Uncontrolled growth isn’t the only way cancers wreak havoc on the human body. These aggregations of freely dividing cells also release chemicals that can cause damage from a distance. But pinning down how they harm faraway healthy tissues isn’t straightforward.

Fortunately, biologists can turn to the tiny fruit fly to address some of these questions: This insect’s body is not as complex as ours in many ways, but we share important genes and organ functions.

Fruit flies already are a crucial and inexpensive animal for genetics research. Because their life span is about 7 weeks, investigators can track the effects of mutations across several generations in a short period. The animals also are proving useful for learning how chemicals released by malignant tumors can harm tissues in the body that are not near the cancer.

One recent lesson from the fruit flies involves the blood-brain barrier, which determines which molecules gain access to the brain. Researchers at the University of California, Berkeley, have found that malignant tumors in the tiny insects release interleukin 6 (IL-6), an inflammatory chemical that disrupts this important barrier. The investigators showed that the tumors act similarly in mice.

When the scientists blocked the effects of IL-6, both the fruit flies and the mice lived longer. Even if cancer cells persisted, damage related to IL-6 could be diminished.

Fruit flies and mice are only distant relatives of each other and of humans, and the relevance of this discovery to human cancers has not been established. One hurdle is that IL-6 has many important, normal functions related to health. Researchers need to learn how to target only its unwanted blood-brain barrier effects.

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

Uncontrolled growth isn’t the only way cancers wreak havoc on the human body. These aggregations of freely dividing cells also release chemicals that can cause damage from a distance. But pinning down how they harm faraway healthy tissues isn’t straightforward.

Fortunately, biologists can turn to the tiny fruit fly to address some of these questions: This insect’s body is not as complex as ours in many ways, but we share important genes and organ functions.

Fruit flies already are a crucial and inexpensive animal for genetics research. Because their life span is about 7 weeks, investigators can track the effects of mutations across several generations in a short period. The animals also are proving useful for learning how chemicals released by malignant tumors can harm tissues in the body that are not near the cancer.

One recent lesson from the fruit flies involves the blood-brain barrier, which determines which molecules gain access to the brain. Researchers at the University of California, Berkeley, have found that malignant tumors in the tiny insects release interleukin 6 (IL-6), an inflammatory chemical that disrupts this important barrier. The investigators showed that the tumors act similarly in mice.

When the scientists blocked the effects of IL-6, both the fruit flies and the mice lived longer. Even if cancer cells persisted, damage related to IL-6 could be diminished.

Fruit flies and mice are only distant relatives of each other and of humans, and the relevance of this discovery to human cancers has not been established. One hurdle is that IL-6 has many important, normal functions related to health. Researchers need to learn how to target only its unwanted blood-brain barrier effects.

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

Uncontrolled growth isn’t the only way cancers wreak havoc on the human body. These aggregations of freely dividing cells also release chemicals that can cause damage from a distance. But pinning down how they harm faraway healthy tissues isn’t straightforward.

Fortunately, biologists can turn to the tiny fruit fly to address some of these questions: This insect’s body is not as complex as ours in many ways, but we share important genes and organ functions.

Fruit flies already are a crucial and inexpensive animal for genetics research. Because their life span is about 7 weeks, investigators can track the effects of mutations across several generations in a short period. The animals also are proving useful for learning how chemicals released by malignant tumors can harm tissues in the body that are not near the cancer.

One recent lesson from the fruit flies involves the blood-brain barrier, which determines which molecules gain access to the brain. Researchers at the University of California, Berkeley, have found that malignant tumors in the tiny insects release interleukin 6 (IL-6), an inflammatory chemical that disrupts this important barrier. The investigators showed that the tumors act similarly in mice.

When the scientists blocked the effects of IL-6, both the fruit flies and the mice lived longer. Even if cancer cells persisted, damage related to IL-6 could be diminished.

Fruit flies and mice are only distant relatives of each other and of humans, and the relevance of this discovery to human cancers has not been established. One hurdle is that IL-6 has many important, normal functions related to health. Researchers need to learn how to target only its unwanted blood-brain barrier effects.

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

The physician-patient relationship is a key factor in preventing litigation following cutaneous laser surgery, according to Mathew M. Avram, MD, JD.

merznatalia/Thinkstock

“Numerous studies indicate that good communication and rapport are the most important means to avoid a lawsuit,” Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, said during a virtual course on laser and aesthetic skin therapy. “It is helpful to say that the outcome was not optimal or what you were anticipating. Communicate your plan [for the complication] clearly and honestly to your patient. The patient may not understand the severity of the complication. If they don’t, they will either leave it alone or they will go elsewhere and may receive poor care.” He added that in New England, “we have some stoic patients who may say ‘I don’t want to bother the doctor’ or ‘It’s my fault for having the procedure done.’ ”

Establishing effective communication with patients from the outset is good practice, he continued, because 75% of physicians in low-risk specialties will face a malpractice claim by age 65. Nearly a decade ago Dr. Avram, H. Ray Jalian, MD, and Chris Jalian, JD, published results from a national legal database analysis identifying common errors and risk factors for litigation in cutaneous surgery. Their search yielded 1,807 documents with 174 unique legal claims involving injury from a cutaneous laser treatment, from 1985 to 2012. The most common litigated procedures were laser hair removal, rejuvenation (mostly related to intense pulsed-light treatments), and laser treatment of leg veins, while the most common injuries sustained were burns, scars, and pigmentary changes. The most common causes of legal action were lack of informed consent and fraud.

Among the 120 cases with public decisions, cases favored the plaintiff 51% of the time. “That’s unusual,” said Dr. Avram, president of American Society for Dermatologic Surgery. “Usually, physicians do better, but I think the fact that they’re cosmetic cases probably shades things a little bit.” The median monetary award was $350,000 and ranged from $5,000 to $2,145,000. The two largest judgments were for improper use of topical anesthesia that led to deaths of patients in laser hair removal cases.

In a separate analysis, the same authors searched an online national database to identify the incidence of medical professional liability claims resulting from cutaneous laser surgery performed by nonphysician operators (NPOs) from 1999 to 2012. Among the 175 cases identified, 43% involved an NPO. “In fact, the cases involving NPOs exploded over a 4-year period; they grew from 36% in 2008 of cases to 78% in 2011,” Dr. Avram said. “This was even more true for laser hair removal.”

The practice setting turned out to be a factor. Only 23% of NPO litigation involving laser procedures arose in medical office settings, while 77% of cases involving NPOs were performed outside of traditional medical settings such as in salons and medical spas – mostly for laser hair removal. “We updated this information by examining the setting for nonphysician operator litigation between 2012 and 2017 and found that 66% of cases involving NPOs were performed outside of a traditional medical setting, while 34% of NPO litigation arose in medical office settings,” Dr. Avram said during the meeting, which was named What’s the Truth? and sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “That’s close to a 2 to 1 ratio.”

In an analysis of medical professional liability claims involving Mohs surgery from 1989 to 2011, 26 of the 42 cases identified involved a primary defendant who was not a Mohs surgeon. In the 26 cases, the most common reasons for lawsuits were failure or delay of diagnosis of a skin cancer, cosmetic outcome issues, lack of informed consent, and delay or failure to refer to a Mohs surgeon. Of the cases that involved Mohs surgeons, the most common causes were lack of proper informed consent and cosmetic outcome issues, but “these cases were overwhelmingly decided in favor of the surgeons,” said Dr. Avram, one of the study authors.

On a related note, Dr. Avram underscored the importance of biopsy-site photography, “because patients and physicians misidentify biopsy sites too commonly,” he said. In a single-center study of 34 biopsy sites of cutaneous head and neck malignancies, patients misidentified the biopsy site 4-7 weeks out in 29% of the cases. Blinded dermatologists and the patient misidentified the biopsy site in 12% of the cases. “Good biopsy site photography should be mandatory in your practice,” he advised.

Clinicians can avoid cutaneous laser surgery complications only by not treating patients. “Complications and side effects are inevitable; you need to know your limits,” he said. “Even in skilled hands, if you treat enough patients, you will encounter challenging side effects. Do not perform a procedure that might produce a side effect that you cannot recognize and treat.”

The best way to avoid complications is to trust your eyes – not the laser – since the same device made by the same manufacturer may produce highly different outputs at the same setting (see J Am Acad Dermatol. 2016;74[5]:807-19).

“Moreover, lasers can produce much different energies after they have been serviced,” Dr. Avram said. “Do not memorize settings. Do not blindly replicate recommended settings from a colleague or a device manufacturer,” he advised. “Some devices are not externally calibrated. Therefore, the settings on one device may not translate the same way to yours. Often, device manufacturers underplay the settings. Safe and unsafe laser endpoints and close observation are the best means to avoiding clinical complications. That means you follow clinical endpoints, not fluences. The key clinical finding is the endpoint, not the energy setting.”

Temporary and expected side effects include erythema, edema, and purpura. “With these it’s just handholding and unlikely to lead to any legal consequences,” he continued. “With temporary hyperpigmentation that can occur with laser hair removal, time is one your side, because typically this will resolve before any litigation progresses. Permanent side effects from lasers and light sources and injectables are a different issue, things like permanent hypopigmentation, depigmentation, and scarring. These are most likely to produce liability.”

In Dr. Avram’s opinion, complications are best handled with widespread communication. “There is a temptation to avoid a patient with a poor outcome or side effect,” he said. “This is bad medicine and rightfully angers your patient and increases the risk of a lawsuit. [Resist] the temptation to avoid showing a poor outcome to a colleague. Many complications can be significantly improved or cleared with timely and appropriate interventions. You should always document your efforts.”

Dr. Avram disclosed that he has received consulting fees from Allergan and Galderma. He is a member of the scientific advisory board for Allergan and Soliton, is an investigator for Endo, and holds stock options in La Jolla NanoMedical Inc.

[email protected]

The physician-patient relationship is a key factor in preventing litigation following cutaneous laser surgery, according to Mathew M. Avram, MD, JD.

merznatalia/Thinkstock

“Numerous studies indicate that good communication and rapport are the most important means to avoid a lawsuit,” Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, said during a virtual course on laser and aesthetic skin therapy. “It is helpful to say that the outcome was not optimal or what you were anticipating. Communicate your plan [for the complication] clearly and honestly to your patient. The patient may not understand the severity of the complication. If they don’t, they will either leave it alone or they will go elsewhere and may receive poor care.” He added that in New England, “we have some stoic patients who may say ‘I don’t want to bother the doctor’ or ‘It’s my fault for having the procedure done.’ ”

Establishing effective communication with patients from the outset is good practice, he continued, because 75% of physicians in low-risk specialties will face a malpractice claim by age 65. Nearly a decade ago Dr. Avram, H. Ray Jalian, MD, and Chris Jalian, JD, published results from a national legal database analysis identifying common errors and risk factors for litigation in cutaneous surgery. Their search yielded 1,807 documents with 174 unique legal claims involving injury from a cutaneous laser treatment, from 1985 to 2012. The most common litigated procedures were laser hair removal, rejuvenation (mostly related to intense pulsed-light treatments), and laser treatment of leg veins, while the most common injuries sustained were burns, scars, and pigmentary changes. The most common causes of legal action were lack of informed consent and fraud.

Among the 120 cases with public decisions, cases favored the plaintiff 51% of the time. “That’s unusual,” said Dr. Avram, president of American Society for Dermatologic Surgery. “Usually, physicians do better, but I think the fact that they’re cosmetic cases probably shades things a little bit.” The median monetary award was $350,000 and ranged from $5,000 to $2,145,000. The two largest judgments were for improper use of topical anesthesia that led to deaths of patients in laser hair removal cases.

In a separate analysis, the same authors searched an online national database to identify the incidence of medical professional liability claims resulting from cutaneous laser surgery performed by nonphysician operators (NPOs) from 1999 to 2012. Among the 175 cases identified, 43% involved an NPO. “In fact, the cases involving NPOs exploded over a 4-year period; they grew from 36% in 2008 of cases to 78% in 2011,” Dr. Avram said. “This was even more true for laser hair removal.”

The practice setting turned out to be a factor. Only 23% of NPO litigation involving laser procedures arose in medical office settings, while 77% of cases involving NPOs were performed outside of traditional medical settings such as in salons and medical spas – mostly for laser hair removal. “We updated this information by examining the setting for nonphysician operator litigation between 2012 and 2017 and found that 66% of cases involving NPOs were performed outside of a traditional medical setting, while 34% of NPO litigation arose in medical office settings,” Dr. Avram said during the meeting, which was named What’s the Truth? and sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “That’s close to a 2 to 1 ratio.”

In an analysis of medical professional liability claims involving Mohs surgery from 1989 to 2011, 26 of the 42 cases identified involved a primary defendant who was not a Mohs surgeon. In the 26 cases, the most common reasons for lawsuits were failure or delay of diagnosis of a skin cancer, cosmetic outcome issues, lack of informed consent, and delay or failure to refer to a Mohs surgeon. Of the cases that involved Mohs surgeons, the most common causes were lack of proper informed consent and cosmetic outcome issues, but “these cases were overwhelmingly decided in favor of the surgeons,” said Dr. Avram, one of the study authors.

On a related note, Dr. Avram underscored the importance of biopsy-site photography, “because patients and physicians misidentify biopsy sites too commonly,” he said. In a single-center study of 34 biopsy sites of cutaneous head and neck malignancies, patients misidentified the biopsy site 4-7 weeks out in 29% of the cases. Blinded dermatologists and the patient misidentified the biopsy site in 12% of the cases. “Good biopsy site photography should be mandatory in your practice,” he advised.

Clinicians can avoid cutaneous laser surgery complications only by not treating patients. “Complications and side effects are inevitable; you need to know your limits,” he said. “Even in skilled hands, if you treat enough patients, you will encounter challenging side effects. Do not perform a procedure that might produce a side effect that you cannot recognize and treat.”

The best way to avoid complications is to trust your eyes – not the laser – since the same device made by the same manufacturer may produce highly different outputs at the same setting (see J Am Acad Dermatol. 2016;74[5]:807-19).

“Moreover, lasers can produce much different energies after they have been serviced,” Dr. Avram said. “Do not memorize settings. Do not blindly replicate recommended settings from a colleague or a device manufacturer,” he advised. “Some devices are not externally calibrated. Therefore, the settings on one device may not translate the same way to yours. Often, device manufacturers underplay the settings. Safe and unsafe laser endpoints and close observation are the best means to avoiding clinical complications. That means you follow clinical endpoints, not fluences. The key clinical finding is the endpoint, not the energy setting.”

Temporary and expected side effects include erythema, edema, and purpura. “With these it’s just handholding and unlikely to lead to any legal consequences,” he continued. “With temporary hyperpigmentation that can occur with laser hair removal, time is one your side, because typically this will resolve before any litigation progresses. Permanent side effects from lasers and light sources and injectables are a different issue, things like permanent hypopigmentation, depigmentation, and scarring. These are most likely to produce liability.”

In Dr. Avram’s opinion, complications are best handled with widespread communication. “There is a temptation to avoid a patient with a poor outcome or side effect,” he said. “This is bad medicine and rightfully angers your patient and increases the risk of a lawsuit. [Resist] the temptation to avoid showing a poor outcome to a colleague. Many complications can be significantly improved or cleared with timely and appropriate interventions. You should always document your efforts.”

Dr. Avram disclosed that he has received consulting fees from Allergan and Galderma. He is a member of the scientific advisory board for Allergan and Soliton, is an investigator for Endo, and holds stock options in La Jolla NanoMedical Inc.

[email protected]

The physician-patient relationship is a key factor in preventing litigation following cutaneous laser surgery, according to Mathew M. Avram, MD, JD.

merznatalia/Thinkstock

“Numerous studies indicate that good communication and rapport are the most important means to avoid a lawsuit,” Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, said during a virtual course on laser and aesthetic skin therapy. “It is helpful to say that the outcome was not optimal or what you were anticipating. Communicate your plan [for the complication] clearly and honestly to your patient. The patient may not understand the severity of the complication. If they don’t, they will either leave it alone or they will go elsewhere and may receive poor care.” He added that in New England, “we have some stoic patients who may say ‘I don’t want to bother the doctor’ or ‘It’s my fault for having the procedure done.’ ”

Establishing effective communication with patients from the outset is good practice, he continued, because 75% of physicians in low-risk specialties will face a malpractice claim by age 65. Nearly a decade ago Dr. Avram, H. Ray Jalian, MD, and Chris Jalian, JD, published results from a national legal database analysis identifying common errors and risk factors for litigation in cutaneous surgery. Their search yielded 1,807 documents with 174 unique legal claims involving injury from a cutaneous laser treatment, from 1985 to 2012. The most common litigated procedures were laser hair removal, rejuvenation (mostly related to intense pulsed-light treatments), and laser treatment of leg veins, while the most common injuries sustained were burns, scars, and pigmentary changes. The most common causes of legal action were lack of informed consent and fraud.

Among the 120 cases with public decisions, cases favored the plaintiff 51% of the time. “That’s unusual,” said Dr. Avram, president of American Society for Dermatologic Surgery. “Usually, physicians do better, but I think the fact that they’re cosmetic cases probably shades things a little bit.” The median monetary award was $350,000 and ranged from $5,000 to $2,145,000. The two largest judgments were for improper use of topical anesthesia that led to deaths of patients in laser hair removal cases.

In a separate analysis, the same authors searched an online national database to identify the incidence of medical professional liability claims resulting from cutaneous laser surgery performed by nonphysician operators (NPOs) from 1999 to 2012. Among the 175 cases identified, 43% involved an NPO. “In fact, the cases involving NPOs exploded over a 4-year period; they grew from 36% in 2008 of cases to 78% in 2011,” Dr. Avram said. “This was even more true for laser hair removal.”

The practice setting turned out to be a factor. Only 23% of NPO litigation involving laser procedures arose in medical office settings, while 77% of cases involving NPOs were performed outside of traditional medical settings such as in salons and medical spas – mostly for laser hair removal. “We updated this information by examining the setting for nonphysician operator litigation between 2012 and 2017 and found that 66% of cases involving NPOs were performed outside of a traditional medical setting, while 34% of NPO litigation arose in medical office settings,” Dr. Avram said during the meeting, which was named What’s the Truth? and sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “That’s close to a 2 to 1 ratio.”

In an analysis of medical professional liability claims involving Mohs surgery from 1989 to 2011, 26 of the 42 cases identified involved a primary defendant who was not a Mohs surgeon. In the 26 cases, the most common reasons for lawsuits were failure or delay of diagnosis of a skin cancer, cosmetic outcome issues, lack of informed consent, and delay or failure to refer to a Mohs surgeon. Of the cases that involved Mohs surgeons, the most common causes were lack of proper informed consent and cosmetic outcome issues, but “these cases were overwhelmingly decided in favor of the surgeons,” said Dr. Avram, one of the study authors.

On a related note, Dr. Avram underscored the importance of biopsy-site photography, “because patients and physicians misidentify biopsy sites too commonly,” he said. In a single-center study of 34 biopsy sites of cutaneous head and neck malignancies, patients misidentified the biopsy site 4-7 weeks out in 29% of the cases. Blinded dermatologists and the patient misidentified the biopsy site in 12% of the cases. “Good biopsy site photography should be mandatory in your practice,” he advised.

Clinicians can avoid cutaneous laser surgery complications only by not treating patients. “Complications and side effects are inevitable; you need to know your limits,” he said. “Even in skilled hands, if you treat enough patients, you will encounter challenging side effects. Do not perform a procedure that might produce a side effect that you cannot recognize and treat.”

The best way to avoid complications is to trust your eyes – not the laser – since the same device made by the same manufacturer may produce highly different outputs at the same setting (see J Am Acad Dermatol. 2016;74[5]:807-19).

“Moreover, lasers can produce much different energies after they have been serviced,” Dr. Avram said. “Do not memorize settings. Do not blindly replicate recommended settings from a colleague or a device manufacturer,” he advised. “Some devices are not externally calibrated. Therefore, the settings on one device may not translate the same way to yours. Often, device manufacturers underplay the settings. Safe and unsafe laser endpoints and close observation are the best means to avoiding clinical complications. That means you follow clinical endpoints, not fluences. The key clinical finding is the endpoint, not the energy setting.”

Temporary and expected side effects include erythema, edema, and purpura. “With these it’s just handholding and unlikely to lead to any legal consequences,” he continued. “With temporary hyperpigmentation that can occur with laser hair removal, time is one your side, because typically this will resolve before any litigation progresses. Permanent side effects from lasers and light sources and injectables are a different issue, things like permanent hypopigmentation, depigmentation, and scarring. These are most likely to produce liability.”

In Dr. Avram’s opinion, complications are best handled with widespread communication. “There is a temptation to avoid a patient with a poor outcome or side effect,” he said. “This is bad medicine and rightfully angers your patient and increases the risk of a lawsuit. [Resist] the temptation to avoid showing a poor outcome to a colleague. Many complications can be significantly improved or cleared with timely and appropriate interventions. You should always document your efforts.”

Dr. Avram disclosed that he has received consulting fees from Allergan and Galderma. He is a member of the scientific advisory board for Allergan and Soliton, is an investigator for Endo, and holds stock options in La Jolla NanoMedical Inc.

[email protected]

On Nov. 2, the Centers for Disease Control and Prevention endorsed vaccination with the Pfizer/BioNTech COVID-19 vaccine for children aged 5-11 years. What are some best practices for meeting the challenges of immunizing this younger age group?

This news organization spoke to several pediatric experts to get answers.

More than 6 million children and adolescents (up to age 18 years) in the United States have been infected with SARS-CoV-2. Children represent about 17% of all cases, and an estimated 0.1%-2% of infected children end up hospitalized, according to Oct. 28 data from the American Academy of Pediatrics.

Physicians and other health care practitioners are gearing up for what could be an influx of patients. “Pediatricians are standing by to talk with families about the vaccine and to administer the vaccine to children as soon as possible,” Lee Savio Beers, MD, FAAP, president of the AAP, said in a statement.

In this Q&A, this news organization asked for additional advice from Sara “Sally” Goza, MD, a pediatrician in Fayetteville, Georgia, and immediate past president of the AAP; Peter Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine and codirector of the Texas Children’s Hospital Center for Vaccine Development, both in Houston; and Danielle M. Zerr, MD, professor and chief of the division of pediatric infectious disease at the University of Washington, Seattle, and medical director of infection prevention at Seattle Children’s Hospital.
 

Q: How are smaller pediatric practices and solo practitioners going to handle the additional vaccinations?

Dr. Goza: It’s a scheduling challenge with this rollout and all the people who want it and want it right now. They’re going to want it this week.

I’ve actually had some children asking their moms: “When can I get it? When can I get it?” It’s been very interesting – they are chomping at the bit.

If I give the vaccine to a patient this week, in 3 weeks the second dose will be right around Thanksgiving. No one in my office is going to want to be here to give the shot on Thanksgiving, and no patient is going to want to come in on Thanksgiving weekend. So I’m trying to delay those parents – saying, let’s do it next week. That way we’re not messing up a holiday.

Children are going to need two doses, and they won’t be fully protected until 2 weeks after their second dose. So they won’t get full protection for Thanksgiving, but they will have full protection for Christmas.

I know there are a lot of pediatricians who have preordered the vaccine. I know in our office they sent us an email ... to let us know our vaccines are being shipped. So I think a lot of pediatricians are going to have the vaccine.
 

Q: How should pediatricians counsel parents who are fearful or hesitant?

Dr. Hotez: It’s important to emphasize the severity of the 2021 summer Delta epidemic in children. We need to get beyond this false narrative that COVID only produces a mild disease in children. It’s caused thousands of pediatric hospitalizations, not to mention long COVID.

Dr. Zerr: It is key to find out what concerns parents have and then focus on answering their specific questions. It is helpful to emphasize the safety and efficacy of the vaccine and to explain the rigorous processes that the vaccine went through to receive Food and Drug Administration approval.
 

Q: How should pediatricians counter any misinformation/disinformation out there about the COVID-19 vaccines?

Dr. Goza: The most important thing is not to discount what they are saying. Don’t say: “That’s crazy” or “That’s not true.” Don’t roll your eyes and say: “Really, you’re going to believe all that?”

Instead, have a conversation with them about why we think that is not true, or why we know that’s not true. We really have to have that relationship and ask: “Well, what are your concerns?” And then really counter (any misinformation) with facts, with science, and based on your experience.
 

Q: Do the data presented to the FDA and the CDC about the safety and effectiveness of the COVID-19 vaccine for 5- to 11-year-olds seem robust to you?

Dr. Zerr: Yes, and data collection will be ongoing.

Dr. Hotez: I’ve only seen what’s publicly available so far, and it seems to support moving forward with emergency use authorization. The only shortfall is the size, roughly 2,200 children, which would not be of sufficient size to detect a rare safety signal.
 

Q: Do previous controversies around pediatric vaccines (for example, the MMR vaccine and autism) give pediatricians some background and experience so they can address any pushback on the COVID-19 vaccines?

Dr. Goza: Pediatricians have been dealing with vaccine hesitancy for a while now, ever since the MMR and autism controversy started. Even before then, there were certain groups of people who didn’t want vaccines.

We’ve really worked hard at helping teach pediatricians how to deal with the misinformation, how to counter it, and how to help parents understand the vaccines are safe and effective – and that they save lives.

That (experience) will help us in some ways. Unfortunately, there is more misinformation out there – there is almost a concerted effort on misinformation. It’s big.

Pediatricians will do everything we can, but we need help countering it. We need the misinformation to quit getting spread on social media. We can talk one on one with patients and families, but if all they are hearing on social media is the misinformation, it’s really hard.
 

Q: Are pediatricians, especially solo practitioners or pediatricians at smaller practices, going to face challenges with multidose vials and not wasting vaccine product?

Dr. Goza: I’m at a small practice. We have 3.5 FTEs (full-time equivalents) of MDs and three FTEs of nurse practitioners. So we’re not that big – about six providers.

You know, it is a challenge. We’re not going to buy the super-duper freezer, and we’re not going to be able to store these vaccines for a long period of time.

So when we order, we need smaller amounts. For the 12- to 18-year-olds, [maximum storage] was 45 days. Now for the 5- to 11-year-olds, we’re going to be able to store the vaccine in the refrigerator for 10 weeks, which gives us more leeway there.

We try to do all of vaccinations on 1 day, so we know how many people are coming in, and we are not going to waste too many doses.

Our Department of Public Health in Georgia has said: “We want these vaccines in the arms of kids, and if you have to waste some doses, don’t worry about it.” But it’s a 10-dose vial. It’s going to be hard for me to open it up for one child. I just don’t like wasting anything like this.

Our main goal is to get this vaccine in to the arms of children whose parents want it.
 

Q: What are some additional sources of information for pediatricians?

Dr. Zerr: There are a lot of great resources on vaccine hesitancy from reputable sources, including these from the CDC and from the National Academies of Sciences, Engineering, and Medicine:

• Building Confidence With OVID-19 Vaccines
• How to Talk With Parents About COVID-19 Vaccination
• Strategies for Building Confidence in the COVID-19 Vaccines
• Communication Strategies for Building Confidence in COVID-19 Vaccines: Addressing Variants and Childhood Vaccinations

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

On Nov. 2, the Centers for Disease Control and Prevention endorsed vaccination with the Pfizer/BioNTech COVID-19 vaccine for children aged 5-11 years. What are some best practices for meeting the challenges of immunizing this younger age group?

This news organization spoke to several pediatric experts to get answers.

More than 6 million children and adolescents (up to age 18 years) in the United States have been infected with SARS-CoV-2. Children represent about 17% of all cases, and an estimated 0.1%-2% of infected children end up hospitalized, according to Oct. 28 data from the American Academy of Pediatrics.

Physicians and other health care practitioners are gearing up for what could be an influx of patients. “Pediatricians are standing by to talk with families about the vaccine and to administer the vaccine to children as soon as possible,” Lee Savio Beers, MD, FAAP, president of the AAP, said in a statement.

In this Q&A, this news organization asked for additional advice from Sara “Sally” Goza, MD, a pediatrician in Fayetteville, Georgia, and immediate past president of the AAP; Peter Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine and codirector of the Texas Children’s Hospital Center for Vaccine Development, both in Houston; and Danielle M. Zerr, MD, professor and chief of the division of pediatric infectious disease at the University of Washington, Seattle, and medical director of infection prevention at Seattle Children’s Hospital.
 

Q: How are smaller pediatric practices and solo practitioners going to handle the additional vaccinations?

Dr. Goza: It’s a scheduling challenge with this rollout and all the people who want it and want it right now. They’re going to want it this week.

I’ve actually had some children asking their moms: “When can I get it? When can I get it?” It’s been very interesting – they are chomping at the bit.

If I give the vaccine to a patient this week, in 3 weeks the second dose will be right around Thanksgiving. No one in my office is going to want to be here to give the shot on Thanksgiving, and no patient is going to want to come in on Thanksgiving weekend. So I’m trying to delay those parents – saying, let’s do it next week. That way we’re not messing up a holiday.

Children are going to need two doses, and they won’t be fully protected until 2 weeks after their second dose. So they won’t get full protection for Thanksgiving, but they will have full protection for Christmas.

I know there are a lot of pediatricians who have preordered the vaccine. I know in our office they sent us an email ... to let us know our vaccines are being shipped. So I think a lot of pediatricians are going to have the vaccine.
 

Q: How should pediatricians counsel parents who are fearful or hesitant?

Dr. Hotez: It’s important to emphasize the severity of the 2021 summer Delta epidemic in children. We need to get beyond this false narrative that COVID only produces a mild disease in children. It’s caused thousands of pediatric hospitalizations, not to mention long COVID.

Dr. Zerr: It is key to find out what concerns parents have and then focus on answering their specific questions. It is helpful to emphasize the safety and efficacy of the vaccine and to explain the rigorous processes that the vaccine went through to receive Food and Drug Administration approval.
 

Q: How should pediatricians counter any misinformation/disinformation out there about the COVID-19 vaccines?

Dr. Goza: The most important thing is not to discount what they are saying. Don’t say: “That’s crazy” or “That’s not true.” Don’t roll your eyes and say: “Really, you’re going to believe all that?”

Instead, have a conversation with them about why we think that is not true, or why we know that’s not true. We really have to have that relationship and ask: “Well, what are your concerns?” And then really counter (any misinformation) with facts, with science, and based on your experience.
 

Q: Do the data presented to the FDA and the CDC about the safety and effectiveness of the COVID-19 vaccine for 5- to 11-year-olds seem robust to you?

Dr. Zerr: Yes, and data collection will be ongoing.

Dr. Hotez: I’ve only seen what’s publicly available so far, and it seems to support moving forward with emergency use authorization. The only shortfall is the size, roughly 2,200 children, which would not be of sufficient size to detect a rare safety signal.
 

Q: Do previous controversies around pediatric vaccines (for example, the MMR vaccine and autism) give pediatricians some background and experience so they can address any pushback on the COVID-19 vaccines?

Dr. Goza: Pediatricians have been dealing with vaccine hesitancy for a while now, ever since the MMR and autism controversy started. Even before then, there were certain groups of people who didn’t want vaccines.

We’ve really worked hard at helping teach pediatricians how to deal with the misinformation, how to counter it, and how to help parents understand the vaccines are safe and effective – and that they save lives.

That (experience) will help us in some ways. Unfortunately, there is more misinformation out there – there is almost a concerted effort on misinformation. It’s big.

Pediatricians will do everything we can, but we need help countering it. We need the misinformation to quit getting spread on social media. We can talk one on one with patients and families, but if all they are hearing on social media is the misinformation, it’s really hard.
 

Q: Are pediatricians, especially solo practitioners or pediatricians at smaller practices, going to face challenges with multidose vials and not wasting vaccine product?

Dr. Goza: I’m at a small practice. We have 3.5 FTEs (full-time equivalents) of MDs and three FTEs of nurse practitioners. So we’re not that big – about six providers.

You know, it is a challenge. We’re not going to buy the super-duper freezer, and we’re not going to be able to store these vaccines for a long period of time.

So when we order, we need smaller amounts. For the 12- to 18-year-olds, [maximum storage] was 45 days. Now for the 5- to 11-year-olds, we’re going to be able to store the vaccine in the refrigerator for 10 weeks, which gives us more leeway there.

We try to do all of vaccinations on 1 day, so we know how many people are coming in, and we are not going to waste too many doses.

Our Department of Public Health in Georgia has said: “We want these vaccines in the arms of kids, and if you have to waste some doses, don’t worry about it.” But it’s a 10-dose vial. It’s going to be hard for me to open it up for one child. I just don’t like wasting anything like this.

Our main goal is to get this vaccine in to the arms of children whose parents want it.
 

Q: What are some additional sources of information for pediatricians?

Dr. Zerr: There are a lot of great resources on vaccine hesitancy from reputable sources, including these from the CDC and from the National Academies of Sciences, Engineering, and Medicine:

• Building Confidence With OVID-19 Vaccines
• How to Talk With Parents About COVID-19 Vaccination
• Strategies for Building Confidence in the COVID-19 Vaccines
• Communication Strategies for Building Confidence in COVID-19 Vaccines: Addressing Variants and Childhood Vaccinations

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

On Nov. 2, the Centers for Disease Control and Prevention endorsed vaccination with the Pfizer/BioNTech COVID-19 vaccine for children aged 5-11 years. What are some best practices for meeting the challenges of immunizing this younger age group?

This news organization spoke to several pediatric experts to get answers.

More than 6 million children and adolescents (up to age 18 years) in the United States have been infected with SARS-CoV-2. Children represent about 17% of all cases, and an estimated 0.1%-2% of infected children end up hospitalized, according to Oct. 28 data from the American Academy of Pediatrics.

Physicians and other health care practitioners are gearing up for what could be an influx of patients. “Pediatricians are standing by to talk with families about the vaccine and to administer the vaccine to children as soon as possible,” Lee Savio Beers, MD, FAAP, president of the AAP, said in a statement.

In this Q&A, this news organization asked for additional advice from Sara “Sally” Goza, MD, a pediatrician in Fayetteville, Georgia, and immediate past president of the AAP; Peter Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine and codirector of the Texas Children’s Hospital Center for Vaccine Development, both in Houston; and Danielle M. Zerr, MD, professor and chief of the division of pediatric infectious disease at the University of Washington, Seattle, and medical director of infection prevention at Seattle Children’s Hospital.
 

Q: How are smaller pediatric practices and solo practitioners going to handle the additional vaccinations?

Dr. Goza: It’s a scheduling challenge with this rollout and all the people who want it and want it right now. They’re going to want it this week.

I’ve actually had some children asking their moms: “When can I get it? When can I get it?” It’s been very interesting – they are chomping at the bit.

If I give the vaccine to a patient this week, in 3 weeks the second dose will be right around Thanksgiving. No one in my office is going to want to be here to give the shot on Thanksgiving, and no patient is going to want to come in on Thanksgiving weekend. So I’m trying to delay those parents – saying, let’s do it next week. That way we’re not messing up a holiday.

Children are going to need two doses, and they won’t be fully protected until 2 weeks after their second dose. So they won’t get full protection for Thanksgiving, but they will have full protection for Christmas.

I know there are a lot of pediatricians who have preordered the vaccine. I know in our office they sent us an email ... to let us know our vaccines are being shipped. So I think a lot of pediatricians are going to have the vaccine.
 

Q: How should pediatricians counsel parents who are fearful or hesitant?

Dr. Hotez: It’s important to emphasize the severity of the 2021 summer Delta epidemic in children. We need to get beyond this false narrative that COVID only produces a mild disease in children. It’s caused thousands of pediatric hospitalizations, not to mention long COVID.

Dr. Zerr: It is key to find out what concerns parents have and then focus on answering their specific questions. It is helpful to emphasize the safety and efficacy of the vaccine and to explain the rigorous processes that the vaccine went through to receive Food and Drug Administration approval.
 

Q: How should pediatricians counter any misinformation/disinformation out there about the COVID-19 vaccines?

Dr. Goza: The most important thing is not to discount what they are saying. Don’t say: “That’s crazy” or “That’s not true.” Don’t roll your eyes and say: “Really, you’re going to believe all that?”

Instead, have a conversation with them about why we think that is not true, or why we know that’s not true. We really have to have that relationship and ask: “Well, what are your concerns?” And then really counter (any misinformation) with facts, with science, and based on your experience.
 

Q: Do the data presented to the FDA and the CDC about the safety and effectiveness of the COVID-19 vaccine for 5- to 11-year-olds seem robust to you?

Dr. Zerr: Yes, and data collection will be ongoing.

Dr. Hotez: I’ve only seen what’s publicly available so far, and it seems to support moving forward with emergency use authorization. The only shortfall is the size, roughly 2,200 children, which would not be of sufficient size to detect a rare safety signal.
 

Q: Do previous controversies around pediatric vaccines (for example, the MMR vaccine and autism) give pediatricians some background and experience so they can address any pushback on the COVID-19 vaccines?

Dr. Goza: Pediatricians have been dealing with vaccine hesitancy for a while now, ever since the MMR and autism controversy started. Even before then, there were certain groups of people who didn’t want vaccines.

We’ve really worked hard at helping teach pediatricians how to deal with the misinformation, how to counter it, and how to help parents understand the vaccines are safe and effective – and that they save lives.

That (experience) will help us in some ways. Unfortunately, there is more misinformation out there – there is almost a concerted effort on misinformation. It’s big.

Pediatricians will do everything we can, but we need help countering it. We need the misinformation to quit getting spread on social media. We can talk one on one with patients and families, but if all they are hearing on social media is the misinformation, it’s really hard.
 

Q: Are pediatricians, especially solo practitioners or pediatricians at smaller practices, going to face challenges with multidose vials and not wasting vaccine product?

Dr. Goza: I’m at a small practice. We have 3.5 FTEs (full-time equivalents) of MDs and three FTEs of nurse practitioners. So we’re not that big – about six providers.

You know, it is a challenge. We’re not going to buy the super-duper freezer, and we’re not going to be able to store these vaccines for a long period of time.

So when we order, we need smaller amounts. For the 12- to 18-year-olds, [maximum storage] was 45 days. Now for the 5- to 11-year-olds, we’re going to be able to store the vaccine in the refrigerator for 10 weeks, which gives us more leeway there.

We try to do all of vaccinations on 1 day, so we know how many people are coming in, and we are not going to waste too many doses.

Our Department of Public Health in Georgia has said: “We want these vaccines in the arms of kids, and if you have to waste some doses, don’t worry about it.” But it’s a 10-dose vial. It’s going to be hard for me to open it up for one child. I just don’t like wasting anything like this.

Our main goal is to get this vaccine in to the arms of children whose parents want it.
 

Q: What are some additional sources of information for pediatricians?

Dr. Zerr: There are a lot of great resources on vaccine hesitancy from reputable sources, including these from the CDC and from the National Academies of Sciences, Engineering, and Medicine:

• Building Confidence With OVID-19 Vaccines
• How to Talk With Parents About COVID-19 Vaccination
• Strategies for Building Confidence in the COVID-19 Vaccines
• Communication Strategies for Building Confidence in COVID-19 Vaccines: Addressing Variants and Childhood Vaccinations

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

Adding anti-inflammatory corticosteroids to antibiotics for certain pediatric throat and ocular infections may have some benefit, according to results from two recent database studies, but their benefit remains unclear.

Using steroids in this setting is a practice many pediatricians consider, although no clear guidance exists.

Drawing on data from a registry of 51 free-standing children’s hospitals in the Pediatric Health Information System (PHIS), and published online in Pediatrics, the analyses looked, respectively, at retro- and parapharyngeal abscesses (RPAs/PPAs) and acute orbital cellulitis.
 

Throat abscesses

In the first study, pediatrician Pratichi K. Goenka, MD, of Cohen Children’s Medical Center–Northwell Health and an assistant professor at Hofstra University, both in New Hyde Park, N.Y., and colleagues reported on the effect of systemic corticosteroids on several outcomes in RPAs/PPAs in 2,259 well-matched patients. The patients, aged 2 months to 8 years, were treated at 46 hospitals during the period from January 2016 to December 2019.

The data revealed that the 582 (25.8%) who received steroids had a significantly lower rate of surgical drainage, the study’s primary endpoint (odds ratio, 0.28; 95% confidence interval, 0.22-0.36). There was no difference, however, in length of hospital stay (rate ratio, 0.97; 95% CI, 0.92-1.02).

Those in the steroid group also had lower overall hospital costs and were less likely to be given opioid medications for pain. They were, however, more likely to undergo repeat CT imaging and also had a higher 7-day ED revisit rate but no increase in readmission 30 days after discharge: 4% versus 3% in the nonsteroid group (P = .29).

“As hospitalists, we share the care of young children with RPAs and PPAs with our otolaryngology colleagues. The primary therapy is antibiotics but there was no clear guidance on the next step, and the current literature had no answers as to how systemic corticosteroids might impact the care of these children,” Dr. Goenka said in an interview. “So we wanted to leverage the PHIS data to better understand the association with the need for surgery and length of stay. Surgery is painful and often involves IV administration of opioid painkillers. It’s something we may be able to avoid if we can optimize medical treatment.”

Pending results from randomized trials, what immediate impact could these registry findings have? “We hope that physicians will think about the best initial medical treatment plan for these children,” Dr. Goenka said. ”Given these data, I would be more likely to incorporate steroids early on in medical treatment.”

She emphasized, however, that before routine adoption prospective studies are needed to clearly identify which patients will have a strong benefit and which will not benefit. “That is the nuanced discussion that will happen with more prospective work.”

Dr. Goenka and associates explained that the rising incidence of RPAs and PPAs over the past 20 years has been attributed to more cases of tonsillitis because of a shift away from tonsillectomies, as well as the changing epidemiology of methicillin-resistant Staphylococcus aureus.

In an accompanying editorial, Ellen R. Wald, MD, and Jens C. Eickhoff, PhD, of the University of Wisconsin–Madison, stated that the use of corticosteroids in bacterial meningitis is often cited as an example of the benefits of steroids in infection. “The specific rationale for use of corticosteroids is [their] anti-inflammatory effects, which may result in decreases of swelling and/ or edema to facilitate drainage, perfusion, reduction in pain, and healing.”

They cautioned, however, that the pharmacologic effects of steroids are myriad and complicated, and include potential masking of the clinical course of disease, thereby delaying appropriate therapy for unrecognized deterioration, as well potential immunosuppression.
 

Acute orbital cellulitis

In the second retrospective analysis, a group led by pediatrician Maria Anna Leszczynska, MD, of Johns Hopkins All Children’s Hospital in Baltimore, analyzed a retrospective PHIS cohort of 5,645 children younger than 18 years with a primary diagnosis of orbital cellulitis treated at 51 hospitals from January 2007 to December 2018.

Of these, 1,347 (24%) received steroids, but, contrary to earlier reports, the data showed no reduction in length of stay associated with these drugs after adjustment for age, meningitis, abscess, or vision issues (e_beta, 1.01; 95% CI, 0.97-1.06). Corticosteroid exposure was, however, associated with operative episodes after 2 days’ hospitalization (OR, 2.05; 95% CI, 1.29-3.27) and 30-day readmission (OR, 2.40; 95% CI, 1.52-3.78).

“Among children hospitalized for orbital cellulitis, we did not observe the reduction in LOS [length of stay] for patients prescribed systemic corticosteroids as described previously in the literature,” the authors wrote.

In terms of surgical procedures, 52.0% of corticosteroid recipients versus 14.0% of nonrecipients underwent surgery (P < .001), and more were hospitalized in the pediatric ICU (4.4% vs 2.6%; P < .001).

According to the editorialists: “Both observations suggest that children who received steroids may have been a sicker group of patients.”

Dr. Wald and Dr. Eickhoff pointed out that the effect of steroids is ultimately unclear because of the retrospective study’s inherent potential for bias because of unobserved confounders. Were steroids prescribed more often when children were perceived to be sicker with more severe disease, or did these medications cause worse outcomes?

The authors agreed that the study could not determine causality. “Although we used all available markers of disease severity, there does not exist a validated disease severity clinical score for pediatric orbital cellulitis,” they wrote.

According to Ricardo A. Quinonez, MD, an associate professor of pediatrics and division and service chief of pediatric hospital medicine at Baylor College of Medicine and Texas Children’s Hospital, both in Houston, “orbital cellulitis is a not very common thing in children so we don’t treat many patients with this. But having said that, there is usually some debate among providers about whether to use steroids.”

Some centers use them routinely for central nervous system and eye infections or extensions of sinusitis, he said, but there is variability in the prescribing of corticosteroids. “There’s ongoing discussion as to whether they‘re as helpful in orbital cellulitis as they are in similar conditions,” Dr. Quinonez said in an interview. “At our institution we don’t typically prescribe them – not never but not routinely. Children who are sicker tend to get steroids, as they do in other conditions.”

In the context of PPA as in the first study, he added, “I think the evidence favoring the use of steroids in infections that affect the airway is stronger, and their use is definitely more prevalent in those instances.”

While both PHIS analyses suggested some benefit from steroids, he continued, some children may not benefit and there may be harms. “The evidence is still mostly retrospective and observational with no multicenter randomized controlled data. Without those data the evidence is difficult to interpret and subject to all the biases that observational and retrospective data is subject to and the current evidence should not lead physicians to change their practice until controlled, randomized evidence is available.”

The editorialists concurred with the study authors and Dr. Quinonez that large, controlled, prospective clinical trials are needed to ascertain the effect of steroids and to standardize the approach to diagnosis and management. “Use of administrative databases are not optimal to answer questions related to outcome,” they wrote.

The study by Dr. Goenka and associates received no external funding; the study by Dr. Leszczynska and associates also received no external funding. None of the authors declared potential competing interests. Dr. Quinonez had no competing interests to declare. Dr. Wald and Dr. Eickhoff disclosed no competing interests with regard to their editorial.

Adding anti-inflammatory corticosteroids to antibiotics for certain pediatric throat and ocular infections may have some benefit, according to results from two recent database studies, but their benefit remains unclear.

Using steroids in this setting is a practice many pediatricians consider, although no clear guidance exists.

Drawing on data from a registry of 51 free-standing children’s hospitals in the Pediatric Health Information System (PHIS), and published online in Pediatrics, the analyses looked, respectively, at retro- and parapharyngeal abscesses (RPAs/PPAs) and acute orbital cellulitis.
 

Throat abscesses

In the first study, pediatrician Pratichi K. Goenka, MD, of Cohen Children’s Medical Center–Northwell Health and an assistant professor at Hofstra University, both in New Hyde Park, N.Y., and colleagues reported on the effect of systemic corticosteroids on several outcomes in RPAs/PPAs in 2,259 well-matched patients. The patients, aged 2 months to 8 years, were treated at 46 hospitals during the period from January 2016 to December 2019.

The data revealed that the 582 (25.8%) who received steroids had a significantly lower rate of surgical drainage, the study’s primary endpoint (odds ratio, 0.28; 95% confidence interval, 0.22-0.36). There was no difference, however, in length of hospital stay (rate ratio, 0.97; 95% CI, 0.92-1.02).

Those in the steroid group also had lower overall hospital costs and were less likely to be given opioid medications for pain. They were, however, more likely to undergo repeat CT imaging and also had a higher 7-day ED revisit rate but no increase in readmission 30 days after discharge: 4% versus 3% in the nonsteroid group (P = .29).

“As hospitalists, we share the care of young children with RPAs and PPAs with our otolaryngology colleagues. The primary therapy is antibiotics but there was no clear guidance on the next step, and the current literature had no answers as to how systemic corticosteroids might impact the care of these children,” Dr. Goenka said in an interview. “So we wanted to leverage the PHIS data to better understand the association with the need for surgery and length of stay. Surgery is painful and often involves IV administration of opioid painkillers. It’s something we may be able to avoid if we can optimize medical treatment.”

Pending results from randomized trials, what immediate impact could these registry findings have? “We hope that physicians will think about the best initial medical treatment plan for these children,” Dr. Goenka said. ”Given these data, I would be more likely to incorporate steroids early on in medical treatment.”

She emphasized, however, that before routine adoption prospective studies are needed to clearly identify which patients will have a strong benefit and which will not benefit. “That is the nuanced discussion that will happen with more prospective work.”

Dr. Goenka and associates explained that the rising incidence of RPAs and PPAs over the past 20 years has been attributed to more cases of tonsillitis because of a shift away from tonsillectomies, as well as the changing epidemiology of methicillin-resistant Staphylococcus aureus.

In an accompanying editorial, Ellen R. Wald, MD, and Jens C. Eickhoff, PhD, of the University of Wisconsin–Madison, stated that the use of corticosteroids in bacterial meningitis is often cited as an example of the benefits of steroids in infection. “The specific rationale for use of corticosteroids is [their] anti-inflammatory effects, which may result in decreases of swelling and/ or edema to facilitate drainage, perfusion, reduction in pain, and healing.”

They cautioned, however, that the pharmacologic effects of steroids are myriad and complicated, and include potential masking of the clinical course of disease, thereby delaying appropriate therapy for unrecognized deterioration, as well potential immunosuppression.
 

Acute orbital cellulitis

In the second retrospective analysis, a group led by pediatrician Maria Anna Leszczynska, MD, of Johns Hopkins All Children’s Hospital in Baltimore, analyzed a retrospective PHIS cohort of 5,645 children younger than 18 years with a primary diagnosis of orbital cellulitis treated at 51 hospitals from January 2007 to December 2018.

Of these, 1,347 (24%) received steroids, but, contrary to earlier reports, the data showed no reduction in length of stay associated with these drugs after adjustment for age, meningitis, abscess, or vision issues (e_beta, 1.01; 95% CI, 0.97-1.06). Corticosteroid exposure was, however, associated with operative episodes after 2 days’ hospitalization (OR, 2.05; 95% CI, 1.29-3.27) and 30-day readmission (OR, 2.40; 95% CI, 1.52-3.78).

“Among children hospitalized for orbital cellulitis, we did not observe the reduction in LOS [length of stay] for patients prescribed systemic corticosteroids as described previously in the literature,” the authors wrote.

In terms of surgical procedures, 52.0% of corticosteroid recipients versus 14.0% of nonrecipients underwent surgery (P < .001), and more were hospitalized in the pediatric ICU (4.4% vs 2.6%; P < .001).

According to the editorialists: “Both observations suggest that children who received steroids may have been a sicker group of patients.”

Dr. Wald and Dr. Eickhoff pointed out that the effect of steroids is ultimately unclear because of the retrospective study’s inherent potential for bias because of unobserved confounders. Were steroids prescribed more often when children were perceived to be sicker with more severe disease, or did these medications cause worse outcomes?

The authors agreed that the study could not determine causality. “Although we used all available markers of disease severity, there does not exist a validated disease severity clinical score for pediatric orbital cellulitis,” they wrote.

According to Ricardo A. Quinonez, MD, an associate professor of pediatrics and division and service chief of pediatric hospital medicine at Baylor College of Medicine and Texas Children’s Hospital, both in Houston, “orbital cellulitis is a not very common thing in children so we don’t treat many patients with this. But having said that, there is usually some debate among providers about whether to use steroids.”

Some centers use them routinely for central nervous system and eye infections or extensions of sinusitis, he said, but there is variability in the prescribing of corticosteroids. “There’s ongoing discussion as to whether they‘re as helpful in orbital cellulitis as they are in similar conditions,” Dr. Quinonez said in an interview. “At our institution we don’t typically prescribe them – not never but not routinely. Children who are sicker tend to get steroids, as they do in other conditions.”

In the context of PPA as in the first study, he added, “I think the evidence favoring the use of steroids in infections that affect the airway is stronger, and their use is definitely more prevalent in those instances.”

While both PHIS analyses suggested some benefit from steroids, he continued, some children may not benefit and there may be harms. “The evidence is still mostly retrospective and observational with no multicenter randomized controlled data. Without those data the evidence is difficult to interpret and subject to all the biases that observational and retrospective data is subject to and the current evidence should not lead physicians to change their practice until controlled, randomized evidence is available.”

The editorialists concurred with the study authors and Dr. Quinonez that large, controlled, prospective clinical trials are needed to ascertain the effect of steroids and to standardize the approach to diagnosis and management. “Use of administrative databases are not optimal to answer questions related to outcome,” they wrote.

The study by Dr. Goenka and associates received no external funding; the study by Dr. Leszczynska and associates also received no external funding. None of the authors declared potential competing interests. Dr. Quinonez had no competing interests to declare. Dr. Wald and Dr. Eickhoff disclosed no competing interests with regard to their editorial.

Adding anti-inflammatory corticosteroids to antibiotics for certain pediatric throat and ocular infections may have some benefit, according to results from two recent database studies, but their benefit remains unclear.

Using steroids in this setting is a practice many pediatricians consider, although no clear guidance exists.

Drawing on data from a registry of 51 free-standing children’s hospitals in the Pediatric Health Information System (PHIS), and published online in Pediatrics, the analyses looked, respectively, at retro- and parapharyngeal abscesses (RPAs/PPAs) and acute orbital cellulitis.
 

Throat abscesses

In the first study, pediatrician Pratichi K. Goenka, MD, of Cohen Children’s Medical Center–Northwell Health and an assistant professor at Hofstra University, both in New Hyde Park, N.Y., and colleagues reported on the effect of systemic corticosteroids on several outcomes in RPAs/PPAs in 2,259 well-matched patients. The patients, aged 2 months to 8 years, were treated at 46 hospitals during the period from January 2016 to December 2019.

The data revealed that the 582 (25.8%) who received steroids had a significantly lower rate of surgical drainage, the study’s primary endpoint (odds ratio, 0.28; 95% confidence interval, 0.22-0.36). There was no difference, however, in length of hospital stay (rate ratio, 0.97; 95% CI, 0.92-1.02).

Those in the steroid group also had lower overall hospital costs and were less likely to be given opioid medications for pain. They were, however, more likely to undergo repeat CT imaging and also had a higher 7-day ED revisit rate but no increase in readmission 30 days after discharge: 4% versus 3% in the nonsteroid group (P = .29).

“As hospitalists, we share the care of young children with RPAs and PPAs with our otolaryngology colleagues. The primary therapy is antibiotics but there was no clear guidance on the next step, and the current literature had no answers as to how systemic corticosteroids might impact the care of these children,” Dr. Goenka said in an interview. “So we wanted to leverage the PHIS data to better understand the association with the need for surgery and length of stay. Surgery is painful and often involves IV administration of opioid painkillers. It’s something we may be able to avoid if we can optimize medical treatment.”

Pending results from randomized trials, what immediate impact could these registry findings have? “We hope that physicians will think about the best initial medical treatment plan for these children,” Dr. Goenka said. ”Given these data, I would be more likely to incorporate steroids early on in medical treatment.”

She emphasized, however, that before routine adoption prospective studies are needed to clearly identify which patients will have a strong benefit and which will not benefit. “That is the nuanced discussion that will happen with more prospective work.”

Dr. Goenka and associates explained that the rising incidence of RPAs and PPAs over the past 20 years has been attributed to more cases of tonsillitis because of a shift away from tonsillectomies, as well as the changing epidemiology of methicillin-resistant Staphylococcus aureus.

In an accompanying editorial, Ellen R. Wald, MD, and Jens C. Eickhoff, PhD, of the University of Wisconsin–Madison, stated that the use of corticosteroids in bacterial meningitis is often cited as an example of the benefits of steroids in infection. “The specific rationale for use of corticosteroids is [their] anti-inflammatory effects, which may result in decreases of swelling and/ or edema to facilitate drainage, perfusion, reduction in pain, and healing.”

They cautioned, however, that the pharmacologic effects of steroids are myriad and complicated, and include potential masking of the clinical course of disease, thereby delaying appropriate therapy for unrecognized deterioration, as well potential immunosuppression.
 

Acute orbital cellulitis

In the second retrospective analysis, a group led by pediatrician Maria Anna Leszczynska, MD, of Johns Hopkins All Children’s Hospital in Baltimore, analyzed a retrospective PHIS cohort of 5,645 children younger than 18 years with a primary diagnosis of orbital cellulitis treated at 51 hospitals from January 2007 to December 2018.

Of these, 1,347 (24%) received steroids, but, contrary to earlier reports, the data showed no reduction in length of stay associated with these drugs after adjustment for age, meningitis, abscess, or vision issues (e_beta, 1.01; 95% CI, 0.97-1.06). Corticosteroid exposure was, however, associated with operative episodes after 2 days’ hospitalization (OR, 2.05; 95% CI, 1.29-3.27) and 30-day readmission (OR, 2.40; 95% CI, 1.52-3.78).

“Among children hospitalized for orbital cellulitis, we did not observe the reduction in LOS [length of stay] for patients prescribed systemic corticosteroids as described previously in the literature,” the authors wrote.

In terms of surgical procedures, 52.0% of corticosteroid recipients versus 14.0% of nonrecipients underwent surgery (P < .001), and more were hospitalized in the pediatric ICU (4.4% vs 2.6%; P < .001).

According to the editorialists: “Both observations suggest that children who received steroids may have been a sicker group of patients.”

Dr. Wald and Dr. Eickhoff pointed out that the effect of steroids is ultimately unclear because of the retrospective study’s inherent potential for bias because of unobserved confounders. Were steroids prescribed more often when children were perceived to be sicker with more severe disease, or did these medications cause worse outcomes?

The authors agreed that the study could not determine causality. “Although we used all available markers of disease severity, there does not exist a validated disease severity clinical score for pediatric orbital cellulitis,” they wrote.

According to Ricardo A. Quinonez, MD, an associate professor of pediatrics and division and service chief of pediatric hospital medicine at Baylor College of Medicine and Texas Children’s Hospital, both in Houston, “orbital cellulitis is a not very common thing in children so we don’t treat many patients with this. But having said that, there is usually some debate among providers about whether to use steroids.”

Some centers use them routinely for central nervous system and eye infections or extensions of sinusitis, he said, but there is variability in the prescribing of corticosteroids. “There’s ongoing discussion as to whether they‘re as helpful in orbital cellulitis as they are in similar conditions,” Dr. Quinonez said in an interview. “At our institution we don’t typically prescribe them – not never but not routinely. Children who are sicker tend to get steroids, as they do in other conditions.”

In the context of PPA as in the first study, he added, “I think the evidence favoring the use of steroids in infections that affect the airway is stronger, and their use is definitely more prevalent in those instances.”

While both PHIS analyses suggested some benefit from steroids, he continued, some children may not benefit and there may be harms. “The evidence is still mostly retrospective and observational with no multicenter randomized controlled data. Without those data the evidence is difficult to interpret and subject to all the biases that observational and retrospective data is subject to and the current evidence should not lead physicians to change their practice until controlled, randomized evidence is available.”

The editorialists concurred with the study authors and Dr. Quinonez that large, controlled, prospective clinical trials are needed to ascertain the effect of steroids and to standardize the approach to diagnosis and management. “Use of administrative databases are not optimal to answer questions related to outcome,” they wrote.

The study by Dr. Goenka and associates received no external funding; the study by Dr. Leszczynska and associates also received no external funding. None of the authors declared potential competing interests. Dr. Quinonez had no competing interests to declare. Dr. Wald and Dr. Eickhoff disclosed no competing interests with regard to their editorial.

The Diagnosis: Calcinosis Cutis Due to Systemic Sclerosis Sine Scleroderma

Laboratory evaluation was notable for high titers of antinuclear antibodies (>1/320; reference range, 0–1/80) and positive anticentromere antibodies. There were no other relevant laboratory findings; phosphocalcic metabolism was within normal limits, and urinary sediment was normal. Biopsy of the edge of the ulcer revealed basophilic material compatible with calcium deposits. In a 3D volume rendering reconstruction from the lower limb scanner, grouped calcifications were observed in subcutaneous cellular tissue near the ulcer (Figure). The patient had a restrictive ventilatory pattern observed in a pulmonary function test. An esophageal motility study was normal.

The patient was diagnosed with systemic sclerosis sine scleroderma (ssSSc) type II because she met the 4 criteria established by Poormoghim et al¹ : (1) Raynaud phenomenon or a peripheral vascular equivalent (ie, digital pitting scars, digital-tip ulcers, digital-tip gangrene, abnormal nail fold capillaries); (2) positive antinuclear antibodies; (3) distal esophageal hypomotility, small bowel hypomotility, pulmonary interstitial fibrosis, primary pulmonary arterial hypertension (without fibrosis), cardiac involvement typical of scleroderma, or renal failure; and (4) no other defined connective tissue or other disease as a cause of the prior conditions.

Systemic sclerosis is a chronic disease characterized by progressive fibrosis of the skin and other internal organs—especially the lungs, kidneys, digestive tract, and heart—as well as generalized vascular dysfunction. Cutaneous induration is its hallmark; however, up to 10% of affected patients have ssSSc.² This entity is characterized by the total or partial absence of cutaneous manifestations of systemic sclerosis with the occurrence of internal organ involvement and serologic abnormalities. There are 3 types of ssSSc depending on the grade of skin involvement. Type I is characterized by the lack of any typical cutaneous stigmata of the disease. Type II is without sclerodactyly but can coexist with other cutaneous findings such as calcifications, telangiectases, or pitting scars. Type III is characterized clinically by internal organ involvement, typical of systemic sclerosis, that has appeared before skin changes.²

An abnormal deposit of calcium in the cutaneous and subcutaneous tissue is called calcinosis cutis. There are 5 subtypes of calcinosis cutis: dystrophic, metastatic, idiopathic, iatrogenic, and calciphylaxis. Dystrophic skin calcifications may appear in patients with connective tissue diseases such as dermatomyositis or systemic sclerosis.³ Up to 25% of patients with systemic sclerosis can develop calcinosis cutis due to local tissue damage, with normal phosphocalcic metabolism.³

Calcinosis cutis is more common in patients with systemic sclerosis and positive anticentromere antibodies.⁴ The calcifications usually are located in areas that are subject to repeated trauma, such as the fingers or arms, though other locations have been described such as cervical, paraspinal, or on the hips.^5,6 Our patient developed calcifications on both legs, which represent atypical areas for this process.

Dermatomyositis also can present with calcinosis cutis. There are 4 patterns of calcification: superficial nodulelike calcified masses; deep calcified masses; deep sheetlike calcifications within the fascial planes; and a rare, diffuse, superficial lacy and reticular calcification that involves almost the entire body surface area.⁷ Patients with calcinosis cutis secondary to dermatomyositis usually develop proximal muscle weakness, high titers of creatine kinase, heliotrope rash, or interstitial lung disease with specific antibodies.

Calciphylaxis is a serious disorder involving the calcification of dermal and subcutaneous arterioles and capillaries. It presents with painful cutaneous areas of necrosis.

Venous ulcers also can present with secondary dystrophic calcification due to local tissue damage. These patients usually have cutaneous signs of chronic venous insufficiency. Our patient denied prior trauma to the area; therefore, a traumatic ulcer with secondary calcification was ruled out.

The most concerning complication of calcinosis cutis is the development of ulcers, which occurred in 154 of 316 calcinoses (48.7%) in patients with systemic sclerosis and secondary calcifications.⁸ These ulcers can cause disabling pain or become superinfected, as in our patient.

There currently is no drug capable of removing dystrophic calcifications, but diltiazem, minocycline, or colchicine can reduce their size and prevent their progression. In the event of neurologic compromise or intractable pain, the treatment of choice is surgical removal of the calcification.⁹ Curettage, intralesional sodium thiosulfate, and intravenous sodium thiosulfate also have been suggested as therapeutic options.¹⁰ Antibiotic treatment was carried out in our patient, which controlled the superinfection of the ulcers. Diltiazem also was started, with stabilization of the calcium deposits without a reduction in their size.

There are few studies evaluating the presence of nondigital ulcers in patients with systemic sclerosis. Shanmugam et al¹¹ calculated a 4% (N=249) prevalence of ulcers in the lower limbs of systemic sclerosis patients. In a study by Bohelay et al¹² of 45 patients, the estimated prevalence of lower limb ulcers was 12.8%, and the etiologies consisted of 22 cases of venous insufficiency (49%), 21 cases of ischemic causes (47%), and 2 cases of other causes (4%).

We present the case of a woman with ssSSc who developed dystrophic calcinosis cutis in atypical areas with secondary ulceration and superinfection. The skin usually plays a key role in the diagnosis of systemic sclerosis, as sclerodactyly and the characteristic generalized skin induration stand out in affected individuals. Although our patient was diagnosed with ssSSc, her skin manifestations also were crucial for the diagnosis, as she had ulcers on the lower limbs.

The Diagnosis: Calcinosis Cutis Due to Systemic Sclerosis Sine Scleroderma

Laboratory evaluation was notable for high titers of antinuclear antibodies (>1/320; reference range, 0–1/80) and positive anticentromere antibodies. There were no other relevant laboratory findings; phosphocalcic metabolism was within normal limits, and urinary sediment was normal. Biopsy of the edge of the ulcer revealed basophilic material compatible with calcium deposits. In a 3D volume rendering reconstruction from the lower limb scanner, grouped calcifications were observed in subcutaneous cellular tissue near the ulcer (Figure). The patient had a restrictive ventilatory pattern observed in a pulmonary function test. An esophageal motility study was normal.

The patient was diagnosed with systemic sclerosis sine scleroderma (ssSSc) type II because she met the 4 criteria established by Poormoghim et al¹ : (1) Raynaud phenomenon or a peripheral vascular equivalent (ie, digital pitting scars, digital-tip ulcers, digital-tip gangrene, abnormal nail fold capillaries); (2) positive antinuclear antibodies; (3) distal esophageal hypomotility, small bowel hypomotility, pulmonary interstitial fibrosis, primary pulmonary arterial hypertension (without fibrosis), cardiac involvement typical of scleroderma, or renal failure; and (4) no other defined connective tissue or other disease as a cause of the prior conditions.

Systemic sclerosis is a chronic disease characterized by progressive fibrosis of the skin and other internal organs—especially the lungs, kidneys, digestive tract, and heart—as well as generalized vascular dysfunction. Cutaneous induration is its hallmark; however, up to 10% of affected patients have ssSSc.² This entity is characterized by the total or partial absence of cutaneous manifestations of systemic sclerosis with the occurrence of internal organ involvement and serologic abnormalities. There are 3 types of ssSSc depending on the grade of skin involvement. Type I is characterized by the lack of any typical cutaneous stigmata of the disease. Type II is without sclerodactyly but can coexist with other cutaneous findings such as calcifications, telangiectases, or pitting scars. Type III is characterized clinically by internal organ involvement, typical of systemic sclerosis, that has appeared before skin changes.²

An abnormal deposit of calcium in the cutaneous and subcutaneous tissue is called calcinosis cutis. There are 5 subtypes of calcinosis cutis: dystrophic, metastatic, idiopathic, iatrogenic, and calciphylaxis. Dystrophic skin calcifications may appear in patients with connective tissue diseases such as dermatomyositis or systemic sclerosis.³ Up to 25% of patients with systemic sclerosis can develop calcinosis cutis due to local tissue damage, with normal phosphocalcic metabolism.³

Calcinosis cutis is more common in patients with systemic sclerosis and positive anticentromere antibodies.⁴ The calcifications usually are located in areas that are subject to repeated trauma, such as the fingers or arms, though other locations have been described such as cervical, paraspinal, or on the hips.^5,6 Our patient developed calcifications on both legs, which represent atypical areas for this process.

Dermatomyositis also can present with calcinosis cutis. There are 4 patterns of calcification: superficial nodulelike calcified masses; deep calcified masses; deep sheetlike calcifications within the fascial planes; and a rare, diffuse, superficial lacy and reticular calcification that involves almost the entire body surface area.⁷ Patients with calcinosis cutis secondary to dermatomyositis usually develop proximal muscle weakness, high titers of creatine kinase, heliotrope rash, or interstitial lung disease with specific antibodies.

Calciphylaxis is a serious disorder involving the calcification of dermal and subcutaneous arterioles and capillaries. It presents with painful cutaneous areas of necrosis.

Venous ulcers also can present with secondary dystrophic calcification due to local tissue damage. These patients usually have cutaneous signs of chronic venous insufficiency. Our patient denied prior trauma to the area; therefore, a traumatic ulcer with secondary calcification was ruled out.

The most concerning complication of calcinosis cutis is the development of ulcers, which occurred in 154 of 316 calcinoses (48.7%) in patients with systemic sclerosis and secondary calcifications.⁸ These ulcers can cause disabling pain or become superinfected, as in our patient.

There currently is no drug capable of removing dystrophic calcifications, but diltiazem, minocycline, or colchicine can reduce their size and prevent their progression. In the event of neurologic compromise or intractable pain, the treatment of choice is surgical removal of the calcification.⁹ Curettage, intralesional sodium thiosulfate, and intravenous sodium thiosulfate also have been suggested as therapeutic options.¹⁰ Antibiotic treatment was carried out in our patient, which controlled the superinfection of the ulcers. Diltiazem also was started, with stabilization of the calcium deposits without a reduction in their size.

There are few studies evaluating the presence of nondigital ulcers in patients with systemic sclerosis. Shanmugam et al¹¹ calculated a 4% (N=249) prevalence of ulcers in the lower limbs of systemic sclerosis patients. In a study by Bohelay et al¹² of 45 patients, the estimated prevalence of lower limb ulcers was 12.8%, and the etiologies consisted of 22 cases of venous insufficiency (49%), 21 cases of ischemic causes (47%), and 2 cases of other causes (4%).

We present the case of a woman with ssSSc who developed dystrophic calcinosis cutis in atypical areas with secondary ulceration and superinfection. The skin usually plays a key role in the diagnosis of systemic sclerosis, as sclerodactyly and the characteristic generalized skin induration stand out in affected individuals. Although our patient was diagnosed with ssSSc, her skin manifestations also were crucial for the diagnosis, as she had ulcers on the lower limbs.

The Diagnosis: Calcinosis Cutis Due to Systemic Sclerosis Sine Scleroderma

Laboratory evaluation was notable for high titers of antinuclear antibodies (>1/320; reference range, 0–1/80) and positive anticentromere antibodies. There were no other relevant laboratory findings; phosphocalcic metabolism was within normal limits, and urinary sediment was normal. Biopsy of the edge of the ulcer revealed basophilic material compatible with calcium deposits. In a 3D volume rendering reconstruction from the lower limb scanner, grouped calcifications were observed in subcutaneous cellular tissue near the ulcer (Figure). The patient had a restrictive ventilatory pattern observed in a pulmonary function test. An esophageal motility study was normal.

The patient was diagnosed with systemic sclerosis sine scleroderma (ssSSc) type II because she met the 4 criteria established by Poormoghim et al¹ : (1) Raynaud phenomenon or a peripheral vascular equivalent (ie, digital pitting scars, digital-tip ulcers, digital-tip gangrene, abnormal nail fold capillaries); (2) positive antinuclear antibodies; (3) distal esophageal hypomotility, small bowel hypomotility, pulmonary interstitial fibrosis, primary pulmonary arterial hypertension (without fibrosis), cardiac involvement typical of scleroderma, or renal failure; and (4) no other defined connective tissue or other disease as a cause of the prior conditions.

Systemic sclerosis is a chronic disease characterized by progressive fibrosis of the skin and other internal organs—especially the lungs, kidneys, digestive tract, and heart—as well as generalized vascular dysfunction. Cutaneous induration is its hallmark; however, up to 10% of affected patients have ssSSc.² This entity is characterized by the total or partial absence of cutaneous manifestations of systemic sclerosis with the occurrence of internal organ involvement and serologic abnormalities. There are 3 types of ssSSc depending on the grade of skin involvement. Type I is characterized by the lack of any typical cutaneous stigmata of the disease. Type II is without sclerodactyly but can coexist with other cutaneous findings such as calcifications, telangiectases, or pitting scars. Type III is characterized clinically by internal organ involvement, typical of systemic sclerosis, that has appeared before skin changes.²

An abnormal deposit of calcium in the cutaneous and subcutaneous tissue is called calcinosis cutis. There are 5 subtypes of calcinosis cutis: dystrophic, metastatic, idiopathic, iatrogenic, and calciphylaxis. Dystrophic skin calcifications may appear in patients with connective tissue diseases such as dermatomyositis or systemic sclerosis.³ Up to 25% of patients with systemic sclerosis can develop calcinosis cutis due to local tissue damage, with normal phosphocalcic metabolism.³

Calcinosis cutis is more common in patients with systemic sclerosis and positive anticentromere antibodies.⁴ The calcifications usually are located in areas that are subject to repeated trauma, such as the fingers or arms, though other locations have been described such as cervical, paraspinal, or on the hips.^5,6 Our patient developed calcifications on both legs, which represent atypical areas for this process.

Dermatomyositis also can present with calcinosis cutis. There are 4 patterns of calcification: superficial nodulelike calcified masses; deep calcified masses; deep sheetlike calcifications within the fascial planes; and a rare, diffuse, superficial lacy and reticular calcification that involves almost the entire body surface area.⁷ Patients with calcinosis cutis secondary to dermatomyositis usually develop proximal muscle weakness, high titers of creatine kinase, heliotrope rash, or interstitial lung disease with specific antibodies.

Calciphylaxis is a serious disorder involving the calcification of dermal and subcutaneous arterioles and capillaries. It presents with painful cutaneous areas of necrosis.

Venous ulcers also can present with secondary dystrophic calcification due to local tissue damage. These patients usually have cutaneous signs of chronic venous insufficiency. Our patient denied prior trauma to the area; therefore, a traumatic ulcer with secondary calcification was ruled out.

The most concerning complication of calcinosis cutis is the development of ulcers, which occurred in 154 of 316 calcinoses (48.7%) in patients with systemic sclerosis and secondary calcifications.⁸ These ulcers can cause disabling pain or become superinfected, as in our patient.

There currently is no drug capable of removing dystrophic calcifications, but diltiazem, minocycline, or colchicine can reduce their size and prevent their progression. In the event of neurologic compromise or intractable pain, the treatment of choice is surgical removal of the calcification.⁹ Curettage, intralesional sodium thiosulfate, and intravenous sodium thiosulfate also have been suggested as therapeutic options.¹⁰ Antibiotic treatment was carried out in our patient, which controlled the superinfection of the ulcers. Diltiazem also was started, with stabilization of the calcium deposits without a reduction in their size.

There are few studies evaluating the presence of nondigital ulcers in patients with systemic sclerosis. Shanmugam et al¹¹ calculated a 4% (N=249) prevalence of ulcers in the lower limbs of systemic sclerosis patients. In a study by Bohelay et al¹² of 45 patients, the estimated prevalence of lower limb ulcers was 12.8%, and the etiologies consisted of 22 cases of venous insufficiency (49%), 21 cases of ischemic causes (47%), and 2 cases of other causes (4%).

We present the case of a woman with ssSSc who developed dystrophic calcinosis cutis in atypical areas with secondary ulceration and superinfection. The skin usually plays a key role in the diagnosis of systemic sclerosis, as sclerodactyly and the characteristic generalized skin induration stand out in affected individuals. Although our patient was diagnosed with ssSSc, her skin manifestations also were crucial for the diagnosis, as she had ulcers on the lower limbs.

Financial hardship remains prevalent among pregnant and postpartum women, despite the implementation of the Affordable Care Act (ACA), according to new findings published in JAMA Network Open.

Nearly a quarter (24%) of pregnant and postpartum women reported having unmet health care needs, 60% had health care unaffordability, and 54% reported general financial stress. Notably, the type of insurance was associated with the ability to afford health care.

Those with private insurance, along with women with lower incomes, were more likely to experience unaffordable health care, compared to those covered by public insurance or who had higher incomes.

Senior study author Michelle H. Moniz, MD, assistant professor in the department of obstetrics and gynecology at the University of Michigan, Ann Arbor, was surprised by multiple study findings. “The prevalence of financial hardship overall, and the three individual indicators of hardship, did not change over time from 2013 to 2018,” she said. “The ACA was enacted just prior to the study period, and while this policy had many benefits for women – especially around increasing insurance coverage – it does not seem to have improved financial hardship among pregnant and postpartum women.”

She emphasized that two groups were at the highest risk of health care unaffordability: those with private insurance and those living on low incomes. “This is notable, as we often think of private insurance as offering ‘Cadillac coverage,’ but our prior work suggests that privately insured women have strikingly high out-of-pocket costs for pregnancy and childbirth-related care,” Dr. Moniz said.

These expenses include deductibles, copays, and coinsurance payments, which come to about $4,500 on average. Medicaid plans, in contrast, have exceedingly low out-of-pocket costs for pregnant and postpartum women. “Findings from the current study call for targeted policy interventions to alleviate financial strain and remove financial barriers to health care access for privately insured families,” she said. “Similarly, families living on lower incomes were also at high risk of health care unaffordability. This may be because even small out-of-pocket costs, or health care–associated costs, account for a larger share of the family’s income.”

This finding for lower-income women calls for targeted policy interventions. “Sliding-scale deductibles, for example, are one solution that might mitigate economic hardship and remove cost-related barriers to health care for pregnant and postpartum women,” Dr. Moniz added.

Health care unaffordability high

In this study, Dr. Moniz and colleagues evaluated the prevalence of financial hardship among peripartum women over time, and how it was affected by their income level and the type of insurance coverage.

They conducted a cross-sectional study that included peripartum women between the ages of 18 and 45 years who reported being currently pregnant or pregnant in the past 12 months. The women were all participants in the National Health Interview Survey, which covers the period from 2013 to 2018, and the data were analyzed from January to May 2021.

The cohort included 3,509 peripartum women, and was weighted to represent 1,050,789 women, with a mean age of 29 years. In 2018, an estimated 39,017 of 184,018 (21.2%) were Black; 36,045 (19.6%) were Hispanic; and 97,366 (52.9%) were White. In the latter years of the study period, the participants tended to be older, more highly educated, and less likely to lack insurance.

When the authors compared the unadjusted reported financial hardship outcome by each study year, unmet health care need (2013: 27.9% [95% confidence interval, 24.4%-31.7%]; 2018: 23.7% [95% CI, 19.5%-28.6%]), health care unaffordability (2013: 65.7% [95% CI, 61.1%-70.0%]; 2018: 58.8% [95% CI, 53.4%-64.0%]), and general financial stress (2013: 60.6% [95% CI, 55.2%-65.8%]; 2018: 53.8% [95% CI, 47.8%-59.8%]) remained largely unchanged between 2013 and 2018.

When they looked at the relationship between insurance type, income, and financial difficulties, some degree of financial hardship was common across all groups; private insurance: 63.8% [95% CI, 61.1%-66.6%]; with public insurance: 49.9% [95% CI, 46.4%-53.4%]; with no insurance: 81.8% [95% CI, 76.4%-87.3%]; with income < 400% of the federal poverty level (FPL): 65.5% [95% CI, 62.1%-66.9%]; with income at least 400% of the FPL: 49.3% [95% CI,44.7%-53.9%]).

Those without any insurance had the highest odds of reporting unmet health care needs (adjusted OR [aOR], 4.40; 95% CI, 3.23-6.00) and health care unaffordability (aOR, 5.18; 95% CI, 3.49-7.70) compared with women who received public insurance.

But while women with private insurance had lower odds of reporting unmet health care needs (aOR, 0.67; 95% CI, 0.52-0.87), they faced higher odds of reporting health care unaffordability (aOR, 1.88; 95% CI, 1.49-2.36) compared to women who had public insurance.

Those with household incomes of less than 400% of the FPL had higher odds of reporting unmet health care need (aOR,1.50; 95% CI, 1.08-2.08) and health care unaffordability (aOR, 1.98; 95% CI, 1.54-2.55) versus women whose household incomes were at least 400% of FPL. The odds of general financial stress did not significantly differ by insurance status/type or income level.

Weighing in on the data

Jamie Daw, PhD, assistant professor of health policy and management, Columbia University Mailman School of Public Health, New York, noted that many people think of private insurance as “good coverage.”

“But the portion of medical costs that patients are required to pay under private plans has risen dramatically over the past decade,” she said. “Over half of the U.S. workforce is now enrolled in high-deductible plans, where the average deductible was $4,500 in 2020. The private insurance of today does not provide sufficient financial protection for most families, who would need to have the liquid assets to cover childbirth.”

Another expert agreed that the high out-of-pocket costs for women with private health insurance were probably responsible for making peripartum health care more unaffordable. These included costs for pregnancy care as well as for maternal and infant care during and after childbirth.

“This study reporting the high unmet medical needs and unaffordability of health care for peripartum women further underscores that the U.S. health care system is not meeting the needs of pregnant women, mothers, and their newborn infants,” said Lois K. Lee, MD, associate professor of pediatrics and emergency medicine at Harvard Medical School and associate director for public policy at the Sandra L. Fenwick Institute for Pediatric Health Equity and Inclusion, Boston.

“It is imperative to optimize the health of pregnant mothers to optimize the health of infants, who are our future society,” she said. “Policies which would expand Medicaid coverage to a full 1-year postpartum across all states is one important strategy to improve health care access and affordability to peripartum women. However, this must be part of a multipronged approach addressing the social determinants of health, as insurance coverage alone will not fully address this important health issue of peripartum women, and their children.”

Dr Moniz reported receiving personal fees from the RAND Corporation, the Society of Family Planning outside the submitted work and grant K08 HS025465 from the Agency for Healthcare Research and Quality. Dr. Daw has no disclosures. Dr. Lee reports speaker fees from the American Academy of Pediatrics and SUNY Upstate Medical University. Coauthor Dr. Taylor was supported by the National Clinician Scholars Program at the University of Michigan. Dr Dalton was supported by grant R01 HS023784 from the Agency for Healthcare Research and Quality.
 

Financial hardship remains prevalent among pregnant and postpartum women, despite the implementation of the Affordable Care Act (ACA), according to new findings published in JAMA Network Open.

Nearly a quarter (24%) of pregnant and postpartum women reported having unmet health care needs, 60% had health care unaffordability, and 54% reported general financial stress. Notably, the type of insurance was associated with the ability to afford health care.

Those with private insurance, along with women with lower incomes, were more likely to experience unaffordable health care, compared to those covered by public insurance or who had higher incomes.

Senior study author Michelle H. Moniz, MD, assistant professor in the department of obstetrics and gynecology at the University of Michigan, Ann Arbor, was surprised by multiple study findings. “The prevalence of financial hardship overall, and the three individual indicators of hardship, did not change over time from 2013 to 2018,” she said. “The ACA was enacted just prior to the study period, and while this policy had many benefits for women – especially around increasing insurance coverage – it does not seem to have improved financial hardship among pregnant and postpartum women.”

She emphasized that two groups were at the highest risk of health care unaffordability: those with private insurance and those living on low incomes. “This is notable, as we often think of private insurance as offering ‘Cadillac coverage,’ but our prior work suggests that privately insured women have strikingly high out-of-pocket costs for pregnancy and childbirth-related care,” Dr. Moniz said.

These expenses include deductibles, copays, and coinsurance payments, which come to about $4,500 on average. Medicaid plans, in contrast, have exceedingly low out-of-pocket costs for pregnant and postpartum women. “Findings from the current study call for targeted policy interventions to alleviate financial strain and remove financial barriers to health care access for privately insured families,” she said. “Similarly, families living on lower incomes were also at high risk of health care unaffordability. This may be because even small out-of-pocket costs, or health care–associated costs, account for a larger share of the family’s income.”

This finding for lower-income women calls for targeted policy interventions. “Sliding-scale deductibles, for example, are one solution that might mitigate economic hardship and remove cost-related barriers to health care for pregnant and postpartum women,” Dr. Moniz added.

Health care unaffordability high

In this study, Dr. Moniz and colleagues evaluated the prevalence of financial hardship among peripartum women over time, and how it was affected by their income level and the type of insurance coverage.

They conducted a cross-sectional study that included peripartum women between the ages of 18 and 45 years who reported being currently pregnant or pregnant in the past 12 months. The women were all participants in the National Health Interview Survey, which covers the period from 2013 to 2018, and the data were analyzed from January to May 2021.

The cohort included 3,509 peripartum women, and was weighted to represent 1,050,789 women, with a mean age of 29 years. In 2018, an estimated 39,017 of 184,018 (21.2%) were Black; 36,045 (19.6%) were Hispanic; and 97,366 (52.9%) were White. In the latter years of the study period, the participants tended to be older, more highly educated, and less likely to lack insurance.

When the authors compared the unadjusted reported financial hardship outcome by each study year, unmet health care need (2013: 27.9% [95% confidence interval, 24.4%-31.7%]; 2018: 23.7% [95% CI, 19.5%-28.6%]), health care unaffordability (2013: 65.7% [95% CI, 61.1%-70.0%]; 2018: 58.8% [95% CI, 53.4%-64.0%]), and general financial stress (2013: 60.6% [95% CI, 55.2%-65.8%]; 2018: 53.8% [95% CI, 47.8%-59.8%]) remained largely unchanged between 2013 and 2018.

When they looked at the relationship between insurance type, income, and financial difficulties, some degree of financial hardship was common across all groups; private insurance: 63.8% [95% CI, 61.1%-66.6%]; with public insurance: 49.9% [95% CI, 46.4%-53.4%]; with no insurance: 81.8% [95% CI, 76.4%-87.3%]; with income < 400% of the federal poverty level (FPL): 65.5% [95% CI, 62.1%-66.9%]; with income at least 400% of the FPL: 49.3% [95% CI,44.7%-53.9%]).

Those without any insurance had the highest odds of reporting unmet health care needs (adjusted OR [aOR], 4.40; 95% CI, 3.23-6.00) and health care unaffordability (aOR, 5.18; 95% CI, 3.49-7.70) compared with women who received public insurance.

But while women with private insurance had lower odds of reporting unmet health care needs (aOR, 0.67; 95% CI, 0.52-0.87), they faced higher odds of reporting health care unaffordability (aOR, 1.88; 95% CI, 1.49-2.36) compared to women who had public insurance.

Those with household incomes of less than 400% of the FPL had higher odds of reporting unmet health care need (aOR,1.50; 95% CI, 1.08-2.08) and health care unaffordability (aOR, 1.98; 95% CI, 1.54-2.55) versus women whose household incomes were at least 400% of FPL. The odds of general financial stress did not significantly differ by insurance status/type or income level.

Weighing in on the data

Jamie Daw, PhD, assistant professor of health policy and management, Columbia University Mailman School of Public Health, New York, noted that many people think of private insurance as “good coverage.”

“But the portion of medical costs that patients are required to pay under private plans has risen dramatically over the past decade,” she said. “Over half of the U.S. workforce is now enrolled in high-deductible plans, where the average deductible was $4,500 in 2020. The private insurance of today does not provide sufficient financial protection for most families, who would need to have the liquid assets to cover childbirth.”

Another expert agreed that the high out-of-pocket costs for women with private health insurance were probably responsible for making peripartum health care more unaffordable. These included costs for pregnancy care as well as for maternal and infant care during and after childbirth.

“This study reporting the high unmet medical needs and unaffordability of health care for peripartum women further underscores that the U.S. health care system is not meeting the needs of pregnant women, mothers, and their newborn infants,” said Lois K. Lee, MD, associate professor of pediatrics and emergency medicine at Harvard Medical School and associate director for public policy at the Sandra L. Fenwick Institute for Pediatric Health Equity and Inclusion, Boston.

“It is imperative to optimize the health of pregnant mothers to optimize the health of infants, who are our future society,” she said. “Policies which would expand Medicaid coverage to a full 1-year postpartum across all states is one important strategy to improve health care access and affordability to peripartum women. However, this must be part of a multipronged approach addressing the social determinants of health, as insurance coverage alone will not fully address this important health issue of peripartum women, and their children.”

Dr Moniz reported receiving personal fees from the RAND Corporation, the Society of Family Planning outside the submitted work and grant K08 HS025465 from the Agency for Healthcare Research and Quality. Dr. Daw has no disclosures. Dr. Lee reports speaker fees from the American Academy of Pediatrics and SUNY Upstate Medical University. Coauthor Dr. Taylor was supported by the National Clinician Scholars Program at the University of Michigan. Dr Dalton was supported by grant R01 HS023784 from the Agency for Healthcare Research and Quality.
 

Financial hardship remains prevalent among pregnant and postpartum women, despite the implementation of the Affordable Care Act (ACA), according to new findings published in JAMA Network Open.

Nearly a quarter (24%) of pregnant and postpartum women reported having unmet health care needs, 60% had health care unaffordability, and 54% reported general financial stress. Notably, the type of insurance was associated with the ability to afford health care.

Those with private insurance, along with women with lower incomes, were more likely to experience unaffordable health care, compared to those covered by public insurance or who had higher incomes.

Senior study author Michelle H. Moniz, MD, assistant professor in the department of obstetrics and gynecology at the University of Michigan, Ann Arbor, was surprised by multiple study findings. “The prevalence of financial hardship overall, and the three individual indicators of hardship, did not change over time from 2013 to 2018,” she said. “The ACA was enacted just prior to the study period, and while this policy had many benefits for women – especially around increasing insurance coverage – it does not seem to have improved financial hardship among pregnant and postpartum women.”

She emphasized that two groups were at the highest risk of health care unaffordability: those with private insurance and those living on low incomes. “This is notable, as we often think of private insurance as offering ‘Cadillac coverage,’ but our prior work suggests that privately insured women have strikingly high out-of-pocket costs for pregnancy and childbirth-related care,” Dr. Moniz said.

These expenses include deductibles, copays, and coinsurance payments, which come to about $4,500 on average. Medicaid plans, in contrast, have exceedingly low out-of-pocket costs for pregnant and postpartum women. “Findings from the current study call for targeted policy interventions to alleviate financial strain and remove financial barriers to health care access for privately insured families,” she said. “Similarly, families living on lower incomes were also at high risk of health care unaffordability. This may be because even small out-of-pocket costs, or health care–associated costs, account for a larger share of the family’s income.”

This finding for lower-income women calls for targeted policy interventions. “Sliding-scale deductibles, for example, are one solution that might mitigate economic hardship and remove cost-related barriers to health care for pregnant and postpartum women,” Dr. Moniz added.

Health care unaffordability high

In this study, Dr. Moniz and colleagues evaluated the prevalence of financial hardship among peripartum women over time, and how it was affected by their income level and the type of insurance coverage.

They conducted a cross-sectional study that included peripartum women between the ages of 18 and 45 years who reported being currently pregnant or pregnant in the past 12 months. The women were all participants in the National Health Interview Survey, which covers the period from 2013 to 2018, and the data were analyzed from January to May 2021.

The cohort included 3,509 peripartum women, and was weighted to represent 1,050,789 women, with a mean age of 29 years. In 2018, an estimated 39,017 of 184,018 (21.2%) were Black; 36,045 (19.6%) were Hispanic; and 97,366 (52.9%) were White. In the latter years of the study period, the participants tended to be older, more highly educated, and less likely to lack insurance.

When the authors compared the unadjusted reported financial hardship outcome by each study year, unmet health care need (2013: 27.9% [95% confidence interval, 24.4%-31.7%]; 2018: 23.7% [95% CI, 19.5%-28.6%]), health care unaffordability (2013: 65.7% [95% CI, 61.1%-70.0%]; 2018: 58.8% [95% CI, 53.4%-64.0%]), and general financial stress (2013: 60.6% [95% CI, 55.2%-65.8%]; 2018: 53.8% [95% CI, 47.8%-59.8%]) remained largely unchanged between 2013 and 2018.

When they looked at the relationship between insurance type, income, and financial difficulties, some degree of financial hardship was common across all groups; private insurance: 63.8% [95% CI, 61.1%-66.6%]; with public insurance: 49.9% [95% CI, 46.4%-53.4%]; with no insurance: 81.8% [95% CI, 76.4%-87.3%]; with income < 400% of the federal poverty level (FPL): 65.5% [95% CI, 62.1%-66.9%]; with income at least 400% of the FPL: 49.3% [95% CI,44.7%-53.9%]).

Those without any insurance had the highest odds of reporting unmet health care needs (adjusted OR [aOR], 4.40; 95% CI, 3.23-6.00) and health care unaffordability (aOR, 5.18; 95% CI, 3.49-7.70) compared with women who received public insurance.

But while women with private insurance had lower odds of reporting unmet health care needs (aOR, 0.67; 95% CI, 0.52-0.87), they faced higher odds of reporting health care unaffordability (aOR, 1.88; 95% CI, 1.49-2.36) compared to women who had public insurance.

Those with household incomes of less than 400% of the FPL had higher odds of reporting unmet health care need (aOR,1.50; 95% CI, 1.08-2.08) and health care unaffordability (aOR, 1.98; 95% CI, 1.54-2.55) versus women whose household incomes were at least 400% of FPL. The odds of general financial stress did not significantly differ by insurance status/type or income level.

Weighing in on the data

Jamie Daw, PhD, assistant professor of health policy and management, Columbia University Mailman School of Public Health, New York, noted that many people think of private insurance as “good coverage.”

“But the portion of medical costs that patients are required to pay under private plans has risen dramatically over the past decade,” she said. “Over half of the U.S. workforce is now enrolled in high-deductible plans, where the average deductible was $4,500 in 2020. The private insurance of today does not provide sufficient financial protection for most families, who would need to have the liquid assets to cover childbirth.”

Another expert agreed that the high out-of-pocket costs for women with private health insurance were probably responsible for making peripartum health care more unaffordable. These included costs for pregnancy care as well as for maternal and infant care during and after childbirth.

“This study reporting the high unmet medical needs and unaffordability of health care for peripartum women further underscores that the U.S. health care system is not meeting the needs of pregnant women, mothers, and their newborn infants,” said Lois K. Lee, MD, associate professor of pediatrics and emergency medicine at Harvard Medical School and associate director for public policy at the Sandra L. Fenwick Institute for Pediatric Health Equity and Inclusion, Boston.

“It is imperative to optimize the health of pregnant mothers to optimize the health of infants, who are our future society,” she said. “Policies which would expand Medicaid coverage to a full 1-year postpartum across all states is one important strategy to improve health care access and affordability to peripartum women. However, this must be part of a multipronged approach addressing the social determinants of health, as insurance coverage alone will not fully address this important health issue of peripartum women, and their children.”

Dr Moniz reported receiving personal fees from the RAND Corporation, the Society of Family Planning outside the submitted work and grant K08 HS025465 from the Agency for Healthcare Research and Quality. Dr. Daw has no disclosures. Dr. Lee reports speaker fees from the American Academy of Pediatrics and SUNY Upstate Medical University. Coauthor Dr. Taylor was supported by the National Clinician Scholars Program at the University of Michigan. Dr Dalton was supported by grant R01 HS023784 from the Agency for Healthcare Research and Quality.
 

My 50th medical school reunion has come and gone. This milestone offered me another opportunity to look back over the last 5 decades of pediatrics that I have watched pass under the bridge. Triggered by the discovery of two recently published studies, this particular view back over my shoulder induced a wave of sadness, anger, and frustration that I have had trouble shaking.

The first study demonstrated a strong positive effect of exercise on academic achievement, the other found that children who were more physically active have weathered the pandemic with fewer mental health problems.

These studies are just two pieces of a growing body of evidence that our sedentary lifestyles are shortening our lives and launching our children into adulthood burdened with a raft of health risks they could possibly have avoided by being more physically active. Encountering these two papers just as the alumni office was inviting me to engage in an orgy of retrospection and introspection made me consider how little I and others in my profession have done to substantially address this scourge on our young people.

Yes, I have tried to encourage my patients to be less sedentary and more active. Yes, I have tried to set a very visible example by bicycling and walking around town. Yes, I have coached youth sports teams. All of my children and grandchildren are leading active lives and appear to be reaping the benefits. But in the grander scheme of things I feel that neither I nor the American Academy of Pediatrics has made a difference.

In March of 2020 the AAP published a clinical report that lists the numerous positive associations between activity and health that includes a comprehensive collection of suggestions for providers on how we might assess the problem of inactivity and then play a role in addressing it with our patients and our communities. Unfortunately, the message’s importance was lost in the glut of pandemic news.

While the AAP’s report should have been published many decades ago, I doubt the delay lessened its impact significantly because the report is primarily a compendium of recommendations that in the long run will be seen as just another example of us believers preaching to the choir.

Making lifestyle changes on the order of magnitude necessary to convert an increasingly sedentary population into one that unconsciously becomes physically active requires more than recommendations. It is only natural that folks have trouble saying “No.”

No to the entertainment of electronic devices. No to the comforts of all-weather enclosed transportation. No to hours on the couch. Overcoming the inertia built into our society is going to require more than encouragement, recommendations, and professional sports–sponsored presidential initiatives.

Mandate has become a politically charged dirty word. But our current experience with the COVID-19 vaccines should help us realize that there is a significant segment of the population that doesn’t like being told what to do even if the outcome is in their best interest. Education and rewards have fallen short, but the evidence is mounting that mandates can work.

There was a time when physical activity was built into every child’s school day. For a variety of bad reasons, vigorous physical education classes and once- or twice-daily outdoor recesses have disappeared from the educational landscape. It is time to return to them in a robust form. Unfortunately, because activity isn’t happening at home it will take a government mandate.

There will be pushback. Even from some educators whose observations should have shown them the critical role of physical activity in health and academic success. We must move the distraction of the phenomenon once known simply as hyperactivity to the back burner and tackle the real epidemic of hypoactivity that is destroying our children.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

My 50th medical school reunion has come and gone. This milestone offered me another opportunity to look back over the last 5 decades of pediatrics that I have watched pass under the bridge. Triggered by the discovery of two recently published studies, this particular view back over my shoulder induced a wave of sadness, anger, and frustration that I have had trouble shaking.

The first study demonstrated a strong positive effect of exercise on academic achievement, the other found that children who were more physically active have weathered the pandemic with fewer mental health problems.

These studies are just two pieces of a growing body of evidence that our sedentary lifestyles are shortening our lives and launching our children into adulthood burdened with a raft of health risks they could possibly have avoided by being more physically active. Encountering these two papers just as the alumni office was inviting me to engage in an orgy of retrospection and introspection made me consider how little I and others in my profession have done to substantially address this scourge on our young people.

Yes, I have tried to encourage my patients to be less sedentary and more active. Yes, I have tried to set a very visible example by bicycling and walking around town. Yes, I have coached youth sports teams. All of my children and grandchildren are leading active lives and appear to be reaping the benefits. But in the grander scheme of things I feel that neither I nor the American Academy of Pediatrics has made a difference.

In March of 2020 the AAP published a clinical report that lists the numerous positive associations between activity and health that includes a comprehensive collection of suggestions for providers on how we might assess the problem of inactivity and then play a role in addressing it with our patients and our communities. Unfortunately, the message’s importance was lost in the glut of pandemic news.

While the AAP’s report should have been published many decades ago, I doubt the delay lessened its impact significantly because the report is primarily a compendium of recommendations that in the long run will be seen as just another example of us believers preaching to the choir.

Making lifestyle changes on the order of magnitude necessary to convert an increasingly sedentary population into one that unconsciously becomes physically active requires more than recommendations. It is only natural that folks have trouble saying “No.”

No to the entertainment of electronic devices. No to the comforts of all-weather enclosed transportation. No to hours on the couch. Overcoming the inertia built into our society is going to require more than encouragement, recommendations, and professional sports–sponsored presidential initiatives.

Mandate has become a politically charged dirty word. But our current experience with the COVID-19 vaccines should help us realize that there is a significant segment of the population that doesn’t like being told what to do even if the outcome is in their best interest. Education and rewards have fallen short, but the evidence is mounting that mandates can work.

There was a time when physical activity was built into every child’s school day. For a variety of bad reasons, vigorous physical education classes and once- or twice-daily outdoor recesses have disappeared from the educational landscape. It is time to return to them in a robust form. Unfortunately, because activity isn’t happening at home it will take a government mandate.

There will be pushback. Even from some educators whose observations should have shown them the critical role of physical activity in health and academic success. We must move the distraction of the phenomenon once known simply as hyperactivity to the back burner and tackle the real epidemic of hypoactivity that is destroying our children.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

My 50th medical school reunion has come and gone. This milestone offered me another opportunity to look back over the last 5 decades of pediatrics that I have watched pass under the bridge. Triggered by the discovery of two recently published studies, this particular view back over my shoulder induced a wave of sadness, anger, and frustration that I have had trouble shaking.

The first study demonstrated a strong positive effect of exercise on academic achievement, the other found that children who were more physically active have weathered the pandemic with fewer mental health problems.

These studies are just two pieces of a growing body of evidence that our sedentary lifestyles are shortening our lives and launching our children into adulthood burdened with a raft of health risks they could possibly have avoided by being more physically active. Encountering these two papers just as the alumni office was inviting me to engage in an orgy of retrospection and introspection made me consider how little I and others in my profession have done to substantially address this scourge on our young people.

Yes, I have tried to encourage my patients to be less sedentary and more active. Yes, I have tried to set a very visible example by bicycling and walking around town. Yes, I have coached youth sports teams. All of my children and grandchildren are leading active lives and appear to be reaping the benefits. But in the grander scheme of things I feel that neither I nor the American Academy of Pediatrics has made a difference.

In March of 2020 the AAP published a clinical report that lists the numerous positive associations between activity and health that includes a comprehensive collection of suggestions for providers on how we might assess the problem of inactivity and then play a role in addressing it with our patients and our communities. Unfortunately, the message’s importance was lost in the glut of pandemic news.

While the AAP’s report should have been published many decades ago, I doubt the delay lessened its impact significantly because the report is primarily a compendium of recommendations that in the long run will be seen as just another example of us believers preaching to the choir.

Making lifestyle changes on the order of magnitude necessary to convert an increasingly sedentary population into one that unconsciously becomes physically active requires more than recommendations. It is only natural that folks have trouble saying “No.”

No to the entertainment of electronic devices. No to the comforts of all-weather enclosed transportation. No to hours on the couch. Overcoming the inertia built into our society is going to require more than encouragement, recommendations, and professional sports–sponsored presidential initiatives.

Mandate has become a politically charged dirty word. But our current experience with the COVID-19 vaccines should help us realize that there is a significant segment of the population that doesn’t like being told what to do even if the outcome is in their best interest. Education and rewards have fallen short, but the evidence is mounting that mandates can work.

There was a time when physical activity was built into every child’s school day. For a variety of bad reasons, vigorous physical education classes and once- or twice-daily outdoor recesses have disappeared from the educational landscape. It is time to return to them in a robust form. Unfortunately, because activity isn’t happening at home it will take a government mandate.

There will be pushback. Even from some educators whose observations should have shown them the critical role of physical activity in health and academic success. We must move the distraction of the phenomenon once known simply as hyperactivity to the back burner and tackle the real epidemic of hypoactivity that is destroying our children.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Use of cannabis is common in patients with multiple sclerosis (MS), especially for the treatment of MS-related spasticity, new research suggests. Findings from a survey conducted through a large registry in 2020 showed that 31% of patients with MS reported trying cannabis to treat their symptoms – and 20% reported regular use.

Spasticity was reported by 80% as the reason why they used cannabis, while pain was cited as the reason by 69% and sleep problems/insomnia was cited by 61%.

Investigators noted that the new data reflect the latest patterns of use amid sweeping changes in recreational and medical marijuana laws.

“Interest in the use of cannabis for managing MS symptoms continues to increase as more data become available and access becomes easier,” co-investigator Amber Salter, PhD, associate professor, UT Southwestern Medical Center, Dallas, told attendees at the 2021 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC).
 

Administration routes vary

The survey was conducted through the longitudinal North American Research Committee on Multiple Sclerosis (NARCOMS) Registry, a voluntary, self-report registry for patients with MS. Of 6,934 registry participants invited to participate, 3,249 (47%) responded. The majority of responders were women (79%) and the mean age was 61 years. About 63% were being treated with disease-modifying therapies.

Overall, 31% of respondents reported having used cannabis to treat their MS symptoms. In addition, 20% reported regular current cannabis use, with an average use of 20 days in the past month. As many as 40% of the current users reported using cannabis daily.

“In general we saw some small differences in current users, who tended to include more males; have higher spasticity, pain, and sleep symptoms; and [were] more likely to be unemployed and younger,” Dr. Salter said.

The most common forms of cannabis administration were smoking (33%) and eating (20%). In addition, 12% reported vaporizing cannabis with a highly concentrated material, 11% administered cannabis sublingually, and 11% reported swallowing it.

Further, 8% reported vaporizing cannabis as a dried flower, 5% used it topically, and 1% reported drinking it.

Of note, the definition of “cannabis/marijuana” in the study excluded hemp cannabidiol (CBD) or products marketed as CBD only.
 

Consistent use

The most common reason for use by far was spasticity (80%). This was followed by for pain (69%) and sleep/insomnia problems (61%). Among users, 37% reported doing so to treat all three of those problems.

Regarding other symptoms, 36% used cannabis for anxiety, 24% for depression, 18% for overactive bladder, 17% for nausea or gastrointestinal problems, 16% for migraine or headaches, 14% for tremors, and 6% for other purposes.

The vast majority (95%) reported cannabis to be very or somewhat helpful for their symptoms.

Among the 69% of respondents who reported not using cannabis for their MS symptoms, the most commonly cited reasons were a lack of evidence on efficacy (40%) or safety (27%), concerns of legality (25%), lack of insurance coverage (22%), prohibitive cost (18%), and adverse side effects.

Surprisingly, the dramatic shift in the legalization of cannabis use in many states does not appear to be reflected in changes in cannabis use for MS, Dr. Salter said.

“We conducted an anonymous NARCOMS survey a couple of years prior to this survey, and our results are generally consistent. There’s been a small increase in the use and an acceptance or willingness to consider cannabis, but it’s relatively consistent,” she said.

“Despite the changes in access, the landscape hasn’t really changed very much in terms of evidence of the effects on MS symptoms, so that could be why,” Dr. Salter added.

Most patients appear to feel comfortable discussing their cannabis use with their physician, with 75% reporting doing so. However, the most common primary source of medical guidance for treating MS with cannabis was “nobody/self”; for 20%, the source for medical guidance was a dispensary professional.

As many as 62% of respondents reported obtaining their cannabis products from dispensaries, while other sources included family/friend (18%) or an acquaintance (13%). About 31% reported their most preferred type of cannabis to be equal parts THC and cannabidiol, while 30% preferred high THC/low cannabidiol (30%).
 

Mirrors clinical practice findings

Commenting on the study, Laura T. Safar, MD, vice chair of Psychiatry at Lahey Hospital and Medical Center and assistant professor of psychiatry at Harvard Medical School, Boston, said the findings generally fall in line with cannabis use among patients with MS in her practice.

“This is [consistent] with my general experience: A high percentage of my patients with MS are using cannabis with the goal of addressing their MS symptoms that way,” said Dr. Safar, who was not involved with the research.

One notable recent change in patients’ inquiries about cannabis is their apparent confidence in the information they’re getting, she noted. This is a sign of the ever-expanding sources of information – but from sources who may or may not have an understanding of effects in MS, she added.

“What seems new is a certain level of specificity in the information patients state – regardless of its accuracy. There is more technical information widely available about cannabis online and in the dispensaries,” said Dr. Safar.

“A lot of that information may not have been tested scientifically, but it is presented with an aura of truth,” she said.

While misconceptions about cannabis use in MS may not be new, “the conviction with which they are stated and believed seems stronger,” even though they have been validated by questionably expert sources, Dr. Safar noted.

She pointed out that psychiatric effects are among her patients’ notable concerns of cannabis use in MS.

“Cannabis use, especially daily use in moderate to large amounts, can have negative cognitive side effects,” she said. “In addition, it can have other psychiatric side effects: worsening of mood and anxiety, apathy, and anhedonia, a lack of pleasure or enjoyment, and a flattening of the emotional experience.”
 

Countering misinformation

Dr. Safar said she works to counter misinformation and provide more reliable, evidence-based recommendations.

“I educate my patients about what we know from scientific trials about the potential benefits, including possible help with pain, excluding central pain, and with spasticity,” she said. Dr. Safar added that she also discusses possible risks, such as worsening of cognition, mood, and anxiety.

On the basis of an individual’s presentation, and working in collaboration with their neurologist as appropriate, Dr. Safar said she discusses the following issues with the patient:

• Does cannabis make sense for the symptoms being presented?
• Has the patient received benefit so far?
• Are there side effects they may be experiencing?
• Would it be appropriate to lower the cannabis dose/frequency of its use?
• If a patient is using cannabis with an objective that is not backed up by the literature, such as depression, are they open to information about other treatment options?

The study was sponsored by GW Research. Dr. Salter has conducted research for GW Pharmaceuticals companies. Dr. Safar has disclosed no relevant financial relationships.

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

Use of cannabis is common in patients with multiple sclerosis (MS), especially for the treatment of MS-related spasticity, new research suggests. Findings from a survey conducted through a large registry in 2020 showed that 31% of patients with MS reported trying cannabis to treat their symptoms – and 20% reported regular use.

Spasticity was reported by 80% as the reason why they used cannabis, while pain was cited as the reason by 69% and sleep problems/insomnia was cited by 61%.

Investigators noted that the new data reflect the latest patterns of use amid sweeping changes in recreational and medical marijuana laws.

“Interest in the use of cannabis for managing MS symptoms continues to increase as more data become available and access becomes easier,” co-investigator Amber Salter, PhD, associate professor, UT Southwestern Medical Center, Dallas, told attendees at the 2021 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC).
 

Administration routes vary

The survey was conducted through the longitudinal North American Research Committee on Multiple Sclerosis (NARCOMS) Registry, a voluntary, self-report registry for patients with MS. Of 6,934 registry participants invited to participate, 3,249 (47%) responded. The majority of responders were women (79%) and the mean age was 61 years. About 63% were being treated with disease-modifying therapies.

Overall, 31% of respondents reported having used cannabis to treat their MS symptoms. In addition, 20% reported regular current cannabis use, with an average use of 20 days in the past month. As many as 40% of the current users reported using cannabis daily.

“In general we saw some small differences in current users, who tended to include more males; have higher spasticity, pain, and sleep symptoms; and [were] more likely to be unemployed and younger,” Dr. Salter said.

The most common forms of cannabis administration were smoking (33%) and eating (20%). In addition, 12% reported vaporizing cannabis with a highly concentrated material, 11% administered cannabis sublingually, and 11% reported swallowing it.

Further, 8% reported vaporizing cannabis as a dried flower, 5% used it topically, and 1% reported drinking it.

Of note, the definition of “cannabis/marijuana” in the study excluded hemp cannabidiol (CBD) or products marketed as CBD only.
 

Consistent use

The most common reason for use by far was spasticity (80%). This was followed by for pain (69%) and sleep/insomnia problems (61%). Among users, 37% reported doing so to treat all three of those problems.

Regarding other symptoms, 36% used cannabis for anxiety, 24% for depression, 18% for overactive bladder, 17% for nausea or gastrointestinal problems, 16% for migraine or headaches, 14% for tremors, and 6% for other purposes.

The vast majority (95%) reported cannabis to be very or somewhat helpful for their symptoms.

Among the 69% of respondents who reported not using cannabis for their MS symptoms, the most commonly cited reasons were a lack of evidence on efficacy (40%) or safety (27%), concerns of legality (25%), lack of insurance coverage (22%), prohibitive cost (18%), and adverse side effects.

Surprisingly, the dramatic shift in the legalization of cannabis use in many states does not appear to be reflected in changes in cannabis use for MS, Dr. Salter said.

“We conducted an anonymous NARCOMS survey a couple of years prior to this survey, and our results are generally consistent. There’s been a small increase in the use and an acceptance or willingness to consider cannabis, but it’s relatively consistent,” she said.

“Despite the changes in access, the landscape hasn’t really changed very much in terms of evidence of the effects on MS symptoms, so that could be why,” Dr. Salter added.

Most patients appear to feel comfortable discussing their cannabis use with their physician, with 75% reporting doing so. However, the most common primary source of medical guidance for treating MS with cannabis was “nobody/self”; for 20%, the source for medical guidance was a dispensary professional.

As many as 62% of respondents reported obtaining their cannabis products from dispensaries, while other sources included family/friend (18%) or an acquaintance (13%). About 31% reported their most preferred type of cannabis to be equal parts THC and cannabidiol, while 30% preferred high THC/low cannabidiol (30%).
 

Mirrors clinical practice findings

Commenting on the study, Laura T. Safar, MD, vice chair of Psychiatry at Lahey Hospital and Medical Center and assistant professor of psychiatry at Harvard Medical School, Boston, said the findings generally fall in line with cannabis use among patients with MS in her practice.

“This is [consistent] with my general experience: A high percentage of my patients with MS are using cannabis with the goal of addressing their MS symptoms that way,” said Dr. Safar, who was not involved with the research.

One notable recent change in patients’ inquiries about cannabis is their apparent confidence in the information they’re getting, she noted. This is a sign of the ever-expanding sources of information – but from sources who may or may not have an understanding of effects in MS, she added.

“What seems new is a certain level of specificity in the information patients state – regardless of its accuracy. There is more technical information widely available about cannabis online and in the dispensaries,” said Dr. Safar.

“A lot of that information may not have been tested scientifically, but it is presented with an aura of truth,” she said.

While misconceptions about cannabis use in MS may not be new, “the conviction with which they are stated and believed seems stronger,” even though they have been validated by questionably expert sources, Dr. Safar noted.

She pointed out that psychiatric effects are among her patients’ notable concerns of cannabis use in MS.

“Cannabis use, especially daily use in moderate to large amounts, can have negative cognitive side effects,” she said. “In addition, it can have other psychiatric side effects: worsening of mood and anxiety, apathy, and anhedonia, a lack of pleasure or enjoyment, and a flattening of the emotional experience.”
 

Countering misinformation

Dr. Safar said she works to counter misinformation and provide more reliable, evidence-based recommendations.

“I educate my patients about what we know from scientific trials about the potential benefits, including possible help with pain, excluding central pain, and with spasticity,” she said. Dr. Safar added that she also discusses possible risks, such as worsening of cognition, mood, and anxiety.

On the basis of an individual’s presentation, and working in collaboration with their neurologist as appropriate, Dr. Safar said she discusses the following issues with the patient:

• Does cannabis make sense for the symptoms being presented?
• Has the patient received benefit so far?
• Are there side effects they may be experiencing?
• Would it be appropriate to lower the cannabis dose/frequency of its use?
• If a patient is using cannabis with an objective that is not backed up by the literature, such as depression, are they open to information about other treatment options?

The study was sponsored by GW Research. Dr. Salter has conducted research for GW Pharmaceuticals companies. Dr. Safar has disclosed no relevant financial relationships.

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

Use of cannabis is common in patients with multiple sclerosis (MS), especially for the treatment of MS-related spasticity, new research suggests. Findings from a survey conducted through a large registry in 2020 showed that 31% of patients with MS reported trying cannabis to treat their symptoms – and 20% reported regular use.

Spasticity was reported by 80% as the reason why they used cannabis, while pain was cited as the reason by 69% and sleep problems/insomnia was cited by 61%.

Investigators noted that the new data reflect the latest patterns of use amid sweeping changes in recreational and medical marijuana laws.

“Interest in the use of cannabis for managing MS symptoms continues to increase as more data become available and access becomes easier,” co-investigator Amber Salter, PhD, associate professor, UT Southwestern Medical Center, Dallas, told attendees at the 2021 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC).
 

Administration routes vary

The survey was conducted through the longitudinal North American Research Committee on Multiple Sclerosis (NARCOMS) Registry, a voluntary, self-report registry for patients with MS. Of 6,934 registry participants invited to participate, 3,249 (47%) responded. The majority of responders were women (79%) and the mean age was 61 years. About 63% were being treated with disease-modifying therapies.

Overall, 31% of respondents reported having used cannabis to treat their MS symptoms. In addition, 20% reported regular current cannabis use, with an average use of 20 days in the past month. As many as 40% of the current users reported using cannabis daily.

“In general we saw some small differences in current users, who tended to include more males; have higher spasticity, pain, and sleep symptoms; and [were] more likely to be unemployed and younger,” Dr. Salter said.

The most common forms of cannabis administration were smoking (33%) and eating (20%). In addition, 12% reported vaporizing cannabis with a highly concentrated material, 11% administered cannabis sublingually, and 11% reported swallowing it.

Further, 8% reported vaporizing cannabis as a dried flower, 5% used it topically, and 1% reported drinking it.

Of note, the definition of “cannabis/marijuana” in the study excluded hemp cannabidiol (CBD) or products marketed as CBD only.
 

Consistent use

The most common reason for use by far was spasticity (80%). This was followed by for pain (69%) and sleep/insomnia problems (61%). Among users, 37% reported doing so to treat all three of those problems.

Regarding other symptoms, 36% used cannabis for anxiety, 24% for depression, 18% for overactive bladder, 17% for nausea or gastrointestinal problems, 16% for migraine or headaches, 14% for tremors, and 6% for other purposes.

The vast majority (95%) reported cannabis to be very or somewhat helpful for their symptoms.

Among the 69% of respondents who reported not using cannabis for their MS symptoms, the most commonly cited reasons were a lack of evidence on efficacy (40%) or safety (27%), concerns of legality (25%), lack of insurance coverage (22%), prohibitive cost (18%), and adverse side effects.

Surprisingly, the dramatic shift in the legalization of cannabis use in many states does not appear to be reflected in changes in cannabis use for MS, Dr. Salter said.

“We conducted an anonymous NARCOMS survey a couple of years prior to this survey, and our results are generally consistent. There’s been a small increase in the use and an acceptance or willingness to consider cannabis, but it’s relatively consistent,” she said.

“Despite the changes in access, the landscape hasn’t really changed very much in terms of evidence of the effects on MS symptoms, so that could be why,” Dr. Salter added.

Most patients appear to feel comfortable discussing their cannabis use with their physician, with 75% reporting doing so. However, the most common primary source of medical guidance for treating MS with cannabis was “nobody/self”; for 20%, the source for medical guidance was a dispensary professional.

As many as 62% of respondents reported obtaining their cannabis products from dispensaries, while other sources included family/friend (18%) or an acquaintance (13%). About 31% reported their most preferred type of cannabis to be equal parts THC and cannabidiol, while 30% preferred high THC/low cannabidiol (30%).
 

Mirrors clinical practice findings

Commenting on the study, Laura T. Safar, MD, vice chair of Psychiatry at Lahey Hospital and Medical Center and assistant professor of psychiatry at Harvard Medical School, Boston, said the findings generally fall in line with cannabis use among patients with MS in her practice.

“This is [consistent] with my general experience: A high percentage of my patients with MS are using cannabis with the goal of addressing their MS symptoms that way,” said Dr. Safar, who was not involved with the research.

One notable recent change in patients’ inquiries about cannabis is their apparent confidence in the information they’re getting, she noted. This is a sign of the ever-expanding sources of information – but from sources who may or may not have an understanding of effects in MS, she added.

“What seems new is a certain level of specificity in the information patients state – regardless of its accuracy. There is more technical information widely available about cannabis online and in the dispensaries,” said Dr. Safar.

“A lot of that information may not have been tested scientifically, but it is presented with an aura of truth,” she said.

While misconceptions about cannabis use in MS may not be new, “the conviction with which they are stated and believed seems stronger,” even though they have been validated by questionably expert sources, Dr. Safar noted.

She pointed out that psychiatric effects are among her patients’ notable concerns of cannabis use in MS.

“Cannabis use, especially daily use in moderate to large amounts, can have negative cognitive side effects,” she said. “In addition, it can have other psychiatric side effects: worsening of mood and anxiety, apathy, and anhedonia, a lack of pleasure or enjoyment, and a flattening of the emotional experience.”
 

Countering misinformation

Dr. Safar said she works to counter misinformation and provide more reliable, evidence-based recommendations.

“I educate my patients about what we know from scientific trials about the potential benefits, including possible help with pain, excluding central pain, and with spasticity,” she said. Dr. Safar added that she also discusses possible risks, such as worsening of cognition, mood, and anxiety.

On the basis of an individual’s presentation, and working in collaboration with their neurologist as appropriate, Dr. Safar said she discusses the following issues with the patient:

• Does cannabis make sense for the symptoms being presented?
• Has the patient received benefit so far?
• Are there side effects they may be experiencing?
• Would it be appropriate to lower the cannabis dose/frequency of its use?
• If a patient is using cannabis with an objective that is not backed up by the literature, such as depression, are they open to information about other treatment options?

The study was sponsored by GW Research. Dr. Salter has conducted research for GW Pharmaceuticals companies. Dr. Safar has disclosed no relevant financial relationships.

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

Several emerging bronchoscopic treatments have the potential to improve the quality of life for patients with chronic obstructive pulmonary disease, an investigator reported at the annual meeting of the American College of Chest Physicians.

Courtesy of Dr. Ghattas

Targeted lung denervation is one promising novel therapeutic option that is safe and may improve clinical outcomes according to investigator Christian Ghattas, MD.

Data from an ongoing phase 3 randomized controlled trial may provide new information on the efficacy of targeted lung denervation in patients with chronic obstructive pulmonary disease (COPD), said Dr. Ghattas, assistant professor of medicine and associate program director for the interventional pulmonary fellowship at The Ohio State University Medical Center in Columbus.

“Outcome data of longer follow-up on previously treated patients will provide us with more information on the durability and the effect of this treatment,” Dr. Ghattas said in an online presentation at the CHEST meeting, which was held virtually this year.

Meanwhile, a few compelling bronchoscopic treatment modalities for patients with chronic bronchitis are in earlier stages of clinical development. “Larger randomized, controlled trials are ongoing to confirm the available data and to evaluate treatment durability,” said Dr. Ghattas.
 

Targeted lung denervation

The targeted lung denervation system under study (dNerva^®, Nuvaira Inc.) involves the use of a radiofrequency catheter to ablate the peribronchial branches of the vagus nerve, Dr. Ghattas said.

The goal of disrupting pulmonary nerve input is to achieve sustained bronchodilation and reduce mucous secretion, thereby simulating the effect of anticholinergic drugs, he added.

In pilot studies, the targeted lung denervation system demonstrated its feasibility and safety, while modifications to the system reduced the rate of serious adverse events, according to Dr. Ghattas.

In the AIRFLOW-1 study, which evaluated the safety of the latest generation version of the system, 30 patients with COPD were randomized to targeted lung denervation at one of two doses, 29 or 32 watts.

Of those 30 patients, 29 (96.7%) had procedural success, meaning the catheter was inserted, guided to its intended location, and removed intact with no reported in-hospital serious adverse events, according to results published in Respiration.

There was no difference between arms in the primary endpoint, which was the rate of adverse airway effects requiring intervention that were associated with targeted lung denervation, investigators reported. Four such events occurred, in 3 of 15 patients treated with 32 watts and 1 of 15 patients treated with 29 watts.

Procedural success, defined as device success without an in-hospital serious adverse event, was 96.7% (29/30). The rate of TLD-associated adverse airway effects requiring intervention was 3/15 in the 32 W versus 1/15 in the 29 W group (P = .6). However, serious gastric events were noted in five patients, prompting safety improvements and procedural enhancements that reduced both gastrointestinal and airway events, according to the study report.

Further data are available from AIRFLOW-2, a randomized, sham-controlled trial enrolling patients with symptomatic COPD.

In that study, targeted lung denervation plus optimal drug treatment led to fewer respiratory adverse events of interest, including hospitalizations for COPD exacerbation, according to a report on the study that appears in The American Journal of Respiratory and Critical Care Medicine.

Respiratory adverse events occurred in 32% of treated patients versus 71% of sham-treated patients in a predefined 3- to 6.5-month postprocedure window, the report says.

Currently underway is AIRFLOW-3, a randomized study of targeted lung denervation versus sham procedure in patients with COPD. The study has a primary outcome measure of moderate or severe COPD exacerbations over 12 months and is slated to enroll 480 patients.

To be eligible for AIRFLOW-3, patients must have had at least two moderate or one severe COPD exacerbation in the previous year, Dr. Ghattas said.
 

Metered cryospray

One novel intervention with the potential to benefit patients with chronic bronchitis is metered cryospray (RejuvenAir), which works by delivering liquid nitrogen to the tracheobronchial airways, according to Dr. Ghattas.

This targeted delivery ablates abnormal epithelium, facilitating the regeneration of healthy mucosa, according to investigators in a recently published single-arm prospective trial.

Metered cryospray was safe, feasible, and linked to clinically meaningful improvements in patient-reported outcomes among patients with COPD, according to authors of the study, which appears in the European Respiratory Journal.

In the study, 34 of 35 participants received three treatments 4-6 weeks apart.

Investigators reported that at 3 months there were significant reductions in the COPD Assessment Test that were durable to 6 months, and changes in the St. George’s Respiratory Questionnaire and the Leicester Cough Questionnaire that were durable to 9 months.

There were 14 serious adverse events, none of which were device- or procedure related, according to investigators.

An ongoing randomized study called SPRAY-CB is comparing metered cryospray to sham procedure in an anticipated 210 patients with COPD with chronic bronchitis.
 

Bronchial rheoplasty

Bronchial rheoplasty (RheOx, Gala Therapeutics), is another promising intervention under investigation for the treatment of chronic bronchitis, according to Dr. Ghattas.

This system delivers nonthermal pulsed electrical energy, Dr. Ghattas said, with the intention of ablating goblet cells in the airways.

“The preclinical studies have demonstrated epithelial ablation, followed by regeneration of normalized epithelium,” he said in his presentation.

In 12-month results of multicenter clinical trial, bronchial rheoplasty was technically feasible and safe, with reductions in goblet cell hyperplasia and changes in patient-reported quality of life seen following the procedure, investigators reported in The American Journal of Respiratory and Critical Care Medicine.

The mean goblet cell hyperplasia score was reduced by 39% from baseline to treatment, according to study results. Four procedure-related serious adverse events were observed through 6 months, and there were no procedure- or device-related serious adverse events over the next 6 months. Mild hemoptysis occurred in 47% of patients, investigators reported.

A larger randomized, double-blind prospective trial with a sham control arm is underway and will include 270 patients, according to Dr. Ghattas. “We’re going to have to wait for the results,” he said.

Dr. Ghattas reported serving as a site principal investigator for clinical trials involving the bronchoscopic interventions he discussed, including AIRFLOW-3 (evaluating the targeted lung denervation system), SPRAY-CB (metered cryospray), and RheSolve (bronchial rheoplasty).

Several emerging bronchoscopic treatments have the potential to improve the quality of life for patients with chronic obstructive pulmonary disease, an investigator reported at the annual meeting of the American College of Chest Physicians.

Courtesy of Dr. Ghattas

Targeted lung denervation is one promising novel therapeutic option that is safe and may improve clinical outcomes according to investigator Christian Ghattas, MD.

Data from an ongoing phase 3 randomized controlled trial may provide new information on the efficacy of targeted lung denervation in patients with chronic obstructive pulmonary disease (COPD), said Dr. Ghattas, assistant professor of medicine and associate program director for the interventional pulmonary fellowship at The Ohio State University Medical Center in Columbus.

“Outcome data of longer follow-up on previously treated patients will provide us with more information on the durability and the effect of this treatment,” Dr. Ghattas said in an online presentation at the CHEST meeting, which was held virtually this year.

Meanwhile, a few compelling bronchoscopic treatment modalities for patients with chronic bronchitis are in earlier stages of clinical development. “Larger randomized, controlled trials are ongoing to confirm the available data and to evaluate treatment durability,” said Dr. Ghattas.
 

Targeted lung denervation

The targeted lung denervation system under study (dNerva^®, Nuvaira Inc.) involves the use of a radiofrequency catheter to ablate the peribronchial branches of the vagus nerve, Dr. Ghattas said.

The goal of disrupting pulmonary nerve input is to achieve sustained bronchodilation and reduce mucous secretion, thereby simulating the effect of anticholinergic drugs, he added.

In pilot studies, the targeted lung denervation system demonstrated its feasibility and safety, while modifications to the system reduced the rate of serious adverse events, according to Dr. Ghattas.

In the AIRFLOW-1 study, which evaluated the safety of the latest generation version of the system, 30 patients with COPD were randomized to targeted lung denervation at one of two doses, 29 or 32 watts.

Of those 30 patients, 29 (96.7%) had procedural success, meaning the catheter was inserted, guided to its intended location, and removed intact with no reported in-hospital serious adverse events, according to results published in Respiration.

There was no difference between arms in the primary endpoint, which was the rate of adverse airway effects requiring intervention that were associated with targeted lung denervation, investigators reported. Four such events occurred, in 3 of 15 patients treated with 32 watts and 1 of 15 patients treated with 29 watts.

Procedural success, defined as device success without an in-hospital serious adverse event, was 96.7% (29/30). The rate of TLD-associated adverse airway effects requiring intervention was 3/15 in the 32 W versus 1/15 in the 29 W group (P = .6). However, serious gastric events were noted in five patients, prompting safety improvements and procedural enhancements that reduced both gastrointestinal and airway events, according to the study report.

Further data are available from AIRFLOW-2, a randomized, sham-controlled trial enrolling patients with symptomatic COPD.

In that study, targeted lung denervation plus optimal drug treatment led to fewer respiratory adverse events of interest, including hospitalizations for COPD exacerbation, according to a report on the study that appears in The American Journal of Respiratory and Critical Care Medicine.

Respiratory adverse events occurred in 32% of treated patients versus 71% of sham-treated patients in a predefined 3- to 6.5-month postprocedure window, the report says.

Currently underway is AIRFLOW-3, a randomized study of targeted lung denervation versus sham procedure in patients with COPD. The study has a primary outcome measure of moderate or severe COPD exacerbations over 12 months and is slated to enroll 480 patients.

To be eligible for AIRFLOW-3, patients must have had at least two moderate or one severe COPD exacerbation in the previous year, Dr. Ghattas said.
 

Metered cryospray

One novel intervention with the potential to benefit patients with chronic bronchitis is metered cryospray (RejuvenAir), which works by delivering liquid nitrogen to the tracheobronchial airways, according to Dr. Ghattas.

This targeted delivery ablates abnormal epithelium, facilitating the regeneration of healthy mucosa, according to investigators in a recently published single-arm prospective trial.

Metered cryospray was safe, feasible, and linked to clinically meaningful improvements in patient-reported outcomes among patients with COPD, according to authors of the study, which appears in the European Respiratory Journal.

In the study, 34 of 35 participants received three treatments 4-6 weeks apart.

Investigators reported that at 3 months there were significant reductions in the COPD Assessment Test that were durable to 6 months, and changes in the St. George’s Respiratory Questionnaire and the Leicester Cough Questionnaire that were durable to 9 months.

There were 14 serious adverse events, none of which were device- or procedure related, according to investigators.

An ongoing randomized study called SPRAY-CB is comparing metered cryospray to sham procedure in an anticipated 210 patients with COPD with chronic bronchitis.
 

Bronchial rheoplasty

Bronchial rheoplasty (RheOx, Gala Therapeutics), is another promising intervention under investigation for the treatment of chronic bronchitis, according to Dr. Ghattas.

This system delivers nonthermal pulsed electrical energy, Dr. Ghattas said, with the intention of ablating goblet cells in the airways.

“The preclinical studies have demonstrated epithelial ablation, followed by regeneration of normalized epithelium,” he said in his presentation.

In 12-month results of multicenter clinical trial, bronchial rheoplasty was technically feasible and safe, with reductions in goblet cell hyperplasia and changes in patient-reported quality of life seen following the procedure, investigators reported in The American Journal of Respiratory and Critical Care Medicine.

The mean goblet cell hyperplasia score was reduced by 39% from baseline to treatment, according to study results. Four procedure-related serious adverse events were observed through 6 months, and there were no procedure- or device-related serious adverse events over the next 6 months. Mild hemoptysis occurred in 47% of patients, investigators reported.

A larger randomized, double-blind prospective trial with a sham control arm is underway and will include 270 patients, according to Dr. Ghattas. “We’re going to have to wait for the results,” he said.

Dr. Ghattas reported serving as a site principal investigator for clinical trials involving the bronchoscopic interventions he discussed, including AIRFLOW-3 (evaluating the targeted lung denervation system), SPRAY-CB (metered cryospray), and RheSolve (bronchial rheoplasty).

Several emerging bronchoscopic treatments have the potential to improve the quality of life for patients with chronic obstructive pulmonary disease, an investigator reported at the annual meeting of the American College of Chest Physicians.

Courtesy of Dr. Ghattas

Targeted lung denervation is one promising novel therapeutic option that is safe and may improve clinical outcomes according to investigator Christian Ghattas, MD.

Data from an ongoing phase 3 randomized controlled trial may provide new information on the efficacy of targeted lung denervation in patients with chronic obstructive pulmonary disease (COPD), said Dr. Ghattas, assistant professor of medicine and associate program director for the interventional pulmonary fellowship at The Ohio State University Medical Center in Columbus.

“Outcome data of longer follow-up on previously treated patients will provide us with more information on the durability and the effect of this treatment,” Dr. Ghattas said in an online presentation at the CHEST meeting, which was held virtually this year.

Meanwhile, a few compelling bronchoscopic treatment modalities for patients with chronic bronchitis are in earlier stages of clinical development. “Larger randomized, controlled trials are ongoing to confirm the available data and to evaluate treatment durability,” said Dr. Ghattas.
 

Targeted lung denervation

The targeted lung denervation system under study (dNerva^®, Nuvaira Inc.) involves the use of a radiofrequency catheter to ablate the peribronchial branches of the vagus nerve, Dr. Ghattas said.

The goal of disrupting pulmonary nerve input is to achieve sustained bronchodilation and reduce mucous secretion, thereby simulating the effect of anticholinergic drugs, he added.

In pilot studies, the targeted lung denervation system demonstrated its feasibility and safety, while modifications to the system reduced the rate of serious adverse events, according to Dr. Ghattas.

In the AIRFLOW-1 study, which evaluated the safety of the latest generation version of the system, 30 patients with COPD were randomized to targeted lung denervation at one of two doses, 29 or 32 watts.

Of those 30 patients, 29 (96.7%) had procedural success, meaning the catheter was inserted, guided to its intended location, and removed intact with no reported in-hospital serious adverse events, according to results published in Respiration.

There was no difference between arms in the primary endpoint, which was the rate of adverse airway effects requiring intervention that were associated with targeted lung denervation, investigators reported. Four such events occurred, in 3 of 15 patients treated with 32 watts and 1 of 15 patients treated with 29 watts.

Procedural success, defined as device success without an in-hospital serious adverse event, was 96.7% (29/30). The rate of TLD-associated adverse airway effects requiring intervention was 3/15 in the 32 W versus 1/15 in the 29 W group (P = .6). However, serious gastric events were noted in five patients, prompting safety improvements and procedural enhancements that reduced both gastrointestinal and airway events, according to the study report.

Further data are available from AIRFLOW-2, a randomized, sham-controlled trial enrolling patients with symptomatic COPD.

In that study, targeted lung denervation plus optimal drug treatment led to fewer respiratory adverse events of interest, including hospitalizations for COPD exacerbation, according to a report on the study that appears in The American Journal of Respiratory and Critical Care Medicine.

Respiratory adverse events occurred in 32% of treated patients versus 71% of sham-treated patients in a predefined 3- to 6.5-month postprocedure window, the report says.

Currently underway is AIRFLOW-3, a randomized study of targeted lung denervation versus sham procedure in patients with COPD. The study has a primary outcome measure of moderate or severe COPD exacerbations over 12 months and is slated to enroll 480 patients.

To be eligible for AIRFLOW-3, patients must have had at least two moderate or one severe COPD exacerbation in the previous year, Dr. Ghattas said.
 

Metered cryospray

One novel intervention with the potential to benefit patients with chronic bronchitis is metered cryospray (RejuvenAir), which works by delivering liquid nitrogen to the tracheobronchial airways, according to Dr. Ghattas.

This targeted delivery ablates abnormal epithelium, facilitating the regeneration of healthy mucosa, according to investigators in a recently published single-arm prospective trial.

Metered cryospray was safe, feasible, and linked to clinically meaningful improvements in patient-reported outcomes among patients with COPD, according to authors of the study, which appears in the European Respiratory Journal.

In the study, 34 of 35 participants received three treatments 4-6 weeks apart.

Investigators reported that at 3 months there were significant reductions in the COPD Assessment Test that were durable to 6 months, and changes in the St. George’s Respiratory Questionnaire and the Leicester Cough Questionnaire that were durable to 9 months.

There were 14 serious adverse events, none of which were device- or procedure related, according to investigators.

An ongoing randomized study called SPRAY-CB is comparing metered cryospray to sham procedure in an anticipated 210 patients with COPD with chronic bronchitis.
 

Bronchial rheoplasty

Bronchial rheoplasty (RheOx, Gala Therapeutics), is another promising intervention under investigation for the treatment of chronic bronchitis, according to Dr. Ghattas.

This system delivers nonthermal pulsed electrical energy, Dr. Ghattas said, with the intention of ablating goblet cells in the airways.

“The preclinical studies have demonstrated epithelial ablation, followed by regeneration of normalized epithelium,” he said in his presentation.

In 12-month results of multicenter clinical trial, bronchial rheoplasty was technically feasible and safe, with reductions in goblet cell hyperplasia and changes in patient-reported quality of life seen following the procedure, investigators reported in The American Journal of Respiratory and Critical Care Medicine.

The mean goblet cell hyperplasia score was reduced by 39% from baseline to treatment, according to study results. Four procedure-related serious adverse events were observed through 6 months, and there were no procedure- or device-related serious adverse events over the next 6 months. Mild hemoptysis occurred in 47% of patients, investigators reported.

A larger randomized, double-blind prospective trial with a sham control arm is underway and will include 270 patients, according to Dr. Ghattas. “We’re going to have to wait for the results,” he said.

Dr. Ghattas reported serving as a site principal investigator for clinical trials involving the bronchoscopic interventions he discussed, including AIRFLOW-3 (evaluating the targeted lung denervation system), SPRAY-CB (metered cryospray), and RheSolve (bronchial rheoplasty).

Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, has endorsed a two-dose regimen of Pfizer’s lower-dose mRNA vaccine for children ages 5 through 11 years-old – meaning the shots are now available for immediate use.

The Nov. 2 decision came mere hours after experts that advise the CDC on vaccinations strongly recommended the vaccine for this age group.

“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against the virus that causes COVID-19. We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine. As a mom, I encourage parents with questions to talk to their pediatrician, school nurse, or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated,” Dr. Walensky said in a prepared statement.

President Joe Biden applauded Dr. Walensky’s endorsement: “Today, we have reached a turning point in our battle against COVID-19: authorization of a safe, effective vaccine for children age 5 to 11. It will allow parents to end months of anxious worrying about their kids, and reduce the extent to which children spread the virus to others. It is a major step forward for our nation in our fight to defeat the virus,” he said in a statement.

The 14 members of the Advisory Committee on Immunization Practices (ACIP) voted unanimously earlier in the day to recommend the vaccine for kids.

“I feel like I have a responsibility to make this vaccine available to children and their parents,” said committee member Beth Bell, MD, MPH, a clinical professor at the University of Washington in Seattle. Bell noted that all evidence the committee had reviewed pointed to a vaccine that was safe and effective for younger children.

“If I had a grandchild, I would certainly get that grandchild vaccinated as soon as possible,” she said.

Their recommendations follow the U.S. Food and Drug Administration’s emergency authorization of Pfizer-BioNTech’s vaccine for this same age group last week.

“I’m voting for this because I think it could have a huge positive impact on [kids’] health and their social and emotional wellbeing,” said Grace Lee, MD, a professor of pediatrics at Stanford University School of Medicine, who chairs the CDC’s ACIP.

She noted that, though masks are available to reduce the risk for kids, they aren’t perfect and transmission still occurs.

“Vaccines are really the only consistent and reliable way to provide that protection,” Lee said.

The vaccine for children is two doses given 3 weeks apart. Each dose is 10 micrograms, which is one-third of the dose used in adults and teens.

To avoid confusion, the smaller dose for kids will come in bottles with orange labels and orange tops. The vaccine for adults is packaged in purple.

The CDC also addressed the question of kids who are close to age 12 when they get their first dose.

In general, pediatricians allow for a 4-day grace period around birthdays to determine which dose is needed. That will be the same with the COVID-19 vaccine.

For kids who are 11 when they start the series, they should get another 10-microgram dose after they turn 12 a few weeks later.

COVID-19 cases in this age group have climbed sharply over the summer and into the fall as schools have fully reopened, sometimes without the benefit of masks.

In the first week of October, roughly 10% of all COVID-19 cases recorded in the United States were among children ages 5 through 11. Since the start of pandemic, about 1.9 million children in this age group have been infected, though that’s almost certainly an undercount. More than 8,300 have been hospitalized, and 94 children have died.

Children of color have been disproportionately impacted. More than two-thirds of hospitalized children have been black or Hispanic.

Weighing benefits and risks

In clinical trials that included more than 4,600 children, the most common adverse events were pain and swelling at the injection site. They could also have side effects like fevers, fatigue, headache, chills, and sometimes swollen lymph nodes.

These kinds of side effects appear to be less common in children ages 5 to 11 than they have been in teens and adults, and they were temporary.

No cases of myocarditis or pericarditis were seen in the studies, but myocarditis is a very rare side effect, and the studies were too small to pick up these cases.

Still, doctors say they’re watching for it. In general, the greatest risk for myocarditis after vaccination has been seen in younger males between the ages of 12 and 30.

Even without COVID-19 or vaccines in the mix, doctors expect to see as many as two cases of myocarditis for every million people over the course of a week. The risk for myocarditis jumps up to about 11 cases for every million doses of mRNA vaccine given to men ages 25 to 30. It’s between 37 and 69 cases per million doses in boys between the ages of 12 and 24.

Still, experts say the possibility of this rare risk shouldn’t deter parents from vaccinating younger children.

Here’s why: The risk for myocarditis is higher after COVID-19 infection than after vaccination. Younger children have a lower risk for myocarditis than teens and young adults, suggesting that this side effect may be less frequent in this age group, although that remains to be seen.

Additionally, the smaller dose authorized for children is expected to minimize the risk for myocarditis even further.

The CDC says parents should call their doctor if a child develops pain in their chest, has trouble breathing, or feels like they have a beating or fluttering heart after vaccination.

What about benefits?

Models looking at the impact of vaccines in this age group predict that, nationally, cases would drop by about 8% if children are vaccinated.

The models also suggested that vaccination of kids this age would slow — but not stop — the emergence of new variants.

For every million doses, the CDC’s modeling predicts that more than 56,000 COVID-19 infections would be prevented in this age group, along with dozens of hospitalizations, and post-COVID conditions like multisystem inflammatory syndrome in children.

CDC experts estimate that just 10 kids would need to be vaccinated over 6 months to prevent a single case of COVID-19.

The CDC pointed out that vaccinating kids may help slow transmission of the virus and would give parents and other caregivers greater confidence in participating in school and extracurricular activities.

CDC experts said they would use a variety of systems, including hospital networks, the open Vaccines and Adverse Events Reporting System (VAERS) database, the cell-phone based V-SAFE app, and insurance claims databases to keep an eye out for any rare adverse events related to the vaccines in children.

This article, a version of which first appeared on Medscape.com, was updated on Nov. 3, 2021.

Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, has endorsed a two-dose regimen of Pfizer’s lower-dose mRNA vaccine for children ages 5 through 11 years-old – meaning the shots are now available for immediate use.

The Nov. 2 decision came mere hours after experts that advise the CDC on vaccinations strongly recommended the vaccine for this age group.

“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against the virus that causes COVID-19. We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine. As a mom, I encourage parents with questions to talk to their pediatrician, school nurse, or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated,” Dr. Walensky said in a prepared statement.

President Joe Biden applauded Dr. Walensky’s endorsement: “Today, we have reached a turning point in our battle against COVID-19: authorization of a safe, effective vaccine for children age 5 to 11. It will allow parents to end months of anxious worrying about their kids, and reduce the extent to which children spread the virus to others. It is a major step forward for our nation in our fight to defeat the virus,” he said in a statement.

The 14 members of the Advisory Committee on Immunization Practices (ACIP) voted unanimously earlier in the day to recommend the vaccine for kids.

“I feel like I have a responsibility to make this vaccine available to children and their parents,” said committee member Beth Bell, MD, MPH, a clinical professor at the University of Washington in Seattle. Bell noted that all evidence the committee had reviewed pointed to a vaccine that was safe and effective for younger children.

“If I had a grandchild, I would certainly get that grandchild vaccinated as soon as possible,” she said.

Their recommendations follow the U.S. Food and Drug Administration’s emergency authorization of Pfizer-BioNTech’s vaccine for this same age group last week.

“I’m voting for this because I think it could have a huge positive impact on [kids’] health and their social and emotional wellbeing,” said Grace Lee, MD, a professor of pediatrics at Stanford University School of Medicine, who chairs the CDC’s ACIP.

She noted that, though masks are available to reduce the risk for kids, they aren’t perfect and transmission still occurs.

“Vaccines are really the only consistent and reliable way to provide that protection,” Lee said.

The vaccine for children is two doses given 3 weeks apart. Each dose is 10 micrograms, which is one-third of the dose used in adults and teens.

To avoid confusion, the smaller dose for kids will come in bottles with orange labels and orange tops. The vaccine for adults is packaged in purple.

The CDC also addressed the question of kids who are close to age 12 when they get their first dose.

In general, pediatricians allow for a 4-day grace period around birthdays to determine which dose is needed. That will be the same with the COVID-19 vaccine.

For kids who are 11 when they start the series, they should get another 10-microgram dose after they turn 12 a few weeks later.

COVID-19 cases in this age group have climbed sharply over the summer and into the fall as schools have fully reopened, sometimes without the benefit of masks.

In the first week of October, roughly 10% of all COVID-19 cases recorded in the United States were among children ages 5 through 11. Since the start of pandemic, about 1.9 million children in this age group have been infected, though that’s almost certainly an undercount. More than 8,300 have been hospitalized, and 94 children have died.

Children of color have been disproportionately impacted. More than two-thirds of hospitalized children have been black or Hispanic.

Weighing benefits and risks

In clinical trials that included more than 4,600 children, the most common adverse events were pain and swelling at the injection site. They could also have side effects like fevers, fatigue, headache, chills, and sometimes swollen lymph nodes.

These kinds of side effects appear to be less common in children ages 5 to 11 than they have been in teens and adults, and they were temporary.

No cases of myocarditis or pericarditis were seen in the studies, but myocarditis is a very rare side effect, and the studies were too small to pick up these cases.

Still, doctors say they’re watching for it. In general, the greatest risk for myocarditis after vaccination has been seen in younger males between the ages of 12 and 30.

Even without COVID-19 or vaccines in the mix, doctors expect to see as many as two cases of myocarditis for every million people over the course of a week. The risk for myocarditis jumps up to about 11 cases for every million doses of mRNA vaccine given to men ages 25 to 30. It’s between 37 and 69 cases per million doses in boys between the ages of 12 and 24.

Still, experts say the possibility of this rare risk shouldn’t deter parents from vaccinating younger children.

Here’s why: The risk for myocarditis is higher after COVID-19 infection than after vaccination. Younger children have a lower risk for myocarditis than teens and young adults, suggesting that this side effect may be less frequent in this age group, although that remains to be seen.

Additionally, the smaller dose authorized for children is expected to minimize the risk for myocarditis even further.

The CDC says parents should call their doctor if a child develops pain in their chest, has trouble breathing, or feels like they have a beating or fluttering heart after vaccination.

What about benefits?

Models looking at the impact of vaccines in this age group predict that, nationally, cases would drop by about 8% if children are vaccinated.

The models also suggested that vaccination of kids this age would slow — but not stop — the emergence of new variants.

For every million doses, the CDC’s modeling predicts that more than 56,000 COVID-19 infections would be prevented in this age group, along with dozens of hospitalizations, and post-COVID conditions like multisystem inflammatory syndrome in children.

CDC experts estimate that just 10 kids would need to be vaccinated over 6 months to prevent a single case of COVID-19.

The CDC pointed out that vaccinating kids may help slow transmission of the virus and would give parents and other caregivers greater confidence in participating in school and extracurricular activities.

CDC experts said they would use a variety of systems, including hospital networks, the open Vaccines and Adverse Events Reporting System (VAERS) database, the cell-phone based V-SAFE app, and insurance claims databases to keep an eye out for any rare adverse events related to the vaccines in children.

This article, a version of which first appeared on Medscape.com, was updated on Nov. 3, 2021.

Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, has endorsed a two-dose regimen of Pfizer’s lower-dose mRNA vaccine for children ages 5 through 11 years-old – meaning the shots are now available for immediate use.

The Nov. 2 decision came mere hours after experts that advise the CDC on vaccinations strongly recommended the vaccine for this age group.

“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against the virus that causes COVID-19. We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine. As a mom, I encourage parents with questions to talk to their pediatrician, school nurse, or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated,” Dr. Walensky said in a prepared statement.

President Joe Biden applauded Dr. Walensky’s endorsement: “Today, we have reached a turning point in our battle against COVID-19: authorization of a safe, effective vaccine for children age 5 to 11. It will allow parents to end months of anxious worrying about their kids, and reduce the extent to which children spread the virus to others. It is a major step forward for our nation in our fight to defeat the virus,” he said in a statement.

The 14 members of the Advisory Committee on Immunization Practices (ACIP) voted unanimously earlier in the day to recommend the vaccine for kids.

“I feel like I have a responsibility to make this vaccine available to children and their parents,” said committee member Beth Bell, MD, MPH, a clinical professor at the University of Washington in Seattle. Bell noted that all evidence the committee had reviewed pointed to a vaccine that was safe and effective for younger children.

“If I had a grandchild, I would certainly get that grandchild vaccinated as soon as possible,” she said.

Their recommendations follow the U.S. Food and Drug Administration’s emergency authorization of Pfizer-BioNTech’s vaccine for this same age group last week.

“I’m voting for this because I think it could have a huge positive impact on [kids’] health and their social and emotional wellbeing,” said Grace Lee, MD, a professor of pediatrics at Stanford University School of Medicine, who chairs the CDC’s ACIP.

She noted that, though masks are available to reduce the risk for kids, they aren’t perfect and transmission still occurs.

“Vaccines are really the only consistent and reliable way to provide that protection,” Lee said.

The vaccine for children is two doses given 3 weeks apart. Each dose is 10 micrograms, which is one-third of the dose used in adults and teens.

To avoid confusion, the smaller dose for kids will come in bottles with orange labels and orange tops. The vaccine for adults is packaged in purple.

The CDC also addressed the question of kids who are close to age 12 when they get their first dose.

In general, pediatricians allow for a 4-day grace period around birthdays to determine which dose is needed. That will be the same with the COVID-19 vaccine.

For kids who are 11 when they start the series, they should get another 10-microgram dose after they turn 12 a few weeks later.

COVID-19 cases in this age group have climbed sharply over the summer and into the fall as schools have fully reopened, sometimes without the benefit of masks.

In the first week of October, roughly 10% of all COVID-19 cases recorded in the United States were among children ages 5 through 11. Since the start of pandemic, about 1.9 million children in this age group have been infected, though that’s almost certainly an undercount. More than 8,300 have been hospitalized, and 94 children have died.

Children of color have been disproportionately impacted. More than two-thirds of hospitalized children have been black or Hispanic.

Weighing benefits and risks

In clinical trials that included more than 4,600 children, the most common adverse events were pain and swelling at the injection site. They could also have side effects like fevers, fatigue, headache, chills, and sometimes swollen lymph nodes.

These kinds of side effects appear to be less common in children ages 5 to 11 than they have been in teens and adults, and they were temporary.

No cases of myocarditis or pericarditis were seen in the studies, but myocarditis is a very rare side effect, and the studies were too small to pick up these cases.

Still, doctors say they’re watching for it. In general, the greatest risk for myocarditis after vaccination has been seen in younger males between the ages of 12 and 30.

Even without COVID-19 or vaccines in the mix, doctors expect to see as many as two cases of myocarditis for every million people over the course of a week. The risk for myocarditis jumps up to about 11 cases for every million doses of mRNA vaccine given to men ages 25 to 30. It’s between 37 and 69 cases per million doses in boys between the ages of 12 and 24.

Still, experts say the possibility of this rare risk shouldn’t deter parents from vaccinating younger children.

Here’s why: The risk for myocarditis is higher after COVID-19 infection than after vaccination. Younger children have a lower risk for myocarditis than teens and young adults, suggesting that this side effect may be less frequent in this age group, although that remains to be seen.

Additionally, the smaller dose authorized for children is expected to minimize the risk for myocarditis even further.

The CDC says parents should call their doctor if a child develops pain in their chest, has trouble breathing, or feels like they have a beating or fluttering heart after vaccination.

What about benefits?

Models looking at the impact of vaccines in this age group predict that, nationally, cases would drop by about 8% if children are vaccinated.

The models also suggested that vaccination of kids this age would slow — but not stop — the emergence of new variants.

For every million doses, the CDC’s modeling predicts that more than 56,000 COVID-19 infections would be prevented in this age group, along with dozens of hospitalizations, and post-COVID conditions like multisystem inflammatory syndrome in children.

CDC experts estimate that just 10 kids would need to be vaccinated over 6 months to prevent a single case of COVID-19.

The CDC pointed out that vaccinating kids may help slow transmission of the virus and would give parents and other caregivers greater confidence in participating in school and extracurricular activities.

CDC experts said they would use a variety of systems, including hospital networks, the open Vaccines and Adverse Events Reporting System (VAERS) database, the cell-phone based V-SAFE app, and insurance claims databases to keep an eye out for any rare adverse events related to the vaccines in children.

This article, a version of which first appeared on Medscape.com, was updated on Nov. 3, 2021.