Pediatric News

Centers for Disease Control and Prevention Director Rochelle Walensky, MD, has officially signed off on a recommendation by an independent panel of 11 experts to allow people with weakened immune function to get a third dose of certain COVID-19 vaccines.

The decision follows a unanimous vote by the CDC’s Advisory Committee on Immunization Practices (ACIP), which in turn came hours after the U.S. Food and Drug Administration updated its Emergency Use Authorization (EUA) for the Pfizer and Moderna mRNA vaccines.

About 7 million adults in the United States have moderately to severely impaired immune function because of a medical condition they live with or a medication they take to manage a health condition.

People who fall into this category are at higher risk of being hospitalized or dying if they get COVID-19. They are also more likely to transmit the infection. About 40% of vaccinated patients who are hospitalized with breakthrough cases are immunocompromised.

Recent studies have shown that between one-third and one-half of immunocompromised people who didn’t develop antibodies after two doses of a vaccine do get some level of protection after a third dose.

Even then, however, the protection immunocompromised people get from vaccines is not as robust as someone who has healthy immune function, and some panel members were concerned that a third dose might come with a false sense of security.

“My only concern with adding a third dose for the immunocompromised is the impression that our immunocompromised population [will] then be safe,” said ACIP member Helen Talbot, MD, MPH, an associate professor of medicine at Vanderbilt University Medical Center in Nashville, Tenn.

“I think the reality is they’ll be safer but still at incredibly high risk for severe disease and death,” she said.

In updating its EUA, the FDA stressed that, even after a third dose, people who are immunocompromised will still need to wear a mask indoors, socially distance, and avoid large crowds. In addition, family members and other close contacts should be fully vaccinated to protect these vulnerable individuals.
 

Johnson & Johnson not in the mix

The boosters will be available to children as young as 12 years of age who’ve had a Pfizer vaccine or those ages 18 and older who’ve gotten the Moderna vaccine.

For now, people who’ve had the one-dose Johnson & Johnson vaccine have not been cleared to get a second dose of any vaccine.

FDA experts acknowledged the gap but said that people who had received the Johnson & Johnson vaccine represented a small slice of vaccinated Americans, and said they couldn’t act before the FDA had updated its authorization for that vaccine, which the agency is actively exploring.

“We had to do what we’re doing based on the data we have in hand,” said Peter Marks, MD, director of the Center for Biologics Evaluation and Research at the FDA, the division of the agency that regulates vaccines.

“We think at least there is a solution here for the very large majority of immunocompromised individuals, and we believe we will probably have a solution for the remainder in the not-too-distant future,” Dr. Marks said.

In its updated EUA, the FDA said that the third shots were intended for people who had undergone solid organ transplants or have an “equivalent level of immunocompromise.”
 

The details

Clinical experts on the CDC panel spent a good deal of time trying to suss out exactly what conditions might fall under the FDA’s umbrella for a third dose.

In a presentation to the committee, Neela Goswami, MD, PhD, an assistant professor of infectious diseases at Emory University School of Medicine and of epidemiology at the Emory Rollins School of Public Health, Atlanta, stressed that the shots are intended for patients who are moderately or severely immunocompromised, in close consultation with their doctors, but that people who should qualify would include those:

• Receiving treatment for solid tumors or blood cancers
• Taking immunosuppressing medications after a solid organ transplant
• Within 2 years of receiving CAR-T therapy or a stem cell transplant
• Who have primary immunodeficiencies – rare genetic disorders that prevent the immune system from working properly
• With advanced or untreated 
• Taking high-dose corticosteroids (more than 20 milligrams of  or its equivalent daily), alkylating agents, antimetabolites, chemotherapy, TNF blockers, or other immunomodulating or immunosuppressing biologics
• With certain chronic medical conditions, such as  or asplenia – living without a spleen
• Receiving dialysis

In discussion, CDC experts clarified that these third doses were not intended for people whose immune function had waned with age, such as elderly residents of long-term care facilities or people with chronic diseases like diabetes.

The idea is to try to get a third dose of the vaccine they’ve already had – Moderna or Pfizer – but if that’s not feasible, it’s fine for the third dose to be different from what someone has had before. The third dose should be given at least 28 days after a second dose, and, ideally, before the initiation of immunosuppressive therapy.

Participants in the meeting said that the CDC would post updated materials on its website to help guide physicians on exactly who should receive third doses.

Ultimately, however, the extra doses will be given on an honor system; no prescriptions or other kinds of clinical documentation will be required for people to get a third dose of these shots.

Tests to measure neutralizing antibodies are also not recommended before the shots are given because of differences in the types of tests used to measure these antibodies and the difficulty in interpreting them. It’s unclear right now what level of neutralizing antibodies is needed for protection.
 

‘Peace of mind’

In public testimony, Heather Braaten, a 44-year-old being treated for ovarian cancer, said she was grateful to have gotten two shots of the Pfizer vaccine last winter, in between rounds of chemotherapy, but she knew she was probably not well protected. She said she’d become obsessive over the past few months reading medical studies and trying to understand her risk.

“I have felt distraught over the situation. My prognosis is poor. I most likely have about two to three years left to live, so everything counts,” Ms. Braaten said.

She said her life ambitions were humble. She wants to visit with friends and family and not have to worry that she’ll be a breakthrough case. She wants to go grocery shopping again and “not panic and leave the store after five minutes.” She’d love to feel free to travel, she said.

“While I understand I still need to be cautious, I am hopeful for the peace of mind and greater freedom a third shot can provide,” Ms. Braaten said.
 

More boosters on the way?

In the second half of the meeting, the CDC also signaled that it was considering the use of boosters for people whose immunity might have waned in the months since they had completed their vaccine series, particularly seniors. About 75% of people hospitalized with vaccine breakthrough cases are over age 65, according to CDC data.

Those considerations are becoming more urgent as the Delta variant continues to pummel less vaccinated states and counties.

In its presentation to the ACIP, Heather Scobie, PhD, MPH, a member of the CDC’s COVID Response Team, highlighted data from Canada, Israel, Qatar, and the United Kingdom showing that, while the Pfizer vaccine was still highly effective at preventing hospitalizations and death, it’s far less likely when faced with Delta to prevent an infection that causes symptoms.

In Israel, Pfizer’s vaccine prevented symptoms an average of 41% of the time. In Qatar, which is also using the Moderna vaccine, Pfizer’s prevented symptomatic infections with Delta about 54% of the time compared with 85% with Moderna’s.

Dr. Scobie noted that Pfizer’s waning efficacy may have something to do with the fact that it uses a lower dosage than Moderna’s. Pfizer’s recommended dosing interval is also shorter – 3 weeks compared with 4 weeks for Moderna’s. Stretching the time between shots has been shown to boost vaccine effectiveness, she said.

New data from the Mayo clinic, published ahead of peer review, also suggest that Pfizer’s protection may be fading more quickly than Moderna’s. 

In February, both shots were nearly 100% effective at preventing the SARS-CoV-2 infection, but by July, against Delta, Pfizer’s efficacy had dropped to somewhere between 13% and 62%, while Moderna’s was still effective at preventing infection between 58% and 87% of the time.

In July, Pfizer’s was between 24% and 94% effective at preventing hospitalization with a COVID-19 infection and Moderna’s was between 33% and 96% effective at preventing hospitalization.

While that may sound like cause for concern, Dr. Scobie noted that, as of August 2, severe COVD-19 outcomes after vaccination are still very rare. Among 164 million fully vaccinated people in the United States there have been about 7,000 hospitalizations and 1,500 deaths; nearly three out of four of these have been in people over the age of 65.

The ACIP will next meet on August 24 to focus solely on the COVID-19 vaccines.

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

Centers for Disease Control and Prevention Director Rochelle Walensky, MD, has officially signed off on a recommendation by an independent panel of 11 experts to allow people with weakened immune function to get a third dose of certain COVID-19 vaccines.

The decision follows a unanimous vote by the CDC’s Advisory Committee on Immunization Practices (ACIP), which in turn came hours after the U.S. Food and Drug Administration updated its Emergency Use Authorization (EUA) for the Pfizer and Moderna mRNA vaccines.

About 7 million adults in the United States have moderately to severely impaired immune function because of a medical condition they live with or a medication they take to manage a health condition.

People who fall into this category are at higher risk of being hospitalized or dying if they get COVID-19. They are also more likely to transmit the infection. About 40% of vaccinated patients who are hospitalized with breakthrough cases are immunocompromised.

Recent studies have shown that between one-third and one-half of immunocompromised people who didn’t develop antibodies after two doses of a vaccine do get some level of protection after a third dose.

Even then, however, the protection immunocompromised people get from vaccines is not as robust as someone who has healthy immune function, and some panel members were concerned that a third dose might come with a false sense of security.

“My only concern with adding a third dose for the immunocompromised is the impression that our immunocompromised population [will] then be safe,” said ACIP member Helen Talbot, MD, MPH, an associate professor of medicine at Vanderbilt University Medical Center in Nashville, Tenn.

“I think the reality is they’ll be safer but still at incredibly high risk for severe disease and death,” she said.

In updating its EUA, the FDA stressed that, even after a third dose, people who are immunocompromised will still need to wear a mask indoors, socially distance, and avoid large crowds. In addition, family members and other close contacts should be fully vaccinated to protect these vulnerable individuals.
 

Johnson & Johnson not in the mix

The boosters will be available to children as young as 12 years of age who’ve had a Pfizer vaccine or those ages 18 and older who’ve gotten the Moderna vaccine.

For now, people who’ve had the one-dose Johnson & Johnson vaccine have not been cleared to get a second dose of any vaccine.

FDA experts acknowledged the gap but said that people who had received the Johnson & Johnson vaccine represented a small slice of vaccinated Americans, and said they couldn’t act before the FDA had updated its authorization for that vaccine, which the agency is actively exploring.

“We had to do what we’re doing based on the data we have in hand,” said Peter Marks, MD, director of the Center for Biologics Evaluation and Research at the FDA, the division of the agency that regulates vaccines.

“We think at least there is a solution here for the very large majority of immunocompromised individuals, and we believe we will probably have a solution for the remainder in the not-too-distant future,” Dr. Marks said.

In its updated EUA, the FDA said that the third shots were intended for people who had undergone solid organ transplants or have an “equivalent level of immunocompromise.”
 

The details

Clinical experts on the CDC panel spent a good deal of time trying to suss out exactly what conditions might fall under the FDA’s umbrella for a third dose.

In a presentation to the committee, Neela Goswami, MD, PhD, an assistant professor of infectious diseases at Emory University School of Medicine and of epidemiology at the Emory Rollins School of Public Health, Atlanta, stressed that the shots are intended for patients who are moderately or severely immunocompromised, in close consultation with their doctors, but that people who should qualify would include those:

• Receiving treatment for solid tumors or blood cancers
• Taking immunosuppressing medications after a solid organ transplant
• Within 2 years of receiving CAR-T therapy or a stem cell transplant
• Who have primary immunodeficiencies – rare genetic disorders that prevent the immune system from working properly
• With advanced or untreated 
• Taking high-dose corticosteroids (more than 20 milligrams of  or its equivalent daily), alkylating agents, antimetabolites, chemotherapy, TNF blockers, or other immunomodulating or immunosuppressing biologics
• With certain chronic medical conditions, such as  or asplenia – living without a spleen
• Receiving dialysis

In discussion, CDC experts clarified that these third doses were not intended for people whose immune function had waned with age, such as elderly residents of long-term care facilities or people with chronic diseases like diabetes.

The idea is to try to get a third dose of the vaccine they’ve already had – Moderna or Pfizer – but if that’s not feasible, it’s fine for the third dose to be different from what someone has had before. The third dose should be given at least 28 days after a second dose, and, ideally, before the initiation of immunosuppressive therapy.

Participants in the meeting said that the CDC would post updated materials on its website to help guide physicians on exactly who should receive third doses.

Ultimately, however, the extra doses will be given on an honor system; no prescriptions or other kinds of clinical documentation will be required for people to get a third dose of these shots.

Tests to measure neutralizing antibodies are also not recommended before the shots are given because of differences in the types of tests used to measure these antibodies and the difficulty in interpreting them. It’s unclear right now what level of neutralizing antibodies is needed for protection.
 

‘Peace of mind’

In public testimony, Heather Braaten, a 44-year-old being treated for ovarian cancer, said she was grateful to have gotten two shots of the Pfizer vaccine last winter, in between rounds of chemotherapy, but she knew she was probably not well protected. She said she’d become obsessive over the past few months reading medical studies and trying to understand her risk.

“I have felt distraught over the situation. My prognosis is poor. I most likely have about two to three years left to live, so everything counts,” Ms. Braaten said.

She said her life ambitions were humble. She wants to visit with friends and family and not have to worry that she’ll be a breakthrough case. She wants to go grocery shopping again and “not panic and leave the store after five minutes.” She’d love to feel free to travel, she said.

“While I understand I still need to be cautious, I am hopeful for the peace of mind and greater freedom a third shot can provide,” Ms. Braaten said.
 

More boosters on the way?

In the second half of the meeting, the CDC also signaled that it was considering the use of boosters for people whose immunity might have waned in the months since they had completed their vaccine series, particularly seniors. About 75% of people hospitalized with vaccine breakthrough cases are over age 65, according to CDC data.

Those considerations are becoming more urgent as the Delta variant continues to pummel less vaccinated states and counties.

In its presentation to the ACIP, Heather Scobie, PhD, MPH, a member of the CDC’s COVID Response Team, highlighted data from Canada, Israel, Qatar, and the United Kingdom showing that, while the Pfizer vaccine was still highly effective at preventing hospitalizations and death, it’s far less likely when faced with Delta to prevent an infection that causes symptoms.

In Israel, Pfizer’s vaccine prevented symptoms an average of 41% of the time. In Qatar, which is also using the Moderna vaccine, Pfizer’s prevented symptomatic infections with Delta about 54% of the time compared with 85% with Moderna’s.

Dr. Scobie noted that Pfizer’s waning efficacy may have something to do with the fact that it uses a lower dosage than Moderna’s. Pfizer’s recommended dosing interval is also shorter – 3 weeks compared with 4 weeks for Moderna’s. Stretching the time between shots has been shown to boost vaccine effectiveness, she said.

New data from the Mayo clinic, published ahead of peer review, also suggest that Pfizer’s protection may be fading more quickly than Moderna’s. 

In February, both shots were nearly 100% effective at preventing the SARS-CoV-2 infection, but by July, against Delta, Pfizer’s efficacy had dropped to somewhere between 13% and 62%, while Moderna’s was still effective at preventing infection between 58% and 87% of the time.

In July, Pfizer’s was between 24% and 94% effective at preventing hospitalization with a COVID-19 infection and Moderna’s was between 33% and 96% effective at preventing hospitalization.

While that may sound like cause for concern, Dr. Scobie noted that, as of August 2, severe COVD-19 outcomes after vaccination are still very rare. Among 164 million fully vaccinated people in the United States there have been about 7,000 hospitalizations and 1,500 deaths; nearly three out of four of these have been in people over the age of 65.

The ACIP will next meet on August 24 to focus solely on the COVID-19 vaccines.

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

Centers for Disease Control and Prevention Director Rochelle Walensky, MD, has officially signed off on a recommendation by an independent panel of 11 experts to allow people with weakened immune function to get a third dose of certain COVID-19 vaccines.

The decision follows a unanimous vote by the CDC’s Advisory Committee on Immunization Practices (ACIP), which in turn came hours after the U.S. Food and Drug Administration updated its Emergency Use Authorization (EUA) for the Pfizer and Moderna mRNA vaccines.

About 7 million adults in the United States have moderately to severely impaired immune function because of a medical condition they live with or a medication they take to manage a health condition.

People who fall into this category are at higher risk of being hospitalized or dying if they get COVID-19. They are also more likely to transmit the infection. About 40% of vaccinated patients who are hospitalized with breakthrough cases are immunocompromised.

Recent studies have shown that between one-third and one-half of immunocompromised people who didn’t develop antibodies after two doses of a vaccine do get some level of protection after a third dose.

Even then, however, the protection immunocompromised people get from vaccines is not as robust as someone who has healthy immune function, and some panel members were concerned that a third dose might come with a false sense of security.

“My only concern with adding a third dose for the immunocompromised is the impression that our immunocompromised population [will] then be safe,” said ACIP member Helen Talbot, MD, MPH, an associate professor of medicine at Vanderbilt University Medical Center in Nashville, Tenn.

“I think the reality is they’ll be safer but still at incredibly high risk for severe disease and death,” she said.

In updating its EUA, the FDA stressed that, even after a third dose, people who are immunocompromised will still need to wear a mask indoors, socially distance, and avoid large crowds. In addition, family members and other close contacts should be fully vaccinated to protect these vulnerable individuals.
 

Johnson & Johnson not in the mix

The boosters will be available to children as young as 12 years of age who’ve had a Pfizer vaccine or those ages 18 and older who’ve gotten the Moderna vaccine.

For now, people who’ve had the one-dose Johnson & Johnson vaccine have not been cleared to get a second dose of any vaccine.

FDA experts acknowledged the gap but said that people who had received the Johnson & Johnson vaccine represented a small slice of vaccinated Americans, and said they couldn’t act before the FDA had updated its authorization for that vaccine, which the agency is actively exploring.

“We had to do what we’re doing based on the data we have in hand,” said Peter Marks, MD, director of the Center for Biologics Evaluation and Research at the FDA, the division of the agency that regulates vaccines.

“We think at least there is a solution here for the very large majority of immunocompromised individuals, and we believe we will probably have a solution for the remainder in the not-too-distant future,” Dr. Marks said.

In its updated EUA, the FDA said that the third shots were intended for people who had undergone solid organ transplants or have an “equivalent level of immunocompromise.”
 

The details

Clinical experts on the CDC panel spent a good deal of time trying to suss out exactly what conditions might fall under the FDA’s umbrella for a third dose.

In a presentation to the committee, Neela Goswami, MD, PhD, an assistant professor of infectious diseases at Emory University School of Medicine and of epidemiology at the Emory Rollins School of Public Health, Atlanta, stressed that the shots are intended for patients who are moderately or severely immunocompromised, in close consultation with their doctors, but that people who should qualify would include those:

• Receiving treatment for solid tumors or blood cancers
• Taking immunosuppressing medications after a solid organ transplant
• Within 2 years of receiving CAR-T therapy or a stem cell transplant
• Who have primary immunodeficiencies – rare genetic disorders that prevent the immune system from working properly
• With advanced or untreated 
• Taking high-dose corticosteroids (more than 20 milligrams of  or its equivalent daily), alkylating agents, antimetabolites, chemotherapy, TNF blockers, or other immunomodulating or immunosuppressing biologics
• With certain chronic medical conditions, such as  or asplenia – living without a spleen
• Receiving dialysis

In discussion, CDC experts clarified that these third doses were not intended for people whose immune function had waned with age, such as elderly residents of long-term care facilities or people with chronic diseases like diabetes.

The idea is to try to get a third dose of the vaccine they’ve already had – Moderna or Pfizer – but if that’s not feasible, it’s fine for the third dose to be different from what someone has had before. The third dose should be given at least 28 days after a second dose, and, ideally, before the initiation of immunosuppressive therapy.

Participants in the meeting said that the CDC would post updated materials on its website to help guide physicians on exactly who should receive third doses.

Ultimately, however, the extra doses will be given on an honor system; no prescriptions or other kinds of clinical documentation will be required for people to get a third dose of these shots.

Tests to measure neutralizing antibodies are also not recommended before the shots are given because of differences in the types of tests used to measure these antibodies and the difficulty in interpreting them. It’s unclear right now what level of neutralizing antibodies is needed for protection.
 

‘Peace of mind’

In public testimony, Heather Braaten, a 44-year-old being treated for ovarian cancer, said she was grateful to have gotten two shots of the Pfizer vaccine last winter, in between rounds of chemotherapy, but she knew she was probably not well protected. She said she’d become obsessive over the past few months reading medical studies and trying to understand her risk.

“I have felt distraught over the situation. My prognosis is poor. I most likely have about two to three years left to live, so everything counts,” Ms. Braaten said.

She said her life ambitions were humble. She wants to visit with friends and family and not have to worry that she’ll be a breakthrough case. She wants to go grocery shopping again and “not panic and leave the store after five minutes.” She’d love to feel free to travel, she said.

“While I understand I still need to be cautious, I am hopeful for the peace of mind and greater freedom a third shot can provide,” Ms. Braaten said.
 

More boosters on the way?

In the second half of the meeting, the CDC also signaled that it was considering the use of boosters for people whose immunity might have waned in the months since they had completed their vaccine series, particularly seniors. About 75% of people hospitalized with vaccine breakthrough cases are over age 65, according to CDC data.

Those considerations are becoming more urgent as the Delta variant continues to pummel less vaccinated states and counties.

In its presentation to the ACIP, Heather Scobie, PhD, MPH, a member of the CDC’s COVID Response Team, highlighted data from Canada, Israel, Qatar, and the United Kingdom showing that, while the Pfizer vaccine was still highly effective at preventing hospitalizations and death, it’s far less likely when faced with Delta to prevent an infection that causes symptoms.

In Israel, Pfizer’s vaccine prevented symptoms an average of 41% of the time. In Qatar, which is also using the Moderna vaccine, Pfizer’s prevented symptomatic infections with Delta about 54% of the time compared with 85% with Moderna’s.

Dr. Scobie noted that Pfizer’s waning efficacy may have something to do with the fact that it uses a lower dosage than Moderna’s. Pfizer’s recommended dosing interval is also shorter – 3 weeks compared with 4 weeks for Moderna’s. Stretching the time between shots has been shown to boost vaccine effectiveness, she said.

New data from the Mayo clinic, published ahead of peer review, also suggest that Pfizer’s protection may be fading more quickly than Moderna’s. 

In February, both shots were nearly 100% effective at preventing the SARS-CoV-2 infection, but by July, against Delta, Pfizer’s efficacy had dropped to somewhere between 13% and 62%, while Moderna’s was still effective at preventing infection between 58% and 87% of the time.

In July, Pfizer’s was between 24% and 94% effective at preventing hospitalization with a COVID-19 infection and Moderna’s was between 33% and 96% effective at preventing hospitalization.

While that may sound like cause for concern, Dr. Scobie noted that, as of August 2, severe COVD-19 outcomes after vaccination are still very rare. Among 164 million fully vaccinated people in the United States there have been about 7,000 hospitalizations and 1,500 deaths; nearly three out of four of these have been in people over the age of 65.

The ACIP will next meet on August 24 to focus solely on the COVID-19 vaccines.

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

Therapeutic levels of heparin can have widely varying effects on COVID-19 patients depending on the severity of their disease, according to a multiplatform clinical trial that analyzed patient data from three international trials.

NYU Langone Health

COVID-19 patients in the ICU, or at least receiving ICU-level care, derived no benefit from anticoagulation with heparin, while non–critically ill COVID-19 patients – those who were hospitalized but not receiving ICU-level care – on the same anticoagulation were less likely to progress to need respiratory or cardiovascular organ support despite a slightly heightened risk of bleeding events.

Reporting in two articles published online in the New England Journal of Medicine, authors of three international trials combined their data into one multiplatform trial that makes a strong case for prescribing therapeutic levels of heparin in hospitalized patients not receiving ICU-level care were non–critically ill and critically ill.

“I think this is going to be a game changer,” said Jeffrey S. Berger, MD, ACTIV-4a co–principal investigator and co–first author of the study of non–critically ill patients. “I think that using therapeutic-dose anticoagulation should improve outcomes in the tens of thousands of patients worldwide. I hope our data can have a global impact.”
 

Outcomes based on disease severity

The multiplatform trial analyzed data from the Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC); A Multicenter, Adaptive, Randomized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic Strategies in Hospitalized Adults with COVID-19 (ACTIV-4a); and Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP).

The trial evaluated 2,219 non–critically ill hospitalized patients, 1,181 of whom were randomized to therapeutic-dose anticoagulation; and 1,098 critically ill patients, 534 of whom were prescribed therapeutic levels of heparin.

In the critically ill patients, those on heparin were no more likely to get discharged or spend fewer days on respiratory or CV organ support – oxygen, mechanical ventilation, life support, vasopressors or inotropes – than were those on usual-care thromboprophylaxis. The investigators stopped the trial in both patient populations: in critically ill patients when it became obvious therapeutic-dose anticoagulation was having no impact; and in moderately ill patients when the trial met the prespecified criteria for the superiority of therapeutic-dose anticoagulation.

ICU patients on therapeutic-level heparin spent an average of 1 day free of organ support vs. 4 for patients on usual-care prophylactic antithrombotic drugs. The percentage of patients who survived to hospital discharge was similar in the therapeutic-level and usual-care critically ill patients: 62.7% and 64.5%, respectively. Major bleeding occurred in 3.8% and 2.8%, respectively. Demographic and clinical characteristics were similar between both patient groups.

However, in non–critically ill patients, therapeutic levels of heparin resulted in a marked improvement in outcomes. The researchers estimated that, for every 1,000 hospitalized patients with what they labeled moderate disease, an initial treatment with therapeutic-dose heparin resulted in 40 additional patients surviving compared to usual-care thromboprophylaxis.

The percentages of patients not needing organ support before hospital discharge was 80.2% on therapeutic-dose heparin and 76.4% on usual-care therapy. In terms of adjusted odds ratio, the anticoagulation group had a 27% improved chance of not needing daily organ support.

Those improvements came with an additional seven major bleeding events per 1,000 patients. That broke down to a rate of 1.9% in the therapeutic-dose and 0.9% in the usual-care patients.

As the Delta variant of COVID-19 spreads, Patrick R. Lawler, MD, MPH, principal investigator of the ATTACC trial, said there’s no reason these findings shouldn’t apply for all variants of the disease.

University of Toronto

Dr. Lawler, a physician-scientist at Peter Munk Cardiac Centre at Toronto General Hospital, noted that the multiplatform study did not account for disease variant. “Ongoing clinical trials are tracking the variant patients have or the variants that are most prevalent in an area at that time,” he said. “It may be easier in future trials to look at that question.”
 

Explaining heparin’s varying effects

The study did not specifically sort out why moderately ill patients fared better on heparin than their critically ill counterparts, but Dr. Lawler speculated on possible reasons. “One might be that the extent of illness severity is too extreme in the ICU-level population for heparin to have a beneficial extent,” he said.

He acknowledged that higher rates of macrovascular thrombosis, such as venous thromboembolism, in ICU patients would suggest that heparin would have a greater beneficial effect, but, he added, “it may also suggest how advanced that process is, and perhaps heparin is not adequate to reverse the course at that point given relatively extensive thrombosis and associate organ failure.”

As clinicians have gained experience dealing with COVID-19, they’ve learned that infected patients carry a high burden of macro- and microthrombosis, Dr. Berger said, which may explain why critically ill patients didn’t respond as well to therapeutic levels of heparin. “I think the cat is out of the bag; patients who are severe are too ill to benefit,” he said. “I would think there’s too much microthrombosis that is already in their bodies.”

However, this doesn’t completely rule out therapeutic levels of heparin in critically ill COVID-19 patients. There are some scenarios where it’s needed, said Dr. Berger, associate professor of medicine and surgery and director of the Center for the Prevention of Cardiovascular Disease at New York University Langone Health. “Anyone who has a known clot already, like a known macrothrombosis in their leg or lung, needs to be on full-dose heparin,” he said.

That rationale can help reconcile the different outcomes in the critically and non–critically ill COVID-19 patients, wrote Hugo ten Cate, MD, PhD, of Maastricht University in the Netherlands, wrote in an accompanying editorial. But differences in the study populations may also explain the divergent outcomes, Dr. ten Cate noted.

The studies suggest that critically ill patients may need hon-heparin antithrombotic approaches “or even profibrinolytic strategies,” Dr. Cate wrote, and that the safety and effectiveness of thromboprophylaxis “remains an important question.” Nonetheless, he added, treating physicians must deal with the bleeding risk when using heparin or low-molecular-weight heparin in moderately ill COVID-19 patients.

Deepak L. Bhatt MD, MPH, of Brigham and Women’s Hospital Heart & Vascular Center, Boston, said in an interview that reconciling the two studies was “a bit challenging,” because effective therapies tend to have a greater impact in sicker patients.

“Of course, with antithrombotic therapies, bleeding side effects can sometimes overwhelm benefits in patients who are at high risk of both bleeding and ischemic complications, though that does not seem to be the explanation here,” Dr. Bhatt said. “I do think we need more data to clarify exactly which COVID patients benefit from various antithrombotic regimens, and fortunately, there are other ongoing studies, some of which will report relatively soon.”

He concurred with Dr. Berger that patients who need anticoagulation should receive it “apart from their COVID status,” Dr. Bhatt said. “Sick, hospitalized patients with or without COVID should receive appropriate prophylactic doses of anticoagulation.” However, he added, “Whether we should routinely go beyond that in COVID-positive inpatients, I think we need more data.”

The ATTACC platform received grants from the Canadian Institutes of Health Research and several other research foundations. The ACTIV-4a platform received funding from the National Heart, Lung, and Blood Institute. REMAP-CAP received funding from the European Union and several international research foundations, as well as Amgen and Eisai.

Dr. Lawler had no relationships to disclose. Dr. Berger disclosed receiving grants from the NHLBI, and financial relationships with AstraZeneca, Janssen, and Amgen outside the submitted work. Dr. ten Cate reported relationships with Alveron, Coagulation Profile, Portola/Alexion, Bayer, Pfizer, Stago, Leo Pharma, Daiichi, and Gilead/Galapagos. Dr. Bhatt is chair of the data safety and monitoring board of the FREEDOM COVID anticoagulation clinical trial.

Therapeutic levels of heparin can have widely varying effects on COVID-19 patients depending on the severity of their disease, according to a multiplatform clinical trial that analyzed patient data from three international trials.

NYU Langone Health

COVID-19 patients in the ICU, or at least receiving ICU-level care, derived no benefit from anticoagulation with heparin, while non–critically ill COVID-19 patients – those who were hospitalized but not receiving ICU-level care – on the same anticoagulation were less likely to progress to need respiratory or cardiovascular organ support despite a slightly heightened risk of bleeding events.

Reporting in two articles published online in the New England Journal of Medicine, authors of three international trials combined their data into one multiplatform trial that makes a strong case for prescribing therapeutic levels of heparin in hospitalized patients not receiving ICU-level care were non–critically ill and critically ill.

“I think this is going to be a game changer,” said Jeffrey S. Berger, MD, ACTIV-4a co–principal investigator and co–first author of the study of non–critically ill patients. “I think that using therapeutic-dose anticoagulation should improve outcomes in the tens of thousands of patients worldwide. I hope our data can have a global impact.”
 

Outcomes based on disease severity

The multiplatform trial analyzed data from the Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC); A Multicenter, Adaptive, Randomized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic Strategies in Hospitalized Adults with COVID-19 (ACTIV-4a); and Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP).

The trial evaluated 2,219 non–critically ill hospitalized patients, 1,181 of whom were randomized to therapeutic-dose anticoagulation; and 1,098 critically ill patients, 534 of whom were prescribed therapeutic levels of heparin.

In the critically ill patients, those on heparin were no more likely to get discharged or spend fewer days on respiratory or CV organ support – oxygen, mechanical ventilation, life support, vasopressors or inotropes – than were those on usual-care thromboprophylaxis. The investigators stopped the trial in both patient populations: in critically ill patients when it became obvious therapeutic-dose anticoagulation was having no impact; and in moderately ill patients when the trial met the prespecified criteria for the superiority of therapeutic-dose anticoagulation.

ICU patients on therapeutic-level heparin spent an average of 1 day free of organ support vs. 4 for patients on usual-care prophylactic antithrombotic drugs. The percentage of patients who survived to hospital discharge was similar in the therapeutic-level and usual-care critically ill patients: 62.7% and 64.5%, respectively. Major bleeding occurred in 3.8% and 2.8%, respectively. Demographic and clinical characteristics were similar between both patient groups.

However, in non–critically ill patients, therapeutic levels of heparin resulted in a marked improvement in outcomes. The researchers estimated that, for every 1,000 hospitalized patients with what they labeled moderate disease, an initial treatment with therapeutic-dose heparin resulted in 40 additional patients surviving compared to usual-care thromboprophylaxis.

The percentages of patients not needing organ support before hospital discharge was 80.2% on therapeutic-dose heparin and 76.4% on usual-care therapy. In terms of adjusted odds ratio, the anticoagulation group had a 27% improved chance of not needing daily organ support.

Those improvements came with an additional seven major bleeding events per 1,000 patients. That broke down to a rate of 1.9% in the therapeutic-dose and 0.9% in the usual-care patients.

As the Delta variant of COVID-19 spreads, Patrick R. Lawler, MD, MPH, principal investigator of the ATTACC trial, said there’s no reason these findings shouldn’t apply for all variants of the disease.

University of Toronto

Dr. Lawler, a physician-scientist at Peter Munk Cardiac Centre at Toronto General Hospital, noted that the multiplatform study did not account for disease variant. “Ongoing clinical trials are tracking the variant patients have or the variants that are most prevalent in an area at that time,” he said. “It may be easier in future trials to look at that question.”
 

Explaining heparin’s varying effects

The study did not specifically sort out why moderately ill patients fared better on heparin than their critically ill counterparts, but Dr. Lawler speculated on possible reasons. “One might be that the extent of illness severity is too extreme in the ICU-level population for heparin to have a beneficial extent,” he said.

He acknowledged that higher rates of macrovascular thrombosis, such as venous thromboembolism, in ICU patients would suggest that heparin would have a greater beneficial effect, but, he added, “it may also suggest how advanced that process is, and perhaps heparin is not adequate to reverse the course at that point given relatively extensive thrombosis and associate organ failure.”

As clinicians have gained experience dealing with COVID-19, they’ve learned that infected patients carry a high burden of macro- and microthrombosis, Dr. Berger said, which may explain why critically ill patients didn’t respond as well to therapeutic levels of heparin. “I think the cat is out of the bag; patients who are severe are too ill to benefit,” he said. “I would think there’s too much microthrombosis that is already in their bodies.”

However, this doesn’t completely rule out therapeutic levels of heparin in critically ill COVID-19 patients. There are some scenarios where it’s needed, said Dr. Berger, associate professor of medicine and surgery and director of the Center for the Prevention of Cardiovascular Disease at New York University Langone Health. “Anyone who has a known clot already, like a known macrothrombosis in their leg or lung, needs to be on full-dose heparin,” he said.

That rationale can help reconcile the different outcomes in the critically and non–critically ill COVID-19 patients, wrote Hugo ten Cate, MD, PhD, of Maastricht University in the Netherlands, wrote in an accompanying editorial. But differences in the study populations may also explain the divergent outcomes, Dr. ten Cate noted.

The studies suggest that critically ill patients may need hon-heparin antithrombotic approaches “or even profibrinolytic strategies,” Dr. Cate wrote, and that the safety and effectiveness of thromboprophylaxis “remains an important question.” Nonetheless, he added, treating physicians must deal with the bleeding risk when using heparin or low-molecular-weight heparin in moderately ill COVID-19 patients.

Deepak L. Bhatt MD, MPH, of Brigham and Women’s Hospital Heart & Vascular Center, Boston, said in an interview that reconciling the two studies was “a bit challenging,” because effective therapies tend to have a greater impact in sicker patients.

“Of course, with antithrombotic therapies, bleeding side effects can sometimes overwhelm benefits in patients who are at high risk of both bleeding and ischemic complications, though that does not seem to be the explanation here,” Dr. Bhatt said. “I do think we need more data to clarify exactly which COVID patients benefit from various antithrombotic regimens, and fortunately, there are other ongoing studies, some of which will report relatively soon.”

He concurred with Dr. Berger that patients who need anticoagulation should receive it “apart from their COVID status,” Dr. Bhatt said. “Sick, hospitalized patients with or without COVID should receive appropriate prophylactic doses of anticoagulation.” However, he added, “Whether we should routinely go beyond that in COVID-positive inpatients, I think we need more data.”

The ATTACC platform received grants from the Canadian Institutes of Health Research and several other research foundations. The ACTIV-4a platform received funding from the National Heart, Lung, and Blood Institute. REMAP-CAP received funding from the European Union and several international research foundations, as well as Amgen and Eisai.

Dr. Lawler had no relationships to disclose. Dr. Berger disclosed receiving grants from the NHLBI, and financial relationships with AstraZeneca, Janssen, and Amgen outside the submitted work. Dr. ten Cate reported relationships with Alveron, Coagulation Profile, Portola/Alexion, Bayer, Pfizer, Stago, Leo Pharma, Daiichi, and Gilead/Galapagos. Dr. Bhatt is chair of the data safety and monitoring board of the FREEDOM COVID anticoagulation clinical trial.

Therapeutic levels of heparin can have widely varying effects on COVID-19 patients depending on the severity of their disease, according to a multiplatform clinical trial that analyzed patient data from three international trials.

NYU Langone Health

COVID-19 patients in the ICU, or at least receiving ICU-level care, derived no benefit from anticoagulation with heparin, while non–critically ill COVID-19 patients – those who were hospitalized but not receiving ICU-level care – on the same anticoagulation were less likely to progress to need respiratory or cardiovascular organ support despite a slightly heightened risk of bleeding events.

Reporting in two articles published online in the New England Journal of Medicine, authors of three international trials combined their data into one multiplatform trial that makes a strong case for prescribing therapeutic levels of heparin in hospitalized patients not receiving ICU-level care were non–critically ill and critically ill.

“I think this is going to be a game changer,” said Jeffrey S. Berger, MD, ACTIV-4a co–principal investigator and co–first author of the study of non–critically ill patients. “I think that using therapeutic-dose anticoagulation should improve outcomes in the tens of thousands of patients worldwide. I hope our data can have a global impact.”
 

Outcomes based on disease severity

The multiplatform trial analyzed data from the Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC); A Multicenter, Adaptive, Randomized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic Strategies in Hospitalized Adults with COVID-19 (ACTIV-4a); and Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP).

The trial evaluated 2,219 non–critically ill hospitalized patients, 1,181 of whom were randomized to therapeutic-dose anticoagulation; and 1,098 critically ill patients, 534 of whom were prescribed therapeutic levels of heparin.

In the critically ill patients, those on heparin were no more likely to get discharged or spend fewer days on respiratory or CV organ support – oxygen, mechanical ventilation, life support, vasopressors or inotropes – than were those on usual-care thromboprophylaxis. The investigators stopped the trial in both patient populations: in critically ill patients when it became obvious therapeutic-dose anticoagulation was having no impact; and in moderately ill patients when the trial met the prespecified criteria for the superiority of therapeutic-dose anticoagulation.

ICU patients on therapeutic-level heparin spent an average of 1 day free of organ support vs. 4 for patients on usual-care prophylactic antithrombotic drugs. The percentage of patients who survived to hospital discharge was similar in the therapeutic-level and usual-care critically ill patients: 62.7% and 64.5%, respectively. Major bleeding occurred in 3.8% and 2.8%, respectively. Demographic and clinical characteristics were similar between both patient groups.

However, in non–critically ill patients, therapeutic levels of heparin resulted in a marked improvement in outcomes. The researchers estimated that, for every 1,000 hospitalized patients with what they labeled moderate disease, an initial treatment with therapeutic-dose heparin resulted in 40 additional patients surviving compared to usual-care thromboprophylaxis.

The percentages of patients not needing organ support before hospital discharge was 80.2% on therapeutic-dose heparin and 76.4% on usual-care therapy. In terms of adjusted odds ratio, the anticoagulation group had a 27% improved chance of not needing daily organ support.

Those improvements came with an additional seven major bleeding events per 1,000 patients. That broke down to a rate of 1.9% in the therapeutic-dose and 0.9% in the usual-care patients.

As the Delta variant of COVID-19 spreads, Patrick R. Lawler, MD, MPH, principal investigator of the ATTACC trial, said there’s no reason these findings shouldn’t apply for all variants of the disease.

University of Toronto

Dr. Lawler, a physician-scientist at Peter Munk Cardiac Centre at Toronto General Hospital, noted that the multiplatform study did not account for disease variant. “Ongoing clinical trials are tracking the variant patients have or the variants that are most prevalent in an area at that time,” he said. “It may be easier in future trials to look at that question.”
 

Explaining heparin’s varying effects

The study did not specifically sort out why moderately ill patients fared better on heparin than their critically ill counterparts, but Dr. Lawler speculated on possible reasons. “One might be that the extent of illness severity is too extreme in the ICU-level population for heparin to have a beneficial extent,” he said.

He acknowledged that higher rates of macrovascular thrombosis, such as venous thromboembolism, in ICU patients would suggest that heparin would have a greater beneficial effect, but, he added, “it may also suggest how advanced that process is, and perhaps heparin is not adequate to reverse the course at that point given relatively extensive thrombosis and associate organ failure.”

As clinicians have gained experience dealing with COVID-19, they’ve learned that infected patients carry a high burden of macro- and microthrombosis, Dr. Berger said, which may explain why critically ill patients didn’t respond as well to therapeutic levels of heparin. “I think the cat is out of the bag; patients who are severe are too ill to benefit,” he said. “I would think there’s too much microthrombosis that is already in their bodies.”

However, this doesn’t completely rule out therapeutic levels of heparin in critically ill COVID-19 patients. There are some scenarios where it’s needed, said Dr. Berger, associate professor of medicine and surgery and director of the Center for the Prevention of Cardiovascular Disease at New York University Langone Health. “Anyone who has a known clot already, like a known macrothrombosis in their leg or lung, needs to be on full-dose heparin,” he said.

That rationale can help reconcile the different outcomes in the critically and non–critically ill COVID-19 patients, wrote Hugo ten Cate, MD, PhD, of Maastricht University in the Netherlands, wrote in an accompanying editorial. But differences in the study populations may also explain the divergent outcomes, Dr. ten Cate noted.

The studies suggest that critically ill patients may need hon-heparin antithrombotic approaches “or even profibrinolytic strategies,” Dr. Cate wrote, and that the safety and effectiveness of thromboprophylaxis “remains an important question.” Nonetheless, he added, treating physicians must deal with the bleeding risk when using heparin or low-molecular-weight heparin in moderately ill COVID-19 patients.

Deepak L. Bhatt MD, MPH, of Brigham and Women’s Hospital Heart & Vascular Center, Boston, said in an interview that reconciling the two studies was “a bit challenging,” because effective therapies tend to have a greater impact in sicker patients.

“Of course, with antithrombotic therapies, bleeding side effects can sometimes overwhelm benefits in patients who are at high risk of both bleeding and ischemic complications, though that does not seem to be the explanation here,” Dr. Bhatt said. “I do think we need more data to clarify exactly which COVID patients benefit from various antithrombotic regimens, and fortunately, there are other ongoing studies, some of which will report relatively soon.”

He concurred with Dr. Berger that patients who need anticoagulation should receive it “apart from their COVID status,” Dr. Bhatt said. “Sick, hospitalized patients with or without COVID should receive appropriate prophylactic doses of anticoagulation.” However, he added, “Whether we should routinely go beyond that in COVID-positive inpatients, I think we need more data.”

The ATTACC platform received grants from the Canadian Institutes of Health Research and several other research foundations. The ACTIV-4a platform received funding from the National Heart, Lung, and Blood Institute. REMAP-CAP received funding from the European Union and several international research foundations, as well as Amgen and Eisai.

Dr. Lawler had no relationships to disclose. Dr. Berger disclosed receiving grants from the NHLBI, and financial relationships with AstraZeneca, Janssen, and Amgen outside the submitted work. Dr. ten Cate reported relationships with Alveron, Coagulation Profile, Portola/Alexion, Bayer, Pfizer, Stago, Leo Pharma, Daiichi, and Gilead/Galapagos. Dr. Bhatt is chair of the data safety and monitoring board of the FREEDOM COVID anticoagulation clinical trial.

Case vignette: Laura is a 14-year-old biological girl who presents to your office for a routine well-child visit. She is doing well medically but notes that over the past 3 months she has been having increasing thoughts of suicide and has self-harmed via cutting on her wrists with a blade removed from a shaving razor. You contemplate what the most salient questions are in order to determine the best disposition for your patient.

The case vignette above may sound like one that you have heard before, and if not, you undoubtedly will encounter such a situation moving forward. The rate of suicidal ideation amongst youth ages 10-24 has increased by 57.4% between 2007 and 2018.¹ Furthermore, suicide is the second leading cause of death in those aged 10 through young adulthood.² According to the Centers for Disease Control and Prevention’s 2019 High School Youth Risk Behavior Survey, 18.8% of high school students seriously considered attempting suicide, 15.7% made a plan about how they would attempt suicide, and 8.9% actually attempted suicide, with 2.5% having a suicide attempt that resulted in an injury, poisoning, or overdose that had to be treated by a doctor or nurse during the 12 months before the survey.³ Children often present first to their primary care provider, and they may be the first individual who the child shares their suicidal or self-harm thoughts with. It may be useful to have a standardized approach, while using your own clinical judgment, to determine best next steps. Given the significant recent surge in children presenting to the emergency department for psychiatric needs and that environment having its own limitations (for example, long wait times, nontherapeutic space, etc.), a simple screen and brief assessment may lead to being able to maintain a patient safely outside of the hospital.
 

Screen all appropriate patients for suicide

There are, at minimum, three validated screening tools that can be used as to determine what the best next step should be. They include the Ask Suicide-Screening Questions (ASQ) developed by the National Institute of Mental Health, the Columbia-Suicide Severity Rating Scale (C-SSRS), and the PHQ-9 (modified for adolescents). We can highlight one of the screening tools here as noted below, but the choice of screener may be based on facility and/or clinician preference.

The Ask Suicide-Screening Questions

The ASQ, developed by the National Institute of Mental Health, include the following four binary questions plus a fifth acuity question, as follows:

1. In the past few weeks, have you wished you were dead?

2. In the past few weeks, have you felt that you or your family would be better off if you were dead?

3. In the past week, have you been having thoughts about killing yourself?

4. Have you ever tried to kill yourself?

a. If yes, how?

b. When?

The following acuity question is to be asked if any of the above are answered “yes”:

5. Are you having thoughts of killing yourself right now?

a. If yes, please describe.
 

Assess the level of risk

Once you have screened a patient, you need to assess the level of risk to help determine the level of care required. Returning to our original case vignette, does the patient warrant outpatient management, crisis evaluation, or an emergency psychiatric evaluation? You may have already decided that the patient needs an emergency mental health evaluation from a local crisis clinician evaluation and/or the emergency department. However, you may also find that the screen did not elicit imminent concern, but it does warrant a brief assessment to further elucidate the level of risk and proper disposition. One such instrument that may be helpful is the Brief Suicide Safety Assessment (BSSA) – also developed by the NIMH as a tool linked to the ASQ. There are clear and specific instructions in the BSSA with suggestions on how to ask questions. Important components to the BSSA include:

• A focus on a more thorough clinical history – including frequency of suicidal ideation, suicide plan, past behavior, associated symptoms, and social support/stressors
• Collateral information (e.g., further details from those who know the patient such as family/friends).
• Safety planning.
• Determining disposition.

The BSSA may suggest that a crisis/psychiatric evaluation is warranted or suggest that a safety plan with a mental health referral will likely be sufficient.
 

Triage and safety planning

A safety plan should be created if you determine that a patient can be safely maintained as an outpatient based on your screening, assessment, and triaging. Traditional safety plans come in many different forms and can be found online (Example of a Safety Plan Template). However, most safety plans include some version of the following:

• Increased supervision: 24/7 supervision with doors open/unlocked.
• Reduced access: medications (prescription and OTC) locked away; sharps and firearms secured.
• Adaptive coping strategies (e.g., relaxation techniques such as drawing or listening to music).
• Reliable persons for support (e.g., parent, therapist, school counselor).
• Outpatient mental health provider follow-up and/or referral.
• Provision of local crisis and national hotline contact information.
• Use of a safety plan phone app completed with patient.

Envision a safety plan as a living document that evolves, grows, and changes with your patient/family – one that can be easily reviewed/updated at each visit.
 

Returning to our case vignette

Laura returns to your office for a follow-up after a 10-day stay at a hospital-diversion program or inpatient psychiatric unit. The decision is made to use the primary care NIMH ASQ/BSSA algorithm, and you determine the patient to not be at imminent risk following the screen and assessment. Laura is triaged as appropriate for outpatient care, you collaborate to update the safety plan, regular follow-ups are scheduled, and a mental health referral has been placed. Thus, there are tools to assist with screening, assessing, and triaging pediatric patients with suicidal ideation that provide the patient with appropriate care and treatment and may help alleviate the need to have a patient present to the emergency department.

Dr. Abdul-Karim is a child psychiatrist at the University of Vermont University Children’s Hospital in Burlington.

Additional resources

The American Academy of Child and Adolescent Psychiatry has developed information that can be provided to families about suicide safety precautions that can be taken at home, which can be found here: Facts for Families. Suicide Safety: Precautions at Home.

Screening tools listed above can be found here:

ASQ Toolkit.

C-SSRS.

PHQ-9 Modified for Adolescents (PHQ-A).

References

1. Curtin SC. National Center for Health Statistics. “State Suicide Rates Among Adolescents and Young Adults Aged 10-24: United States, 2000-2018” National Vital Statistics Reports..

2. Centers for Disease Control and Prevention, National Center for Health Statistics. “Underlying Cause of Death 2018-2019” CDC WONDER Online Database. Accessed 2021 Jul 31, 6:57:39 p.m.

3. Centers for Disease Control and Prevention. 1991-2019 High School Youth Risk Behavior Survey Data.

Case vignette: Laura is a 14-year-old biological girl who presents to your office for a routine well-child visit. She is doing well medically but notes that over the past 3 months she has been having increasing thoughts of suicide and has self-harmed via cutting on her wrists with a blade removed from a shaving razor. You contemplate what the most salient questions are in order to determine the best disposition for your patient.

The case vignette above may sound like one that you have heard before, and if not, you undoubtedly will encounter such a situation moving forward. The rate of suicidal ideation amongst youth ages 10-24 has increased by 57.4% between 2007 and 2018.¹ Furthermore, suicide is the second leading cause of death in those aged 10 through young adulthood.² According to the Centers for Disease Control and Prevention’s 2019 High School Youth Risk Behavior Survey, 18.8% of high school students seriously considered attempting suicide, 15.7% made a plan about how they would attempt suicide, and 8.9% actually attempted suicide, with 2.5% having a suicide attempt that resulted in an injury, poisoning, or overdose that had to be treated by a doctor or nurse during the 12 months before the survey.³ Children often present first to their primary care provider, and they may be the first individual who the child shares their suicidal or self-harm thoughts with. It may be useful to have a standardized approach, while using your own clinical judgment, to determine best next steps. Given the significant recent surge in children presenting to the emergency department for psychiatric needs and that environment having its own limitations (for example, long wait times, nontherapeutic space, etc.), a simple screen and brief assessment may lead to being able to maintain a patient safely outside of the hospital.
 

Screen all appropriate patients for suicide

There are, at minimum, three validated screening tools that can be used as to determine what the best next step should be. They include the Ask Suicide-Screening Questions (ASQ) developed by the National Institute of Mental Health, the Columbia-Suicide Severity Rating Scale (C-SSRS), and the PHQ-9 (modified for adolescents). We can highlight one of the screening tools here as noted below, but the choice of screener may be based on facility and/or clinician preference.

The Ask Suicide-Screening Questions

The ASQ, developed by the National Institute of Mental Health, include the following four binary questions plus a fifth acuity question, as follows:

1. In the past few weeks, have you wished you were dead?

2. In the past few weeks, have you felt that you or your family would be better off if you were dead?

3. In the past week, have you been having thoughts about killing yourself?

4. Have you ever tried to kill yourself?

a. If yes, how?

b. When?

The following acuity question is to be asked if any of the above are answered “yes”:

5. Are you having thoughts of killing yourself right now?

a. If yes, please describe.
 

Assess the level of risk

Once you have screened a patient, you need to assess the level of risk to help determine the level of care required. Returning to our original case vignette, does the patient warrant outpatient management, crisis evaluation, or an emergency psychiatric evaluation? You may have already decided that the patient needs an emergency mental health evaluation from a local crisis clinician evaluation and/or the emergency department. However, you may also find that the screen did not elicit imminent concern, but it does warrant a brief assessment to further elucidate the level of risk and proper disposition. One such instrument that may be helpful is the Brief Suicide Safety Assessment (BSSA) – also developed by the NIMH as a tool linked to the ASQ. There are clear and specific instructions in the BSSA with suggestions on how to ask questions. Important components to the BSSA include:

• A focus on a more thorough clinical history – including frequency of suicidal ideation, suicide plan, past behavior, associated symptoms, and social support/stressors
• Collateral information (e.g., further details from those who know the patient such as family/friends).
• Safety planning.
• Determining disposition.

The BSSA may suggest that a crisis/psychiatric evaluation is warranted or suggest that a safety plan with a mental health referral will likely be sufficient.
 

Triage and safety planning

A safety plan should be created if you determine that a patient can be safely maintained as an outpatient based on your screening, assessment, and triaging. Traditional safety plans come in many different forms and can be found online (Example of a Safety Plan Template). However, most safety plans include some version of the following:

• Increased supervision: 24/7 supervision with doors open/unlocked.
• Reduced access: medications (prescription and OTC) locked away; sharps and firearms secured.
• Adaptive coping strategies (e.g., relaxation techniques such as drawing or listening to music).
• Reliable persons for support (e.g., parent, therapist, school counselor).
• Outpatient mental health provider follow-up and/or referral.
• Provision of local crisis and national hotline contact information.
• Use of a safety plan phone app completed with patient.

Envision a safety plan as a living document that evolves, grows, and changes with your patient/family – one that can be easily reviewed/updated at each visit.
 

Returning to our case vignette

Laura returns to your office for a follow-up after a 10-day stay at a hospital-diversion program or inpatient psychiatric unit. The decision is made to use the primary care NIMH ASQ/BSSA algorithm, and you determine the patient to not be at imminent risk following the screen and assessment. Laura is triaged as appropriate for outpatient care, you collaborate to update the safety plan, regular follow-ups are scheduled, and a mental health referral has been placed. Thus, there are tools to assist with screening, assessing, and triaging pediatric patients with suicidal ideation that provide the patient with appropriate care and treatment and may help alleviate the need to have a patient present to the emergency department.

Dr. Abdul-Karim is a child psychiatrist at the University of Vermont University Children’s Hospital in Burlington.

Additional resources

The American Academy of Child and Adolescent Psychiatry has developed information that can be provided to families about suicide safety precautions that can be taken at home, which can be found here: Facts for Families. Suicide Safety: Precautions at Home.

Screening tools listed above can be found here:

ASQ Toolkit.

C-SSRS.

PHQ-9 Modified for Adolescents (PHQ-A).

References

1. Curtin SC. National Center for Health Statistics. “State Suicide Rates Among Adolescents and Young Adults Aged 10-24: United States, 2000-2018” National Vital Statistics Reports..

2. Centers for Disease Control and Prevention, National Center for Health Statistics. “Underlying Cause of Death 2018-2019” CDC WONDER Online Database. Accessed 2021 Jul 31, 6:57:39 p.m.

3. Centers for Disease Control and Prevention. 1991-2019 High School Youth Risk Behavior Survey Data.

Case vignette: Laura is a 14-year-old biological girl who presents to your office for a routine well-child visit. She is doing well medically but notes that over the past 3 months she has been having increasing thoughts of suicide and has self-harmed via cutting on her wrists with a blade removed from a shaving razor. You contemplate what the most salient questions are in order to determine the best disposition for your patient.

The case vignette above may sound like one that you have heard before, and if not, you undoubtedly will encounter such a situation moving forward. The rate of suicidal ideation amongst youth ages 10-24 has increased by 57.4% between 2007 and 2018.¹ Furthermore, suicide is the second leading cause of death in those aged 10 through young adulthood.² According to the Centers for Disease Control and Prevention’s 2019 High School Youth Risk Behavior Survey, 18.8% of high school students seriously considered attempting suicide, 15.7% made a plan about how they would attempt suicide, and 8.9% actually attempted suicide, with 2.5% having a suicide attempt that resulted in an injury, poisoning, or overdose that had to be treated by a doctor or nurse during the 12 months before the survey.³ Children often present first to their primary care provider, and they may be the first individual who the child shares their suicidal or self-harm thoughts with. It may be useful to have a standardized approach, while using your own clinical judgment, to determine best next steps. Given the significant recent surge in children presenting to the emergency department for psychiatric needs and that environment having its own limitations (for example, long wait times, nontherapeutic space, etc.), a simple screen and brief assessment may lead to being able to maintain a patient safely outside of the hospital.
 

Screen all appropriate patients for suicide

There are, at minimum, three validated screening tools that can be used as to determine what the best next step should be. They include the Ask Suicide-Screening Questions (ASQ) developed by the National Institute of Mental Health, the Columbia-Suicide Severity Rating Scale (C-SSRS), and the PHQ-9 (modified for adolescents). We can highlight one of the screening tools here as noted below, but the choice of screener may be based on facility and/or clinician preference.

The Ask Suicide-Screening Questions

The ASQ, developed by the National Institute of Mental Health, include the following four binary questions plus a fifth acuity question, as follows:

1. In the past few weeks, have you wished you were dead?

2. In the past few weeks, have you felt that you or your family would be better off if you were dead?

3. In the past week, have you been having thoughts about killing yourself?

4. Have you ever tried to kill yourself?

a. If yes, how?

b. When?

The following acuity question is to be asked if any of the above are answered “yes”:

5. Are you having thoughts of killing yourself right now?

a. If yes, please describe.
 

Assess the level of risk

Once you have screened a patient, you need to assess the level of risk to help determine the level of care required. Returning to our original case vignette, does the patient warrant outpatient management, crisis evaluation, or an emergency psychiatric evaluation? You may have already decided that the patient needs an emergency mental health evaluation from a local crisis clinician evaluation and/or the emergency department. However, you may also find that the screen did not elicit imminent concern, but it does warrant a brief assessment to further elucidate the level of risk and proper disposition. One such instrument that may be helpful is the Brief Suicide Safety Assessment (BSSA) – also developed by the NIMH as a tool linked to the ASQ. There are clear and specific instructions in the BSSA with suggestions on how to ask questions. Important components to the BSSA include:

• A focus on a more thorough clinical history – including frequency of suicidal ideation, suicide plan, past behavior, associated symptoms, and social support/stressors
• Collateral information (e.g., further details from those who know the patient such as family/friends).
• Safety planning.
• Determining disposition.

The BSSA may suggest that a crisis/psychiatric evaluation is warranted or suggest that a safety plan with a mental health referral will likely be sufficient.
 

Triage and safety planning

A safety plan should be created if you determine that a patient can be safely maintained as an outpatient based on your screening, assessment, and triaging. Traditional safety plans come in many different forms and can be found online (Example of a Safety Plan Template). However, most safety plans include some version of the following:

• Increased supervision: 24/7 supervision with doors open/unlocked.
• Reduced access: medications (prescription and OTC) locked away; sharps and firearms secured.
• Adaptive coping strategies (e.g., relaxation techniques such as drawing or listening to music).
• Reliable persons for support (e.g., parent, therapist, school counselor).
• Outpatient mental health provider follow-up and/or referral.
• Provision of local crisis and national hotline contact information.
• Use of a safety plan phone app completed with patient.

Envision a safety plan as a living document that evolves, grows, and changes with your patient/family – one that can be easily reviewed/updated at each visit.
 

Returning to our case vignette

Laura returns to your office for a follow-up after a 10-day stay at a hospital-diversion program or inpatient psychiatric unit. The decision is made to use the primary care NIMH ASQ/BSSA algorithm, and you determine the patient to not be at imminent risk following the screen and assessment. Laura is triaged as appropriate for outpatient care, you collaborate to update the safety plan, regular follow-ups are scheduled, and a mental health referral has been placed. Thus, there are tools to assist with screening, assessing, and triaging pediatric patients with suicidal ideation that provide the patient with appropriate care and treatment and may help alleviate the need to have a patient present to the emergency department.

Dr. Abdul-Karim is a child psychiatrist at the University of Vermont University Children’s Hospital in Burlington.

Additional resources

The American Academy of Child and Adolescent Psychiatry has developed information that can be provided to families about suicide safety precautions that can be taken at home, which can be found here: Facts for Families. Suicide Safety: Precautions at Home.

Screening tools listed above can be found here:

ASQ Toolkit.

C-SSRS.

PHQ-9 Modified for Adolescents (PHQ-A).

References

1. Curtin SC. National Center for Health Statistics. “State Suicide Rates Among Adolescents and Young Adults Aged 10-24: United States, 2000-2018” National Vital Statistics Reports..

2. Centers for Disease Control and Prevention, National Center for Health Statistics. “Underlying Cause of Death 2018-2019” CDC WONDER Online Database. Accessed 2021 Jul 31, 6:57:39 p.m.

3. Centers for Disease Control and Prevention. 1991-2019 High School Youth Risk Behavior Survey Data.

Tachycardia is commonly reported in patients with post-acute COVID-19 syndrome (PACS), also known as long COVID, authors report in a new article. The researchers say tachycardia syndrome should be considered a distinct phenotype.

The study by Marcus Ståhlberg, MD, PhD, of Karolinska University Hospital, Stockholm, and colleagues was published online August 11 in The American Journal of Medicine.

Dr. Ståhlberg told this news organization that although much attention has been paid to cases of clotting and perimyocarditis in patients after COVID, relatively little attention has been paid to tachycardia, despite case reports that show that palpitations are a common complaint.

“We have diagnosed a large number of patients with postural orthostatic tachycardia syndrome [POTS] and other forms of COVID-related tachycardia at our post-COVID outpatient clinic at Karolinska University Hospital and wanted to highlight this phenomenon,” he said.

Between 25% and 50% of patients at the clinic report tachycardia and/or palpitations that last 12 weeks or longer, the authors report.

“Systematic investigations suggest that 9% of Post-acute COVID-19 syndrome patients report palpitations at six months,” the authors write.

The findings also shed light on potential tests and treatments, he said.

“Physicians should be liberal in performing a basic cardiological workup, including an ECG [electrocardiogram], echocardiography, and Holter ECG monitoring in patients complaining of palpitations and/or chest pain,” Dr. Ståhlberg said.

“If orthostatic intolerance is also reported – such as vertigo, nausea, dyspnea – suspicion of POTS should be raised and a head-up tilt test or at least an active standing test should be performed,” he said.

If POTS is confirmed, he said, patients should be offered a heart rate–lowering drug, such as low-dose propranolol or ivabradine. Compression garments, increased fluid intake, and a structured rehabilitation program also help.

“According to our clinical experience, ivabradine can also reduce symptoms in patients with inappropriate sinus tachycardia and post-COVID,” Dr. Ståhlberg said. “Another finding on Holter-ECG to look out for is frequent premature extrasystoles, which could indicate myocarditis and should warrant a cardiac MRI.”

Dr. Ståhlberg said the researchers think the mechanism underlying the tachycardia is autoimmune and that primary SARS-CoV-2 infections trigger an autoimmune response with formation of autoantibodies that can activate receptors regulating blood pressure and heart rate.

Long-lasting symptoms from COVID are prevalent, the authors note, especially in patients who experienced severe forms of the disease.

In the longest follow-up study to date of patients hospitalized with COVID, more than 60% experienced fatigue or muscle weakness 6 months after hospitalization.

PACS should not be considered a single syndrome; the term denotes an array of subsyndromes and phenotypes, the authors write. Typical symptoms include headache, fatigue, dyspnea, and mental fog but can involve multiple organs and systems.

Tachycardia can also be used as a marker to help gauge the severity of long COVID, the authors write.

“[T]achycardia can be considered a universal and easily obtainable quantitative marker of Post-acute COVID-19 syndrome and its severity rather than patient-reported symptoms, blood testing, and thoracic CT-scans,” they write.

An underrecognized complication

Erin D. Michos, MD, MHS, director of women’s cardiovascular health and associate director of preventive cardiology at Johns Hopkins University, Baltimore, said in an interview that she has seen many similar symptoms in the long-COVID patients referred to her practice.

Dr. Michos, who is also an associate professor of medicine and epidemiology, said she’s been receiving a “huge number” of referrals of long-COVID patients with postural tachycardia, inappropriate sinus tachycardia, and POTS.

“I think this is all in the spectrum of autonomic dysfunction that has been recognized a lot since COVID. POTS has been thought to have [a potentially] viral cause that triggers an autoimmune response. Even before COVID, many patients had POTS triggered by a viral infection. The question is whether COVID-related POTS for long COVID is different from other kinds of POTS.”

She says she treats long-COVID patients who complain of elevated heart rates with many of the cardiac workup procedures the authors list and that she treats them in a way similar to the way she treats patients with POTS.

She recommends checking resting oxygen levels and having patients walk the halls and measure their oxygen levels after walking, because their elevated heart rate may be related to ongoing lung injury from COVID.

Eric Adler, MD, a cardiologist with University of San Diego Health, told this news organization that the findings by Dr. Ståhlberg and colleagues are consistent with what he’s seeing in his clinical practice.

Dr. Adler agrees with the authors that tachycardia is an underrecognized complication of long COVID.

He said the article represents further proof that though people may survive COVID, the threat of long-term symptoms, such as heart palpitations, is real and supports the case for vaccinations.

The authors, Dr. Michos, and Dr. Adler have disclosed no relevant financial relationships.

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

Tachycardia is commonly reported in patients with post-acute COVID-19 syndrome (PACS), also known as long COVID, authors report in a new article. The researchers say tachycardia syndrome should be considered a distinct phenotype.

The study by Marcus Ståhlberg, MD, PhD, of Karolinska University Hospital, Stockholm, and colleagues was published online August 11 in The American Journal of Medicine.

Dr. Ståhlberg told this news organization that although much attention has been paid to cases of clotting and perimyocarditis in patients after COVID, relatively little attention has been paid to tachycardia, despite case reports that show that palpitations are a common complaint.

“We have diagnosed a large number of patients with postural orthostatic tachycardia syndrome [POTS] and other forms of COVID-related tachycardia at our post-COVID outpatient clinic at Karolinska University Hospital and wanted to highlight this phenomenon,” he said.

Between 25% and 50% of patients at the clinic report tachycardia and/or palpitations that last 12 weeks or longer, the authors report.

“Systematic investigations suggest that 9% of Post-acute COVID-19 syndrome patients report palpitations at six months,” the authors write.

The findings also shed light on potential tests and treatments, he said.

“Physicians should be liberal in performing a basic cardiological workup, including an ECG [electrocardiogram], echocardiography, and Holter ECG monitoring in patients complaining of palpitations and/or chest pain,” Dr. Ståhlberg said.

“If orthostatic intolerance is also reported – such as vertigo, nausea, dyspnea – suspicion of POTS should be raised and a head-up tilt test or at least an active standing test should be performed,” he said.

If POTS is confirmed, he said, patients should be offered a heart rate–lowering drug, such as low-dose propranolol or ivabradine. Compression garments, increased fluid intake, and a structured rehabilitation program also help.

“According to our clinical experience, ivabradine can also reduce symptoms in patients with inappropriate sinus tachycardia and post-COVID,” Dr. Ståhlberg said. “Another finding on Holter-ECG to look out for is frequent premature extrasystoles, which could indicate myocarditis and should warrant a cardiac MRI.”

Dr. Ståhlberg said the researchers think the mechanism underlying the tachycardia is autoimmune and that primary SARS-CoV-2 infections trigger an autoimmune response with formation of autoantibodies that can activate receptors regulating blood pressure and heart rate.

Long-lasting symptoms from COVID are prevalent, the authors note, especially in patients who experienced severe forms of the disease.

In the longest follow-up study to date of patients hospitalized with COVID, more than 60% experienced fatigue or muscle weakness 6 months after hospitalization.

PACS should not be considered a single syndrome; the term denotes an array of subsyndromes and phenotypes, the authors write. Typical symptoms include headache, fatigue, dyspnea, and mental fog but can involve multiple organs and systems.

Tachycardia can also be used as a marker to help gauge the severity of long COVID, the authors write.

“[T]achycardia can be considered a universal and easily obtainable quantitative marker of Post-acute COVID-19 syndrome and its severity rather than patient-reported symptoms, blood testing, and thoracic CT-scans,” they write.

An underrecognized complication

Erin D. Michos, MD, MHS, director of women’s cardiovascular health and associate director of preventive cardiology at Johns Hopkins University, Baltimore, said in an interview that she has seen many similar symptoms in the long-COVID patients referred to her practice.

Dr. Michos, who is also an associate professor of medicine and epidemiology, said she’s been receiving a “huge number” of referrals of long-COVID patients with postural tachycardia, inappropriate sinus tachycardia, and POTS.

“I think this is all in the spectrum of autonomic dysfunction that has been recognized a lot since COVID. POTS has been thought to have [a potentially] viral cause that triggers an autoimmune response. Even before COVID, many patients had POTS triggered by a viral infection. The question is whether COVID-related POTS for long COVID is different from other kinds of POTS.”

She says she treats long-COVID patients who complain of elevated heart rates with many of the cardiac workup procedures the authors list and that she treats them in a way similar to the way she treats patients with POTS.

She recommends checking resting oxygen levels and having patients walk the halls and measure their oxygen levels after walking, because their elevated heart rate may be related to ongoing lung injury from COVID.

Eric Adler, MD, a cardiologist with University of San Diego Health, told this news organization that the findings by Dr. Ståhlberg and colleagues are consistent with what he’s seeing in his clinical practice.

Dr. Adler agrees with the authors that tachycardia is an underrecognized complication of long COVID.

He said the article represents further proof that though people may survive COVID, the threat of long-term symptoms, such as heart palpitations, is real and supports the case for vaccinations.

The authors, Dr. Michos, and Dr. Adler have disclosed no relevant financial relationships.

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

Tachycardia is commonly reported in patients with post-acute COVID-19 syndrome (PACS), also known as long COVID, authors report in a new article. The researchers say tachycardia syndrome should be considered a distinct phenotype.

The study by Marcus Ståhlberg, MD, PhD, of Karolinska University Hospital, Stockholm, and colleagues was published online August 11 in The American Journal of Medicine.

Dr. Ståhlberg told this news organization that although much attention has been paid to cases of clotting and perimyocarditis in patients after COVID, relatively little attention has been paid to tachycardia, despite case reports that show that palpitations are a common complaint.

“We have diagnosed a large number of patients with postural orthostatic tachycardia syndrome [POTS] and other forms of COVID-related tachycardia at our post-COVID outpatient clinic at Karolinska University Hospital and wanted to highlight this phenomenon,” he said.

Between 25% and 50% of patients at the clinic report tachycardia and/or palpitations that last 12 weeks or longer, the authors report.

“Systematic investigations suggest that 9% of Post-acute COVID-19 syndrome patients report palpitations at six months,” the authors write.

The findings also shed light on potential tests and treatments, he said.

“Physicians should be liberal in performing a basic cardiological workup, including an ECG [electrocardiogram], echocardiography, and Holter ECG monitoring in patients complaining of palpitations and/or chest pain,” Dr. Ståhlberg said.

“If orthostatic intolerance is also reported – such as vertigo, nausea, dyspnea – suspicion of POTS should be raised and a head-up tilt test or at least an active standing test should be performed,” he said.

If POTS is confirmed, he said, patients should be offered a heart rate–lowering drug, such as low-dose propranolol or ivabradine. Compression garments, increased fluid intake, and a structured rehabilitation program also help.

“According to our clinical experience, ivabradine can also reduce symptoms in patients with inappropriate sinus tachycardia and post-COVID,” Dr. Ståhlberg said. “Another finding on Holter-ECG to look out for is frequent premature extrasystoles, which could indicate myocarditis and should warrant a cardiac MRI.”

Dr. Ståhlberg said the researchers think the mechanism underlying the tachycardia is autoimmune and that primary SARS-CoV-2 infections trigger an autoimmune response with formation of autoantibodies that can activate receptors regulating blood pressure and heart rate.

Long-lasting symptoms from COVID are prevalent, the authors note, especially in patients who experienced severe forms of the disease.

In the longest follow-up study to date of patients hospitalized with COVID, more than 60% experienced fatigue or muscle weakness 6 months after hospitalization.

PACS should not be considered a single syndrome; the term denotes an array of subsyndromes and phenotypes, the authors write. Typical symptoms include headache, fatigue, dyspnea, and mental fog but can involve multiple organs and systems.

Tachycardia can also be used as a marker to help gauge the severity of long COVID, the authors write.

“[T]achycardia can be considered a universal and easily obtainable quantitative marker of Post-acute COVID-19 syndrome and its severity rather than patient-reported symptoms, blood testing, and thoracic CT-scans,” they write.

An underrecognized complication

Erin D. Michos, MD, MHS, director of women’s cardiovascular health and associate director of preventive cardiology at Johns Hopkins University, Baltimore, said in an interview that she has seen many similar symptoms in the long-COVID patients referred to her practice.

Dr. Michos, who is also an associate professor of medicine and epidemiology, said she’s been receiving a “huge number” of referrals of long-COVID patients with postural tachycardia, inappropriate sinus tachycardia, and POTS.

“I think this is all in the spectrum of autonomic dysfunction that has been recognized a lot since COVID. POTS has been thought to have [a potentially] viral cause that triggers an autoimmune response. Even before COVID, many patients had POTS triggered by a viral infection. The question is whether COVID-related POTS for long COVID is different from other kinds of POTS.”

She says she treats long-COVID patients who complain of elevated heart rates with many of the cardiac workup procedures the authors list and that she treats them in a way similar to the way she treats patients with POTS.

She recommends checking resting oxygen levels and having patients walk the halls and measure their oxygen levels after walking, because their elevated heart rate may be related to ongoing lung injury from COVID.

Eric Adler, MD, a cardiologist with University of San Diego Health, told this news organization that the findings by Dr. Ståhlberg and colleagues are consistent with what he’s seeing in his clinical practice.

Dr. Adler agrees with the authors that tachycardia is an underrecognized complication of long COVID.

He said the article represents further proof that though people may survive COVID, the threat of long-term symptoms, such as heart palpitations, is real and supports the case for vaccinations.

The authors, Dr. Michos, and Dr. Adler have disclosed no relevant financial relationships.

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

The FDA has authorized a third dose of either the Pfizer or Moderna COVID-19 vaccines for people with compromised immune systems.

The decision, which came late on Aug. 12, was not unexpected and a Centers for Disease Control and Prevention (CDC) panel meeting Aug. 13 is expected to approve directions to doctors and health care providers on who should receive the booster shot.

“The country has entered yet another wave of the COVID-19 pandemic, and the FDA is especially cognizant that immunocompromised people are particularly at risk for severe disease. After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna Vaccines,” acting FDA Commissioner Janet Woodcock, MD, said in a statement.

Those eligible for a third dose include solid organ transplant recipients, those undergoing cancer treatments, and people with autoimmune diseases that suppress their immune systems.

Meanwhile, White House officials said Aug. 12 they “have supply and are prepared” to give all U.S. residents COVID-19 boosters -- which, as of now, are likely to be authorized first only for immunocompromised people.

“We believe sooner or later you will need a booster,” Anthony Fauci, MD, said at a news briefing Aug. 12. “Right now, we are evaluating this on a day-by-day, week-by-week, month-by-month basis.”

He added: “Right at this moment, apart from the immunocompromised -- elderly or not elderly -- people do not need a booster.” But, he said, “We’re preparing for the eventuality of doing that.”

White House COVID-19 Response Coordinator Jeff Zients said officials “have supply and are prepared” to at some point provide widespread access to boosters.

The immunocompromised population is very small -- less than 3% of adults, said CDC Director Rochelle Walensky, MD.

Meanwhile, COVID-19 rates continue to rise. Dr. Walensky reported that the 7-day average of daily cases is 132,384 -- an increase of 24% from the previous week. Average daily hospitalizations are up 31%, at 9,700, and deaths are up to 452 -- an increase of 22%.

In the past week, Florida has had more COVID-19 cases than the 30 states with the lowest case rates combined, Mr. Zients said. Florida and Texas alone have accounted for nearly 40% of new hospitalizations across the country.


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

The FDA has authorized a third dose of either the Pfizer or Moderna COVID-19 vaccines for people with compromised immune systems.

The decision, which came late on Aug. 12, was not unexpected and a Centers for Disease Control and Prevention (CDC) panel meeting Aug. 13 is expected to approve directions to doctors and health care providers on who should receive the booster shot.

“The country has entered yet another wave of the COVID-19 pandemic, and the FDA is especially cognizant that immunocompromised people are particularly at risk for severe disease. After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna Vaccines,” acting FDA Commissioner Janet Woodcock, MD, said in a statement.

Those eligible for a third dose include solid organ transplant recipients, those undergoing cancer treatments, and people with autoimmune diseases that suppress their immune systems.

Meanwhile, White House officials said Aug. 12 they “have supply and are prepared” to give all U.S. residents COVID-19 boosters -- which, as of now, are likely to be authorized first only for immunocompromised people.

“We believe sooner or later you will need a booster,” Anthony Fauci, MD, said at a news briefing Aug. 12. “Right now, we are evaluating this on a day-by-day, week-by-week, month-by-month basis.”

He added: “Right at this moment, apart from the immunocompromised -- elderly or not elderly -- people do not need a booster.” But, he said, “We’re preparing for the eventuality of doing that.”

White House COVID-19 Response Coordinator Jeff Zients said officials “have supply and are prepared” to at some point provide widespread access to boosters.

The immunocompromised population is very small -- less than 3% of adults, said CDC Director Rochelle Walensky, MD.

Meanwhile, COVID-19 rates continue to rise. Dr. Walensky reported that the 7-day average of daily cases is 132,384 -- an increase of 24% from the previous week. Average daily hospitalizations are up 31%, at 9,700, and deaths are up to 452 -- an increase of 22%.

In the past week, Florida has had more COVID-19 cases than the 30 states with the lowest case rates combined, Mr. Zients said. Florida and Texas alone have accounted for nearly 40% of new hospitalizations across the country.


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

The FDA has authorized a third dose of either the Pfizer or Moderna COVID-19 vaccines for people with compromised immune systems.

The decision, which came late on Aug. 12, was not unexpected and a Centers for Disease Control and Prevention (CDC) panel meeting Aug. 13 is expected to approve directions to doctors and health care providers on who should receive the booster shot.

“The country has entered yet another wave of the COVID-19 pandemic, and the FDA is especially cognizant that immunocompromised people are particularly at risk for severe disease. After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna Vaccines,” acting FDA Commissioner Janet Woodcock, MD, said in a statement.

Those eligible for a third dose include solid organ transplant recipients, those undergoing cancer treatments, and people with autoimmune diseases that suppress their immune systems.

Meanwhile, White House officials said Aug. 12 they “have supply and are prepared” to give all U.S. residents COVID-19 boosters -- which, as of now, are likely to be authorized first only for immunocompromised people.

“We believe sooner or later you will need a booster,” Anthony Fauci, MD, said at a news briefing Aug. 12. “Right now, we are evaluating this on a day-by-day, week-by-week, month-by-month basis.”

He added: “Right at this moment, apart from the immunocompromised -- elderly or not elderly -- people do not need a booster.” But, he said, “We’re preparing for the eventuality of doing that.”

White House COVID-19 Response Coordinator Jeff Zients said officials “have supply and are prepared” to at some point provide widespread access to boosters.

The immunocompromised population is very small -- less than 3% of adults, said CDC Director Rochelle Walensky, MD.

Meanwhile, COVID-19 rates continue to rise. Dr. Walensky reported that the 7-day average of daily cases is 132,384 -- an increase of 24% from the previous week. Average daily hospitalizations are up 31%, at 9,700, and deaths are up to 452 -- an increase of 22%.

In the past week, Florida has had more COVID-19 cases than the 30 states with the lowest case rates combined, Mr. Zients said. Florida and Texas alone have accounted for nearly 40% of new hospitalizations across the country.


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

The breast milk of women who had received Pfizer’s COVID-19 vaccine contained specific antibodies against the infectious disease, new research found.

“The COVID-19 pandemic has raised questions among individuals who are breastfeeding, both because of the possibility of viral transmission to infants during breastfeeding and, more recently, of the potential risks and benefits of vaccination in this specific population,” researchers wrote.

In August, the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine, and most recently, the Centers for Disease Control and Prevention, recommended that pregnant people receive the COVID-19 vaccine.

The study, published Aug. 11 in JAMA Network Open, adds to a growing collection of research that has found COVID-19 antibodies in the breast milk of women who were vaccinated against or have been infected with the illness.

Study author Erika Esteve-Palau, MD, PhD, and her colleagues collected blood and milk samples from 33 people who were on average 37 years old and who were on average 17.5 months post partum to examine the correlation of the levels of immunoglobulin G antibodies against the spike protein (S1 subunit) and against the nucleocapsid (NC) of SARS-CoV-2.

Blood and milk samples were taken from each study participant at three time points – 2 weeks after receiving the first dose of the vaccine, 2 weeks after receiving the second dose, and 4 weeks after the second dose. No participants had confirmed SARS-CoV-2 infection prior to vaccination or during the study period.

Researchers found that, after the second dose of the vaccine, IgG(S1) levels in breast milk increased and were positively associated with corresponding levels in the blood samples. The median range of IgG(S1) levels for serum-milk pairs at each time point were 519 to 1 arbitrary units (AU) per mL 2 weeks after receiving the first dose of the vaccine, 8,644 to 78 AU/mL 2 weeks after receiving the second dose, and 12,478 to 50.4 AU/mL 4 weeks after receiving the second dose.

Lisette D. Tanner, MD, MPH, FACOG, who was not involved in the study, said she was not surprised by the findings as previous studies have shown the passage of antibodies in breast milk in vaccinated women. One 2021 study published in JAMA found SARS-CoV-2–specific IgA and IgG antibodies in breast milk for 6 weeks after vaccination. IgA secretion was evident as early as 2 weeks after vaccination followed by a spike in IgG after 4 weeks (a week after the second vaccine). Meanwhile, another 2021 study published in mBio found that breast milk produced by parents with COVID-19 is a source of SARS-CoV-2 IgA and IgG antibodies and can neutralize COVID-19 activity.

“While the data from this and other studies is promising in regards to the passage of antibodies, it is currently unclear what the long-term effects for children will be,” said Dr. Tanner of the department of gynecology and obstetrics at Emory University, Atlanta. “It is not yet known what level of antibodies is necessary to convey protection to either neonates or children. This is an active area of investigation at multiple institutions.”

Dr. Tanner said she wished the study “evaluated neonatal cord blood or serum levels to better understand the immune response mounted by the children of women who received vaccination.”

Researchers of the current study said larger prospective studies are needed to confirm the safety of SARS-CoV-2 vaccination in individuals who are breastfeeding and further assess the association of vaccination with infants’ health and SARS-CoV-2–specific immunity.

Dr. Palau and Dr. Tanner had no relevant financial disclosures.

The breast milk of women who had received Pfizer’s COVID-19 vaccine contained specific antibodies against the infectious disease, new research found.

“The COVID-19 pandemic has raised questions among individuals who are breastfeeding, both because of the possibility of viral transmission to infants during breastfeeding and, more recently, of the potential risks and benefits of vaccination in this specific population,” researchers wrote.

In August, the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine, and most recently, the Centers for Disease Control and Prevention, recommended that pregnant people receive the COVID-19 vaccine.

The study, published Aug. 11 in JAMA Network Open, adds to a growing collection of research that has found COVID-19 antibodies in the breast milk of women who were vaccinated against or have been infected with the illness.

Study author Erika Esteve-Palau, MD, PhD, and her colleagues collected blood and milk samples from 33 people who were on average 37 years old and who were on average 17.5 months post partum to examine the correlation of the levels of immunoglobulin G antibodies against the spike protein (S1 subunit) and against the nucleocapsid (NC) of SARS-CoV-2.

Blood and milk samples were taken from each study participant at three time points – 2 weeks after receiving the first dose of the vaccine, 2 weeks after receiving the second dose, and 4 weeks after the second dose. No participants had confirmed SARS-CoV-2 infection prior to vaccination or during the study period.

Researchers found that, after the second dose of the vaccine, IgG(S1) levels in breast milk increased and were positively associated with corresponding levels in the blood samples. The median range of IgG(S1) levels for serum-milk pairs at each time point were 519 to 1 arbitrary units (AU) per mL 2 weeks after receiving the first dose of the vaccine, 8,644 to 78 AU/mL 2 weeks after receiving the second dose, and 12,478 to 50.4 AU/mL 4 weeks after receiving the second dose.

Lisette D. Tanner, MD, MPH, FACOG, who was not involved in the study, said she was not surprised by the findings as previous studies have shown the passage of antibodies in breast milk in vaccinated women. One 2021 study published in JAMA found SARS-CoV-2–specific IgA and IgG antibodies in breast milk for 6 weeks after vaccination. IgA secretion was evident as early as 2 weeks after vaccination followed by a spike in IgG after 4 weeks (a week after the second vaccine). Meanwhile, another 2021 study published in mBio found that breast milk produced by parents with COVID-19 is a source of SARS-CoV-2 IgA and IgG antibodies and can neutralize COVID-19 activity.

“While the data from this and other studies is promising in regards to the passage of antibodies, it is currently unclear what the long-term effects for children will be,” said Dr. Tanner of the department of gynecology and obstetrics at Emory University, Atlanta. “It is not yet known what level of antibodies is necessary to convey protection to either neonates or children. This is an active area of investigation at multiple institutions.”

Dr. Tanner said she wished the study “evaluated neonatal cord blood or serum levels to better understand the immune response mounted by the children of women who received vaccination.”

Researchers of the current study said larger prospective studies are needed to confirm the safety of SARS-CoV-2 vaccination in individuals who are breastfeeding and further assess the association of vaccination with infants’ health and SARS-CoV-2–specific immunity.

Dr. Palau and Dr. Tanner had no relevant financial disclosures.

The breast milk of women who had received Pfizer’s COVID-19 vaccine contained specific antibodies against the infectious disease, new research found.

“The COVID-19 pandemic has raised questions among individuals who are breastfeeding, both because of the possibility of viral transmission to infants during breastfeeding and, more recently, of the potential risks and benefits of vaccination in this specific population,” researchers wrote.

In August, the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine, and most recently, the Centers for Disease Control and Prevention, recommended that pregnant people receive the COVID-19 vaccine.

The study, published Aug. 11 in JAMA Network Open, adds to a growing collection of research that has found COVID-19 antibodies in the breast milk of women who were vaccinated against or have been infected with the illness.

Study author Erika Esteve-Palau, MD, PhD, and her colleagues collected blood and milk samples from 33 people who were on average 37 years old and who were on average 17.5 months post partum to examine the correlation of the levels of immunoglobulin G antibodies against the spike protein (S1 subunit) and against the nucleocapsid (NC) of SARS-CoV-2.

Blood and milk samples were taken from each study participant at three time points – 2 weeks after receiving the first dose of the vaccine, 2 weeks after receiving the second dose, and 4 weeks after the second dose. No participants had confirmed SARS-CoV-2 infection prior to vaccination or during the study period.

Researchers found that, after the second dose of the vaccine, IgG(S1) levels in breast milk increased and were positively associated with corresponding levels in the blood samples. The median range of IgG(S1) levels for serum-milk pairs at each time point were 519 to 1 arbitrary units (AU) per mL 2 weeks after receiving the first dose of the vaccine, 8,644 to 78 AU/mL 2 weeks after receiving the second dose, and 12,478 to 50.4 AU/mL 4 weeks after receiving the second dose.

Lisette D. Tanner, MD, MPH, FACOG, who was not involved in the study, said she was not surprised by the findings as previous studies have shown the passage of antibodies in breast milk in vaccinated women. One 2021 study published in JAMA found SARS-CoV-2–specific IgA and IgG antibodies in breast milk for 6 weeks after vaccination. IgA secretion was evident as early as 2 weeks after vaccination followed by a spike in IgG after 4 weeks (a week after the second vaccine). Meanwhile, another 2021 study published in mBio found that breast milk produced by parents with COVID-19 is a source of SARS-CoV-2 IgA and IgG antibodies and can neutralize COVID-19 activity.

“While the data from this and other studies is promising in regards to the passage of antibodies, it is currently unclear what the long-term effects for children will be,” said Dr. Tanner of the department of gynecology and obstetrics at Emory University, Atlanta. “It is not yet known what level of antibodies is necessary to convey protection to either neonates or children. This is an active area of investigation at multiple institutions.”

Dr. Tanner said she wished the study “evaluated neonatal cord blood or serum levels to better understand the immune response mounted by the children of women who received vaccination.”

Researchers of the current study said larger prospective studies are needed to confirm the safety of SARS-CoV-2 vaccination in individuals who are breastfeeding and further assess the association of vaccination with infants’ health and SARS-CoV-2–specific immunity.

Dr. Palau and Dr. Tanner had no relevant financial disclosures.

Wishful thinking. “Repeated involuntary passage of stool in the underwear after the acquisition of toileting skills (typically > 4 years of age) in the absence of overt neuromuscular anorectal dysfunction,” formerly called encopresis, certainly still exists, renamed functional fecal incontinence (FFI). You have surely cared for many children with FFI over the years, mostly the 80% retentive (constipated) type but newer information may make your management more successful!

The first step in managing FFI is detecting it. This may seem easy as we get a whiff of its presence, even if the child and parents are unaware because of habituation to the odor. Children lose sensation from rectal dilation by the stool mass and become unaware of leakage. But they also are ashamed of and deny “accidents,” hide soiled underwear, and keep distance from parents and peers. Our physical exam may reveal an abdominal mass or perianal stool. While there, check the anal wink, anus placement, lower spine integrity, and ankle reflexes for rare neurological causes. A rectal exam is not required if the story fits but, if not, may show a dilated rectal vault and hard mass. Blood work, x-ray, ultrasound, barium enemas, or manometry are rarely indicated.

Instead of counting on expressed concern, we should routinely ask children about large, painful, or infrequent poops. There are even Rome IV criteria for constipation – at least two of the following without organic pathology and with duration of at least 1 month: less than 2 defecations/week, a history of hard or painful stools, retentive posturing or excessive stool retention, large stools blocking the toilet, large rectal fecal mass, or at least 1 episode of incontinence/week. Our history should request this but parents are often unaware of their child’s patterns except for that blocked toilet!

Other actionable history includes struggles over toilet training, early anal fissure or painful stools, a history of “straining”, crying, or crossing legs (attempts to withhold), short stature and/or diarrhea (possible celiac disease), abdominal pain, poor appetite, or a diet high in milk products or low in fiber. Family history may suggest rare organic causes such as hypothyroidism, Hirschsprung disease, multiple endocrine neoplasia type 2, or celiac disease, but also constipation (in 55%). After the newborn period (imperforate anus or meconium ileus), 95% of constipation is functional.

While constipation has a worldwide prevalence of 9.5%, low exercise and low-fiber diet are particularly American. Low total food intake as a cause is uncommon in the United States but another reason to screen for food insecurity.

Patterns of behavior can predispose to constipation and FFI. For the child, oppositionality, social anxiety, depression, or eating disorders may interfere with sufficient stool frequency and relaxation needed to fully evacuate at home, daycare, or school. Query every child with ADHD about stool patterns as inattention to urge plus impatience with completing defection (and ODD) are common disorders leading to FFI. Parents who are overly demanding, intrusive, rushing, irritable, anxious, or obsessive may also make routine toileting stressful. When caregivers are neglectful, fail to maintain routines for eating, or ignore dirty diapers, toilet training is more likely to fail and constipation ensue.

Clean out and maintenance using medication are needed for FFI, but child and family behavior change are also critical; the combination has proven more successful. Both the child and parents need clear a explanation of how constipation develops from withholding, regardless of the reason (pain, anxiety, conflict, diet), leading to larger stools more difficult to pass as water is absorbed in the colon. The large mass stretches the bowel so that sensation and strength for motility is impaired and softer stool leaks by and out the rectum unbeknownst to the child. I find drawing “the rock of poop” in a dilated thin walled colon with nerves sparse and “liquid stool sneaking by” compared to a “muscular” colon with soft poop animates and objectifies this explanation. Making it clear that leaking is involuntary is key to having the parent and child directly forgive each other for prior anger, blaming, sneaking, or punishment. While the school-aged child needs to be in charge of toileting, resolving the conflict is essential.

The critical next step is cleaning out “the rocks,” which should only rarely be omitted. Polyethylene glycol (PEG, for example, Miralax) has the best evidence, tastes better (without electrolytes), and dosing 1-1.5 g/kg per day premixed in 10 mL/kg fluid of the child’s choice kept cold and swallowed within 30 minutes daily for 3-6 days until feces have no more chunks. This process disimpacts 95% of the time. Reassure parents of the long-term safety despite the warning on the label that it is intended for adult users. Lactulose or sorbitol (1 mL/kg, once or twice daily), magnesium hydroxide, bisacodyl, or senna are long second choices. Only if these fail should mineral oil 15-30 mL per year of age, up to 240 mL per day be used and then not in infants or if there is aspiration risk. While enemas (mineral oil, sodium phosphate, or saline) and p.o. PEG are equally effective, enemas are very intrusive and unnecessary. There is insufficient evidence for probiotics, prebiotics, or synbiotics.

It is crucial to be honest with the child and parents that clean out can be uncomfortable as cramping or leaking may occur. Thus, starting PEG after school on Friday and being prepared to stay home Monday (if rocks are still emerging) may be needed to avoid accidents.

After clean out, maintenance using daily PEG 0.4-0.8 g/kg per day (best) or lactulose needs to be continued for 2-6 or even 12 months to prevent relapse as the bowel recovers. Bowels need to produce 1-2 soft stools per day for 1 month before considering weaning off PEG. High-fiber (age of child plus 5-10 g/day) diet perpetually is more acceptable if we suggest Frosted Mini-Wheats, Fig Newtons, cookies or muffins baked with wheat bran, popcorn, or fruits with “p” in the name (for example, prunes, pears, apricots), Raisin Bran, or methylcellulose in juice or Popsicles, wafers (with jelly or frosting), or tablets. Infant diet can include brown sugar, or prune/apple/pear juice (Karo is no longer reliably osmotic). Diet needs to include 32-64 ounces of nonmilk fluids, although this will not serve as treatment alone. Limit cow milk to 16 oz. or consider eliminating it entirely if other treatments fail as cow milk is constipating.

Maintenance also requires coaching the child to commence “exercises” to “strengthen the bowel.” These consist of sitting with feet supported to elevate at the hip for 10 minutes by a timer after meals 2-3 times per day and pushing. Entertainment such as music, books, small toys, or a noncompetitive video game and/or rewards of cash, tokens, or treats may lighten the routine. These “exercises” need to be continued indefinitely and monitored with a stool diary. Monthly check-ins are essential to adherence and success, especially in the first 3-4 months, to address any relapses.

While constipation has consequences besides FFI: physical (abdominal pain, anal fissure, rectal prolapse, enuresis, UTI, vesicoureteral reflux, and upper urinary tract dilatation, poor appetite, or poor growth), emotional problems (lability, depression, anxiety, aggression, and low self-esteem), social problems (peer humiliation, teasing, rejection, parent upset, anger, shaming, and punishment), and school absence, we can be supportive and effective coaches for this chronic condition.

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at [email protected].

Wishful thinking. “Repeated involuntary passage of stool in the underwear after the acquisition of toileting skills (typically > 4 years of age) in the absence of overt neuromuscular anorectal dysfunction,” formerly called encopresis, certainly still exists, renamed functional fecal incontinence (FFI). You have surely cared for many children with FFI over the years, mostly the 80% retentive (constipated) type but newer information may make your management more successful!

The first step in managing FFI is detecting it. This may seem easy as we get a whiff of its presence, even if the child and parents are unaware because of habituation to the odor. Children lose sensation from rectal dilation by the stool mass and become unaware of leakage. But they also are ashamed of and deny “accidents,” hide soiled underwear, and keep distance from parents and peers. Our physical exam may reveal an abdominal mass or perianal stool. While there, check the anal wink, anus placement, lower spine integrity, and ankle reflexes for rare neurological causes. A rectal exam is not required if the story fits but, if not, may show a dilated rectal vault and hard mass. Blood work, x-ray, ultrasound, barium enemas, or manometry are rarely indicated.

Instead of counting on expressed concern, we should routinely ask children about large, painful, or infrequent poops. There are even Rome IV criteria for constipation – at least two of the following without organic pathology and with duration of at least 1 month: less than 2 defecations/week, a history of hard or painful stools, retentive posturing or excessive stool retention, large stools blocking the toilet, large rectal fecal mass, or at least 1 episode of incontinence/week. Our history should request this but parents are often unaware of their child’s patterns except for that blocked toilet!

Other actionable history includes struggles over toilet training, early anal fissure or painful stools, a history of “straining”, crying, or crossing legs (attempts to withhold), short stature and/or diarrhea (possible celiac disease), abdominal pain, poor appetite, or a diet high in milk products or low in fiber. Family history may suggest rare organic causes such as hypothyroidism, Hirschsprung disease, multiple endocrine neoplasia type 2, or celiac disease, but also constipation (in 55%). After the newborn period (imperforate anus or meconium ileus), 95% of constipation is functional.

While constipation has a worldwide prevalence of 9.5%, low exercise and low-fiber diet are particularly American. Low total food intake as a cause is uncommon in the United States but another reason to screen for food insecurity.

Patterns of behavior can predispose to constipation and FFI. For the child, oppositionality, social anxiety, depression, or eating disorders may interfere with sufficient stool frequency and relaxation needed to fully evacuate at home, daycare, or school. Query every child with ADHD about stool patterns as inattention to urge plus impatience with completing defection (and ODD) are common disorders leading to FFI. Parents who are overly demanding, intrusive, rushing, irritable, anxious, or obsessive may also make routine toileting stressful. When caregivers are neglectful, fail to maintain routines for eating, or ignore dirty diapers, toilet training is more likely to fail and constipation ensue.

Clean out and maintenance using medication are needed for FFI, but child and family behavior change are also critical; the combination has proven more successful. Both the child and parents need clear a explanation of how constipation develops from withholding, regardless of the reason (pain, anxiety, conflict, diet), leading to larger stools more difficult to pass as water is absorbed in the colon. The large mass stretches the bowel so that sensation and strength for motility is impaired and softer stool leaks by and out the rectum unbeknownst to the child. I find drawing “the rock of poop” in a dilated thin walled colon with nerves sparse and “liquid stool sneaking by” compared to a “muscular” colon with soft poop animates and objectifies this explanation. Making it clear that leaking is involuntary is key to having the parent and child directly forgive each other for prior anger, blaming, sneaking, or punishment. While the school-aged child needs to be in charge of toileting, resolving the conflict is essential.

The critical next step is cleaning out “the rocks,” which should only rarely be omitted. Polyethylene glycol (PEG, for example, Miralax) has the best evidence, tastes better (without electrolytes), and dosing 1-1.5 g/kg per day premixed in 10 mL/kg fluid of the child’s choice kept cold and swallowed within 30 minutes daily for 3-6 days until feces have no more chunks. This process disimpacts 95% of the time. Reassure parents of the long-term safety despite the warning on the label that it is intended for adult users. Lactulose or sorbitol (1 mL/kg, once or twice daily), magnesium hydroxide, bisacodyl, or senna are long second choices. Only if these fail should mineral oil 15-30 mL per year of age, up to 240 mL per day be used and then not in infants or if there is aspiration risk. While enemas (mineral oil, sodium phosphate, or saline) and p.o. PEG are equally effective, enemas are very intrusive and unnecessary. There is insufficient evidence for probiotics, prebiotics, or synbiotics.

It is crucial to be honest with the child and parents that clean out can be uncomfortable as cramping or leaking may occur. Thus, starting PEG after school on Friday and being prepared to stay home Monday (if rocks are still emerging) may be needed to avoid accidents.

After clean out, maintenance using daily PEG 0.4-0.8 g/kg per day (best) or lactulose needs to be continued for 2-6 or even 12 months to prevent relapse as the bowel recovers. Bowels need to produce 1-2 soft stools per day for 1 month before considering weaning off PEG. High-fiber (age of child plus 5-10 g/day) diet perpetually is more acceptable if we suggest Frosted Mini-Wheats, Fig Newtons, cookies or muffins baked with wheat bran, popcorn, or fruits with “p” in the name (for example, prunes, pears, apricots), Raisin Bran, or methylcellulose in juice or Popsicles, wafers (with jelly or frosting), or tablets. Infant diet can include brown sugar, or prune/apple/pear juice (Karo is no longer reliably osmotic). Diet needs to include 32-64 ounces of nonmilk fluids, although this will not serve as treatment alone. Limit cow milk to 16 oz. or consider eliminating it entirely if other treatments fail as cow milk is constipating.

Maintenance also requires coaching the child to commence “exercises” to “strengthen the bowel.” These consist of sitting with feet supported to elevate at the hip for 10 minutes by a timer after meals 2-3 times per day and pushing. Entertainment such as music, books, small toys, or a noncompetitive video game and/or rewards of cash, tokens, or treats may lighten the routine. These “exercises” need to be continued indefinitely and monitored with a stool diary. Monthly check-ins are essential to adherence and success, especially in the first 3-4 months, to address any relapses.

While constipation has consequences besides FFI: physical (abdominal pain, anal fissure, rectal prolapse, enuresis, UTI, vesicoureteral reflux, and upper urinary tract dilatation, poor appetite, or poor growth), emotional problems (lability, depression, anxiety, aggression, and low self-esteem), social problems (peer humiliation, teasing, rejection, parent upset, anger, shaming, and punishment), and school absence, we can be supportive and effective coaches for this chronic condition.

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at [email protected].

Wishful thinking. “Repeated involuntary passage of stool in the underwear after the acquisition of toileting skills (typically > 4 years of age) in the absence of overt neuromuscular anorectal dysfunction,” formerly called encopresis, certainly still exists, renamed functional fecal incontinence (FFI). You have surely cared for many children with FFI over the years, mostly the 80% retentive (constipated) type but newer information may make your management more successful!

The first step in managing FFI is detecting it. This may seem easy as we get a whiff of its presence, even if the child and parents are unaware because of habituation to the odor. Children lose sensation from rectal dilation by the stool mass and become unaware of leakage. But they also are ashamed of and deny “accidents,” hide soiled underwear, and keep distance from parents and peers. Our physical exam may reveal an abdominal mass or perianal stool. While there, check the anal wink, anus placement, lower spine integrity, and ankle reflexes for rare neurological causes. A rectal exam is not required if the story fits but, if not, may show a dilated rectal vault and hard mass. Blood work, x-ray, ultrasound, barium enemas, or manometry are rarely indicated.

Instead of counting on expressed concern, we should routinely ask children about large, painful, or infrequent poops. There are even Rome IV criteria for constipation – at least two of the following without organic pathology and with duration of at least 1 month: less than 2 defecations/week, a history of hard or painful stools, retentive posturing or excessive stool retention, large stools blocking the toilet, large rectal fecal mass, or at least 1 episode of incontinence/week. Our history should request this but parents are often unaware of their child’s patterns except for that blocked toilet!

Other actionable history includes struggles over toilet training, early anal fissure or painful stools, a history of “straining”, crying, or crossing legs (attempts to withhold), short stature and/or diarrhea (possible celiac disease), abdominal pain, poor appetite, or a diet high in milk products or low in fiber. Family history may suggest rare organic causes such as hypothyroidism, Hirschsprung disease, multiple endocrine neoplasia type 2, or celiac disease, but also constipation (in 55%). After the newborn period (imperforate anus or meconium ileus), 95% of constipation is functional.

While constipation has a worldwide prevalence of 9.5%, low exercise and low-fiber diet are particularly American. Low total food intake as a cause is uncommon in the United States but another reason to screen for food insecurity.

Patterns of behavior can predispose to constipation and FFI. For the child, oppositionality, social anxiety, depression, or eating disorders may interfere with sufficient stool frequency and relaxation needed to fully evacuate at home, daycare, or school. Query every child with ADHD about stool patterns as inattention to urge plus impatience with completing defection (and ODD) are common disorders leading to FFI. Parents who are overly demanding, intrusive, rushing, irritable, anxious, or obsessive may also make routine toileting stressful. When caregivers are neglectful, fail to maintain routines for eating, or ignore dirty diapers, toilet training is more likely to fail and constipation ensue.

Clean out and maintenance using medication are needed for FFI, but child and family behavior change are also critical; the combination has proven more successful. Both the child and parents need clear a explanation of how constipation develops from withholding, regardless of the reason (pain, anxiety, conflict, diet), leading to larger stools more difficult to pass as water is absorbed in the colon. The large mass stretches the bowel so that sensation and strength for motility is impaired and softer stool leaks by and out the rectum unbeknownst to the child. I find drawing “the rock of poop” in a dilated thin walled colon with nerves sparse and “liquid stool sneaking by” compared to a “muscular” colon with soft poop animates and objectifies this explanation. Making it clear that leaking is involuntary is key to having the parent and child directly forgive each other for prior anger, blaming, sneaking, or punishment. While the school-aged child needs to be in charge of toileting, resolving the conflict is essential.

The critical next step is cleaning out “the rocks,” which should only rarely be omitted. Polyethylene glycol (PEG, for example, Miralax) has the best evidence, tastes better (without electrolytes), and dosing 1-1.5 g/kg per day premixed in 10 mL/kg fluid of the child’s choice kept cold and swallowed within 30 minutes daily for 3-6 days until feces have no more chunks. This process disimpacts 95% of the time. Reassure parents of the long-term safety despite the warning on the label that it is intended for adult users. Lactulose or sorbitol (1 mL/kg, once or twice daily), magnesium hydroxide, bisacodyl, or senna are long second choices. Only if these fail should mineral oil 15-30 mL per year of age, up to 240 mL per day be used and then not in infants or if there is aspiration risk. While enemas (mineral oil, sodium phosphate, or saline) and p.o. PEG are equally effective, enemas are very intrusive and unnecessary. There is insufficient evidence for probiotics, prebiotics, or synbiotics.

It is crucial to be honest with the child and parents that clean out can be uncomfortable as cramping or leaking may occur. Thus, starting PEG after school on Friday and being prepared to stay home Monday (if rocks are still emerging) may be needed to avoid accidents.

After clean out, maintenance using daily PEG 0.4-0.8 g/kg per day (best) or lactulose needs to be continued for 2-6 or even 12 months to prevent relapse as the bowel recovers. Bowels need to produce 1-2 soft stools per day for 1 month before considering weaning off PEG. High-fiber (age of child plus 5-10 g/day) diet perpetually is more acceptable if we suggest Frosted Mini-Wheats, Fig Newtons, cookies or muffins baked with wheat bran, popcorn, or fruits with “p” in the name (for example, prunes, pears, apricots), Raisin Bran, or methylcellulose in juice or Popsicles, wafers (with jelly or frosting), or tablets. Infant diet can include brown sugar, or prune/apple/pear juice (Karo is no longer reliably osmotic). Diet needs to include 32-64 ounces of nonmilk fluids, although this will not serve as treatment alone. Limit cow milk to 16 oz. or consider eliminating it entirely if other treatments fail as cow milk is constipating.

Maintenance also requires coaching the child to commence “exercises” to “strengthen the bowel.” These consist of sitting with feet supported to elevate at the hip for 10 minutes by a timer after meals 2-3 times per day and pushing. Entertainment such as music, books, small toys, or a noncompetitive video game and/or rewards of cash, tokens, or treats may lighten the routine. These “exercises” need to be continued indefinitely and monitored with a stool diary. Monthly check-ins are essential to adherence and success, especially in the first 3-4 months, to address any relapses.

While constipation has consequences besides FFI: physical (abdominal pain, anal fissure, rectal prolapse, enuresis, UTI, vesicoureteral reflux, and upper urinary tract dilatation, poor appetite, or poor growth), emotional problems (lability, depression, anxiety, aggression, and low self-esteem), social problems (peer humiliation, teasing, rejection, parent upset, anger, shaming, and punishment), and school absence, we can be supportive and effective coaches for this chronic condition.

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at [email protected].

Structural racism and implicit bias are connected, and both must be addressed to move from awareness of racism to action, said Nathan Chomilo, MD, of HealthPartners/Park Nicollet, Brooklyn Center, Minn., in a presentation at the virtual Pediatric Hospital Medicine annual conference.

“We need pediatricians with the courage to address racism head on,” he said.

One step in moving from awareness to action against structural and institutional racism in medicine is examining policies, Dr. Chomilo said. He cited the creation of Medicare and Medicaid in 1965 as examples of how policy changes can make a difference, illustrated by data from 1955-1975 that showed a significant decrease in infant deaths among Black infants in Mississippi after 1965.

Medicaid expansion has helped to narrow, but not eliminate, racial disparities in health care, Dr. Chomilo said. The impact of Medicare and Medicaid is evident in the current COVID-19 pandemic, as county level data show that areas where more than 25% of the population are uninsured have higher rates of COVID-19 infections, said Dr. Chomilo. Policies that impact access to care also impact their incidence of chronic diseases and risk for severe disease, he noted.

“If you don’t have ready access to a health care provider, you don’t have access to the vaccine, and you don’t have information that would inform your getting the vaccine,” he added.
 

Prioritizing the power of voting

“Voting is one of many ways we can impact structural racism in health care policy,” Dr. Chomilo emphasized.

However, voting inequity remains a challenge, Dr. Chomilo noted. Community level disparities lead to inequity in voting access and subsequent disparities in voter participation, he said. “Leaders are less responsive to nonvoting constituents,” which can result in policies that impact health inequitably, and loop back to community level health disparities, he explained.

Historically, physicians have had an 8%-9% lower voter turnout than the general public, although this may have changed in recent elections, Dr. Chomilo said. He encouraged all clinicians to set an example and vote, and to empower their patients to vote. Evidence shows that enfranchisement of Black voters is associated with reductions in education gaps for Blacks and Whites, and that enfranchisement of women is associated with increased spending on children and lower child mortality, he said. Dr. Chomilo encouraged pediatricians and all clinicians to take advantage of the resources on voting available from the American Academy of Pediatrics (aap.org/votekids).

“When we see more people in a community vote, leaders are more responsive to their needs,” he said.
 

Informing racial identity

“Racial identity is informed by racial socialization,” Dr. Chomilo said. “All of us are socialized along the lines of race; it happens in conversations with parents, family, peers, community.” Another point in moving from awareness to action in eliminating structural racism is recognizing that children are not too young to talk about race, Dr. Chomilo emphasized.

Children start to navigate racial identity and to take note of other differences at an early age. For example, a 3-year-old might ask, “why does that person talk funny, why is that person being pushed in a chair?” Dr. Chomilo said, and it is important for parents and as pediatricians to be prepared for these questions, which are part of normal development. As children get older, they start to reflect on what differences mean for them, which is not rooted in anything negative, he noted.

Children first develop racial identity at home, but children solidify their identities in child care and school settings, Dr. Chomilo said. The American Academy of Pediatrics has acknowledged the potential for racial bias in education and child care, and said in a statement that, “it is critical for pediatricians to recognize the institutional personally mediated, and internalized levels of racism that occur in the educational setting, because education is a critical social determinant of health for children.” In fact, data from children in preschool show that they use racial categories to identify themselves and others, to include or exclude children from activities, and to negotiate power in their social and play networks.

Early intervention matters in educating children about racism, Dr. Chomilo said. “If we were not taught to talk about race, it is on us to learn about it ourselves as well,” he said.

Ultimately, the goal is to create active antiracism among adults and children, said Dr. Chomilo. He encouraged pediatricians and parents not to shut down or discourage children when they raise questions of race, but to take the opportunity to teach. “There may be hurt feelings around what a child said, even if they didn’t mean to offend someone,” he noted. Take the topic seriously, and make racism conversations ongoing; teach children to safely oppose negative messages and behaviors in others, and replace them with something positive, he emphasized.
 

Addressing bias in clinical settings

Dr. Chomilo also encouraged hospitalists to consider internalized racism in clinical settings and take action to build confidence and cultural pride in all patients by ensuring that a pediatric hospital unit is welcoming and representative of the diversity in a given community, with appropriate options for books, movies, and toys. He also encouraged pediatric hospitalists to assess children for experiences of racism as part of a social assessment. Be aware of signs of posttraumatic stress, anxiety, depression, or grief that might have a racial component, he said.

Dr. Chomilo had no financial conflicts to disclose.

Structural racism and implicit bias are connected, and both must be addressed to move from awareness of racism to action, said Nathan Chomilo, MD, of HealthPartners/Park Nicollet, Brooklyn Center, Minn., in a presentation at the virtual Pediatric Hospital Medicine annual conference.

“We need pediatricians with the courage to address racism head on,” he said.

One step in moving from awareness to action against structural and institutional racism in medicine is examining policies, Dr. Chomilo said. He cited the creation of Medicare and Medicaid in 1965 as examples of how policy changes can make a difference, illustrated by data from 1955-1975 that showed a significant decrease in infant deaths among Black infants in Mississippi after 1965.

Medicaid expansion has helped to narrow, but not eliminate, racial disparities in health care, Dr. Chomilo said. The impact of Medicare and Medicaid is evident in the current COVID-19 pandemic, as county level data show that areas where more than 25% of the population are uninsured have higher rates of COVID-19 infections, said Dr. Chomilo. Policies that impact access to care also impact their incidence of chronic diseases and risk for severe disease, he noted.

“If you don’t have ready access to a health care provider, you don’t have access to the vaccine, and you don’t have information that would inform your getting the vaccine,” he added.
 

Prioritizing the power of voting

“Voting is one of many ways we can impact structural racism in health care policy,” Dr. Chomilo emphasized.

However, voting inequity remains a challenge, Dr. Chomilo noted. Community level disparities lead to inequity in voting access and subsequent disparities in voter participation, he said. “Leaders are less responsive to nonvoting constituents,” which can result in policies that impact health inequitably, and loop back to community level health disparities, he explained.

Historically, physicians have had an 8%-9% lower voter turnout than the general public, although this may have changed in recent elections, Dr. Chomilo said. He encouraged all clinicians to set an example and vote, and to empower their patients to vote. Evidence shows that enfranchisement of Black voters is associated with reductions in education gaps for Blacks and Whites, and that enfranchisement of women is associated with increased spending on children and lower child mortality, he said. Dr. Chomilo encouraged pediatricians and all clinicians to take advantage of the resources on voting available from the American Academy of Pediatrics (aap.org/votekids).

“When we see more people in a community vote, leaders are more responsive to their needs,” he said.
 

Informing racial identity

“Racial identity is informed by racial socialization,” Dr. Chomilo said. “All of us are socialized along the lines of race; it happens in conversations with parents, family, peers, community.” Another point in moving from awareness to action in eliminating structural racism is recognizing that children are not too young to talk about race, Dr. Chomilo emphasized.

Children start to navigate racial identity and to take note of other differences at an early age. For example, a 3-year-old might ask, “why does that person talk funny, why is that person being pushed in a chair?” Dr. Chomilo said, and it is important for parents and as pediatricians to be prepared for these questions, which are part of normal development. As children get older, they start to reflect on what differences mean for them, which is not rooted in anything negative, he noted.

Children first develop racial identity at home, but children solidify their identities in child care and school settings, Dr. Chomilo said. The American Academy of Pediatrics has acknowledged the potential for racial bias in education and child care, and said in a statement that, “it is critical for pediatricians to recognize the institutional personally mediated, and internalized levels of racism that occur in the educational setting, because education is a critical social determinant of health for children.” In fact, data from children in preschool show that they use racial categories to identify themselves and others, to include or exclude children from activities, and to negotiate power in their social and play networks.

Early intervention matters in educating children about racism, Dr. Chomilo said. “If we were not taught to talk about race, it is on us to learn about it ourselves as well,” he said.

Ultimately, the goal is to create active antiracism among adults and children, said Dr. Chomilo. He encouraged pediatricians and parents not to shut down or discourage children when they raise questions of race, but to take the opportunity to teach. “There may be hurt feelings around what a child said, even if they didn’t mean to offend someone,” he noted. Take the topic seriously, and make racism conversations ongoing; teach children to safely oppose negative messages and behaviors in others, and replace them with something positive, he emphasized.
 

Addressing bias in clinical settings

Dr. Chomilo also encouraged hospitalists to consider internalized racism in clinical settings and take action to build confidence and cultural pride in all patients by ensuring that a pediatric hospital unit is welcoming and representative of the diversity in a given community, with appropriate options for books, movies, and toys. He also encouraged pediatric hospitalists to assess children for experiences of racism as part of a social assessment. Be aware of signs of posttraumatic stress, anxiety, depression, or grief that might have a racial component, he said.

Dr. Chomilo had no financial conflicts to disclose.

Structural racism and implicit bias are connected, and both must be addressed to move from awareness of racism to action, said Nathan Chomilo, MD, of HealthPartners/Park Nicollet, Brooklyn Center, Minn., in a presentation at the virtual Pediatric Hospital Medicine annual conference.

“We need pediatricians with the courage to address racism head on,” he said.

One step in moving from awareness to action against structural and institutional racism in medicine is examining policies, Dr. Chomilo said. He cited the creation of Medicare and Medicaid in 1965 as examples of how policy changes can make a difference, illustrated by data from 1955-1975 that showed a significant decrease in infant deaths among Black infants in Mississippi after 1965.

Medicaid expansion has helped to narrow, but not eliminate, racial disparities in health care, Dr. Chomilo said. The impact of Medicare and Medicaid is evident in the current COVID-19 pandemic, as county level data show that areas where more than 25% of the population are uninsured have higher rates of COVID-19 infections, said Dr. Chomilo. Policies that impact access to care also impact their incidence of chronic diseases and risk for severe disease, he noted.

“If you don’t have ready access to a health care provider, you don’t have access to the vaccine, and you don’t have information that would inform your getting the vaccine,” he added.
 

Prioritizing the power of voting

“Voting is one of many ways we can impact structural racism in health care policy,” Dr. Chomilo emphasized.

However, voting inequity remains a challenge, Dr. Chomilo noted. Community level disparities lead to inequity in voting access and subsequent disparities in voter participation, he said. “Leaders are less responsive to nonvoting constituents,” which can result in policies that impact health inequitably, and loop back to community level health disparities, he explained.

Historically, physicians have had an 8%-9% lower voter turnout than the general public, although this may have changed in recent elections, Dr. Chomilo said. He encouraged all clinicians to set an example and vote, and to empower their patients to vote. Evidence shows that enfranchisement of Black voters is associated with reductions in education gaps for Blacks and Whites, and that enfranchisement of women is associated with increased spending on children and lower child mortality, he said. Dr. Chomilo encouraged pediatricians and all clinicians to take advantage of the resources on voting available from the American Academy of Pediatrics (aap.org/votekids).

“When we see more people in a community vote, leaders are more responsive to their needs,” he said.
 

Informing racial identity

“Racial identity is informed by racial socialization,” Dr. Chomilo said. “All of us are socialized along the lines of race; it happens in conversations with parents, family, peers, community.” Another point in moving from awareness to action in eliminating structural racism is recognizing that children are not too young to talk about race, Dr. Chomilo emphasized.

Children start to navigate racial identity and to take note of other differences at an early age. For example, a 3-year-old might ask, “why does that person talk funny, why is that person being pushed in a chair?” Dr. Chomilo said, and it is important for parents and as pediatricians to be prepared for these questions, which are part of normal development. As children get older, they start to reflect on what differences mean for them, which is not rooted in anything negative, he noted.

Children first develop racial identity at home, but children solidify their identities in child care and school settings, Dr. Chomilo said. The American Academy of Pediatrics has acknowledged the potential for racial bias in education and child care, and said in a statement that, “it is critical for pediatricians to recognize the institutional personally mediated, and internalized levels of racism that occur in the educational setting, because education is a critical social determinant of health for children.” In fact, data from children in preschool show that they use racial categories to identify themselves and others, to include or exclude children from activities, and to negotiate power in their social and play networks.

Early intervention matters in educating children about racism, Dr. Chomilo said. “If we were not taught to talk about race, it is on us to learn about it ourselves as well,” he said.

Ultimately, the goal is to create active antiracism among adults and children, said Dr. Chomilo. He encouraged pediatricians and parents not to shut down or discourage children when they raise questions of race, but to take the opportunity to teach. “There may be hurt feelings around what a child said, even if they didn’t mean to offend someone,” he noted. Take the topic seriously, and make racism conversations ongoing; teach children to safely oppose negative messages and behaviors in others, and replace them with something positive, he emphasized.
 

Addressing bias in clinical settings

Dr. Chomilo also encouraged hospitalists to consider internalized racism in clinical settings and take action to build confidence and cultural pride in all patients by ensuring that a pediatric hospital unit is welcoming and representative of the diversity in a given community, with appropriate options for books, movies, and toys. He also encouraged pediatric hospitalists to assess children for experiences of racism as part of a social assessment. Be aware of signs of posttraumatic stress, anxiety, depression, or grief that might have a racial component, he said.

Dr. Chomilo had no financial conflicts to disclose.

Most pediatric patients diagnosed with an inflammatory or autoimmune disorder lacked evidence of an immune response to the hepatitis B vaccine, results from a single-center retrospective study showed.

“Hepatitis B is a common viral infection with 2 billion people worldwide having evidence of prior or current infection, and it can present as an acute or chronic infection,” or with chronic sequelae, including cirrhosis and hepatocellular carcinoma, Alexandra Ritter said during the annual meeting of the Society for Pediatric Dermatology. A three-dose vaccination series is recommended beginning at birth, and in 2016, the Centers for Disease Control and Prevention reported that 90.5% of U.S. children aged 19-35 months had completed the series.

While the vaccine series provides protection in healthy individuals more than 95% of the time, a decreased response has been noted in specific pediatric populations, including those with inflammatory and autoimmune diseases. “This is important to note and investigate further because a decreased vaccine response increases the risk for this high-risk population, and the use of boosters is currently debated,” said Ms. Ritter, who is a fourth-year student at the Medical University of South Carolina, Charleston.

To determine the percent of pediatric patients with inflammatory or autoimmune disease who lack evidence of immunity following the hepatitis B vaccine series, Ms. Ritter and colleagues Abigail Truitt and pediatric dermatologist Lara Wine Lee, MD, PhD, of MUSC, retrospectively reviewed the charts of 160 patients between the ages of 6 months and 21 years, who were diagnosed with an autoimmune or autoinflammatory disease, or inflammatory bowel disease (IBD), and had documented evidence of vaccination and serologic testing prior to the start of immunosuppressive therapy.

Of the 160 patients, 100 (63%) had IBD, 34 (21%) had an autoimmune disease, 26 (16%) had an autoinflammatory disease, 89 (56%) were female, and their mean age was 15 years.

The researchers observed variation in the testing ordered between the three patient groups. Specifically, 88.2% of autoimmune patients had hepatitis B surface antigen (HBsAg) testing, compared with 96.15% of patients with an autoinflammatory disease and 67% of patients with IBD, while 76.47% of patients with an autoimmune disease had hepatitis B core antibody (anti-HBc) testing, compared with 88.46% of patients with an autoinflammatory disease and 31% of patients with IBD.

In addition, 82.35% of patients with an autoimmune disease had HBsAg testing, compared with 100% of patients with an autoinflammatory disease and 94% of patients with IBD.

Of the 148 patients who had HBsAg testing ordered and completed prior to starting an immunosuppressive drug, there was no statistically significant difference in the percent of patients showing evidence of an immune response to the hepatitis B vaccine (32.14% among patients with an autoimmune disease, 34.62% among patients with an autoinflammatory disease, and 31.91% among patients with IBD). Combined, 67.57% of tested negative for the hepatitis B surface antibody.

“Our study showed that the majority of these patients did not show serologic evidence of immunity despite being fully vaccinated,” Ms. Ritter said. “There was also variation in the testing ordered and a more standardized approach is needed in this high-risk population.” She acknowledged certain limitations of the study, including its retrospective design and lack of a control group.

“This brings us to our next question of whether this indicates a failure of the vaccine, or the way immunity is tested,” she continued. “The CDC and the European Consensus Group on Hepatitis B Immunity recommend a cutoff of greater than 10 mIU/mL. Those that achieve immunity are protected for up to 20 years due to immune memory, even if their antibody levels later drop. There have been rare cases of immunocompetent individuals having evidence of transient asymptomatic infections when antibody levels drop. The chronic disease has only been documented in infants born to positive mothers. In hemodialysis patients, however, clinically significant infections have been documented when antibody levels drop.”

The CDC only recommends postvaccination testing to infants born to positive mothers, health care workers at high risk, hemodialysis patients, people with HIV and other immunocompromised people, and needle-sharing partners of chronically infected people. This is completed 1-2 months following the third vaccine dose, and those with antibody levels less than 10 mIU/mL should be revaccinated. “As some groups do not respond to the vaccine series, alternative dosing and the intradermal vaccine have been studied and shown to be effective in certain groups,” she said.

When it comes to monitoring immunocompromised individuals and giving booster shots, however, there are conflicting recommendations. The CDC recommends yearly testing and booster shots when levels drop below 10 mIU/mL only in hemodialysis patients, while the European Consensus Group recommends testing every 6-12 months for immunocompromised individuals and boosters when their levels drop below 10 mIU/mL.

“The CDC has not yet determined if other immunocompromised individuals should receive a booster, with more research required, but studies have shown it to be effective,” Ms. Ritter said. In a similar study looking at evidence of immunity in children with connective tissue disease who were on immunosuppressive treatment, 50% had no evidence of protective antibodies, compared with 96% in the control group. “In that study, a booster shot was given, and protective antibody concentrations were found at follow-up,” she said.

The researchers reported having no financial disclosures.

[email protected]

Most pediatric patients diagnosed with an inflammatory or autoimmune disorder lacked evidence of an immune response to the hepatitis B vaccine, results from a single-center retrospective study showed.

“Hepatitis B is a common viral infection with 2 billion people worldwide having evidence of prior or current infection, and it can present as an acute or chronic infection,” or with chronic sequelae, including cirrhosis and hepatocellular carcinoma, Alexandra Ritter said during the annual meeting of the Society for Pediatric Dermatology. A three-dose vaccination series is recommended beginning at birth, and in 2016, the Centers for Disease Control and Prevention reported that 90.5% of U.S. children aged 19-35 months had completed the series.

While the vaccine series provides protection in healthy individuals more than 95% of the time, a decreased response has been noted in specific pediatric populations, including those with inflammatory and autoimmune diseases. “This is important to note and investigate further because a decreased vaccine response increases the risk for this high-risk population, and the use of boosters is currently debated,” said Ms. Ritter, who is a fourth-year student at the Medical University of South Carolina, Charleston.

To determine the percent of pediatric patients with inflammatory or autoimmune disease who lack evidence of immunity following the hepatitis B vaccine series, Ms. Ritter and colleagues Abigail Truitt and pediatric dermatologist Lara Wine Lee, MD, PhD, of MUSC, retrospectively reviewed the charts of 160 patients between the ages of 6 months and 21 years, who were diagnosed with an autoimmune or autoinflammatory disease, or inflammatory bowel disease (IBD), and had documented evidence of vaccination and serologic testing prior to the start of immunosuppressive therapy.

Of the 160 patients, 100 (63%) had IBD, 34 (21%) had an autoimmune disease, 26 (16%) had an autoinflammatory disease, 89 (56%) were female, and their mean age was 15 years.

The researchers observed variation in the testing ordered between the three patient groups. Specifically, 88.2% of autoimmune patients had hepatitis B surface antigen (HBsAg) testing, compared with 96.15% of patients with an autoinflammatory disease and 67% of patients with IBD, while 76.47% of patients with an autoimmune disease had hepatitis B core antibody (anti-HBc) testing, compared with 88.46% of patients with an autoinflammatory disease and 31% of patients with IBD.

In addition, 82.35% of patients with an autoimmune disease had HBsAg testing, compared with 100% of patients with an autoinflammatory disease and 94% of patients with IBD.

Of the 148 patients who had HBsAg testing ordered and completed prior to starting an immunosuppressive drug, there was no statistically significant difference in the percent of patients showing evidence of an immune response to the hepatitis B vaccine (32.14% among patients with an autoimmune disease, 34.62% among patients with an autoinflammatory disease, and 31.91% among patients with IBD). Combined, 67.57% of tested negative for the hepatitis B surface antibody.

“Our study showed that the majority of these patients did not show serologic evidence of immunity despite being fully vaccinated,” Ms. Ritter said. “There was also variation in the testing ordered and a more standardized approach is needed in this high-risk population.” She acknowledged certain limitations of the study, including its retrospective design and lack of a control group.

“This brings us to our next question of whether this indicates a failure of the vaccine, or the way immunity is tested,” she continued. “The CDC and the European Consensus Group on Hepatitis B Immunity recommend a cutoff of greater than 10 mIU/mL. Those that achieve immunity are protected for up to 20 years due to immune memory, even if their antibody levels later drop. There have been rare cases of immunocompetent individuals having evidence of transient asymptomatic infections when antibody levels drop. The chronic disease has only been documented in infants born to positive mothers. In hemodialysis patients, however, clinically significant infections have been documented when antibody levels drop.”

The CDC only recommends postvaccination testing to infants born to positive mothers, health care workers at high risk, hemodialysis patients, people with HIV and other immunocompromised people, and needle-sharing partners of chronically infected people. This is completed 1-2 months following the third vaccine dose, and those with antibody levels less than 10 mIU/mL should be revaccinated. “As some groups do not respond to the vaccine series, alternative dosing and the intradermal vaccine have been studied and shown to be effective in certain groups,” she said.

When it comes to monitoring immunocompromised individuals and giving booster shots, however, there are conflicting recommendations. The CDC recommends yearly testing and booster shots when levels drop below 10 mIU/mL only in hemodialysis patients, while the European Consensus Group recommends testing every 6-12 months for immunocompromised individuals and boosters when their levels drop below 10 mIU/mL.

“The CDC has not yet determined if other immunocompromised individuals should receive a booster, with more research required, but studies have shown it to be effective,” Ms. Ritter said. In a similar study looking at evidence of immunity in children with connective tissue disease who were on immunosuppressive treatment, 50% had no evidence of protective antibodies, compared with 96% in the control group. “In that study, a booster shot was given, and protective antibody concentrations were found at follow-up,” she said.

The researchers reported having no financial disclosures.

[email protected]

Most pediatric patients diagnosed with an inflammatory or autoimmune disorder lacked evidence of an immune response to the hepatitis B vaccine, results from a single-center retrospective study showed.

“Hepatitis B is a common viral infection with 2 billion people worldwide having evidence of prior or current infection, and it can present as an acute or chronic infection,” or with chronic sequelae, including cirrhosis and hepatocellular carcinoma, Alexandra Ritter said during the annual meeting of the Society for Pediatric Dermatology. A three-dose vaccination series is recommended beginning at birth, and in 2016, the Centers for Disease Control and Prevention reported that 90.5% of U.S. children aged 19-35 months had completed the series.

While the vaccine series provides protection in healthy individuals more than 95% of the time, a decreased response has been noted in specific pediatric populations, including those with inflammatory and autoimmune diseases. “This is important to note and investigate further because a decreased vaccine response increases the risk for this high-risk population, and the use of boosters is currently debated,” said Ms. Ritter, who is a fourth-year student at the Medical University of South Carolina, Charleston.

To determine the percent of pediatric patients with inflammatory or autoimmune disease who lack evidence of immunity following the hepatitis B vaccine series, Ms. Ritter and colleagues Abigail Truitt and pediatric dermatologist Lara Wine Lee, MD, PhD, of MUSC, retrospectively reviewed the charts of 160 patients between the ages of 6 months and 21 years, who were diagnosed with an autoimmune or autoinflammatory disease, or inflammatory bowel disease (IBD), and had documented evidence of vaccination and serologic testing prior to the start of immunosuppressive therapy.

Of the 160 patients, 100 (63%) had IBD, 34 (21%) had an autoimmune disease, 26 (16%) had an autoinflammatory disease, 89 (56%) were female, and their mean age was 15 years.

The researchers observed variation in the testing ordered between the three patient groups. Specifically, 88.2% of autoimmune patients had hepatitis B surface antigen (HBsAg) testing, compared with 96.15% of patients with an autoinflammatory disease and 67% of patients with IBD, while 76.47% of patients with an autoimmune disease had hepatitis B core antibody (anti-HBc) testing, compared with 88.46% of patients with an autoinflammatory disease and 31% of patients with IBD.

In addition, 82.35% of patients with an autoimmune disease had HBsAg testing, compared with 100% of patients with an autoinflammatory disease and 94% of patients with IBD.

Of the 148 patients who had HBsAg testing ordered and completed prior to starting an immunosuppressive drug, there was no statistically significant difference in the percent of patients showing evidence of an immune response to the hepatitis B vaccine (32.14% among patients with an autoimmune disease, 34.62% among patients with an autoinflammatory disease, and 31.91% among patients with IBD). Combined, 67.57% of tested negative for the hepatitis B surface antibody.

“Our study showed that the majority of these patients did not show serologic evidence of immunity despite being fully vaccinated,” Ms. Ritter said. “There was also variation in the testing ordered and a more standardized approach is needed in this high-risk population.” She acknowledged certain limitations of the study, including its retrospective design and lack of a control group.

“This brings us to our next question of whether this indicates a failure of the vaccine, or the way immunity is tested,” she continued. “The CDC and the European Consensus Group on Hepatitis B Immunity recommend a cutoff of greater than 10 mIU/mL. Those that achieve immunity are protected for up to 20 years due to immune memory, even if their antibody levels later drop. There have been rare cases of immunocompetent individuals having evidence of transient asymptomatic infections when antibody levels drop. The chronic disease has only been documented in infants born to positive mothers. In hemodialysis patients, however, clinically significant infections have been documented when antibody levels drop.”

The CDC only recommends postvaccination testing to infants born to positive mothers, health care workers at high risk, hemodialysis patients, people with HIV and other immunocompromised people, and needle-sharing partners of chronically infected people. This is completed 1-2 months following the third vaccine dose, and those with antibody levels less than 10 mIU/mL should be revaccinated. “As some groups do not respond to the vaccine series, alternative dosing and the intradermal vaccine have been studied and shown to be effective in certain groups,” she said.

When it comes to monitoring immunocompromised individuals and giving booster shots, however, there are conflicting recommendations. The CDC recommends yearly testing and booster shots when levels drop below 10 mIU/mL only in hemodialysis patients, while the European Consensus Group recommends testing every 6-12 months for immunocompromised individuals and boosters when their levels drop below 10 mIU/mL.

“The CDC has not yet determined if other immunocompromised individuals should receive a booster, with more research required, but studies have shown it to be effective,” Ms. Ritter said. In a similar study looking at evidence of immunity in children with connective tissue disease who were on immunosuppressive treatment, 50% had no evidence of protective antibodies, compared with 96% in the control group. “In that study, a booster shot was given, and protective antibody concentrations were found at follow-up,” she said.

The researchers reported having no financial disclosures.

[email protected]

The long-anticipated American Academy of Pediatrics guidelines for the treatment of well-appearing febrile infants have arrived, and key points include updated guidance for cerebrospinal fluid testing and urine cultures, according to Robert Pantell, MD, and Kenneth Roberts, MD, who presented the guidelines at the virtual Pediatric Hospital Medicine annual conference.

The AAP guideline was published in the August 2021 issue of Pediatrics. The guideline includes 21 key action statements and 40 total recommendations, and describes separate management algorithms for three age groups: infants aged 8-21 days, 22-28 days, and 29-60 days.

Dr. Roberts, of the University of North Carolina at Chapel Hill, and Dr. Pantell, of the University of California, San Francisco, emphasized that all pediatricians should read the full guideline, but they offered an overview of some of the notable points.

Some changes that drove the development of evidence-based guideline included changes in technology, such as the increased use of procalcitonin, the development of large research networks for studies of sufficient size, and a need to reduce the costs of unnecessary care and unnecessary trauma for infants, Dr. Roberts said. Use of data from large networks such as the Pediatric Emergency Care Applied Research Network provided enough evidence to support dividing the aged 8- to 60-day population into three groups.

The guideline applies to well-appearing term infants aged 8-60 days and at least 37 weeks’ gestation, with fever of 38° C (100.4° F) or higher in the past 24 hours in the home or clinical setting. The decision to exclude infants in the first week of life from the guideline was because at this age, infants “are sufficiently different in rates and types of illness, including early-onset bacterial infection,” according to the authors.

Dr. Roberts emphasized that the guidelines apply to “well-appearing infants,” which is not always obvious. “If a clinician is not confident an infant is well appearing, the clinical practice guideline should not be applied,” he said.

The guideline also includes a visual algorithm for each age group.

Dr. Pantell summarized the key action statements for the three age groups, and encouraged pediatricians to review the visual algorithms and footnotes available in the full text of the guideline.

The guideline includes seven key action statements for each of the three age groups. Four of these address evaluations, using urine, blood culture, inflammatory markers (IM), and cerebrospinal fluid (CSF). One action statement focuses on initial treatment, and two on management: hospital admission versus monitoring at home, and treatment cessation.
 

Infants aged 8-21 days

The key action statements for well-appearing infants aged 8-21 days are similar to what clinicians likely would do for ill-appearing infants, the authors noted, based in part on the challenge of assessing an infant this age as “well appearing,” because they don’t yet have the ability to interact with the clinician.

For the 8- to 21-day group, the first two key actions are to obtain a urine specimen and blood culture, Dr. Pantell said. Also, clinicians “should” obtain a CSF for analysis and culture. “We recognize that the ability to get CSF quickly is a challenge,” he added. However, for the 8- to 21-day age group, a new feature is that these infants may be discharged if the CSF is negative. Evaluation in this youngest group states that clinicians “may assess inflammatory markers” including height of fever, absolute neutrophil count, C-reactive protein, and procalcitonin.

Treatment of infants in the 8- to 21-day group “should” include parenteral antimicrobial therapy, according to the guideline, and these infants “should” be actively monitored in the hospital by nurses and staff experienced in neonatal care, Dr. Pantell said. The guideline also includes a key action statement to stop antimicrobials at 24-36 hours if cultures are negative, but to treat identified organisms.
 

Infants aged 22-28 days

In both the 22- to 28-day-old and 29- to 60-day-old groups, the guideline offers opportunities for less testing and treatment, such as avoiding a lumbar puncture, and fewer hospitalizations. The development of a separate guideline for the 22- to 28-day group is something new, said Dr. Pantell. The guideline states that clinicians should obtain urine specimens and blood culture, and should assess IM in this group. Further key action statements note that clinicians “should obtain a CSF if any IM is positive,” but “may” obtain CSF if the infant is hospitalized, if blood and urine cultures have been obtained, and if none of the IMs are abnormal.

As with younger patients, those with a negative CSF can go home, he said. As for treatment, clinicians “should” administer parenteral antimicrobial therapy to infants managed at home even if they have a negative CSF and urinalysis (UA), and no abnormal inflammatory markers Other points for management of infants in this age group at home include verbal teaching and written instructions for caregivers, plans for a re-evaluation at home in 24 hours, and a plan for communication and access to emergency care in case of a change in clinical status, Dr. Pantell explained. The guideline states that infants “should” be hospitalized if CSF is either not obtained or not interpretable, which leaves room for clinical judgment and individual circumstances. Antimicrobials “should” be discontinued in this group once all cultures are negative after 24-36 hours and no other infection requires treatment.
 

Infants aged 29-60 days

For the 29- to 60-day group, there are some differences, the main one is the recommendation of blood cultures in this group, said Dr. Pantell. “We are seeing a lot of UTIs [urinary tract infections], and we would like those treated.” However, clinicians need not obtain a CSF if other IMs are normal, but may do so if any IM is abnormal. Antimicrobial therapy may include ceftriaxone or cephalexin for UTIs, or vancomycin for bacteremia.

Although antimicrobial therapy is an option for UTIs and bacterial meningitis, clinicians “need not” use antimicrobials if CSF is normal, if UA is negative, and if no IMs are abnormal, Dr. Pantell added. Overall, further management of infants in this oldest age group should focus on discharge to home in the absence of abnormal findings, but hospitalization in the presence of abnormal CSF, IMs, or other concerns.

During a question-and-answer session, Dr. Roberts said that, while rectal temperature is preferable, any method is acceptable as a starting point for applying the guideline. Importantly, the guideline still leaves room for clinical judgment. “We hope this will change some thinking as far as whether one model fits all,” he noted. The authors tried to temper the word “should” with the word “may” when possible, so clinicians can say: “I’m going to individualize my decision to the infant in front of me.”

Ultimately, the guideline is meant as a guide, and not an absolute standard of care, the authors said. The language of the key action statements includes the words “should, may, need not” in place of “must, must not.” The guideline recommends factoring family values and preferences into any treatment decisions. “Variations, taking into account individual circumstances, may be appropriate.”

The guideline received no outside funding. The authors had no financial conflicts to disclose.

The long-anticipated American Academy of Pediatrics guidelines for the treatment of well-appearing febrile infants have arrived, and key points include updated guidance for cerebrospinal fluid testing and urine cultures, according to Robert Pantell, MD, and Kenneth Roberts, MD, who presented the guidelines at the virtual Pediatric Hospital Medicine annual conference.

The AAP guideline was published in the August 2021 issue of Pediatrics. The guideline includes 21 key action statements and 40 total recommendations, and describes separate management algorithms for three age groups: infants aged 8-21 days, 22-28 days, and 29-60 days.

Dr. Roberts, of the University of North Carolina at Chapel Hill, and Dr. Pantell, of the University of California, San Francisco, emphasized that all pediatricians should read the full guideline, but they offered an overview of some of the notable points.

Some changes that drove the development of evidence-based guideline included changes in technology, such as the increased use of procalcitonin, the development of large research networks for studies of sufficient size, and a need to reduce the costs of unnecessary care and unnecessary trauma for infants, Dr. Roberts said. Use of data from large networks such as the Pediatric Emergency Care Applied Research Network provided enough evidence to support dividing the aged 8- to 60-day population into three groups.

The guideline applies to well-appearing term infants aged 8-60 days and at least 37 weeks’ gestation, with fever of 38° C (100.4° F) or higher in the past 24 hours in the home or clinical setting. The decision to exclude infants in the first week of life from the guideline was because at this age, infants “are sufficiently different in rates and types of illness, including early-onset bacterial infection,” according to the authors.

Dr. Roberts emphasized that the guidelines apply to “well-appearing infants,” which is not always obvious. “If a clinician is not confident an infant is well appearing, the clinical practice guideline should not be applied,” he said.

The guideline also includes a visual algorithm for each age group.

Dr. Pantell summarized the key action statements for the three age groups, and encouraged pediatricians to review the visual algorithms and footnotes available in the full text of the guideline.

The guideline includes seven key action statements for each of the three age groups. Four of these address evaluations, using urine, blood culture, inflammatory markers (IM), and cerebrospinal fluid (CSF). One action statement focuses on initial treatment, and two on management: hospital admission versus monitoring at home, and treatment cessation.
 

Infants aged 8-21 days

The key action statements for well-appearing infants aged 8-21 days are similar to what clinicians likely would do for ill-appearing infants, the authors noted, based in part on the challenge of assessing an infant this age as “well appearing,” because they don’t yet have the ability to interact with the clinician.

For the 8- to 21-day group, the first two key actions are to obtain a urine specimen and blood culture, Dr. Pantell said. Also, clinicians “should” obtain a CSF for analysis and culture. “We recognize that the ability to get CSF quickly is a challenge,” he added. However, for the 8- to 21-day age group, a new feature is that these infants may be discharged if the CSF is negative. Evaluation in this youngest group states that clinicians “may assess inflammatory markers” including height of fever, absolute neutrophil count, C-reactive protein, and procalcitonin.

Treatment of infants in the 8- to 21-day group “should” include parenteral antimicrobial therapy, according to the guideline, and these infants “should” be actively monitored in the hospital by nurses and staff experienced in neonatal care, Dr. Pantell said. The guideline also includes a key action statement to stop antimicrobials at 24-36 hours if cultures are negative, but to treat identified organisms.
 

Infants aged 22-28 days

In both the 22- to 28-day-old and 29- to 60-day-old groups, the guideline offers opportunities for less testing and treatment, such as avoiding a lumbar puncture, and fewer hospitalizations. The development of a separate guideline for the 22- to 28-day group is something new, said Dr. Pantell. The guideline states that clinicians should obtain urine specimens and blood culture, and should assess IM in this group. Further key action statements note that clinicians “should obtain a CSF if any IM is positive,” but “may” obtain CSF if the infant is hospitalized, if blood and urine cultures have been obtained, and if none of the IMs are abnormal.

As with younger patients, those with a negative CSF can go home, he said. As for treatment, clinicians “should” administer parenteral antimicrobial therapy to infants managed at home even if they have a negative CSF and urinalysis (UA), and no abnormal inflammatory markers Other points for management of infants in this age group at home include verbal teaching and written instructions for caregivers, plans for a re-evaluation at home in 24 hours, and a plan for communication and access to emergency care in case of a change in clinical status, Dr. Pantell explained. The guideline states that infants “should” be hospitalized if CSF is either not obtained or not interpretable, which leaves room for clinical judgment and individual circumstances. Antimicrobials “should” be discontinued in this group once all cultures are negative after 24-36 hours and no other infection requires treatment.
 

Infants aged 29-60 days

For the 29- to 60-day group, there are some differences, the main one is the recommendation of blood cultures in this group, said Dr. Pantell. “We are seeing a lot of UTIs [urinary tract infections], and we would like those treated.” However, clinicians need not obtain a CSF if other IMs are normal, but may do so if any IM is abnormal. Antimicrobial therapy may include ceftriaxone or cephalexin for UTIs, or vancomycin for bacteremia.

Although antimicrobial therapy is an option for UTIs and bacterial meningitis, clinicians “need not” use antimicrobials if CSF is normal, if UA is negative, and if no IMs are abnormal, Dr. Pantell added. Overall, further management of infants in this oldest age group should focus on discharge to home in the absence of abnormal findings, but hospitalization in the presence of abnormal CSF, IMs, or other concerns.

During a question-and-answer session, Dr. Roberts said that, while rectal temperature is preferable, any method is acceptable as a starting point for applying the guideline. Importantly, the guideline still leaves room for clinical judgment. “We hope this will change some thinking as far as whether one model fits all,” he noted. The authors tried to temper the word “should” with the word “may” when possible, so clinicians can say: “I’m going to individualize my decision to the infant in front of me.”

Ultimately, the guideline is meant as a guide, and not an absolute standard of care, the authors said. The language of the key action statements includes the words “should, may, need not” in place of “must, must not.” The guideline recommends factoring family values and preferences into any treatment decisions. “Variations, taking into account individual circumstances, may be appropriate.”

The guideline received no outside funding. The authors had no financial conflicts to disclose.

The long-anticipated American Academy of Pediatrics guidelines for the treatment of well-appearing febrile infants have arrived, and key points include updated guidance for cerebrospinal fluid testing and urine cultures, according to Robert Pantell, MD, and Kenneth Roberts, MD, who presented the guidelines at the virtual Pediatric Hospital Medicine annual conference.

The AAP guideline was published in the August 2021 issue of Pediatrics. The guideline includes 21 key action statements and 40 total recommendations, and describes separate management algorithms for three age groups: infants aged 8-21 days, 22-28 days, and 29-60 days.

Dr. Roberts, of the University of North Carolina at Chapel Hill, and Dr. Pantell, of the University of California, San Francisco, emphasized that all pediatricians should read the full guideline, but they offered an overview of some of the notable points.

Some changes that drove the development of evidence-based guideline included changes in technology, such as the increased use of procalcitonin, the development of large research networks for studies of sufficient size, and a need to reduce the costs of unnecessary care and unnecessary trauma for infants, Dr. Roberts said. Use of data from large networks such as the Pediatric Emergency Care Applied Research Network provided enough evidence to support dividing the aged 8- to 60-day population into three groups.

The guideline applies to well-appearing term infants aged 8-60 days and at least 37 weeks’ gestation, with fever of 38° C (100.4° F) or higher in the past 24 hours in the home or clinical setting. The decision to exclude infants in the first week of life from the guideline was because at this age, infants “are sufficiently different in rates and types of illness, including early-onset bacterial infection,” according to the authors.

Dr. Roberts emphasized that the guidelines apply to “well-appearing infants,” which is not always obvious. “If a clinician is not confident an infant is well appearing, the clinical practice guideline should not be applied,” he said.

The guideline also includes a visual algorithm for each age group.

Dr. Pantell summarized the key action statements for the three age groups, and encouraged pediatricians to review the visual algorithms and footnotes available in the full text of the guideline.

The guideline includes seven key action statements for each of the three age groups. Four of these address evaluations, using urine, blood culture, inflammatory markers (IM), and cerebrospinal fluid (CSF). One action statement focuses on initial treatment, and two on management: hospital admission versus monitoring at home, and treatment cessation.
 

Infants aged 8-21 days

The key action statements for well-appearing infants aged 8-21 days are similar to what clinicians likely would do for ill-appearing infants, the authors noted, based in part on the challenge of assessing an infant this age as “well appearing,” because they don’t yet have the ability to interact with the clinician.

For the 8- to 21-day group, the first two key actions are to obtain a urine specimen and blood culture, Dr. Pantell said. Also, clinicians “should” obtain a CSF for analysis and culture. “We recognize that the ability to get CSF quickly is a challenge,” he added. However, for the 8- to 21-day age group, a new feature is that these infants may be discharged if the CSF is negative. Evaluation in this youngest group states that clinicians “may assess inflammatory markers” including height of fever, absolute neutrophil count, C-reactive protein, and procalcitonin.

Treatment of infants in the 8- to 21-day group “should” include parenteral antimicrobial therapy, according to the guideline, and these infants “should” be actively monitored in the hospital by nurses and staff experienced in neonatal care, Dr. Pantell said. The guideline also includes a key action statement to stop antimicrobials at 24-36 hours if cultures are negative, but to treat identified organisms.
 

Infants aged 22-28 days

In both the 22- to 28-day-old and 29- to 60-day-old groups, the guideline offers opportunities for less testing and treatment, such as avoiding a lumbar puncture, and fewer hospitalizations. The development of a separate guideline for the 22- to 28-day group is something new, said Dr. Pantell. The guideline states that clinicians should obtain urine specimens and blood culture, and should assess IM in this group. Further key action statements note that clinicians “should obtain a CSF if any IM is positive,” but “may” obtain CSF if the infant is hospitalized, if blood and urine cultures have been obtained, and if none of the IMs are abnormal.

As with younger patients, those with a negative CSF can go home, he said. As for treatment, clinicians “should” administer parenteral antimicrobial therapy to infants managed at home even if they have a negative CSF and urinalysis (UA), and no abnormal inflammatory markers Other points for management of infants in this age group at home include verbal teaching and written instructions for caregivers, plans for a re-evaluation at home in 24 hours, and a plan for communication and access to emergency care in case of a change in clinical status, Dr. Pantell explained. The guideline states that infants “should” be hospitalized if CSF is either not obtained or not interpretable, which leaves room for clinical judgment and individual circumstances. Antimicrobials “should” be discontinued in this group once all cultures are negative after 24-36 hours and no other infection requires treatment.
 

Infants aged 29-60 days

For the 29- to 60-day group, there are some differences, the main one is the recommendation of blood cultures in this group, said Dr. Pantell. “We are seeing a lot of UTIs [urinary tract infections], and we would like those treated.” However, clinicians need not obtain a CSF if other IMs are normal, but may do so if any IM is abnormal. Antimicrobial therapy may include ceftriaxone or cephalexin for UTIs, or vancomycin for bacteremia.

Although antimicrobial therapy is an option for UTIs and bacterial meningitis, clinicians “need not” use antimicrobials if CSF is normal, if UA is negative, and if no IMs are abnormal, Dr. Pantell added. Overall, further management of infants in this oldest age group should focus on discharge to home in the absence of abnormal findings, but hospitalization in the presence of abnormal CSF, IMs, or other concerns.

During a question-and-answer session, Dr. Roberts said that, while rectal temperature is preferable, any method is acceptable as a starting point for applying the guideline. Importantly, the guideline still leaves room for clinical judgment. “We hope this will change some thinking as far as whether one model fits all,” he noted. The authors tried to temper the word “should” with the word “may” when possible, so clinicians can say: “I’m going to individualize my decision to the infant in front of me.”

Ultimately, the guideline is meant as a guide, and not an absolute standard of care, the authors said. The language of the key action statements includes the words “should, may, need not” in place of “must, must not.” The guideline recommends factoring family values and preferences into any treatment decisions. “Variations, taking into account individual circumstances, may be appropriate.”

The guideline received no outside funding. The authors had no financial conflicts to disclose.