiotic, with or without the test, had no impact on revisit risk.

Discussion

Published data on revisits for pharyngitis are lacking with the concentration of prior research focused more on systemic complications of undertreated GABHS disease or on identifying carrier status. Our study results suggest that GAS testing is the most important factor in reducing revisit risk. Being prescribed an antibiotic, on its own, does not have a significant impact on the risk of a revisit. However, once the GAS test is used, the decision not to use an antibiotic was correlated with the lowest revisit rate, likely because the source of the pharyngitis infection was viral and more likely to resolve without a revisit. Prior studies have reported variable rates of testing among children with pharyngitis prescribed an antibiotic, ranging from 23% to 91%,^14,15 with testing important toward more appropriate antibiotic use.¹⁶ More recently, among more than 67 000 patients aged 3 to 21 years presenting with sore throat and receiving a GAS test, 32.6% were positive.¹⁷

Our analysis found that more than 46% of pediatric pharyngitis patients were given the rapid GAS test. While this testing rate is substantially lower than HEDIS recommendations and lower than testing rates achieved by several health maintenance organizations,¹⁰ it is similar to the 53% of children receiving such testing in a recent National Ambulatory Medical Care Survey.¹⁸ Furthermore, we found that when antibiotics are prescribed following a GAS test, the revisit risk is not significantly reduced, possibly because antibiotics lower revisit risk when informed by diagnostic testing tools that determine the infectious organism. This is supported by a similar population analysis in which we observed reduced revisit rates in children with AOM managed with antibiotics within 3 days of index diagnosis.¹⁹

Several other factors also affect the likelihood of a child receiving the GAS test. Children aged 1 to 12 years were significantly more likely to receive the GAS test than children over the age of 12. This included children in the 1 to 5 years old bracket who had a 15% higher likelihood of undergoing a GAS test, despite children less than 3 years of age as not recommended targets for GAS testing.²⁰ As expected, children with reported ARTI-associated comorbidities were also less likely to receive a GAS test. Additionally, specialty care physicians were less inclined to implement the GAS test, possibly because of diagnostic confidence without testing or referral after GAS was ruled out. Black and low-income children had statistically lower odds of receiving the test, even after controlling for other factors, and yet were less likely to consume a revisit. As the overall data suggested more revisits in those not tested, further study is needed to examine if race or income discrepancies are equity based. Finally, children in the Pacific region, compared to the rest of the nation, were the least likely to receive a GAS test and yet there were no significant differences in revisit rates by region. Regional differences in antibiotic use were also observed in our study, as has been seen by others.²¹

After statistically controlling for having received the diagnostic GAS test and filled a prescription for an antibiotic, there are multitude of factors that independently affect the revisit risk, the most important of which if which was a history of an ARTI infection in the prior 90 days. While prior visit history had no impact on the likelihood of being tested or filling an antibiotic, patients with prior visits were more than 7 times more likely to consume a revisit. This was not reflected in nor related to comorbid ARTIs as these patients did not have statistically higher revisits than those with pharyngitis as the sole-coded diagnosis. Moreover, speculation for bacterial etiology of primary or superinfection based on a recent history of ARTI accounting for revisits seems unlikely as it did not yield greater antibiotic use in that group. Further analysis is required to determine the clinical and behavioral factors that promote for prior ARTI history as a major factor in revisit risk after an index visit for pharyngitis.

Children aged between 1 and 5 years, though 15% more likely to be tested than those aged 12 through 17 years, were also 39% more likely to initiate a revisit compared to older children when statistically controlling for other covariates. This perhaps suggests longer illness, wrong diagnosis, delay in appropriate treatment, or more caution by parents and providers in this age group. Justification for testing children less than 3 years of age who are outside of the HEDIS suggested age group, when clinical judgement does not point to another infection source, can result in positivity rates between 22% and 30% as previously observed.^22,23 Patients visiting nonphysician providers and outpatient facility providers were less likely to have a revisit than those visiting primary and specialty care physicians, though slightly higher propensity for antibiotic prescriptions was seen for nonphysician providers. Pediatricians have been noted to be less likely to prescribe antibiotics without GAS testing than nonpediatric providers, and more guidelines-compliant in prescribing.²⁴

Recommendations to not test children under 3 years of age are based on the lack of acute rheumatic fever and other complications in this age group together with more frequent viral syndromes. Selectivity in applying clinical criteria to testing can be attempted to separate bacterial from viral illness. Postnasal drainage/rhinorrhea, hoarse voice, and cough have been used successfully to identify those with viral illness and less need for testing, with greater certainty of low risk for GABHS in those over 11 years of age without tonsillar exudates, cervical adenopathy, or fever.¹⁷ However, the marginal benefits of those who have all 3 features of viral illness versus none in identifying GAS positivity was 23.3% vs 37.6% - helpful, but certainly not diminishing the need for testing. These constitutional findings of viral URI also do not exclude the GAS carrier state that features these symptoms.²⁵ Others have reinforced the doubt of pharyngeal exudates as the premier diagnostic finding for test-positive GAS.²⁶

This study had several limitations. The Optum claims dataset only contains ICD-9 codes for diagnoses. It does not include data on infection severity and clinical findings related to symptoms, thus empiric treatment warranted based in clinical severity is not assessed. Antibiotics are commonly available as generics and very inexpensive. Patients may fill and pay for these prescriptions directly, in which case, a claim for payment may not be filed with Optum. This could result in an undercount of treated patients in our study.

There is no corresponding problem of missing medical claims for GAS testing which were obtained from the CPT codes within the Optum claims data set. However, we elected not to verify the test results due to these data being missing for 75% of the study population. Nevertheless, this study’s focus was less about justifying antibiotic treatment, but dealt with the outcomes generated by testing and treatment. Toward that end, we used CPT codes to identify a revisit, and while those can at times be affected by financial reimbursement incentives, differences related to revisits in the 4 patient groups should not be subject to bias.

Conclusion

This study used data from real world practices to document the patterns of GAS testing and antibiotic use in pediatric pharyngitis patients. Revisit rates were under 5% for all patient groups and the use of rapid diagnostic tools were found to be the determining factor in further reducing the risk of revisits. This supports the need for compliance with the HEDIS quality metric for pharyngitis to the recommended levels of rapid testing which have been falling in recent years. Use of more accurate antigen and newer molecular detection testing methods may help further delineate important factors in determining pediatric pharyngitis treatment and need for revisits.²⁷

Corresponding author: Jeffrey McCombs, MD, University of Southern California School of Pharmacy, Department of Pharmaceutical and Health Economics, Leonard D. Schaeffer Center for Health Policy & Economics, 635 Downey Way, Verna & Peter Dauterive Hall 310, Los Angeles, CA 90089-3333; [email protected].

Financial disclosures: None.

From the Department of Pharmaceutical and Health Economics, University of Southern California, Los Angeles, CA, (Drs. Sangha and McCombs), Department of Pediatrics, Keck School of Medicine, and Department of Clinical Pharmacy, School of Pharmacy, University of Southern California, Los Angeles, CA, (Dr. Steinberg), and Leonard Schaeffer Center for Health Policy and Economics, University of Southern California, Los Angeles, CA (Dr. McCombs).

Objective: The recommended treatment for children and adolescents under 18 years of age who have a positive test for group A Streptococcus (GAS) are antibiotics using the “test and treat” strategy to detect and treat GAS for pediatric pharyngitis. This study used paid claims data to document the extent to which real-world treatment patterns are consistent with these recommendations. We document the factors correlated with testing and treatment, then examine the effects of receiving a GAS test and being treated with an antibiotic impact the likelihood of a revisit for an acute respiratory tract infection within 28 days.

Methods: This retrospective cohort study used Optum Insight Clinformatics data for medical and pharmacy claims from 2011-2013 to identify episodes of care for children and adolescents with pharyngitis around their index visit (± 6 months). The sample population included children and adolescents under 18 years of age with a diagnosis of pharyngitis. Multivariable logistic regression analyses were used to document factors associated with receipt of GAS test and antibiotic treatment. Next, we used logistic regression models to estimate the impact of test and treat recommendation on revisit risk.

Results: There were 24 685 treatment episodes for children and adolescents diagnosed with pharyngitis. Nearly 47% of these episodes included a GAS test and 48% of tested patients were prescribed an antibiotic prescription. Failing to perform a GAS test increased the risk of a revisit within 28 days by 44%. The use of antibiotics by tested and untested patients had no impact on revisit risk.

Conclusion: While the judicious use of antibiotics is important in managing pharyngitis infections and managing complications, the use of rapid diagnostic tools was found to be the determining factor in reducing revisits for pediatric patients with pharyngitis.

Keywords: pediatrics; pharyngitis; respiratory infections; acute infections; diagnostic tests; group A Streptococcus; antibiotics; revisits.

Acute pharyngitis is a common acute respiratory tract infection (ARTI) in children. Group A β-hemolytic streptococci (GABHS) is the most common bacterial etiology for pediatric pharyngitis, accounting for 15% to 30% of cases.¹

Beyond clinical assessment, laboratory diagnostic testing generally plays a limited role in guiding appropriate antibiotic prescribing for patients with an ARTI.^2,3 Most diagnostic tests require 2 or 3 days to result, incur additional costs, and may delay treatment.⁴ While these tests do not provide clear and timely guidance on which specific antibiotic is appropriate for ARTI patients, this is not the case for patients with pharyngitis.^5,6,7 A rapid diagnostic test exists to identify pharyngitis patients with GABHS which accounts for 1 in 4 children with acute sore throat.^1,4,6 Both the American Academy of Pediatrics and the Infectious Diseases Society of America recommend antibiotic treatment for children and adolescents under 18 years of age who have a positive test for group A Streptococcus (GAS).^8,9 This “test and treat” protocol has been consistently included in the Healthcare Effectiveness Data and Information Set (HEDIS) standards over time for pediatric pharyngitis patients aged 3 to 18 years before dispensing an antibiotic.¹⁰

Sinusitis, pneumonia, and acute otitis media are considered ARTIs where antibiotic treatment is justified. Therefore, pharyngitis of unclear etiology seen with these comorbid infections may not always undergo GAS testing but move directly to the patient being prescribed antibiotics. This analysis enumerates ARTI-related comorbidities present together with the initial coded pharyngitis diagnosis to evaluate their impact on the provider’s decision to test and treat, and on revisit risk.

Antibiotic treatment for GAS patients is likely to eradicate the acute GABHS infection within 10 days. Penicillin and amoxicillin are commonly recommended because of their narrow spectrum of activity, few adverse effects, established efficacy, and modest cost. Alternative antibiotics for patients with penicillin allergy, or with polymicrobial infection seen on culture results, include a first-generation cephalosporin, clindamycin, clarithromycin (Biaxin), or azithromycin (Zithromax).^1,8,11 However, while compliance with these HEDIS guidelines has been evaluated, the outcome effects of following the HEDIS “test and treat” recommendations for children with pharyngitis have not been adequately evaluated.

These outcome evaluations have increasing importance as the latest HEDIS survey has shown testing rates in commercial Preferred Provider Organizations (PPO) falling from 86.4% in 2018 to 75.9% in 2019, the lowest rate of testing since 2009, with similar reductions under 80% for Health Maintenance Organizations (HMO).¹⁰ While health plans may execute cost-benefit analyses and algorithms to forge best practices for GAS testing in children and adolescents presenting with symptoms of pharyngitis, it is important to regard the wasteful resource utilization and additional cost of revisits that may offset any gains accrued by more focused GAS testing outside the existing clinical guidelines and HEDIS measures. This may be of particular importance in documenting infection and sparing antibiotic therapy in toddlers and younger.

The objective of this study was to investigate the correlation between testing and antibiotic use on the likelihood of a revisit for an acute respiratory tract infection within 28 days. To achieve this objective, this investigation consists of 3 sequential analyses. First, we document the factors associated with the decision to test the patient for a GABHS infection using the GAS test. Next, we document the factors associated with the decision to use an antibiotic to treat the patient as a function of having tested the patient. Finally, we investigate the impact of the testing and treatment decisions on the likelihood of a revisit within 28 days.

Methods

Study design

This was a retrospective cohort study of episodes of treatment for pediatric patients with pharyngitis. Episodes were identified using data derived from the Optum Insight Clinformatics claims database provided to the University of Southern California to facilitate the training of graduate students. These data cover commercially insured patients with both medical and pharmacy benefits. Data were retrieved from the 3-year period spanning 2011-2013. An episode of care was identified based on date of the first (index) outpatient visit for a pharyngitis diagnosis (International Classification of Diseases, Ninth Revision [ICD-9]: 462, 463, 034.0). Outpatient visits were defined by visit setting: ambulatory clinics, physician offices, emergency rooms, and urgent care facilities. Each pharyngitis treatment episode was then screened for at least a 6-month enrollment in a health insurance plan prior and subsequent to the index visit using Optum enrollment data. Finally, eligible treatment episodes were restricted to children and adolescents under 18 years of age, who had an index outpatient visit for a primary diagnosis of acute pharyngitis.

A diagnostic profile was created for each episode using the diagnoses recorded for the index visit. Up to 3 diagnoses may be recorded for any outpatient visit and the first recorded diagnosis was assumed to be the primary diagnosis for that episode. Any secondary diagnoses recorded on the index visit were used to define comorbidities present at the index visit. ARTI-related comorbidities included: acute otitis media (AOM), bronchitis, sinusitis, pneumonia, and upper respiratory infection (URI). Other comorbid medical diagnoses were documented using diagnostic data from the pre-index period. Dichotomous variables for the following categories were created: mental disorders, nervous system disorders, respiratory symptoms, fever, injury and poisoning, other, or no diseases.

Prior visits for other respiratory infections in the previous 90 days were also identified for patients based on their index visit for pharyngitis. Similarly, any subsequent visits, within 28 days of the index visit, were also recorded to measure the health outcome for analysis. Practice settings include physician offices and federally qualified health centers, state and local health clinics, outpatient hospitals facilities, emergency departments, and other outpatient settings such as walk-in retail health clinic or ambulatory centers. Providers include primary care physicians (family practice, pediatricians, internal medicine), specialty care physicians (emergency medicine, preventive medicine), nonphysician providers (nurse practitioners, physician assistants) and other providers (urgent care, acute outpatient care, ambulatory care centers). Seasons of the year were determined based on the index date of the episode to account for possible seasonality in pharyngitis treatment. Lastly, a previous visits variable was created to identify whether the child had nonpharyngitis ARTI visits in the 3 months prior to the index visit.

Demographic variables were created based on enrollment and the socioeconomic data available in the Optum socioeconomic status file. These variables include patient age, race, sex, household income, geographic location, practice setting type, provider specialty, and type of insurance. An estimate of patient household income was based on algorithms using census block groups. Income categories were informed by the federal guidelines for a family of 4. A low-income family was defined as earning less than $50 000; a middle-income family earned between $50 000 and $75 000, and a high-income family earned $75 000 and above.¹² Patient insurance type was categorized as HMO, Exclusive Provider Organization (EPO), Point of Service (POS), and PPO. Race was identified as White, Black, Hispanic, and Asian. Patient location was defined according to national census regions.

Outcomes

GAS test

The HEDIS measures for pharyngitis recommend using the GAS test to identify the bacterial etiology of the pharyngitis infection. Patients who received the test were identified based on Current Procedural Terminology (CPT) codes 87070-71, 87081, 87430, 87650-52, and 87880.¹⁰

The pharmacy administrative claims dataset was used to identify study patients who filled a prescription for an antibiotic during their pharyngitis treatment episode. Optum pharmacy data identify the medications received, specifies the date of prescription filling, National Drug Codes, and American Hospital Formulary Service (AHFS) Classification System codes for each medication. We used the AHFS Pharmacologic-Therapeutic classification of antibiotics to create dichotomous variables documenting the antibacterial used by each patient.¹³ These are categorized under antibacterial including penicillins, cephalosporins (first, second, third, fourth generation cephalosporins), macrolides (first generation and others), tetracyclines, sulfonamides, fluoroquinolones (ciprofloxacin, levofloxacin, moxifloxacin), cephamycin, carbapenems, and β-lactam antibiotics (amoxicillin, amoxicillin/clavulanate, cephalexin, cefuroxime, cefdinir).

Revisits to physician or other provider

Revisits within 28 days were used as the measure of patient outcomes related to testing and filling of an antibiotic prescription for acute pharyngitis. Revisits may also be due to a patient returning for a follow-up, alternative treatment, worsening pharyngitis, or for another ARTI. An ARTI-related revisit also increases total resources used to treat pediatric pharyngitis patients.

Statistical analysis

Logistic regression was used for all 3 analyses conducted in this study. First, we determined the patient and treating physician characteristics that impact the decision to use GAS testing for pharyngitis. Second, we identified those factors that impact the decision to use antibiotic prescriptions among children who were diagnosed with pharyngitis adding in the dichotomous variable indicating if the patient had received a GAS test. Third, we used a logit regression analysis to document if receiving a GAS test and/or an antibiotic impacted the likelihood of a revisit by comparing revisit risk. To estimate the effect of testing and/or antibiotic use, we divided patients into 4 groups based on whether the patient received a GAS test and/or an antibiotic prescription. This specification of the analysis of revisits as an outcome focuses on adherence to HEDIS “test and treat” guidelines¹⁰:

1. Patients who were not tested yet filled an antibiotic prescription. This decision was likely based on the clinician’s judgment of the patient’s signs and symptoms, and confirmational testing not performed.
2. Patients who were not tested and did not fill an antibiotic prescription. Apparently, in the clinician’s judgment the patient’s signs and symptoms were such that the infection did not warrant treatment and the clinical presentation did not necessitate the GAS test to confirm the recorded diagnosis of pharyngitis.
3. Patients who were tested and received antibiotic prescription, likely because the test was positive for GABHS.
4. Patients who were tested and did not receive antibiotic prescription.

We tested for statistically significant differences in baseline characteristics across these 4 patient groups using t tests for continuous variables and χ² tests for categorical variables. Odds ratios (OR) and CI were computed for the influential variables included the regression analyses.

We conducted a sensitivity analysis using a model specification which included the dichotomous variables for testing and for treatment, and the interaction term between these variables to assess if treatment effects varied in tested and untested patients. We also estimated this model of revisit risk using revisits within 7 days as the outcome variable.

All analyses were completed using STATA/IC 13 (StataCorp, College Station, TX).

Results

There were 24 685 treatment episodes for children diagnosed with pharyngitis. Nearly 47% of these episodes included GAS testing and 47% of the tested patients filled an antibiotic prescription. Similarly, 53% of patients were not tested and 49% of untested patients filled an antibiotic prescription. As a result, the 4 groups identified for analysis were evenly distributed: untested and no prescription (26.9%), untested and prescription (26.3%), tested and prescription (21.9%), and tested and no prescription (24.9%) (Figure).

Table 1 presents the descriptive statistics for these 4 patient groups. Note first that the rate of revisits within 28 days is under 5% across all groups. Second, the 2 tested groups have a lower revisit rate than the untested groups: the tested and treated have a revisit rate of 3.3%, and the tested and untreated have a revisit rate of 2.4%, while both the untested groups have a revisit rate of nearly 5%. These small absolute differences in revisit rates across groups were statistically significant.

Factors associated with receiving GAS test

Several factors were found to impact the decision to test (Table 2). Only 9.7% of children were reported to have any ARTI coinfection. As expected, these comorbidities resulted in a significantly lower likelihood of receiving the GAS test: AOM, bronchitis, sinusitis, pneumonia, and URI as comorbid infections had a 48%, 41%, 37%, 63%, and 13% lower likelihood of receiving the GAS test, respectively, than those with no comorbidities. Similarly, children with fever and respiratory symptoms were 35% and 45% less likely to receiving the GAS test, respectively. This is consistent with our expectation that comorbid ARTI infections will lead many providers to forgo testing.

Provider type and patient age also plays a role in receipt of the GAS test. Relative to outpatient facility providers, primary care physicians were 24% more likely and specialty physicians were 38% less likely of employing the GAS test. The child’s age played a significant role in receipt of the GAS test. Children aged 1 to 5 years and 5 to 12 years were 15% and 14% more likely to receive the test compared to children older than 12 years.

Pharyngitis patients have disproportionately higher odds of receiving a GAS test in most regions of the country compared to the Pacific region. For instance, children in the Mid-Atlantic region have 51% higher odds of receiving a GAS test while children in New England have 80% higher odds of receiving the same test.

Black children have 11% lower odds of receiving the GAS test compared to White children. Both middle-income and high-income children have 12% and 32% higher odds of receiving the test compared to low-income children. Compared to office-based visits, children visiting a clinic were twice as likely to receive a GAS test while those seen in the emergency room have 43% lower odds of receiving a GAS test. Hospital outpatient departments, which account for less than 1% of all visits, rarely used a GAS test which could be a statistical artifact due to small sample size. Lastly, insurance and season of the year had no significant impact of receipt of a GAS test.

Factors associated with receiving antibiotic prescription

Surprisingly, receiving the GAS test has a small but insignificant impact on the likelihood that the patient will receive an antibiotic prescription (Table 3) (Adjusted OR = 1.055, P = .07). After controlling for receipt of a GAS test, children with AOM and sinusitis comorbidities have an increased likelihood of being prescribed an antibiotic. Children with URI have a lower likelihood of being prescribed an antibiotic. Additionally, relative to primary care physicians, children visiting nonphysician providers for pharyngitis were more likely to be prescribed an antibiotic.

Children under 12 years of age were more likely to use an antibiotic compared to children 12 years and older. Geographically, there is some evidence of regional variation in antibiotic use as well. Children in the south Atlantic, west-south central, and southeast central regions had a significantly lower odds of being prescribed an antibiotic respectively than pharyngitis patients in the Pacific region. Black children had a 10% lower likelihood of being prescribed an antibiotic compared to White children, possibly related to their lower rate of GAS testing. Compared to office-based visits, children visiting a clinic were less likely to use an antibiotic. Household income, insurance type, and season had no significant impact on revisit risk.

Effects of GAS test and antibiotic prescriptions on likelihood of revisits

The multivariate analysis of the risk of a revisit within 28 days is presented in Table 4. Children with pharyngitis who tested and did not receive an antibiotic serve as the reference comparison group for this analysis to illustrate the impact of using the GAS test and treatment with an antibiotic. The results in Table 4 are quite clear: patients who receive the GAS test were significantly less likely to have a revisit within 28 days. Moreover, within the group of patients who were tested, those not receiving an antibiotic, presumedly because their GAS test was negative, experienced the lowest risk of a revisit. This result is consistent with the data in Table 1. Moreover, using an antibiotic had no impact on the likelihood of a revisit in patients not receiving the GAS test. This result is also consistent with Table 1.

Other results from the analysis of revisit risk may be of interest to clinicians. Pharyngitis patients with a prior episode of treatment within 90 days for an acute respiratory tract infection were more than 7 times more likely to experience a revisit within 28 days of the pharyngitis diagnosis than patients without a history of recent ARTI infections. Age is also a risk factor in likelihood of initiating a revisit. Children under 1 year and children aged 1 to 5 years were more likely to have a revisit than children aged more than 12 years. Compared to White children, Black children were 25% (P = .04) less likely to have a revisit. The care setting also has a significant impact on revisit risk. Children visiting outpatient hospital and other care settings had a significantly higher revisit risk than those visiting a physician’s office. Lastly, household income, geographic region, season, medical comorbidities, gender, and insurance type have no significant impact on revisit risk.

Sensitivity analysis

The results from the analysis of 7-day and 28-day revisit risk are summarized in Table 5. These results indicate that patients who were tested had a more significant decrease in revisit risk at 7 days (72%) than was evident at 28 days (47% reduction). Receiving an antibiotic, with or without the test, had no impact on revisit risk.

Discussion

Published data on revisits for pharyngitis are lacking with the concentration of prior research focused more on systemic complications of undertreated GABHS disease or on identifying carrier status. Our study results suggest that GAS testing is the most important factor in reducing revisit risk. Being prescribed an antibiotic, on its own, does not have a significant impact on the risk of a revisit. However, once the GAS test is used, the decision not to use an antibiotic was correlated with the lowest revisit rate, likely because the source of the pharyngitis infection was viral and more likely to resolve without a revisit. Prior studies have reported variable rates of testing among children with pharyngitis prescribed an antibiotic, ranging from 23% to 91%,^14,15 with testing important toward more appropriate antibiotic use.¹⁶ More recently, among more than 67 000 patients aged 3 to 21 years presenting with sore throat and receiving a GAS test, 32.6% were positive.¹⁷

Our analysis found that more than 46% of pediatric pharyngitis patients were given the rapid GAS test. While this testing rate is substantially lower than HEDIS recommendations and lower than testing rates achieved by several health maintenance organizations,¹⁰ it is similar to the 53% of children receiving such testing in a recent National Ambulatory Medical Care Survey.¹⁸ Furthermore, we found that when antibiotics are prescribed following a GAS test, the revisit risk is not significantly reduced, possibly because antibiotics lower revisit risk when informed by diagnostic testing tools that determine the infectious organism. This is supported by a similar population analysis in which we observed reduced revisit rates in children with AOM managed with antibiotics within 3 days of index diagnosis.¹⁹

Several other factors also affect the likelihood of a child receiving the GAS test. Children aged 1 to 12 years were significantly more likely to receive the GAS test than children over the age of 12. This included children in the 1 to 5 years old bracket who had a 15% higher likelihood of undergoing a GAS test, despite children less than 3 years of age as not recommended targets for GAS testing.²⁰ As expected, children with reported ARTI-associated comorbidities were also less likely to receive a GAS test. Additionally, specialty care physicians were less inclined to implement the GAS test, possibly because of diagnostic confidence without testing or referral after GAS was ruled out. Black and low-income children had statistically lower odds of receiving the test, even after controlling for other factors, and yet were less likely to consume a revisit. As the overall data suggested more revisits in those not tested, further study is needed to examine if race or income discrepancies are equity based. Finally, children in the Pacific region, compared to the rest of the nation, were the least likely to receive a GAS test and yet there were no significant differences in revisit rates by region. Regional differences in antibiotic use were also observed in our study, as has been seen by others.²¹

After statistically controlling for having received the diagnostic GAS test and filled a prescription for an antibiotic, there are multitude of factors that independently affect the revisit risk, the most important of which if which was a history of an ARTI infection in the prior 90 days. While prior visit history had no impact on the likelihood of being tested or filling an antibiotic, patients with prior visits were more than 7 times more likely to consume a revisit. This was not reflected in nor related to comorbid ARTIs as these patients did not have statistically higher revisits than those with pharyngitis as the sole-coded diagnosis. Moreover, speculation for bacterial etiology of primary or superinfection based on a recent history of ARTI accounting for revisits seems unlikely as it did not yield greater antibiotic use in that group. Further analysis is required to determine the clinical and behavioral factors that promote for prior ARTI history as a major factor in revisit risk after an index visit for pharyngitis.

Children aged between 1 and 5 years, though 15% more likely to be tested than those aged 12 through 17 years, were also 39% more likely to initiate a revisit compared to older children when statistically controlling for other covariates. This perhaps suggests longer illness, wrong diagnosis, delay in appropriate treatment, or more caution by parents and providers in this age group. Justification for testing children less than 3 years of age who are outside of the HEDIS suggested age group, when clinical judgement does not point to another infection source, can result in positivity rates between 22% and 30% as previously observed.^22,23 Patients visiting nonphysician providers and outpatient facility providers were less likely to have a revisit than those visiting primary and specialty care physicians, though slightly higher propensity for antibiotic prescriptions was seen for nonphysician providers. Pediatricians have been noted to be less likely to prescribe antibiotics without GAS testing than nonpediatric providers, and more guidelines-compliant in prescribing.²⁴

Recommendations to not test children under 3 years of age are based on the lack of acute rheumatic fever and other complications in this age group together with more frequent viral syndromes. Selectivity in applying clinical criteria to testing can be attempted to separate bacterial from viral illness. Postnasal drainage/rhinorrhea, hoarse voice, and cough have been used successfully to identify those with viral illness and less need for testing, with greater certainty of low risk for GABHS in those over 11 years of age without tonsillar exudates, cervical adenopathy, or fever.¹⁷ However, the marginal benefits of those who have all 3 features of viral illness versus none in identifying GAS positivity was 23.3% vs 37.6% - helpful, but certainly not diminishing the need for testing. These constitutional findings of viral URI also do not exclude the GAS carrier state that features these symptoms.²⁵ Others have reinforced the doubt of pharyngeal exudates as the premier diagnostic finding for test-positive GAS.²⁶

This study had several limitations. The Optum claims dataset only contains ICD-9 codes for diagnoses. It does not include data on infection severity and clinical findings related to symptoms, thus empiric treatment warranted based in clinical severity is not assessed. Antibiotics are commonly available as generics and very inexpensive. Patients may fill and pay for these prescriptions directly, in which case, a claim for payment may not be filed with Optum. This could result in an undercount of treated patients in our study.

There is no corresponding problem of missing medical claims for GAS testing which were obtained from the CPT codes within the Optum claims data set. However, we elected not to verify the test results due to these data being missing for 75% of the study population. Nevertheless, this study’s focus was less about justifying antibiotic treatment, but dealt with the outcomes generated by testing and treatment. Toward that end, we used CPT codes to identify a revisit, and while those can at times be affected by financial reimbursement incentives, differences related to revisits in the 4 patient groups should not be subject to bias.

Conclusion

This study used data from real world practices to document the patterns of GAS testing and antibiotic use in pediatric pharyngitis patients. Revisit rates were under 5% for all patient groups and the use of rapid diagnostic tools were found to be the determining factor in further reducing the risk of revisits. This supports the need for compliance with the HEDIS quality metric for pharyngitis to the recommended levels of rapid testing which have been falling in recent years. Use of more accurate antigen and newer molecular detection testing methods may help further delineate important factors in determining pediatric pharyngitis treatment and need for revisits.²⁷

Corresponding author: Jeffrey McCombs, MD, University of Southern California School of Pharmacy, Department of Pharmaceutical and Health Economics, Leonard D. Schaeffer Center for Health Policy & Economics, 635 Downey Way, Verna & Peter Dauterive Hall 310, Los Angeles, CA 90089-3333; [email protected].

Financial disclosures: None.

From the Department of Pharmaceutical and Health Economics, University of Southern California, Los Angeles, CA, (Drs. Sangha and McCombs), Department of Pediatrics, Keck School of Medicine, and Department of Clinical Pharmacy, School of Pharmacy, University of Southern California, Los Angeles, CA, (Dr. Steinberg), and Leonard Schaeffer Center for Health Policy and Economics, University of Southern California, Los Angeles, CA (Dr. McCombs).

Objective: The recommended treatment for children and adolescents under 18 years of age who have a positive test for group A Streptococcus (GAS) are antibiotics using the “test and treat” strategy to detect and treat GAS for pediatric pharyngitis. This study used paid claims data to document the extent to which real-world treatment patterns are consistent with these recommendations. We document the factors correlated with testing and treatment, then examine the effects of receiving a GAS test and being treated with an antibiotic impact the likelihood of a revisit for an acute respiratory tract infection within 28 days.

Methods: This retrospective cohort study used Optum Insight Clinformatics data for medical and pharmacy claims from 2011-2013 to identify episodes of care for children and adolescents with pharyngitis around their index visit (± 6 months). The sample population included children and adolescents under 18 years of age with a diagnosis of pharyngitis. Multivariable logistic regression analyses were used to document factors associated with receipt of GAS test and antibiotic treatment. Next, we used logistic regression models to estimate the impact of test and treat recommendation on revisit risk.

Results: There were 24 685 treatment episodes for children and adolescents diagnosed with pharyngitis. Nearly 47% of these episodes included a GAS test and 48% of tested patients were prescribed an antibiotic prescription. Failing to perform a GAS test increased the risk of a revisit within 28 days by 44%. The use of antibiotics by tested and untested patients had no impact on revisit risk.

Conclusion: While the judicious use of antibiotics is important in managing pharyngitis infections and managing complications, the use of rapid diagnostic tools was found to be the determining factor in reducing revisits for pediatric patients with pharyngitis.

Keywords: pediatrics; pharyngitis; respiratory infections; acute infections; diagnostic tests; group A Streptococcus; antibiotics; revisits.

Acute pharyngitis is a common acute respiratory tract infection (ARTI) in children. Group A β-hemolytic streptococci (GABHS) is the most common bacterial etiology for pediatric pharyngitis, accounting for 15% to 30% of cases.¹

Beyond clinical assessment, laboratory diagnostic testing generally plays a limited role in guiding appropriate antibiotic prescribing for patients with an ARTI.^2,3 Most diagnostic tests require 2 or 3 days to result, incur additional costs, and may delay treatment.⁴ While these tests do not provide clear and timely guidance on which specific antibiotic is appropriate for ARTI patients, this is not the case for patients with pharyngitis.^5,6,7 A rapid diagnostic test exists to identify pharyngitis patients with GABHS which accounts for 1 in 4 children with acute sore throat.^1,4,6 Both the American Academy of Pediatrics and the Infectious Diseases Society of America recommend antibiotic treatment for children and adolescents under 18 years of age who have a positive test for group A Streptococcus (GAS).^8,9 This “test and treat” protocol has been consistently included in the Healthcare Effectiveness Data and Information Set (HEDIS) standards over time for pediatric pharyngitis patients aged 3 to 18 years before dispensing an antibiotic.¹⁰

Sinusitis, pneumonia, and acute otitis media are considered ARTIs where antibiotic treatment is justified. Therefore, pharyngitis of unclear etiology seen with these comorbid infections may not always undergo GAS testing but move directly to the patient being prescribed antibiotics. This analysis enumerates ARTI-related comorbidities present together with the initial coded pharyngitis diagnosis to evaluate their impact on the provider’s decision to test and treat, and on revisit risk.

Antibiotic treatment for GAS patients is likely to eradicate the acute GABHS infection within 10 days. Penicillin and amoxicillin are commonly recommended because of their narrow spectrum of activity, few adverse effects, established efficacy, and modest cost. Alternative antibiotics for patients with penicillin allergy, or with polymicrobial infection seen on culture results, include a first-generation cephalosporin, clindamycin, clarithromycin (Biaxin), or azithromycin (Zithromax).^1,8,11 However, while compliance with these HEDIS guidelines has been evaluated, the outcome effects of following the HEDIS “test and treat” recommendations for children with pharyngitis have not been adequately evaluated.

These outcome evaluations have increasing importance as the latest HEDIS survey has shown testing rates in commercial Preferred Provider Organizations (PPO) falling from 86.4% in 2018 to 75.9% in 2019, the lowest rate of testing since 2009, with similar reductions under 80% for Health Maintenance Organizations (HMO).¹⁰ While health plans may execute cost-benefit analyses and algorithms to forge best practices for GAS testing in children and adolescents presenting with symptoms of pharyngitis, it is important to regard the wasteful resource utilization and additional cost of revisits that may offset any gains accrued by more focused GAS testing outside the existing clinical guidelines and HEDIS measures. This may be of particular importance in documenting infection and sparing antibiotic therapy in toddlers and younger.

The objective of this study was to investigate the correlation between testing and antibiotic use on the likelihood of a revisit for an acute respiratory tract infection within 28 days. To achieve this objective, this investigation consists of 3 sequential analyses. First, we document the factors associated with the decision to test the patient for a GABHS infection using the GAS test. Next, we document the factors associated with the decision to use an antibiotic to treat the patient as a function of having tested the patient. Finally, we investigate the impact of the testing and treatment decisions on the likelihood of a revisit within 28 days.

Methods

Study design

This was a retrospective cohort study of episodes of treatment for pediatric patients with pharyngitis. Episodes were identified using data derived from the Optum Insight Clinformatics claims database provided to the University of Southern California to facilitate the training of graduate students. These data cover commercially insured patients with both medical and pharmacy benefits. Data were retrieved from the 3-year period spanning 2011-2013. An episode of care was identified based on date of the first (index) outpatient visit for a pharyngitis diagnosis (International Classification of Diseases, Ninth Revision [ICD-9]: 462, 463, 034.0). Outpatient visits were defined by visit setting: ambulatory clinics, physician offices, emergency rooms, and urgent care facilities. Each pharyngitis treatment episode was then screened for at least a 6-month enrollment in a health insurance plan prior and subsequent to the index visit using Optum enrollment data. Finally, eligible treatment episodes were restricted to children and adolescents under 18 years of age, who had an index outpatient visit for a primary diagnosis of acute pharyngitis.

A diagnostic profile was created for each episode using the diagnoses recorded for the index visit. Up to 3 diagnoses may be recorded for any outpatient visit and the first recorded diagnosis was assumed to be the primary diagnosis for that episode. Any secondary diagnoses recorded on the index visit were used to define comorbidities present at the index visit. ARTI-related comorbidities included: acute otitis media (AOM), bronchitis, sinusitis, pneumonia, and upper respiratory infection (URI). Other comorbid medical diagnoses were documented using diagnostic data from the pre-index period. Dichotomous variables for the following categories were created: mental disorders, nervous system disorders, respiratory symptoms, fever, injury and poisoning, other, or no diseases.

Prior visits for other respiratory infections in the previous 90 days were also identified for patients based on their index visit for pharyngitis. Similarly, any subsequent visits, within 28 days of the index visit, were also recorded to measure the health outcome for analysis. Practice settings include physician offices and federally qualified health centers, state and local health clinics, outpatient hospitals facilities, emergency departments, and other outpatient settings such as walk-in retail health clinic or ambulatory centers. Providers include primary care physicians (family practice, pediatricians, internal medicine), specialty care physicians (emergency medicine, preventive medicine), nonphysician providers (nurse practitioners, physician assistants) and other providers (urgent care, acute outpatient care, ambulatory care centers). Seasons of the year were determined based on the index date of the episode to account for possible seasonality in pharyngitis treatment. Lastly, a previous visits variable was created to identify whether the child had nonpharyngitis ARTI visits in the 3 months prior to the index visit.

Demographic variables were created based on enrollment and the socioeconomic data available in the Optum socioeconomic status file. These variables include patient age, race, sex, household income, geographic location, practice setting type, provider specialty, and type of insurance. An estimate of patient household income was based on algorithms using census block groups. Income categories were informed by the federal guidelines for a family of 4. A low-income family was defined as earning less than $50 000; a middle-income family earned between $50 000 and $75 000, and a high-income family earned $75 000 and above.¹² Patient insurance type was categorized as HMO, Exclusive Provider Organization (EPO), Point of Service (POS), and PPO. Race was identified as White, Black, Hispanic, and Asian. Patient location was defined according to national census regions.

Outcomes

GAS test

The HEDIS measures for pharyngitis recommend using the GAS test to identify the bacterial etiology of the pharyngitis infection. Patients who received the test were identified based on Current Procedural Terminology (CPT) codes 87070-71, 87081, 87430, 87650-52, and 87880.¹⁰

The pharmacy administrative claims dataset was used to identify study patients who filled a prescription for an antibiotic during their pharyngitis treatment episode. Optum pharmacy data identify the medications received, specifies the date of prescription filling, National Drug Codes, and American Hospital Formulary Service (AHFS) Classification System codes for each medication. We used the AHFS Pharmacologic-Therapeutic classification of antibiotics to create dichotomous variables documenting the antibacterial used by each patient.¹³ These are categorized under antibacterial including penicillins, cephalosporins (first, second, third, fourth generation cephalosporins), macrolides (first generation and others), tetracyclines, sulfonamides, fluoroquinolones (ciprofloxacin, levofloxacin, moxifloxacin), cephamycin, carbapenems, and β-lactam antibiotics (amoxicillin, amoxicillin/clavulanate, cephalexin, cefuroxime, cefdinir).

Revisits to physician or other provider

Revisits within 28 days were used as the measure of patient outcomes related to testing and filling of an antibiotic prescription for acute pharyngitis. Revisits may also be due to a patient returning for a follow-up, alternative treatment, worsening pharyngitis, or for another ARTI. An ARTI-related revisit also increases total resources used to treat pediatric pharyngitis patients.

Statistical analysis

Logistic regression was used for all 3 analyses conducted in this study. First, we determined the patient and treating physician characteristics that impact the decision to use GAS testing for pharyngitis. Second, we identified those factors that impact the decision to use antibiotic prescriptions among children who were diagnosed with pharyngitis adding in the dichotomous variable indicating if the patient had received a GAS test. Third, we used a logit regression analysis to document if receiving a GAS test and/or an antibiotic impacted the likelihood of a revisit by comparing revisit risk. To estimate the effect of testing and/or antibiotic use, we divided patients into 4 groups based on whether the patient received a GAS test and/or an antibiotic prescription. This specification of the analysis of revisits as an outcome focuses on adherence to HEDIS “test and treat” guidelines¹⁰:

1. Patients who were not tested yet filled an antibiotic prescription. This decision was likely based on the clinician’s judgment of the patient’s signs and symptoms, and confirmational testing not performed.
2. Patients who were not tested and did not fill an antibiotic prescription. Apparently, in the clinician’s judgment the patient’s signs and symptoms were such that the infection did not warrant treatment and the clinical presentation did not necessitate the GAS test to confirm the recorded diagnosis of pharyngitis.
3. Patients who were tested and received antibiotic prescription, likely because the test was positive for GABHS.
4. Patients who were tested and did not receive antibiotic prescription.

We tested for statistically significant differences in baseline characteristics across these 4 patient groups using t tests for continuous variables and χ² tests for categorical variables. Odds ratios (OR) and CI were computed for the influential variables included the regression analyses.

We conducted a sensitivity analysis using a model specification which included the dichotomous variables for testing and for treatment, and the interaction term between these variables to assess if treatment effects varied in tested and untested patients. We also estimated this model of revisit risk using revisits within 7 days as the outcome variable.

All analyses were completed using STATA/IC 13 (StataCorp, College Station, TX).

Results

There were 24 685 treatment episodes for children diagnosed with pharyngitis. Nearly 47% of these episodes included GAS testing and 47% of the tested patients filled an antibiotic prescription. Similarly, 53% of patients were not tested and 49% of untested patients filled an antibiotic prescription. As a result, the 4 groups identified for analysis were evenly distributed: untested and no prescription (26.9%), untested and prescription (26.3%), tested and prescription (21.9%), and tested and no prescription (24.9%) (Figure).

Table 1 presents the descriptive statistics for these 4 patient groups. Note first that the rate of revisits within 28 days is under 5% across all groups. Second, the 2 tested groups have a lower revisit rate than the untested groups: the tested and treated have a revisit rate of 3.3%, and the tested and untreated have a revisit rate of 2.4%, while both the untested groups have a revisit rate of nearly 5%. These small absolute differences in revisit rates across groups were statistically significant.

Factors associated with receiving GAS test

Several factors were found to impact the decision to test (Table 2). Only 9.7% of children were reported to have any ARTI coinfection. As expected, these comorbidities resulted in a significantly lower likelihood of receiving the GAS test: AOM, bronchitis, sinusitis, pneumonia, and URI as comorbid infections had a 48%, 41%, 37%, 63%, and 13% lower likelihood of receiving the GAS test, respectively, than those with no comorbidities. Similarly, children with fever and respiratory symptoms were 35% and 45% less likely to receiving the GAS test, respectively. This is consistent with our expectation that comorbid ARTI infections will lead many providers to forgo testing.

Provider type and patient age also plays a role in receipt of the GAS test. Relative to outpatient facility providers, primary care physicians were 24% more likely and specialty physicians were 38% less likely of employing the GAS test. The child’s age played a significant role in receipt of the GAS test. Children aged 1 to 5 years and 5 to 12 years were 15% and 14% more likely to receive the test compared to children older than 12 years.

Pharyngitis patients have disproportionately higher odds of receiving a GAS test in most regions of the country compared to the Pacific region. For instance, children in the Mid-Atlantic region have 51% higher odds of receiving a GAS test while children in New England have 80% higher odds of receiving the same test.

Black children have 11% lower odds of receiving the GAS test compared to White children. Both middle-income and high-income children have 12% and 32% higher odds of receiving the test compared to low-income children. Compared to office-based visits, children visiting a clinic were twice as likely to receive a GAS test while those seen in the emergency room have 43% lower odds of receiving a GAS test. Hospital outpatient departments, which account for less than 1% of all visits, rarely used a GAS test which could be a statistical artifact due to small sample size. Lastly, insurance and season of the year had no significant impact of receipt of a GAS test.

Factors associated with receiving antibiotic prescription

Surprisingly, receiving the GAS test has a small but insignificant impact on the likelihood that the patient will receive an antibiotic prescription (Table 3) (Adjusted OR = 1.055, P = .07). After controlling for receipt of a GAS test, children with AOM and sinusitis comorbidities have an increased likelihood of being prescribed an antibiotic. Children with URI have a lower likelihood of being prescribed an antibiotic. Additionally, relative to primary care physicians, children visiting nonphysician providers for pharyngitis were more likely to be prescribed an antibiotic.

Children under 12 years of age were more likely to use an antibiotic compared to children 12 years and older. Geographically, there is some evidence of regional variation in antibiotic use as well. Children in the south Atlantic, west-south central, and southeast central regions had a significantly lower odds of being prescribed an antibiotic respectively than pharyngitis patients in the Pacific region. Black children had a 10% lower likelihood of being prescribed an antibiotic compared to White children, possibly related to their lower rate of GAS testing. Compared to office-based visits, children visiting a clinic were less likely to use an antibiotic. Household income, insurance type, and season had no significant impact on revisit risk.

Effects of GAS test and antibiotic prescriptions on likelihood of revisits

The multivariate analysis of the risk of a revisit within 28 days is presented in Table 4. Children with pharyngitis who tested and did not receive an antibiotic serve as the reference comparison group for this analysis to illustrate the impact of using the GAS test and treatment with an antibiotic. The results in Table 4 are quite clear: patients who receive the GAS test were significantly less likely to have a revisit within 28 days. Moreover, within the group of patients who were tested, those not receiving an antibiotic, presumedly because their GAS test was negative, experienced the lowest risk of a revisit. This result is consistent with the data in Table 1. Moreover, using an antibiotic had no impact on the likelihood of a revisit in patients not receiving the GAS test. This result is also consistent with Table 1.

Other results from the analysis of revisit risk may be of interest to clinicians. Pharyngitis patients with a prior episode of treatment within 90 days for an acute respiratory tract infection were more than 7 times more likely to experience a revisit within 28 days of the pharyngitis diagnosis than patients without a history of recent ARTI infections. Age is also a risk factor in likelihood of initiating a revisit. Children under 1 year and children aged 1 to 5 years were more likely to have a revisit than children aged more than 12 years. Compared to White children, Black children were 25% (P = .04) less likely to have a revisit. The care setting also has a significant impact on revisit risk. Children visiting outpatient hospital and other care settings had a significantly higher revisit risk than those visiting a physician’s office. Lastly, household income, geographic region, season, medical comorbidities, gender, and insurance type have no significant impact on revisit risk.

Sensitivity analysis

The results from the analysis of 7-day and 28-day revisit risk are summarized in Table 5. These results indicate that patients who were tested had a more significant decrease in revisit risk at 7 days (72%) than was evident at 28 days (47% reduction). Receiving an antibiotic, with or without the test, had no impact on revisit risk.

Discussion

Published data on revisits for pharyngitis are lacking with the concentration of prior research focused more on systemic complications of undertreated GABHS disease or on identifying carrier status. Our study results suggest that GAS testing is the most important factor in reducing revisit risk. Being prescribed an antibiotic, on its own, does not have a significant impact on the risk of a revisit. However, once the GAS test is used, the decision not to use an antibiotic was correlated with the lowest revisit rate, likely because the source of the pharyngitis infection was viral and more likely to resolve without a revisit. Prior studies have reported variable rates of testing among children with pharyngitis prescribed an antibiotic, ranging from 23% to 91%,^14,15 with testing important toward more appropriate antibiotic use.¹⁶ More recently, among more than 67 000 patients aged 3 to 21 years presenting with sore throat and receiving a GAS test, 32.6% were positive.¹⁷

Our analysis found that more than 46% of pediatric pharyngitis patients were given the rapid GAS test. While this testing rate is substantially lower than HEDIS recommendations and lower than testing rates achieved by several health maintenance organizations,¹⁰ it is similar to the 53% of children receiving such testing in a recent National Ambulatory Medical Care Survey.¹⁸ Furthermore, we found that when antibiotics are prescribed following a GAS test, the revisit risk is not significantly reduced, possibly because antibiotics lower revisit risk when informed by diagnostic testing tools that determine the infectious organism. This is supported by a similar population analysis in which we observed reduced revisit rates in children with AOM managed with antibiotics within 3 days of index diagnosis.¹⁹

Several other factors also affect the likelihood of a child receiving the GAS test. Children aged 1 to 12 years were significantly more likely to receive the GAS test than children over the age of 12. This included children in the 1 to 5 years old bracket who had a 15% higher likelihood of undergoing a GAS test, despite children less than 3 years of age as not recommended targets for GAS testing.²⁰ As expected, children with reported ARTI-associated comorbidities were also less likely to receive a GAS test. Additionally, specialty care physicians were less inclined to implement the GAS test, possibly because of diagnostic confidence without testing or referral after GAS was ruled out. Black and low-income children had statistically lower odds of receiving the test, even after controlling for other factors, and yet were less likely to consume a revisit. As the overall data suggested more revisits in those not tested, further study is needed to examine if race or income discrepancies are equity based. Finally, children in the Pacific region, compared to the rest of the nation, were the least likely to receive a GAS test and yet there were no significant differences in revisit rates by region. Regional differences in antibiotic use were also observed in our study, as has been seen by others.²¹

After statistically controlling for having received the diagnostic GAS test and filled a prescription for an antibiotic, there are multitude of factors that independently affect the revisit risk, the most important of which if which was a history of an ARTI infection in the prior 90 days. While prior visit history had no impact on the likelihood of being tested or filling an antibiotic, patients with prior visits were more than 7 times more likely to consume a revisit. This was not reflected in nor related to comorbid ARTIs as these patients did not have statistically higher revisits than those with pharyngitis as the sole-coded diagnosis. Moreover, speculation for bacterial etiology of primary or superinfection based on a recent history of ARTI accounting for revisits seems unlikely as it did not yield greater antibiotic use in that group. Further analysis is required to determine the clinical and behavioral factors that promote for prior ARTI history as a major factor in revisit risk after an index visit for pharyngitis.

Children aged between 1 and 5 years, though 15% more likely to be tested than those aged 12 through 17 years, were also 39% more likely to initiate a revisit compared to older children when statistically controlling for other covariates. This perhaps suggests longer illness, wrong diagnosis, delay in appropriate treatment, or more caution by parents and providers in this age group. Justification for testing children less than 3 years of age who are outside of the HEDIS suggested age group, when clinical judgement does not point to another infection source, can result in positivity rates between 22% and 30% as previously observed.^22,23 Patients visiting nonphysician providers and outpatient facility providers were less likely to have a revisit than those visiting primary and specialty care physicians, though slightly higher propensity for antibiotic prescriptions was seen for nonphysician providers. Pediatricians have been noted to be less likely to prescribe antibiotics without GAS testing than nonpediatric providers, and more guidelines-compliant in prescribing.²⁴

Recommendations to not test children under 3 years of age are based on the lack of acute rheumatic fever and other complications in this age group together with more frequent viral syndromes. Selectivity in applying clinical criteria to testing can be attempted to separate bacterial from viral illness. Postnasal drainage/rhinorrhea, hoarse voice, and cough have been used successfully to identify those with viral illness and less need for testing, with greater certainty of low risk for GABHS in those over 11 years of age without tonsillar exudates, cervical adenopathy, or fever.¹⁷ However, the marginal benefits of those who have all 3 features of viral illness versus none in identifying GAS positivity was 23.3% vs 37.6% - helpful, but certainly not diminishing the need for testing. These constitutional findings of viral URI also do not exclude the GAS carrier state that features these symptoms.²⁵ Others have reinforced the doubt of pharyngeal exudates as the premier diagnostic finding for test-positive GAS.²⁶

This study had several limitations. The Optum claims dataset only contains ICD-9 codes for diagnoses. It does not include data on infection severity and clinical findings related to symptoms, thus empiric treatment warranted based in clinical severity is not assessed. Antibiotics are commonly available as generics and very inexpensive. Patients may fill and pay for these prescriptions directly, in which case, a claim for payment may not be filed with Optum. This could result in an undercount of treated patients in our study.

There is no corresponding problem of missing medical claims for GAS testing which were obtained from the CPT codes within the Optum claims data set. However, we elected not to verify the test results due to these data being missing for 75% of the study population. Nevertheless, this study’s focus was less about justifying antibiotic treatment, but dealt with the outcomes generated by testing and treatment. Toward that end, we used CPT codes to identify a revisit, and while those can at times be affected by financial reimbursement incentives, differences related to revisits in the 4 patient groups should not be subject to bias.

Conclusion

This study used data from real world practices to document the patterns of GAS testing and antibiotic use in pediatric pharyngitis patients. Revisit rates were under 5% for all patient groups and the use of rapid diagnostic tools were found to be the determining factor in further reducing the risk of revisits. This supports the need for compliance with the HEDIS quality metric for pharyngitis to the recommended levels of rapid testing which have been falling in recent years. Use of more accurate antigen and newer molecular detection testing methods may help further delineate important factors in determining pediatric pharyngitis treatment and need for revisits.²⁷

Corresponding author: Jeffrey McCombs, MD, University of Southern California School of Pharmacy, Department of Pharmaceutical and Health Economics, Leonard D. Schaeffer Center for Health Policy & Economics, 635 Downey Way, Verna & Peter Dauterive Hall 310, Los Angeles, CA 90089-3333; [email protected].

Financial disclosures: None.

From Children’s Health System of Texas, Division of Pediatric Anesthesiology, Dallas, TX (Drs. Sakhai, Bocanegra, Chandran, Kimatian, and Kiss), UT Southwestern Medical Center, Department of Anesthesiology and Pain Management, Dallas, TX (Drs. Bocanegra, Chandran, Kimatian, and Kiss), and UT Southwestern Medical Center, Department of Population and Data Sciences, Dallas, TX (Dr. Reisch).

Objective: Policy-driven changes in medical practice have long been the norm. Seldom are changes in clinical practice sought to be brought about by a person’s tendency toward growth or self‐actualization. Many hospitals have instituted hypothermia bundles to help reduce the incidence of unanticipated postoperative hypothermia. Although successful in the short-term, sustained changes are difficult to maintain. We implemented a quality-improvement project focused on addressing the affective components of self-determination theory (SDT) to create sustainable behavioral change while satisfying providers’ basic psychological needs for autonomy, competence, and relatedness.

Methods: A total of 3 Plan-Do-Study-Act (PDSA) cycles were enacted over the span of 14 months at a major tertiary care pediatric hospital to recruit and motivate anesthesia providers and perioperative team members to reduce the percentage of hypothermic postsurgical patients by 50%. As an optional initial incentive for participation, anesthesiologists would qualify for American Board of Anesthesiology Maintenance of Certification in Anesthesiology (MOCA) Part 4 Quality Improvement credits for monitoring their own temperature data and participating in project-related meetings. Providers were given autonomy to develop a personal plan for achieving the desired goals.

Results: The median rate of hypothermia was reduced from 6.9% to 1.6% in July 2019 and was reduced again in July 2020 to 1.3%, an 81% reduction overall. A low hypothermia rate was successfully maintained for at least 21 subsequent months after participants received their MOCA credits in July 2019.

Conclusions: Using an approach that focused on the elements of competency, autonomy, and relatedness central to the principles of SDT, we observed the development of a new culture of vigilance for prevention of hypothermia that successfully endured beyond the project end date.

Keywords: postoperative hypothermia; self-determination theory; motivation; quality improvement.

Perioperative hypothermia, generally accepted as a core temperature less than 36 °C in clinical practice, is a common complication in the pediatric surgical population and is associated with poor postoperative outcomes.¹ Hypothermic patients may develop respiratory depression, hypoglycemia, and metabolic acidosis that may lead to decreased oxygen delivery and end organ tissue hypoxia.^2-4 Other potential detrimental effects of failing to maintain normal body temperature are impaired clotting factor enzyme function and platelet dysfunction, increasing the risk for postoperative bleeding.^5,6 In addition, there are financial implications when hypothermic patients require care and resources postoperatively because of delayed emergence or shivering.⁷

The American Society of Anesthesiologists recommends intraoperative temperature monitoring for procedures when clinically significant changes in body temperature are anticipated.⁸ Maintenance of normothermia in the pediatric population is especially challenging owing to a larger skin-surface area compared with body mass ratio and less subcutaneous fat content than in adults. Preventing postoperative hypothermia starts preoperatively with parental education and can be as simple as covering the child with a blanket and setting the preoperative room to an acceptably warm temperature.^9,10 Intraoperatively, maintaining operating room (OR) temperatures at or above 21.1 °C and using active warming devices and radiant warmers when appropriate are important techniques to preserve the child’s body temperature.^11,12

Despite the knowledge of these risks and vigilant avoidance of hypothermia, unplanned perioperative hypothermia can occur in up to 70% of surgical patients.¹ Beyond the clinical benefits, as health care marches toward a value-based payment methodology, quality indicators such as avoiding hypothermia may be linked directly to payment.

Self-determination theory (SDT) was first developed in 1980 by Deci and Ryan.¹³ The central premise of the theory states that people develop their full potential if circumstances allow them to satisfy their basic psychological needs: autonomy, competence, and relatedness. Under these conditions, people’s natural inclination toward growth can be realized, and they are more likely to internalize external goals. Under an extrinsic reward system, motivation can waver, as people may perceive rewards as controlling.

Many institutions have implemented hypothermia bundles to help decrease the rate of hypothermic patients, but while initially successful, the effectiveness of these interventions tends to fade over time as participants settle into old, comfortable routines.¹⁴ With SDT in mind, we designed our quality-improvement (QI) project with interventions to allow clinicians autonomy without instituting rigid guidelines or punitive actions. We aimed to directly address the affective components central to motivation and engagement so that we could bring about long-term meaningful changes in our practice.

Methods

Setting

The hypothermia QI intervention was instituted at a major tertiary care children’s hospital that performs more than 40 000 pediatric general anesthetics annually. Our division of pediatric anesthesiology consists of 66 fellowship-trained pediatric anesthesiologists, 15 or more rotating trainees per month, 13 anesthesiology assistants, 15 anesthesia technicians, and more than 50 perioperative nurses.

The most frequent pediatric surgeries include, but are not limited to, general surgery, otolaryngology, urology, gastroenterology, plastic surgery, neurosurgery, and dentistry. The surgeries are conducted in the hospital’s main operative floor, which consists of 15 ORs and 2 gastroenterology procedure rooms. Although the implementation of the QI project included several operating sites, we focused on collecting temperature data from surgical patients at our main campus recovery unit. We obtained the patients’ initial temperatures upon arrival to the recovery unit from a retrospective electronic health record review of all patients who underwent anesthesia from January 2016 through April 2021.

Postoperative hypothermia was identified as an area of potential improvement after several patients were reported to be hypothermic upon arrival to the recovery unit in the later part of 2018. Further review revealed significant heterogeneity of practices and lack of standardization of patient-warming methods. By comparing the temperatures pre- and postintervention, we could measure the effectiveness of the QI initiative. Prior to the start of our project, the hypothermia rate in our patient population was not actively tracked, and the effectiveness of our variable practice was not measured.

The cutoff for hypothermia for our QI project was defined as body temperature below 36 °C, since this value has been previously used in the literature and is commonly accepted in anesthesia practice as the delineation for hypothermia in patients undergoing general anesthesia.¹

Interventions

This QI project was designed and modeled after the Institute for Healthcare Improvement Model for Improvement.¹⁵ Three cycles of Plan-Do-Study-Act (PDSA) were developed and instituted over a 14-month period until December 2019 (Table 1).

A retrospective review was conducted to determine the percentage of surgical patients arriving to our recovery units with an initial temperature reading of less than 36 °C. A project key driver diagram and smart aim were created and approved by the hospital’s continuing medical education (CME) committee for credit via the American Board of Medical Specialties (ABMS) Multi-Specialty Portfolio Program, Maintenance of Certification in Anesthesiology (MOCA) Part 4.

The first PDSA cycle involved introducing the QI project and sharing the aims of the project at a department grand rounds in the latter part of October 2018. Enrollment to participate in the project was open to all anesthesiologists in the division, and participants could earn up to 20 hours of MOCA Part 4 credits. A spreadsheet was developed and maintained to track each anesthesiologist’s monthly percentage of hypothermic patients. The de-identified patient data were shared with the division via monthly emails. In addition, individual providers with a hypothermic patient in the recovery room received a notification email.

The anesthesiologists participated in the QI project by reviewing their personal percentage of hypothermic patients on an ongoing basis to earn the credit. There was no explicit requirement to decrease their own rate of patients with body temperature less than 36 °C or expectation to achieve a predetermined goal, so the participants could not “fail.”

Because of the large interest in this project, a hypothermia committee was formed that consisted of 36 anesthesiologists. This group reviewed the data and exchanged ideas for improvement in November 2018 as part of the first PDSA cycle. The committee met monthly and was responsible for actively engaging other members of the department and perioperative staff to help in this multidisciplinary effort of combating hypothermia in our surgical pediatric population.

PDSA cycle 2 involved several major initiatives, including direct incorporation of the rest of the perioperative team. The perioperative nursing team was educated on the risks of hypothermia and engaged to take an active role by maintaining the operating suite temperature at 21.1 °C and turning on the Bair Hugger (3M) blanket to 43 °C on the OR bed prior to patient arrival to the OR. Additionally, anesthesia technicians (ATs) were tasked with ensuring an adequate supply of Bair Hugger drapes for all cases of the day. The facility’s engineering team was engaged to move the preoperative room temperature controls away from families (who frequently made the rooms cold) and instead set it at a consistent temperature of 23.9 °C. ATs were also asked to place axillary and nasal temperature probes on the anesthesia workstations as a visual reminder to facilitate temperature monitoring closer to the start of anesthesia (instead of the anesthesia provider having to remember to retrieve a temperature probe out of a drawer and place it on the patient). Furthermore, anesthesiologists were instructed via the aforementioned monthly emails and at monthly department meetings to place the temperature probes as early as possible in order to recognize and respond to intraoperative hypothermia in a timelier manner. Finally, supply chain leaders were informed of our expected increase in the use of the blankets and probes and proportionally increased ordering of these supplies to make sure availability would not present an obstacle.

In PDSA cycle 3, trainees (anesthesia assistant students, anesthesia residents and fellows) and advanced practice providers (APPs) (certified registered nurse-anesthetists [CRNAs] and certified anesthesia assistants [C-AAs]) were informed of the QI project. This initiative was guided toward improving vigilance for hypothermia in the rest of the anesthesia team members. The trainees and APPs usually set up the anesthesia area prior to patient arrival, so their recruitment in support of this effort would ensure appropriate OR temperature, active warming device deployment, and the availability and early placement of the correct temperature probe for the case. To facilitate personal accountability, the trainees and APPs were also emailed their own patients’ rate of hypothermia.

Along the course of the project, quarterly committee meetings and departmental monthly meetings served as venues to express concerns and look for areas of improvement, such as specific patterns or trends leading to hypothermic patients. One specific example was the identification of the gastrointestinal endoscopic patients having a rate of hypothermia that was 2% higher than average. Directed education on the importance of Bair Hugger blankets and using warm intravenous fluids worked well to decrease the rate of hypothermia in these patients. This collection of data was shared at regular intervals during monthly department meetings as well and more frequently using departmental emails. The hospital’s secure intranet SharePoint (Microsoft) site was used to share the data among providers.

Study of the interventions and measures

To study the effectiveness and impact of the project to motivate our anesthesiologists and other team members, we compared the first temperatures obtained in the recovery unit prior to the start of the intervention with those collected after the start of the QI project in November 2018. Because of the variability of temperature monitoring intraoperatively (nasal, axillary, rectal), we decided to use the temperature obtained by the nurse in the recovery room upon the patient’s arrival. Over the years analyzed, the nurse’s technique of measuring the temperature remained consistent. All patient temperature measurements were performed using the TAT-5000 (Exergen Corporation). This temporal artery thermometer has been previously shown to correlate well with bladder temperatures (70% of measurements differ by no more than 0.5 °C, as reported by Langham et al¹⁶).

Admittedly, we could not measure the degree of motivation or internalization of the project goals by our cohort, but we could measure the reduction in the rate of hypothermia and subjectively gauge engagement in the project by the various groups of participants and the sustainability of the results. In addition, all participating anesthesiologists received MOCA Part 4 credits in July 2019. We continued our data collection until April 2021 to determine if our project had brought about sustainable changes in practice that would continue past the initial motivator of obtaining CME credit.

Analysis

Data analysis was performed using Excel (Microsoft) and SAS, version 9.4 (SAS Institute).

The median of the monthly percentage of patients with a temperature of less than 36.0 °C was also determined for the preintervention time frame. This served as our baseline hypothermia rate, and we aimed to lower it by 50%. Run charts, a well-described methodology to gauge the effectiveness of the QI project, were constructed with the collected data.¹⁷

We performed additional analysis to adjust for different time periods throughout the year. The time period between January 2016 and October 2018 was considered preintervention. We considered November 2018 the start of our intervention, or more specifically, the start of our PDSA cycles. October 2018 was analyzed as part of the preintervention data. To account for seasonal temperature variations, the statistical analysis focused on the comparisons of the same calendar quarters for before and after starting intervention using Wilcoxon Mann-Whitney U tests. To reach an overall conclusion, the probabilities for the 4 quarters were combined for each criterion separately utilizing the Fisher χ² combined probability method.

The hypothermia QI project was reviewed by the institutional review board and determined to be exempt.

Results

The temperatures of 40 875 patients were available for analysis for the preintervention period between January 2016 and October 2018. The median percentage of patients with temperatures less than 36.0 °C was 6.9% (interquartile range [IQR], 5.8%-8.4%). The highest percentage was in February 2016 (9.9%), and the lowest was in March 2018 (3.4%). Following the start of the first PDSA cycle, the next 6 consecutive rates of hypothermia were below the median preintervention value, and a new median for these percentages was calculated at 3.4% (IQR, 2.6%-4.3%). In July 2019, the proportion of hypothermic patients decreased once more for 6 consecutive months, yielding a new median of 1.6% (IQR, 1.2%-1.8%) and again in July 2020, to yield a median of 1.3% (IQR, 1.2%-1.5%) (Figure). In all, 33 799 patients were analyzed after the start of the project from November 2018 to the end of the data collection period through April 2021.

The preintervention monthly rates of hypothermia were compared, quarter to quarter, with those starting in November 2018 using the Wilcoxon Mann-Whitney U test. The decrease in proportion of hypothermic patients after the start of the intervention was statistically significant (P < .001). In addition, the percentage of patients with temperatures greater than 38 °C was not significantly different between the pre- and postintervention time periods (P < .25) (Table 2). The decrease in the number of patients available for analysis from March 2020 to May 2020 was due to the COVID-19 pandemic.

Subjectively, we did not experience any notable resistance to our efforts, and the experience was largely positive for everyone involved. Clinicians identified as having high monthly rates of hypothermia (5% or higher) corrected their numbers the following month after being notified via email or in person.

To achieve changes in practice, the health care industry has relied on instituting guidelines, regulations, and policies, often with punitive consequences. We call into question this long-standing framework and propose a novel approach to help evolve the field of QI. Studies in human psychology have long demonstrated the demotivation power of a reward system and the negative response to attempts by authority to use incentives to control or coerce. In our QI project, we instituted 3 PDSA cycles and applied elements from SDT to motivate people’s behaviors. We demonstrate how a new culture focused on maintaining intraoperative normothermia was developed and brought about a measurable and significant decrease in the rate of hypothermia. The relevance of SDT, a widely accepted unifying theory that bridges and links social and personality psychology, should not be understated in health care. Authorities wishing to have long-standing influence should consider a person’s right to make their own decisions and, if possible, a unique way of doing things.

Positively reinforcing behavior has been shown to have a paradoxical effect by dampening an individual’s intrinsic motivation or desire to perform certain tasks.¹⁸ Deadlines, surveillance, and authoritative commands are also deterrents.^19,20 We focused on providing the tools and information to the clinicians and relied on their innate need for autonomy, growth, and self-actualization to bring about change in clinical practice.²¹ Group meetings served as a construct for exchanging ideas and to encourage participation, but without the implementation of rigid guidelines or policies. Intraoperative active warming devices and temperature probes were made available, but their use was not mandated. The use of these devices was intentionally not audited to avoid any overbearing control. Providers were, however, given monthly temperature data to help individually assess the effectiveness of their interventions. We did not impose any negative or punitive actions for those clinicians who had high rates of hypothermic patients, and we did not reward those who had low rates of hypothermia. We wanted the participants to feel that the inner self was the source of their behavior, and this was in parallel with their own interests and values. If providers could feel their need for competency could be realized, we hoped they would continue to adhere to the measures we provided to maintain a low rate of hypothermia.

The effectiveness of our efforts was demonstrated by a decrease in the prevalence of postoperative hypothermia in our surgical patients. The initial decrease of the median rate of hypothermia from 6.9% to 3.4% occurred shortly into the start of the first PDSA cycle. The second PDSA cycle started in January 2019 with a multimodal approach and included almost all parties involved in the perioperative care of our surgical patients. Not only was this intervention responsible for a continued downward trend in the percentage of hypothermic patients, but it set the stage for the third and final PDSA cycle, which started in July 2019. The architecture was in place to integrate trainees and APPs to reinforce our initiative. Subsequently, the new median percentage of hypothermic patients was further decreased to an all-time low of 1.6% per month, satisfying and surpassing the goal of the QI project of decreasing the rate of hypothermia by only 50%. Our organization thereafter maintained a monthly hypothermia rate below 2%, except for April 2020, when it reached 2.5%. Our lowest median percentage was obtained after July 2020, reaching 1.3%.

To account for seasonal variations in temperatures and types of surgeries performed, we compared the percentage of hypothermic patients before and after the start of intervention, quarter by quarter. The decrease in the proportion of hypothermic patients after the start of intervention was statistically significant (P < .001). In addition, the data failed to prove any statistical difference for temperatures above 38 °C between the 2 periods, indicating that our interventions did not result in significant overwarming of patients. The clinical implications of decreasing the percentage of hypothermic patients from 6.9% to 1.3% is likely clinically important when considering the large number of patients who undergo surgery at large tertiary care pediatric centers. Even if simple interventions reduce hypothermia in only a handful of patients, routine applications of simple measures to keep patients normothermic is likely best clinical practice.

Anesthesiologists who participated in the hypothermia QI project by tracking the incidence of hypothermia in their patients were able to collect MOCA Part 4 credits in July 2019. There was no requirement for the individual anesthesiologist to reduce the rate of hypothermia or apply any of the encouraged strategies to obtain credit. As previously stated, there were also no rewards for obtaining low hypothermia rates for the providers. The temperature data continued to be collected through April 2021, 21 months after the credits were distributed, to demonstrate a continued, meaningful change, at least in the short-term. While the MOCA Part 4 credits likely served as an initial motivating factor to encourage participation in the QI project, they certainly were not responsible for the sustained low hypothermia rate after July 2019. We showed that the low rate of hypothermia was successfully maintained, indicating that the change in providers’ behavior was independent of the external motivator of obtaining the credit hours. Mere participation in the project by reviewing one’s temperature data was all that was required to obtain the credit. The Organismic Integration Theory, a mini-theory within SDT, best explains this phenomenon by describing any motivated behavior on a continuum ranging from controlled to autonomous.²² Do people perform the task resentfully, on their own volition because they believe it is the correct action, or somewhere in between? We explain the sustained low rates of hypothermia after the MOCA credits were distributed due to a shift to the autonomous end of the continuum with the clinician’s active willingness to meet the challenges and apply intrinsically motivated behaviors to lower the rate of hypothermia. The internalization of external motivators is difficult to prove, but the evidence supports that the methods we used to motivate individuals were effective and have resulted in a significant downward trend in our hypothermia rate.

There are several limitations to our QI project. The first involves the measuring of postoperative temperature in the recovery units. The temperatures were obtained using the same medical-grade infrared thermometer for all the patients, but other variables, such as timing and techniques, were not standardized. Secondly, overall surgical outcomes related to hypothermia were not tracked because we were unable to control for other confounding variables in our large cohort of patients, so we cannot say if the drop in the hypothermia rate had a clinically significant outcome. Thirdly, we propose that SDT offers a compellingly fitting explanation of the psychology of motivation in our efforts, but it may be possible that other theories may offer equally fitting explanations. The ability to measure the degree of motivation is lacking, and we did not explicitly ask participants what their specific source of motivation was. Aside from SDT, the reduction in hypothermia rate could also be attributed to the ease and availability of warming equipment that was made in each OR. This QI project was successfully applied to only 1 institution, so its ability to be widely applicable remains uncertain. In addition, data collection continued during the COVID-19 pandemic when case volumes decreased. However, by June 2020, the number of surgical cases at our institution had largely returned to prepandemic levels. Additional data collection beyond April 2021 would be helpful to determine if the reduction in hypothermia rates is truly sustained.

Conclusion

Overall, the importance of maintaining perioperative normothermia was well disseminated and agreed upon by all departments involved. Despite the limitations of the project, there was a significant reduction in rates of hypothermia, and sustainability of outcomes was consistently demonstrated in the poststudy period.

Using 3 cycles of the PDSA method, we successfully decreased the median rate of postoperative hypothermia in our pediatric surgical population from a preintervention value of 6.9% to 1.3%—a reduction of more than 81.2%. We provided motivation for members of our anesthesiology staff to participate by offering MOCA 2.0 Part 4 credits, but the lower rate of hypothermic patients was maintained for 15 months after the credits were distributed. Over the course of the project, there was a shift in culture, and extra vigilance was given to temperature monitoring and assessment. We attribute this sustained cultural change to the deliberate incorporation of the principles of competency, autonomy, and relatedness central to SDT to the structure of the interventions, avoiding rigid guidelines and pathways in favor of affective engagement to establish intrinsic motivation.

Acknowledgements: The authors thank Joan Reisch, PhD, for her assistance with the statistical analysis.

Corresponding author: Edgar Erold Kiss, MD, 1935 Medical District Dr, Dallas, TX 75235; [email protected].

Financial disclosures: None.

From Children’s Health System of Texas, Division of Pediatric Anesthesiology, Dallas, TX (Drs. Sakhai, Bocanegra, Chandran, Kimatian, and Kiss), UT Southwestern Medical Center, Department of Anesthesiology and Pain Management, Dallas, TX (Drs. Bocanegra, Chandran, Kimatian, and Kiss), and UT Southwestern Medical Center, Department of Population and Data Sciences, Dallas, TX (Dr. Reisch).

Objective: Policy-driven changes in medical practice have long been the norm. Seldom are changes in clinical practice sought to be brought about by a person’s tendency toward growth or self‐actualization. Many hospitals have instituted hypothermia bundles to help reduce the incidence of unanticipated postoperative hypothermia. Although successful in the short-term, sustained changes are difficult to maintain. We implemented a quality-improvement project focused on addressing the affective components of self-determination theory (SDT) to create sustainable behavioral change while satisfying providers’ basic psychological needs for autonomy, competence, and relatedness.

Methods: A total of 3 Plan-Do-Study-Act (PDSA) cycles were enacted over the span of 14 months at a major tertiary care pediatric hospital to recruit and motivate anesthesia providers and perioperative team members to reduce the percentage of hypothermic postsurgical patients by 50%. As an optional initial incentive for participation, anesthesiologists would qualify for American Board of Anesthesiology Maintenance of Certification in Anesthesiology (MOCA) Part 4 Quality Improvement credits for monitoring their own temperature data and participating in project-related meetings. Providers were given autonomy to develop a personal plan for achieving the desired goals.

Results: The median rate of hypothermia was reduced from 6.9% to 1.6% in July 2019 and was reduced again in July 2020 to 1.3%, an 81% reduction overall. A low hypothermia rate was successfully maintained for at least 21 subsequent months after participants received their MOCA credits in July 2019.

Conclusions: Using an approach that focused on the elements of competency, autonomy, and relatedness central to the principles of SDT, we observed the development of a new culture of vigilance for prevention of hypothermia that successfully endured beyond the project end date.

Keywords: postoperative hypothermia; self-determination theory; motivation; quality improvement.

Perioperative hypothermia, generally accepted as a core temperature less than 36 °C in clinical practice, is a common complication in the pediatric surgical population and is associated with poor postoperative outcomes.¹ Hypothermic patients may develop respiratory depression, hypoglycemia, and metabolic acidosis that may lead to decreased oxygen delivery and end organ tissue hypoxia.^2-4 Other potential detrimental effects of failing to maintain normal body temperature are impaired clotting factor enzyme function and platelet dysfunction, increasing the risk for postoperative bleeding.^5,6 In addition, there are financial implications when hypothermic patients require care and resources postoperatively because of delayed emergence or shivering.⁷

The American Society of Anesthesiologists recommends intraoperative temperature monitoring for procedures when clinically significant changes in body temperature are anticipated.⁸ Maintenance of normothermia in the pediatric population is especially challenging owing to a larger skin-surface area compared with body mass ratio and less subcutaneous fat content than in adults. Preventing postoperative hypothermia starts preoperatively with parental education and can be as simple as covering the child with a blanket and setting the preoperative room to an acceptably warm temperature.^9,10 Intraoperatively, maintaining operating room (OR) temperatures at or above 21.1 °C and using active warming devices and radiant warmers when appropriate are important techniques to preserve the child’s body temperature.^11,12

Despite the knowledge of these risks and vigilant avoidance of hypothermia, unplanned perioperative hypothermia can occur in up to 70% of surgical patients.¹ Beyond the clinical benefits, as health care marches toward a value-based payment methodology, quality indicators such as avoiding hypothermia may be linked directly to payment.

Self-determination theory (SDT) was first developed in 1980 by Deci and Ryan.¹³ The central premise of the theory states that people develop their full potential if circumstances allow them to satisfy their basic psychological needs: autonomy, competence, and relatedness. Under these conditions, people’s natural inclination toward growth can be realized, and they are more likely to internalize external goals. Under an extrinsic reward system, motivation can waver, as people may perceive rewards as controlling.

Many institutions have implemented hypothermia bundles to help decrease the rate of hypothermic patients, but while initially successful, the effectiveness of these interventions tends to fade over time as participants settle into old, comfortable routines.¹⁴ With SDT in mind, we designed our quality-improvement (QI) project with interventions to allow clinicians autonomy without instituting rigid guidelines or punitive actions. We aimed to directly address the affective components central to motivation and engagement so that we could bring about long-term meaningful changes in our practice.

Methods

Setting

The hypothermia QI intervention was instituted at a major tertiary care children’s hospital that performs more than 40 000 pediatric general anesthetics annually. Our division of pediatric anesthesiology consists of 66 fellowship-trained pediatric anesthesiologists, 15 or more rotating trainees per month, 13 anesthesiology assistants, 15 anesthesia technicians, and more than 50 perioperative nurses.

The most frequent pediatric surgeries include, but are not limited to, general surgery, otolaryngology, urology, gastroenterology, plastic surgery, neurosurgery, and dentistry. The surgeries are conducted in the hospital’s main operative floor, which consists of 15 ORs and 2 gastroenterology procedure rooms. Although the implementation of the QI project included several operating sites, we focused on collecting temperature data from surgical patients at our main campus recovery unit. We obtained the patients’ initial temperatures upon arrival to the recovery unit from a retrospective electronic health record review of all patients who underwent anesthesia from January 2016 through April 2021.

Postoperative hypothermia was identified as an area of potential improvement after several patients were reported to be hypothermic upon arrival to the recovery unit in the later part of 2018. Further review revealed significant heterogeneity of practices and lack of standardization of patient-warming methods. By comparing the temperatures pre- and postintervention, we could measure the effectiveness of the QI initiative. Prior to the start of our project, the hypothermia rate in our patient population was not actively tracked, and the effectiveness of our variable practice was not measured.

The cutoff for hypothermia for our QI project was defined as body temperature below 36 °C, since this value has been previously used in the literature and is commonly accepted in anesthesia practice as the delineation for hypothermia in patients undergoing general anesthesia.¹

Interventions

This QI project was designed and modeled after the Institute for Healthcare Improvement Model for Improvement.¹⁵ Three cycles of Plan-Do-Study-Act (PDSA) were developed and instituted over a 14-month period until December 2019 (Table 1).

A retrospective review was conducted to determine the percentage of surgical patients arriving to our recovery units with an initial temperature reading of less than 36 °C. A project key driver diagram and smart aim were created and approved by the hospital’s continuing medical education (CME) committee for credit via the American Board of Medical Specialties (ABMS) Multi-Specialty Portfolio Program, Maintenance of Certification in Anesthesiology (MOCA) Part 4.

The first PDSA cycle involved introducing the QI project and sharing the aims of the project at a department grand rounds in the latter part of October 2018. Enrollment to participate in the project was open to all anesthesiologists in the division, and participants could earn up to 20 hours of MOCA Part 4 credits. A spreadsheet was developed and maintained to track each anesthesiologist’s monthly percentage of hypothermic patients. The de-identified patient data were shared with the division via monthly emails. In addition, individual providers with a hypothermic patient in the recovery room received a notification email.

The anesthesiologists participated in the QI project by reviewing their personal percentage of hypothermic patients on an ongoing basis to earn the credit. There was no explicit requirement to decrease their own rate of patients with body temperature less than 36 °C or expectation to achieve a predetermined goal, so the participants could not “fail.”

Because of the large interest in this project, a hypothermia committee was formed that consisted of 36 anesthesiologists. This group reviewed the data and exchanged ideas for improvement in November 2018 as part of the first PDSA cycle. The committee met monthly and was responsible for actively engaging other members of the department and perioperative staff to help in this multidisciplinary effort of combating hypothermia in our surgical pediatric population.

PDSA cycle 2 involved several major initiatives, including direct incorporation of the rest of the perioperative team. The perioperative nursing team was educated on the risks of hypothermia and engaged to take an active role by maintaining the operating suite temperature at 21.1 °C and turning on the Bair Hugger (3M) blanket to 43 °C on the OR bed prior to patient arrival to the OR. Additionally, anesthesia technicians (ATs) were tasked with ensuring an adequate supply of Bair Hugger drapes for all cases of the day. The facility’s engineering team was engaged to move the preoperative room temperature controls away from families (who frequently made the rooms cold) and instead set it at a consistent temperature of 23.9 °C. ATs were also asked to place axillary and nasal temperature probes on the anesthesia workstations as a visual reminder to facilitate temperature monitoring closer to the start of anesthesia (instead of the anesthesia provider having to remember to retrieve a temperature probe out of a drawer and place it on the patient). Furthermore, anesthesiologists were instructed via the aforementioned monthly emails and at monthly department meetings to place the temperature probes as early as possible in order to recognize and respond to intraoperative hypothermia in a timelier manner. Finally, supply chain leaders were informed of our expected increase in the use of the blankets and probes and proportionally increased ordering of these supplies to make sure availability would not present an obstacle.

In PDSA cycle 3, trainees (anesthesia assistant students, anesthesia residents and fellows) and advanced practice providers (APPs) (certified registered nurse-anesthetists [CRNAs] and certified anesthesia assistants [C-AAs]) were informed of the QI project. This initiative was guided toward improving vigilance for hypothermia in the rest of the anesthesia team members. The trainees and APPs usually set up the anesthesia area prior to patient arrival, so their recruitment in support of this effort would ensure appropriate OR temperature, active warming device deployment, and the availability and early placement of the correct temperature probe for the case. To facilitate personal accountability, the trainees and APPs were also emailed their own patients’ rate of hypothermia.

Along the course of the project, quarterly committee meetings and departmental monthly meetings served as venues to express concerns and look for areas of improvement, such as specific patterns or trends leading to hypothermic patients. One specific example was the identification of the gastrointestinal endoscopic patients having a rate of hypothermia that was 2% higher than average. Directed education on the importance of Bair Hugger blankets and using warm intravenous fluids worked well to decrease the rate of hypothermia in these patients. This collection of data was shared at regular intervals during monthly department meetings as well and more frequently using departmental emails. The hospital’s secure intranet SharePoint (Microsoft) site was used to share the data among providers.

Study of the interventions and measures

To study the effectiveness and impact of the project to motivate our anesthesiologists and other team members, we compared the first temperatures obtained in the recovery unit prior to the start of the intervention with those collected after the start of the QI project in November 2018. Because of the variability of temperature monitoring intraoperatively (nasal, axillary, rectal), we decided to use the temperature obtained by the nurse in the recovery room upon the patient’s arrival. Over the years analyzed, the nurse’s technique of measuring the temperature remained consistent. All patient temperature measurements were performed using the TAT-5000 (Exergen Corporation). This temporal artery thermometer has been previously shown to correlate well with bladder temperatures (70% of measurements differ by no more than 0.5 °C, as reported by Langham et al¹⁶).

Admittedly, we could not measure the degree of motivation or internalization of the project goals by our cohort, but we could measure the reduction in the rate of hypothermia and subjectively gauge engagement in the project by the various groups of participants and the sustainability of the results. In addition, all participating anesthesiologists received MOCA Part 4 credits in July 2019. We continued our data collection until April 2021 to determine if our project had brought about sustainable changes in practice that would continue past the initial motivator of obtaining CME credit.

Analysis

Data analysis was performed using Excel (Microsoft) and SAS, version 9.4 (SAS Institute).

The median of the monthly percentage of patients with a temperature of less than 36.0 °C was also determined for the preintervention time frame. This served as our baseline hypothermia rate, and we aimed to lower it by 50%. Run charts, a well-described methodology to gauge the effectiveness of the QI project, were constructed with the collected data.¹⁷

We performed additional analysis to adjust for different time periods throughout the year. The time period between January 2016 and October 2018 was considered preintervention. We considered November 2018 the start of our intervention, or more specifically, the start of our PDSA cycles. October 2018 was analyzed as part of the preintervention data. To account for seasonal temperature variations, the statistical analysis focused on the comparisons of the same calendar quarters for before and after starting intervention using Wilcoxon Mann-Whitney U tests. To reach an overall conclusion, the probabilities for the 4 quarters were combined for each criterion separately utilizing the Fisher χ² combined probability method.

The hypothermia QI project was reviewed by the institutional review board and determined to be exempt.

Results

The temperatures of 40 875 patients were available for analysis for the preintervention period between January 2016 and October 2018. The median percentage of patients with temperatures less than 36.0 °C was 6.9% (interquartile range [IQR], 5.8%-8.4%). The highest percentage was in February 2016 (9.9%), and the lowest was in March 2018 (3.4%). Following the start of the first PDSA cycle, the next 6 consecutive rates of hypothermia were below the median preintervention value, and a new median for these percentages was calculated at 3.4% (IQR, 2.6%-4.3%). In July 2019, the proportion of hypothermic patients decreased once more for 6 consecutive months, yielding a new median of 1.6% (IQR, 1.2%-1.8%) and again in July 2020, to yield a median of 1.3% (IQR, 1.2%-1.5%) (Figure). In all, 33 799 patients were analyzed after the start of the project from November 2018 to the end of the data collection period through April 2021.

The preintervention monthly rates of hypothermia were compared, quarter to quarter, with those starting in November 2018 using the Wilcoxon Mann-Whitney U test. The decrease in proportion of hypothermic patients after the start of the intervention was statistically significant (P < .001). In addition, the percentage of patients with temperatures greater than 38 °C was not significantly different between the pre- and postintervention time periods (P < .25) (Table 2). The decrease in the number of patients available for analysis from March 2020 to May 2020 was due to the COVID-19 pandemic.

Subjectively, we did not experience any notable resistance to our efforts, and the experience was largely positive for everyone involved. Clinicians identified as having high monthly rates of hypothermia (5% or higher) corrected their numbers the following month after being notified via email or in person.

To achieve changes in practice, the health care industry has relied on instituting guidelines, regulations, and policies, often with punitive consequences. We call into question this long-standing framework and propose a novel approach to help evolve the field of QI. Studies in human psychology have long demonstrated the demotivation power of a reward system and the negative response to attempts by authority to use incentives to control or coerce. In our QI project, we instituted 3 PDSA cycles and applied elements from SDT to motivate people’s behaviors. We demonstrate how a new culture focused on maintaining intraoperative normothermia was developed and brought about a measurable and significant decrease in the rate of hypothermia. The relevance of SDT, a widely accepted unifying theory that bridges and links social and personality psychology, should not be understated in health care. Authorities wishing to have long-standing influence should consider a person’s right to make their own decisions and, if possible, a unique way of doing things.

Positively reinforcing behavior has been shown to have a paradoxical effect by dampening an individual’s intrinsic motivation or desire to perform certain tasks.¹⁸ Deadlines, surveillance, and authoritative commands are also deterrents.^19,20 We focused on providing the tools and information to the clinicians and relied on their innate need for autonomy, growth, and self-actualization to bring about change in clinical practice.²¹ Group meetings served as a construct for exchanging ideas and to encourage participation, but without the implementation of rigid guidelines or policies. Intraoperative active warming devices and temperature probes were made available, but their use was not mandated. The use of these devices was intentionally not audited to avoid any overbearing control. Providers were, however, given monthly temperature data to help individually assess the effectiveness of their interventions. We did not impose any negative or punitive actions for those clinicians who had high rates of hypothermic patients, and we did not reward those who had low rates of hypothermia. We wanted the participants to feel that the inner self was the source of their behavior, and this was in parallel with their own interests and values. If providers could feel their need for competency could be realized, we hoped they would continue to adhere to the measures we provided to maintain a low rate of hypothermia.

The effectiveness of our efforts was demonstrated by a decrease in the prevalence of postoperative hypothermia in our surgical patients. The initial decrease of the median rate of hypothermia from 6.9% to 3.4% occurred shortly into the start of the first PDSA cycle. The second PDSA cycle started in January 2019 with a multimodal approach and included almost all parties involved in the perioperative care of our surgical patients. Not only was this intervention responsible for a continued downward trend in the percentage of hypothermic patients, but it set the stage for the third and final PDSA cycle, which started in July 2019. The architecture was in place to integrate trainees and APPs to reinforce our initiative. Subsequently, the new median percentage of hypothermic patients was further decreased to an all-time low of 1.6% per month, satisfying and surpassing the goal of the QI project of decreasing the rate of hypothermia by only 50%. Our organization thereafter maintained a monthly hypothermia rate below 2%, except for April 2020, when it reached 2.5%. Our lowest median percentage was obtained after July 2020, reaching 1.3%.

To account for seasonal variations in temperatures and types of surgeries performed, we compared the percentage of hypothermic patients before and after the start of intervention, quarter by quarter. The decrease in the proportion of hypothermic patients after the start of intervention was statistically significant (P < .001). In addition, the data failed to prove any statistical difference for temperatures above 38 °C between the 2 periods, indicating that our interventions did not result in significant overwarming of patients. The clinical implications of decreasing the percentage of hypothermic patients from 6.9% to 1.3% is likely clinically important when considering the large number of patients who undergo surgery at large tertiary care pediatric centers. Even if simple interventions reduce hypothermia in only a handful of patients, routine applications of simple measures to keep patients normothermic is likely best clinical practice.

Anesthesiologists who participated in the hypothermia QI project by tracking the incidence of hypothermia in their patients were able to collect MOCA Part 4 credits in July 2019. There was no requirement for the individual anesthesiologist to reduce the rate of hypothermia or apply any of the encouraged strategies to obtain credit. As previously stated, there were also no rewards for obtaining low hypothermia rates for the providers. The temperature data continued to be collected through April 2021, 21 months after the credits were distributed, to demonstrate a continued, meaningful change, at least in the short-term. While the MOCA Part 4 credits likely served as an initial motivating factor to encourage participation in the QI project, they certainly were not responsible for the sustained low hypothermia rate after July 2019. We showed that the low rate of hypothermia was successfully maintained, indicating that the change in providers’ behavior was independent of the external motivator of obtaining the credit hours. Mere participation in the project by reviewing one’s temperature data was all that was required to obtain the credit. The Organismic Integration Theory, a mini-theory within SDT, best explains this phenomenon by describing any motivated behavior on a continuum ranging from controlled to autonomous.²² Do people perform the task resentfully, on their own volition because they believe it is the correct action, or somewhere in between? We explain the sustained low rates of hypothermia after the MOCA credits were distributed due to a shift to the autonomous end of the continuum with the clinician’s active willingness to meet the challenges and apply intrinsically motivated behaviors to lower the rate of hypothermia. The internalization of external motivators is difficult to prove, but the evidence supports that the methods we used to motivate individuals were effective and have resulted in a significant downward trend in our hypothermia rate.

There are several limitations to our QI project. The first involves the measuring of postoperative temperature in the recovery units. The temperatures were obtained using the same medical-grade infrared thermometer for all the patients, but other variables, such as timing and techniques, were not standardized. Secondly, overall surgical outcomes related to hypothermia were not tracked because we were unable to control for other confounding variables in our large cohort of patients, so we cannot say if the drop in the hypothermia rate had a clinically significant outcome. Thirdly, we propose that SDT offers a compellingly fitting explanation of the psychology of motivation in our efforts, but it may be possible that other theories may offer equally fitting explanations. The ability to measure the degree of motivation is lacking, and we did not explicitly ask participants what their specific source of motivation was. Aside from SDT, the reduction in hypothermia rate could also be attributed to the ease and availability of warming equipment that was made in each OR. This QI project was successfully applied to only 1 institution, so its ability to be widely applicable remains uncertain. In addition, data collection continued during the COVID-19 pandemic when case volumes decreased. However, by June 2020, the number of surgical cases at our institution had largely returned to prepandemic levels. Additional data collection beyond April 2021 would be helpful to determine if the reduction in hypothermia rates is truly sustained.

Conclusion

Overall, the importance of maintaining perioperative normothermia was well disseminated and agreed upon by all departments involved. Despite the limitations of the project, there was a significant reduction in rates of hypothermia, and sustainability of outcomes was consistently demonstrated in the poststudy period.

Using 3 cycles of the PDSA method, we successfully decreased the median rate of postoperative hypothermia in our pediatric surgical population from a preintervention value of 6.9% to 1.3%—a reduction of more than 81.2%. We provided motivation for members of our anesthesiology staff to participate by offering MOCA 2.0 Part 4 credits, but the lower rate of hypothermic patients was maintained for 15 months after the credits were distributed. Over the course of the project, there was a shift in culture, and extra vigilance was given to temperature monitoring and assessment. We attribute this sustained cultural change to the deliberate incorporation of the principles of competency, autonomy, and relatedness central to SDT to the structure of the interventions, avoiding rigid guidelines and pathways in favor of affective engagement to establish intrinsic motivation.

Acknowledgements: The authors thank Joan Reisch, PhD, for her assistance with the statistical analysis.

Corresponding author: Edgar Erold Kiss, MD, 1935 Medical District Dr, Dallas, TX 75235; [email protected].

Financial disclosures: None.

From Children’s Health System of Texas, Division of Pediatric Anesthesiology, Dallas, TX (Drs. Sakhai, Bocanegra, Chandran, Kimatian, and Kiss), UT Southwestern Medical Center, Department of Anesthesiology and Pain Management, Dallas, TX (Drs. Bocanegra, Chandran, Kimatian, and Kiss), and UT Southwestern Medical Center, Department of Population and Data Sciences, Dallas, TX (Dr. Reisch).

Objective: Policy-driven changes in medical practice have long been the norm. Seldom are changes in clinical practice sought to be brought about by a person’s tendency toward growth or self‐actualization. Many hospitals have instituted hypothermia bundles to help reduce the incidence of unanticipated postoperative hypothermia. Although successful in the short-term, sustained changes are difficult to maintain. We implemented a quality-improvement project focused on addressing the affective components of self-determination theory (SDT) to create sustainable behavioral change while satisfying providers’ basic psychological needs for autonomy, competence, and relatedness.

Methods: A total of 3 Plan-Do-Study-Act (PDSA) cycles were enacted over the span of 14 months at a major tertiary care pediatric hospital to recruit and motivate anesthesia providers and perioperative team members to reduce the percentage of hypothermic postsurgical patients by 50%. As an optional initial incentive for participation, anesthesiologists would qualify for American Board of Anesthesiology Maintenance of Certification in Anesthesiology (MOCA) Part 4 Quality Improvement credits for monitoring their own temperature data and participating in project-related meetings. Providers were given autonomy to develop a personal plan for achieving the desired goals.

Results: The median rate of hypothermia was reduced from 6.9% to 1.6% in July 2019 and was reduced again in July 2020 to 1.3%, an 81% reduction overall. A low hypothermia rate was successfully maintained for at least 21 subsequent months after participants received their MOCA credits in July 2019.

Conclusions: Using an approach that focused on the elements of competency, autonomy, and relatedness central to the principles of SDT, we observed the development of a new culture of vigilance for prevention of hypothermia that successfully endured beyond the project end date.

Keywords: postoperative hypothermia; self-determination theory; motivation; quality improvement.

Perioperative hypothermia, generally accepted as a core temperature less than 36 °C in clinical practice, is a common complication in the pediatric surgical population and is associated with poor postoperative outcomes.¹ Hypothermic patients may develop respiratory depression, hypoglycemia, and metabolic acidosis that may lead to decreased oxygen delivery and end organ tissue hypoxia.^2-4 Other potential detrimental effects of failing to maintain normal body temperature are impaired clotting factor enzyme function and platelet dysfunction, increasing the risk for postoperative bleeding.^5,6 In addition, there are financial implications when hypothermic patients require care and resources postoperatively because of delayed emergence or shivering.⁷

The American Society of Anesthesiologists recommends intraoperative temperature monitoring for procedures when clinically significant changes in body temperature are anticipated.⁸ Maintenance of normothermia in the pediatric population is especially challenging owing to a larger skin-surface area compared with body mass ratio and less subcutaneous fat content than in adults. Preventing postoperative hypothermia starts preoperatively with parental education and can be as simple as covering the child with a blanket and setting the preoperative room to an acceptably warm temperature.^9,10 Intraoperatively, maintaining operating room (OR) temperatures at or above 21.1 °C and using active warming devices and radiant warmers when appropriate are important techniques to preserve the child’s body temperature.^11,12

Despite the knowledge of these risks and vigilant avoidance of hypothermia, unplanned perioperative hypothermia can occur in up to 70% of surgical patients.¹ Beyond the clinical benefits, as health care marches toward a value-based payment methodology, quality indicators such as avoiding hypothermia may be linked directly to payment.

Self-determination theory (SDT) was first developed in 1980 by Deci and Ryan.¹³ The central premise of the theory states that people develop their full potential if circumstances allow them to satisfy their basic psychological needs: autonomy, competence, and relatedness. Under these conditions, people’s natural inclination toward growth can be realized, and they are more likely to internalize external goals. Under an extrinsic reward system, motivation can waver, as people may perceive rewards as controlling.

Many institutions have implemented hypothermia bundles to help decrease the rate of hypothermic patients, but while initially successful, the effectiveness of these interventions tends to fade over time as participants settle into old, comfortable routines.¹⁴ With SDT in mind, we designed our quality-improvement (QI) project with interventions to allow clinicians autonomy without instituting rigid guidelines or punitive actions. We aimed to directly address the affective components central to motivation and engagement so that we could bring about long-term meaningful changes in our practice.

Methods

Setting

The hypothermia QI intervention was instituted at a major tertiary care children’s hospital that performs more than 40 000 pediatric general anesthetics annually. Our division of pediatric anesthesiology consists of 66 fellowship-trained pediatric anesthesiologists, 15 or more rotating trainees per month, 13 anesthesiology assistants, 15 anesthesia technicians, and more than 50 perioperative nurses.

The most frequent pediatric surgeries include, but are not limited to, general surgery, otolaryngology, urology, gastroenterology, plastic surgery, neurosurgery, and dentistry. The surgeries are conducted in the hospital’s main operative floor, which consists of 15 ORs and 2 gastroenterology procedure rooms. Although the implementation of the QI project included several operating sites, we focused on collecting temperature data from surgical patients at our main campus recovery unit. We obtained the patients’ initial temperatures upon arrival to the recovery unit from a retrospective electronic health record review of all patients who underwent anesthesia from January 2016 through April 2021.

Postoperative hypothermia was identified as an area of potential improvement after several patients were reported to be hypothermic upon arrival to the recovery unit in the later part of 2018. Further review revealed significant heterogeneity of practices and lack of standardization of patient-warming methods. By comparing the temperatures pre- and postintervention, we could measure the effectiveness of the QI initiative. Prior to the start of our project, the hypothermia rate in our patient population was not actively tracked, and the effectiveness of our variable practice was not measured.

The cutoff for hypothermia for our QI project was defined as body temperature below 36 °C, since this value has been previously used in the literature and is commonly accepted in anesthesia practice as the delineation for hypothermia in patients undergoing general anesthesia.¹

Interventions

This QI project was designed and modeled after the Institute for Healthcare Improvement Model for Improvement.¹⁵ Three cycles of Plan-Do-Study-Act (PDSA) were developed and instituted over a 14-month period until December 2019 (Table 1).

A retrospective review was conducted to determine the percentage of surgical patients arriving to our recovery units with an initial temperature reading of less than 36 °C. A project key driver diagram and smart aim were created and approved by the hospital’s continuing medical education (CME) committee for credit via the American Board of Medical Specialties (ABMS) Multi-Specialty Portfolio Program, Maintenance of Certification in Anesthesiology (MOCA) Part 4.

The first PDSA cycle involved introducing the QI project and sharing the aims of the project at a department grand rounds in the latter part of October 2018. Enrollment to participate in the project was open to all anesthesiologists in the division, and participants could earn up to 20 hours of MOCA Part 4 credits. A spreadsheet was developed and maintained to track each anesthesiologist’s monthly percentage of hypothermic patients. The de-identified patient data were shared with the division via monthly emails. In addition, individual providers with a hypothermic patient in the recovery room received a notification email.

The anesthesiologists participated in the QI project by reviewing their personal percentage of hypothermic patients on an ongoing basis to earn the credit. There was no explicit requirement to decrease their own rate of patients with body temperature less than 36 °C or expectation to achieve a predetermined goal, so the participants could not “fail.”

Because of the large interest in this project, a hypothermia committee was formed that consisted of 36 anesthesiologists. This group reviewed the data and exchanged ideas for improvement in November 2018 as part of the first PDSA cycle. The committee met monthly and was responsible for actively engaging other members of the department and perioperative staff to help in this multidisciplinary effort of combating hypothermia in our surgical pediatric population.

PDSA cycle 2 involved several major initiatives, including direct incorporation of the rest of the perioperative team. The perioperative nursing team was educated on the risks of hypothermia and engaged to take an active role by maintaining the operating suite temperature at 21.1 °C and turning on the Bair Hugger (3M) blanket to 43 °C on the OR bed prior to patient arrival to the OR. Additionally, anesthesia technicians (ATs) were tasked with ensuring an adequate supply of Bair Hugger drapes for all cases of the day. The facility’s engineering team was engaged to move the preoperative room temperature controls away from families (who frequently made the rooms cold) and instead set it at a consistent temperature of 23.9 °C. ATs were also asked to place axillary and nasal temperature probes on the anesthesia workstations as a visual reminder to facilitate temperature monitoring closer to the start of anesthesia (instead of the anesthesia provider having to remember to retrieve a temperature probe out of a drawer and place it on the patient). Furthermore, anesthesiologists were instructed via the aforementioned monthly emails and at monthly department meetings to place the temperature probes as early as possible in order to recognize and respond to intraoperative hypothermia in a timelier manner. Finally, supply chain leaders were informed of our expected increase in the use of the blankets and probes and proportionally increased ordering of these supplies to make sure availability would not present an obstacle.

In PDSA cycle 3, trainees (anesthesia assistant students, anesthesia residents and fellows) and advanced practice providers (APPs) (certified registered nurse-anesthetists [CRNAs] and certified anesthesia assistants [C-AAs]) were informed of the QI project. This initiative was guided toward improving vigilance for hypothermia in the rest of the anesthesia team members. The trainees and APPs usually set up the anesthesia area prior to patient arrival, so their recruitment in support of this effort would ensure appropriate OR temperature, active warming device deployment, and the availability and early placement of the correct temperature probe for the case. To facilitate personal accountability, the trainees and APPs were also emailed their own patients’ rate of hypothermia.

Along the course of the project, quarterly committee meetings and departmental monthly meetings served as venues to express concerns and look for areas of improvement, such as specific patterns or trends leading to hypothermic patients. One specific example was the identification of the gastrointestinal endoscopic patients having a rate of hypothermia that was 2% higher than average. Directed education on the importance of Bair Hugger blankets and using warm intravenous fluids worked well to decrease the rate of hypothermia in these patients. This collection of data was shared at regular intervals during monthly department meetings as well and more frequently using departmental emails. The hospital’s secure intranet SharePoint (Microsoft) site was used to share the data among providers.

Study of the interventions and measures

To study the effectiveness and impact of the project to motivate our anesthesiologists and other team members, we compared the first temperatures obtained in the recovery unit prior to the start of the intervention with those collected after the start of the QI project in November 2018. Because of the variability of temperature monitoring intraoperatively (nasal, axillary, rectal), we decided to use the temperature obtained by the nurse in the recovery room upon the patient’s arrival. Over the years analyzed, the nurse’s technique of measuring the temperature remained consistent. All patient temperature measurements were performed using the TAT-5000 (Exergen Corporation). This temporal artery thermometer has been previously shown to correlate well with bladder temperatures (70% of measurements differ by no more than 0.5 °C, as reported by Langham et al¹⁶).

Admittedly, we could not measure the degree of motivation or internalization of the project goals by our cohort, but we could measure the reduction in the rate of hypothermia and subjectively gauge engagement in the project by the various groups of participants and the sustainability of the results. In addition, all participating anesthesiologists received MOCA Part 4 credits in July 2019. We continued our data collection until April 2021 to determine if our project had brought about sustainable changes in practice that would continue past the initial motivator of obtaining CME credit.

Analysis

Data analysis was performed using Excel (Microsoft) and SAS, version 9.4 (SAS Institute).

The median of the monthly percentage of patients with a temperature of less than 36.0 °C was also determined for the preintervention time frame. This served as our baseline hypothermia rate, and we aimed to lower it by 50%. Run charts, a well-described methodology to gauge the effectiveness of the QI project, were constructed with the collected data.¹⁷

We performed additional analysis to adjust for different time periods throughout the year. The time period between January 2016 and October 2018 was considered preintervention. We considered November 2018 the start of our intervention, or more specifically, the start of our PDSA cycles. October 2018 was analyzed as part of the preintervention data. To account for seasonal temperature variations, the statistical analysis focused on the comparisons of the same calendar quarters for before and after starting intervention using Wilcoxon Mann-Whitney U tests. To reach an overall conclusion, the probabilities for the 4 quarters were combined for each criterion separately utilizing the Fisher χ² combined probability method.

The hypothermia QI project was reviewed by the institutional review board and determined to be exempt.

Results

The temperatures of 40 875 patients were available for analysis for the preintervention period between January 2016 and October 2018. The median percentage of patients with temperatures less than 36.0 °C was 6.9% (interquartile range [IQR], 5.8%-8.4%). The highest percentage was in February 2016 (9.9%), and the lowest was in March 2018 (3.4%). Following the start of the first PDSA cycle, the next 6 consecutive rates of hypothermia were below the median preintervention value, and a new median for these percentages was calculated at 3.4% (IQR, 2.6%-4.3%). In July 2019, the proportion of hypothermic patients decreased once more for 6 consecutive months, yielding a new median of 1.6% (IQR, 1.2%-1.8%) and again in July 2020, to yield a median of 1.3% (IQR, 1.2%-1.5%) (Figure). In all, 33 799 patients were analyzed after the start of the project from November 2018 to the end of the data collection period through April 2021.

The preintervention monthly rates of hypothermia were compared, quarter to quarter, with those starting in November 2018 using the Wilcoxon Mann-Whitney U test. The decrease in proportion of hypothermic patients after the start of the intervention was statistically significant (P < .001). In addition, the percentage of patients with temperatures greater than 38 °C was not significantly different between the pre- and postintervention time periods (P < .25) (Table 2). The decrease in the number of patients available for analysis from March 2020 to May 2020 was due to the COVID-19 pandemic.

Subjectively, we did not experience any notable resistance to our efforts, and the experience was largely positive for everyone involved. Clinicians identified as having high monthly rates of hypothermia (5% or higher) corrected their numbers the following month after being notified via email or in person.

To achieve changes in practice, the health care industry has relied on instituting guidelines, regulations, and policies, often with punitive consequences. We call into question this long-standing framework and propose a novel approach to help evolve the field of QI. Studies in human psychology have long demonstrated the demotivation power of a reward system and the negative response to attempts by authority to use incentives to control or coerce. In our QI project, we instituted 3 PDSA cycles and applied elements from SDT to motivate people’s behaviors. We demonstrate how a new culture focused on maintaining intraoperative normothermia was developed and brought about a measurable and significant decrease in the rate of hypothermia. The relevance of SDT, a widely accepted unifying theory that bridges and links social and personality psychology, should not be understated in health care. Authorities wishing to have long-standing influence should consider a person’s right to make their own decisions and, if possible, a unique way of doing things.

Positively reinforcing behavior has been shown to have a paradoxical effect by dampening an individual’s intrinsic motivation or desire to perform certain tasks.¹⁸ Deadlines, surveillance, and authoritative commands are also deterrents.^19,20 We focused on providing the tools and information to the clinicians and relied on their innate need for autonomy, growth, and self-actualization to bring about change in clinical practice.²¹ Group meetings served as a construct for exchanging ideas and to encourage participation, but without the implementation of rigid guidelines or policies. Intraoperative active warming devices and temperature probes were made available, but their use was not mandated. The use of these devices was intentionally not audited to avoid any overbearing control. Providers were, however, given monthly temperature data to help individually assess the effectiveness of their interventions. We did not impose any negative or punitive actions for those clinicians who had high rates of hypothermic patients, and we did not reward those who had low rates of hypothermia. We wanted the participants to feel that the inner self was the source of their behavior, and this was in parallel with their own interests and values. If providers could feel their need for competency could be realized, we hoped they would continue to adhere to the measures we provided to maintain a low rate of hypothermia.

The effectiveness of our efforts was demonstrated by a decrease in the prevalence of postoperative hypothermia in our surgical patients. The initial decrease of the median rate of hypothermia from 6.9% to 3.4% occurred shortly into the start of the first PDSA cycle. The second PDSA cycle started in January 2019 with a multimodal approach and included almost all parties involved in the perioperative care of our surgical patients. Not only was this intervention responsible for a continued downward trend in the percentage of hypothermic patients, but it set the stage for the third and final PDSA cycle, which started in July 2019. The architecture was in place to integrate trainees and APPs to reinforce our initiative. Subsequently, the new median percentage of hypothermic patients was further decreased to an all-time low of 1.6% per month, satisfying and surpassing the goal of the QI project of decreasing the rate of hypothermia by only 50%. Our organization thereafter maintained a monthly hypothermia rate below 2%, except for April 2020, when it reached 2.5%. Our lowest median percentage was obtained after July 2020, reaching 1.3%.

To account for seasonal variations in temperatures and types of surgeries performed, we compared the percentage of hypothermic patients before and after the start of intervention, quarter by quarter. The decrease in the proportion of hypothermic patients after the start of intervention was statistically significant (P < .001). In addition, the data failed to prove any statistical difference for temperatures above 38 °C between the 2 periods, indicating that our interventions did not result in significant overwarming of patients. The clinical implications of decreasing the percentage of hypothermic patients from 6.9% to 1.3% is likely clinically important when considering the large number of patients who undergo surgery at large tertiary care pediatric centers. Even if simple interventions reduce hypothermia in only a handful of patients, routine applications of simple measures to keep patients normothermic is likely best clinical practice.

Anesthesiologists who participated in the hypothermia QI project by tracking the incidence of hypothermia in their patients were able to collect MOCA Part 4 credits in July 2019. There was no requirement for the individual anesthesiologist to reduce the rate of hypothermia or apply any of the encouraged strategies to obtain credit. As previously stated, there were also no rewards for obtaining low hypothermia rates for the providers. The temperature data continued to be collected through April 2021, 21 months after the credits were distributed, to demonstrate a continued, meaningful change, at least in the short-term. While the MOCA Part 4 credits likely served as an initial motivating factor to encourage participation in the QI project, they certainly were not responsible for the sustained low hypothermia rate after July 2019. We showed that the low rate of hypothermia was successfully maintained, indicating that the change in providers’ behavior was independent of the external motivator of obtaining the credit hours. Mere participation in the project by reviewing one’s temperature data was all that was required to obtain the credit. The Organismic Integration Theory, a mini-theory within SDT, best explains this phenomenon by describing any motivated behavior on a continuum ranging from controlled to autonomous.²² Do people perform the task resentfully, on their own volition because they believe it is the correct action, or somewhere in between? We explain the sustained low rates of hypothermia after the MOCA credits were distributed due to a shift to the autonomous end of the continuum with the clinician’s active willingness to meet the challenges and apply intrinsically motivated behaviors to lower the rate of hypothermia. The internalization of external motivators is difficult to prove, but the evidence supports that the methods we used to motivate individuals were effective and have resulted in a significant downward trend in our hypothermia rate.

There are several limitations to our QI project. The first involves the measuring of postoperative temperature in the recovery units. The temperatures were obtained using the same medical-grade infrared thermometer for all the patients, but other variables, such as timing and techniques, were not standardized. Secondly, overall surgical outcomes related to hypothermia were not tracked because we were unable to control for other confounding variables in our large cohort of patients, so we cannot say if the drop in the hypothermia rate had a clinically significant outcome. Thirdly, we propose that SDT offers a compellingly fitting explanation of the psychology of motivation in our efforts, but it may be possible that other theories may offer equally fitting explanations. The ability to measure the degree of motivation is lacking, and we did not explicitly ask participants what their specific source of motivation was. Aside from SDT, the reduction in hypothermia rate could also be attributed to the ease and availability of warming equipment that was made in each OR. This QI project was successfully applied to only 1 institution, so its ability to be widely applicable remains uncertain. In addition, data collection continued during the COVID-19 pandemic when case volumes decreased. However, by June 2020, the number of surgical cases at our institution had largely returned to prepandemic levels. Additional data collection beyond April 2021 would be helpful to determine if the reduction in hypothermia rates is truly sustained.

Conclusion

Overall, the importance of maintaining perioperative normothermia was well disseminated and agreed upon by all departments involved. Despite the limitations of the project, there was a significant reduction in rates of hypothermia, and sustainability of outcomes was consistently demonstrated in the poststudy period.

Using 3 cycles of the PDSA method, we successfully decreased the median rate of postoperative hypothermia in our pediatric surgical population from a preintervention value of 6.9% to 1.3%—a reduction of more than 81.2%. We provided motivation for members of our anesthesiology staff to participate by offering MOCA 2.0 Part 4 credits, but the lower rate of hypothermic patients was maintained for 15 months after the credits were distributed. Over the course of the project, there was a shift in culture, and extra vigilance was given to temperature monitoring and assessment. We attribute this sustained cultural change to the deliberate incorporation of the principles of competency, autonomy, and relatedness central to SDT to the structure of the interventions, avoiding rigid guidelines and pathways in favor of affective engagement to establish intrinsic motivation.

Acknowledgements: The authors thank Joan Reisch, PhD, for her assistance with the statistical analysis.

Corresponding author: Edgar Erold Kiss, MD, 1935 Medical District Dr, Dallas, TX 75235; [email protected].

Financial disclosures: None.

Younger children may be vulnerable to the reemergence of common respiratory viruses such as influenza and respiratory syncytial virus (RSV) as COVID-19 restrictions wane, experts say. The impact could be detrimental.

The COVID-19 pandemic and the implementation of preventative measures such as social distancing, travel restrictions, mask use, and shelter in place, reduced the transmission of respiratory viruses, according to the Centers for Disease Control and Prevention. However, because older infants and toddlers have not been exposed to these bugs during the pandemic, they are vulnerable to suffering severe viral infections.

“[We’ve] been in the honeymoon for 18 months,” said Christopher J. Harrison, MD, professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospitals and Clinics in Kansas City, Mo. “We are going to be coming out of the honeymoon and the children who didn’t get sick are going to start packing 2 years’ worth of infections into the next 9 months so there’s going to be twice as many as would be normal.”

The CDC issued a health advisory in June for parts of the southern United States, such as Texas, the Carolinas, and Oklahoma, encouraging broader testing for RSV – a virus that usually causes mild, cold-like symptoms and is the most common cause of bronchiolitis and pneumonia in children – among those who test negative for COVID-19. Virtually all children get an RSV infection by the time they are 2 years old, according to the CDC.

In previous years, RSV usually spread during the fall and spring seasons and usually peaked late December to mid-February. However, there’s been an offseason spike in the common illness this year, with nearly 2,000 confirmed cases each week of July.

Richard J. Webby, PhD, of the infectious diseases department at St. Jude Children’s Research Hospital, Memphis, Tenn., said that although RSV transmits more easily during the winter, the virus is able to thrive during this summer because many children have limited immunity and are more vulnerable to catching the virus than before. Population immunity normally limits a virus to circulating under its most favorable conditions, which is usually the winter. However, because there are a few more “susceptible hosts,” it gives the virus the ability to spread during a time when it typically wouldn’t be able to.

“Now we have a wider range of susceptible kids because they haven’t had that exposure over the past 18 months,” said Dr. Webby, who is on the World Health Organization’s Influenza Vaccine Composition Advisory Team. “It gives the virus more chances to transmit during conditions that are less favorable.”

Dr. Harrison said that, if children continue to take preventative measures such as wearing masks and sanitizing, they can delay catching the RSV – which can be severe in infants and young children – until they’re older and symptoms won’t be as severe.

“The swelling that these viruses cause in the trachea and the bronchial tubes is much bigger in proportion to the overall size of the tubes, so it takes less swelling to clog up the trachea or bronchial tube for the 9-month-old than it does of a 9-year-old,” Dr. Harrison said. “So if a 9-year-old was to get RSV, they’re not going to have nearly the same amount symptoms as the 9-month-old.

Dr. Harrison said delaying RSV in children was never an option before because it’s a virus that’s almost impossible to avoid.

“Hopefully, the mask means that if you get exposed, instead of getting a million virus particles from your classmate or your playmate, you may only get a couple thousand,” Dr. Harrison explained. “And maybe that’s enough that you can fight it off or it may be small enough that you get a mild infection instead of a severe infection.”

A summer surge of RSV has also occurred in Australia. A study published in Clinical Infectious Diseases found that Western Australia saw a 98% reduction in RSV cases. This suggests that COVID-19 restrictions also delayed the RSV season.

Dr. Webby said the lax in penetrative measures against COVID-19 may also affect this upcoming flu season. Usually, around 10%-30% of the population gets infected with the flu each year, but that hasn’t happened the past couple of seasons, he said.

“There might be slightly less overall immunity to these viruses,” Dr. Webby said. “When these viruses do come back, there’s a little bit more room for them to take off.”

Although a severe influenza season rebound this winter is a possibility, Australia continues to experience a historically low flu season. Dr. Harrison, who said the northern hemisphere looks at what’s happening in Australia and the rest of the “southern half of the world because their influenza season is during our summer,” hopes this is an indication that the northern hemisphere will also experience a mild season.

However, there’s no indication of how this upcoming flu season will hit the United States and there isn’t any guidance on what could happen because these historically low levels of respiratory viruses have never happened before, Dr. Webby explained.

He said that, if COVID-19’s delta variant continues to circulate during the fall and winter seasons, it will keep other viruses at low levels. This is because there is rarely a peak of activity of different viruses at the same time.

“When you get infected with the virus, your body’s immune response has this nonspecific reaction that protects you from anything else for a short period of time,” Dr. Webby explained. “When you get a lot of one virus circulating, it’s really hard for these other viruses to get into that population and sort of set off an epidemic of their own.”

To prepare for an unsure influenza season, Dr. Harrison suggests making the influenza vaccine available in August as opposed to October.

Dr. Harrison and Dr. Webby reported no conflicts of interest.

Younger children may be vulnerable to the reemergence of common respiratory viruses such as influenza and respiratory syncytial virus (RSV) as COVID-19 restrictions wane, experts say. The impact could be detrimental.

The COVID-19 pandemic and the implementation of preventative measures such as social distancing, travel restrictions, mask use, and shelter in place, reduced the transmission of respiratory viruses, according to the Centers for Disease Control and Prevention. However, because older infants and toddlers have not been exposed to these bugs during the pandemic, they are vulnerable to suffering severe viral infections.

“[We’ve] been in the honeymoon for 18 months,” said Christopher J. Harrison, MD, professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospitals and Clinics in Kansas City, Mo. “We are going to be coming out of the honeymoon and the children who didn’t get sick are going to start packing 2 years’ worth of infections into the next 9 months so there’s going to be twice as many as would be normal.”

The CDC issued a health advisory in June for parts of the southern United States, such as Texas, the Carolinas, and Oklahoma, encouraging broader testing for RSV – a virus that usually causes mild, cold-like symptoms and is the most common cause of bronchiolitis and pneumonia in children – among those who test negative for COVID-19. Virtually all children get an RSV infection by the time they are 2 years old, according to the CDC.

In previous years, RSV usually spread during the fall and spring seasons and usually peaked late December to mid-February. However, there’s been an offseason spike in the common illness this year, with nearly 2,000 confirmed cases each week of July.

Richard J. Webby, PhD, of the infectious diseases department at St. Jude Children’s Research Hospital, Memphis, Tenn., said that although RSV transmits more easily during the winter, the virus is able to thrive during this summer because many children have limited immunity and are more vulnerable to catching the virus than before. Population immunity normally limits a virus to circulating under its most favorable conditions, which is usually the winter. However, because there are a few more “susceptible hosts,” it gives the virus the ability to spread during a time when it typically wouldn’t be able to.

“Now we have a wider range of susceptible kids because they haven’t had that exposure over the past 18 months,” said Dr. Webby, who is on the World Health Organization’s Influenza Vaccine Composition Advisory Team. “It gives the virus more chances to transmit during conditions that are less favorable.”

Dr. Harrison said that, if children continue to take preventative measures such as wearing masks and sanitizing, they can delay catching the RSV – which can be severe in infants and young children – until they’re older and symptoms won’t be as severe.

“The swelling that these viruses cause in the trachea and the bronchial tubes is much bigger in proportion to the overall size of the tubes, so it takes less swelling to clog up the trachea or bronchial tube for the 9-month-old than it does of a 9-year-old,” Dr. Harrison said. “So if a 9-year-old was to get RSV, they’re not going to have nearly the same amount symptoms as the 9-month-old.

Dr. Harrison said delaying RSV in children was never an option before because it’s a virus that’s almost impossible to avoid.

“Hopefully, the mask means that if you get exposed, instead of getting a million virus particles from your classmate or your playmate, you may only get a couple thousand,” Dr. Harrison explained. “And maybe that’s enough that you can fight it off or it may be small enough that you get a mild infection instead of a severe infection.”

A summer surge of RSV has also occurred in Australia. A study published in Clinical Infectious Diseases found that Western Australia saw a 98% reduction in RSV cases. This suggests that COVID-19 restrictions also delayed the RSV season.

Dr. Webby said the lax in penetrative measures against COVID-19 may also affect this upcoming flu season. Usually, around 10%-30% of the population gets infected with the flu each year, but that hasn’t happened the past couple of seasons, he said.

“There might be slightly less overall immunity to these viruses,” Dr. Webby said. “When these viruses do come back, there’s a little bit more room for them to take off.”

Although a severe influenza season rebound this winter is a possibility, Australia continues to experience a historically low flu season. Dr. Harrison, who said the northern hemisphere looks at what’s happening in Australia and the rest of the “southern half of the world because their influenza season is during our summer,” hopes this is an indication that the northern hemisphere will also experience a mild season.

However, there’s no indication of how this upcoming flu season will hit the United States and there isn’t any guidance on what could happen because these historically low levels of respiratory viruses have never happened before, Dr. Webby explained.

He said that, if COVID-19’s delta variant continues to circulate during the fall and winter seasons, it will keep other viruses at low levels. This is because there is rarely a peak of activity of different viruses at the same time.

“When you get infected with the virus, your body’s immune response has this nonspecific reaction that protects you from anything else for a short period of time,” Dr. Webby explained. “When you get a lot of one virus circulating, it’s really hard for these other viruses to get into that population and sort of set off an epidemic of their own.”

To prepare for an unsure influenza season, Dr. Harrison suggests making the influenza vaccine available in August as opposed to October.

Dr. Harrison and Dr. Webby reported no conflicts of interest.

Younger children may be vulnerable to the reemergence of common respiratory viruses such as influenza and respiratory syncytial virus (RSV) as COVID-19 restrictions wane, experts say. The impact could be detrimental.

The COVID-19 pandemic and the implementation of preventative measures such as social distancing, travel restrictions, mask use, and shelter in place, reduced the transmission of respiratory viruses, according to the Centers for Disease Control and Prevention. However, because older infants and toddlers have not been exposed to these bugs during the pandemic, they are vulnerable to suffering severe viral infections.

“[We’ve] been in the honeymoon for 18 months,” said Christopher J. Harrison, MD, professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospitals and Clinics in Kansas City, Mo. “We are going to be coming out of the honeymoon and the children who didn’t get sick are going to start packing 2 years’ worth of infections into the next 9 months so there’s going to be twice as many as would be normal.”

The CDC issued a health advisory in June for parts of the southern United States, such as Texas, the Carolinas, and Oklahoma, encouraging broader testing for RSV – a virus that usually causes mild, cold-like symptoms and is the most common cause of bronchiolitis and pneumonia in children – among those who test negative for COVID-19. Virtually all children get an RSV infection by the time they are 2 years old, according to the CDC.

In previous years, RSV usually spread during the fall and spring seasons and usually peaked late December to mid-February. However, there’s been an offseason spike in the common illness this year, with nearly 2,000 confirmed cases each week of July.

Richard J. Webby, PhD, of the infectious diseases department at St. Jude Children’s Research Hospital, Memphis, Tenn., said that although RSV transmits more easily during the winter, the virus is able to thrive during this summer because many children have limited immunity and are more vulnerable to catching the virus than before. Population immunity normally limits a virus to circulating under its most favorable conditions, which is usually the winter. However, because there are a few more “susceptible hosts,” it gives the virus the ability to spread during a time when it typically wouldn’t be able to.

“Now we have a wider range of susceptible kids because they haven’t had that exposure over the past 18 months,” said Dr. Webby, who is on the World Health Organization’s Influenza Vaccine Composition Advisory Team. “It gives the virus more chances to transmit during conditions that are less favorable.”

Dr. Harrison said that, if children continue to take preventative measures such as wearing masks and sanitizing, they can delay catching the RSV – which can be severe in infants and young children – until they’re older and symptoms won’t be as severe.

“The swelling that these viruses cause in the trachea and the bronchial tubes is much bigger in proportion to the overall size of the tubes, so it takes less swelling to clog up the trachea or bronchial tube for the 9-month-old than it does of a 9-year-old,” Dr. Harrison said. “So if a 9-year-old was to get RSV, they’re not going to have nearly the same amount symptoms as the 9-month-old.

Dr. Harrison said delaying RSV in children was never an option before because it’s a virus that’s almost impossible to avoid.

“Hopefully, the mask means that if you get exposed, instead of getting a million virus particles from your classmate or your playmate, you may only get a couple thousand,” Dr. Harrison explained. “And maybe that’s enough that you can fight it off or it may be small enough that you get a mild infection instead of a severe infection.”

A summer surge of RSV has also occurred in Australia. A study published in Clinical Infectious Diseases found that Western Australia saw a 98% reduction in RSV cases. This suggests that COVID-19 restrictions also delayed the RSV season.

Dr. Webby said the lax in penetrative measures against COVID-19 may also affect this upcoming flu season. Usually, around 10%-30% of the population gets infected with the flu each year, but that hasn’t happened the past couple of seasons, he said.

“There might be slightly less overall immunity to these viruses,” Dr. Webby said. “When these viruses do come back, there’s a little bit more room for them to take off.”

Although a severe influenza season rebound this winter is a possibility, Australia continues to experience a historically low flu season. Dr. Harrison, who said the northern hemisphere looks at what’s happening in Australia and the rest of the “southern half of the world because their influenza season is during our summer,” hopes this is an indication that the northern hemisphere will also experience a mild season.

However, there’s no indication of how this upcoming flu season will hit the United States and there isn’t any guidance on what could happen because these historically low levels of respiratory viruses have never happened before, Dr. Webby explained.

He said that, if COVID-19’s delta variant continues to circulate during the fall and winter seasons, it will keep other viruses at low levels. This is because there is rarely a peak of activity of different viruses at the same time.

“When you get infected with the virus, your body’s immune response has this nonspecific reaction that protects you from anything else for a short period of time,” Dr. Webby explained. “When you get a lot of one virus circulating, it’s really hard for these other viruses to get into that population and sort of set off an epidemic of their own.”

To prepare for an unsure influenza season, Dr. Harrison suggests making the influenza vaccine available in August as opposed to October.

Dr. Harrison and Dr. Webby reported no conflicts of interest.

When used for appropriate patients, MRI imaging is helpful in congenital melanocytic nevus (CMN) management and may help predict neurologic outcomes or drive neurosurgical intervention, results from a small multi-institutional study showed.

“The majority of congenital nevi are considered low risk for cutaneous and/or systemic complications,” Holly Neale said at the annual meeting of the Society for Pediatric Dermatology. “However, a subset of children born with higher-risk congenital nevi require close monitoring, as some features of congenital nevi have been associated with cutaneous melanoma, central nervous system melanoma, melanin in the brain or spine, and structural irregularities in the brain or spine. It’s important to understand which congenital nevi are considered higher risk in order to guide management and counseling decisions.”

One major management decision is to do a screening magnetic resonance image of the CNS to evaluate for neurologic involvement, said Ms. Neale, a fourth-year medical student at the University of Massachusetts, Worcester. Prior studies have shown that congenital nevi that are bigger than 20 cm, posterior axial location, and having more than one congenital nevus may predict CNS abnormalities, while recent guidelines from experts in the field suggest that any child with more than one congenital nevus at birth undergo screening MRI.

“However, guidelines are evolving, and more data is required to better understand the CNS abnormalities and patient outcomes for children with congenital nevi,” said Ms. Neale, who spent the past year as a pediatric dermatology research fellow at Massachusetts General Hospital, Boston.

To address this knowledge gap, she and colleagues at the University of Massachusetts, Massachusetts General Hospital, and Boston Children’s Hospital performed a retrospective chart review between Jan. 1, 2009, and Dec. 31, 2019, of individuals ages 18 and younger who had an MRI of the brain or spine with at least one dermatologist-diagnosed nevus as identified via key words in the medical record. Of the 909 patients screened, 46 met inclusion criteria, evenly split between males and females.

The most common location of the largest nevus was the trunk (in 41% of patients), followed by lesions that spanned multiple regions. More than one-third of patients had giant nevi (greater than 40 cm).

“The majority of images were considered nonconcerning, which includes normal, benign, or other findings such as trauma related, infectious, or orthopedic, which we did not classify as abnormal as it did not guide our study question,” Ms. Neale said. Specifically, 8% of spine images and 27% of brain images were considered “concerning,” defined as any finding that prompted further workup or monitoring, which includes findings concerning for melanin.

The most common brain finding was melanin (in eight children), and one child with brain melanin also had findings suggestive of melanin in the thoracic spine. The most common finding in spine MRIs was fatty filum (in four children), requiring intervention for tethering in only one individual. No cases of cutaneous melanoma developed during the study period, and only one patient with abnormal imaging had CNS melanoma, which was fatal.

All patients with findings suggestive of CNS melanin had more than four nevi present at birth, which is in line with current imaging screening guidelines. In addition, children with concerning imaging had higher rates of death, neurodevelopmental problems, seizures, and neurosurgery, compared with their counterparts with unremarkable imaging findings. Describing preliminary analyses, Ms. Neale said that a chi square analysis was performed to test statistical significance of these differences, “and neurosurgery was the only variable that children with concerning imaging were significantly more likely to experience, although sample size limits detection for the other variables.”

The authors concluded that MRI is a helpful tool when used in the appropriate clinical context for the management of congenital nevi. “As more children undergo imaging, we may discover more nonmelanin abnormalities,” she said.

Joseph M. Lam, MD, who was asked to comment on the study, said that the increased risk of CNS melanin in patients with larger lesions and in those with multiple lesions confirms previous reports.

“It is interesting to note that some patients with nonconcerning imaging results still had neurodevelopmental problems and seizures, albeit at a lower rate than those with concerning imaging results,” said Dr. Lam, a pediatric dermatologist at British Columbia Children’s Hospital, Vancouver. “The lack of a control group for comparison of rates of neurological sequelae, such as NDP, seizures and nonmelanin structural anomalies, limits the generalizability of the findings. However, this is a nice study that helps us understand better the CNS anomalies in CMN.”

Ms. Neale acknowledged certain limitations of the study, including the lack of a control group without CMN, the small number of patients, the potential for referral bias, and its retrospective design. Also, the proximity of the study period does not allow for chronic follow-up and detection of the development of melanoma or other problems in the future.

Ms. Neale and associates reported having no relevant financial disclosures. Dr. Lam disclosed that he has received speaker fees from Pierre Fabre.

[email protected]

When used for appropriate patients, MRI imaging is helpful in congenital melanocytic nevus (CMN) management and may help predict neurologic outcomes or drive neurosurgical intervention, results from a small multi-institutional study showed.

“The majority of congenital nevi are considered low risk for cutaneous and/or systemic complications,” Holly Neale said at the annual meeting of the Society for Pediatric Dermatology. “However, a subset of children born with higher-risk congenital nevi require close monitoring, as some features of congenital nevi have been associated with cutaneous melanoma, central nervous system melanoma, melanin in the brain or spine, and structural irregularities in the brain or spine. It’s important to understand which congenital nevi are considered higher risk in order to guide management and counseling decisions.”

One major management decision is to do a screening magnetic resonance image of the CNS to evaluate for neurologic involvement, said Ms. Neale, a fourth-year medical student at the University of Massachusetts, Worcester. Prior studies have shown that congenital nevi that are bigger than 20 cm, posterior axial location, and having more than one congenital nevus may predict CNS abnormalities, while recent guidelines from experts in the field suggest that any child with more than one congenital nevus at birth undergo screening MRI.

“However, guidelines are evolving, and more data is required to better understand the CNS abnormalities and patient outcomes for children with congenital nevi,” said Ms. Neale, who spent the past year as a pediatric dermatology research fellow at Massachusetts General Hospital, Boston.

To address this knowledge gap, she and colleagues at the University of Massachusetts, Massachusetts General Hospital, and Boston Children’s Hospital performed a retrospective chart review between Jan. 1, 2009, and Dec. 31, 2019, of individuals ages 18 and younger who had an MRI of the brain or spine with at least one dermatologist-diagnosed nevus as identified via key words in the medical record. Of the 909 patients screened, 46 met inclusion criteria, evenly split between males and females.

The most common location of the largest nevus was the trunk (in 41% of patients), followed by lesions that spanned multiple regions. More than one-third of patients had giant nevi (greater than 40 cm).

“The majority of images were considered nonconcerning, which includes normal, benign, or other findings such as trauma related, infectious, or orthopedic, which we did not classify as abnormal as it did not guide our study question,” Ms. Neale said. Specifically, 8% of spine images and 27% of brain images were considered “concerning,” defined as any finding that prompted further workup or monitoring, which includes findings concerning for melanin.

The most common brain finding was melanin (in eight children), and one child with brain melanin also had findings suggestive of melanin in the thoracic spine. The most common finding in spine MRIs was fatty filum (in four children), requiring intervention for tethering in only one individual. No cases of cutaneous melanoma developed during the study period, and only one patient with abnormal imaging had CNS melanoma, which was fatal.

All patients with findings suggestive of CNS melanin had more than four nevi present at birth, which is in line with current imaging screening guidelines. In addition, children with concerning imaging had higher rates of death, neurodevelopmental problems, seizures, and neurosurgery, compared with their counterparts with unremarkable imaging findings. Describing preliminary analyses, Ms. Neale said that a chi square analysis was performed to test statistical significance of these differences, “and neurosurgery was the only variable that children with concerning imaging were significantly more likely to experience, although sample size limits detection for the other variables.”

The authors concluded that MRI is a helpful tool when used in the appropriate clinical context for the management of congenital nevi. “As more children undergo imaging, we may discover more nonmelanin abnormalities,” she said.

Joseph M. Lam, MD, who was asked to comment on the study, said that the increased risk of CNS melanin in patients with larger lesions and in those with multiple lesions confirms previous reports.

“It is interesting to note that some patients with nonconcerning imaging results still had neurodevelopmental problems and seizures, albeit at a lower rate than those with concerning imaging results,” said Dr. Lam, a pediatric dermatologist at British Columbia Children’s Hospital, Vancouver. “The lack of a control group for comparison of rates of neurological sequelae, such as NDP, seizures and nonmelanin structural anomalies, limits the generalizability of the findings. However, this is a nice study that helps us understand better the CNS anomalies in CMN.”

Ms. Neale acknowledged certain limitations of the study, including the lack of a control group without CMN, the small number of patients, the potential for referral bias, and its retrospective design. Also, the proximity of the study period does not allow for chronic follow-up and detection of the development of melanoma or other problems in the future.

Ms. Neale and associates reported having no relevant financial disclosures. Dr. Lam disclosed that he has received speaker fees from Pierre Fabre.

[email protected]

When used for appropriate patients, MRI imaging is helpful in congenital melanocytic nevus (CMN) management and may help predict neurologic outcomes or drive neurosurgical intervention, results from a small multi-institutional study showed.

“The majority of congenital nevi are considered low risk for cutaneous and/or systemic complications,” Holly Neale said at the annual meeting of the Society for Pediatric Dermatology. “However, a subset of children born with higher-risk congenital nevi require close monitoring, as some features of congenital nevi have been associated with cutaneous melanoma, central nervous system melanoma, melanin in the brain or spine, and structural irregularities in the brain or spine. It’s important to understand which congenital nevi are considered higher risk in order to guide management and counseling decisions.”

One major management decision is to do a screening magnetic resonance image of the CNS to evaluate for neurologic involvement, said Ms. Neale, a fourth-year medical student at the University of Massachusetts, Worcester. Prior studies have shown that congenital nevi that are bigger than 20 cm, posterior axial location, and having more than one congenital nevus may predict CNS abnormalities, while recent guidelines from experts in the field suggest that any child with more than one congenital nevus at birth undergo screening MRI.

“However, guidelines are evolving, and more data is required to better understand the CNS abnormalities and patient outcomes for children with congenital nevi,” said Ms. Neale, who spent the past year as a pediatric dermatology research fellow at Massachusetts General Hospital, Boston.

To address this knowledge gap, she and colleagues at the University of Massachusetts, Massachusetts General Hospital, and Boston Children’s Hospital performed a retrospective chart review between Jan. 1, 2009, and Dec. 31, 2019, of individuals ages 18 and younger who had an MRI of the brain or spine with at least one dermatologist-diagnosed nevus as identified via key words in the medical record. Of the 909 patients screened, 46 met inclusion criteria, evenly split between males and females.

The most common location of the largest nevus was the trunk (in 41% of patients), followed by lesions that spanned multiple regions. More than one-third of patients had giant nevi (greater than 40 cm).

“The majority of images were considered nonconcerning, which includes normal, benign, or other findings such as trauma related, infectious, or orthopedic, which we did not classify as abnormal as it did not guide our study question,” Ms. Neale said. Specifically, 8% of spine images and 27% of brain images were considered “concerning,” defined as any finding that prompted further workup or monitoring, which includes findings concerning for melanin.

The most common brain finding was melanin (in eight children), and one child with brain melanin also had findings suggestive of melanin in the thoracic spine. The most common finding in spine MRIs was fatty filum (in four children), requiring intervention for tethering in only one individual. No cases of cutaneous melanoma developed during the study period, and only one patient with abnormal imaging had CNS melanoma, which was fatal.

All patients with findings suggestive of CNS melanin had more than four nevi present at birth, which is in line with current imaging screening guidelines. In addition, children with concerning imaging had higher rates of death, neurodevelopmental problems, seizures, and neurosurgery, compared with their counterparts with unremarkable imaging findings. Describing preliminary analyses, Ms. Neale said that a chi square analysis was performed to test statistical significance of these differences, “and neurosurgery was the only variable that children with concerning imaging were significantly more likely to experience, although sample size limits detection for the other variables.”

The authors concluded that MRI is a helpful tool when used in the appropriate clinical context for the management of congenital nevi. “As more children undergo imaging, we may discover more nonmelanin abnormalities,” she said.

Joseph M. Lam, MD, who was asked to comment on the study, said that the increased risk of CNS melanin in patients with larger lesions and in those with multiple lesions confirms previous reports.

“It is interesting to note that some patients with nonconcerning imaging results still had neurodevelopmental problems and seizures, albeit at a lower rate than those with concerning imaging results,” said Dr. Lam, a pediatric dermatologist at British Columbia Children’s Hospital, Vancouver. “The lack of a control group for comparison of rates of neurological sequelae, such as NDP, seizures and nonmelanin structural anomalies, limits the generalizability of the findings. However, this is a nice study that helps us understand better the CNS anomalies in CMN.”

Ms. Neale acknowledged certain limitations of the study, including the lack of a control group without CMN, the small number of patients, the potential for referral bias, and its retrospective design. Also, the proximity of the study period does not allow for chronic follow-up and detection of the development of melanoma or other problems in the future.

Ms. Neale and associates reported having no relevant financial disclosures. Dr. Lam disclosed that he has received speaker fees from Pierre Fabre.

[email protected]

A practice-changing study that used molecular testing to distinguish between subtypes of medulloblastoma has shown a significant improvement in survival for children with high-risk disease who underwent treatment intensification with carboplatin.

“Each of the four subgroups of medulloblastoma has a different prognosis, but for this particular subgroup, 20 fewer children out of every 100 would have survived prior to this study,” James Olson, MD, professor of medicine, French Hutchinson Cancer Research Center, University of Washington, Seattle, said in an interview.

“This is the reason for celebration – for now and forevermore, we can expect 20 more children with high-risk, group 3 medulloblastoma to survive,” he said.

“We recommend that all children with high-risk, group 3 medulloblastoma receive carboplatin and all children in the other subgroups do not, because we don’t want them to experience the toxicity without benefit,” Dr. Olson said.

The study was published online July 22, 2021, in JAMA Oncology.

Hematologic toxicity was more pronounced in the carboplatin arm in the induction phase of the protocol, and toxicity persisted into the first cycles of maintenance therapy. On the other hand, “there weren’t enough additional side effects to recommend children not get carboplatin if they would benefit from it,” Dr. Olson noted.

At least 75% of children with newly diagnosed medulloblastoma survive, although those with high-risk, group 3 disease have a substantially poorer prognosis than those with other molecular subtypes.

However, if a child with medulloblastoma experiences relapse, “the likelihood of survival is near zero, so it’s important to get it right the first time,” Dr. Olson said.

One of the patients who took part in this trial, Sammy Loch of Seattle, is now 27 years old and has been cancer free for 11 years.

She was diagnosed with medulloblastoma when in high school. At the time of her diagnosis, she was asked by her pediatric oncologist at Seattle Children’s Hospital about taking part in the study. After careful consideration, she agreed.

“Participating in research was my way to give back and pay it forward,” Ms. Loch said in a statement. “It’s really exciting to know more people will survive because of the research I was involved in,” she added. She continues to pay her debt forward, serving as a therapist for people with chronic health conditions and raising funds for pediatric cancer research.
 

Patients had high-risk features

The study involved 261 evaluable patients (median age, 8.6 years). All patients had high-risk features, including metastatic disease (72.4% of the group), diffuse anaplastic histologic characteristics (22.2%), and incomplete surgical resection (5.4%), defined as residual tumor greater than 1.5 cm2.

“All patients received 36 Gy craniospinal radiotherapy with boost to the posterior fossa of 55.8 Gy cumulative dose with conventional fractionation of 1.8 Gy/d,” Dr. Olson and colleagues explain. Patients also received six doses of vincristine 1.5 mg/m² weekly during radiotherapy and were randomly assigned to receive carboplatin 35 mg/m² for a total of 30 doses given daily prior to radiotherapy or placebo.

This regimen was followed by maintenance therapy, which consisted of six 28-day cycles of the combination of cisplatin 75 mg/m² on day 1; cyclophosphamide 1,000 mg/m² on days 2 and 3; and vincristine 1.5 mg/m² on days 1 and 8.

Patients were originally assigned to receive an additional 12 cycles of isotretinoin or placebo, to be given during and after maintenance therapy. However, randomization to isotretinoin was discontinued early because of futility.

The study was initially powered to evaluate medulloblastoma as a single disease. However, as a result of biologic insights gained after the study was conceived, it was amended to include a molecular subgroup analysis to better distinguish patients who might truly benefit from intensified therapy, the authors explained.
 

Study results

The World Health Organization categorizes tumors of the central nervous system into four groups. The authors followed this system of categorization for their patients with medulloblastoma. The four groups are WNT, in which WNT signaling pathway is activated; SHH, in which the SHH signaling pathway is activated; with or without TP53 mutation (provisionally designated group 3); and non-WNT/non-SHH (provisionally designed group 4)

The primary endpoint of the trial was event-free survival (EFS). In the patient population overall, there was no significant difference regarding this endpoint among those who received carboplatin and those who did not (EFS at 5 years, 66.4% vs. 59.2%).

However, there was a significant improvement among the patients in subgroup 3. Among those patients, EFS at 5 years was 73.2% with carboplatin versus 53.7% without (P = .047).

Similarly, in the overall group, there was no significant improvement in overall survival (OS) at 5 years from the addition of carboplatin (77.6% vs. 68.8% without carboplatin). However, the OS at 5 years varied widely between the different subtypes. There was again a significant improvement in OS at 5 years among the patients in subgroup 3 (82% with carboplation vs 63.7% without).

The beneficial effects from the addition of carboplatin on both endpoints were seen exclusively in patients in group 3, the authors emphasized.

“The WNT group does really well with less therapy, so if we treated all children the same, we would likely be overtreating WNT children and undertreating group 3 children,” Dr. Olson observed. “Genetic analysis is essential.”

In an earlier study, Dr. Olson and colleagues found that 70% of children with primitive neuroectodermal tumor of the CNS and pineoblastoma had been misdiagnosed even by outstanding children’s oncology centers because clinicians were relying on microscopic diagnosis.

“With molecular diagnosis, we were able to learn that many of these children had completely different diseases that require complexly different treatments, so doing diagnosis by molecular classification is absolutely essential,” he reemphasized.
 

“Glimmers of hope”

This study provides clinicians with “glimmers of hope” that children with high-risk, group 3 medulloblastoma will experience improvements in survival, wrote Allison Martin, MD, Albert Einstein College of Medicine, New York, and Sadhana Jackson, MD, National Institutes of Health, Bethesda, M.d., in an accompanying editorial.

The editorialists hope that “the treatment paradigm for all patients with high-risk disease can be improved through incorporation of detailed molecular analyses.”

However, they pointed out that DNA methylation and other advanced testing methods used to distinguish subgroups 3 and 4 in this study are not widely available, even at most Children’s Oncology Group member institutions. (Dr. Olson countered that, even if these sophisticated tests are not available at all pediatric oncology centers, tests will be performed if clinicians send tissue to the few sites that are equipped to conduct them.)

The editorialists also noted that therapy intensification with carboplatin is associated with an increased risk for adverse effects – “underscoring the importance of correctly identifying patients who could benefit from this intervention and avoid unnecessary toxic effects.”

The study was funded by the National Cancer Institute. Dr. Olson has disclosed no relevant financial relationships. Dr. Martin reported that she previously owed shares in Celgene, which she has subsequently sold.

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

A practice-changing study that used molecular testing to distinguish between subtypes of medulloblastoma has shown a significant improvement in survival for children with high-risk disease who underwent treatment intensification with carboplatin.

“Each of the four subgroups of medulloblastoma has a different prognosis, but for this particular subgroup, 20 fewer children out of every 100 would have survived prior to this study,” James Olson, MD, professor of medicine, French Hutchinson Cancer Research Center, University of Washington, Seattle, said in an interview.

“This is the reason for celebration – for now and forevermore, we can expect 20 more children with high-risk, group 3 medulloblastoma to survive,” he said.

“We recommend that all children with high-risk, group 3 medulloblastoma receive carboplatin and all children in the other subgroups do not, because we don’t want them to experience the toxicity without benefit,” Dr. Olson said.

The study was published online July 22, 2021, in JAMA Oncology.

Hematologic toxicity was more pronounced in the carboplatin arm in the induction phase of the protocol, and toxicity persisted into the first cycles of maintenance therapy. On the other hand, “there weren’t enough additional side effects to recommend children not get carboplatin if they would benefit from it,” Dr. Olson noted.

At least 75% of children with newly diagnosed medulloblastoma survive, although those with high-risk, group 3 disease have a substantially poorer prognosis than those with other molecular subtypes.

However, if a child with medulloblastoma experiences relapse, “the likelihood of survival is near zero, so it’s important to get it right the first time,” Dr. Olson said.

One of the patients who took part in this trial, Sammy Loch of Seattle, is now 27 years old and has been cancer free for 11 years.

She was diagnosed with medulloblastoma when in high school. At the time of her diagnosis, she was asked by her pediatric oncologist at Seattle Children’s Hospital about taking part in the study. After careful consideration, she agreed.

“Participating in research was my way to give back and pay it forward,” Ms. Loch said in a statement. “It’s really exciting to know more people will survive because of the research I was involved in,” she added. She continues to pay her debt forward, serving as a therapist for people with chronic health conditions and raising funds for pediatric cancer research.
 

Patients had high-risk features

The study involved 261 evaluable patients (median age, 8.6 years). All patients had high-risk features, including metastatic disease (72.4% of the group), diffuse anaplastic histologic characteristics (22.2%), and incomplete surgical resection (5.4%), defined as residual tumor greater than 1.5 cm2.

“All patients received 36 Gy craniospinal radiotherapy with boost to the posterior fossa of 55.8 Gy cumulative dose with conventional fractionation of 1.8 Gy/d,” Dr. Olson and colleagues explain. Patients also received six doses of vincristine 1.5 mg/m² weekly during radiotherapy and were randomly assigned to receive carboplatin 35 mg/m² for a total of 30 doses given daily prior to radiotherapy or placebo.

This regimen was followed by maintenance therapy, which consisted of six 28-day cycles of the combination of cisplatin 75 mg/m² on day 1; cyclophosphamide 1,000 mg/m² on days 2 and 3; and vincristine 1.5 mg/m² on days 1 and 8.

Patients were originally assigned to receive an additional 12 cycles of isotretinoin or placebo, to be given during and after maintenance therapy. However, randomization to isotretinoin was discontinued early because of futility.

The study was initially powered to evaluate medulloblastoma as a single disease. However, as a result of biologic insights gained after the study was conceived, it was amended to include a molecular subgroup analysis to better distinguish patients who might truly benefit from intensified therapy, the authors explained.
 

Study results

The World Health Organization categorizes tumors of the central nervous system into four groups. The authors followed this system of categorization for their patients with medulloblastoma. The four groups are WNT, in which WNT signaling pathway is activated; SHH, in which the SHH signaling pathway is activated; with or without TP53 mutation (provisionally designated group 3); and non-WNT/non-SHH (provisionally designed group 4)

The primary endpoint of the trial was event-free survival (EFS). In the patient population overall, there was no significant difference regarding this endpoint among those who received carboplatin and those who did not (EFS at 5 years, 66.4% vs. 59.2%).

However, there was a significant improvement among the patients in subgroup 3. Among those patients, EFS at 5 years was 73.2% with carboplatin versus 53.7% without (P = .047).

Similarly, in the overall group, there was no significant improvement in overall survival (OS) at 5 years from the addition of carboplatin (77.6% vs. 68.8% without carboplatin). However, the OS at 5 years varied widely between the different subtypes. There was again a significant improvement in OS at 5 years among the patients in subgroup 3 (82% with carboplation vs 63.7% without).

The beneficial effects from the addition of carboplatin on both endpoints were seen exclusively in patients in group 3, the authors emphasized.

“The WNT group does really well with less therapy, so if we treated all children the same, we would likely be overtreating WNT children and undertreating group 3 children,” Dr. Olson observed. “Genetic analysis is essential.”

In an earlier study, Dr. Olson and colleagues found that 70% of children with primitive neuroectodermal tumor of the CNS and pineoblastoma had been misdiagnosed even by outstanding children’s oncology centers because clinicians were relying on microscopic diagnosis.

“With molecular diagnosis, we were able to learn that many of these children had completely different diseases that require complexly different treatments, so doing diagnosis by molecular classification is absolutely essential,” he reemphasized.
 

“Glimmers of hope”

This study provides clinicians with “glimmers of hope” that children with high-risk, group 3 medulloblastoma will experience improvements in survival, wrote Allison Martin, MD, Albert Einstein College of Medicine, New York, and Sadhana Jackson, MD, National Institutes of Health, Bethesda, M.d., in an accompanying editorial.

The editorialists hope that “the treatment paradigm for all patients with high-risk disease can be improved through incorporation of detailed molecular analyses.”

However, they pointed out that DNA methylation and other advanced testing methods used to distinguish subgroups 3 and 4 in this study are not widely available, even at most Children’s Oncology Group member institutions. (Dr. Olson countered that, even if these sophisticated tests are not available at all pediatric oncology centers, tests will be performed if clinicians send tissue to the few sites that are equipped to conduct them.)

The editorialists also noted that therapy intensification with carboplatin is associated with an increased risk for adverse effects – “underscoring the importance of correctly identifying patients who could benefit from this intervention and avoid unnecessary toxic effects.”

The study was funded by the National Cancer Institute. Dr. Olson has disclosed no relevant financial relationships. Dr. Martin reported that she previously owed shares in Celgene, which she has subsequently sold.

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

A practice-changing study that used molecular testing to distinguish between subtypes of medulloblastoma has shown a significant improvement in survival for children with high-risk disease who underwent treatment intensification with carboplatin.

“Each of the four subgroups of medulloblastoma has a different prognosis, but for this particular subgroup, 20 fewer children out of every 100 would have survived prior to this study,” James Olson, MD, professor of medicine, French Hutchinson Cancer Research Center, University of Washington, Seattle, said in an interview.

“This is the reason for celebration – for now and forevermore, we can expect 20 more children with high-risk, group 3 medulloblastoma to survive,” he said.

“We recommend that all children with high-risk, group 3 medulloblastoma receive carboplatin and all children in the other subgroups do not, because we don’t want them to experience the toxicity without benefit,” Dr. Olson said.

The study was published online July 22, 2021, in JAMA Oncology.

Hematologic toxicity was more pronounced in the carboplatin arm in the induction phase of the protocol, and toxicity persisted into the first cycles of maintenance therapy. On the other hand, “there weren’t enough additional side effects to recommend children not get carboplatin if they would benefit from it,” Dr. Olson noted.

At least 75% of children with newly diagnosed medulloblastoma survive, although those with high-risk, group 3 disease have a substantially poorer prognosis than those with other molecular subtypes.

However, if a child with medulloblastoma experiences relapse, “the likelihood of survival is near zero, so it’s important to get it right the first time,” Dr. Olson said.

One of the patients who took part in this trial, Sammy Loch of Seattle, is now 27 years old and has been cancer free for 11 years.

She was diagnosed with medulloblastoma when in high school. At the time of her diagnosis, she was asked by her pediatric oncologist at Seattle Children’s Hospital about taking part in the study. After careful consideration, she agreed.

“Participating in research was my way to give back and pay it forward,” Ms. Loch said in a statement. “It’s really exciting to know more people will survive because of the research I was involved in,” she added. She continues to pay her debt forward, serving as a therapist for people with chronic health conditions and raising funds for pediatric cancer research.
 

Patients had high-risk features

The study involved 261 evaluable patients (median age, 8.6 years). All patients had high-risk features, including metastatic disease (72.4% of the group), diffuse anaplastic histologic characteristics (22.2%), and incomplete surgical resection (5.4%), defined as residual tumor greater than 1.5 cm2.

“All patients received 36 Gy craniospinal radiotherapy with boost to the posterior fossa of 55.8 Gy cumulative dose with conventional fractionation of 1.8 Gy/d,” Dr. Olson and colleagues explain. Patients also received six doses of vincristine 1.5 mg/m² weekly during radiotherapy and were randomly assigned to receive carboplatin 35 mg/m² for a total of 30 doses given daily prior to radiotherapy or placebo.

This regimen was followed by maintenance therapy, which consisted of six 28-day cycles of the combination of cisplatin 75 mg/m² on day 1; cyclophosphamide 1,000 mg/m² on days 2 and 3; and vincristine 1.5 mg/m² on days 1 and 8.

Patients were originally assigned to receive an additional 12 cycles of isotretinoin or placebo, to be given during and after maintenance therapy. However, randomization to isotretinoin was discontinued early because of futility.

The study was initially powered to evaluate medulloblastoma as a single disease. However, as a result of biologic insights gained after the study was conceived, it was amended to include a molecular subgroup analysis to better distinguish patients who might truly benefit from intensified therapy, the authors explained.
 

Study results

The World Health Organization categorizes tumors of the central nervous system into four groups. The authors followed this system of categorization for their patients with medulloblastoma. The four groups are WNT, in which WNT signaling pathway is activated; SHH, in which the SHH signaling pathway is activated; with or without TP53 mutation (provisionally designated group 3); and non-WNT/non-SHH (provisionally designed group 4)

The primary endpoint of the trial was event-free survival (EFS). In the patient population overall, there was no significant difference regarding this endpoint among those who received carboplatin and those who did not (EFS at 5 years, 66.4% vs. 59.2%).

However, there was a significant improvement among the patients in subgroup 3. Among those patients, EFS at 5 years was 73.2% with carboplatin versus 53.7% without (P = .047).

Similarly, in the overall group, there was no significant improvement in overall survival (OS) at 5 years from the addition of carboplatin (77.6% vs. 68.8% without carboplatin). However, the OS at 5 years varied widely between the different subtypes. There was again a significant improvement in OS at 5 years among the patients in subgroup 3 (82% with carboplation vs 63.7% without).

The beneficial effects from the addition of carboplatin on both endpoints were seen exclusively in patients in group 3, the authors emphasized.

“The WNT group does really well with less therapy, so if we treated all children the same, we would likely be overtreating WNT children and undertreating group 3 children,” Dr. Olson observed. “Genetic analysis is essential.”

In an earlier study, Dr. Olson and colleagues found that 70% of children with primitive neuroectodermal tumor of the CNS and pineoblastoma had been misdiagnosed even by outstanding children’s oncology centers because clinicians were relying on microscopic diagnosis.

“With molecular diagnosis, we were able to learn that many of these children had completely different diseases that require complexly different treatments, so doing diagnosis by molecular classification is absolutely essential,” he reemphasized.
 

“Glimmers of hope”

This study provides clinicians with “glimmers of hope” that children with high-risk, group 3 medulloblastoma will experience improvements in survival, wrote Allison Martin, MD, Albert Einstein College of Medicine, New York, and Sadhana Jackson, MD, National Institutes of Health, Bethesda, M.d., in an accompanying editorial.

The editorialists hope that “the treatment paradigm for all patients with high-risk disease can be improved through incorporation of detailed molecular analyses.”

However, they pointed out that DNA methylation and other advanced testing methods used to distinguish subgroups 3 and 4 in this study are not widely available, even at most Children’s Oncology Group member institutions. (Dr. Olson countered that, even if these sophisticated tests are not available at all pediatric oncology centers, tests will be performed if clinicians send tissue to the few sites that are equipped to conduct them.)

The editorialists also noted that therapy intensification with carboplatin is associated with an increased risk for adverse effects – “underscoring the importance of correctly identifying patients who could benefit from this intervention and avoid unnecessary toxic effects.”

The study was funded by the National Cancer Institute. Dr. Olson has disclosed no relevant financial relationships. Dr. Martin reported that she previously owed shares in Celgene, which she has subsequently sold.

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

The environmental impact of virtual isotretinoin management at West Virginia University Hospital (WVUH) in 2020 has been estimated in a new study: A reduction of 5,137 kg of greenhouse gas emissions in carbon dioxide equivalents.

In what they say is “one of the first studies to evaluate the environmental impact of any aspect of dermatology,” the authors of the retrospective cross-sectional study identified patients who had virtual visits for isotretinoin management between March 25 and May 29, 2020, – the period during which all such visits were conducted virtually in keeping with hospital recommendations to minimize the spread of COVID-19.

The investigators, from the department of dermatology and the department of civil and environmental engineering at West Virginia University, Morgantown, then counted the number of virtual visits that occurred during this period and through Dec. 1, 2020, (175 virtual visits), calculated the distance patients would have traveled round-trip had these visits been in-person, and converted miles saved into the environmental impact using U.S. Environmental Protection Agency and Federal Highway Administration data and relevant EPA standards.

Most patients had elected to continue virtual visits after May 29, the point at which patients were given the option to return to the WVUH clinic. (Patients who initiated treatment during the 2-month identification period were not included.)

The investigators determined that virtual management of isotretinoin saved a median of 37.8 miles per visit during the study period of March 25 to Dec. 1, and estimated that the virtual visits reduced total travel by 14,450 miles. For the analysis, patients were assumed to use light-duty vehicles.

In addition to calculating the reduction in emissions during the study period (5,137 kg of CO₂equivalents) they used patient census data from 2019 to 2020 and data from the study period to project the mileage – and the associated emissions – that would be saved annually if all in-person visits for isotretinoin management occurred virtually.

Their calculation for a projected emissions reduction with 1 year of all-virtual isotretinoin management was 49,400 kg of greenhouse gas emissions in CO₂equivalents. This is the emission load released when 24,690 kg of coal are burned or 6.3 million smartphones are charged, the researchers wrote.

“Considering that more than 1,000,000 prescriptions of isotretinoin are authorized annually in the United States, the environmental impact could be magnified if virtual delivery of isotretinoin care is adopted on a national scale,” they commented.“Given the serious consequences of global climate change, analysis of the environmental impact of all fields of medicine, including dermatology, is warranted,” they added.

The reduced greenhouse gas emissions are “definitely [being taken] into consideration for future decisions about virtual visits” in the department of dermatology, said Zachary Zinn, MD, residency director and associate professor in the department of dermatology at West Virginia University, Morgantown, who is the senior author of the study. “The main benefit of virtual care in my opinion,” he said in an interview, “is the potential to reduce our carbon footprint.”

Justin Lee, MD, an intern at WVU and the study’s first author, said that the research team was motivated to think about how they “could reduce the negative environmental impact of practicing dermatology” after they read a paper about the environmental impact of endoscopy, written by a gastroenterologist.

In the study, no pregnancies occurred and monthly tests were performed, but “formal assessment of pregnancy risk with virtual isotretinoin management would be warranted,” Dr. Lee and coauthors wrote, noting too that, while no differences were seen with respect to isotretinoin side effects, these were not formally analyzed.

Dr. Zinn said that he and colleagues at WVUH are currently conducting clinical trials to assess the quality and efficacy of virtual care for patients with acne, atopic dermatitis, and psoriasis. Delivering care virtually “will be easier to do if there are data supporting [its] quality and efficacy,” he said. Rosacea is another condition that may be amendable to virtual care, he noted.

Meanwhile, he said, isotretinoin management is “well suited” for virtual visits. When initiating isotretinoin treatment, Dr. Zinn now “proactively inquires” if patients would like to pursue their follow-up visits virtually. “I’ll note that it will save the time and decrease the burden of travel, including the financial cost as well as the environmental cost of travel,” he said, estimating that about half of their management visits are currently virtual.

Asked about the study, Misha Rosenbach, MD, associate professor of dermatology at the University of Pennsylvania, Philadelphia, said the reduced carbon footprint calculated by the researchers and its downstream health benefits “should be taken into consideration by [dermatology] departments, insurers and policymakers” when making decisions about teledermatology.

While environmental impact is “not something I think most institutions are considering for virtual versus in-person care, they should be. And some are,” said Dr. Rosenbach, a founder and cochair of the American Academy of Dermatology Expert Resource Group for Climate Change and Environmental Issues.

Limitations of the study include the generalizability of the results. The impact of virtual isotretinoin management “may be less in predominantly urban areas” than it is in predominately rural West Virginia, the study authors note. And in the case of West Virginia, travel to a local laboratory and pharmacy offsets some of the environmental benefits for the virtual care, they noted. Such travel wasn’t accounted for in the study, but it was found to be a fraction of travel to the WVU hospital clinic. (Patients traveled a median of 5.8 miles to a lab 2.4 times from March 25 to Dec. 1, 2020.)

Dr. Lee will start his dermatology residency at WVU next year. The study was funded by a grant from the U.S. National Science Foundation. The authors have no relevant conflicts of interest, according to Dr. Lee.

The environmental impact of virtual isotretinoin management at West Virginia University Hospital (WVUH) in 2020 has been estimated in a new study: A reduction of 5,137 kg of greenhouse gas emissions in carbon dioxide equivalents.

In what they say is “one of the first studies to evaluate the environmental impact of any aspect of dermatology,” the authors of the retrospective cross-sectional study identified patients who had virtual visits for isotretinoin management between March 25 and May 29, 2020, – the period during which all such visits were conducted virtually in keeping with hospital recommendations to minimize the spread of COVID-19.

The investigators, from the department of dermatology and the department of civil and environmental engineering at West Virginia University, Morgantown, then counted the number of virtual visits that occurred during this period and through Dec. 1, 2020, (175 virtual visits), calculated the distance patients would have traveled round-trip had these visits been in-person, and converted miles saved into the environmental impact using U.S. Environmental Protection Agency and Federal Highway Administration data and relevant EPA standards.

Most patients had elected to continue virtual visits after May 29, the point at which patients were given the option to return to the WVUH clinic. (Patients who initiated treatment during the 2-month identification period were not included.)

The investigators determined that virtual management of isotretinoin saved a median of 37.8 miles per visit during the study period of March 25 to Dec. 1, and estimated that the virtual visits reduced total travel by 14,450 miles. For the analysis, patients were assumed to use light-duty vehicles.

In addition to calculating the reduction in emissions during the study period (5,137 kg of CO₂equivalents) they used patient census data from 2019 to 2020 and data from the study period to project the mileage – and the associated emissions – that would be saved annually if all in-person visits for isotretinoin management occurred virtually.

Their calculation for a projected emissions reduction with 1 year of all-virtual isotretinoin management was 49,400 kg of greenhouse gas emissions in CO₂equivalents. This is the emission load released when 24,690 kg of coal are burned or 6.3 million smartphones are charged, the researchers wrote.

“Considering that more than 1,000,000 prescriptions of isotretinoin are authorized annually in the United States, the environmental impact could be magnified if virtual delivery of isotretinoin care is adopted on a national scale,” they commented.“Given the serious consequences of global climate change, analysis of the environmental impact of all fields of medicine, including dermatology, is warranted,” they added.

The reduced greenhouse gas emissions are “definitely [being taken] into consideration for future decisions about virtual visits” in the department of dermatology, said Zachary Zinn, MD, residency director and associate professor in the department of dermatology at West Virginia University, Morgantown, who is the senior author of the study. “The main benefit of virtual care in my opinion,” he said in an interview, “is the potential to reduce our carbon footprint.”

Justin Lee, MD, an intern at WVU and the study’s first author, said that the research team was motivated to think about how they “could reduce the negative environmental impact of practicing dermatology” after they read a paper about the environmental impact of endoscopy, written by a gastroenterologist.

In the study, no pregnancies occurred and monthly tests were performed, but “formal assessment of pregnancy risk with virtual isotretinoin management would be warranted,” Dr. Lee and coauthors wrote, noting too that, while no differences were seen with respect to isotretinoin side effects, these were not formally analyzed.

Dr. Zinn said that he and colleagues at WVUH are currently conducting clinical trials to assess the quality and efficacy of virtual care for patients with acne, atopic dermatitis, and psoriasis. Delivering care virtually “will be easier to do if there are data supporting [its] quality and efficacy,” he said. Rosacea is another condition that may be amendable to virtual care, he noted.

Meanwhile, he said, isotretinoin management is “well suited” for virtual visits. When initiating isotretinoin treatment, Dr. Zinn now “proactively inquires” if patients would like to pursue their follow-up visits virtually. “I’ll note that it will save the time and decrease the burden of travel, including the financial cost as well as the environmental cost of travel,” he said, estimating that about half of their management visits are currently virtual.

Asked about the study, Misha Rosenbach, MD, associate professor of dermatology at the University of Pennsylvania, Philadelphia, said the reduced carbon footprint calculated by the researchers and its downstream health benefits “should be taken into consideration by [dermatology] departments, insurers and policymakers” when making decisions about teledermatology.

While environmental impact is “not something I think most institutions are considering for virtual versus in-person care, they should be. And some are,” said Dr. Rosenbach, a founder and cochair of the American Academy of Dermatology Expert Resource Group for Climate Change and Environmental Issues.

Limitations of the study include the generalizability of the results. The impact of virtual isotretinoin management “may be less in predominantly urban areas” than it is in predominately rural West Virginia, the study authors note. And in the case of West Virginia, travel to a local laboratory and pharmacy offsets some of the environmental benefits for the virtual care, they noted. Such travel wasn’t accounted for in the study, but it was found to be a fraction of travel to the WVU hospital clinic. (Patients traveled a median of 5.8 miles to a lab 2.4 times from March 25 to Dec. 1, 2020.)

Dr. Lee will start his dermatology residency at WVU next year. The study was funded by a grant from the U.S. National Science Foundation. The authors have no relevant conflicts of interest, according to Dr. Lee.

The environmental impact of virtual isotretinoin management at West Virginia University Hospital (WVUH) in 2020 has been estimated in a new study: A reduction of 5,137 kg of greenhouse gas emissions in carbon dioxide equivalents.

In what they say is “one of the first studies to evaluate the environmental impact of any aspect of dermatology,” the authors of the retrospective cross-sectional study identified patients who had virtual visits for isotretinoin management between March 25 and May 29, 2020, – the period during which all such visits were conducted virtually in keeping with hospital recommendations to minimize the spread of COVID-19.

The investigators, from the department of dermatology and the department of civil and environmental engineering at West Virginia University, Morgantown, then counted the number of virtual visits that occurred during this period and through Dec. 1, 2020, (175 virtual visits), calculated the distance patients would have traveled round-trip had these visits been in-person, and converted miles saved into the environmental impact using U.S. Environmental Protection Agency and Federal Highway Administration data and relevant EPA standards.

Most patients had elected to continue virtual visits after May 29, the point at which patients were given the option to return to the WVUH clinic. (Patients who initiated treatment during the 2-month identification period were not included.)

The investigators determined that virtual management of isotretinoin saved a median of 37.8 miles per visit during the study period of March 25 to Dec. 1, and estimated that the virtual visits reduced total travel by 14,450 miles. For the analysis, patients were assumed to use light-duty vehicles.

In addition to calculating the reduction in emissions during the study period (5,137 kg of CO₂equivalents) they used patient census data from 2019 to 2020 and data from the study period to project the mileage – and the associated emissions – that would be saved annually if all in-person visits for isotretinoin management occurred virtually.

Their calculation for a projected emissions reduction with 1 year of all-virtual isotretinoin management was 49,400 kg of greenhouse gas emissions in CO₂equivalents. This is the emission load released when 24,690 kg of coal are burned or 6.3 million smartphones are charged, the researchers wrote.

“Considering that more than 1,000,000 prescriptions of isotretinoin are authorized annually in the United States, the environmental impact could be magnified if virtual delivery of isotretinoin care is adopted on a national scale,” they commented.“Given the serious consequences of global climate change, analysis of the environmental impact of all fields of medicine, including dermatology, is warranted,” they added.

The reduced greenhouse gas emissions are “definitely [being taken] into consideration for future decisions about virtual visits” in the department of dermatology, said Zachary Zinn, MD, residency director and associate professor in the department of dermatology at West Virginia University, Morgantown, who is the senior author of the study. “The main benefit of virtual care in my opinion,” he said in an interview, “is the potential to reduce our carbon footprint.”

Justin Lee, MD, an intern at WVU and the study’s first author, said that the research team was motivated to think about how they “could reduce the negative environmental impact of practicing dermatology” after they read a paper about the environmental impact of endoscopy, written by a gastroenterologist.

In the study, no pregnancies occurred and monthly tests were performed, but “formal assessment of pregnancy risk with virtual isotretinoin management would be warranted,” Dr. Lee and coauthors wrote, noting too that, while no differences were seen with respect to isotretinoin side effects, these were not formally analyzed.

Dr. Zinn said that he and colleagues at WVUH are currently conducting clinical trials to assess the quality and efficacy of virtual care for patients with acne, atopic dermatitis, and psoriasis. Delivering care virtually “will be easier to do if there are data supporting [its] quality and efficacy,” he said. Rosacea is another condition that may be amendable to virtual care, he noted.

Meanwhile, he said, isotretinoin management is “well suited” for virtual visits. When initiating isotretinoin treatment, Dr. Zinn now “proactively inquires” if patients would like to pursue their follow-up visits virtually. “I’ll note that it will save the time and decrease the burden of travel, including the financial cost as well as the environmental cost of travel,” he said, estimating that about half of their management visits are currently virtual.

Asked about the study, Misha Rosenbach, MD, associate professor of dermatology at the University of Pennsylvania, Philadelphia, said the reduced carbon footprint calculated by the researchers and its downstream health benefits “should be taken into consideration by [dermatology] departments, insurers and policymakers” when making decisions about teledermatology.

While environmental impact is “not something I think most institutions are considering for virtual versus in-person care, they should be. And some are,” said Dr. Rosenbach, a founder and cochair of the American Academy of Dermatology Expert Resource Group for Climate Change and Environmental Issues.

Limitations of the study include the generalizability of the results. The impact of virtual isotretinoin management “may be less in predominantly urban areas” than it is in predominately rural West Virginia, the study authors note. And in the case of West Virginia, travel to a local laboratory and pharmacy offsets some of the environmental benefits for the virtual care, they noted. Such travel wasn’t accounted for in the study, but it was found to be a fraction of travel to the WVU hospital clinic. (Patients traveled a median of 5.8 miles to a lab 2.4 times from March 25 to Dec. 1, 2020.)

Dr. Lee will start his dermatology residency at WVU next year. The study was funded by a grant from the U.S. National Science Foundation. The authors have no relevant conflicts of interest, according to Dr. Lee.