M. Alexander Otto

More than 1,625 pediatricians have applied to take the first pediatric hospitalist certification exam in November 2019, and approximately 93% of them have been accepted, according to a statement from the American Board of Pediatrics.

It was the rejection of the 7%, however, that set off a firestorm on the electronic discussion board for American Academy of Pediatrics (AAP) hospital medicine this summer, and led to a petition to the board to revise its eligibility requirements, ensure that the requirements are fair to women, and bring transparency to its decision process. The petition has more than 1,400 signatures.

Seattle Children’s Hospital and Yale New Haven (Conn.) Children’s Hospital have both said they will not consider board certification in hiring decisions until the situation is resolved.

The American Board of Pediatrics (ABP) declined an interview request pending its formal response to the Aug. 6 petition, but in a statement to this news organization, executive vice president Suzanne Woods, MD, said, “The percentage of women and men meeting the eligibility requirements for the exam did not differ. We stress this point because a concern about possible gender bias appears to have been the principal reason for this ... petition, and we wanted to offer immediate reassurance that no unintended bias has occurred.”

“We are carefully considering the requests and will release detailed data to hospitalists on the AAP’s [pediatric hospital medicine (PHM) electronic discussion board] ... and on the ABP’s website. We are conferring with ABP PHM subboard members as well as leaders from our volunteer community. We expect to provide a thoughtful response within the next 3 weeks,” Dr. Woods said in the Aug. 15 statement.
 

“Case-by-case” exceptions

The backstory is that, for better or worse depending on who you talk to, pediatric hospital medicine is becoming a board certified subspecialty. A fellowship will be required to sit for the exam after a few years, which is standard for subspecialties.

What’s generated concern is how the board is grandfathering current pediatric hospitalists into certification via a “practice pathway” until the fellowship requirement takes hold after 2023.

To qualify for the November test, hospitalists had to complete 4 years of full-time practice by June 30, 2019, which has been understood to mean 48 months of continual employment. At least 50% of that time had to be devoted to “professional activities ... related to the care of hospitalized children,” and at least 25% of that “devoted to direct patient care.” Assuming about 2,000 work hours per year, it translated to “450-500 hours” of direct patient care “per year over the most recent four years” to sit for the test, the board said.

“For individuals who have interrupted practice during the most recent four years for family leave or other such circumstances, an exception may be considered if there is substantial prior experience in pediatric hospital medicine. ... Such exceptions are made at the discretion of the ABP and will be considered on a case-by-case basis.” Specific criteria for exceptions were not spelled out.

In the end, there were more than a few surprises when denial letters went out in recent months, and scores of appeals have been filed. There’s “a lot of tension and a lot of confusion” about why some people with practice gaps during the 4 years were approved, but others were denied. There’s been “a lack of transparency on the ABP’s part,” said H. Barrett Fromme, MD, section chief of pediatric hospital medicine and a professor of pediatrics at the University of Chicago.
 

“The standard has to be reasonable”

There are concerns about the availability of fellowship slots and other issues, but the 4-year rule – instead of averaging clinical hours over 4 or 5 years, for instance – is the main sticking point. It’s a gender issue because “women take maternity; women move with their spouse; women take care of elders; women tend to be in these roles that require time off” more than men do, Dr. Fromme said.

Until the board releases its data, the gender breakdown of the denials and the degree to which practice gaps due to such issues led to them is unknown. There’s concern that women have been unfairly penalized.

The storm was set off on the discussion board this summer by stories from physicians such as Chandani DeZure, MD, a pediatric hospitalist currently working in the neonatal ICU at Stanford (Calif.) University. She was denied a seat at the table in November, appealed, and was denied again.

She was a full-time pediatric hospitalist at Children’s National Medical Center in Washington, from 2014, when she graduated residency, until Oct. 2018, when her husband, also a doctor, was offered a promising research position in California, and “we decided to take it,” Dr. DeZure said.

They moved to California with their young son in November. Dr. DeZure got her California medical license in 6 weeks, was hired by Stanford in January, and started her new postion in mid-April.

Because of the move, she worked only 3.5 years in the board’s 4 year practice window, but, as is common with young physicians, that time was spent in direct patient care, for a total of over 6,000 hours.

“How is that not good enough? How is a person that worked 500 hours with patients for 4 years” – for a total of 2,000 hours – “better qualified than someone who worked 100% for 3 and a half years? Nobody is saying there shouldn’t be a standard, but the standard has to be reasonable,” Dr. DeZure said.
 

“Illegal regardless of intent”

It’s situations like Dr. DeZure’s that led to the petition. One of demands is that ABP “revise the practice pathway criteria to be more inclusive of applicants with interrupted practice and varied clinical experience, to include clear-cut parameters rather than considering these applications on a closed-door ‘case-by-case basis...at the discretion of the ABP.’ ” Also, the petition asks the board to “clarify the appeals process and improve responsiveness to appeals and inquiries regarding denials.”

As ABP noted in its statement, however, the major demand is that the board “facilitate a timely analysis to determine if gender bias is present.” The petition noted that signers “do not suspect intentional bias on the part of the ABP; however, if gender bias is present it is unethical and potentially illegal regardless of intent.”

For now, the perception is that the board has “a hard 48-month rule” with not many exceptions; there are people who are “very concerned that, ‘Oh my gosh, I can’t have children for 4 years because I won’t be able to sit for the boards.’ No one should ever have to have that in their head,” Dr. Fromme said. At this point, it seems that 3 months off for maternity is being grandfathered in, but perhaps not 6 months for a second child; no one knows for sure.

Dr. DeZure, meanwhile, continues to study for the board exam, just in case.

Looking back over the past year, she said “I could have somehow picked up one shift a week moonlighting that would have kept me eligible, but the [board] didn’t respond to me” when contacted about her situation during the California move.

“The other option was for me was to live cross country from my husband with a small child,” she said.

[email protected]

More than 1,625 pediatricians have applied to take the first pediatric hospitalist certification exam in November 2019, and approximately 93% of them have been accepted, according to a statement from the American Board of Pediatrics.

It was the rejection of the 7%, however, that set off a firestorm on the electronic discussion board for American Academy of Pediatrics (AAP) hospital medicine this summer, and led to a petition to the board to revise its eligibility requirements, ensure that the requirements are fair to women, and bring transparency to its decision process. The petition has more than 1,400 signatures.

Seattle Children’s Hospital and Yale New Haven (Conn.) Children’s Hospital have both said they will not consider board certification in hiring decisions until the situation is resolved.

The American Board of Pediatrics (ABP) declined an interview request pending its formal response to the Aug. 6 petition, but in a statement to this news organization, executive vice president Suzanne Woods, MD, said, “The percentage of women and men meeting the eligibility requirements for the exam did not differ. We stress this point because a concern about possible gender bias appears to have been the principal reason for this ... petition, and we wanted to offer immediate reassurance that no unintended bias has occurred.”

“We are carefully considering the requests and will release detailed data to hospitalists on the AAP’s [pediatric hospital medicine (PHM) electronic discussion board] ... and on the ABP’s website. We are conferring with ABP PHM subboard members as well as leaders from our volunteer community. We expect to provide a thoughtful response within the next 3 weeks,” Dr. Woods said in the Aug. 15 statement.
 

“Case-by-case” exceptions

The backstory is that, for better or worse depending on who you talk to, pediatric hospital medicine is becoming a board certified subspecialty. A fellowship will be required to sit for the exam after a few years, which is standard for subspecialties.

What’s generated concern is how the board is grandfathering current pediatric hospitalists into certification via a “practice pathway” until the fellowship requirement takes hold after 2023.

To qualify for the November test, hospitalists had to complete 4 years of full-time practice by June 30, 2019, which has been understood to mean 48 months of continual employment. At least 50% of that time had to be devoted to “professional activities ... related to the care of hospitalized children,” and at least 25% of that “devoted to direct patient care.” Assuming about 2,000 work hours per year, it translated to “450-500 hours” of direct patient care “per year over the most recent four years” to sit for the test, the board said.

“For individuals who have interrupted practice during the most recent four years for family leave or other such circumstances, an exception may be considered if there is substantial prior experience in pediatric hospital medicine. ... Such exceptions are made at the discretion of the ABP and will be considered on a case-by-case basis.” Specific criteria for exceptions were not spelled out.

In the end, there were more than a few surprises when denial letters went out in recent months, and scores of appeals have been filed. There’s “a lot of tension and a lot of confusion” about why some people with practice gaps during the 4 years were approved, but others were denied. There’s been “a lack of transparency on the ABP’s part,” said H. Barrett Fromme, MD, section chief of pediatric hospital medicine and a professor of pediatrics at the University of Chicago.
 

“The standard has to be reasonable”

There are concerns about the availability of fellowship slots and other issues, but the 4-year rule – instead of averaging clinical hours over 4 or 5 years, for instance – is the main sticking point. It’s a gender issue because “women take maternity; women move with their spouse; women take care of elders; women tend to be in these roles that require time off” more than men do, Dr. Fromme said.

Until the board releases its data, the gender breakdown of the denials and the degree to which practice gaps due to such issues led to them is unknown. There’s concern that women have been unfairly penalized.

The storm was set off on the discussion board this summer by stories from physicians such as Chandani DeZure, MD, a pediatric hospitalist currently working in the neonatal ICU at Stanford (Calif.) University. She was denied a seat at the table in November, appealed, and was denied again.

She was a full-time pediatric hospitalist at Children’s National Medical Center in Washington, from 2014, when she graduated residency, until Oct. 2018, when her husband, also a doctor, was offered a promising research position in California, and “we decided to take it,” Dr. DeZure said.

They moved to California with their young son in November. Dr. DeZure got her California medical license in 6 weeks, was hired by Stanford in January, and started her new postion in mid-April.

Because of the move, she worked only 3.5 years in the board’s 4 year practice window, but, as is common with young physicians, that time was spent in direct patient care, for a total of over 6,000 hours.

“How is that not good enough? How is a person that worked 500 hours with patients for 4 years” – for a total of 2,000 hours – “better qualified than someone who worked 100% for 3 and a half years? Nobody is saying there shouldn’t be a standard, but the standard has to be reasonable,” Dr. DeZure said.
 

“Illegal regardless of intent”

It’s situations like Dr. DeZure’s that led to the petition. One of demands is that ABP “revise the practice pathway criteria to be more inclusive of applicants with interrupted practice and varied clinical experience, to include clear-cut parameters rather than considering these applications on a closed-door ‘case-by-case basis...at the discretion of the ABP.’ ” Also, the petition asks the board to “clarify the appeals process and improve responsiveness to appeals and inquiries regarding denials.”

As ABP noted in its statement, however, the major demand is that the board “facilitate a timely analysis to determine if gender bias is present.” The petition noted that signers “do not suspect intentional bias on the part of the ABP; however, if gender bias is present it is unethical and potentially illegal regardless of intent.”

For now, the perception is that the board has “a hard 48-month rule” with not many exceptions; there are people who are “very concerned that, ‘Oh my gosh, I can’t have children for 4 years because I won’t be able to sit for the boards.’ No one should ever have to have that in their head,” Dr. Fromme said. At this point, it seems that 3 months off for maternity is being grandfathered in, but perhaps not 6 months for a second child; no one knows for sure.

Dr. DeZure, meanwhile, continues to study for the board exam, just in case.

Looking back over the past year, she said “I could have somehow picked up one shift a week moonlighting that would have kept me eligible, but the [board] didn’t respond to me” when contacted about her situation during the California move.

“The other option was for me was to live cross country from my husband with a small child,” she said.

[email protected]

More than 1,625 pediatricians have applied to take the first pediatric hospitalist certification exam in November 2019, and approximately 93% of them have been accepted, according to a statement from the American Board of Pediatrics.

It was the rejection of the 7%, however, that set off a firestorm on the electronic discussion board for American Academy of Pediatrics (AAP) hospital medicine this summer, and led to a petition to the board to revise its eligibility requirements, ensure that the requirements are fair to women, and bring transparency to its decision process. The petition has more than 1,400 signatures.

Seattle Children’s Hospital and Yale New Haven (Conn.) Children’s Hospital have both said they will not consider board certification in hiring decisions until the situation is resolved.

The American Board of Pediatrics (ABP) declined an interview request pending its formal response to the Aug. 6 petition, but in a statement to this news organization, executive vice president Suzanne Woods, MD, said, “The percentage of women and men meeting the eligibility requirements for the exam did not differ. We stress this point because a concern about possible gender bias appears to have been the principal reason for this ... petition, and we wanted to offer immediate reassurance that no unintended bias has occurred.”

“We are carefully considering the requests and will release detailed data to hospitalists on the AAP’s [pediatric hospital medicine (PHM) electronic discussion board] ... and on the ABP’s website. We are conferring with ABP PHM subboard members as well as leaders from our volunteer community. We expect to provide a thoughtful response within the next 3 weeks,” Dr. Woods said in the Aug. 15 statement.
 

“Case-by-case” exceptions

The backstory is that, for better or worse depending on who you talk to, pediatric hospital medicine is becoming a board certified subspecialty. A fellowship will be required to sit for the exam after a few years, which is standard for subspecialties.

What’s generated concern is how the board is grandfathering current pediatric hospitalists into certification via a “practice pathway” until the fellowship requirement takes hold after 2023.

To qualify for the November test, hospitalists had to complete 4 years of full-time practice by June 30, 2019, which has been understood to mean 48 months of continual employment. At least 50% of that time had to be devoted to “professional activities ... related to the care of hospitalized children,” and at least 25% of that “devoted to direct patient care.” Assuming about 2,000 work hours per year, it translated to “450-500 hours” of direct patient care “per year over the most recent four years” to sit for the test, the board said.

“For individuals who have interrupted practice during the most recent four years for family leave or other such circumstances, an exception may be considered if there is substantial prior experience in pediatric hospital medicine. ... Such exceptions are made at the discretion of the ABP and will be considered on a case-by-case basis.” Specific criteria for exceptions were not spelled out.

In the end, there were more than a few surprises when denial letters went out in recent months, and scores of appeals have been filed. There’s “a lot of tension and a lot of confusion” about why some people with practice gaps during the 4 years were approved, but others were denied. There’s been “a lack of transparency on the ABP’s part,” said H. Barrett Fromme, MD, section chief of pediatric hospital medicine and a professor of pediatrics at the University of Chicago.
 

“The standard has to be reasonable”

There are concerns about the availability of fellowship slots and other issues, but the 4-year rule – instead of averaging clinical hours over 4 or 5 years, for instance – is the main sticking point. It’s a gender issue because “women take maternity; women move with their spouse; women take care of elders; women tend to be in these roles that require time off” more than men do, Dr. Fromme said.

Until the board releases its data, the gender breakdown of the denials and the degree to which practice gaps due to such issues led to them is unknown. There’s concern that women have been unfairly penalized.

The storm was set off on the discussion board this summer by stories from physicians such as Chandani DeZure, MD, a pediatric hospitalist currently working in the neonatal ICU at Stanford (Calif.) University. She was denied a seat at the table in November, appealed, and was denied again.

She was a full-time pediatric hospitalist at Children’s National Medical Center in Washington, from 2014, when she graduated residency, until Oct. 2018, when her husband, also a doctor, was offered a promising research position in California, and “we decided to take it,” Dr. DeZure said.

They moved to California with their young son in November. Dr. DeZure got her California medical license in 6 weeks, was hired by Stanford in January, and started her new postion in mid-April.

Because of the move, she worked only 3.5 years in the board’s 4 year practice window, but, as is common with young physicians, that time was spent in direct patient care, for a total of over 6,000 hours.

“How is that not good enough? How is a person that worked 500 hours with patients for 4 years” – for a total of 2,000 hours – “better qualified than someone who worked 100% for 3 and a half years? Nobody is saying there shouldn’t be a standard, but the standard has to be reasonable,” Dr. DeZure said.
 

“Illegal regardless of intent”

It’s situations like Dr. DeZure’s that led to the petition. One of demands is that ABP “revise the practice pathway criteria to be more inclusive of applicants with interrupted practice and varied clinical experience, to include clear-cut parameters rather than considering these applications on a closed-door ‘case-by-case basis...at the discretion of the ABP.’ ” Also, the petition asks the board to “clarify the appeals process and improve responsiveness to appeals and inquiries regarding denials.”

As ABP noted in its statement, however, the major demand is that the board “facilitate a timely analysis to determine if gender bias is present.” The petition noted that signers “do not suspect intentional bias on the part of the ABP; however, if gender bias is present it is unethical and potentially illegal regardless of intent.”

For now, the perception is that the board has “a hard 48-month rule” with not many exceptions; there are people who are “very concerned that, ‘Oh my gosh, I can’t have children for 4 years because I won’t be able to sit for the boards.’ No one should ever have to have that in their head,” Dr. Fromme said. At this point, it seems that 3 months off for maternity is being grandfathered in, but perhaps not 6 months for a second child; no one knows for sure.

Dr. DeZure, meanwhile, continues to study for the board exam, just in case.

Looking back over the past year, she said “I could have somehow picked up one shift a week moonlighting that would have kept me eligible, but the [board] didn’t respond to me” when contacted about her situation during the California move.

“The other option was for me was to live cross country from my husband with a small child,” she said.

[email protected]

The Food and Drug Administration has approved the Barostim Neo System, an electronic carotid sinus baroreceptor stimulator, for advanced heart failure patients who have a regular heart rhythm, an ejection fraction of 35% or less, and who are not candidates for cardiac resynchronization.

A tiny, unilateral electrode delivers a pulse that decreases sympathetic but increases parasympathetic tone. The effect is that blood vessels relax and production of stress hormones drops. The device is powered by a small generator implanted under the collarbone.

Approval was based on BeAT-HF, a randomized trial with 408 patients on guideline-directed medical therapy with left ventricular ejection fractions at or below 35% and New York Heart Association class III disease.

At 6 months, 125 patients implanted with the device had improved about 14 points more than controls on a quality of life scale, walked about 60 meters farther in 6 minutes, and were more likely to have improved a functional class or two. The benefits corresponded with a drop in the N-terminal of the prohormone brain natriuretic peptide.

Possible complications include infection, low blood pressure, nerve damage, arterial damage, heart failure exacerbation, stroke, and death. Contraindications include certain nervous system disorders, uncontrolled and symptomatic bradycardia, and atherosclerosis or ulcerative carotid plaques near the implant zone, the FDA said.

The system, from CRVx in Minneapolis, received priority review as a breakthrough device. The agency is requiring a phase 4 investigation of its potential to reduce hospitalizations and prolong life.

[email protected]

The Food and Drug Administration has approved the Barostim Neo System, an electronic carotid sinus baroreceptor stimulator, for advanced heart failure patients who have a regular heart rhythm, an ejection fraction of 35% or less, and who are not candidates for cardiac resynchronization.

A tiny, unilateral electrode delivers a pulse that decreases sympathetic but increases parasympathetic tone. The effect is that blood vessels relax and production of stress hormones drops. The device is powered by a small generator implanted under the collarbone.

Approval was based on BeAT-HF, a randomized trial with 408 patients on guideline-directed medical therapy with left ventricular ejection fractions at or below 35% and New York Heart Association class III disease.

At 6 months, 125 patients implanted with the device had improved about 14 points more than controls on a quality of life scale, walked about 60 meters farther in 6 minutes, and were more likely to have improved a functional class or two. The benefits corresponded with a drop in the N-terminal of the prohormone brain natriuretic peptide.

Possible complications include infection, low blood pressure, nerve damage, arterial damage, heart failure exacerbation, stroke, and death. Contraindications include certain nervous system disorders, uncontrolled and symptomatic bradycardia, and atherosclerosis or ulcerative carotid plaques near the implant zone, the FDA said.

The system, from CRVx in Minneapolis, received priority review as a breakthrough device. The agency is requiring a phase 4 investigation of its potential to reduce hospitalizations and prolong life.

[email protected]

The Food and Drug Administration has approved the Barostim Neo System, an electronic carotid sinus baroreceptor stimulator, for advanced heart failure patients who have a regular heart rhythm, an ejection fraction of 35% or less, and who are not candidates for cardiac resynchronization.

A tiny, unilateral electrode delivers a pulse that decreases sympathetic but increases parasympathetic tone. The effect is that blood vessels relax and production of stress hormones drops. The device is powered by a small generator implanted under the collarbone.

Approval was based on BeAT-HF, a randomized trial with 408 patients on guideline-directed medical therapy with left ventricular ejection fractions at or below 35% and New York Heart Association class III disease.

At 6 months, 125 patients implanted with the device had improved about 14 points more than controls on a quality of life scale, walked about 60 meters farther in 6 minutes, and were more likely to have improved a functional class or two. The benefits corresponded with a drop in the N-terminal of the prohormone brain natriuretic peptide.

Possible complications include infection, low blood pressure, nerve damage, arterial damage, heart failure exacerbation, stroke, and death. Contraindications include certain nervous system disorders, uncontrolled and symptomatic bradycardia, and atherosclerosis or ulcerative carotid plaques near the implant zone, the FDA said.

The system, from CRVx in Minneapolis, received priority review as a breakthrough device. The agency is requiring a phase 4 investigation of its potential to reduce hospitalizations and prolong life.

[email protected]

The U.S. Food and Drug Administration has proposed warnings for cigarette packs and advertisements on Aug. 15, 2019, that feature graphic, colored images illustrating the harms of smoking, but this could be subjected to legal challenge.

U.S. Food and Drug Administration

Several years ago, tobacco companies filed a lawsuit, which ultimately shut down a similar proposal.

The warnings focus on lesser-known complications – including diabetes, cataracts, gangrene, stroke, bladder cancer, erectile dysfunction, and obstructive pulmonary disease – and would take up the top half of the front and back of cigarette packs, and at least the top 20% of print advertisements. Each pack and ad would be required to carry 1 of the 13 proposed warnings, according to the announcement.

The approach would be similar to, but not as aggressive as Canada’s. For years, cigarettes packs sold in Canada have included disturbing photographs of diseased lungs, rotted teeth, and dying patients. The lasting impact of such imagery has been demonstrated in the literature (for example, Am J Prev Med. 2007 Mar;32[3]:202-9).

The new proposal is the FDA’s second attempt to enact something comparable in the United States, after being directed to do so by the Tobacco Control Act of 2009.

The first effort to add strong, illustrated warnings to cigarette packs was widely backed by medical groups, but challenged in the courts by R.J. Reynolds and other tobacco companies, and blocked on appeal in 2012 as an abridgment of commercial free speech. The federal government dropped the case in 2013.

The American Lung Association and other public health groups subsequently sued the FDA in 2016 to enact the Tobacco Act mandate. Subsequently, a federal judge ordered the agency to publish a new rule by August 2019, and issue a final rule in March 2020.

This time around, the FDA “took the necessary time to get these new proposed warnings right ... based on – and within the limits of – both science and the law,” the agency said. The new images, though graphic, are less disturbing than those used in Canada and the agency’s previous proposals, which included an apparent corpse with a sternotomy. The 1-800-Quit-Now cessation hotline number, which was a sticking point in the 2012 ruling, has also been dropped.

When asked about the new efforts, R.J. Reynolds spokesperson Kaelan Hollon said, “We are carefully reviewing FDA’s latest proposal for graphic warnings on cigarettes. We firmly support public awareness of the harms of smoking cigarettes, but the manner in which those messages are delivered to the public cannot run afoul of the First Amendment protections that apply to all speakers, including cigarette manufacturers.”

Warnings on U.S. cigarettes haven’t changed since 1984, when the risks of lung cancer, heart disease, emphysema, and pregnancy complications were added to the side of cigarette packs. With time, the FDA said the surgeon general’s warnings have become “virtually invisible” to consumers.

The American Lung Association, American Academy of Pediatrics, and other plaintiffs in the 2016 suit called the new proposal a “dramatic improvement” over the current situation and “long overdue” in a joint statement on Aug. 15.

Although rates have declined substantially in recent decades, about 34.3 million U.S. adults and almost 1.4 million teenagers still smoke. The habit kills about a half million Americans every year, at a health cost of more than $300 billion, the FDA said.

Comments on the proposed rule are being accepted through Oct. 15. The agency is open to suggestions for alternative text and images.
 

[email protected]

The U.S. Food and Drug Administration has proposed warnings for cigarette packs and advertisements on Aug. 15, 2019, that feature graphic, colored images illustrating the harms of smoking, but this could be subjected to legal challenge.

U.S. Food and Drug Administration

Several years ago, tobacco companies filed a lawsuit, which ultimately shut down a similar proposal.

The warnings focus on lesser-known complications – including diabetes, cataracts, gangrene, stroke, bladder cancer, erectile dysfunction, and obstructive pulmonary disease – and would take up the top half of the front and back of cigarette packs, and at least the top 20% of print advertisements. Each pack and ad would be required to carry 1 of the 13 proposed warnings, according to the announcement.

The approach would be similar to, but not as aggressive as Canada’s. For years, cigarettes packs sold in Canada have included disturbing photographs of diseased lungs, rotted teeth, and dying patients. The lasting impact of such imagery has been demonstrated in the literature (for example, Am J Prev Med. 2007 Mar;32[3]:202-9).

The new proposal is the FDA’s second attempt to enact something comparable in the United States, after being directed to do so by the Tobacco Control Act of 2009.

The first effort to add strong, illustrated warnings to cigarette packs was widely backed by medical groups, but challenged in the courts by R.J. Reynolds and other tobacco companies, and blocked on appeal in 2012 as an abridgment of commercial free speech. The federal government dropped the case in 2013.

The American Lung Association and other public health groups subsequently sued the FDA in 2016 to enact the Tobacco Act mandate. Subsequently, a federal judge ordered the agency to publish a new rule by August 2019, and issue a final rule in March 2020.

This time around, the FDA “took the necessary time to get these new proposed warnings right ... based on – and within the limits of – both science and the law,” the agency said. The new images, though graphic, are less disturbing than those used in Canada and the agency’s previous proposals, which included an apparent corpse with a sternotomy. The 1-800-Quit-Now cessation hotline number, which was a sticking point in the 2012 ruling, has also been dropped.

When asked about the new efforts, R.J. Reynolds spokesperson Kaelan Hollon said, “We are carefully reviewing FDA’s latest proposal for graphic warnings on cigarettes. We firmly support public awareness of the harms of smoking cigarettes, but the manner in which those messages are delivered to the public cannot run afoul of the First Amendment protections that apply to all speakers, including cigarette manufacturers.”

Warnings on U.S. cigarettes haven’t changed since 1984, when the risks of lung cancer, heart disease, emphysema, and pregnancy complications were added to the side of cigarette packs. With time, the FDA said the surgeon general’s warnings have become “virtually invisible” to consumers.

The American Lung Association, American Academy of Pediatrics, and other plaintiffs in the 2016 suit called the new proposal a “dramatic improvement” over the current situation and “long overdue” in a joint statement on Aug. 15.

Although rates have declined substantially in recent decades, about 34.3 million U.S. adults and almost 1.4 million teenagers still smoke. The habit kills about a half million Americans every year, at a health cost of more than $300 billion, the FDA said.

Comments on the proposed rule are being accepted through Oct. 15. The agency is open to suggestions for alternative text and images.
 

[email protected]

The U.S. Food and Drug Administration has proposed warnings for cigarette packs and advertisements on Aug. 15, 2019, that feature graphic, colored images illustrating the harms of smoking, but this could be subjected to legal challenge.

U.S. Food and Drug Administration

Several years ago, tobacco companies filed a lawsuit, which ultimately shut down a similar proposal.

The warnings focus on lesser-known complications – including diabetes, cataracts, gangrene, stroke, bladder cancer, erectile dysfunction, and obstructive pulmonary disease – and would take up the top half of the front and back of cigarette packs, and at least the top 20% of print advertisements. Each pack and ad would be required to carry 1 of the 13 proposed warnings, according to the announcement.

The approach would be similar to, but not as aggressive as Canada’s. For years, cigarettes packs sold in Canada have included disturbing photographs of diseased lungs, rotted teeth, and dying patients. The lasting impact of such imagery has been demonstrated in the literature (for example, Am J Prev Med. 2007 Mar;32[3]:202-9).

The new proposal is the FDA’s second attempt to enact something comparable in the United States, after being directed to do so by the Tobacco Control Act of 2009.

The first effort to add strong, illustrated warnings to cigarette packs was widely backed by medical groups, but challenged in the courts by R.J. Reynolds and other tobacco companies, and blocked on appeal in 2012 as an abridgment of commercial free speech. The federal government dropped the case in 2013.

The American Lung Association and other public health groups subsequently sued the FDA in 2016 to enact the Tobacco Act mandate. Subsequently, a federal judge ordered the agency to publish a new rule by August 2019, and issue a final rule in March 2020.

This time around, the FDA “took the necessary time to get these new proposed warnings right ... based on – and within the limits of – both science and the law,” the agency said. The new images, though graphic, are less disturbing than those used in Canada and the agency’s previous proposals, which included an apparent corpse with a sternotomy. The 1-800-Quit-Now cessation hotline number, which was a sticking point in the 2012 ruling, has also been dropped.

When asked about the new efforts, R.J. Reynolds spokesperson Kaelan Hollon said, “We are carefully reviewing FDA’s latest proposal for graphic warnings on cigarettes. We firmly support public awareness of the harms of smoking cigarettes, but the manner in which those messages are delivered to the public cannot run afoul of the First Amendment protections that apply to all speakers, including cigarette manufacturers.”

Warnings on U.S. cigarettes haven’t changed since 1984, when the risks of lung cancer, heart disease, emphysema, and pregnancy complications were added to the side of cigarette packs. With time, the FDA said the surgeon general’s warnings have become “virtually invisible” to consumers.

The American Lung Association, American Academy of Pediatrics, and other plaintiffs in the 2016 suit called the new proposal a “dramatic improvement” over the current situation and “long overdue” in a joint statement on Aug. 15.

Although rates have declined substantially in recent decades, about 34.3 million U.S. adults and almost 1.4 million teenagers still smoke. The habit kills about a half million Americans every year, at a health cost of more than $300 billion, the FDA said.

Comments on the proposed rule are being accepted through Oct. 15. The agency is open to suggestions for alternative text and images.
 

[email protected]

SEATTLE – Levine Children’s Hospital, in Charlotte, N.C., dropped its central line–associated bloodstream infection rate from 1.13 per 1,000 line days to 0.67 in just a few months, with a mix of common sense steps and public accountability.

M. Alexander Otto/MDedge News

Levine Children’s was at about the 50th percentile for CLABSIs, compared with other children’s hospitals, but dropped to the 10th percentile after the changes. There were 21 CLABSIs in 2017, but only 12 in 2018. The hospital went 6 straight months without a CLABSI after the changes were made. The efforts saved about $300,000 and 63 patient days.

“We really had great success,” said Kayla S. Koch, MD, a pediatric hospitalist at Levine Children’s, who presented the findings at Pediatric Hospital Medicine.

Hospital units had been working to reduce CLABSIs, but they were each doing their own thing. “Many of our units were already dabbling, so we just sort of brought them together. We standardized the process and got everyone on the same page,” said copresenter Ketan P. Nadkarni, MD, also a pediatric hospitalist at Levine Children’s.

It wasn’t hard to get buy-in. “I don’t think the units were aware that everyone was doing it differently,” and were on board once the problem was explained. Also, using the same approach throughout the hospital made it easier for nurses and physicians moving between units, he said.

Each morning, the nurse supervisor and patient nurse would partner up at the bedside to check that central venous lines were set up correctly. They examined the alcohol disinfectant caps to make sure they were clean; determined that children were getting chlorhexidine gluconate baths; checked the dressings for bleeding and soiling; noted in the electronic medical record why the patient had a central line; and discussed with hospitalists if it were still needed. Problems were addressed immediately.

These quality processes were all tracked on wall racks placed in plain sight on each unit, including the neonatal and pediatric ICUs. Each central line patient had a card that listed what needed to be done, with a green stripe on one side and a red stripe on the other. If everything was done right, the green side faced out; if even one thing was done wrong, the red side was displayed, for all to see. It brought accountability to the process, the presenters said at the meeting sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

The wall rack also had the central line audit schedule, plus diagrams that showed every failed item, the reason for it, and the unit’s compliance rate. Anyone walking by could see at a glance how the unit was doing that day and overall.

The number of dressing options was reduced from 10 to 2, a SorbaView SHIELD and a Tegaderm-like dressing, which made it easier to standardize the efforts. A protocol also was put in place to reinforce oozing dressings, instead of automatically changing them. “We were doing too many changes,” Dr. Koch said.

Compliance with the bundle was almost 90%. Staff “really got into it, and it was great to see,” she said.

The “initial success was almost unexpected, and so dramatic.” The goal now is to sustain the improvements, and roll them out to radiology and other places were central lines are placed, Dr. Nadkarni said.

There was no external funding, and the investigators had no disclosures.

[email protected]

SEATTLE – Levine Children’s Hospital, in Charlotte, N.C., dropped its central line–associated bloodstream infection rate from 1.13 per 1,000 line days to 0.67 in just a few months, with a mix of common sense steps and public accountability.

M. Alexander Otto/MDedge News

Levine Children’s was at about the 50th percentile for CLABSIs, compared with other children’s hospitals, but dropped to the 10th percentile after the changes. There were 21 CLABSIs in 2017, but only 12 in 2018. The hospital went 6 straight months without a CLABSI after the changes were made. The efforts saved about $300,000 and 63 patient days.

“We really had great success,” said Kayla S. Koch, MD, a pediatric hospitalist at Levine Children’s, who presented the findings at Pediatric Hospital Medicine.

Hospital units had been working to reduce CLABSIs, but they were each doing their own thing. “Many of our units were already dabbling, so we just sort of brought them together. We standardized the process and got everyone on the same page,” said copresenter Ketan P. Nadkarni, MD, also a pediatric hospitalist at Levine Children’s.

It wasn’t hard to get buy-in. “I don’t think the units were aware that everyone was doing it differently,” and were on board once the problem was explained. Also, using the same approach throughout the hospital made it easier for nurses and physicians moving between units, he said.

Each morning, the nurse supervisor and patient nurse would partner up at the bedside to check that central venous lines were set up correctly. They examined the alcohol disinfectant caps to make sure they were clean; determined that children were getting chlorhexidine gluconate baths; checked the dressings for bleeding and soiling; noted in the electronic medical record why the patient had a central line; and discussed with hospitalists if it were still needed. Problems were addressed immediately.

These quality processes were all tracked on wall racks placed in plain sight on each unit, including the neonatal and pediatric ICUs. Each central line patient had a card that listed what needed to be done, with a green stripe on one side and a red stripe on the other. If everything was done right, the green side faced out; if even one thing was done wrong, the red side was displayed, for all to see. It brought accountability to the process, the presenters said at the meeting sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

The wall rack also had the central line audit schedule, plus diagrams that showed every failed item, the reason for it, and the unit’s compliance rate. Anyone walking by could see at a glance how the unit was doing that day and overall.

The number of dressing options was reduced from 10 to 2, a SorbaView SHIELD and a Tegaderm-like dressing, which made it easier to standardize the efforts. A protocol also was put in place to reinforce oozing dressings, instead of automatically changing them. “We were doing too many changes,” Dr. Koch said.

Compliance with the bundle was almost 90%. Staff “really got into it, and it was great to see,” she said.

The “initial success was almost unexpected, and so dramatic.” The goal now is to sustain the improvements, and roll them out to radiology and other places were central lines are placed, Dr. Nadkarni said.

There was no external funding, and the investigators had no disclosures.

[email protected]

SEATTLE – Levine Children’s Hospital, in Charlotte, N.C., dropped its central line–associated bloodstream infection rate from 1.13 per 1,000 line days to 0.67 in just a few months, with a mix of common sense steps and public accountability.

M. Alexander Otto/MDedge News

Levine Children’s was at about the 50th percentile for CLABSIs, compared with other children’s hospitals, but dropped to the 10th percentile after the changes. There were 21 CLABSIs in 2017, but only 12 in 2018. The hospital went 6 straight months without a CLABSI after the changes were made. The efforts saved about $300,000 and 63 patient days.

“We really had great success,” said Kayla S. Koch, MD, a pediatric hospitalist at Levine Children’s, who presented the findings at Pediatric Hospital Medicine.

Hospital units had been working to reduce CLABSIs, but they were each doing their own thing. “Many of our units were already dabbling, so we just sort of brought them together. We standardized the process and got everyone on the same page,” said copresenter Ketan P. Nadkarni, MD, also a pediatric hospitalist at Levine Children’s.

It wasn’t hard to get buy-in. “I don’t think the units were aware that everyone was doing it differently,” and were on board once the problem was explained. Also, using the same approach throughout the hospital made it easier for nurses and physicians moving between units, he said.

Each morning, the nurse supervisor and patient nurse would partner up at the bedside to check that central venous lines were set up correctly. They examined the alcohol disinfectant caps to make sure they were clean; determined that children were getting chlorhexidine gluconate baths; checked the dressings for bleeding and soiling; noted in the electronic medical record why the patient had a central line; and discussed with hospitalists if it were still needed. Problems were addressed immediately.

These quality processes were all tracked on wall racks placed in plain sight on each unit, including the neonatal and pediatric ICUs. Each central line patient had a card that listed what needed to be done, with a green stripe on one side and a red stripe on the other. If everything was done right, the green side faced out; if even one thing was done wrong, the red side was displayed, for all to see. It brought accountability to the process, the presenters said at the meeting sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

The wall rack also had the central line audit schedule, plus diagrams that showed every failed item, the reason for it, and the unit’s compliance rate. Anyone walking by could see at a glance how the unit was doing that day and overall.

The number of dressing options was reduced from 10 to 2, a SorbaView SHIELD and a Tegaderm-like dressing, which made it easier to standardize the efforts. A protocol also was put in place to reinforce oozing dressings, instead of automatically changing them. “We were doing too many changes,” Dr. Koch said.

Compliance with the bundle was almost 90%. Staff “really got into it, and it was great to see,” she said.

The “initial success was almost unexpected, and so dramatic.” The goal now is to sustain the improvements, and roll them out to radiology and other places were central lines are placed, Dr. Nadkarni said.

There was no external funding, and the investigators had no disclosures.

[email protected]

SEATTLE – Procalcitonin, a marker of bacterial infection, rises and peaks sooner than C-reactive protein (CRP), and is especially useful to help rule out invasive bacterial infections in young infants and pediatric community acquired pneumonia due to typical bacteria, according to a presentation at the 2019 Pediatric Hospital Medicine Conference.

M. Alexander Otto/MDedge News

It’s “excellent for identifying low risk patients” and has the potential to decrease lumbar punctures and antibiotic exposure, but “the specificity isn’t great,” so there’s the potential for false positives, said Russell McCulloh, MD, a pediatric infectious disease specialist at the University of Nebraska Medical Center, Omaha.

There was great interest in procalcitonin at the meeting; the presentation room was packed, with a line out the door. It’s used mostly in Europe at this point. Testing is available in many U.S. hospitals, but a large majority of audience members, when polled, said they don’t currently use it in clinical practice, and that it’s not a part of diagnostic algorithms at their institutions.

Levels of procalcitonin, a calcitonin precursor normally produced by the thyroid, are low or undetectable in healthy people, but inflammation, be it from infectious or noninfectious causes, triggers production by parenchymal cells throughout the body.

Levels began to rise as early as 2.5 hours after healthy subjects in one study were injected with bacterial endotoxins, and peaked as early as 6 hours; CRP, in contrast, started to rise after 12 hours, and peaked at 30 hours. Procalcitonin levels also seem to correlate with bacterial load and severity of infection, said Nivedita Srinivas, MD, a pediatric infectious disease specialist at Stanford (Calif.) University (J Pediatr Intensive Care. 2016 Dec;5[4]:162-71).

Due to time, the presenters focused their talk on community acquired pneumonia (CAP) and invasive bacterial infections (IBI) in young infants, meaning essentially bacteremia and meningitis.

Different studies use different cutoffs, but a procalcitonin below, for instance, 0.5 ng/mL is “certainly more sensitive [for IBI] than any single biomarker we currently use,” including CRP, white blood cells, and absolute neutrophil count (ANC). “If it’s negative, you’re really confident it’s negative,” but “a positive test does not necessarily indicate the presence of IBI,” Dr. McCulloh said (Pediatrics. 2012 Nov;130[5]:815-22).

“Procalcitonin works really well as part of a validated step-wise rule” that includes, for instance, CRP and ANC; “I think that’s where its utility is. On its own, it is not a substitute for you examining the patient and doing your basic risk stratification, but it may enhance your decision making incrementally above what we currently have,” he said.

Meanwhile, in a study of 532 children a median age of 2.4 years with radiographically confirmed CAP, procalcitonin levels were a median of 6.1 ng/mL in children whose pneumonia was caused by Streptococcus pneumoniae or other typical bacteria, and no child infected with typical bacteria had a level under 0.1 ng/mL. Below that level, “you can be very sure you do not have typical bacteria pneumonia,” said Marie Wang, MD, also a pediatric infectious disease specialist at Stanford (J Pediatric Infect Dis Soc. 2018 Feb 19;7[1]:46-53).

As procalcitonin levels went up, the likelihood of having bacterial pneumonia increased; at 2 ng/mL, 26% of subjects were infected with typical bacteria, “but even in that group, 58% still had viral infection, so you are still detecting a lot of viral” disease, she said.

Prolcalcitonin-guided therapy – antibiotics until patients fall below a level of 0.25 ng/ml, for instance – has also been associated with decreased antibiotic exposure (Respir Med. 2011 Dec;105[12]:1939-45).

The speakers had no disclosures. The meeting was sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

[email protected]

SEATTLE – Procalcitonin, a marker of bacterial infection, rises and peaks sooner than C-reactive protein (CRP), and is especially useful to help rule out invasive bacterial infections in young infants and pediatric community acquired pneumonia due to typical bacteria, according to a presentation at the 2019 Pediatric Hospital Medicine Conference.

M. Alexander Otto/MDedge News

It’s “excellent for identifying low risk patients” and has the potential to decrease lumbar punctures and antibiotic exposure, but “the specificity isn’t great,” so there’s the potential for false positives, said Russell McCulloh, MD, a pediatric infectious disease specialist at the University of Nebraska Medical Center, Omaha.

There was great interest in procalcitonin at the meeting; the presentation room was packed, with a line out the door. It’s used mostly in Europe at this point. Testing is available in many U.S. hospitals, but a large majority of audience members, when polled, said they don’t currently use it in clinical practice, and that it’s not a part of diagnostic algorithms at their institutions.

Levels of procalcitonin, a calcitonin precursor normally produced by the thyroid, are low or undetectable in healthy people, but inflammation, be it from infectious or noninfectious causes, triggers production by parenchymal cells throughout the body.

Levels began to rise as early as 2.5 hours after healthy subjects in one study were injected with bacterial endotoxins, and peaked as early as 6 hours; CRP, in contrast, started to rise after 12 hours, and peaked at 30 hours. Procalcitonin levels also seem to correlate with bacterial load and severity of infection, said Nivedita Srinivas, MD, a pediatric infectious disease specialist at Stanford (Calif.) University (J Pediatr Intensive Care. 2016 Dec;5[4]:162-71).

Due to time, the presenters focused their talk on community acquired pneumonia (CAP) and invasive bacterial infections (IBI) in young infants, meaning essentially bacteremia and meningitis.

Different studies use different cutoffs, but a procalcitonin below, for instance, 0.5 ng/mL is “certainly more sensitive [for IBI] than any single biomarker we currently use,” including CRP, white blood cells, and absolute neutrophil count (ANC). “If it’s negative, you’re really confident it’s negative,” but “a positive test does not necessarily indicate the presence of IBI,” Dr. McCulloh said (Pediatrics. 2012 Nov;130[5]:815-22).

“Procalcitonin works really well as part of a validated step-wise rule” that includes, for instance, CRP and ANC; “I think that’s where its utility is. On its own, it is not a substitute for you examining the patient and doing your basic risk stratification, but it may enhance your decision making incrementally above what we currently have,” he said.

Meanwhile, in a study of 532 children a median age of 2.4 years with radiographically confirmed CAP, procalcitonin levels were a median of 6.1 ng/mL in children whose pneumonia was caused by Streptococcus pneumoniae or other typical bacteria, and no child infected with typical bacteria had a level under 0.1 ng/mL. Below that level, “you can be very sure you do not have typical bacteria pneumonia,” said Marie Wang, MD, also a pediatric infectious disease specialist at Stanford (J Pediatric Infect Dis Soc. 2018 Feb 19;7[1]:46-53).

As procalcitonin levels went up, the likelihood of having bacterial pneumonia increased; at 2 ng/mL, 26% of subjects were infected with typical bacteria, “but even in that group, 58% still had viral infection, so you are still detecting a lot of viral” disease, she said.

Prolcalcitonin-guided therapy – antibiotics until patients fall below a level of 0.25 ng/ml, for instance – has also been associated with decreased antibiotic exposure (Respir Med. 2011 Dec;105[12]:1939-45).

The speakers had no disclosures. The meeting was sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

[email protected]

SEATTLE – Procalcitonin, a marker of bacterial infection, rises and peaks sooner than C-reactive protein (CRP), and is especially useful to help rule out invasive bacterial infections in young infants and pediatric community acquired pneumonia due to typical bacteria, according to a presentation at the 2019 Pediatric Hospital Medicine Conference.

M. Alexander Otto/MDedge News

It’s “excellent for identifying low risk patients” and has the potential to decrease lumbar punctures and antibiotic exposure, but “the specificity isn’t great,” so there’s the potential for false positives, said Russell McCulloh, MD, a pediatric infectious disease specialist at the University of Nebraska Medical Center, Omaha.

There was great interest in procalcitonin at the meeting; the presentation room was packed, with a line out the door. It’s used mostly in Europe at this point. Testing is available in many U.S. hospitals, but a large majority of audience members, when polled, said they don’t currently use it in clinical practice, and that it’s not a part of diagnostic algorithms at their institutions.

Levels of procalcitonin, a calcitonin precursor normally produced by the thyroid, are low or undetectable in healthy people, but inflammation, be it from infectious or noninfectious causes, triggers production by parenchymal cells throughout the body.

Levels began to rise as early as 2.5 hours after healthy subjects in one study were injected with bacterial endotoxins, and peaked as early as 6 hours; CRP, in contrast, started to rise after 12 hours, and peaked at 30 hours. Procalcitonin levels also seem to correlate with bacterial load and severity of infection, said Nivedita Srinivas, MD, a pediatric infectious disease specialist at Stanford (Calif.) University (J Pediatr Intensive Care. 2016 Dec;5[4]:162-71).

Due to time, the presenters focused their talk on community acquired pneumonia (CAP) and invasive bacterial infections (IBI) in young infants, meaning essentially bacteremia and meningitis.

Different studies use different cutoffs, but a procalcitonin below, for instance, 0.5 ng/mL is “certainly more sensitive [for IBI] than any single biomarker we currently use,” including CRP, white blood cells, and absolute neutrophil count (ANC). “If it’s negative, you’re really confident it’s negative,” but “a positive test does not necessarily indicate the presence of IBI,” Dr. McCulloh said (Pediatrics. 2012 Nov;130[5]:815-22).

“Procalcitonin works really well as part of a validated step-wise rule” that includes, for instance, CRP and ANC; “I think that’s where its utility is. On its own, it is not a substitute for you examining the patient and doing your basic risk stratification, but it may enhance your decision making incrementally above what we currently have,” he said.

Meanwhile, in a study of 532 children a median age of 2.4 years with radiographically confirmed CAP, procalcitonin levels were a median of 6.1 ng/mL in children whose pneumonia was caused by Streptococcus pneumoniae or other typical bacteria, and no child infected with typical bacteria had a level under 0.1 ng/mL. Below that level, “you can be very sure you do not have typical bacteria pneumonia,” said Marie Wang, MD, also a pediatric infectious disease specialist at Stanford (J Pediatric Infect Dis Soc. 2018 Feb 19;7[1]:46-53).

As procalcitonin levels went up, the likelihood of having bacterial pneumonia increased; at 2 ng/mL, 26% of subjects were infected with typical bacteria, “but even in that group, 58% still had viral infection, so you are still detecting a lot of viral” disease, she said.

Prolcalcitonin-guided therapy – antibiotics until patients fall below a level of 0.25 ng/ml, for instance – has also been associated with decreased antibiotic exposure (Respir Med. 2011 Dec;105[12]:1939-45).

The speakers had no disclosures. The meeting was sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

[email protected]

SEATTLE – The more concentrated urine is in newborns, the more you can trust negative nitrite tests to rule out urinary tract infections, according to investigators at the University of Texas Health Science Center, Houston.

M. Alexander Otto/MDedge News

The researchers found that urine testing negative for nitrites with a specific gravity above 1.015 in children up to 2 months old had a sensitivity of 53% for ruling out UTIs, but that urine with a specific gravity below that mark had a sensitivity of just 14%. The finding “should be taken into account when interpreting nitrite results ... in this high-risk population,” they concluded.

Bacteria in the bladder convert nitrates to nitrites, so positive results are pretty much pathognomonic for UTIs, with a specificity of nearly 100%, according to the researchers.

Negative results, however, don’t reliably rule out infection, and are even less reliable in infants because they urinate frequently, which means they usually flush out bacteria before they have enough time to make the conversion, which takes several hours, they said.

The lead investigator Raymond Parlar-Chun, MD, an assistant professor of pediatrics at the University of Texas McGovern Medical School in Houston, said he had a hunch that negative results might be more reliable when newborns urinate less frequently and have more concentrated urine.

He and his team reviewed data collected on 413 infants up to 2 months old who were admitted for fever workup and treated for UTIs both in the hospital and after discharge. Nitrite results were stratified by urine concentration. A specific gravity of 1.015 was used as the cutoff between concentrated and dilute urine, which was “midway between the parameters reported” in every urinalysis, Dr. Parlar-Chun said.

Although the sensitivity of concentrated urine was only 53%, “it’s a stark difference from” the 14% in dilute urine, he said.“You should take a look at specific gravity to interpret nitrites. If urine is concentrated, you have [more confidence] that you don’t have a UTI if you’re negative. It’s better than taking [nitrites] at face value.”

The subjects were 31 days old, on average, and 62% were boys; 112 had a specific gravity above 1.015, and 301 below.

There was no external funding, and Dr. Parlar-Chun didn’t have any disclosures.

[email protected]

SEATTLE – The more concentrated urine is in newborns, the more you can trust negative nitrite tests to rule out urinary tract infections, according to investigators at the University of Texas Health Science Center, Houston.

M. Alexander Otto/MDedge News

The researchers found that urine testing negative for nitrites with a specific gravity above 1.015 in children up to 2 months old had a sensitivity of 53% for ruling out UTIs, but that urine with a specific gravity below that mark had a sensitivity of just 14%. The finding “should be taken into account when interpreting nitrite results ... in this high-risk population,” they concluded.

Bacteria in the bladder convert nitrates to nitrites, so positive results are pretty much pathognomonic for UTIs, with a specificity of nearly 100%, according to the researchers.

Negative results, however, don’t reliably rule out infection, and are even less reliable in infants because they urinate frequently, which means they usually flush out bacteria before they have enough time to make the conversion, which takes several hours, they said.

The lead investigator Raymond Parlar-Chun, MD, an assistant professor of pediatrics at the University of Texas McGovern Medical School in Houston, said he had a hunch that negative results might be more reliable when newborns urinate less frequently and have more concentrated urine.

He and his team reviewed data collected on 413 infants up to 2 months old who were admitted for fever workup and treated for UTIs both in the hospital and after discharge. Nitrite results were stratified by urine concentration. A specific gravity of 1.015 was used as the cutoff between concentrated and dilute urine, which was “midway between the parameters reported” in every urinalysis, Dr. Parlar-Chun said.

Although the sensitivity of concentrated urine was only 53%, “it’s a stark difference from” the 14% in dilute urine, he said.“You should take a look at specific gravity to interpret nitrites. If urine is concentrated, you have [more confidence] that you don’t have a UTI if you’re negative. It’s better than taking [nitrites] at face value.”

The subjects were 31 days old, on average, and 62% were boys; 112 had a specific gravity above 1.015, and 301 below.

There was no external funding, and Dr. Parlar-Chun didn’t have any disclosures.

[email protected]

SEATTLE – The more concentrated urine is in newborns, the more you can trust negative nitrite tests to rule out urinary tract infections, according to investigators at the University of Texas Health Science Center, Houston.

M. Alexander Otto/MDedge News

The researchers found that urine testing negative for nitrites with a specific gravity above 1.015 in children up to 2 months old had a sensitivity of 53% for ruling out UTIs, but that urine with a specific gravity below that mark had a sensitivity of just 14%. The finding “should be taken into account when interpreting nitrite results ... in this high-risk population,” they concluded.

Bacteria in the bladder convert nitrates to nitrites, so positive results are pretty much pathognomonic for UTIs, with a specificity of nearly 100%, according to the researchers.

Negative results, however, don’t reliably rule out infection, and are even less reliable in infants because they urinate frequently, which means they usually flush out bacteria before they have enough time to make the conversion, which takes several hours, they said.

The lead investigator Raymond Parlar-Chun, MD, an assistant professor of pediatrics at the University of Texas McGovern Medical School in Houston, said he had a hunch that negative results might be more reliable when newborns urinate less frequently and have more concentrated urine.

He and his team reviewed data collected on 413 infants up to 2 months old who were admitted for fever workup and treated for UTIs both in the hospital and after discharge. Nitrite results were stratified by urine concentration. A specific gravity of 1.015 was used as the cutoff between concentrated and dilute urine, which was “midway between the parameters reported” in every urinalysis, Dr. Parlar-Chun said.

Although the sensitivity of concentrated urine was only 53%, “it’s a stark difference from” the 14% in dilute urine, he said.“You should take a look at specific gravity to interpret nitrites. If urine is concentrated, you have [more confidence] that you don’t have a UTI if you’re negative. It’s better than taking [nitrites] at face value.”

The subjects were 31 days old, on average, and 62% were boys; 112 had a specific gravity above 1.015, and 301 below.

There was no external funding, and Dr. Parlar-Chun didn’t have any disclosures.

[email protected]

SEATTLE – Intravenous fluids can simply be stopped after children with acute viral gastroenteritis are rehydrated in the hospital; there’s no need for a slow wean, according to a review at the Connecticut Children’s Medical Center, Hartford.

Researchers found that children leave the hospital hours sooner, with no ill effects. “This study suggests that slowly weaning IV fluids may not be necessary,” said lead investigator Danielle Klima, DO, a University of Connecticut pediatrics resident.

The team at Connecticut Children’s noticed that weaning practices after gastroenteritis rehydration varied widely on the pediatric floors, and appeared to be largely provider dependent, with “much subjective decision making.” The team wanted to see if it made a difference one way or the other, Dr. Klima said at Pediatric Hospital Medicine.

During respiratory season, “our pediatric floors are surging. Saving even a couple hours to get these kids out” quicker matters, she said, noting that it’s likely the first time the issue has been studied.

The team reviewed 153 children aged 2 months to 18 years, 95 of whom had IV fluids stopped once physicians deemed they were fluid resuscitated and ready for an oral feeding trial; the other 58 were weaned, with at least two reductions by half before final discontinuation.

There were no significant differences in age, gender, race, or insurance type between the two groups. The mean age was 2.6 years, and there were slightly more boys. The ED triage level was a mean of 3.2 points in both groups on a scale of 1-5, with 1 being the most urgent. Children with serious comorbidities, chronic diarrhea, feeding tubes, severe electrolyte abnormalities, or feeding problems were among those excluded.

Overall length of stay was 36 hours in the stop group versus 40.5 hours in the weaning group (P = .004). Children left the hospital about 6 hours after IV fluids were discontinued, versus 26 hours after weaning was started (P less than .001).

Electrolyte abnormalities on admission were more common in the weaning group (65% versus 57%), but not significantly so (P = .541). Electrolyte abnormalities were also more common at the end of fluid resuscitation in the weaning arm, but again not significantly (65% 42%, P = .077).

Fluid resuscitation needed to be restarted in 15 children in the stop group (16%), versus 11 (19%) in the wean arm (P = .459). One child in the stop group (1%) versus four (7%) who were weaned were readmitted to the hospital within a week for acute viral gastroenteritis (P = .067).

“I expected we were taking a more conservative weaning approach in younger infants,” but age didn’t seem to affect whether patients were weaned or not, Dr. Klima said.

With the results in hand, “our group is taking a closer look at exactly what we are doing,” perhaps with an eye toward standardization or even a randomized trial, she said.

She noted that weaning still makes sense for a fussy toddler who refuses to take anything by mouth.

There was no external funding, and Dr. Klima had no disclosures. The conference was sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.
 

[email protected]

SEATTLE – Intravenous fluids can simply be stopped after children with acute viral gastroenteritis are rehydrated in the hospital; there’s no need for a slow wean, according to a review at the Connecticut Children’s Medical Center, Hartford.

Researchers found that children leave the hospital hours sooner, with no ill effects. “This study suggests that slowly weaning IV fluids may not be necessary,” said lead investigator Danielle Klima, DO, a University of Connecticut pediatrics resident.

The team at Connecticut Children’s noticed that weaning practices after gastroenteritis rehydration varied widely on the pediatric floors, and appeared to be largely provider dependent, with “much subjective decision making.” The team wanted to see if it made a difference one way or the other, Dr. Klima said at Pediatric Hospital Medicine.

During respiratory season, “our pediatric floors are surging. Saving even a couple hours to get these kids out” quicker matters, she said, noting that it’s likely the first time the issue has been studied.

The team reviewed 153 children aged 2 months to 18 years, 95 of whom had IV fluids stopped once physicians deemed they were fluid resuscitated and ready for an oral feeding trial; the other 58 were weaned, with at least two reductions by half before final discontinuation.

There were no significant differences in age, gender, race, or insurance type between the two groups. The mean age was 2.6 years, and there were slightly more boys. The ED triage level was a mean of 3.2 points in both groups on a scale of 1-5, with 1 being the most urgent. Children with serious comorbidities, chronic diarrhea, feeding tubes, severe electrolyte abnormalities, or feeding problems were among those excluded.

Overall length of stay was 36 hours in the stop group versus 40.5 hours in the weaning group (P = .004). Children left the hospital about 6 hours after IV fluids were discontinued, versus 26 hours after weaning was started (P less than .001).

Electrolyte abnormalities on admission were more common in the weaning group (65% versus 57%), but not significantly so (P = .541). Electrolyte abnormalities were also more common at the end of fluid resuscitation in the weaning arm, but again not significantly (65% 42%, P = .077).

Fluid resuscitation needed to be restarted in 15 children in the stop group (16%), versus 11 (19%) in the wean arm (P = .459). One child in the stop group (1%) versus four (7%) who were weaned were readmitted to the hospital within a week for acute viral gastroenteritis (P = .067).

“I expected we were taking a more conservative weaning approach in younger infants,” but age didn’t seem to affect whether patients were weaned or not, Dr. Klima said.

With the results in hand, “our group is taking a closer look at exactly what we are doing,” perhaps with an eye toward standardization or even a randomized trial, she said.

She noted that weaning still makes sense for a fussy toddler who refuses to take anything by mouth.

There was no external funding, and Dr. Klima had no disclosures. The conference was sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.
 

[email protected]

SEATTLE – Intravenous fluids can simply be stopped after children with acute viral gastroenteritis are rehydrated in the hospital; there’s no need for a slow wean, according to a review at the Connecticut Children’s Medical Center, Hartford.

Researchers found that children leave the hospital hours sooner, with no ill effects. “This study suggests that slowly weaning IV fluids may not be necessary,” said lead investigator Danielle Klima, DO, a University of Connecticut pediatrics resident.

The team at Connecticut Children’s noticed that weaning practices after gastroenteritis rehydration varied widely on the pediatric floors, and appeared to be largely provider dependent, with “much subjective decision making.” The team wanted to see if it made a difference one way or the other, Dr. Klima said at Pediatric Hospital Medicine.

During respiratory season, “our pediatric floors are surging. Saving even a couple hours to get these kids out” quicker matters, she said, noting that it’s likely the first time the issue has been studied.

The team reviewed 153 children aged 2 months to 18 years, 95 of whom had IV fluids stopped once physicians deemed they were fluid resuscitated and ready for an oral feeding trial; the other 58 were weaned, with at least two reductions by half before final discontinuation.

There were no significant differences in age, gender, race, or insurance type between the two groups. The mean age was 2.6 years, and there were slightly more boys. The ED triage level was a mean of 3.2 points in both groups on a scale of 1-5, with 1 being the most urgent. Children with serious comorbidities, chronic diarrhea, feeding tubes, severe electrolyte abnormalities, or feeding problems were among those excluded.

Overall length of stay was 36 hours in the stop group versus 40.5 hours in the weaning group (P = .004). Children left the hospital about 6 hours after IV fluids were discontinued, versus 26 hours after weaning was started (P less than .001).

Electrolyte abnormalities on admission were more common in the weaning group (65% versus 57%), but not significantly so (P = .541). Electrolyte abnormalities were also more common at the end of fluid resuscitation in the weaning arm, but again not significantly (65% 42%, P = .077).

Fluid resuscitation needed to be restarted in 15 children in the stop group (16%), versus 11 (19%) in the wean arm (P = .459). One child in the stop group (1%) versus four (7%) who were weaned were readmitted to the hospital within a week for acute viral gastroenteritis (P = .067).

“I expected we were taking a more conservative weaning approach in younger infants,” but age didn’t seem to affect whether patients were weaned or not, Dr. Klima said.

With the results in hand, “our group is taking a closer look at exactly what we are doing,” perhaps with an eye toward standardization or even a randomized trial, she said.

She noted that weaning still makes sense for a fussy toddler who refuses to take anything by mouth.

There was no external funding, and Dr. Klima had no disclosures. The conference was sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.
 

[email protected]

SEATTLE – Blood cultures were ordered for over half of pediatric skin infection encounters across 38 children’s hospitals, with rates varying from about 20% to 80% between hospitals, according to a review of almost 50,000 encounters in the Pediatric Health Information System database.

M. Alexander Otto/MDedge News

It was a surprising finding, because current guidelines from the Infectious Diseases Society of America do not recommend blood cultures as part of the routine evaluation of uncomplicated pediatric skin and soft-tissue infections (SSTIs), meaning infections in children who are otherwise healthy without neutropenia or other complicating factors.

Just 0.6% of the cultures were positive in the review, and it’s likely some of those were caused by contamination. After adjustment for demographics, complex chronic conditions, and severity of illness, culture draws were associated with a 20% increase in hospital length of stay (LOS), hospital costs, and 30-day readmission rates.

“Our data provide more evidence that [routine] blood cultures for children with SSTI represents low-value practice and should be avoided,” said lead investigator John Stephens, MD, a pediatrics professor and hospitalist at the University of North Carolina at Chapel Hill.

Dr. Stephens became curious about how common the practice was across hospitals after he and a friend penned an article about the issue for the Journal of Hospital Medicine’s “Things We Do for No Reason” series. The single-center studies they reviewed showed similarly high rates of both testing and negative cultures (J Hosp Med. 2018 Jul;13[7]:496-9).

Dr. Stephens and his team queried the Pediatric Health Information System database for encounters in children aged 2 months to 18 years with the diagnostic code 383, “cellulitis and other skin infections,” from 2012 to 2017, during which time “there really wasn’t a change” in IDSA guidance, he noted. Transfers, encounters with ICU care, and immunocompromised children were excluded.

Hospital admissions were included in the review if they had an additional code for erysipelas, cellulitis, impetigo, or other localized skin infection. The rate of positive cultures was inferred from subsequent codes for bacteremia or septicemia.

Across 49,291 encounters, the median rate of blood culture for skin infection was 51.6%, with tremendous variation between hospitals. With blood cultures, the hospital LOS was about 1.9 days, the hospital cost was $4,030, and the 30-day readmission rate was 1.3%. Without cultures, LOS was 1.6 days, the cost was $3,291, and the readmission rate was 1%.

Although infrequent, it’s likely that positive cultures triggered additional work-up, time in the hospital, and other measures, which might help account for the increase in LOS and costs.

As for why blood testing was so common, especially in some hospitals, “I think it’s just institutional culture. No amount of clinical variation in patient population could explain” a 20%-80% “variation across hospitals. It’s really just ingrained habits,” Dr. Stephens said at Pediatric Hospital Medicine.

“The rate of positive blood culture was really low, and the association was for higher cost and utilization. I think this really reinforces the IDSA guidelines. We need to focus on quality improvement efforts to do this better,” he said, noting that he hopes to do so at his own institution.

“I’d also like to know more on the positives. In the single center studies, we know more than half of them are contaminants. Often, there’s more contamination than true positives,” he said at the meeting sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Instead of routine blood culture, Dr. Stephens recommended in his article to send pus for a Gram stain and culture and sensitivity, while noting that blood cultures remain reasonable for complicated infections, immunocompromised patients, and neonates.

There was no external funding, and Dr. Stephens didn’t report any disclosures.

[email protected]

SEATTLE – Blood cultures were ordered for over half of pediatric skin infection encounters across 38 children’s hospitals, with rates varying from about 20% to 80% between hospitals, according to a review of almost 50,000 encounters in the Pediatric Health Information System database.

M. Alexander Otto/MDedge News

It was a surprising finding, because current guidelines from the Infectious Diseases Society of America do not recommend blood cultures as part of the routine evaluation of uncomplicated pediatric skin and soft-tissue infections (SSTIs), meaning infections in children who are otherwise healthy without neutropenia or other complicating factors.

Just 0.6% of the cultures were positive in the review, and it’s likely some of those were caused by contamination. After adjustment for demographics, complex chronic conditions, and severity of illness, culture draws were associated with a 20% increase in hospital length of stay (LOS), hospital costs, and 30-day readmission rates.

“Our data provide more evidence that [routine] blood cultures for children with SSTI represents low-value practice and should be avoided,” said lead investigator John Stephens, MD, a pediatrics professor and hospitalist at the University of North Carolina at Chapel Hill.

Dr. Stephens became curious about how common the practice was across hospitals after he and a friend penned an article about the issue for the Journal of Hospital Medicine’s “Things We Do for No Reason” series. The single-center studies they reviewed showed similarly high rates of both testing and negative cultures (J Hosp Med. 2018 Jul;13[7]:496-9).

Dr. Stephens and his team queried the Pediatric Health Information System database for encounters in children aged 2 months to 18 years with the diagnostic code 383, “cellulitis and other skin infections,” from 2012 to 2017, during which time “there really wasn’t a change” in IDSA guidance, he noted. Transfers, encounters with ICU care, and immunocompromised children were excluded.

Hospital admissions were included in the review if they had an additional code for erysipelas, cellulitis, impetigo, or other localized skin infection. The rate of positive cultures was inferred from subsequent codes for bacteremia or septicemia.

Across 49,291 encounters, the median rate of blood culture for skin infection was 51.6%, with tremendous variation between hospitals. With blood cultures, the hospital LOS was about 1.9 days, the hospital cost was $4,030, and the 30-day readmission rate was 1.3%. Without cultures, LOS was 1.6 days, the cost was $3,291, and the readmission rate was 1%.

Although infrequent, it’s likely that positive cultures triggered additional work-up, time in the hospital, and other measures, which might help account for the increase in LOS and costs.

As for why blood testing was so common, especially in some hospitals, “I think it’s just institutional culture. No amount of clinical variation in patient population could explain” a 20%-80% “variation across hospitals. It’s really just ingrained habits,” Dr. Stephens said at Pediatric Hospital Medicine.

“The rate of positive blood culture was really low, and the association was for higher cost and utilization. I think this really reinforces the IDSA guidelines. We need to focus on quality improvement efforts to do this better,” he said, noting that he hopes to do so at his own institution.

“I’d also like to know more on the positives. In the single center studies, we know more than half of them are contaminants. Often, there’s more contamination than true positives,” he said at the meeting sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Instead of routine blood culture, Dr. Stephens recommended in his article to send pus for a Gram stain and culture and sensitivity, while noting that blood cultures remain reasonable for complicated infections, immunocompromised patients, and neonates.

There was no external funding, and Dr. Stephens didn’t report any disclosures.

[email protected]

SEATTLE – Blood cultures were ordered for over half of pediatric skin infection encounters across 38 children’s hospitals, with rates varying from about 20% to 80% between hospitals, according to a review of almost 50,000 encounters in the Pediatric Health Information System database.

M. Alexander Otto/MDedge News

It was a surprising finding, because current guidelines from the Infectious Diseases Society of America do not recommend blood cultures as part of the routine evaluation of uncomplicated pediatric skin and soft-tissue infections (SSTIs), meaning infections in children who are otherwise healthy without neutropenia or other complicating factors.

Just 0.6% of the cultures were positive in the review, and it’s likely some of those were caused by contamination. After adjustment for demographics, complex chronic conditions, and severity of illness, culture draws were associated with a 20% increase in hospital length of stay (LOS), hospital costs, and 30-day readmission rates.

“Our data provide more evidence that [routine] blood cultures for children with SSTI represents low-value practice and should be avoided,” said lead investigator John Stephens, MD, a pediatrics professor and hospitalist at the University of North Carolina at Chapel Hill.

Dr. Stephens became curious about how common the practice was across hospitals after he and a friend penned an article about the issue for the Journal of Hospital Medicine’s “Things We Do for No Reason” series. The single-center studies they reviewed showed similarly high rates of both testing and negative cultures (J Hosp Med. 2018 Jul;13[7]:496-9).

Dr. Stephens and his team queried the Pediatric Health Information System database for encounters in children aged 2 months to 18 years with the diagnostic code 383, “cellulitis and other skin infections,” from 2012 to 2017, during which time “there really wasn’t a change” in IDSA guidance, he noted. Transfers, encounters with ICU care, and immunocompromised children were excluded.

Hospital admissions were included in the review if they had an additional code for erysipelas, cellulitis, impetigo, or other localized skin infection. The rate of positive cultures was inferred from subsequent codes for bacteremia or septicemia.

Across 49,291 encounters, the median rate of blood culture for skin infection was 51.6%, with tremendous variation between hospitals. With blood cultures, the hospital LOS was about 1.9 days, the hospital cost was $4,030, and the 30-day readmission rate was 1.3%. Without cultures, LOS was 1.6 days, the cost was $3,291, and the readmission rate was 1%.

Although infrequent, it’s likely that positive cultures triggered additional work-up, time in the hospital, and other measures, which might help account for the increase in LOS and costs.

As for why blood testing was so common, especially in some hospitals, “I think it’s just institutional culture. No amount of clinical variation in patient population could explain” a 20%-80% “variation across hospitals. It’s really just ingrained habits,” Dr. Stephens said at Pediatric Hospital Medicine.

“The rate of positive blood culture was really low, and the association was for higher cost and utilization. I think this really reinforces the IDSA guidelines. We need to focus on quality improvement efforts to do this better,” he said, noting that he hopes to do so at his own institution.

“I’d also like to know more on the positives. In the single center studies, we know more than half of them are contaminants. Often, there’s more contamination than true positives,” he said at the meeting sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Instead of routine blood culture, Dr. Stephens recommended in his article to send pus for a Gram stain and culture and sensitivity, while noting that blood cultures remain reasonable for complicated infections, immunocompromised patients, and neonates.

There was no external funding, and Dr. Stephens didn’t report any disclosures.

[email protected]

SEATTLE – There were no cases of aspiration with enteric feeds of 60 children aged up to 2 years on high flow nasal cannula (HFNC) for bronchiolitis at the University of Oklahoma Children’s Hospital, Oklahoma City, according to research presented at the 2019 Pediatric Hospital Medicine Conference.

M. Alexander Otto/MDedge News

HFNC has become common for bronchiolitis management; it often saves infants from intubation. However, many providers opt for total parenteral nutrition during therapy instead of enteral feeding because of concerns about aspiration pneumonia.

Pediatricians at the children’s hospital began to wonder if the concern was really necessary. There have been reports of safe feeding during HFNC, and “clinical care literature has shown that feeding the gut throughout illness improves outcomes,” said lead investigator, Sarah Walter, MD, a third-year pediatrics resident at the hospital.

So her team took a leap of faith. They consulted the HFNC literature, asked their fellow providers what they would be comfortable with, and instituted a pediatric HFNC enteral feeding protocol at the children’s hospital for use on inpatient floors, pediatric ICUs, and elsewhere.

Feedings – formula or breast milk – are triggered by stable respiratory Tal scores over 8 hours, meaning that respiratory rates, breath sounds, and accessory muscle use were stable or improving. Children on a flow of 6 L/min or less, with a respiratory rate below 60 breaths per minute, are started on oral feeds, and those on higher flows on nasogastric (NG) tube feeds.

Feeds are started at 1 mL/kg per hour and advanced by the same amount every 3 hours until volume goals are reached; IV fluids are tapered accordingly. It’s a standing order, so nurses are able to initiate and advance feeding as indicated, any time of day.

Feeding was temporarily suspended in only 17 children: 6 for emesis, 6 for worsening respiratory scores, and the rest for dislodged NG tubes, procedures, or other issues. Enteric feeds were restarted with two stable scores below 7 points, at half the rate at which they were stopped.

NG tubes were used in over half of the 478 nursing shifts during which the 60 children – the majority aged 4-24 months – were fed; oral feeds in more than a third; and gastric tubes and other options in the rest. IV nutrition was used during just 1.8% of the shifts.

Enteric feeds were given up to a flow rate of 3.5 L/kg. There were no aspirations, even when children vomited. “We have seen good results so far that feeding is safe in these children,” Dr. Walters said.

“Our hospitalist team has been very receptive; they have been using the order set pretty continuously.” Parents also feel better when they know their children were “getting food in their belly,” even if by NG tube. “It’s important for family satisfaction,” she said.

The next step is to assess impact on length of stay, and education efforts to encourage broader use of the order set.

There was no external funding, and Dr. Walter had no disclosures. The meeting was sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

[email protected]

SEATTLE – There were no cases of aspiration with enteric feeds of 60 children aged up to 2 years on high flow nasal cannula (HFNC) for bronchiolitis at the University of Oklahoma Children’s Hospital, Oklahoma City, according to research presented at the 2019 Pediatric Hospital Medicine Conference.

M. Alexander Otto/MDedge News

HFNC has become common for bronchiolitis management; it often saves infants from intubation. However, many providers opt for total parenteral nutrition during therapy instead of enteral feeding because of concerns about aspiration pneumonia.

Pediatricians at the children’s hospital began to wonder if the concern was really necessary. There have been reports of safe feeding during HFNC, and “clinical care literature has shown that feeding the gut throughout illness improves outcomes,” said lead investigator, Sarah Walter, MD, a third-year pediatrics resident at the hospital.

So her team took a leap of faith. They consulted the HFNC literature, asked their fellow providers what they would be comfortable with, and instituted a pediatric HFNC enteral feeding protocol at the children’s hospital for use on inpatient floors, pediatric ICUs, and elsewhere.

Feedings – formula or breast milk – are triggered by stable respiratory Tal scores over 8 hours, meaning that respiratory rates, breath sounds, and accessory muscle use were stable or improving. Children on a flow of 6 L/min or less, with a respiratory rate below 60 breaths per minute, are started on oral feeds, and those on higher flows on nasogastric (NG) tube feeds.

Feeds are started at 1 mL/kg per hour and advanced by the same amount every 3 hours until volume goals are reached; IV fluids are tapered accordingly. It’s a standing order, so nurses are able to initiate and advance feeding as indicated, any time of day.

Feeding was temporarily suspended in only 17 children: 6 for emesis, 6 for worsening respiratory scores, and the rest for dislodged NG tubes, procedures, or other issues. Enteric feeds were restarted with two stable scores below 7 points, at half the rate at which they were stopped.

NG tubes were used in over half of the 478 nursing shifts during which the 60 children – the majority aged 4-24 months – were fed; oral feeds in more than a third; and gastric tubes and other options in the rest. IV nutrition was used during just 1.8% of the shifts.

Enteric feeds were given up to a flow rate of 3.5 L/kg. There were no aspirations, even when children vomited. “We have seen good results so far that feeding is safe in these children,” Dr. Walters said.

“Our hospitalist team has been very receptive; they have been using the order set pretty continuously.” Parents also feel better when they know their children were “getting food in their belly,” even if by NG tube. “It’s important for family satisfaction,” she said.

The next step is to assess impact on length of stay, and education efforts to encourage broader use of the order set.

There was no external funding, and Dr. Walter had no disclosures. The meeting was sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

[email protected]

SEATTLE – There were no cases of aspiration with enteric feeds of 60 children aged up to 2 years on high flow nasal cannula (HFNC) for bronchiolitis at the University of Oklahoma Children’s Hospital, Oklahoma City, according to research presented at the 2019 Pediatric Hospital Medicine Conference.

M. Alexander Otto/MDedge News

HFNC has become common for bronchiolitis management; it often saves infants from intubation. However, many providers opt for total parenteral nutrition during therapy instead of enteral feeding because of concerns about aspiration pneumonia.

Pediatricians at the children’s hospital began to wonder if the concern was really necessary. There have been reports of safe feeding during HFNC, and “clinical care literature has shown that feeding the gut throughout illness improves outcomes,” said lead investigator, Sarah Walter, MD, a third-year pediatrics resident at the hospital.

So her team took a leap of faith. They consulted the HFNC literature, asked their fellow providers what they would be comfortable with, and instituted a pediatric HFNC enteral feeding protocol at the children’s hospital for use on inpatient floors, pediatric ICUs, and elsewhere.

Feedings – formula or breast milk – are triggered by stable respiratory Tal scores over 8 hours, meaning that respiratory rates, breath sounds, and accessory muscle use were stable or improving. Children on a flow of 6 L/min or less, with a respiratory rate below 60 breaths per minute, are started on oral feeds, and those on higher flows on nasogastric (NG) tube feeds.

Feeds are started at 1 mL/kg per hour and advanced by the same amount every 3 hours until volume goals are reached; IV fluids are tapered accordingly. It’s a standing order, so nurses are able to initiate and advance feeding as indicated, any time of day.

Feeding was temporarily suspended in only 17 children: 6 for emesis, 6 for worsening respiratory scores, and the rest for dislodged NG tubes, procedures, or other issues. Enteric feeds were restarted with two stable scores below 7 points, at half the rate at which they were stopped.

NG tubes were used in over half of the 478 nursing shifts during which the 60 children – the majority aged 4-24 months – were fed; oral feeds in more than a third; and gastric tubes and other options in the rest. IV nutrition was used during just 1.8% of the shifts.

Enteric feeds were given up to a flow rate of 3.5 L/kg. There were no aspirations, even when children vomited. “We have seen good results so far that feeding is safe in these children,” Dr. Walters said.

“Our hospitalist team has been very receptive; they have been using the order set pretty continuously.” Parents also feel better when they know their children were “getting food in their belly,” even if by NG tube. “It’s important for family satisfaction,” she said.

The next step is to assess impact on length of stay, and education efforts to encourage broader use of the order set.

There was no external funding, and Dr. Walter had no disclosures. The meeting was sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

[email protected]

SEATTLE – Adding a 3-day course of azithromycin to treatment regimens of children hospitalized with asthma did not shorten length of stay or bring other benefits in a randomized, blinded trial of more than 150 youngsters at The Children’s Hospital at Montefiore, New York.

M. Alexander Otto/MDedge News

In recent years, some pediatricians at Montefiore had begun giving short-course azithromycin to hospitalized children who were not recovering as quickly as they had hoped, spurred by outpatient reports of reduced exacerbations and other benefits with long-term azithromycin (e.g., Lancet. 2017 Aug 12;390(10095):659-68).

“We had no evidence for doing that at all” in the hospital, and it might be going on elsewhere, said senior investigator Alyssa Silver, MD, assistant professor of pediatrics at Montefiore and Albert Einstein College of Medicine, New York. She and her colleagues, including primary investigator Lindsey Douglas, MD, assistant professor of pediatrics at the Icahn School of Medicine at Mount Sinai, New York, took a closer look.

The negative results mean that “we can stop doing this, giving kids unnecessary things. Word is starting to get out” at Montefiore. “People are not using it as much,” she said at Pediatric Hospital Medicine, sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

The team had expected azithromycin to shorten length of stay (LOS) by about half a day, due to its anti-inflammatory effects, but that’s not what was found when they randomized 80 children aged 4-12 years with persistent asthma to oral azithromycin 10 mg/kg per day for 3 days within 12 hours of admission, and 79 to placebo.

LOS was 1.86 days in the placebo arm, and 1.69 days in the azithromycin group (P = .23). One placebo child was transferred to the pediatric ICU, versus none in the azithromycin arm (P = .50). The study was stopped short of its 214 subject enrollment goal because of futility, but even so, it was well powered to detect a difference in LOS, the primary outcome, Dr. Silver said.

At 1 week phone follow-up, 7 placebo children and 11 in the azithromycin arm had persistent asthma symptoms (P = .42), and 1 placebo child and 2 azithromycin children had been readmitted (P greater than .99). There were no differences in days of school missed, or work days missed among parents and guardians.

At one month, 23 placebo and 18 azithromycin children had persistent asthma symptoms (P = .5); 7 placebo and 6 azithromycin children had returned to the ED (P = .75).

In short, “we really found no difference” with short-course azithromycin. “Clinicians should consider [these] data before prescribing azithromycin [to] children hospitalized with asthma,” Dr. Silver and her team concluded.

Subjects were an average of about 7 years old, and about two-thirds were boys. They were not on azithromycin or other antibiotics prior to admission. About half had been admitted in the previous year, and about a quarter had at least one previous pediatric ICU admission. Over two-thirds had been on daily asthma medications. There were about 2 days of symptoms prior to admission.

There was no external funding, and Dr. Silver had no disclosures.

[email protected]

SEATTLE – Adding a 3-day course of azithromycin to treatment regimens of children hospitalized with asthma did not shorten length of stay or bring other benefits in a randomized, blinded trial of more than 150 youngsters at The Children’s Hospital at Montefiore, New York.

M. Alexander Otto/MDedge News

In recent years, some pediatricians at Montefiore had begun giving short-course azithromycin to hospitalized children who were not recovering as quickly as they had hoped, spurred by outpatient reports of reduced exacerbations and other benefits with long-term azithromycin (e.g., Lancet. 2017 Aug 12;390(10095):659-68).

“We had no evidence for doing that at all” in the hospital, and it might be going on elsewhere, said senior investigator Alyssa Silver, MD, assistant professor of pediatrics at Montefiore and Albert Einstein College of Medicine, New York. She and her colleagues, including primary investigator Lindsey Douglas, MD, assistant professor of pediatrics at the Icahn School of Medicine at Mount Sinai, New York, took a closer look.

The negative results mean that “we can stop doing this, giving kids unnecessary things. Word is starting to get out” at Montefiore. “People are not using it as much,” she said at Pediatric Hospital Medicine, sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

The team had expected azithromycin to shorten length of stay (LOS) by about half a day, due to its anti-inflammatory effects, but that’s not what was found when they randomized 80 children aged 4-12 years with persistent asthma to oral azithromycin 10 mg/kg per day for 3 days within 12 hours of admission, and 79 to placebo.

LOS was 1.86 days in the placebo arm, and 1.69 days in the azithromycin group (P = .23). One placebo child was transferred to the pediatric ICU, versus none in the azithromycin arm (P = .50). The study was stopped short of its 214 subject enrollment goal because of futility, but even so, it was well powered to detect a difference in LOS, the primary outcome, Dr. Silver said.

At 1 week phone follow-up, 7 placebo children and 11 in the azithromycin arm had persistent asthma symptoms (P = .42), and 1 placebo child and 2 azithromycin children had been readmitted (P greater than .99). There were no differences in days of school missed, or work days missed among parents and guardians.

At one month, 23 placebo and 18 azithromycin children had persistent asthma symptoms (P = .5); 7 placebo and 6 azithromycin children had returned to the ED (P = .75).

In short, “we really found no difference” with short-course azithromycin. “Clinicians should consider [these] data before prescribing azithromycin [to] children hospitalized with asthma,” Dr. Silver and her team concluded.

Subjects were an average of about 7 years old, and about two-thirds were boys. They were not on azithromycin or other antibiotics prior to admission. About half had been admitted in the previous year, and about a quarter had at least one previous pediatric ICU admission. Over two-thirds had been on daily asthma medications. There were about 2 days of symptoms prior to admission.

There was no external funding, and Dr. Silver had no disclosures.

[email protected]

SEATTLE – Adding a 3-day course of azithromycin to treatment regimens of children hospitalized with asthma did not shorten length of stay or bring other benefits in a randomized, blinded trial of more than 150 youngsters at The Children’s Hospital at Montefiore, New York.

M. Alexander Otto/MDedge News

In recent years, some pediatricians at Montefiore had begun giving short-course azithromycin to hospitalized children who were not recovering as quickly as they had hoped, spurred by outpatient reports of reduced exacerbations and other benefits with long-term azithromycin (e.g., Lancet. 2017 Aug 12;390(10095):659-68).

“We had no evidence for doing that at all” in the hospital, and it might be going on elsewhere, said senior investigator Alyssa Silver, MD, assistant professor of pediatrics at Montefiore and Albert Einstein College of Medicine, New York. She and her colleagues, including primary investigator Lindsey Douglas, MD, assistant professor of pediatrics at the Icahn School of Medicine at Mount Sinai, New York, took a closer look.

The negative results mean that “we can stop doing this, giving kids unnecessary things. Word is starting to get out” at Montefiore. “People are not using it as much,” she said at Pediatric Hospital Medicine, sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

The team had expected azithromycin to shorten length of stay (LOS) by about half a day, due to its anti-inflammatory effects, but that’s not what was found when they randomized 80 children aged 4-12 years with persistent asthma to oral azithromycin 10 mg/kg per day for 3 days within 12 hours of admission, and 79 to placebo.

LOS was 1.86 days in the placebo arm, and 1.69 days in the azithromycin group (P = .23). One placebo child was transferred to the pediatric ICU, versus none in the azithromycin arm (P = .50). The study was stopped short of its 214 subject enrollment goal because of futility, but even so, it was well powered to detect a difference in LOS, the primary outcome, Dr. Silver said.

At 1 week phone follow-up, 7 placebo children and 11 in the azithromycin arm had persistent asthma symptoms (P = .42), and 1 placebo child and 2 azithromycin children had been readmitted (P greater than .99). There were no differences in days of school missed, or work days missed among parents and guardians.

At one month, 23 placebo and 18 azithromycin children had persistent asthma symptoms (P = .5); 7 placebo and 6 azithromycin children had returned to the ED (P = .75).

In short, “we really found no difference” with short-course azithromycin. “Clinicians should consider [these] data before prescribing azithromycin [to] children hospitalized with asthma,” Dr. Silver and her team concluded.

Subjects were an average of about 7 years old, and about two-thirds were boys. They were not on azithromycin or other antibiotics prior to admission. About half had been admitted in the previous year, and about a quarter had at least one previous pediatric ICU admission. Over two-thirds had been on daily asthma medications. There were about 2 days of symptoms prior to admission.

There was no external funding, and Dr. Silver had no disclosures.

[email protected]