DEMO: Severe Asthma – Treatment and Management

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High tibial osteotomy achieves sustained improvements in knee OA

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A study of long-term outcomes after medial opening wedge high tibial osteotomy for knee osteoarthritis suggests the procedure is associated with significant and sustained improvements in pain, function, quality of life, and gait biomechanics.

At the OARSI 2021 World Congress, PhD candidate Codie Primeau, MSc, of the Fowler Kennedy Sport Medicine Clinic at the University of Western Ontario, London, presented the findings from a 10-year prospective cohort study of 102 patients with symptomatic medial compartment knee osteoarthritis who underwent medial opening wedge high tibial osteotomy but did not get a total knee replacement during the study.

The surgical procedure aims to correct malalignment by redistributing knee joint loads away from the affected compartment of the knee, with the ultimate goal of slowing disease progression and improving pain and function, Mr. Primeau told the conference, which was sponsored by the Osteoarthritis Research Society International.

At 10 years, the procedure was associated with a mean 14.3-point improvement in the 0-100 Knee Injury and Osteoarthritis Outcome Score (KOOS) for pain, a mean 12-point improvement in the score for function in daily living, a 15.5-point improvement in the score for function in sport and recreation, and a 24.5-point improvement in knee-related quality of life score. Researchers also saw a 35%-45% reduction in the magnitude of the external knee adduction moment from baseline, and a gradual reduction in the knee flexion moment over the course of the study.



While the improvements did decline somewhat over the 10 years, 53% of patients still met the criteria for responder at the end of the follow-up period, meaning that they had a relative change of at least 20% in both KOOS pain and function scores, and an absolute change of at least 10 points.

Mr. Primeau noted that the patient population represented those who were the best candidates for high tibial osteotomy, in that they were keen to avoid total knee replacement.

“While these types of patients may have the best outcomes, our studies suggest patients traditionally not considered ideal candidates for HTO [high tibial osteotomy] – such as females, and patients with limited disease in other knee compartments – also have large improvements in pain and function after HTO, and around 70% of those patients do not get a total knee replacement within 10 years,” he said in an interview.

Mr. Primeau suggested that the improvements achieved with high tibial osteotomy might extend the time before a knee replacement is required, or even help some patients avoid it altogether.

“Importantly, recent studies show HTO does not complicate future joint replacement surgery,” he said. “One can get a knee replacement after HTO; the reverse is not possible.”

The ideal patient for a high tibial osteotomy would be one whose osteoarthritis was confined to the medial compartment of the knee, was younger – in their 40s or 50s – and with relatively high activity levels, he said. Some studies also suggest better outcomes in men than women.



In response to an audience question about the rehabilitation requirements after high tibial osteotomy, Mr. Primeau commented that the design of the plates used in the procedure have changed over time, and this has influenced rehabilitation needs. When the study began, patients needed anywhere from 8 to 12 weeks of no weight bearing, using crutches, to allow for bone consolidation to occur.

“Since then, plate designs have changed a lot, and patients are able to start ambulating as early as 2 weeks after the surgery now,” he said. The rehabilitation is similar to what is required for knee osteoarthritis in general, focusing on range of motion, strengthening, proprioception, and muscle training.

No conflicts of interest were declared.

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A study of long-term outcomes after medial opening wedge high tibial osteotomy for knee osteoarthritis suggests the procedure is associated with significant and sustained improvements in pain, function, quality of life, and gait biomechanics.

At the OARSI 2021 World Congress, PhD candidate Codie Primeau, MSc, of the Fowler Kennedy Sport Medicine Clinic at the University of Western Ontario, London, presented the findings from a 10-year prospective cohort study of 102 patients with symptomatic medial compartment knee osteoarthritis who underwent medial opening wedge high tibial osteotomy but did not get a total knee replacement during the study.

The surgical procedure aims to correct malalignment by redistributing knee joint loads away from the affected compartment of the knee, with the ultimate goal of slowing disease progression and improving pain and function, Mr. Primeau told the conference, which was sponsored by the Osteoarthritis Research Society International.

At 10 years, the procedure was associated with a mean 14.3-point improvement in the 0-100 Knee Injury and Osteoarthritis Outcome Score (KOOS) for pain, a mean 12-point improvement in the score for function in daily living, a 15.5-point improvement in the score for function in sport and recreation, and a 24.5-point improvement in knee-related quality of life score. Researchers also saw a 35%-45% reduction in the magnitude of the external knee adduction moment from baseline, and a gradual reduction in the knee flexion moment over the course of the study.



While the improvements did decline somewhat over the 10 years, 53% of patients still met the criteria for responder at the end of the follow-up period, meaning that they had a relative change of at least 20% in both KOOS pain and function scores, and an absolute change of at least 10 points.

Mr. Primeau noted that the patient population represented those who were the best candidates for high tibial osteotomy, in that they were keen to avoid total knee replacement.

“While these types of patients may have the best outcomes, our studies suggest patients traditionally not considered ideal candidates for HTO [high tibial osteotomy] – such as females, and patients with limited disease in other knee compartments – also have large improvements in pain and function after HTO, and around 70% of those patients do not get a total knee replacement within 10 years,” he said in an interview.

Mr. Primeau suggested that the improvements achieved with high tibial osteotomy might extend the time before a knee replacement is required, or even help some patients avoid it altogether.

“Importantly, recent studies show HTO does not complicate future joint replacement surgery,” he said. “One can get a knee replacement after HTO; the reverse is not possible.”

The ideal patient for a high tibial osteotomy would be one whose osteoarthritis was confined to the medial compartment of the knee, was younger – in their 40s or 50s – and with relatively high activity levels, he said. Some studies also suggest better outcomes in men than women.



In response to an audience question about the rehabilitation requirements after high tibial osteotomy, Mr. Primeau commented that the design of the plates used in the procedure have changed over time, and this has influenced rehabilitation needs. When the study began, patients needed anywhere from 8 to 12 weeks of no weight bearing, using crutches, to allow for bone consolidation to occur.

“Since then, plate designs have changed a lot, and patients are able to start ambulating as early as 2 weeks after the surgery now,” he said. The rehabilitation is similar to what is required for knee osteoarthritis in general, focusing on range of motion, strengthening, proprioception, and muscle training.

No conflicts of interest were declared.

A study of long-term outcomes after medial opening wedge high tibial osteotomy for knee osteoarthritis suggests the procedure is associated with significant and sustained improvements in pain, function, quality of life, and gait biomechanics.

At the OARSI 2021 World Congress, PhD candidate Codie Primeau, MSc, of the Fowler Kennedy Sport Medicine Clinic at the University of Western Ontario, London, presented the findings from a 10-year prospective cohort study of 102 patients with symptomatic medial compartment knee osteoarthritis who underwent medial opening wedge high tibial osteotomy but did not get a total knee replacement during the study.

The surgical procedure aims to correct malalignment by redistributing knee joint loads away from the affected compartment of the knee, with the ultimate goal of slowing disease progression and improving pain and function, Mr. Primeau told the conference, which was sponsored by the Osteoarthritis Research Society International.

At 10 years, the procedure was associated with a mean 14.3-point improvement in the 0-100 Knee Injury and Osteoarthritis Outcome Score (KOOS) for pain, a mean 12-point improvement in the score for function in daily living, a 15.5-point improvement in the score for function in sport and recreation, and a 24.5-point improvement in knee-related quality of life score. Researchers also saw a 35%-45% reduction in the magnitude of the external knee adduction moment from baseline, and a gradual reduction in the knee flexion moment over the course of the study.



While the improvements did decline somewhat over the 10 years, 53% of patients still met the criteria for responder at the end of the follow-up period, meaning that they had a relative change of at least 20% in both KOOS pain and function scores, and an absolute change of at least 10 points.

Mr. Primeau noted that the patient population represented those who were the best candidates for high tibial osteotomy, in that they were keen to avoid total knee replacement.

“While these types of patients may have the best outcomes, our studies suggest patients traditionally not considered ideal candidates for HTO [high tibial osteotomy] – such as females, and patients with limited disease in other knee compartments – also have large improvements in pain and function after HTO, and around 70% of those patients do not get a total knee replacement within 10 years,” he said in an interview.

Mr. Primeau suggested that the improvements achieved with high tibial osteotomy might extend the time before a knee replacement is required, or even help some patients avoid it altogether.

“Importantly, recent studies show HTO does not complicate future joint replacement surgery,” he said. “One can get a knee replacement after HTO; the reverse is not possible.”

The ideal patient for a high tibial osteotomy would be one whose osteoarthritis was confined to the medial compartment of the knee, was younger – in their 40s or 50s – and with relatively high activity levels, he said. Some studies also suggest better outcomes in men than women.



In response to an audience question about the rehabilitation requirements after high tibial osteotomy, Mr. Primeau commented that the design of the plates used in the procedure have changed over time, and this has influenced rehabilitation needs. When the study began, patients needed anywhere from 8 to 12 weeks of no weight bearing, using crutches, to allow for bone consolidation to occur.

“Since then, plate designs have changed a lot, and patients are able to start ambulating as early as 2 weeks after the surgery now,” he said. The rehabilitation is similar to what is required for knee osteoarthritis in general, focusing on range of motion, strengthening, proprioception, and muscle training.

No conflicts of interest were declared.

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FROM OARSI 2021

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Who is my neighbor? The ethics of sharing medical resources in the world

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India is in a crisis as the burden of COVID-19 has collapsed parts of the health care system. There are not enough beds, not enough oxygen, and not enough crematoria to handle the pandemic. India is also a major supplier of vaccines for itself and many other countries. That production capacity has also been affected by the local events, further worsening the response to the pandemic over the next few months.

Dr. Kevin T. Powell

This collapse is the specter that, in April 2020, placed a hospital ship next to Manhattan and rows of beds in its convention center. Fortunately, the lockdown in March 2020 sufficiently flattened the curve. The city avoided utilizing that disaster capacity, though many New Yorkers died out of sight in nursing homes. When the third and largest wave of cases in the United States peaked in January 2021, hospitals throughout California reached capacity but avoided bursting. In April 2021, localized outbreaks in Michigan, Arizona, and Ontario again tested the maximum capacity for providing modern medical treatments. Great Britain used a second lockdown in October 2020 and a third in January 2021 to control the pandemic, with Prime Minister Boris Johnson emphasizing that it was these social interventions, and not vaccines, which provided the mitigating effects. Other European Union nations adopted similar strategies. Prudent choices by government guided by science, combined with the cooperation of the public, have been and still are crucial to mollify the pandemic.

There is hope that soon vaccines will return daily life to a new normal. In the United States, the Centers for Disease Control and Prevention has loosened restrictions on social gathering. An increase in daily new cases of COVID-19 in April 2021 has turned into just a blip before continuing to recede. Perhaps that is the first sign of vaccination working at the level of public health. However, the May 2021 lockdown in highly vaccinated Seychelles is a warning that the danger remains. A single match can start a huge forest fire. The first 150 million cases of COVID-19 worldwide have, through natural rates of mutation, produced several variants that might partially evade current vaccines. The danger of newer variants persists with the next 150 million cases as the pandemic continues to rage in many nations which are just one airplane ride away. All human inhabitants of this blue-covered third rock from the sun are interconnected.

The benefits of scientific advancement have been extolled for centuries. This includes both individual discoveries as well as a mindset that favors rationalism over fatalism. On the whole, the benefits of scientific progress outweigh the negatives. Negative environmental impacts include pollution and climate change. Economic impacts include raising the mean economic standard of living but with greater inequity. Historically, governmental and social institutions have attempted to mitigate these negative consequences. Those efforts have attempted to provide guidance and a moral compass to direct the progress of scientific advancement, particularly in fields like gene therapy. Those efforts have called upon developed nations to share the bounties of progress with other nations.

Modern medicine has provided the fruit of these scientific advancements to a limited fraction of the world’s population during the 20th century. The improvements in life expectancy and infant mortality have come primarily from civil engineers getting running water into cities and sewage out. A smaller portion of the benefits are from public health measures that reduced tuberculosis, smallpox, polio, and measles. Agriculture became more reliable, productive, and nutritious. In the 21st century, medical care (control of hypertension, diabetes, and clotting) aimed at reducing heart disease and strokes have added another 2-3 years to the life expectancy in the United States, with much of that benefit erased by the epidemics of obesity and opioid abuse.

Modern medical technology has created treatments that cost $10,000 a month to add a few extra months of life to geriatric patients with terminal cancer. Meanwhile, in more mundane care, efforts like Choosing Wisely seek to save money wasted on low-value, useless, and even harmful tests and therapies. There is no single person or agency managing this chaotic process of inventing expensive new technologies while inadequately addressing the widespread shortages of mental health care, disparities in education, and other social determinants of health. The pandemic has highlighted these preexisting weaknesses in the social fabric.

The cries from India have been accompanied by voices of anger from India and other nations accusing the United States of hoarding vaccines and the raw materials needed to produce them. This has been called vaccine apartheid. The United States is not alone in its political decision to prioritize domestic interests over international ones; India’s recent government is similarly nationalistic. Scientists warn that no one is safe locally as long as the pandemic rages in other countries. The Biden administration, in a delayed response to the crisis in India, finally announced plans to share some unused vaccines (of a brand not yet Food and Drug Administration approved) as well as some vaccine raw materials whose export was forbidden by a regulation under the Defense Production Act. Reading below the headlines, the promised response won’t be implemented for weeks or months. We must do better.

The logistics of sharing the benefits of advanced science are complicated. The ethics are not. Who is my neighbor? If you didn’t learn the answer to that in Sunday school, there isn’t much more I can say.

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. He has no financial disclosures, Email him at [email protected]

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India is in a crisis as the burden of COVID-19 has collapsed parts of the health care system. There are not enough beds, not enough oxygen, and not enough crematoria to handle the pandemic. India is also a major supplier of vaccines for itself and many other countries. That production capacity has also been affected by the local events, further worsening the response to the pandemic over the next few months.

Dr. Kevin T. Powell

This collapse is the specter that, in April 2020, placed a hospital ship next to Manhattan and rows of beds in its convention center. Fortunately, the lockdown in March 2020 sufficiently flattened the curve. The city avoided utilizing that disaster capacity, though many New Yorkers died out of sight in nursing homes. When the third and largest wave of cases in the United States peaked in January 2021, hospitals throughout California reached capacity but avoided bursting. In April 2021, localized outbreaks in Michigan, Arizona, and Ontario again tested the maximum capacity for providing modern medical treatments. Great Britain used a second lockdown in October 2020 and a third in January 2021 to control the pandemic, with Prime Minister Boris Johnson emphasizing that it was these social interventions, and not vaccines, which provided the mitigating effects. Other European Union nations adopted similar strategies. Prudent choices by government guided by science, combined with the cooperation of the public, have been and still are crucial to mollify the pandemic.

There is hope that soon vaccines will return daily life to a new normal. In the United States, the Centers for Disease Control and Prevention has loosened restrictions on social gathering. An increase in daily new cases of COVID-19 in April 2021 has turned into just a blip before continuing to recede. Perhaps that is the first sign of vaccination working at the level of public health. However, the May 2021 lockdown in highly vaccinated Seychelles is a warning that the danger remains. A single match can start a huge forest fire. The first 150 million cases of COVID-19 worldwide have, through natural rates of mutation, produced several variants that might partially evade current vaccines. The danger of newer variants persists with the next 150 million cases as the pandemic continues to rage in many nations which are just one airplane ride away. All human inhabitants of this blue-covered third rock from the sun are interconnected.

The benefits of scientific advancement have been extolled for centuries. This includes both individual discoveries as well as a mindset that favors rationalism over fatalism. On the whole, the benefits of scientific progress outweigh the negatives. Negative environmental impacts include pollution and climate change. Economic impacts include raising the mean economic standard of living but with greater inequity. Historically, governmental and social institutions have attempted to mitigate these negative consequences. Those efforts have attempted to provide guidance and a moral compass to direct the progress of scientific advancement, particularly in fields like gene therapy. Those efforts have called upon developed nations to share the bounties of progress with other nations.

Modern medicine has provided the fruit of these scientific advancements to a limited fraction of the world’s population during the 20th century. The improvements in life expectancy and infant mortality have come primarily from civil engineers getting running water into cities and sewage out. A smaller portion of the benefits are from public health measures that reduced tuberculosis, smallpox, polio, and measles. Agriculture became more reliable, productive, and nutritious. In the 21st century, medical care (control of hypertension, diabetes, and clotting) aimed at reducing heart disease and strokes have added another 2-3 years to the life expectancy in the United States, with much of that benefit erased by the epidemics of obesity and opioid abuse.

Modern medical technology has created treatments that cost $10,000 a month to add a few extra months of life to geriatric patients with terminal cancer. Meanwhile, in more mundane care, efforts like Choosing Wisely seek to save money wasted on low-value, useless, and even harmful tests and therapies. There is no single person or agency managing this chaotic process of inventing expensive new technologies while inadequately addressing the widespread shortages of mental health care, disparities in education, and other social determinants of health. The pandemic has highlighted these preexisting weaknesses in the social fabric.

The cries from India have been accompanied by voices of anger from India and other nations accusing the United States of hoarding vaccines and the raw materials needed to produce them. This has been called vaccine apartheid. The United States is not alone in its political decision to prioritize domestic interests over international ones; India’s recent government is similarly nationalistic. Scientists warn that no one is safe locally as long as the pandemic rages in other countries. The Biden administration, in a delayed response to the crisis in India, finally announced plans to share some unused vaccines (of a brand not yet Food and Drug Administration approved) as well as some vaccine raw materials whose export was forbidden by a regulation under the Defense Production Act. Reading below the headlines, the promised response won’t be implemented for weeks or months. We must do better.

The logistics of sharing the benefits of advanced science are complicated. The ethics are not. Who is my neighbor? If you didn’t learn the answer to that in Sunday school, there isn’t much more I can say.

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. He has no financial disclosures, Email him at [email protected]

India is in a crisis as the burden of COVID-19 has collapsed parts of the health care system. There are not enough beds, not enough oxygen, and not enough crematoria to handle the pandemic. India is also a major supplier of vaccines for itself and many other countries. That production capacity has also been affected by the local events, further worsening the response to the pandemic over the next few months.

Dr. Kevin T. Powell

This collapse is the specter that, in April 2020, placed a hospital ship next to Manhattan and rows of beds in its convention center. Fortunately, the lockdown in March 2020 sufficiently flattened the curve. The city avoided utilizing that disaster capacity, though many New Yorkers died out of sight in nursing homes. When the third and largest wave of cases in the United States peaked in January 2021, hospitals throughout California reached capacity but avoided bursting. In April 2021, localized outbreaks in Michigan, Arizona, and Ontario again tested the maximum capacity for providing modern medical treatments. Great Britain used a second lockdown in October 2020 and a third in January 2021 to control the pandemic, with Prime Minister Boris Johnson emphasizing that it was these social interventions, and not vaccines, which provided the mitigating effects. Other European Union nations adopted similar strategies. Prudent choices by government guided by science, combined with the cooperation of the public, have been and still are crucial to mollify the pandemic.

There is hope that soon vaccines will return daily life to a new normal. In the United States, the Centers for Disease Control and Prevention has loosened restrictions on social gathering. An increase in daily new cases of COVID-19 in April 2021 has turned into just a blip before continuing to recede. Perhaps that is the first sign of vaccination working at the level of public health. However, the May 2021 lockdown in highly vaccinated Seychelles is a warning that the danger remains. A single match can start a huge forest fire. The first 150 million cases of COVID-19 worldwide have, through natural rates of mutation, produced several variants that might partially evade current vaccines. The danger of newer variants persists with the next 150 million cases as the pandemic continues to rage in many nations which are just one airplane ride away. All human inhabitants of this blue-covered third rock from the sun are interconnected.

The benefits of scientific advancement have been extolled for centuries. This includes both individual discoveries as well as a mindset that favors rationalism over fatalism. On the whole, the benefits of scientific progress outweigh the negatives. Negative environmental impacts include pollution and climate change. Economic impacts include raising the mean economic standard of living but with greater inequity. Historically, governmental and social institutions have attempted to mitigate these negative consequences. Those efforts have attempted to provide guidance and a moral compass to direct the progress of scientific advancement, particularly in fields like gene therapy. Those efforts have called upon developed nations to share the bounties of progress with other nations.

Modern medicine has provided the fruit of these scientific advancements to a limited fraction of the world’s population during the 20th century. The improvements in life expectancy and infant mortality have come primarily from civil engineers getting running water into cities and sewage out. A smaller portion of the benefits are from public health measures that reduced tuberculosis, smallpox, polio, and measles. Agriculture became more reliable, productive, and nutritious. In the 21st century, medical care (control of hypertension, diabetes, and clotting) aimed at reducing heart disease and strokes have added another 2-3 years to the life expectancy in the United States, with much of that benefit erased by the epidemics of obesity and opioid abuse.

Modern medical technology has created treatments that cost $10,000 a month to add a few extra months of life to geriatric patients with terminal cancer. Meanwhile, in more mundane care, efforts like Choosing Wisely seek to save money wasted on low-value, useless, and even harmful tests and therapies. There is no single person or agency managing this chaotic process of inventing expensive new technologies while inadequately addressing the widespread shortages of mental health care, disparities in education, and other social determinants of health. The pandemic has highlighted these preexisting weaknesses in the social fabric.

The cries from India have been accompanied by voices of anger from India and other nations accusing the United States of hoarding vaccines and the raw materials needed to produce them. This has been called vaccine apartheid. The United States is not alone in its political decision to prioritize domestic interests over international ones; India’s recent government is similarly nationalistic. Scientists warn that no one is safe locally as long as the pandemic rages in other countries. The Biden administration, in a delayed response to the crisis in India, finally announced plans to share some unused vaccines (of a brand not yet Food and Drug Administration approved) as well as some vaccine raw materials whose export was forbidden by a regulation under the Defense Production Act. Reading below the headlines, the promised response won’t be implemented for weeks or months. We must do better.

The logistics of sharing the benefits of advanced science are complicated. The ethics are not. Who is my neighbor? If you didn’t learn the answer to that in Sunday school, there isn’t much more I can say.

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. He has no financial disclosures, Email him at [email protected]

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Perinatal depression and the pediatrician’s role

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Postpartum depression (PPD) is a common and treatable problem affecting over 10% of all pregnant women. Without routine use of a screening questionnaire, many women go undiagnosed and without treatment. The risks of untreated PPD in a new mother are the risks of depression tripled: to her health and to the health of her new infant and their whole family. Although pediatricians treat children, they take care of the whole family. They appreciate their role in offering support and guidance to new parents, and in the case of PPD, they are in a unique position. The American Academy of Pediatrics recognized this when they issued their policy statement, “Incorporating Recognition and Management of Perinatal Depression into Pediatric Practice,” in January 2019. By screening, tracking, and connecting affected mothers to care and services, you can truly provide “two-generational care” for your youngest patients.

Dr. Susan D. Swick

PPD affects an estimated one in seven women (13%) globally. In one large retrospective study that looked at the 39 weeks before and after delivery, 15.4% of mothers received a diagnosis of PPD and a second study indicated that 22% of new mothers had depressive symptoms that were persistent for 6 months.1 The pathways to PPD include prior personal or family history of depression, stressors in the family (connected to social determinants of health), previous miscarriage or serious complications in a previous pregnancy, and sensitivity to hormonal changes. Indeed, PPD is the most common complication of childbirth.2 Although as many as half of all women eventually diagnosed with PPD had symptoms during their pregnancy, the misperception that PPD is only post partum leads to it being mistaken for the normal process of adjustment to parenthood. PPD is particularly insidious as new mothers are likely to be silent if they feel shame for not enjoying what they have been told will be a special and happy time, and those around them may mistake symptoms for the normal “baby blues” that will resolve quickly and with routine supports.

Untreated PPD, creates risks for mother, infant, and family as she manages needless suffering during a critical period for her new baby. While depression may remit over months without treatment, suicide is a real risk, and accounts for 20% of postpartum deaths.3 Infants face serious developmental consequences when their mothers are withdrawn and disconnected from them during the first months of life, including impaired social development, physical growth, and cognitive development. This impairment persists. Exposure to maternal depression during infancy is associated with lower IQ, attentional problems, and special educational needs by elementary school,4 and is a risk factor for psychiatric illnesses in childhood and adolescence.5,6 PPD has a broad range of severity, including psychosis that may include paranoia with the rare risk of infanticide. And maternal depression can add to the strains in a vulnerable caregiver relationship that can raise the risk for neglect or abuse of the mother, children, or both.

It is important to note that anxiety is often the presenting problem in perinatal mood disorders, with mothers experiencing intense morbid worries about their infant’s safety and health, and fear of inadequacy, criticism, and even infant removal. These fears may reinforce silence and isolation. But pediatricians are one group that these mothers are most likely to share their anxieties with as they look for reassurance. It can be challenging to distinguish PPD from obsessive-compulsive disorder or PTSD. The critical work of the pediatrician is not specific diagnosis and treatment. Instead, your task is to provide screening and support, to create a safe place to overcome silence and shame.

Dr. Michael S. Jellinek

There are many reliable and valid screening instruments available for depression, but the Edinburgh Postnatal Depression Scale (EDPS) has been specially developed for and tested in this population. It is a 10-item scale that is easy to complete and to score. Scores range from 0 to 30 and a score of 10 is considered a cutoff for depression. It can be used to track symptoms and is free and widely available online and in multiple languages. Ideally, this scale can be administered as part of a previsit, automatically entered into an electronic medical record and given at regular intervals during the infant’s first year of primary care. Some new mothers, especially if they are suffering from depression, may feel anxious about filling this out. It is important that your staff tell them that you screen all new mothers in your practice, and that PPD is common and treatable and the pediatrician’s office is committed to the health of the whole family.

If a new mother screens positive, you might consider yourself to have three tasks: Reassure her that she is a wonderful mother and this is a treatable illness, not a cause for guilt, shame, or alarm; expand her support and decrease her isolation by helping her to communicate with her family; and identify treatment resources for her. Start by being curious about some of her specific worries or feelings, her energy level, feelings of isolation or trouble with sleep. Offer compassion and validation around the pain of these experiences in the midst of so much transition. Only after hearing a little detail about her experience, then you may offer that such feelings are common, but when they are persistent or severe, they often indicate PPD, and that her screening test suggests they do for her. Offer that this form of depression is very treatable, with both pharmacologic and psychotherapy interventions. And if she is resistant, gently offer that treatment will be very protective of her new infant’s physical, social, and cognitive growth and development. Hearing this from a pediatrician is powerful for a new mother, even if depressed. Finally, ask if you might help her bring other important adults in her family into an understanding of this. Could she tell her spouse? Her sister? Her best friend? Perhaps she could bring one of them to the next weekly visit, so you can all speak together. This intervention greatly improves the likelihood of her engaging in treatment, and strong interpersonal connections are therapeutic in and of themselves.

For treatment, the easier your office can make it, the more likely she is to follow up. Identify local resources, perhaps through connected community organizations such as Jewish Family and Children’s Services or through a public program like California’s First Five. Connect with the local obstetric practice, which may already have a referral process in place. If you can connect with her primary care provider, they may take on the referral process or may even have integrated capacity for treatment. Identify strategies that may support her restful sleep, including realistic daily exercise, sharing infant care, and being cautious with caffeine and screen time. Identify ways for her to meet other new mothers or reconnect with friends. Reassure her that easy attachment activities, such as reading a book or singing to her baby can be good for both of them without requiring much energy. This may sound like a daunting task, but the conversation will only take a few minutes. Helping an isolated new parent recognize that their feelings of fear, inadequacy, and guilt are not facts, offering some simple immediate strategies and facilitating a referral can be lifesaving.

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected]

References

1. Dietz PM et al. Am J Psychiatry. 2007;164(10):1515-20.

2. Hanusa BH et al. J Women’s Health (Larchmt) 2008;17(4):585-96.

3. Lindahl V et al. Arch Womens Ment Health. 2005;8(2):77-87.

4. Hay DF et al. J Child Psychol Psychiatry. 2001;42(7):871-89.

5. Tully EC et al. Am J Psychiatry. 2008:165(9):1148-54.

6. Maternal depression and child development. Paediatr. Child Health 2004;9(8):575-98.

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Postpartum depression (PPD) is a common and treatable problem affecting over 10% of all pregnant women. Without routine use of a screening questionnaire, many women go undiagnosed and without treatment. The risks of untreated PPD in a new mother are the risks of depression tripled: to her health and to the health of her new infant and their whole family. Although pediatricians treat children, they take care of the whole family. They appreciate their role in offering support and guidance to new parents, and in the case of PPD, they are in a unique position. The American Academy of Pediatrics recognized this when they issued their policy statement, “Incorporating Recognition and Management of Perinatal Depression into Pediatric Practice,” in January 2019. By screening, tracking, and connecting affected mothers to care and services, you can truly provide “two-generational care” for your youngest patients.

Dr. Susan D. Swick

PPD affects an estimated one in seven women (13%) globally. In one large retrospective study that looked at the 39 weeks before and after delivery, 15.4% of mothers received a diagnosis of PPD and a second study indicated that 22% of new mothers had depressive symptoms that were persistent for 6 months.1 The pathways to PPD include prior personal or family history of depression, stressors in the family (connected to social determinants of health), previous miscarriage or serious complications in a previous pregnancy, and sensitivity to hormonal changes. Indeed, PPD is the most common complication of childbirth.2 Although as many as half of all women eventually diagnosed with PPD had symptoms during their pregnancy, the misperception that PPD is only post partum leads to it being mistaken for the normal process of adjustment to parenthood. PPD is particularly insidious as new mothers are likely to be silent if they feel shame for not enjoying what they have been told will be a special and happy time, and those around them may mistake symptoms for the normal “baby blues” that will resolve quickly and with routine supports.

Untreated PPD, creates risks for mother, infant, and family as she manages needless suffering during a critical period for her new baby. While depression may remit over months without treatment, suicide is a real risk, and accounts for 20% of postpartum deaths.3 Infants face serious developmental consequences when their mothers are withdrawn and disconnected from them during the first months of life, including impaired social development, physical growth, and cognitive development. This impairment persists. Exposure to maternal depression during infancy is associated with lower IQ, attentional problems, and special educational needs by elementary school,4 and is a risk factor for psychiatric illnesses in childhood and adolescence.5,6 PPD has a broad range of severity, including psychosis that may include paranoia with the rare risk of infanticide. And maternal depression can add to the strains in a vulnerable caregiver relationship that can raise the risk for neglect or abuse of the mother, children, or both.

It is important to note that anxiety is often the presenting problem in perinatal mood disorders, with mothers experiencing intense morbid worries about their infant’s safety and health, and fear of inadequacy, criticism, and even infant removal. These fears may reinforce silence and isolation. But pediatricians are one group that these mothers are most likely to share their anxieties with as they look for reassurance. It can be challenging to distinguish PPD from obsessive-compulsive disorder or PTSD. The critical work of the pediatrician is not specific diagnosis and treatment. Instead, your task is to provide screening and support, to create a safe place to overcome silence and shame.

Dr. Michael S. Jellinek

There are many reliable and valid screening instruments available for depression, but the Edinburgh Postnatal Depression Scale (EDPS) has been specially developed for and tested in this population. It is a 10-item scale that is easy to complete and to score. Scores range from 0 to 30 and a score of 10 is considered a cutoff for depression. It can be used to track symptoms and is free and widely available online and in multiple languages. Ideally, this scale can be administered as part of a previsit, automatically entered into an electronic medical record and given at regular intervals during the infant’s first year of primary care. Some new mothers, especially if they are suffering from depression, may feel anxious about filling this out. It is important that your staff tell them that you screen all new mothers in your practice, and that PPD is common and treatable and the pediatrician’s office is committed to the health of the whole family.

If a new mother screens positive, you might consider yourself to have three tasks: Reassure her that she is a wonderful mother and this is a treatable illness, not a cause for guilt, shame, or alarm; expand her support and decrease her isolation by helping her to communicate with her family; and identify treatment resources for her. Start by being curious about some of her specific worries or feelings, her energy level, feelings of isolation or trouble with sleep. Offer compassion and validation around the pain of these experiences in the midst of so much transition. Only after hearing a little detail about her experience, then you may offer that such feelings are common, but when they are persistent or severe, they often indicate PPD, and that her screening test suggests they do for her. Offer that this form of depression is very treatable, with both pharmacologic and psychotherapy interventions. And if she is resistant, gently offer that treatment will be very protective of her new infant’s physical, social, and cognitive growth and development. Hearing this from a pediatrician is powerful for a new mother, even if depressed. Finally, ask if you might help her bring other important adults in her family into an understanding of this. Could she tell her spouse? Her sister? Her best friend? Perhaps she could bring one of them to the next weekly visit, so you can all speak together. This intervention greatly improves the likelihood of her engaging in treatment, and strong interpersonal connections are therapeutic in and of themselves.

For treatment, the easier your office can make it, the more likely she is to follow up. Identify local resources, perhaps through connected community organizations such as Jewish Family and Children’s Services or through a public program like California’s First Five. Connect with the local obstetric practice, which may already have a referral process in place. If you can connect with her primary care provider, they may take on the referral process or may even have integrated capacity for treatment. Identify strategies that may support her restful sleep, including realistic daily exercise, sharing infant care, and being cautious with caffeine and screen time. Identify ways for her to meet other new mothers or reconnect with friends. Reassure her that easy attachment activities, such as reading a book or singing to her baby can be good for both of them without requiring much energy. This may sound like a daunting task, but the conversation will only take a few minutes. Helping an isolated new parent recognize that their feelings of fear, inadequacy, and guilt are not facts, offering some simple immediate strategies and facilitating a referral can be lifesaving.

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected]

References

1. Dietz PM et al. Am J Psychiatry. 2007;164(10):1515-20.

2. Hanusa BH et al. J Women’s Health (Larchmt) 2008;17(4):585-96.

3. Lindahl V et al. Arch Womens Ment Health. 2005;8(2):77-87.

4. Hay DF et al. J Child Psychol Psychiatry. 2001;42(7):871-89.

5. Tully EC et al. Am J Psychiatry. 2008:165(9):1148-54.

6. Maternal depression and child development. Paediatr. Child Health 2004;9(8):575-98.

Postpartum depression (PPD) is a common and treatable problem affecting over 10% of all pregnant women. Without routine use of a screening questionnaire, many women go undiagnosed and without treatment. The risks of untreated PPD in a new mother are the risks of depression tripled: to her health and to the health of her new infant and their whole family. Although pediatricians treat children, they take care of the whole family. They appreciate their role in offering support and guidance to new parents, and in the case of PPD, they are in a unique position. The American Academy of Pediatrics recognized this when they issued their policy statement, “Incorporating Recognition and Management of Perinatal Depression into Pediatric Practice,” in January 2019. By screening, tracking, and connecting affected mothers to care and services, you can truly provide “two-generational care” for your youngest patients.

Dr. Susan D. Swick

PPD affects an estimated one in seven women (13%) globally. In one large retrospective study that looked at the 39 weeks before and after delivery, 15.4% of mothers received a diagnosis of PPD and a second study indicated that 22% of new mothers had depressive symptoms that were persistent for 6 months.1 The pathways to PPD include prior personal or family history of depression, stressors in the family (connected to social determinants of health), previous miscarriage or serious complications in a previous pregnancy, and sensitivity to hormonal changes. Indeed, PPD is the most common complication of childbirth.2 Although as many as half of all women eventually diagnosed with PPD had symptoms during their pregnancy, the misperception that PPD is only post partum leads to it being mistaken for the normal process of adjustment to parenthood. PPD is particularly insidious as new mothers are likely to be silent if they feel shame for not enjoying what they have been told will be a special and happy time, and those around them may mistake symptoms for the normal “baby blues” that will resolve quickly and with routine supports.

Untreated PPD, creates risks for mother, infant, and family as she manages needless suffering during a critical period for her new baby. While depression may remit over months without treatment, suicide is a real risk, and accounts for 20% of postpartum deaths.3 Infants face serious developmental consequences when their mothers are withdrawn and disconnected from them during the first months of life, including impaired social development, physical growth, and cognitive development. This impairment persists. Exposure to maternal depression during infancy is associated with lower IQ, attentional problems, and special educational needs by elementary school,4 and is a risk factor for psychiatric illnesses in childhood and adolescence.5,6 PPD has a broad range of severity, including psychosis that may include paranoia with the rare risk of infanticide. And maternal depression can add to the strains in a vulnerable caregiver relationship that can raise the risk for neglect or abuse of the mother, children, or both.

It is important to note that anxiety is often the presenting problem in perinatal mood disorders, with mothers experiencing intense morbid worries about their infant’s safety and health, and fear of inadequacy, criticism, and even infant removal. These fears may reinforce silence and isolation. But pediatricians are one group that these mothers are most likely to share their anxieties with as they look for reassurance. It can be challenging to distinguish PPD from obsessive-compulsive disorder or PTSD. The critical work of the pediatrician is not specific diagnosis and treatment. Instead, your task is to provide screening and support, to create a safe place to overcome silence and shame.

Dr. Michael S. Jellinek

There are many reliable and valid screening instruments available for depression, but the Edinburgh Postnatal Depression Scale (EDPS) has been specially developed for and tested in this population. It is a 10-item scale that is easy to complete and to score. Scores range from 0 to 30 and a score of 10 is considered a cutoff for depression. It can be used to track symptoms and is free and widely available online and in multiple languages. Ideally, this scale can be administered as part of a previsit, automatically entered into an electronic medical record and given at regular intervals during the infant’s first year of primary care. Some new mothers, especially if they are suffering from depression, may feel anxious about filling this out. It is important that your staff tell them that you screen all new mothers in your practice, and that PPD is common and treatable and the pediatrician’s office is committed to the health of the whole family.

If a new mother screens positive, you might consider yourself to have three tasks: Reassure her that she is a wonderful mother and this is a treatable illness, not a cause for guilt, shame, or alarm; expand her support and decrease her isolation by helping her to communicate with her family; and identify treatment resources for her. Start by being curious about some of her specific worries or feelings, her energy level, feelings of isolation or trouble with sleep. Offer compassion and validation around the pain of these experiences in the midst of so much transition. Only after hearing a little detail about her experience, then you may offer that such feelings are common, but when they are persistent or severe, they often indicate PPD, and that her screening test suggests they do for her. Offer that this form of depression is very treatable, with both pharmacologic and psychotherapy interventions. And if she is resistant, gently offer that treatment will be very protective of her new infant’s physical, social, and cognitive growth and development. Hearing this from a pediatrician is powerful for a new mother, even if depressed. Finally, ask if you might help her bring other important adults in her family into an understanding of this. Could she tell her spouse? Her sister? Her best friend? Perhaps she could bring one of them to the next weekly visit, so you can all speak together. This intervention greatly improves the likelihood of her engaging in treatment, and strong interpersonal connections are therapeutic in and of themselves.

For treatment, the easier your office can make it, the more likely she is to follow up. Identify local resources, perhaps through connected community organizations such as Jewish Family and Children’s Services or through a public program like California’s First Five. Connect with the local obstetric practice, which may already have a referral process in place. If you can connect with her primary care provider, they may take on the referral process or may even have integrated capacity for treatment. Identify strategies that may support her restful sleep, including realistic daily exercise, sharing infant care, and being cautious with caffeine and screen time. Identify ways for her to meet other new mothers or reconnect with friends. Reassure her that easy attachment activities, such as reading a book or singing to her baby can be good for both of them without requiring much energy. This may sound like a daunting task, but the conversation will only take a few minutes. Helping an isolated new parent recognize that their feelings of fear, inadequacy, and guilt are not facts, offering some simple immediate strategies and facilitating a referral can be lifesaving.

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected]

References

1. Dietz PM et al. Am J Psychiatry. 2007;164(10):1515-20.

2. Hanusa BH et al. J Women’s Health (Larchmt) 2008;17(4):585-96.

3. Lindahl V et al. Arch Womens Ment Health. 2005;8(2):77-87.

4. Hay DF et al. J Child Psychol Psychiatry. 2001;42(7):871-89.

5. Tully EC et al. Am J Psychiatry. 2008:165(9):1148-54.

6. Maternal depression and child development. Paediatr. Child Health 2004;9(8):575-98.

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Updates in skin cancer from AAD VMX 2021

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Anthony Rossi, MD, Assistant Attending Physician at Memorial Sloan Kettering Cancer Center, shares several updates in non-melanoma skin cancers emerging from the American Academy of Dermatology’s AAD VMX 2021 meeting.

 

With PD-1 inhibitors emerging as an immunotherapeutic option in this area, Dr. Rossi discusses a literature review that was conducted to compare the efficacy and safety of pembrolizumab, nivolumab, and cemiplimab in patients with advanced basal cell carcinoma or cutaneous squamous cell carcinoma.

 

Another review analyzed statin use as a predictor of more aggressive tumor characteristics in squamous cell carcinoma. Dr. Rossi shares that while there were no significant findings when examining the cohort as a whole, the male study population did see an elevated correlation between statin history and high-risk tumors.

 

Lastly, Dr. Rossi highlights an analysis of tumor burden in patients taking sonidegib 200 mg once daily as part of the 42-month BOLT study. Sonidegib demonstrated durable tumor response and substantial reduction in tumor burden, and safety and tolerability were consistent with earlier data.

 

--

Anthony Rossi, MD, Assistant Professor, Department of Dermatology, Weill Cornell Medical College; Assistant Attending Physician, Dermatology Service, Memorial Sloan Kettering Cancer Center, New York, NY

 

 

Anthony Rossi, MD, has disclosed the following relevant financial relationships:

Serve(d) as a board member, director, officer, partner, employee, advisor, consultant, or trustee for: DAR Inc; American Society for Dermatologic Surgery Association.

Received research grant from: Regeneron; Biofrontera; Memorial Sloan Kettering Society; Skin Cancer Foundation.

Have a 5% or greater equity interest in: DAR Inc.

Received income in an amount equal to or greater than $250 from: Allergan; Regeneron; Evolus; Cutera; Biofrontera; Iam; DynaMed; Canfield; Merz.

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Anthony Rossi, MD, Assistant Attending Physician at Memorial Sloan Kettering Cancer Center, shares several updates in non-melanoma skin cancers emerging from the American Academy of Dermatology’s AAD VMX 2021 meeting.

 

With PD-1 inhibitors emerging as an immunotherapeutic option in this area, Dr. Rossi discusses a literature review that was conducted to compare the efficacy and safety of pembrolizumab, nivolumab, and cemiplimab in patients with advanced basal cell carcinoma or cutaneous squamous cell carcinoma.

 

Another review analyzed statin use as a predictor of more aggressive tumor characteristics in squamous cell carcinoma. Dr. Rossi shares that while there were no significant findings when examining the cohort as a whole, the male study population did see an elevated correlation between statin history and high-risk tumors.

 

Lastly, Dr. Rossi highlights an analysis of tumor burden in patients taking sonidegib 200 mg once daily as part of the 42-month BOLT study. Sonidegib demonstrated durable tumor response and substantial reduction in tumor burden, and safety and tolerability were consistent with earlier data.

 

--

Anthony Rossi, MD, Assistant Professor, Department of Dermatology, Weill Cornell Medical College; Assistant Attending Physician, Dermatology Service, Memorial Sloan Kettering Cancer Center, New York, NY

 

 

Anthony Rossi, MD, has disclosed the following relevant financial relationships:

Serve(d) as a board member, director, officer, partner, employee, advisor, consultant, or trustee for: DAR Inc; American Society for Dermatologic Surgery Association.

Received research grant from: Regeneron; Biofrontera; Memorial Sloan Kettering Society; Skin Cancer Foundation.

Have a 5% or greater equity interest in: DAR Inc.

Received income in an amount equal to or greater than $250 from: Allergan; Regeneron; Evolus; Cutera; Biofrontera; Iam; DynaMed; Canfield; Merz.

Anthony Rossi, MD, Assistant Attending Physician at Memorial Sloan Kettering Cancer Center, shares several updates in non-melanoma skin cancers emerging from the American Academy of Dermatology’s AAD VMX 2021 meeting.

 

With PD-1 inhibitors emerging as an immunotherapeutic option in this area, Dr. Rossi discusses a literature review that was conducted to compare the efficacy and safety of pembrolizumab, nivolumab, and cemiplimab in patients with advanced basal cell carcinoma or cutaneous squamous cell carcinoma.

 

Another review analyzed statin use as a predictor of more aggressive tumor characteristics in squamous cell carcinoma. Dr. Rossi shares that while there were no significant findings when examining the cohort as a whole, the male study population did see an elevated correlation between statin history and high-risk tumors.

 

Lastly, Dr. Rossi highlights an analysis of tumor burden in patients taking sonidegib 200 mg once daily as part of the 42-month BOLT study. Sonidegib demonstrated durable tumor response and substantial reduction in tumor burden, and safety and tolerability were consistent with earlier data.

 

--

Anthony Rossi, MD, Assistant Professor, Department of Dermatology, Weill Cornell Medical College; Assistant Attending Physician, Dermatology Service, Memorial Sloan Kettering Cancer Center, New York, NY

 

 

Anthony Rossi, MD, has disclosed the following relevant financial relationships:

Serve(d) as a board member, director, officer, partner, employee, advisor, consultant, or trustee for: DAR Inc; American Society for Dermatologic Surgery Association.

Received research grant from: Regeneron; Biofrontera; Memorial Sloan Kettering Society; Skin Cancer Foundation.

Have a 5% or greater equity interest in: DAR Inc.

Received income in an amount equal to or greater than $250 from: Allergan; Regeneron; Evolus; Cutera; Biofrontera; Iam; DynaMed; Canfield; Merz.

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Psoriasis Highlights From AADVMX 2021

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Key studies on psoriasis presented at the American Academy of Dermatology Virtual Meeting Experience (AAD VMX) 2021included data on new topical treatments and biological therapies.

 

Dr Steven Feldman, of Wake Forest School of Medicine, reviews trial data demonstrating the efficacy of a topical formulation of roflumilast, a phosphodiesterase type 4 (PDE-4) inhibitor previously used in oral systemic form to treat psoriasis.

 

He also discusses a meta-analysis of the efficacy of biologics favoring newer treatments, such as drugs targeting IL-17 and IL-23.

 

Dr Feldman reviews the results of two pivotal phase 3 trials presented at the meeting. The POETYK study examined deucravacitinib, a TYK2 inhibitor. In a head-to-head comparison, deucravacitinib was found to be more effective and better tolerated than apremilast in treating psoriasis. BE RADIANT, another head-to-head study, compared the IL-17 blockers bimekizumab and secukinumab. The year-long study favored bimekizumab, though it was associated with a higher risk for candidiasis.

 

Finally, Dr Feldman discusses the significance of a study showing that psoriasis patients have an approximately 20% higher risk for COVID-19 infection compared with a control group.

--

Steven R. Feldman, MD, PhD, Professor, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, North Carolina

Steven R. Feldman, MD, PhD, has disclosed the following relevant financial relationships:
Serve(d) as a consultant for: AbbVie; Alvotech; Advance Medical; Almirall; Arena; Bristol-Myers Squibb; Caremark; Amgen; Celgene; Galderma Laboratories; Gerson Lehrman Group; Guidepoint Global; Helsinn; Janssen; Kikaku; Leo Pharma; Eli Lilly and Company; Merck; Mylan; Novartis; Ortho Dermatology; Pfizer; Regeneron; Sanofi; Sienna; Sun Pharma; Suncare Research; Xenoport
Serve(d) as a speaker for: AbbVie; Amgen; Celgene; Janssen; Leo Pharma; Eli Lilly and Company; Novartis; Ortho Dermatology; Pfizer; Regeneron; Sanofi; Sun Pharma
Receive(d) grant support from: AbbVie; Amgen; Celgene; Galderma Laboratories; Janssen; Eli Lilly and Company; Novartis; Pfizer; Regeneron; Sanofi
Receive(d) royalties from: Informa; UpToDate; Xlibris
Holds stock in: Causa Technologies; Medical Quality Enhancement Corporation
Serves as founder and chief technology officer for: Causa Technologies

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Key studies on psoriasis presented at the American Academy of Dermatology Virtual Meeting Experience (AAD VMX) 2021included data on new topical treatments and biological therapies.

 

Dr Steven Feldman, of Wake Forest School of Medicine, reviews trial data demonstrating the efficacy of a topical formulation of roflumilast, a phosphodiesterase type 4 (PDE-4) inhibitor previously used in oral systemic form to treat psoriasis.

 

He also discusses a meta-analysis of the efficacy of biologics favoring newer treatments, such as drugs targeting IL-17 and IL-23.

 

Dr Feldman reviews the results of two pivotal phase 3 trials presented at the meeting. The POETYK study examined deucravacitinib, a TYK2 inhibitor. In a head-to-head comparison, deucravacitinib was found to be more effective and better tolerated than apremilast in treating psoriasis. BE RADIANT, another head-to-head study, compared the IL-17 blockers bimekizumab and secukinumab. The year-long study favored bimekizumab, though it was associated with a higher risk for candidiasis.

 

Finally, Dr Feldman discusses the significance of a study showing that psoriasis patients have an approximately 20% higher risk for COVID-19 infection compared with a control group.

--

Steven R. Feldman, MD, PhD, Professor, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, North Carolina

Steven R. Feldman, MD, PhD, has disclosed the following relevant financial relationships:
Serve(d) as a consultant for: AbbVie; Alvotech; Advance Medical; Almirall; Arena; Bristol-Myers Squibb; Caremark; Amgen; Celgene; Galderma Laboratories; Gerson Lehrman Group; Guidepoint Global; Helsinn; Janssen; Kikaku; Leo Pharma; Eli Lilly and Company; Merck; Mylan; Novartis; Ortho Dermatology; Pfizer; Regeneron; Sanofi; Sienna; Sun Pharma; Suncare Research; Xenoport
Serve(d) as a speaker for: AbbVie; Amgen; Celgene; Janssen; Leo Pharma; Eli Lilly and Company; Novartis; Ortho Dermatology; Pfizer; Regeneron; Sanofi; Sun Pharma
Receive(d) grant support from: AbbVie; Amgen; Celgene; Galderma Laboratories; Janssen; Eli Lilly and Company; Novartis; Pfizer; Regeneron; Sanofi
Receive(d) royalties from: Informa; UpToDate; Xlibris
Holds stock in: Causa Technologies; Medical Quality Enhancement Corporation
Serves as founder and chief technology officer for: Causa Technologies

Key studies on psoriasis presented at the American Academy of Dermatology Virtual Meeting Experience (AAD VMX) 2021included data on new topical treatments and biological therapies.

 

Dr Steven Feldman, of Wake Forest School of Medicine, reviews trial data demonstrating the efficacy of a topical formulation of roflumilast, a phosphodiesterase type 4 (PDE-4) inhibitor previously used in oral systemic form to treat psoriasis.

 

He also discusses a meta-analysis of the efficacy of biologics favoring newer treatments, such as drugs targeting IL-17 and IL-23.

 

Dr Feldman reviews the results of two pivotal phase 3 trials presented at the meeting. The POETYK study examined deucravacitinib, a TYK2 inhibitor. In a head-to-head comparison, deucravacitinib was found to be more effective and better tolerated than apremilast in treating psoriasis. BE RADIANT, another head-to-head study, compared the IL-17 blockers bimekizumab and secukinumab. The year-long study favored bimekizumab, though it was associated with a higher risk for candidiasis.

 

Finally, Dr Feldman discusses the significance of a study showing that psoriasis patients have an approximately 20% higher risk for COVID-19 infection compared with a control group.

--

Steven R. Feldman, MD, PhD, Professor, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, North Carolina

Steven R. Feldman, MD, PhD, has disclosed the following relevant financial relationships:
Serve(d) as a consultant for: AbbVie; Alvotech; Advance Medical; Almirall; Arena; Bristol-Myers Squibb; Caremark; Amgen; Celgene; Galderma Laboratories; Gerson Lehrman Group; Guidepoint Global; Helsinn; Janssen; Kikaku; Leo Pharma; Eli Lilly and Company; Merck; Mylan; Novartis; Ortho Dermatology; Pfizer; Regeneron; Sanofi; Sienna; Sun Pharma; Suncare Research; Xenoport
Serve(d) as a speaker for: AbbVie; Amgen; Celgene; Janssen; Leo Pharma; Eli Lilly and Company; Novartis; Ortho Dermatology; Pfizer; Regeneron; Sanofi; Sun Pharma
Receive(d) grant support from: AbbVie; Amgen; Celgene; Galderma Laboratories; Janssen; Eli Lilly and Company; Novartis; Pfizer; Regeneron; Sanofi
Receive(d) royalties from: Informa; UpToDate; Xlibris
Holds stock in: Causa Technologies; Medical Quality Enhancement Corporation
Serves as founder and chief technology officer for: Causa Technologies

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Ear tubes no better than antibiotics for otitis media in young kids

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The debate over tympanostomy tubes versus antibiotics for recurrent acute otitis media (AOM) in young children is long-standing. Now, results of a randomized controlled trial show that tubes do not significantly lower the rate of episodes, compared with antibiotics, and medical management doesn’t increase antibiotic resistance.

“We found no evidence of microbial resistance from treating with antibiotics. If there’s not an impact on resistance, why take unnecessary chances on complications of surgery?” lead author Alejandro Hoberman, MD, from Children’s Hospital of Pittsburgh, said in an interview.

The study by Dr. Hoberman and colleagues was published May 13 in the New England Journal of Medicine.

AOM is the most frequent condition diagnosed in children in the United States after the common cold, affecting five of six children younger than 3 years. It is the leading indication for antimicrobial treatment, and tympanostomy tube insertion is the most frequently performed pediatric operation after the newborn period.

Randomized controlled clinical trials were conducted in the 1980s, but by the 1990s, questions of overuse arose. The American Academy of Otolaryngology–Head and Neck Surgery Foundation published the first clinical practice guidelines in 2013.

Parents must weigh the pros and cons. The use of tubes may avoid or delay the next round of drugs, but tubes cost more and introduce small risks (anesthesia, refractory otorrhea, tube blockage, premature dislocation or extrusion, and mild conductive hearing loss).

“We addressed issues that plagued older studies – a longer-term follow-up of 2 years, validated diagnoses of infection to determine eligibility – and used rating scales to measure quality of life,” Dr. Hoberman said.

The researchers randomly assigned children to receive antibiotics or tubes. To be eligible, children had to be 6-35 months of age and have had at least three episodes of AOM within 6 months or at least four episodes within 12 months, including at least one within the preceding 6 months.

The primary outcome was the mean number of episodes of AOM per child-year. Children were assessed at 8-week intervals and within 48 hours of developing symptoms of ear infection. The medically treated children received oral amoxicillin or, if that was ineffective, intramuscular ceftriaxone.

Criteria for determining treatment failure included persistent otorrhea, tympanic membrane perforation, antibiotic-associated diarrhea, reaction to anesthesia, and recurrence of AOM at a frequency equal to the frequency before antibiotic treatment.

In comparing tympanostomy tubes with antibiotics, Dr. Hoberman said, “We were unable to show benefit in the rate of ear infections per child per year over a 2-year period.” As expected, the infection rate fell by about half from the first year to the second in all children.

Overall, the investigators found “no substantial differences between treatment groups” with regard to AOM frequency, percentage of severe episodes, extent of antimicrobial resistance, quality of life for the children, and parental stress.

In an intention-to-treat analysis, the rate of AOM episodes per child-year during the study was 1.48 ± 0.08 for tubes and 1.56 ± 0.08 for antibiotics (P = .66).

However, randomization was not maintained in the intention-to-treat arm. Ten percent (13 of 129) of the children slated to receive tubes didn’t get them because of parental request. Conversely, 16% (54 of 121) of children in the antibiotic group received tubes, 35 (29%) of them in accordance with the trial protocol because of frequent recurrences, and 19 (16%) at parental request.

In a per-protocol analysis, rates of AOM episodes per child-year were 1.47 ± 0.08 for tubes and 1.72 ± 0.11 for antibiotics.

Tubes were associated with longer time until the first ear infection post placement, at a median of 4.34 months, compared with 2.33 months for children who received antibiotics. A smaller percentage of children in the tube group had treatment failure than in the antibiotic group (45% vs. 62%). Children who received tubes also had fewer days per year with symptoms in comparison with the children in the antibiotic group (mean, 2.00 ± 0.29 days vs. 8.33 ± 0.59 days).

The frequency distribution of AOM episodes, the percentage of severe episodes, and antimicrobial resistance detected in respiratory specimens were the same for both groups.

“Hoberman and colleagues add to our knowledge of managing children with recurrent ear infections with a large and rigorous clinical trial showing comparable efficacy of tympanostomy tube insertion, with antibiotic eardrops for new infections versus watchful waiting, with intermittent oral antibiotics, if further ear infections occur,” said Richard M. Rosenfeld, MD, MPH, MBA, distinguished professor and chairman, department of otolaryngology, SUNY Downstate Medical Center, New York.

However, in an accompanying editorial, Ellen R. Wald, MD, from the University of Wisconsin, Madison, pointed out that the sample size was smaller than desired, owing to participants switching groups.

In addition, Dr. Rosenfeld, who was the lead author of the 2013 guidelines, said the study likely underestimates the impact of tubes “because about two-thirds of the children who received them did not have persistent middle-ear fluid at baseline and would not have been candidates for tubes based on the current national guideline on tube indications.”

“Both tubes and intermittent antibiotic therapy are effective for managing recurrent AOM, and parents of children with persistent middle-ear effusion should engage in shared decision-making with their physician to decide on the best management option,” said Dr. Rosenfeld. “When in doubt, watchful waiting is appropriate because many children with recurrent AOM do better over time.”

Dr. Hoberman owns stock in Kaizen Bioscience and holds patents on devices to diagnose and treat AOM. One coauthor consults for Merck. Dr. Wald and Dr. Rosenfeld report no relevant financial relationships.

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

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The debate over tympanostomy tubes versus antibiotics for recurrent acute otitis media (AOM) in young children is long-standing. Now, results of a randomized controlled trial show that tubes do not significantly lower the rate of episodes, compared with antibiotics, and medical management doesn’t increase antibiotic resistance.

“We found no evidence of microbial resistance from treating with antibiotics. If there’s not an impact on resistance, why take unnecessary chances on complications of surgery?” lead author Alejandro Hoberman, MD, from Children’s Hospital of Pittsburgh, said in an interview.

The study by Dr. Hoberman and colleagues was published May 13 in the New England Journal of Medicine.

AOM is the most frequent condition diagnosed in children in the United States after the common cold, affecting five of six children younger than 3 years. It is the leading indication for antimicrobial treatment, and tympanostomy tube insertion is the most frequently performed pediatric operation after the newborn period.

Randomized controlled clinical trials were conducted in the 1980s, but by the 1990s, questions of overuse arose. The American Academy of Otolaryngology–Head and Neck Surgery Foundation published the first clinical practice guidelines in 2013.

Parents must weigh the pros and cons. The use of tubes may avoid or delay the next round of drugs, but tubes cost more and introduce small risks (anesthesia, refractory otorrhea, tube blockage, premature dislocation or extrusion, and mild conductive hearing loss).

“We addressed issues that plagued older studies – a longer-term follow-up of 2 years, validated diagnoses of infection to determine eligibility – and used rating scales to measure quality of life,” Dr. Hoberman said.

The researchers randomly assigned children to receive antibiotics or tubes. To be eligible, children had to be 6-35 months of age and have had at least three episodes of AOM within 6 months or at least four episodes within 12 months, including at least one within the preceding 6 months.

The primary outcome was the mean number of episodes of AOM per child-year. Children were assessed at 8-week intervals and within 48 hours of developing symptoms of ear infection. The medically treated children received oral amoxicillin or, if that was ineffective, intramuscular ceftriaxone.

Criteria for determining treatment failure included persistent otorrhea, tympanic membrane perforation, antibiotic-associated diarrhea, reaction to anesthesia, and recurrence of AOM at a frequency equal to the frequency before antibiotic treatment.

In comparing tympanostomy tubes with antibiotics, Dr. Hoberman said, “We were unable to show benefit in the rate of ear infections per child per year over a 2-year period.” As expected, the infection rate fell by about half from the first year to the second in all children.

Overall, the investigators found “no substantial differences between treatment groups” with regard to AOM frequency, percentage of severe episodes, extent of antimicrobial resistance, quality of life for the children, and parental stress.

In an intention-to-treat analysis, the rate of AOM episodes per child-year during the study was 1.48 ± 0.08 for tubes and 1.56 ± 0.08 for antibiotics (P = .66).

However, randomization was not maintained in the intention-to-treat arm. Ten percent (13 of 129) of the children slated to receive tubes didn’t get them because of parental request. Conversely, 16% (54 of 121) of children in the antibiotic group received tubes, 35 (29%) of them in accordance with the trial protocol because of frequent recurrences, and 19 (16%) at parental request.

In a per-protocol analysis, rates of AOM episodes per child-year were 1.47 ± 0.08 for tubes and 1.72 ± 0.11 for antibiotics.

Tubes were associated with longer time until the first ear infection post placement, at a median of 4.34 months, compared with 2.33 months for children who received antibiotics. A smaller percentage of children in the tube group had treatment failure than in the antibiotic group (45% vs. 62%). Children who received tubes also had fewer days per year with symptoms in comparison with the children in the antibiotic group (mean, 2.00 ± 0.29 days vs. 8.33 ± 0.59 days).

The frequency distribution of AOM episodes, the percentage of severe episodes, and antimicrobial resistance detected in respiratory specimens were the same for both groups.

“Hoberman and colleagues add to our knowledge of managing children with recurrent ear infections with a large and rigorous clinical trial showing comparable efficacy of tympanostomy tube insertion, with antibiotic eardrops for new infections versus watchful waiting, with intermittent oral antibiotics, if further ear infections occur,” said Richard M. Rosenfeld, MD, MPH, MBA, distinguished professor and chairman, department of otolaryngology, SUNY Downstate Medical Center, New York.

However, in an accompanying editorial, Ellen R. Wald, MD, from the University of Wisconsin, Madison, pointed out that the sample size was smaller than desired, owing to participants switching groups.

In addition, Dr. Rosenfeld, who was the lead author of the 2013 guidelines, said the study likely underestimates the impact of tubes “because about two-thirds of the children who received them did not have persistent middle-ear fluid at baseline and would not have been candidates for tubes based on the current national guideline on tube indications.”

“Both tubes and intermittent antibiotic therapy are effective for managing recurrent AOM, and parents of children with persistent middle-ear effusion should engage in shared decision-making with their physician to decide on the best management option,” said Dr. Rosenfeld. “When in doubt, watchful waiting is appropriate because many children with recurrent AOM do better over time.”

Dr. Hoberman owns stock in Kaizen Bioscience and holds patents on devices to diagnose and treat AOM. One coauthor consults for Merck. Dr. Wald and Dr. Rosenfeld report no relevant financial relationships.

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

 

The debate over tympanostomy tubes versus antibiotics for recurrent acute otitis media (AOM) in young children is long-standing. Now, results of a randomized controlled trial show that tubes do not significantly lower the rate of episodes, compared with antibiotics, and medical management doesn’t increase antibiotic resistance.

“We found no evidence of microbial resistance from treating with antibiotics. If there’s not an impact on resistance, why take unnecessary chances on complications of surgery?” lead author Alejandro Hoberman, MD, from Children’s Hospital of Pittsburgh, said in an interview.

The study by Dr. Hoberman and colleagues was published May 13 in the New England Journal of Medicine.

AOM is the most frequent condition diagnosed in children in the United States after the common cold, affecting five of six children younger than 3 years. It is the leading indication for antimicrobial treatment, and tympanostomy tube insertion is the most frequently performed pediatric operation after the newborn period.

Randomized controlled clinical trials were conducted in the 1980s, but by the 1990s, questions of overuse arose. The American Academy of Otolaryngology–Head and Neck Surgery Foundation published the first clinical practice guidelines in 2013.

Parents must weigh the pros and cons. The use of tubes may avoid or delay the next round of drugs, but tubes cost more and introduce small risks (anesthesia, refractory otorrhea, tube blockage, premature dislocation or extrusion, and mild conductive hearing loss).

“We addressed issues that plagued older studies – a longer-term follow-up of 2 years, validated diagnoses of infection to determine eligibility – and used rating scales to measure quality of life,” Dr. Hoberman said.

The researchers randomly assigned children to receive antibiotics or tubes. To be eligible, children had to be 6-35 months of age and have had at least three episodes of AOM within 6 months or at least four episodes within 12 months, including at least one within the preceding 6 months.

The primary outcome was the mean number of episodes of AOM per child-year. Children were assessed at 8-week intervals and within 48 hours of developing symptoms of ear infection. The medically treated children received oral amoxicillin or, if that was ineffective, intramuscular ceftriaxone.

Criteria for determining treatment failure included persistent otorrhea, tympanic membrane perforation, antibiotic-associated diarrhea, reaction to anesthesia, and recurrence of AOM at a frequency equal to the frequency before antibiotic treatment.

In comparing tympanostomy tubes with antibiotics, Dr. Hoberman said, “We were unable to show benefit in the rate of ear infections per child per year over a 2-year period.” As expected, the infection rate fell by about half from the first year to the second in all children.

Overall, the investigators found “no substantial differences between treatment groups” with regard to AOM frequency, percentage of severe episodes, extent of antimicrobial resistance, quality of life for the children, and parental stress.

In an intention-to-treat analysis, the rate of AOM episodes per child-year during the study was 1.48 ± 0.08 for tubes and 1.56 ± 0.08 for antibiotics (P = .66).

However, randomization was not maintained in the intention-to-treat arm. Ten percent (13 of 129) of the children slated to receive tubes didn’t get them because of parental request. Conversely, 16% (54 of 121) of children in the antibiotic group received tubes, 35 (29%) of them in accordance with the trial protocol because of frequent recurrences, and 19 (16%) at parental request.

In a per-protocol analysis, rates of AOM episodes per child-year were 1.47 ± 0.08 for tubes and 1.72 ± 0.11 for antibiotics.

Tubes were associated with longer time until the first ear infection post placement, at a median of 4.34 months, compared with 2.33 months for children who received antibiotics. A smaller percentage of children in the tube group had treatment failure than in the antibiotic group (45% vs. 62%). Children who received tubes also had fewer days per year with symptoms in comparison with the children in the antibiotic group (mean, 2.00 ± 0.29 days vs. 8.33 ± 0.59 days).

The frequency distribution of AOM episodes, the percentage of severe episodes, and antimicrobial resistance detected in respiratory specimens were the same for both groups.

“Hoberman and colleagues add to our knowledge of managing children with recurrent ear infections with a large and rigorous clinical trial showing comparable efficacy of tympanostomy tube insertion, with antibiotic eardrops for new infections versus watchful waiting, with intermittent oral antibiotics, if further ear infections occur,” said Richard M. Rosenfeld, MD, MPH, MBA, distinguished professor and chairman, department of otolaryngology, SUNY Downstate Medical Center, New York.

However, in an accompanying editorial, Ellen R. Wald, MD, from the University of Wisconsin, Madison, pointed out that the sample size was smaller than desired, owing to participants switching groups.

In addition, Dr. Rosenfeld, who was the lead author of the 2013 guidelines, said the study likely underestimates the impact of tubes “because about two-thirds of the children who received them did not have persistent middle-ear fluid at baseline and would not have been candidates for tubes based on the current national guideline on tube indications.”

“Both tubes and intermittent antibiotic therapy are effective for managing recurrent AOM, and parents of children with persistent middle-ear effusion should engage in shared decision-making with their physician to decide on the best management option,” said Dr. Rosenfeld. “When in doubt, watchful waiting is appropriate because many children with recurrent AOM do better over time.”

Dr. Hoberman owns stock in Kaizen Bioscience and holds patents on devices to diagnose and treat AOM. One coauthor consults for Merck. Dr. Wald and Dr. Rosenfeld report no relevant financial relationships.

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

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Low-risk preterm infants may not need antibiotics

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Selective use of antibiotics based on birth circumstances may reduce unnecessary antibiotic exposure for preterm infants at risk of early-onset sepsis, based on data from 340 preterm infants at a single center.

Dr. Kirtan Patel

Preterm infants born because of preterm labor, premature rupture of membranes, and/or intraamniotic infection (IAI) are considered at increased risk for early-onset sepsis, and current management strategies include a blood culture and initiation of empirical antibiotics, said Kirtan Patel, MD, of Texas A&M University, Dallas, and colleagues in a poster (# 1720) presented at the Pediatric Academic Societies annual meeting.

However, this blanket approach “may increase the unnecessary early antibiotic exposure in preterm infants possibly leading to future adverse health outcomes,” and physicians are advised to review the risks and benefits, Dr. Patel said.

Data from previous studies suggest that preterm infants born as a result of preterm labor and/or premature rupture of membranes with adequate Group B Streptococcus (GBS) intrapartum antibiotic prophylaxis and no indication of IAI may be managed without empiric antibiotics because the early-onset sepsis risk in these infants is much lower than the ones born through IAI and inadequate GBS intrapartum antibiotic prophylaxis.

To better identify preterm birth circumstances in which antibiotics might be avoided, the researchers conducted a retrospective cohort study of preterm infants born at 28-34 weeks’ gestation during the period from Jan. 1, 2015, to Dec. 31, 2018. These infants were in the low-risk category of preterm birth because of preterm labor or premature rupture of membranes, with no IAI and adequate GBS intrapartum antibiotic prophylaxis, and no signs of cardiovascular or respiratory instability after birth. Of these, 157 (46.2%) received empiric antibiotics soon after birth and 183 infants (53.8%) did not receive empiric antibiotics.

The mean gestational age and birth weight were significantly lower in the empiric antibiotic group, but after correcting for these variables, the factors with the greatest influence on the initiation of antibiotics were maternal intrapartum antibiotic prophylaxis (odds ratio, 3.13); premature rupture of membranes (OR, 3.75); use of continuous positive airway pressure (CPAP) in the delivery room (OR, 1.84); CPAP on admission to the neonatal intensive care unit (OR, 1.94); drawing a blood culture (OR, 13.72); and a complete blood count with immature to total neutrophil ratio greater than 0.2 (OR, 3.84).

Three infants (2%) in the antibiotics group had culture-positive early-onset sepsis with Escherichia coli, compared with no infants in the no-antibiotics group. No differences in short-term hospital outcomes appeared between the two groups. The study was limited in part by the retrospective design and sample size, the researchers noted.

However, the results support a selective approach to antibiotics for preterm infants, taking various birth circumstances into account, they said.
 

Further risk factor identification could curb antibiotic use

In this study, empiric antibiotics were cast as a wide net to avoid missing serious infections in a few patients, said Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, in an interview.

“It is interesting in this retrospective review of 340 preterm infants that the three newborns that did have serious bacterial infection were correctly given empiric antibiotics from the start,” Dr. Joos noted. “The authors were very effective at elucidating the possible factors that go into starting or not starting empiric antibiotics, although there may be other factors in the clinician’s judgment that are being missed. … More studies are needed on this topic,” Dr. Joos said. “Further research examining how the septic newborns differ from the nonseptic ones could help to even further narrow the use of empiric antibiotics,” he added.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Joos had no financial conflicts to disclose, but serves as a member of the Pediatric News Editorial Advisory Board.

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Selective use of antibiotics based on birth circumstances may reduce unnecessary antibiotic exposure for preterm infants at risk of early-onset sepsis, based on data from 340 preterm infants at a single center.

Dr. Kirtan Patel

Preterm infants born because of preterm labor, premature rupture of membranes, and/or intraamniotic infection (IAI) are considered at increased risk for early-onset sepsis, and current management strategies include a blood culture and initiation of empirical antibiotics, said Kirtan Patel, MD, of Texas A&M University, Dallas, and colleagues in a poster (# 1720) presented at the Pediatric Academic Societies annual meeting.

However, this blanket approach “may increase the unnecessary early antibiotic exposure in preterm infants possibly leading to future adverse health outcomes,” and physicians are advised to review the risks and benefits, Dr. Patel said.

Data from previous studies suggest that preterm infants born as a result of preterm labor and/or premature rupture of membranes with adequate Group B Streptococcus (GBS) intrapartum antibiotic prophylaxis and no indication of IAI may be managed without empiric antibiotics because the early-onset sepsis risk in these infants is much lower than the ones born through IAI and inadequate GBS intrapartum antibiotic prophylaxis.

To better identify preterm birth circumstances in which antibiotics might be avoided, the researchers conducted a retrospective cohort study of preterm infants born at 28-34 weeks’ gestation during the period from Jan. 1, 2015, to Dec. 31, 2018. These infants were in the low-risk category of preterm birth because of preterm labor or premature rupture of membranes, with no IAI and adequate GBS intrapartum antibiotic prophylaxis, and no signs of cardiovascular or respiratory instability after birth. Of these, 157 (46.2%) received empiric antibiotics soon after birth and 183 infants (53.8%) did not receive empiric antibiotics.

The mean gestational age and birth weight were significantly lower in the empiric antibiotic group, but after correcting for these variables, the factors with the greatest influence on the initiation of antibiotics were maternal intrapartum antibiotic prophylaxis (odds ratio, 3.13); premature rupture of membranes (OR, 3.75); use of continuous positive airway pressure (CPAP) in the delivery room (OR, 1.84); CPAP on admission to the neonatal intensive care unit (OR, 1.94); drawing a blood culture (OR, 13.72); and a complete blood count with immature to total neutrophil ratio greater than 0.2 (OR, 3.84).

Three infants (2%) in the antibiotics group had culture-positive early-onset sepsis with Escherichia coli, compared with no infants in the no-antibiotics group. No differences in short-term hospital outcomes appeared between the two groups. The study was limited in part by the retrospective design and sample size, the researchers noted.

However, the results support a selective approach to antibiotics for preterm infants, taking various birth circumstances into account, they said.
 

Further risk factor identification could curb antibiotic use

In this study, empiric antibiotics were cast as a wide net to avoid missing serious infections in a few patients, said Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, in an interview.

“It is interesting in this retrospective review of 340 preterm infants that the three newborns that did have serious bacterial infection were correctly given empiric antibiotics from the start,” Dr. Joos noted. “The authors were very effective at elucidating the possible factors that go into starting or not starting empiric antibiotics, although there may be other factors in the clinician’s judgment that are being missed. … More studies are needed on this topic,” Dr. Joos said. “Further research examining how the septic newborns differ from the nonseptic ones could help to even further narrow the use of empiric antibiotics,” he added.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Joos had no financial conflicts to disclose, but serves as a member of the Pediatric News Editorial Advisory Board.

Selective use of antibiotics based on birth circumstances may reduce unnecessary antibiotic exposure for preterm infants at risk of early-onset sepsis, based on data from 340 preterm infants at a single center.

Dr. Kirtan Patel

Preterm infants born because of preterm labor, premature rupture of membranes, and/or intraamniotic infection (IAI) are considered at increased risk for early-onset sepsis, and current management strategies include a blood culture and initiation of empirical antibiotics, said Kirtan Patel, MD, of Texas A&M University, Dallas, and colleagues in a poster (# 1720) presented at the Pediatric Academic Societies annual meeting.

However, this blanket approach “may increase the unnecessary early antibiotic exposure in preterm infants possibly leading to future adverse health outcomes,” and physicians are advised to review the risks and benefits, Dr. Patel said.

Data from previous studies suggest that preterm infants born as a result of preterm labor and/or premature rupture of membranes with adequate Group B Streptococcus (GBS) intrapartum antibiotic prophylaxis and no indication of IAI may be managed without empiric antibiotics because the early-onset sepsis risk in these infants is much lower than the ones born through IAI and inadequate GBS intrapartum antibiotic prophylaxis.

To better identify preterm birth circumstances in which antibiotics might be avoided, the researchers conducted a retrospective cohort study of preterm infants born at 28-34 weeks’ gestation during the period from Jan. 1, 2015, to Dec. 31, 2018. These infants were in the low-risk category of preterm birth because of preterm labor or premature rupture of membranes, with no IAI and adequate GBS intrapartum antibiotic prophylaxis, and no signs of cardiovascular or respiratory instability after birth. Of these, 157 (46.2%) received empiric antibiotics soon after birth and 183 infants (53.8%) did not receive empiric antibiotics.

The mean gestational age and birth weight were significantly lower in the empiric antibiotic group, but after correcting for these variables, the factors with the greatest influence on the initiation of antibiotics were maternal intrapartum antibiotic prophylaxis (odds ratio, 3.13); premature rupture of membranes (OR, 3.75); use of continuous positive airway pressure (CPAP) in the delivery room (OR, 1.84); CPAP on admission to the neonatal intensive care unit (OR, 1.94); drawing a blood culture (OR, 13.72); and a complete blood count with immature to total neutrophil ratio greater than 0.2 (OR, 3.84).

Three infants (2%) in the antibiotics group had culture-positive early-onset sepsis with Escherichia coli, compared with no infants in the no-antibiotics group. No differences in short-term hospital outcomes appeared between the two groups. The study was limited in part by the retrospective design and sample size, the researchers noted.

However, the results support a selective approach to antibiotics for preterm infants, taking various birth circumstances into account, they said.
 

Further risk factor identification could curb antibiotic use

In this study, empiric antibiotics were cast as a wide net to avoid missing serious infections in a few patients, said Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, in an interview.

“It is interesting in this retrospective review of 340 preterm infants that the three newborns that did have serious bacterial infection were correctly given empiric antibiotics from the start,” Dr. Joos noted. “The authors were very effective at elucidating the possible factors that go into starting or not starting empiric antibiotics, although there may be other factors in the clinician’s judgment that are being missed. … More studies are needed on this topic,” Dr. Joos said. “Further research examining how the septic newborns differ from the nonseptic ones could help to even further narrow the use of empiric antibiotics,” he added.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Joos had no financial conflicts to disclose, but serves as a member of the Pediatric News Editorial Advisory Board.

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Update in Hospital Medicine relays important findings

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Two experts scoured the medical journals for the practice-changing research most relevant to hospital medicine in 2020 at a recent session at SHM Converge, the annual conference of the Society of Hospital Medicine.

The presenters chose findings they considered either practice changing or practice confirming, and in areas over which hospitalists have at least some control. Here is what they highlighted:
 

IV iron administration before hospital discharge

In a randomized double-blind, placebo-controlled trial across 121 centers in Europe, South America, and Singapore, 1,108 patients hospitalized with acute heart failure and iron deficiency were randomized to receive intravenous ferric carboxymaltose or placebo, with a first dose before discharge and a second at 6 weeks.

Those in the intravenous iron group had a significant reduction in hospitalizations for heart failure up to 52 weeks after randomization, but there was no significant reduction in deaths because of heart failure. There was no difference in serious adverse events.

Dr. Anthony Breu

Anthony Breu, MD, assistant professor of medicine at Harvard Medical School, Boston, said the findings should alter hospitalist practice.

“In patients hospitalized with acute heart failure and left ventricular ejection fraction of less than 50%, check iron studies and start IV iron prior to discharge if they have iron deficiency, with or without anemia,” he said.
 

Apixaban versus dalteparin for venous thromboembolism in cancer

This noninferiority trial involved 1,155 adults with cancer who had symptomatic or incidental acute proximal deep vein thrombosis or pulmonary embolism. The patients were randomized to receive oral apixaban or subcutaneous dalteparin for 6 months.

Patients in the apixaban group had a significantly lower rate of recurrent venous thromboembolism (P = .09), with no increase in major bleeds, Dr. Breu said. He noted that those with brain cancer and leukemia were excluded.

“In patients with cancer and acute venous thromboembolism, consider apixaban as your first-line treatment, with some caveats,” he said.
 

Clinical decision rule for penicillin allergy

With fewer than 10% of patients who report a penicillin allergy actually testing positive on a standard allergy test, a simpler way to predict an allergy would help clinicians, said Shoshana Herzig, MD, MPH, associate professor of medicine at Harvard Medical School.

Dr. Shoshana Herzig

A 622-patient cohort that had undergone penicillin allergy testing was used to identify factors that could help predict an allergy. A scoring system called PEN-FAST was developed based on five factors – a penicillin allergy reported by the patient, 5 years or less since the last reaction (2 points); anaphylaxis or angioedema, or severe cutaneous adverse reaction (2 points); and treatment being required for the reaction (1 point).

Researchers, after validation at three sites, found that a score below a threshold identified a group that had a 96% negative predictive value for penicillin allergy skin testing.

“A PEN-FAST score of less than 3 can be used to identify patients with reported penicillin allergy who can likely proceed safely to oral challenge,” Dr. Herzig said. She said the findings would benefit from validation in an inpatient setting.
 

 

 

Prehydration before contrast-enhanced computed tomography in CKD

Previous studies have found that omitting prehydration was noninferior to volume expansion with isotonic saline, and this trial looked at omission versus sodium bicarbonate hydration.

Participants were 523 adults with stage 3 chronic kidney disease who were getting elective outpatient CT with contrast. They were randomized to either no prehydration or prehydration with 250 mL of 1.4% sodium bicarbonate an hour before CT.

Researchers found that postcontrast acute kidney injury was rare even in this high-risk patient population overall, and that withholding prehydration was noninferior to prehydration with sodium bicarbonate, Dr. Herzig said.
 

Gabapentin for alcohol use disorder in those with alcohol withdrawal symptoms

Dr. Breu noted that only about one in five patients with alcohol use disorder receive medications to help preserve abstinence or to reduce drinking, and many medications target cravings but not symptoms of withdrawal.

In a double-blind, randomized, placebo-controlled trial at a single academic outpatient medical center in South Carolina, 90 patients were randomized to receive titrated gabapentin or placebo for 16 weeks.

Researchers found that, among those with abstinence of at least 2 days, gabapentin reduced the number of days of heavy drinking and the days of any drinking, especially in those with high symptoms of withdrawal.

“In patients with alcohol use disorder and high alcohol withdrawal symptoms, consider gabapentin to help reduce heavy drinking or maintain abstinence,” Dr. Breu said.
 

Hospitalist continuity of care and patient outcomes

In a retrospective study examining all medical admissions of Medicare patients with a 3- to 6-day length of stay, and in which all general medical care was provided by hospitalists, researchers examined the effects of continuity of care. Nearly 115,000 patient stays were included in the study, which covered 229 Texas hospitals.

The stays were grouped into quartiles of continuity of care, based on the number of hospitalists involved in a patient’s stay. Greater continuity was associated with lower 30-day mortality, with a linear relationship between the two. Researchers also found costs to be lower as continuity increased.

“Efforts by hospitals and hospitalist groups to promote working schedules with more continuity,” Dr. Herzig said, “could lead to improved postdischarge outcomes.”


 

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Two experts scoured the medical journals for the practice-changing research most relevant to hospital medicine in 2020 at a recent session at SHM Converge, the annual conference of the Society of Hospital Medicine.

The presenters chose findings they considered either practice changing or practice confirming, and in areas over which hospitalists have at least some control. Here is what they highlighted:
 

IV iron administration before hospital discharge

In a randomized double-blind, placebo-controlled trial across 121 centers in Europe, South America, and Singapore, 1,108 patients hospitalized with acute heart failure and iron deficiency were randomized to receive intravenous ferric carboxymaltose or placebo, with a first dose before discharge and a second at 6 weeks.

Those in the intravenous iron group had a significant reduction in hospitalizations for heart failure up to 52 weeks after randomization, but there was no significant reduction in deaths because of heart failure. There was no difference in serious adverse events.

Dr. Anthony Breu

Anthony Breu, MD, assistant professor of medicine at Harvard Medical School, Boston, said the findings should alter hospitalist practice.

“In patients hospitalized with acute heart failure and left ventricular ejection fraction of less than 50%, check iron studies and start IV iron prior to discharge if they have iron deficiency, with or without anemia,” he said.
 

Apixaban versus dalteparin for venous thromboembolism in cancer

This noninferiority trial involved 1,155 adults with cancer who had symptomatic or incidental acute proximal deep vein thrombosis or pulmonary embolism. The patients were randomized to receive oral apixaban or subcutaneous dalteparin for 6 months.

Patients in the apixaban group had a significantly lower rate of recurrent venous thromboembolism (P = .09), with no increase in major bleeds, Dr. Breu said. He noted that those with brain cancer and leukemia were excluded.

“In patients with cancer and acute venous thromboembolism, consider apixaban as your first-line treatment, with some caveats,” he said.
 

Clinical decision rule for penicillin allergy

With fewer than 10% of patients who report a penicillin allergy actually testing positive on a standard allergy test, a simpler way to predict an allergy would help clinicians, said Shoshana Herzig, MD, MPH, associate professor of medicine at Harvard Medical School.

Dr. Shoshana Herzig

A 622-patient cohort that had undergone penicillin allergy testing was used to identify factors that could help predict an allergy. A scoring system called PEN-FAST was developed based on five factors – a penicillin allergy reported by the patient, 5 years or less since the last reaction (2 points); anaphylaxis or angioedema, or severe cutaneous adverse reaction (2 points); and treatment being required for the reaction (1 point).

Researchers, after validation at three sites, found that a score below a threshold identified a group that had a 96% negative predictive value for penicillin allergy skin testing.

“A PEN-FAST score of less than 3 can be used to identify patients with reported penicillin allergy who can likely proceed safely to oral challenge,” Dr. Herzig said. She said the findings would benefit from validation in an inpatient setting.
 

 

 

Prehydration before contrast-enhanced computed tomography in CKD

Previous studies have found that omitting prehydration was noninferior to volume expansion with isotonic saline, and this trial looked at omission versus sodium bicarbonate hydration.

Participants were 523 adults with stage 3 chronic kidney disease who were getting elective outpatient CT with contrast. They were randomized to either no prehydration or prehydration with 250 mL of 1.4% sodium bicarbonate an hour before CT.

Researchers found that postcontrast acute kidney injury was rare even in this high-risk patient population overall, and that withholding prehydration was noninferior to prehydration with sodium bicarbonate, Dr. Herzig said.
 

Gabapentin for alcohol use disorder in those with alcohol withdrawal symptoms

Dr. Breu noted that only about one in five patients with alcohol use disorder receive medications to help preserve abstinence or to reduce drinking, and many medications target cravings but not symptoms of withdrawal.

In a double-blind, randomized, placebo-controlled trial at a single academic outpatient medical center in South Carolina, 90 patients were randomized to receive titrated gabapentin or placebo for 16 weeks.

Researchers found that, among those with abstinence of at least 2 days, gabapentin reduced the number of days of heavy drinking and the days of any drinking, especially in those with high symptoms of withdrawal.

“In patients with alcohol use disorder and high alcohol withdrawal symptoms, consider gabapentin to help reduce heavy drinking or maintain abstinence,” Dr. Breu said.
 

Hospitalist continuity of care and patient outcomes

In a retrospective study examining all medical admissions of Medicare patients with a 3- to 6-day length of stay, and in which all general medical care was provided by hospitalists, researchers examined the effects of continuity of care. Nearly 115,000 patient stays were included in the study, which covered 229 Texas hospitals.

The stays were grouped into quartiles of continuity of care, based on the number of hospitalists involved in a patient’s stay. Greater continuity was associated with lower 30-day mortality, with a linear relationship between the two. Researchers also found costs to be lower as continuity increased.

“Efforts by hospitals and hospitalist groups to promote working schedules with more continuity,” Dr. Herzig said, “could lead to improved postdischarge outcomes.”


 

 

Two experts scoured the medical journals for the practice-changing research most relevant to hospital medicine in 2020 at a recent session at SHM Converge, the annual conference of the Society of Hospital Medicine.

The presenters chose findings they considered either practice changing or practice confirming, and in areas over which hospitalists have at least some control. Here is what they highlighted:
 

IV iron administration before hospital discharge

In a randomized double-blind, placebo-controlled trial across 121 centers in Europe, South America, and Singapore, 1,108 patients hospitalized with acute heart failure and iron deficiency were randomized to receive intravenous ferric carboxymaltose or placebo, with a first dose before discharge and a second at 6 weeks.

Those in the intravenous iron group had a significant reduction in hospitalizations for heart failure up to 52 weeks after randomization, but there was no significant reduction in deaths because of heart failure. There was no difference in serious adverse events.

Dr. Anthony Breu

Anthony Breu, MD, assistant professor of medicine at Harvard Medical School, Boston, said the findings should alter hospitalist practice.

“In patients hospitalized with acute heart failure and left ventricular ejection fraction of less than 50%, check iron studies and start IV iron prior to discharge if they have iron deficiency, with or without anemia,” he said.
 

Apixaban versus dalteparin for venous thromboembolism in cancer

This noninferiority trial involved 1,155 adults with cancer who had symptomatic or incidental acute proximal deep vein thrombosis or pulmonary embolism. The patients were randomized to receive oral apixaban or subcutaneous dalteparin for 6 months.

Patients in the apixaban group had a significantly lower rate of recurrent venous thromboembolism (P = .09), with no increase in major bleeds, Dr. Breu said. He noted that those with brain cancer and leukemia were excluded.

“In patients with cancer and acute venous thromboembolism, consider apixaban as your first-line treatment, with some caveats,” he said.
 

Clinical decision rule for penicillin allergy

With fewer than 10% of patients who report a penicillin allergy actually testing positive on a standard allergy test, a simpler way to predict an allergy would help clinicians, said Shoshana Herzig, MD, MPH, associate professor of medicine at Harvard Medical School.

Dr. Shoshana Herzig

A 622-patient cohort that had undergone penicillin allergy testing was used to identify factors that could help predict an allergy. A scoring system called PEN-FAST was developed based on five factors – a penicillin allergy reported by the patient, 5 years or less since the last reaction (2 points); anaphylaxis or angioedema, or severe cutaneous adverse reaction (2 points); and treatment being required for the reaction (1 point).

Researchers, after validation at three sites, found that a score below a threshold identified a group that had a 96% negative predictive value for penicillin allergy skin testing.

“A PEN-FAST score of less than 3 can be used to identify patients with reported penicillin allergy who can likely proceed safely to oral challenge,” Dr. Herzig said. She said the findings would benefit from validation in an inpatient setting.
 

 

 

Prehydration before contrast-enhanced computed tomography in CKD

Previous studies have found that omitting prehydration was noninferior to volume expansion with isotonic saline, and this trial looked at omission versus sodium bicarbonate hydration.

Participants were 523 adults with stage 3 chronic kidney disease who were getting elective outpatient CT with contrast. They were randomized to either no prehydration or prehydration with 250 mL of 1.4% sodium bicarbonate an hour before CT.

Researchers found that postcontrast acute kidney injury was rare even in this high-risk patient population overall, and that withholding prehydration was noninferior to prehydration with sodium bicarbonate, Dr. Herzig said.
 

Gabapentin for alcohol use disorder in those with alcohol withdrawal symptoms

Dr. Breu noted that only about one in five patients with alcohol use disorder receive medications to help preserve abstinence or to reduce drinking, and many medications target cravings but not symptoms of withdrawal.

In a double-blind, randomized, placebo-controlled trial at a single academic outpatient medical center in South Carolina, 90 patients were randomized to receive titrated gabapentin or placebo for 16 weeks.

Researchers found that, among those with abstinence of at least 2 days, gabapentin reduced the number of days of heavy drinking and the days of any drinking, especially in those with high symptoms of withdrawal.

“In patients with alcohol use disorder and high alcohol withdrawal symptoms, consider gabapentin to help reduce heavy drinking or maintain abstinence,” Dr. Breu said.
 

Hospitalist continuity of care and patient outcomes

In a retrospective study examining all medical admissions of Medicare patients with a 3- to 6-day length of stay, and in which all general medical care was provided by hospitalists, researchers examined the effects of continuity of care. Nearly 115,000 patient stays were included in the study, which covered 229 Texas hospitals.

The stays were grouped into quartiles of continuity of care, based on the number of hospitalists involved in a patient’s stay. Greater continuity was associated with lower 30-day mortality, with a linear relationship between the two. Researchers also found costs to be lower as continuity increased.

“Efforts by hospitals and hospitalist groups to promote working schedules with more continuity,” Dr. Herzig said, “could lead to improved postdischarge outcomes.”


 

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COVID-19 in children and adolescents: Disease burden and severity

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My first thought on this column was maybe Pediatric News has written sufficiently about SARS-CoV-2 infection, and it is time to move on. However, the agenda for the May 12th Advisory Committee on Immunization Practice includes a review of the Pfizer-BioNTech COVID-19 vaccine safety and immunogenicity data for the 12- to 15-year-old age cohort that suggests the potential for vaccine availability and roll out for early adolescents in the near future and the need for up-to-date knowledge about the incidence, severity, and long-term outcome of COVID-19 in the pediatric population.

Dr. Stephen I. Pelton

Updating and summarizing the pediatric experience for the pediatric community on what children and adolescents have experienced because of SARS-CoV-2 infection is critical to address the myriad of questions that will come from colleagues, parents, and adolescents themselves. A great resource, published weekly, is the joint report from the American Academy of Pediatrics and the Children’s Hospital Association.1 As of April 29, 2021, 3,782,724 total child COVID-19 cases have been reported from 49 states, New York City (NYC), the District of Columbia, Guam, and Puerto Rico. Children represent approximately 14% of cases in the United States and not surprisingly are an increasing proportion of total cases as vaccine impact reduces cases among older age groups. Nearly 5% of the pediatric population has already been infected with SARS-CoV-2. Fortunately, compared with adults, hospitalization, severe disease, and mortality remain far lower both in number and proportion than in the adult population. Cumulative hospitalizations from 24 states and NYC total 15,456 (0.8%) among those infected, with 303 deaths reported (from 43 states, NYC, Guam, and Puerto Rico). Case fatality rate approximates 0.01% in the most recent summary of state reports. One of the limitations of this report is that each state decides how to report the age distribution of COVID-19 cases resulting in variation in age range; another is the data are limited to those details individual states chose to make publicly available.

Although children do not commonly develop severe disease, and the case fatality is low, there are still insights to be learned from understanding risk features for severe disease. Preston et al. reviewed discharge data from 869 medical facilities to describe patients 18 years or younger who had an inpatient or emergency department encounter with a primary or secondary COVID-19 discharge diagnosis from March 1 through October 31, 2020.2 They reported that approximately 2,430 (11.7%) children were hospitalized and 746, nearly 31% of those hospitalized, had severe COVID disease. Those at greatest risk for severe disease were children with comorbid conditions and those less than 12 years, compared with the 12- to 18-year age group. They did not identify race as a risk for severe disease in this study. Moreira et al. described risk factors for morbidity and death from COVID in children less than 18 years of age3 using CDC COVID-NET, the Centers for Disease Control and Prevention COVID-19–associated hospitalization surveillance network. They reported a hospitalization rate of 4.7% among 27,045 cases. They identified three risk factors for hospitalization – age, race/ethnicity, and comorbid conditions. Thirty-nine children (0.19%) died; children who were black, non-Hispanic, and those with an underlying medical condition had a significantly increased risk of death. Thirty-three (85%) children who died had a comorbidity, and 27 (69%) were African American or Hispanic/Latino. The U.S. experience in children is also consistent with reports from the United Kingdom, Italy, Spain, Germany, France, and South Korea.4 Deaths from COVID-19 were uncommon but relatively more frequent in older children, compared with younger age groups among children less than 18 years of age in these countries.

Acute COVID-19 and multisystem inflammatory syndrome in children (MIS-C) do not predominantly target the neurologic systems; however, neurologic complications have been reported, some of which appear to result in long-lasting disability. LaRovere et al. identified 354 (22%) of 1,695 patients less than 21 years of age with acute COVID or MIS-C who had neurologic signs or symptoms during their illness. Among those with neurologic involvement, most children had prior neurologic deficits, mild symptoms, that resolved by the time of discharge. Forty-three (12%) were considered life threatening and included severe encephalopathy, stroke, central nervous system infection/demyelination, Guillain-Barre syndrome or variant, or acute cerebral edema. Several children, including some who were previously healthy prior to COVID, had persistent neurologic deficits at discharge. In addition to neurologic morbidity, long COVID – a syndrome of persistent symptoms following acute COVID that lasts for more than 12 weeks without alternative diagnosis – has also been described in children. Buonsenso et al. assessed 129 children diagnosed with COVID-19 between March and November 2020 in Rome, Italy.5 Persisting symptoms after 120 days were reported by more than 50%. Symptoms like fatigue, muscle and joint pain, headache, insomnia, respiratory problems, and palpitations were most common. Clearly, further follow-up of the long-term outcomes is necessary to understand the full spectrum of morbidity resulting from COVID-19 disease in children and its natural history.

The current picture of COVID infection in children younger than 18 reinforces that children are part of the pandemic. Although deaths in children have now exceeded 300 cases, severe disease remains uncommon in both the United States and western Europe. Risk factors for severe disease include comorbid illness and race/ethnicity with a disproportionate number of severe cases in children with underlying comorbidity and in African American and Hispanic/Latino children. Ongoing surveillance is critical as changes are likely to be observed over time as viral evolution affects disease burden and characteristics.
 

Dr. Pelton is professor of pediatrics and epidemiology at Boston University schools of medicine and public health and senior attending physician in pediatric infectious diseases, Boston Medical Center. Email him at [email protected].

References

1. Children and COVID-19: State-Level Data Report. Services AAP.org.

2. Preston LE et al. JAMA Network Open. 2021;4(4):e215298. doi:10.1001/jamanetworkopen.2021.5298

3. Moreira A et al. Eur J Pediatr. 2021;180:1659-63.

4. SS Bhopal et al. Lancet 2021. doi: 10.1016/ S2352-4642(21)00066-3.

5. Buonsenso D et al. medRxiv preprint. doi: 10.1101/2021.01.23.21250375.

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My first thought on this column was maybe Pediatric News has written sufficiently about SARS-CoV-2 infection, and it is time to move on. However, the agenda for the May 12th Advisory Committee on Immunization Practice includes a review of the Pfizer-BioNTech COVID-19 vaccine safety and immunogenicity data for the 12- to 15-year-old age cohort that suggests the potential for vaccine availability and roll out for early adolescents in the near future and the need for up-to-date knowledge about the incidence, severity, and long-term outcome of COVID-19 in the pediatric population.

Dr. Stephen I. Pelton

Updating and summarizing the pediatric experience for the pediatric community on what children and adolescents have experienced because of SARS-CoV-2 infection is critical to address the myriad of questions that will come from colleagues, parents, and adolescents themselves. A great resource, published weekly, is the joint report from the American Academy of Pediatrics and the Children’s Hospital Association.1 As of April 29, 2021, 3,782,724 total child COVID-19 cases have been reported from 49 states, New York City (NYC), the District of Columbia, Guam, and Puerto Rico. Children represent approximately 14% of cases in the United States and not surprisingly are an increasing proportion of total cases as vaccine impact reduces cases among older age groups. Nearly 5% of the pediatric population has already been infected with SARS-CoV-2. Fortunately, compared with adults, hospitalization, severe disease, and mortality remain far lower both in number and proportion than in the adult population. Cumulative hospitalizations from 24 states and NYC total 15,456 (0.8%) among those infected, with 303 deaths reported (from 43 states, NYC, Guam, and Puerto Rico). Case fatality rate approximates 0.01% in the most recent summary of state reports. One of the limitations of this report is that each state decides how to report the age distribution of COVID-19 cases resulting in variation in age range; another is the data are limited to those details individual states chose to make publicly available.

Although children do not commonly develop severe disease, and the case fatality is low, there are still insights to be learned from understanding risk features for severe disease. Preston et al. reviewed discharge data from 869 medical facilities to describe patients 18 years or younger who had an inpatient or emergency department encounter with a primary or secondary COVID-19 discharge diagnosis from March 1 through October 31, 2020.2 They reported that approximately 2,430 (11.7%) children were hospitalized and 746, nearly 31% of those hospitalized, had severe COVID disease. Those at greatest risk for severe disease were children with comorbid conditions and those less than 12 years, compared with the 12- to 18-year age group. They did not identify race as a risk for severe disease in this study. Moreira et al. described risk factors for morbidity and death from COVID in children less than 18 years of age3 using CDC COVID-NET, the Centers for Disease Control and Prevention COVID-19–associated hospitalization surveillance network. They reported a hospitalization rate of 4.7% among 27,045 cases. They identified three risk factors for hospitalization – age, race/ethnicity, and comorbid conditions. Thirty-nine children (0.19%) died; children who were black, non-Hispanic, and those with an underlying medical condition had a significantly increased risk of death. Thirty-three (85%) children who died had a comorbidity, and 27 (69%) were African American or Hispanic/Latino. The U.S. experience in children is also consistent with reports from the United Kingdom, Italy, Spain, Germany, France, and South Korea.4 Deaths from COVID-19 were uncommon but relatively more frequent in older children, compared with younger age groups among children less than 18 years of age in these countries.

Acute COVID-19 and multisystem inflammatory syndrome in children (MIS-C) do not predominantly target the neurologic systems; however, neurologic complications have been reported, some of which appear to result in long-lasting disability. LaRovere et al. identified 354 (22%) of 1,695 patients less than 21 years of age with acute COVID or MIS-C who had neurologic signs or symptoms during their illness. Among those with neurologic involvement, most children had prior neurologic deficits, mild symptoms, that resolved by the time of discharge. Forty-three (12%) were considered life threatening and included severe encephalopathy, stroke, central nervous system infection/demyelination, Guillain-Barre syndrome or variant, or acute cerebral edema. Several children, including some who were previously healthy prior to COVID, had persistent neurologic deficits at discharge. In addition to neurologic morbidity, long COVID – a syndrome of persistent symptoms following acute COVID that lasts for more than 12 weeks without alternative diagnosis – has also been described in children. Buonsenso et al. assessed 129 children diagnosed with COVID-19 between March and November 2020 in Rome, Italy.5 Persisting symptoms after 120 days were reported by more than 50%. Symptoms like fatigue, muscle and joint pain, headache, insomnia, respiratory problems, and palpitations were most common. Clearly, further follow-up of the long-term outcomes is necessary to understand the full spectrum of morbidity resulting from COVID-19 disease in children and its natural history.

The current picture of COVID infection in children younger than 18 reinforces that children are part of the pandemic. Although deaths in children have now exceeded 300 cases, severe disease remains uncommon in both the United States and western Europe. Risk factors for severe disease include comorbid illness and race/ethnicity with a disproportionate number of severe cases in children with underlying comorbidity and in African American and Hispanic/Latino children. Ongoing surveillance is critical as changes are likely to be observed over time as viral evolution affects disease burden and characteristics.
 

Dr. Pelton is professor of pediatrics and epidemiology at Boston University schools of medicine and public health and senior attending physician in pediatric infectious diseases, Boston Medical Center. Email him at [email protected].

References

1. Children and COVID-19: State-Level Data Report. Services AAP.org.

2. Preston LE et al. JAMA Network Open. 2021;4(4):e215298. doi:10.1001/jamanetworkopen.2021.5298

3. Moreira A et al. Eur J Pediatr. 2021;180:1659-63.

4. SS Bhopal et al. Lancet 2021. doi: 10.1016/ S2352-4642(21)00066-3.

5. Buonsenso D et al. medRxiv preprint. doi: 10.1101/2021.01.23.21250375.

My first thought on this column was maybe Pediatric News has written sufficiently about SARS-CoV-2 infection, and it is time to move on. However, the agenda for the May 12th Advisory Committee on Immunization Practice includes a review of the Pfizer-BioNTech COVID-19 vaccine safety and immunogenicity data for the 12- to 15-year-old age cohort that suggests the potential for vaccine availability and roll out for early adolescents in the near future and the need for up-to-date knowledge about the incidence, severity, and long-term outcome of COVID-19 in the pediatric population.

Dr. Stephen I. Pelton

Updating and summarizing the pediatric experience for the pediatric community on what children and adolescents have experienced because of SARS-CoV-2 infection is critical to address the myriad of questions that will come from colleagues, parents, and adolescents themselves. A great resource, published weekly, is the joint report from the American Academy of Pediatrics and the Children’s Hospital Association.1 As of April 29, 2021, 3,782,724 total child COVID-19 cases have been reported from 49 states, New York City (NYC), the District of Columbia, Guam, and Puerto Rico. Children represent approximately 14% of cases in the United States and not surprisingly are an increasing proportion of total cases as vaccine impact reduces cases among older age groups. Nearly 5% of the pediatric population has already been infected with SARS-CoV-2. Fortunately, compared with adults, hospitalization, severe disease, and mortality remain far lower both in number and proportion than in the adult population. Cumulative hospitalizations from 24 states and NYC total 15,456 (0.8%) among those infected, with 303 deaths reported (from 43 states, NYC, Guam, and Puerto Rico). Case fatality rate approximates 0.01% in the most recent summary of state reports. One of the limitations of this report is that each state decides how to report the age distribution of COVID-19 cases resulting in variation in age range; another is the data are limited to those details individual states chose to make publicly available.

Although children do not commonly develop severe disease, and the case fatality is low, there are still insights to be learned from understanding risk features for severe disease. Preston et al. reviewed discharge data from 869 medical facilities to describe patients 18 years or younger who had an inpatient or emergency department encounter with a primary or secondary COVID-19 discharge diagnosis from March 1 through October 31, 2020.2 They reported that approximately 2,430 (11.7%) children were hospitalized and 746, nearly 31% of those hospitalized, had severe COVID disease. Those at greatest risk for severe disease were children with comorbid conditions and those less than 12 years, compared with the 12- to 18-year age group. They did not identify race as a risk for severe disease in this study. Moreira et al. described risk factors for morbidity and death from COVID in children less than 18 years of age3 using CDC COVID-NET, the Centers for Disease Control and Prevention COVID-19–associated hospitalization surveillance network. They reported a hospitalization rate of 4.7% among 27,045 cases. They identified three risk factors for hospitalization – age, race/ethnicity, and comorbid conditions. Thirty-nine children (0.19%) died; children who were black, non-Hispanic, and those with an underlying medical condition had a significantly increased risk of death. Thirty-three (85%) children who died had a comorbidity, and 27 (69%) were African American or Hispanic/Latino. The U.S. experience in children is also consistent with reports from the United Kingdom, Italy, Spain, Germany, France, and South Korea.4 Deaths from COVID-19 were uncommon but relatively more frequent in older children, compared with younger age groups among children less than 18 years of age in these countries.

Acute COVID-19 and multisystem inflammatory syndrome in children (MIS-C) do not predominantly target the neurologic systems; however, neurologic complications have been reported, some of which appear to result in long-lasting disability. LaRovere et al. identified 354 (22%) of 1,695 patients less than 21 years of age with acute COVID or MIS-C who had neurologic signs or symptoms during their illness. Among those with neurologic involvement, most children had prior neurologic deficits, mild symptoms, that resolved by the time of discharge. Forty-three (12%) were considered life threatening and included severe encephalopathy, stroke, central nervous system infection/demyelination, Guillain-Barre syndrome or variant, or acute cerebral edema. Several children, including some who were previously healthy prior to COVID, had persistent neurologic deficits at discharge. In addition to neurologic morbidity, long COVID – a syndrome of persistent symptoms following acute COVID that lasts for more than 12 weeks without alternative diagnosis – has also been described in children. Buonsenso et al. assessed 129 children diagnosed with COVID-19 between March and November 2020 in Rome, Italy.5 Persisting symptoms after 120 days were reported by more than 50%. Symptoms like fatigue, muscle and joint pain, headache, insomnia, respiratory problems, and palpitations were most common. Clearly, further follow-up of the long-term outcomes is necessary to understand the full spectrum of morbidity resulting from COVID-19 disease in children and its natural history.

The current picture of COVID infection in children younger than 18 reinforces that children are part of the pandemic. Although deaths in children have now exceeded 300 cases, severe disease remains uncommon in both the United States and western Europe. Risk factors for severe disease include comorbid illness and race/ethnicity with a disproportionate number of severe cases in children with underlying comorbidity and in African American and Hispanic/Latino children. Ongoing surveillance is critical as changes are likely to be observed over time as viral evolution affects disease burden and characteristics.
 

Dr. Pelton is professor of pediatrics and epidemiology at Boston University schools of medicine and public health and senior attending physician in pediatric infectious diseases, Boston Medical Center. Email him at [email protected].

References

1. Children and COVID-19: State-Level Data Report. Services AAP.org.

2. Preston LE et al. JAMA Network Open. 2021;4(4):e215298. doi:10.1001/jamanetworkopen.2021.5298

3. Moreira A et al. Eur J Pediatr. 2021;180:1659-63.

4. SS Bhopal et al. Lancet 2021. doi: 10.1016/ S2352-4642(21)00066-3.

5. Buonsenso D et al. medRxiv preprint. doi: 10.1101/2021.01.23.21250375.

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