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Learning about the curve

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Tue, 02/14/2023 - 13:03

Empty shelves that once cradled toilet paper rolls; lines of shoppers, some with masks; waiting 6 feet or at least a shopping cart length apart to get into grocery stores; hazmat-suited workers loading body bags into makeshift mortuaries ... These are the images we have come to associate with the COVID-19 pandemic. But then there also are the graphs and charts, none of them bearing good news. Some are difficult to interpret because they may be missing a key ingredient, such as a scale. Day to day fluctuations in the timeliness of the data points can make valid comparisons impossible. In most cases, it is too early to look at the graphs and hope for the big picture. Whether you are concerned about the stock market or the number of new cases of the virus in your county, you are hoping to see some graphic depiction of a favorable trend.

Richard McMillin/iStock Editorial/Getty Images

We have suddenly learned about the urgency of a process called “flattening the curve.” Are we doing as good a job of flattening as we could be? Are we doing better than France or Spain? Or are we heading toward an Italianesque apocalypse? Who is going to tell us when the flattening is for real and not just a 2- or 3-day statistical aberration?

The curves we are obsessed with today are those showing us new cases and new deaths. But there is another curve that we will need to concentrate on long after the much yearned for flattening of the death curve has been achieved. And we won’t be seeing this curve in four-color graphics on the front page of our newspapers. It is the learning curve, and we want it to be as steep as we can make it without any hint of flattening in the foreseeable future.

We need to learn more about corona-like viruses. Why are some of us more vulnerable? We need to learn more about contagion. Does the 6-foot guideline make any sense? How long are viral particles floating in the air capable of initiating disease? What about air flow and dilution? Can we build a cruise ship or airplane that will be less of a health hazard?

More importantly, we need to learn to be better prepared. Even before the pandemic there have been shortages in intravenous solutions and drugs of critical importance to common diseases. Can we learn how to create reliable and affordable supply chains that allow researchers and developers to make a reasonable profit? Can we relearn to value science? Can we learn to invest more heavily in epidemiology and make it a specialty that attracts our best thinkers and communicators? Then can we elect officials who will share our trust in their recommendations?

Can we do a better job of resolving the tension between those who believe in a strong federal government and those who believe in local autonomy because we are seeing every day that this is an issue of survival, not just coexistence? Can we learn that the globalization that has allowed this viral spread can also be leveraged to beat it into submission?

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

Over the last half century there has been an unfortunate flattening of the learning curve. Ironically we have seen exponential growth among hi-tech industries that have forced us to keep abreast of new developments. But along with this has been a growing skepticism about value of scientific investigation. It is time we climbed back on that steep learning curve. The view gets better the higher we climb.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

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Empty shelves that once cradled toilet paper rolls; lines of shoppers, some with masks; waiting 6 feet or at least a shopping cart length apart to get into grocery stores; hazmat-suited workers loading body bags into makeshift mortuaries ... These are the images we have come to associate with the COVID-19 pandemic. But then there also are the graphs and charts, none of them bearing good news. Some are difficult to interpret because they may be missing a key ingredient, such as a scale. Day to day fluctuations in the timeliness of the data points can make valid comparisons impossible. In most cases, it is too early to look at the graphs and hope for the big picture. Whether you are concerned about the stock market or the number of new cases of the virus in your county, you are hoping to see some graphic depiction of a favorable trend.

Richard McMillin/iStock Editorial/Getty Images

We have suddenly learned about the urgency of a process called “flattening the curve.” Are we doing as good a job of flattening as we could be? Are we doing better than France or Spain? Or are we heading toward an Italianesque apocalypse? Who is going to tell us when the flattening is for real and not just a 2- or 3-day statistical aberration?

The curves we are obsessed with today are those showing us new cases and new deaths. But there is another curve that we will need to concentrate on long after the much yearned for flattening of the death curve has been achieved. And we won’t be seeing this curve in four-color graphics on the front page of our newspapers. It is the learning curve, and we want it to be as steep as we can make it without any hint of flattening in the foreseeable future.

We need to learn more about corona-like viruses. Why are some of us more vulnerable? We need to learn more about contagion. Does the 6-foot guideline make any sense? How long are viral particles floating in the air capable of initiating disease? What about air flow and dilution? Can we build a cruise ship or airplane that will be less of a health hazard?

More importantly, we need to learn to be better prepared. Even before the pandemic there have been shortages in intravenous solutions and drugs of critical importance to common diseases. Can we learn how to create reliable and affordable supply chains that allow researchers and developers to make a reasonable profit? Can we relearn to value science? Can we learn to invest more heavily in epidemiology and make it a specialty that attracts our best thinkers and communicators? Then can we elect officials who will share our trust in their recommendations?

Can we do a better job of resolving the tension between those who believe in a strong federal government and those who believe in local autonomy because we are seeing every day that this is an issue of survival, not just coexistence? Can we learn that the globalization that has allowed this viral spread can also be leveraged to beat it into submission?

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

Over the last half century there has been an unfortunate flattening of the learning curve. Ironically we have seen exponential growth among hi-tech industries that have forced us to keep abreast of new developments. But along with this has been a growing skepticism about value of scientific investigation. It is time we climbed back on that steep learning curve. The view gets better the higher we climb.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

Empty shelves that once cradled toilet paper rolls; lines of shoppers, some with masks; waiting 6 feet or at least a shopping cart length apart to get into grocery stores; hazmat-suited workers loading body bags into makeshift mortuaries ... These are the images we have come to associate with the COVID-19 pandemic. But then there also are the graphs and charts, none of them bearing good news. Some are difficult to interpret because they may be missing a key ingredient, such as a scale. Day to day fluctuations in the timeliness of the data points can make valid comparisons impossible. In most cases, it is too early to look at the graphs and hope for the big picture. Whether you are concerned about the stock market or the number of new cases of the virus in your county, you are hoping to see some graphic depiction of a favorable trend.

Richard McMillin/iStock Editorial/Getty Images

We have suddenly learned about the urgency of a process called “flattening the curve.” Are we doing as good a job of flattening as we could be? Are we doing better than France or Spain? Or are we heading toward an Italianesque apocalypse? Who is going to tell us when the flattening is for real and not just a 2- or 3-day statistical aberration?

The curves we are obsessed with today are those showing us new cases and new deaths. But there is another curve that we will need to concentrate on long after the much yearned for flattening of the death curve has been achieved. And we won’t be seeing this curve in four-color graphics on the front page of our newspapers. It is the learning curve, and we want it to be as steep as we can make it without any hint of flattening in the foreseeable future.

We need to learn more about corona-like viruses. Why are some of us more vulnerable? We need to learn more about contagion. Does the 6-foot guideline make any sense? How long are viral particles floating in the air capable of initiating disease? What about air flow and dilution? Can we build a cruise ship or airplane that will be less of a health hazard?

More importantly, we need to learn to be better prepared. Even before the pandemic there have been shortages in intravenous solutions and drugs of critical importance to common diseases. Can we learn how to create reliable and affordable supply chains that allow researchers and developers to make a reasonable profit? Can we relearn to value science? Can we learn to invest more heavily in epidemiology and make it a specialty that attracts our best thinkers and communicators? Then can we elect officials who will share our trust in their recommendations?

Can we do a better job of resolving the tension between those who believe in a strong federal government and those who believe in local autonomy because we are seeing every day that this is an issue of survival, not just coexistence? Can we learn that the globalization that has allowed this viral spread can also be leveraged to beat it into submission?

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

Over the last half century there has been an unfortunate flattening of the learning curve. Ironically we have seen exponential growth among hi-tech industries that have forced us to keep abreast of new developments. But along with this has been a growing skepticism about value of scientific investigation. It is time we climbed back on that steep learning curve. The view gets better the higher we climb.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

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Resources for LGBTQ youth during challenging times

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Tue, 02/14/2023 - 13:03

If you are anything like me, March 1 came and went as just another first day of the month. Few of us could have imagined that our day-to-day way of life would soon be upended, and our country would be in the midst of the COVID-19 pandemic. While there is considerable anxiety around protecting our individual health, social distancing and the physical isolation that comes from it have cut off a vital source of support for many of our lesbian, gay, bisexual, transgender, and questioning (or queer) (LGBTQ) youth. Shared experiences with other young people like themselves provide these youth with a sense of community that they may not find in their schools, towns, etc.

LGBTQ youth already face increased rates of anxiety and depression compared with their heterosexual and cisgender peers. According to the 2017 Youth Risk Behavior Survey, 63% of LGB youth nationwide reported feeling sad or hopeless compared with 28% of their heterosexual peers. While quarantined at home, many of these youth now are stuck for many more hours per day with families who may not accept them for who they are. Previous research by Ryan et al. shows that LGB adolescents who have higher rates of family rejection are nearly six times more likely to have higher rates of depression and more than eight times more likely to attempt suicide than their peers who come from families with low or no levels of rejection (Pediatrics. 2009 Jan;123[1]:346-52). Going to school for roughly 8 hours a day allows some of these youth an escape from what is otherwise an unpleasant home situation. In addition, educators and other school staff may be among the only allies that a student has in his/her life, and school cancellations remove students from access to these important people.

AJ_Watt/E+

Due to stay-at-home orders and physical distancing measures, lack of in-person access to medical and psychological care can be distressing for many LGBTQ youth. While many practices have been able to convert to audiovisual telemedicine visits, not all of them have the resources or capability to do so. Consequently, LGBTQ youth may have reduced access to support services that help to bolster their social and emotional health. In addition, many trans youth suffer from physical dysphoria that can make it distressing to see themselves on camera doing teletherapy and so they wish to avoid it for this reason.

This is not to say that everything is bleak. LGBTQ youth can also be resilient in times of stress and worry. “The LGBTQ community has a long history of overcoming adversity and utilizing challenges to build an even stronger sense of community. This pandemic will create yet another opportunity for us to highlight existing health disparities and to support our LGBTQ young people in finding creative responses,” said Heather Newby, LCSW, clinical social worker for the GENECIS (GENder Education and Care Interdisciplinary Support) Program at Children’s Medical Center Dallas. In addition, she reported that many LGBTQ advocacy groups have created excellent online support networks and resources to provide nationwide, regional, and local help. By leveraging these youths’ capability for resilience, we are best able to support them during a time of crisis.

During these challenging times, there are a number of resources that LGBTQ youth can turn to while trying to maintain their connection to their peers. First, many local LGBTQ service organizations have moved their in-person support groups to a virtual or online platform. Check with your local service organization to see what they are offering during these times. National organizations, such as Gender Spectrum, continue to have online groups as well that youth can participate in. Second, many virtual mental health helplines, such as those through the Trevor Project, remain staffed should LGBTQ youth need to access their services (1-866-488-7386, plus text and chat). They can be reached 24/7 to help those whose mental health has been affected during this pandemic. Third, youth can continue to stay connected to their friends through means such as Zoom, FaceTime, or other virtual audiovisual tools. Lastly, some youth have taken to meeting in school parking lots, mall parking lots, etc., and staying at least 6 feet apart so that they can still see their friends in person.

Dr. M. Brett Cooper

While the current times may be challenging, they will pass and we will be able to return to those activities that bring us joy. Do not hesitate to reach out if you need help. As Rainer Maria Rilke once said, “In the difficult, we must have our joys, our happiness, our dreams: There against the depth of this background, they stand out, there for the first time we see how beautiful they are.”
 

Dr. Cooper is assistant professor of pediatrics at University of Texas Southwestern, Dallas, and an adolescent medicine specialist at Children’s Medical Center Dallas. He has no relevant financial disclosures. Dr. Cooper is on Twitter @teendocmbc. Email him at [email protected].

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If you are anything like me, March 1 came and went as just another first day of the month. Few of us could have imagined that our day-to-day way of life would soon be upended, and our country would be in the midst of the COVID-19 pandemic. While there is considerable anxiety around protecting our individual health, social distancing and the physical isolation that comes from it have cut off a vital source of support for many of our lesbian, gay, bisexual, transgender, and questioning (or queer) (LGBTQ) youth. Shared experiences with other young people like themselves provide these youth with a sense of community that they may not find in their schools, towns, etc.

LGBTQ youth already face increased rates of anxiety and depression compared with their heterosexual and cisgender peers. According to the 2017 Youth Risk Behavior Survey, 63% of LGB youth nationwide reported feeling sad or hopeless compared with 28% of their heterosexual peers. While quarantined at home, many of these youth now are stuck for many more hours per day with families who may not accept them for who they are. Previous research by Ryan et al. shows that LGB adolescents who have higher rates of family rejection are nearly six times more likely to have higher rates of depression and more than eight times more likely to attempt suicide than their peers who come from families with low or no levels of rejection (Pediatrics. 2009 Jan;123[1]:346-52). Going to school for roughly 8 hours a day allows some of these youth an escape from what is otherwise an unpleasant home situation. In addition, educators and other school staff may be among the only allies that a student has in his/her life, and school cancellations remove students from access to these important people.

AJ_Watt/E+

Due to stay-at-home orders and physical distancing measures, lack of in-person access to medical and psychological care can be distressing for many LGBTQ youth. While many practices have been able to convert to audiovisual telemedicine visits, not all of them have the resources or capability to do so. Consequently, LGBTQ youth may have reduced access to support services that help to bolster their social and emotional health. In addition, many trans youth suffer from physical dysphoria that can make it distressing to see themselves on camera doing teletherapy and so they wish to avoid it for this reason.

This is not to say that everything is bleak. LGBTQ youth can also be resilient in times of stress and worry. “The LGBTQ community has a long history of overcoming adversity and utilizing challenges to build an even stronger sense of community. This pandemic will create yet another opportunity for us to highlight existing health disparities and to support our LGBTQ young people in finding creative responses,” said Heather Newby, LCSW, clinical social worker for the GENECIS (GENder Education and Care Interdisciplinary Support) Program at Children’s Medical Center Dallas. In addition, she reported that many LGBTQ advocacy groups have created excellent online support networks and resources to provide nationwide, regional, and local help. By leveraging these youths’ capability for resilience, we are best able to support them during a time of crisis.

During these challenging times, there are a number of resources that LGBTQ youth can turn to while trying to maintain their connection to their peers. First, many local LGBTQ service organizations have moved their in-person support groups to a virtual or online platform. Check with your local service organization to see what they are offering during these times. National organizations, such as Gender Spectrum, continue to have online groups as well that youth can participate in. Second, many virtual mental health helplines, such as those through the Trevor Project, remain staffed should LGBTQ youth need to access their services (1-866-488-7386, plus text and chat). They can be reached 24/7 to help those whose mental health has been affected during this pandemic. Third, youth can continue to stay connected to their friends through means such as Zoom, FaceTime, or other virtual audiovisual tools. Lastly, some youth have taken to meeting in school parking lots, mall parking lots, etc., and staying at least 6 feet apart so that they can still see their friends in person.

Dr. M. Brett Cooper

While the current times may be challenging, they will pass and we will be able to return to those activities that bring us joy. Do not hesitate to reach out if you need help. As Rainer Maria Rilke once said, “In the difficult, we must have our joys, our happiness, our dreams: There against the depth of this background, they stand out, there for the first time we see how beautiful they are.”
 

Dr. Cooper is assistant professor of pediatrics at University of Texas Southwestern, Dallas, and an adolescent medicine specialist at Children’s Medical Center Dallas. He has no relevant financial disclosures. Dr. Cooper is on Twitter @teendocmbc. Email him at [email protected].

If you are anything like me, March 1 came and went as just another first day of the month. Few of us could have imagined that our day-to-day way of life would soon be upended, and our country would be in the midst of the COVID-19 pandemic. While there is considerable anxiety around protecting our individual health, social distancing and the physical isolation that comes from it have cut off a vital source of support for many of our lesbian, gay, bisexual, transgender, and questioning (or queer) (LGBTQ) youth. Shared experiences with other young people like themselves provide these youth with a sense of community that they may not find in their schools, towns, etc.

LGBTQ youth already face increased rates of anxiety and depression compared with their heterosexual and cisgender peers. According to the 2017 Youth Risk Behavior Survey, 63% of LGB youth nationwide reported feeling sad or hopeless compared with 28% of their heterosexual peers. While quarantined at home, many of these youth now are stuck for many more hours per day with families who may not accept them for who they are. Previous research by Ryan et al. shows that LGB adolescents who have higher rates of family rejection are nearly six times more likely to have higher rates of depression and more than eight times more likely to attempt suicide than their peers who come from families with low or no levels of rejection (Pediatrics. 2009 Jan;123[1]:346-52). Going to school for roughly 8 hours a day allows some of these youth an escape from what is otherwise an unpleasant home situation. In addition, educators and other school staff may be among the only allies that a student has in his/her life, and school cancellations remove students from access to these important people.

AJ_Watt/E+

Due to stay-at-home orders and physical distancing measures, lack of in-person access to medical and psychological care can be distressing for many LGBTQ youth. While many practices have been able to convert to audiovisual telemedicine visits, not all of them have the resources or capability to do so. Consequently, LGBTQ youth may have reduced access to support services that help to bolster their social and emotional health. In addition, many trans youth suffer from physical dysphoria that can make it distressing to see themselves on camera doing teletherapy and so they wish to avoid it for this reason.

This is not to say that everything is bleak. LGBTQ youth can also be resilient in times of stress and worry. “The LGBTQ community has a long history of overcoming adversity and utilizing challenges to build an even stronger sense of community. This pandemic will create yet another opportunity for us to highlight existing health disparities and to support our LGBTQ young people in finding creative responses,” said Heather Newby, LCSW, clinical social worker for the GENECIS (GENder Education and Care Interdisciplinary Support) Program at Children’s Medical Center Dallas. In addition, she reported that many LGBTQ advocacy groups have created excellent online support networks and resources to provide nationwide, regional, and local help. By leveraging these youths’ capability for resilience, we are best able to support them during a time of crisis.

During these challenging times, there are a number of resources that LGBTQ youth can turn to while trying to maintain their connection to their peers. First, many local LGBTQ service organizations have moved their in-person support groups to a virtual or online platform. Check with your local service organization to see what they are offering during these times. National organizations, such as Gender Spectrum, continue to have online groups as well that youth can participate in. Second, many virtual mental health helplines, such as those through the Trevor Project, remain staffed should LGBTQ youth need to access their services (1-866-488-7386, plus text and chat). They can be reached 24/7 to help those whose mental health has been affected during this pandemic. Third, youth can continue to stay connected to their friends through means such as Zoom, FaceTime, or other virtual audiovisual tools. Lastly, some youth have taken to meeting in school parking lots, mall parking lots, etc., and staying at least 6 feet apart so that they can still see their friends in person.

Dr. M. Brett Cooper

While the current times may be challenging, they will pass and we will be able to return to those activities that bring us joy. Do not hesitate to reach out if you need help. As Rainer Maria Rilke once said, “In the difficult, we must have our joys, our happiness, our dreams: There against the depth of this background, they stand out, there for the first time we see how beautiful they are.”
 

Dr. Cooper is assistant professor of pediatrics at University of Texas Southwestern, Dallas, and an adolescent medicine specialist at Children’s Medical Center Dallas. He has no relevant financial disclosures. Dr. Cooper is on Twitter @teendocmbc. Email him at [email protected].

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COVID-19 pandemic brings unexpected pediatric consequences

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As physicians and advanced practitioners, we have been preparing to face COVID-19 – anticipating increasing volumes of patients with fevers, cough, and shortness of breath, and potential surges in emergency departments (EDs) and primary care offices. Fortunately, while COVID-19 has demonstrated more mild symptoms in pediatric patients, the heightened public health fears and mandated social isolation have created some unforeseen consequences for pediatric patients. This article presents cases encountered over the course of 2 weeks in our ED that shed light on the unexpected ramifications of living in the time of a pandemic. These encounters should remind us as providers to be diligent and thorough in giving guidance to families during a time when face-to-face medicine has become increasingly difficult and limited.

These stories have been modified to protect patient confidentiality.

recep-bg/E+/Getty Images

Case 1

A 2-week-old full-term infant arrived in the ED after having a fever for 48 hours. The patient’s mother reported that she had called the pediatrician yesterday to ask for advice on treating the fever and was instructed to give acetaminophen and bring the infant into the ED for testing.

When we asked mom why she did not bring the infant in yesterday, she stated that the fever went down with acetaminophen, and the baby was drinking well and urinating normally. Mostly, she was afraid to bring the child into the ED given concern for COVID-19; however, when the fever persisted today, she came in. During the work-up, the infant was noted to have focal seizures and was ultimately diagnosed with bacterial meningitis.

Takeaway: Families may be hesitant to follow pediatrician’s advice to seek medical attention at an ED or doctor’s office because of the fear of being exposed to COVID-19.

  • If something is urgent or emergent, be sure to stress the importance to families that the advice is non-negotiable for their child’s health.
  • Attempt to call ahead for patients who might be more vulnerable in waiting rooms or overcrowded hospitals.

Case 2

A 5-month-old baby presented to the ED with new-onset seizures. Immediate bedside blood work performed demonstrated a normal blood glucose, but the baby was profoundly hyponatremic. Upon asking the mother if the baby has had any vomiting, diarrhea, or difficulty tolerating feeds, she says that she has been diluting formula because all the stores were out of formula. Today, she gave the baby plain water because they were completely out of formula.

Takeaway: With economists estimating unemployment rates in the United States at 13% at press time (the worst since the Great Depression), many families may lack resources to purchase necessities.

  • Even if families have the ability to purchase necessities, they may be difficult to find or unavailable (e.g., formula, medications, diapers).
  • Consider reaching out to patients in your practice to ask about their ability to find essentials and with advice on what to do if they run out of formula or diapers, or who they should contact if they cannot refill a medication.
  • Are you in a position to speak with your mayor or local council to ensure there are regulations on the hoarding of essential items?
  • In a time when breast milk or formula is not available for children younger than 1 year of age, what will you recommend for families? There are no current American Academy of Pediatrics’ guidelines.

Case 3

A school-aged girl was helping her mother sanitize the home during the COVID-19 pandemic. She had her gloves on, her commercial antiseptic cleaner ready to go, but it was not spraying. She turned the bottle around to check the nozzle and sprayed herself in the eyes. The family presented to the ED for alkaline burn to her eyes, which required copious irrigation.

Takeaway: Children are spending more time in the house with access to button batteries, choking hazards, and cleaning supplies.

  • Cleaning products can cause chemical burns. These products should not be used by young children.

Dr. Angelica Despain

Case 4

A school-aged boy arrived via emergency medical services (EMS) for altered mental status. He told his father he was feeling dizzy and then lost consciousness. EMS noticed that he had some tonic movements of his lower extremities, and when he arrived in the ED, he had eye deviation and was unresponsive.

Work-up ultimately demonstrated that this patient had a seizure and a dangerously elevated ethanol level from drinking an entire bottle of hand sanitizer. Hand sanitizer may contain high concentrations of ethyl alcohol or isopropyl alcohol, which when ingested can cause intoxication or poisoning.

Takeaway: Many products that we may view as harmless can be toxic if ingested in large amounts.

  • Consider making a list of products that families may have acquired and have around the home during this COVID-19 pandemic and instruct families to make sure dangerous items (e.g., acetaminophen, aspirin, hand sanitizer, lighters, firearms, batteries) are locked up and/or out of reach of children.
  • Make sure families know the Poison Control phone number (800-222-1222).
     

     

Case 5

An adolescent female currently being treated with immunosuppressants arrived from home with fever. Her medical history revealed that the patient’s guardian recently passed away from suspected COVID-19. The patient was tested and is herself found to be positive for COVID-19. The patient is currently being cared for by relatives who also live in the same home. They require extensive education and teaching regarding the patient’s medication regimen, while also dealing with the loss of their loved one and the fear of personal exposure.

Takeaway: Communicate with families – especially those with special health care needs – about issues of guardianship in case a child’s primary caretaker falls ill.

  • Discuss with families about having easily accessible lists of medications and medical conditions.
  • Involve social work and child life specialists to help children and their families deal with life-altering changes and losses suffered during this time, as well as fears related to mortality and exposure.

Case 6

A 3-year-old boy arrived covered in bruises and complaining of stomachache. While the mother denies any known abuse, she states that her significant other has been getting more and more “worked up having to deal with the child’s behavior all day every day.” The preschool the child previously attended has closed due to the pandemic.

Takeaway: Abuse is more common when the parents perceive that there is little community support and when families feel a lack of connection to the community.1 Huang et al. examined the relationship between the economy and nonaccidental trauma, showing a doubling in the rate of nonaccidental head trauma during economic recession.2

  • Allow families to know that they are not alone and that child care is difficult
  • Offer advice on what caretakers can do if they feel alone or at their mental or physical limit.
  • Provide strategies on your practice’s website if a situation at home becomes tense and strained.

Dr. Rachel Hatcliffe

Case 7

An adolescent female arrived to the ED with increased suicidality. She normally follows with her psychiatrist once a month and her therapist once a week. Since the beginning of COVID-19 restrictions, she has been using telemedicine for her therapy visits. While previously doing well, she reports that her suicidal ideations have worsened because of feeling isolated from her friends now that school is out and she is not allowed to see them. Although compliant with her medications, her thoughts have increased to the point where she has to be admitted to inpatient psychiatry.

Takeaway: Anxiety, depression, and suicide may increase in a down economy. After the 2008 global economic crisis, rates of suicide drastically increased.3

  • Recognize the limitations of telemedicine (technology limitations, patient cooperation, etc.)
  • Social isolation may contribute to worsening mental health
  • Know when to advise patients to seek in-person evaluation and care for medical and mental health concerns.

Pediatricians are at the forefront of preventative medicine. Families rely on pediatricians for trustworthy and accurate anticipatory guidance, a need that is only heightened during times of local and national stress. The social isolation, fear, and lack of resources accompanying this pandemic have serious consequences for our families. What can you and your practice do to keep children safe in the time of COVID-19?

Dr. Angelica DesPain is a pediatric emergency medicine fellow at Children’s National Hospital in Washington. Dr. Rachel Hatcliffe is an attending physician at the hospital. Neither physician had any relevant financial disclosures. Email Dr. DesPain and/or Dr. Hatcliffe at [email protected].

References

1. Child Dev. 1978;49:604-16.

2. J Neurosurg Pediatr 2011 Aug;8(2):171-6.

3. BMJ 2013;347:f5239.

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As physicians and advanced practitioners, we have been preparing to face COVID-19 – anticipating increasing volumes of patients with fevers, cough, and shortness of breath, and potential surges in emergency departments (EDs) and primary care offices. Fortunately, while COVID-19 has demonstrated more mild symptoms in pediatric patients, the heightened public health fears and mandated social isolation have created some unforeseen consequences for pediatric patients. This article presents cases encountered over the course of 2 weeks in our ED that shed light on the unexpected ramifications of living in the time of a pandemic. These encounters should remind us as providers to be diligent and thorough in giving guidance to families during a time when face-to-face medicine has become increasingly difficult and limited.

These stories have been modified to protect patient confidentiality.

recep-bg/E+/Getty Images

Case 1

A 2-week-old full-term infant arrived in the ED after having a fever for 48 hours. The patient’s mother reported that she had called the pediatrician yesterday to ask for advice on treating the fever and was instructed to give acetaminophen and bring the infant into the ED for testing.

When we asked mom why she did not bring the infant in yesterday, she stated that the fever went down with acetaminophen, and the baby was drinking well and urinating normally. Mostly, she was afraid to bring the child into the ED given concern for COVID-19; however, when the fever persisted today, she came in. During the work-up, the infant was noted to have focal seizures and was ultimately diagnosed with bacterial meningitis.

Takeaway: Families may be hesitant to follow pediatrician’s advice to seek medical attention at an ED or doctor’s office because of the fear of being exposed to COVID-19.

  • If something is urgent or emergent, be sure to stress the importance to families that the advice is non-negotiable for their child’s health.
  • Attempt to call ahead for patients who might be more vulnerable in waiting rooms or overcrowded hospitals.

Case 2

A 5-month-old baby presented to the ED with new-onset seizures. Immediate bedside blood work performed demonstrated a normal blood glucose, but the baby was profoundly hyponatremic. Upon asking the mother if the baby has had any vomiting, diarrhea, or difficulty tolerating feeds, she says that she has been diluting formula because all the stores were out of formula. Today, she gave the baby plain water because they were completely out of formula.

Takeaway: With economists estimating unemployment rates in the United States at 13% at press time (the worst since the Great Depression), many families may lack resources to purchase necessities.

  • Even if families have the ability to purchase necessities, they may be difficult to find or unavailable (e.g., formula, medications, diapers).
  • Consider reaching out to patients in your practice to ask about their ability to find essentials and with advice on what to do if they run out of formula or diapers, or who they should contact if they cannot refill a medication.
  • Are you in a position to speak with your mayor or local council to ensure there are regulations on the hoarding of essential items?
  • In a time when breast milk or formula is not available for children younger than 1 year of age, what will you recommend for families? There are no current American Academy of Pediatrics’ guidelines.

Case 3

A school-aged girl was helping her mother sanitize the home during the COVID-19 pandemic. She had her gloves on, her commercial antiseptic cleaner ready to go, but it was not spraying. She turned the bottle around to check the nozzle and sprayed herself in the eyes. The family presented to the ED for alkaline burn to her eyes, which required copious irrigation.

Takeaway: Children are spending more time in the house with access to button batteries, choking hazards, and cleaning supplies.

  • Cleaning products can cause chemical burns. These products should not be used by young children.

Dr. Angelica Despain

Case 4

A school-aged boy arrived via emergency medical services (EMS) for altered mental status. He told his father he was feeling dizzy and then lost consciousness. EMS noticed that he had some tonic movements of his lower extremities, and when he arrived in the ED, he had eye deviation and was unresponsive.

Work-up ultimately demonstrated that this patient had a seizure and a dangerously elevated ethanol level from drinking an entire bottle of hand sanitizer. Hand sanitizer may contain high concentrations of ethyl alcohol or isopropyl alcohol, which when ingested can cause intoxication or poisoning.

Takeaway: Many products that we may view as harmless can be toxic if ingested in large amounts.

  • Consider making a list of products that families may have acquired and have around the home during this COVID-19 pandemic and instruct families to make sure dangerous items (e.g., acetaminophen, aspirin, hand sanitizer, lighters, firearms, batteries) are locked up and/or out of reach of children.
  • Make sure families know the Poison Control phone number (800-222-1222).
     

     

Case 5

An adolescent female currently being treated with immunosuppressants arrived from home with fever. Her medical history revealed that the patient’s guardian recently passed away from suspected COVID-19. The patient was tested and is herself found to be positive for COVID-19. The patient is currently being cared for by relatives who also live in the same home. They require extensive education and teaching regarding the patient’s medication regimen, while also dealing with the loss of their loved one and the fear of personal exposure.

Takeaway: Communicate with families – especially those with special health care needs – about issues of guardianship in case a child’s primary caretaker falls ill.

  • Discuss with families about having easily accessible lists of medications and medical conditions.
  • Involve social work and child life specialists to help children and their families deal with life-altering changes and losses suffered during this time, as well as fears related to mortality and exposure.

Case 6

A 3-year-old boy arrived covered in bruises and complaining of stomachache. While the mother denies any known abuse, she states that her significant other has been getting more and more “worked up having to deal with the child’s behavior all day every day.” The preschool the child previously attended has closed due to the pandemic.

Takeaway: Abuse is more common when the parents perceive that there is little community support and when families feel a lack of connection to the community.1 Huang et al. examined the relationship between the economy and nonaccidental trauma, showing a doubling in the rate of nonaccidental head trauma during economic recession.2

  • Allow families to know that they are not alone and that child care is difficult
  • Offer advice on what caretakers can do if they feel alone or at their mental or physical limit.
  • Provide strategies on your practice’s website if a situation at home becomes tense and strained.

Dr. Rachel Hatcliffe

Case 7

An adolescent female arrived to the ED with increased suicidality. She normally follows with her psychiatrist once a month and her therapist once a week. Since the beginning of COVID-19 restrictions, she has been using telemedicine for her therapy visits. While previously doing well, she reports that her suicidal ideations have worsened because of feeling isolated from her friends now that school is out and she is not allowed to see them. Although compliant with her medications, her thoughts have increased to the point where she has to be admitted to inpatient psychiatry.

Takeaway: Anxiety, depression, and suicide may increase in a down economy. After the 2008 global economic crisis, rates of suicide drastically increased.3

  • Recognize the limitations of telemedicine (technology limitations, patient cooperation, etc.)
  • Social isolation may contribute to worsening mental health
  • Know when to advise patients to seek in-person evaluation and care for medical and mental health concerns.

Pediatricians are at the forefront of preventative medicine. Families rely on pediatricians for trustworthy and accurate anticipatory guidance, a need that is only heightened during times of local and national stress. The social isolation, fear, and lack of resources accompanying this pandemic have serious consequences for our families. What can you and your practice do to keep children safe in the time of COVID-19?

Dr. Angelica DesPain is a pediatric emergency medicine fellow at Children’s National Hospital in Washington. Dr. Rachel Hatcliffe is an attending physician at the hospital. Neither physician had any relevant financial disclosures. Email Dr. DesPain and/or Dr. Hatcliffe at [email protected].

References

1. Child Dev. 1978;49:604-16.

2. J Neurosurg Pediatr 2011 Aug;8(2):171-6.

3. BMJ 2013;347:f5239.

As physicians and advanced practitioners, we have been preparing to face COVID-19 – anticipating increasing volumes of patients with fevers, cough, and shortness of breath, and potential surges in emergency departments (EDs) and primary care offices. Fortunately, while COVID-19 has demonstrated more mild symptoms in pediatric patients, the heightened public health fears and mandated social isolation have created some unforeseen consequences for pediatric patients. This article presents cases encountered over the course of 2 weeks in our ED that shed light on the unexpected ramifications of living in the time of a pandemic. These encounters should remind us as providers to be diligent and thorough in giving guidance to families during a time when face-to-face medicine has become increasingly difficult and limited.

These stories have been modified to protect patient confidentiality.

recep-bg/E+/Getty Images

Case 1

A 2-week-old full-term infant arrived in the ED after having a fever for 48 hours. The patient’s mother reported that she had called the pediatrician yesterday to ask for advice on treating the fever and was instructed to give acetaminophen and bring the infant into the ED for testing.

When we asked mom why she did not bring the infant in yesterday, she stated that the fever went down with acetaminophen, and the baby was drinking well and urinating normally. Mostly, she was afraid to bring the child into the ED given concern for COVID-19; however, when the fever persisted today, she came in. During the work-up, the infant was noted to have focal seizures and was ultimately diagnosed with bacterial meningitis.

Takeaway: Families may be hesitant to follow pediatrician’s advice to seek medical attention at an ED or doctor’s office because of the fear of being exposed to COVID-19.

  • If something is urgent or emergent, be sure to stress the importance to families that the advice is non-negotiable for their child’s health.
  • Attempt to call ahead for patients who might be more vulnerable in waiting rooms or overcrowded hospitals.

Case 2

A 5-month-old baby presented to the ED with new-onset seizures. Immediate bedside blood work performed demonstrated a normal blood glucose, but the baby was profoundly hyponatremic. Upon asking the mother if the baby has had any vomiting, diarrhea, or difficulty tolerating feeds, she says that she has been diluting formula because all the stores were out of formula. Today, she gave the baby plain water because they were completely out of formula.

Takeaway: With economists estimating unemployment rates in the United States at 13% at press time (the worst since the Great Depression), many families may lack resources to purchase necessities.

  • Even if families have the ability to purchase necessities, they may be difficult to find or unavailable (e.g., formula, medications, diapers).
  • Consider reaching out to patients in your practice to ask about their ability to find essentials and with advice on what to do if they run out of formula or diapers, or who they should contact if they cannot refill a medication.
  • Are you in a position to speak with your mayor or local council to ensure there are regulations on the hoarding of essential items?
  • In a time when breast milk or formula is not available for children younger than 1 year of age, what will you recommend for families? There are no current American Academy of Pediatrics’ guidelines.

Case 3

A school-aged girl was helping her mother sanitize the home during the COVID-19 pandemic. She had her gloves on, her commercial antiseptic cleaner ready to go, but it was not spraying. She turned the bottle around to check the nozzle and sprayed herself in the eyes. The family presented to the ED for alkaline burn to her eyes, which required copious irrigation.

Takeaway: Children are spending more time in the house with access to button batteries, choking hazards, and cleaning supplies.

  • Cleaning products can cause chemical burns. These products should not be used by young children.

Dr. Angelica Despain

Case 4

A school-aged boy arrived via emergency medical services (EMS) for altered mental status. He told his father he was feeling dizzy and then lost consciousness. EMS noticed that he had some tonic movements of his lower extremities, and when he arrived in the ED, he had eye deviation and was unresponsive.

Work-up ultimately demonstrated that this patient had a seizure and a dangerously elevated ethanol level from drinking an entire bottle of hand sanitizer. Hand sanitizer may contain high concentrations of ethyl alcohol or isopropyl alcohol, which when ingested can cause intoxication or poisoning.

Takeaway: Many products that we may view as harmless can be toxic if ingested in large amounts.

  • Consider making a list of products that families may have acquired and have around the home during this COVID-19 pandemic and instruct families to make sure dangerous items (e.g., acetaminophen, aspirin, hand sanitizer, lighters, firearms, batteries) are locked up and/or out of reach of children.
  • Make sure families know the Poison Control phone number (800-222-1222).
     

     

Case 5

An adolescent female currently being treated with immunosuppressants arrived from home with fever. Her medical history revealed that the patient’s guardian recently passed away from suspected COVID-19. The patient was tested and is herself found to be positive for COVID-19. The patient is currently being cared for by relatives who also live in the same home. They require extensive education and teaching regarding the patient’s medication regimen, while also dealing with the loss of their loved one and the fear of personal exposure.

Takeaway: Communicate with families – especially those with special health care needs – about issues of guardianship in case a child’s primary caretaker falls ill.

  • Discuss with families about having easily accessible lists of medications and medical conditions.
  • Involve social work and child life specialists to help children and their families deal with life-altering changes and losses suffered during this time, as well as fears related to mortality and exposure.

Case 6

A 3-year-old boy arrived covered in bruises and complaining of stomachache. While the mother denies any known abuse, she states that her significant other has been getting more and more “worked up having to deal with the child’s behavior all day every day.” The preschool the child previously attended has closed due to the pandemic.

Takeaway: Abuse is more common when the parents perceive that there is little community support and when families feel a lack of connection to the community.1 Huang et al. examined the relationship between the economy and nonaccidental trauma, showing a doubling in the rate of nonaccidental head trauma during economic recession.2

  • Allow families to know that they are not alone and that child care is difficult
  • Offer advice on what caretakers can do if they feel alone or at their mental or physical limit.
  • Provide strategies on your practice’s website if a situation at home becomes tense and strained.

Dr. Rachel Hatcliffe

Case 7

An adolescent female arrived to the ED with increased suicidality. She normally follows with her psychiatrist once a month and her therapist once a week. Since the beginning of COVID-19 restrictions, she has been using telemedicine for her therapy visits. While previously doing well, she reports that her suicidal ideations have worsened because of feeling isolated from her friends now that school is out and she is not allowed to see them. Although compliant with her medications, her thoughts have increased to the point where she has to be admitted to inpatient psychiatry.

Takeaway: Anxiety, depression, and suicide may increase in a down economy. After the 2008 global economic crisis, rates of suicide drastically increased.3

  • Recognize the limitations of telemedicine (technology limitations, patient cooperation, etc.)
  • Social isolation may contribute to worsening mental health
  • Know when to advise patients to seek in-person evaluation and care for medical and mental health concerns.

Pediatricians are at the forefront of preventative medicine. Families rely on pediatricians for trustworthy and accurate anticipatory guidance, a need that is only heightened during times of local and national stress. The social isolation, fear, and lack of resources accompanying this pandemic have serious consequences for our families. What can you and your practice do to keep children safe in the time of COVID-19?

Dr. Angelica DesPain is a pediatric emergency medicine fellow at Children’s National Hospital in Washington. Dr. Rachel Hatcliffe is an attending physician at the hospital. Neither physician had any relevant financial disclosures. Email Dr. DesPain and/or Dr. Hatcliffe at [email protected].

References

1. Child Dev. 1978;49:604-16.

2. J Neurosurg Pediatr 2011 Aug;8(2):171-6.

3. BMJ 2013;347:f5239.

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Managing gynecologic cancers during the COVID-19 pandemic

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To manage patients with gynecologic cancers, oncologists in the United States and Europe are recommending reducing outpatient visits, delaying surgeries, prolonging chemotherapy regimens, and generally trying to keep cancer patients away from those who have tested positive for COVID-19.

“We recognize that, in this special situation, we must continue to provide our gynecologic oncology patients with the highest quality of medical services,” Pedro T. Ramirez, MD, of the University of Texas MD Anderson Cancer Center in Houston and associates wrote in an editorial published in the International Journal of Gynecological Cancer.

At the same time, the authors added, the safety of patients, their families, and medical staff needs to be assured.

Dr. Ramirez and colleagues’ editorial includes recommendations on how to optimize the care of patients with gynecologic cancers while prioritizing safety and minimizing the burden to the healthcare system. The group’s recommendations outline when surgery, radiotherapy, and other treatments might be safely postponed and when they need to proceed out of urgency.

Some authors of the editorial also described their experiences with COVID-19 during a webinar on managing patients with advanced ovarian cancer, which was hosted by the European Society of Gynaecological Oncology (ESGO).
 

A lack of resources

In Spain, health resources “are collapsed” by the pandemic, editorial author Luis Chiva, MD, said during the webinar.

At his institution, the Clínica Universidad de Navarra in Madrid, 98% of the 1,500 intensive care beds were occupied by COVID-19 patients at the end of March. So the hope was to be able to refer their patients to other communities where there may still be some capacity.

Another problem in Spain is the high percentage of health workers infected with SARS-CoV-2, the virus behind COVID-19. More than 15,000 health workers were recently reported to be sick or self-isolating, which is around 14% of the health care workforce in the country.

Dr. Chiva noted that this puts those treating gynecologic cancers in a difficult position. On the one hand, surgery to remove a high-risk ovarian mass should not be delayed, but the majority of hospitals in Spain simply cannot perform this type of surgery during the pandemic.

“Unfortunately, due to this specific situation, almost, I would say in 80%-90% of hospitals, we are only able to carry out emergency surgical procedures,” Dr. Chiva said. That’s general emergency procedures such as appendectomies, removing blockages, and dealing with hemorrhages, not gynecologic surgeries. “It’s almost impossible to schedule the typical oncological cases,” he said.

Even with the Hospital IFEMA now set up at the Feria de Madrid, which is usually used to host large-scale events, there are “minimal options for performing standard oncological surgery,” Dr. Chiva said. He estimated that just 5% of hospitals in Spain are able to perform oncologic surgeries as normal, with maybe 15% able to offer surgery without the backup of postsurgical intensive care.
 

‘Ring-fencing’

“This is really an unusual time for us,” commented Jonathan Ledermann, MD, vice president of ESGO and a professor of medical oncology at University College London, who moderated the webinar.

 

 

“This is affecting the way in which we diagnose our patients and have access to care,” he said. “It compromises the way in which we treat patients. We have to adjust our treatment pathways. We have to look at the risks of coronavirus infection in cancer patients and how we manage patients in a socially distancing environment. We also need to think about managing gynecological oncology departments in the face of disease amongst staff, the risks of transmission, and the reduced clinical service.”

Dr. Ledermann noted that “ring-fencing” a few hospitals to deal only with patients free of COVID-19 might be a way forward. This approach has been used in Northern Italy and was recently started in London.

“We try to divide and have separate access between COVID-positive and -negative patients,” said Anna Fagotti, MD, an assistant professor at Fondazione Policlinico Universitario Agostino Gemelli IRCCS in Rome and another coauthor of the editorial.

“We are trying to divide the work flow of patients and try to ensure treatment to cancer patients as much as we can,” she explained. “This means that it’s a very difficult situation, and, every time, you have to deal with the number of places available as some places have been taken by other patients from the emergency room. We are still trying to have a number of beds and intensive care unit beds available for our patients.”

Setting up dedicated hospitals is a good idea, but it has to be done before the “tsunami” of cases hits and there are no more intensive care beds or ventilators, according to Antonio González-Martín, MD, of Clínica Universidad de Navarra in Madrid, another coauthor of the editorial.
 

Limiting hospital visits

Strategies to limit the number of times patients need to come into hospital for appointments and treatment is key to getting through the pandemic, Sandro Pignata, MD, of Instituto Nazionale Tumori IRCCS Fondazione G. Pascale in Naples, Italy, said during the webinar.

“It will be imperative to explore options that reduce the number of procedures or surgical interventions that may be associated with prolonged operative time, risk of major blood loss, necessitating blood products, risk of infection to the medical personnel, or admission to intensive care units,” Dr. Ramirez and colleagues wrote in their editorial.

“In considering management of disease, we must recognize that, in many centers, access to routine visits and surgery may be either completely restricted or significantly reduced. We must, therefore, consider options that may still offer our patients a treatment plan that addresses their disease while at the same time limiting risk of exposure,” the authors wrote.

The authors declared no competing interests or specific funding in relation to their work, and the webinar participants had no conflicts of interest.

SOURCE: Ramirez PT et al. Int J Gynecol Cancer. 2020 Mar 27. doi: 10.1136/ijgc-2020-001419.
 

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To manage patients with gynecologic cancers, oncologists in the United States and Europe are recommending reducing outpatient visits, delaying surgeries, prolonging chemotherapy regimens, and generally trying to keep cancer patients away from those who have tested positive for COVID-19.

“We recognize that, in this special situation, we must continue to provide our gynecologic oncology patients with the highest quality of medical services,” Pedro T. Ramirez, MD, of the University of Texas MD Anderson Cancer Center in Houston and associates wrote in an editorial published in the International Journal of Gynecological Cancer.

At the same time, the authors added, the safety of patients, their families, and medical staff needs to be assured.

Dr. Ramirez and colleagues’ editorial includes recommendations on how to optimize the care of patients with gynecologic cancers while prioritizing safety and minimizing the burden to the healthcare system. The group’s recommendations outline when surgery, radiotherapy, and other treatments might be safely postponed and when they need to proceed out of urgency.

Some authors of the editorial also described their experiences with COVID-19 during a webinar on managing patients with advanced ovarian cancer, which was hosted by the European Society of Gynaecological Oncology (ESGO).
 

A lack of resources

In Spain, health resources “are collapsed” by the pandemic, editorial author Luis Chiva, MD, said during the webinar.

At his institution, the Clínica Universidad de Navarra in Madrid, 98% of the 1,500 intensive care beds were occupied by COVID-19 patients at the end of March. So the hope was to be able to refer their patients to other communities where there may still be some capacity.

Another problem in Spain is the high percentage of health workers infected with SARS-CoV-2, the virus behind COVID-19. More than 15,000 health workers were recently reported to be sick or self-isolating, which is around 14% of the health care workforce in the country.

Dr. Chiva noted that this puts those treating gynecologic cancers in a difficult position. On the one hand, surgery to remove a high-risk ovarian mass should not be delayed, but the majority of hospitals in Spain simply cannot perform this type of surgery during the pandemic.

“Unfortunately, due to this specific situation, almost, I would say in 80%-90% of hospitals, we are only able to carry out emergency surgical procedures,” Dr. Chiva said. That’s general emergency procedures such as appendectomies, removing blockages, and dealing with hemorrhages, not gynecologic surgeries. “It’s almost impossible to schedule the typical oncological cases,” he said.

Even with the Hospital IFEMA now set up at the Feria de Madrid, which is usually used to host large-scale events, there are “minimal options for performing standard oncological surgery,” Dr. Chiva said. He estimated that just 5% of hospitals in Spain are able to perform oncologic surgeries as normal, with maybe 15% able to offer surgery without the backup of postsurgical intensive care.
 

‘Ring-fencing’

“This is really an unusual time for us,” commented Jonathan Ledermann, MD, vice president of ESGO and a professor of medical oncology at University College London, who moderated the webinar.

 

 

“This is affecting the way in which we diagnose our patients and have access to care,” he said. “It compromises the way in which we treat patients. We have to adjust our treatment pathways. We have to look at the risks of coronavirus infection in cancer patients and how we manage patients in a socially distancing environment. We also need to think about managing gynecological oncology departments in the face of disease amongst staff, the risks of transmission, and the reduced clinical service.”

Dr. Ledermann noted that “ring-fencing” a few hospitals to deal only with patients free of COVID-19 might be a way forward. This approach has been used in Northern Italy and was recently started in London.

“We try to divide and have separate access between COVID-positive and -negative patients,” said Anna Fagotti, MD, an assistant professor at Fondazione Policlinico Universitario Agostino Gemelli IRCCS in Rome and another coauthor of the editorial.

“We are trying to divide the work flow of patients and try to ensure treatment to cancer patients as much as we can,” she explained. “This means that it’s a very difficult situation, and, every time, you have to deal with the number of places available as some places have been taken by other patients from the emergency room. We are still trying to have a number of beds and intensive care unit beds available for our patients.”

Setting up dedicated hospitals is a good idea, but it has to be done before the “tsunami” of cases hits and there are no more intensive care beds or ventilators, according to Antonio González-Martín, MD, of Clínica Universidad de Navarra in Madrid, another coauthor of the editorial.
 

Limiting hospital visits

Strategies to limit the number of times patients need to come into hospital for appointments and treatment is key to getting through the pandemic, Sandro Pignata, MD, of Instituto Nazionale Tumori IRCCS Fondazione G. Pascale in Naples, Italy, said during the webinar.

“It will be imperative to explore options that reduce the number of procedures or surgical interventions that may be associated with prolonged operative time, risk of major blood loss, necessitating blood products, risk of infection to the medical personnel, or admission to intensive care units,” Dr. Ramirez and colleagues wrote in their editorial.

“In considering management of disease, we must recognize that, in many centers, access to routine visits and surgery may be either completely restricted or significantly reduced. We must, therefore, consider options that may still offer our patients a treatment plan that addresses their disease while at the same time limiting risk of exposure,” the authors wrote.

The authors declared no competing interests or specific funding in relation to their work, and the webinar participants had no conflicts of interest.

SOURCE: Ramirez PT et al. Int J Gynecol Cancer. 2020 Mar 27. doi: 10.1136/ijgc-2020-001419.
 

 

To manage patients with gynecologic cancers, oncologists in the United States and Europe are recommending reducing outpatient visits, delaying surgeries, prolonging chemotherapy regimens, and generally trying to keep cancer patients away from those who have tested positive for COVID-19.

“We recognize that, in this special situation, we must continue to provide our gynecologic oncology patients with the highest quality of medical services,” Pedro T. Ramirez, MD, of the University of Texas MD Anderson Cancer Center in Houston and associates wrote in an editorial published in the International Journal of Gynecological Cancer.

At the same time, the authors added, the safety of patients, their families, and medical staff needs to be assured.

Dr. Ramirez and colleagues’ editorial includes recommendations on how to optimize the care of patients with gynecologic cancers while prioritizing safety and minimizing the burden to the healthcare system. The group’s recommendations outline when surgery, radiotherapy, and other treatments might be safely postponed and when they need to proceed out of urgency.

Some authors of the editorial also described their experiences with COVID-19 during a webinar on managing patients with advanced ovarian cancer, which was hosted by the European Society of Gynaecological Oncology (ESGO).
 

A lack of resources

In Spain, health resources “are collapsed” by the pandemic, editorial author Luis Chiva, MD, said during the webinar.

At his institution, the Clínica Universidad de Navarra in Madrid, 98% of the 1,500 intensive care beds were occupied by COVID-19 patients at the end of March. So the hope was to be able to refer their patients to other communities where there may still be some capacity.

Another problem in Spain is the high percentage of health workers infected with SARS-CoV-2, the virus behind COVID-19. More than 15,000 health workers were recently reported to be sick or self-isolating, which is around 14% of the health care workforce in the country.

Dr. Chiva noted that this puts those treating gynecologic cancers in a difficult position. On the one hand, surgery to remove a high-risk ovarian mass should not be delayed, but the majority of hospitals in Spain simply cannot perform this type of surgery during the pandemic.

“Unfortunately, due to this specific situation, almost, I would say in 80%-90% of hospitals, we are only able to carry out emergency surgical procedures,” Dr. Chiva said. That’s general emergency procedures such as appendectomies, removing blockages, and dealing with hemorrhages, not gynecologic surgeries. “It’s almost impossible to schedule the typical oncological cases,” he said.

Even with the Hospital IFEMA now set up at the Feria de Madrid, which is usually used to host large-scale events, there are “minimal options for performing standard oncological surgery,” Dr. Chiva said. He estimated that just 5% of hospitals in Spain are able to perform oncologic surgeries as normal, with maybe 15% able to offer surgery without the backup of postsurgical intensive care.
 

‘Ring-fencing’

“This is really an unusual time for us,” commented Jonathan Ledermann, MD, vice president of ESGO and a professor of medical oncology at University College London, who moderated the webinar.

 

 

“This is affecting the way in which we diagnose our patients and have access to care,” he said. “It compromises the way in which we treat patients. We have to adjust our treatment pathways. We have to look at the risks of coronavirus infection in cancer patients and how we manage patients in a socially distancing environment. We also need to think about managing gynecological oncology departments in the face of disease amongst staff, the risks of transmission, and the reduced clinical service.”

Dr. Ledermann noted that “ring-fencing” a few hospitals to deal only with patients free of COVID-19 might be a way forward. This approach has been used in Northern Italy and was recently started in London.

“We try to divide and have separate access between COVID-positive and -negative patients,” said Anna Fagotti, MD, an assistant professor at Fondazione Policlinico Universitario Agostino Gemelli IRCCS in Rome and another coauthor of the editorial.

“We are trying to divide the work flow of patients and try to ensure treatment to cancer patients as much as we can,” she explained. “This means that it’s a very difficult situation, and, every time, you have to deal with the number of places available as some places have been taken by other patients from the emergency room. We are still trying to have a number of beds and intensive care unit beds available for our patients.”

Setting up dedicated hospitals is a good idea, but it has to be done before the “tsunami” of cases hits and there are no more intensive care beds or ventilators, according to Antonio González-Martín, MD, of Clínica Universidad de Navarra in Madrid, another coauthor of the editorial.
 

Limiting hospital visits

Strategies to limit the number of times patients need to come into hospital for appointments and treatment is key to getting through the pandemic, Sandro Pignata, MD, of Instituto Nazionale Tumori IRCCS Fondazione G. Pascale in Naples, Italy, said during the webinar.

“It will be imperative to explore options that reduce the number of procedures or surgical interventions that may be associated with prolonged operative time, risk of major blood loss, necessitating blood products, risk of infection to the medical personnel, or admission to intensive care units,” Dr. Ramirez and colleagues wrote in their editorial.

“In considering management of disease, we must recognize that, in many centers, access to routine visits and surgery may be either completely restricted or significantly reduced. We must, therefore, consider options that may still offer our patients a treatment plan that addresses their disease while at the same time limiting risk of exposure,” the authors wrote.

The authors declared no competing interests or specific funding in relation to their work, and the webinar participants had no conflicts of interest.

SOURCE: Ramirez PT et al. Int J Gynecol Cancer. 2020 Mar 27. doi: 10.1136/ijgc-2020-001419.
 

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FROM THE INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER

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Most endometrial cancers treated with minimally invasive procedures

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Mon, 06/08/2020 - 16:30

 

Rates of minimally invasive surgery for early-stage endometrial cancer may be higher than previously reported, results of a registry study suggest.

Of 3,730 women with endometrial cancer in the Society of Gynecologic Oncology Clinical Outcomes Registry (SGO-COR), 88.8% underwent minimally invasive procedures, reported Amanda Nickles Fader, MD, of Johns Hopkins Hospital, Baltimore, and colleagues.

“When you have surgery with a gyn-oncologist who is specially trained in this type of surgery, we see that women have a very high likelihood of having the appropriate surgery, the minimally invasive surgery, and we thought that this benchmark of an 80% rate of minimally invasive surgery in these patients is very feasible and should be recognized as the standard of care,” Dr. Nickles Fader said in an interview.

Coinvestigator Summer B. Dewdney, MD, of Rush University Medical Center, Chicago, who was instrumental in creating and running the SGO-COR registry, said these findings are encouraging.

“We’re happy to see that rate. It’s the rate that it should be because minimally invasive surgery is the standard of care for endometrial cancer,” Dr. Dewdney said. She added, however, that data supplied to the registry come from gynecologic oncologists who are highly motivated to participate and follow best practice guidelines, which could skew the results slightly toward more favorable outcomes.

Results of the registry-based study are detailed in an abstract that was slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.
 

Assessing adherence to guidelines

In 2015, the SGO Clinical Practice Committee and the American College of Obstetricians and Gynecologists issued a practice bulletin, which stated that “minimally invasive surgery should be embraced as the standard surgical approach for comprehensive surgical staging in women with endometrial cancer.”

Similarly, National Comprehensive Cancer Network guidelines for uterine cancer state that “minimally invasive surgery is the preferred approach when technically feasible” for treatment of endometrial cancer confined to the uterus.

Despite these recommendations, the overall rate of minimally invasive endometrial cancer surgery in the United States is reported be around to 60%, Dr. Nickles Fader and colleagues wrote.

With this in mind, the investigators set out to determine the rate of minimally invasive surgery in women with apparent stage I, II, or III endometrial cancer who underwent hysterectomy with or without staging from 2012 to 2017 at a center reporting to SGO-COR.

The team identified 3,730 women treated at 25 SGO-COR centers; 12 of which were university-affiliated centers and 13 of which were nonuniversity based. Most patients (83.2%) had stage I disease, 4.7% had stage II cancer, and 12.1% had stage III disease. The median patient age was 57 years. Most patients (88%) were white, and two-thirds (67.1%) were obese. In all, 80.4% of samples had endometrioid histology, and 77.7% were either grade 1 or 2.
 

Factors associated with minimally invasive surgery

The data showed that 88.8% of patients underwent a minimally invasive hysterectomy, composed of robotic-assisted procedures in 73.9% of cases, laparoscopy in 13.4%, and vaginal access in 1.6%.

The proportion of patients who underwent a minimally invasive procedure was significantly higher at nonuniversity centers, compared with academic centers (92.6% vs. 82.7%; P < .0001), but rates of minimally invasive procedures did not differ significantly across U.S. geographic regions.

Dr. Dewdney said that the higher proportion of open surgeries performed at university centers may be attributable to those centers treating patients with more advanced disease or rare aggressive cancers that may not be amenable to a minimally invasive approach.

In a multivariate analysis, factors associated with a failure to perform minimally invasive surgery were black race of the patient (adjusted odds ratio, 0.57), body mass index over 35 kg/m2 (aOR, 1.40), stage II disease (aOR, 0.49), stage III disease (aOR, 0.36), carcinosarcoma/leiomyosarcoma (aOR, 0.58), and university hospital (aOR, 3.46).

Looking at perioperative complications, the investigators found that laparotomy was associated with more in-hospital complications than minimally invasive procedures, including more unscheduled ICU stays (P < .001) and prolonged hospital stays (P = .0002).

Dr. Dewdney said that investigators are planning further registry-based studies focusing on ovarian cancer, uterine cancer, and cervical cancer.

Dr. Nickles Fader and Dr. Dewdney reported having no relevant conflicts of interest.

SOURCE: Nickles Fader A et al. SGO 2020, Abstract 63.

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Rates of minimally invasive surgery for early-stage endometrial cancer may be higher than previously reported, results of a registry study suggest.

Of 3,730 women with endometrial cancer in the Society of Gynecologic Oncology Clinical Outcomes Registry (SGO-COR), 88.8% underwent minimally invasive procedures, reported Amanda Nickles Fader, MD, of Johns Hopkins Hospital, Baltimore, and colleagues.

“When you have surgery with a gyn-oncologist who is specially trained in this type of surgery, we see that women have a very high likelihood of having the appropriate surgery, the minimally invasive surgery, and we thought that this benchmark of an 80% rate of minimally invasive surgery in these patients is very feasible and should be recognized as the standard of care,” Dr. Nickles Fader said in an interview.

Coinvestigator Summer B. Dewdney, MD, of Rush University Medical Center, Chicago, who was instrumental in creating and running the SGO-COR registry, said these findings are encouraging.

“We’re happy to see that rate. It’s the rate that it should be because minimally invasive surgery is the standard of care for endometrial cancer,” Dr. Dewdney said. She added, however, that data supplied to the registry come from gynecologic oncologists who are highly motivated to participate and follow best practice guidelines, which could skew the results slightly toward more favorable outcomes.

Results of the registry-based study are detailed in an abstract that was slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.
 

Assessing adherence to guidelines

In 2015, the SGO Clinical Practice Committee and the American College of Obstetricians and Gynecologists issued a practice bulletin, which stated that “minimally invasive surgery should be embraced as the standard surgical approach for comprehensive surgical staging in women with endometrial cancer.”

Similarly, National Comprehensive Cancer Network guidelines for uterine cancer state that “minimally invasive surgery is the preferred approach when technically feasible” for treatment of endometrial cancer confined to the uterus.

Despite these recommendations, the overall rate of minimally invasive endometrial cancer surgery in the United States is reported be around to 60%, Dr. Nickles Fader and colleagues wrote.

With this in mind, the investigators set out to determine the rate of minimally invasive surgery in women with apparent stage I, II, or III endometrial cancer who underwent hysterectomy with or without staging from 2012 to 2017 at a center reporting to SGO-COR.

The team identified 3,730 women treated at 25 SGO-COR centers; 12 of which were university-affiliated centers and 13 of which were nonuniversity based. Most patients (83.2%) had stage I disease, 4.7% had stage II cancer, and 12.1% had stage III disease. The median patient age was 57 years. Most patients (88%) were white, and two-thirds (67.1%) were obese. In all, 80.4% of samples had endometrioid histology, and 77.7% were either grade 1 or 2.
 

Factors associated with minimally invasive surgery

The data showed that 88.8% of patients underwent a minimally invasive hysterectomy, composed of robotic-assisted procedures in 73.9% of cases, laparoscopy in 13.4%, and vaginal access in 1.6%.

The proportion of patients who underwent a minimally invasive procedure was significantly higher at nonuniversity centers, compared with academic centers (92.6% vs. 82.7%; P < .0001), but rates of minimally invasive procedures did not differ significantly across U.S. geographic regions.

Dr. Dewdney said that the higher proportion of open surgeries performed at university centers may be attributable to those centers treating patients with more advanced disease or rare aggressive cancers that may not be amenable to a minimally invasive approach.

In a multivariate analysis, factors associated with a failure to perform minimally invasive surgery were black race of the patient (adjusted odds ratio, 0.57), body mass index over 35 kg/m2 (aOR, 1.40), stage II disease (aOR, 0.49), stage III disease (aOR, 0.36), carcinosarcoma/leiomyosarcoma (aOR, 0.58), and university hospital (aOR, 3.46).

Looking at perioperative complications, the investigators found that laparotomy was associated with more in-hospital complications than minimally invasive procedures, including more unscheduled ICU stays (P < .001) and prolonged hospital stays (P = .0002).

Dr. Dewdney said that investigators are planning further registry-based studies focusing on ovarian cancer, uterine cancer, and cervical cancer.

Dr. Nickles Fader and Dr. Dewdney reported having no relevant conflicts of interest.

SOURCE: Nickles Fader A et al. SGO 2020, Abstract 63.

 

Rates of minimally invasive surgery for early-stage endometrial cancer may be higher than previously reported, results of a registry study suggest.

Of 3,730 women with endometrial cancer in the Society of Gynecologic Oncology Clinical Outcomes Registry (SGO-COR), 88.8% underwent minimally invasive procedures, reported Amanda Nickles Fader, MD, of Johns Hopkins Hospital, Baltimore, and colleagues.

“When you have surgery with a gyn-oncologist who is specially trained in this type of surgery, we see that women have a very high likelihood of having the appropriate surgery, the minimally invasive surgery, and we thought that this benchmark of an 80% rate of minimally invasive surgery in these patients is very feasible and should be recognized as the standard of care,” Dr. Nickles Fader said in an interview.

Coinvestigator Summer B. Dewdney, MD, of Rush University Medical Center, Chicago, who was instrumental in creating and running the SGO-COR registry, said these findings are encouraging.

“We’re happy to see that rate. It’s the rate that it should be because minimally invasive surgery is the standard of care for endometrial cancer,” Dr. Dewdney said. She added, however, that data supplied to the registry come from gynecologic oncologists who are highly motivated to participate and follow best practice guidelines, which could skew the results slightly toward more favorable outcomes.

Results of the registry-based study are detailed in an abstract that was slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.
 

Assessing adherence to guidelines

In 2015, the SGO Clinical Practice Committee and the American College of Obstetricians and Gynecologists issued a practice bulletin, which stated that “minimally invasive surgery should be embraced as the standard surgical approach for comprehensive surgical staging in women with endometrial cancer.”

Similarly, National Comprehensive Cancer Network guidelines for uterine cancer state that “minimally invasive surgery is the preferred approach when technically feasible” for treatment of endometrial cancer confined to the uterus.

Despite these recommendations, the overall rate of minimally invasive endometrial cancer surgery in the United States is reported be around to 60%, Dr. Nickles Fader and colleagues wrote.

With this in mind, the investigators set out to determine the rate of minimally invasive surgery in women with apparent stage I, II, or III endometrial cancer who underwent hysterectomy with or without staging from 2012 to 2017 at a center reporting to SGO-COR.

The team identified 3,730 women treated at 25 SGO-COR centers; 12 of which were university-affiliated centers and 13 of which were nonuniversity based. Most patients (83.2%) had stage I disease, 4.7% had stage II cancer, and 12.1% had stage III disease. The median patient age was 57 years. Most patients (88%) were white, and two-thirds (67.1%) were obese. In all, 80.4% of samples had endometrioid histology, and 77.7% were either grade 1 or 2.
 

Factors associated with minimally invasive surgery

The data showed that 88.8% of patients underwent a minimally invasive hysterectomy, composed of robotic-assisted procedures in 73.9% of cases, laparoscopy in 13.4%, and vaginal access in 1.6%.

The proportion of patients who underwent a minimally invasive procedure was significantly higher at nonuniversity centers, compared with academic centers (92.6% vs. 82.7%; P < .0001), but rates of minimally invasive procedures did not differ significantly across U.S. geographic regions.

Dr. Dewdney said that the higher proportion of open surgeries performed at university centers may be attributable to those centers treating patients with more advanced disease or rare aggressive cancers that may not be amenable to a minimally invasive approach.

In a multivariate analysis, factors associated with a failure to perform minimally invasive surgery were black race of the patient (adjusted odds ratio, 0.57), body mass index over 35 kg/m2 (aOR, 1.40), stage II disease (aOR, 0.49), stage III disease (aOR, 0.36), carcinosarcoma/leiomyosarcoma (aOR, 0.58), and university hospital (aOR, 3.46).

Looking at perioperative complications, the investigators found that laparotomy was associated with more in-hospital complications than minimally invasive procedures, including more unscheduled ICU stays (P < .001) and prolonged hospital stays (P = .0002).

Dr. Dewdney said that investigators are planning further registry-based studies focusing on ovarian cancer, uterine cancer, and cervical cancer.

Dr. Nickles Fader and Dr. Dewdney reported having no relevant conflicts of interest.

SOURCE: Nickles Fader A et al. SGO 2020, Abstract 63.

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Learning to live with COVID-19: Postpandemic life will be reflected in how effectively we leverage this crisis

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While often compared with the Spanish influenza contagion of 1918, the current COVID-19 pandemic is arguably unprecedented in scale and scope, global reach, and the rate at which it has spread across the world.
 

Unprecedented times

The United States now has the greatest burden of COVID-19 disease worldwide.1 Although Boston has thus far been spared the full force of the disease’s impact, it is likely only a matter of time before it reaches here. To prepare for the imminent surge, we at Tufts Medical Center defined 4 short-term strategic imperatives to help guide our COVID-19 preparedness. Having a single unified strategy across our organization has helped to maintain focus and consistency in the messaging amidst all of the uncertainty. Our focus areas are outlined below.
 

1 Flatten the curve

This term refers to the use of “social distancing” and community isolation measures to keep the number of disease cases at a manageable level. COVID-19 is spread almost exclusively through contact with contaminated respiratory droplets. While several categories of risk have been described, the US Centers for Disease Control and Prevention (CDC) defines disease “exposure” as face-to-face contact within 6 feet of an infected individual for more than 15 minutes without wearing a mask.2 Intervening at all 3 of these touchpoints effectively reduces transmission. Interventions include limiting in-person meetings, increasing the space between individuals (both providers and patients), and routinely using personal protective equipment (PPE).

Another effective strategy is to divide frontline providers into smaller units or teams to limit cross-contamination: the inpatient team versus the outpatient team, the day team versus the night team, the “on” team versus the “off” team. If the infection lays one team low, other providers can step in until they recover and return to work.

Visitor policies should be developed and strictly implemented. Many institutions do allow one support person in labor and delivery (L&D) regardless of the patient’s COVID-19 status, although that person should not be symptomatic or COVID-19 positive. Whether to test all patients and support persons for COVID-19 on arrival at L&D remains controversial.3 At a minimum, these individuals should be screened for symptoms. Although it was a major focus of initial preventative efforts, taking a travel and exposure history is no longer informative as the virus is now endemic and community spread is common.

Initial preventative efforts focused also on high-risk patients, but routine use of PPE for all encounters clearly is more effective because of the high rate of asymptomatic shedding. The virus can survive suspended in the air for up to 2 hours following an aerosol-generating procedure (AGP) and on surfaces for several hours or even days. Practices such as regular handwashing, cleaning of exposed work surfaces, and avoiding face touching should by now be part of our everyday routine.

Institutions throughout the United States have established inpatient COVID-19 units—so-called “dirty” units—with mixed success. As the pandemic spreads and the number of patients with asymptomatic shedding increases, it is harder to determine who is and who is not infected. Cross-contamination has rendered this approach largely ineffective. Whether this will change with the introduction of rapid point-of-care testing remains to be seen.

Continue to: 2 Preserve PPE...

 

 

2 Preserve PPE

PPE use is effective in reducing transmission. This includes tier 1 PPE with or without enhanced droplet precaution (surgical mask, eye protection, gloves, yellow gown) and tier 2 PPE (tier 1 plus N95 respirators or powered air-purifying respirators [PAPR]). Given the acute PPE shortage in many parts of the country, appropriate use of PPE is critical to maintain an adequate supply. For example, tier 2 PPE is required only in the setting of an AGP. This includes intubation and, in our determination, the second stage of labor for COVID-19–positive patients and patients under investigation (PUIs); we do not employ tier 2 PPE for all patients in the second stage of labor, although some hospitals endorse this practice.

Creative solutions to the impending PPE shortage abound, such as the use of 3D printers to make face shields and novel techniques to sterilize and reuse N95 respirators.

3 Create capacity

In the absence of effective treatment for COVID-19 and with a vaccine still many months away, supportive care is critical. The pulmonary sequelae with cytokine storm and acute hypoxemia can come on quickly, require urgent mechanical ventilatory support, and take several weeks to resolve.

Our ability to create inpatient capacity to accommodate ill patients, monitor them closely, and intubate early will likely be the most critical driver of the case fatality rate. This requires deferring outpatient visits (or doing them via telemedicine), expanding intensive care unit capabilities (especially ventilator beds), and canceling elective surgeries. What constitutes “elective surgery” is not always clear. Our institution, for example, regards abortion services as essential and not elective, but this is not the case throughout the United States.

Creating capacity also refers to staffing. Where necessary, providers should be retrained and redeployed. This may require emergency credentialing of providers in areas outside their usual clinical practice and permission may be needed from the Accreditation Council for Graduate Medical Education to engage trainees outside their usual duty hours.
 

4 Support and protect your workforce

Everyone is anxious, and people convey their anxiety in different ways. I have found it helpful to acknowledge those feelings and provide a forum for staff to express and share their anxieties. That said, hospitals are not a democracy. While staff members should be encouraged to ask questions and voice their opinions, everyone is expected to follow protocol regarding patient care.

Celebrating small successes and finding creative ways to alleviate the stress and inject humor can help. Most institutions are using electronic conferencing platforms (such as Zoom or Microsoft Teams) to stay in touch and to continue education initiatives through interactive didactic sessions, grand rounds, morbidity and mortality conferences, and e-journal clubs. These are also a great platform for social events, such as w(h)ine and book clubs and virtual karaoke.

Since many ObGyn providers are women, the closure of day-care centers and schools is particularly challenging. Share best practices among your staff on how to address this problem, such as alternating on-call shifts or matching providers needing day care with ‘furloughed’ college students who are looking to keep busy and make a little money.

Continue to: Avoid overcommunicating...

 

 

Avoid overcommunicating

Clear, concise, and timely communication is key. This can be challenging given the rapidly evolving science of COVID-19 and the daily barrage of information from both reliable and unreliable sources. Setting up regular online meetings with your faculty 2 or 3 times per week can keep people informed, promote engagement, and boost morale.

If an urgent e-mail announcement is needed, keep the message focused. Highlight only updated information and changes to existing policies and guidelines. And consider adding a brief anecdote to illustrate the staff’s creativity and resilience: a “best catch” story, for example, or a staff member who started a “commit to sit” program (spending time in the room with patients who want company but are not able to have their family in attendance).
 

Look to the future

COVID-19 will pass. Herd immunity will inevitably develop. The question is how quickly and at what cost. Children delivered today are being born into a society already profoundly altered by COVID-19. Some have started to call them Generation C.

Exactly what life will look like at the back end of this pandemic depends on how effectively we leverage this crisis. There are numerous opportunities to change the way we think about health care and educate the next generation of providers. These include increasing the use of telehealth and remote education, redesigning our traditional prenatal care paradigms, and reinforcing the importance of preventive medicine. This is an opportunity to put the “health” back into “health care.”

Look after yourself

Amid all the chaos and uncertainty, do not forget to take care of yourself and your family. Be calm, be kind, and be flexible. Stay safe.

References
  1. Kommenda N, Gutierrez P, Adolphe J. Coronavirus world map: which countries have the most cases and deaths? The Guardian. April 1, 2020. https://www.theguardian.com/world/2020/mar/31/coronavirus-mapped-which-countries-have-the-most-cases-and-deaths. Accessed April 1, 2020.
  2. Centers for Disease Control and Prevention. Coronavirus disease 2019 (COVID-19).Interim US guidance for risk assessment and public health management of healthcare personnel with potential exposure in a healthcare setting to patients with coronavirus disease (COVID-19). https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-risk-assesment-hcp.html. Accessed April 1, 2020.
  3. Centers for Disease Control and Prevention. Coronavirus disease 2019 (COVID-19). Evaluating and testing persons for coronavirus disease 2020 (COVID-19). https://www.cdc.gov/coronavirus/2019-nCoV/hcp/clinical-criteria.html. Accessed April 1, 2020.
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The author reports no financial relationships relevant to this article.

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Boston, Massachusetts
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The author reports no financial relationships relevant to this article.

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While often compared with the Spanish influenza contagion of 1918, the current COVID-19 pandemic is arguably unprecedented in scale and scope, global reach, and the rate at which it has spread across the world.
 

Unprecedented times

The United States now has the greatest burden of COVID-19 disease worldwide.1 Although Boston has thus far been spared the full force of the disease’s impact, it is likely only a matter of time before it reaches here. To prepare for the imminent surge, we at Tufts Medical Center defined 4 short-term strategic imperatives to help guide our COVID-19 preparedness. Having a single unified strategy across our organization has helped to maintain focus and consistency in the messaging amidst all of the uncertainty. Our focus areas are outlined below.
 

1 Flatten the curve

This term refers to the use of “social distancing” and community isolation measures to keep the number of disease cases at a manageable level. COVID-19 is spread almost exclusively through contact with contaminated respiratory droplets. While several categories of risk have been described, the US Centers for Disease Control and Prevention (CDC) defines disease “exposure” as face-to-face contact within 6 feet of an infected individual for more than 15 minutes without wearing a mask.2 Intervening at all 3 of these touchpoints effectively reduces transmission. Interventions include limiting in-person meetings, increasing the space between individuals (both providers and patients), and routinely using personal protective equipment (PPE).

Another effective strategy is to divide frontline providers into smaller units or teams to limit cross-contamination: the inpatient team versus the outpatient team, the day team versus the night team, the “on” team versus the “off” team. If the infection lays one team low, other providers can step in until they recover and return to work.

Visitor policies should be developed and strictly implemented. Many institutions do allow one support person in labor and delivery (L&D) regardless of the patient’s COVID-19 status, although that person should not be symptomatic or COVID-19 positive. Whether to test all patients and support persons for COVID-19 on arrival at L&D remains controversial.3 At a minimum, these individuals should be screened for symptoms. Although it was a major focus of initial preventative efforts, taking a travel and exposure history is no longer informative as the virus is now endemic and community spread is common.

Initial preventative efforts focused also on high-risk patients, but routine use of PPE for all encounters clearly is more effective because of the high rate of asymptomatic shedding. The virus can survive suspended in the air for up to 2 hours following an aerosol-generating procedure (AGP) and on surfaces for several hours or even days. Practices such as regular handwashing, cleaning of exposed work surfaces, and avoiding face touching should by now be part of our everyday routine.

Institutions throughout the United States have established inpatient COVID-19 units—so-called “dirty” units—with mixed success. As the pandemic spreads and the number of patients with asymptomatic shedding increases, it is harder to determine who is and who is not infected. Cross-contamination has rendered this approach largely ineffective. Whether this will change with the introduction of rapid point-of-care testing remains to be seen.

Continue to: 2 Preserve PPE...

 

 

2 Preserve PPE

PPE use is effective in reducing transmission. This includes tier 1 PPE with or without enhanced droplet precaution (surgical mask, eye protection, gloves, yellow gown) and tier 2 PPE (tier 1 plus N95 respirators or powered air-purifying respirators [PAPR]). Given the acute PPE shortage in many parts of the country, appropriate use of PPE is critical to maintain an adequate supply. For example, tier 2 PPE is required only in the setting of an AGP. This includes intubation and, in our determination, the second stage of labor for COVID-19–positive patients and patients under investigation (PUIs); we do not employ tier 2 PPE for all patients in the second stage of labor, although some hospitals endorse this practice.

Creative solutions to the impending PPE shortage abound, such as the use of 3D printers to make face shields and novel techniques to sterilize and reuse N95 respirators.

3 Create capacity

In the absence of effective treatment for COVID-19 and with a vaccine still many months away, supportive care is critical. The pulmonary sequelae with cytokine storm and acute hypoxemia can come on quickly, require urgent mechanical ventilatory support, and take several weeks to resolve.

Our ability to create inpatient capacity to accommodate ill patients, monitor them closely, and intubate early will likely be the most critical driver of the case fatality rate. This requires deferring outpatient visits (or doing them via telemedicine), expanding intensive care unit capabilities (especially ventilator beds), and canceling elective surgeries. What constitutes “elective surgery” is not always clear. Our institution, for example, regards abortion services as essential and not elective, but this is not the case throughout the United States.

Creating capacity also refers to staffing. Where necessary, providers should be retrained and redeployed. This may require emergency credentialing of providers in areas outside their usual clinical practice and permission may be needed from the Accreditation Council for Graduate Medical Education to engage trainees outside their usual duty hours.
 

4 Support and protect your workforce

Everyone is anxious, and people convey their anxiety in different ways. I have found it helpful to acknowledge those feelings and provide a forum for staff to express and share their anxieties. That said, hospitals are not a democracy. While staff members should be encouraged to ask questions and voice their opinions, everyone is expected to follow protocol regarding patient care.

Celebrating small successes and finding creative ways to alleviate the stress and inject humor can help. Most institutions are using electronic conferencing platforms (such as Zoom or Microsoft Teams) to stay in touch and to continue education initiatives through interactive didactic sessions, grand rounds, morbidity and mortality conferences, and e-journal clubs. These are also a great platform for social events, such as w(h)ine and book clubs and virtual karaoke.

Since many ObGyn providers are women, the closure of day-care centers and schools is particularly challenging. Share best practices among your staff on how to address this problem, such as alternating on-call shifts or matching providers needing day care with ‘furloughed’ college students who are looking to keep busy and make a little money.

Continue to: Avoid overcommunicating...

 

 

Avoid overcommunicating

Clear, concise, and timely communication is key. This can be challenging given the rapidly evolving science of COVID-19 and the daily barrage of information from both reliable and unreliable sources. Setting up regular online meetings with your faculty 2 or 3 times per week can keep people informed, promote engagement, and boost morale.

If an urgent e-mail announcement is needed, keep the message focused. Highlight only updated information and changes to existing policies and guidelines. And consider adding a brief anecdote to illustrate the staff’s creativity and resilience: a “best catch” story, for example, or a staff member who started a “commit to sit” program (spending time in the room with patients who want company but are not able to have their family in attendance).
 

Look to the future

COVID-19 will pass. Herd immunity will inevitably develop. The question is how quickly and at what cost. Children delivered today are being born into a society already profoundly altered by COVID-19. Some have started to call them Generation C.

Exactly what life will look like at the back end of this pandemic depends on how effectively we leverage this crisis. There are numerous opportunities to change the way we think about health care and educate the next generation of providers. These include increasing the use of telehealth and remote education, redesigning our traditional prenatal care paradigms, and reinforcing the importance of preventive medicine. This is an opportunity to put the “health” back into “health care.”

Look after yourself

Amid all the chaos and uncertainty, do not forget to take care of yourself and your family. Be calm, be kind, and be flexible. Stay safe.

 

While often compared with the Spanish influenza contagion of 1918, the current COVID-19 pandemic is arguably unprecedented in scale and scope, global reach, and the rate at which it has spread across the world.
 

Unprecedented times

The United States now has the greatest burden of COVID-19 disease worldwide.1 Although Boston has thus far been spared the full force of the disease’s impact, it is likely only a matter of time before it reaches here. To prepare for the imminent surge, we at Tufts Medical Center defined 4 short-term strategic imperatives to help guide our COVID-19 preparedness. Having a single unified strategy across our organization has helped to maintain focus and consistency in the messaging amidst all of the uncertainty. Our focus areas are outlined below.
 

1 Flatten the curve

This term refers to the use of “social distancing” and community isolation measures to keep the number of disease cases at a manageable level. COVID-19 is spread almost exclusively through contact with contaminated respiratory droplets. While several categories of risk have been described, the US Centers for Disease Control and Prevention (CDC) defines disease “exposure” as face-to-face contact within 6 feet of an infected individual for more than 15 minutes without wearing a mask.2 Intervening at all 3 of these touchpoints effectively reduces transmission. Interventions include limiting in-person meetings, increasing the space between individuals (both providers and patients), and routinely using personal protective equipment (PPE).

Another effective strategy is to divide frontline providers into smaller units or teams to limit cross-contamination: the inpatient team versus the outpatient team, the day team versus the night team, the “on” team versus the “off” team. If the infection lays one team low, other providers can step in until they recover and return to work.

Visitor policies should be developed and strictly implemented. Many institutions do allow one support person in labor and delivery (L&D) regardless of the patient’s COVID-19 status, although that person should not be symptomatic or COVID-19 positive. Whether to test all patients and support persons for COVID-19 on arrival at L&D remains controversial.3 At a minimum, these individuals should be screened for symptoms. Although it was a major focus of initial preventative efforts, taking a travel and exposure history is no longer informative as the virus is now endemic and community spread is common.

Initial preventative efforts focused also on high-risk patients, but routine use of PPE for all encounters clearly is more effective because of the high rate of asymptomatic shedding. The virus can survive suspended in the air for up to 2 hours following an aerosol-generating procedure (AGP) and on surfaces for several hours or even days. Practices such as regular handwashing, cleaning of exposed work surfaces, and avoiding face touching should by now be part of our everyday routine.

Institutions throughout the United States have established inpatient COVID-19 units—so-called “dirty” units—with mixed success. As the pandemic spreads and the number of patients with asymptomatic shedding increases, it is harder to determine who is and who is not infected. Cross-contamination has rendered this approach largely ineffective. Whether this will change with the introduction of rapid point-of-care testing remains to be seen.

Continue to: 2 Preserve PPE...

 

 

2 Preserve PPE

PPE use is effective in reducing transmission. This includes tier 1 PPE with or without enhanced droplet precaution (surgical mask, eye protection, gloves, yellow gown) and tier 2 PPE (tier 1 plus N95 respirators or powered air-purifying respirators [PAPR]). Given the acute PPE shortage in many parts of the country, appropriate use of PPE is critical to maintain an adequate supply. For example, tier 2 PPE is required only in the setting of an AGP. This includes intubation and, in our determination, the second stage of labor for COVID-19–positive patients and patients under investigation (PUIs); we do not employ tier 2 PPE for all patients in the second stage of labor, although some hospitals endorse this practice.

Creative solutions to the impending PPE shortage abound, such as the use of 3D printers to make face shields and novel techniques to sterilize and reuse N95 respirators.

3 Create capacity

In the absence of effective treatment for COVID-19 and with a vaccine still many months away, supportive care is critical. The pulmonary sequelae with cytokine storm and acute hypoxemia can come on quickly, require urgent mechanical ventilatory support, and take several weeks to resolve.

Our ability to create inpatient capacity to accommodate ill patients, monitor them closely, and intubate early will likely be the most critical driver of the case fatality rate. This requires deferring outpatient visits (or doing them via telemedicine), expanding intensive care unit capabilities (especially ventilator beds), and canceling elective surgeries. What constitutes “elective surgery” is not always clear. Our institution, for example, regards abortion services as essential and not elective, but this is not the case throughout the United States.

Creating capacity also refers to staffing. Where necessary, providers should be retrained and redeployed. This may require emergency credentialing of providers in areas outside their usual clinical practice and permission may be needed from the Accreditation Council for Graduate Medical Education to engage trainees outside their usual duty hours.
 

4 Support and protect your workforce

Everyone is anxious, and people convey their anxiety in different ways. I have found it helpful to acknowledge those feelings and provide a forum for staff to express and share their anxieties. That said, hospitals are not a democracy. While staff members should be encouraged to ask questions and voice their opinions, everyone is expected to follow protocol regarding patient care.

Celebrating small successes and finding creative ways to alleviate the stress and inject humor can help. Most institutions are using electronic conferencing platforms (such as Zoom or Microsoft Teams) to stay in touch and to continue education initiatives through interactive didactic sessions, grand rounds, morbidity and mortality conferences, and e-journal clubs. These are also a great platform for social events, such as w(h)ine and book clubs and virtual karaoke.

Since many ObGyn providers are women, the closure of day-care centers and schools is particularly challenging. Share best practices among your staff on how to address this problem, such as alternating on-call shifts or matching providers needing day care with ‘furloughed’ college students who are looking to keep busy and make a little money.

Continue to: Avoid overcommunicating...

 

 

Avoid overcommunicating

Clear, concise, and timely communication is key. This can be challenging given the rapidly evolving science of COVID-19 and the daily barrage of information from both reliable and unreliable sources. Setting up regular online meetings with your faculty 2 or 3 times per week can keep people informed, promote engagement, and boost morale.

If an urgent e-mail announcement is needed, keep the message focused. Highlight only updated information and changes to existing policies and guidelines. And consider adding a brief anecdote to illustrate the staff’s creativity and resilience: a “best catch” story, for example, or a staff member who started a “commit to sit” program (spending time in the room with patients who want company but are not able to have their family in attendance).
 

Look to the future

COVID-19 will pass. Herd immunity will inevitably develop. The question is how quickly and at what cost. Children delivered today are being born into a society already profoundly altered by COVID-19. Some have started to call them Generation C.

Exactly what life will look like at the back end of this pandemic depends on how effectively we leverage this crisis. There are numerous opportunities to change the way we think about health care and educate the next generation of providers. These include increasing the use of telehealth and remote education, redesigning our traditional prenatal care paradigms, and reinforcing the importance of preventive medicine. This is an opportunity to put the “health” back into “health care.”

Look after yourself

Amid all the chaos and uncertainty, do not forget to take care of yourself and your family. Be calm, be kind, and be flexible. Stay safe.

References
  1. Kommenda N, Gutierrez P, Adolphe J. Coronavirus world map: which countries have the most cases and deaths? The Guardian. April 1, 2020. https://www.theguardian.com/world/2020/mar/31/coronavirus-mapped-which-countries-have-the-most-cases-and-deaths. Accessed April 1, 2020.
  2. Centers for Disease Control and Prevention. Coronavirus disease 2019 (COVID-19).Interim US guidance for risk assessment and public health management of healthcare personnel with potential exposure in a healthcare setting to patients with coronavirus disease (COVID-19). https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-risk-assesment-hcp.html. Accessed April 1, 2020.
  3. Centers for Disease Control and Prevention. Coronavirus disease 2019 (COVID-19). Evaluating and testing persons for coronavirus disease 2020 (COVID-19). https://www.cdc.gov/coronavirus/2019-nCoV/hcp/clinical-criteria.html. Accessed April 1, 2020.
References
  1. Kommenda N, Gutierrez P, Adolphe J. Coronavirus world map: which countries have the most cases and deaths? The Guardian. April 1, 2020. https://www.theguardian.com/world/2020/mar/31/coronavirus-mapped-which-countries-have-the-most-cases-and-deaths. Accessed April 1, 2020.
  2. Centers for Disease Control and Prevention. Coronavirus disease 2019 (COVID-19).Interim US guidance for risk assessment and public health management of healthcare personnel with potential exposure in a healthcare setting to patients with coronavirus disease (COVID-19). https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-risk-assesment-hcp.html. Accessed April 1, 2020.
  3. Centers for Disease Control and Prevention. Coronavirus disease 2019 (COVID-19). Evaluating and testing persons for coronavirus disease 2020 (COVID-19). https://www.cdc.gov/coronavirus/2019-nCoV/hcp/clinical-criteria.html. Accessed April 1, 2020.
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Can a drug FDA approved for endometriosis become a mainstay for nonsurgical treatment of HMB in women with fibroids?

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Schlaff WD, Ackerman RT, Al-Hendy A, et al. Elagolix for heavy menstrual bleeding in women with uterine fibroids. N Engl J Med. 2020;382:328-340.

Expert Commentary

Any women’s health care provider is extremely aware of how common uterine fibroids (leiomyomas) are in reproductive-aged women. Bleeding associated with such fibroids is a common source of medical morbidity and reduced quality of life for many patients. The mainstay treatment approach for such patients has been surgical, which over time has become minimally invasive. Finding a nonsurgical treatment for patients with fibroid-associated HMB is of huge importance. The recent failure of the selective progesterone receptor modulator ulipristal acetate to be approved by the US Food and Drug Administration (FDA) was a significant setback to finding an excellent option for medical management. A gonadotropin-releasing hormone (GnRH) antagonist like elagolix could become an incredibly important “arrow in the quiver” of women’s health clinicians.

Details about elagolix

As mentioned, elagolix was FDA approved in 2-dose regimens for the treatment of dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia associated with endometriosis. One would expect that such a GnRH antagonist would reduce or eliminate HMB in patients with fibroids, although formal study had never been undertaken. Previous studies of elagolix had shown the most common adverse reaction to be vasomotor symptoms—hot flashes and night sweats. In addition, the drug shows a dose-dependent decrease in bone mineral density (BMD), although its effect on long-term bone health and future fracture risk is unknown.1

Study specifics. The current study by Schlaff and colleagues was performed including 3 arms: a placebo arm, an elagolix 300 mg twice daily arm, and a third arm that received elagolix 300 mg twice daily and hormonal “add-back” therapy in the form of estradiol 1 mg and norethindrone acetate 0.5 mg daily. The authors actually report on two phase 3 six-month trials that were identical, double-blind, and randomized in nature. Both trials involved approximately 400 women. About 70% of the study participants overall were black, and the average age was approximately 42 years (range, 18 to 51). At baseline, BMD scores were mostly in the normal range. HMB for inclusion was defined as a volume of more than 80 mL per month.

The primary end point was menstrual blood loss volume less than 80 mL in the final month and at least a 50% reduction in menstrual blood loss from baseline to the final month. In the placebo group, only 9% and 10%, respectively, met these criteria.

Continue to: Results...

 

 

Results. In the first study group, 84% of those receiving elagolix alone achieved the primary end point, while the group that received elagolix plus add-back therapy had 69% success.

In the second study, both the elagolix group and the add-back group showed that 77% of patients met the primary end point criteria.

The incidences of hot flashes in the elagolix-alone groups were 64% and 43%, respectively, while with add-back therapy, they were 20% in both trials. In the placebo groups, 9% and 4% of participants reported hot flashes. At 6 months, the elagolix-only groups in both trials lost more BMD than the placebo groups, while BMD loss in both add-back groups was not statistically significant from the placebo groups.

Study strengths

Schlaff and colleagues conducted a very well-designed study. The two phase 3 clinical trials in preparation for drug approval were thorough and well reported. The authors are to be commended for including nearly 70% black women as study participants, since this is a racial group known to be affected by HMB resulting from fibroids.

Another strength was the addition of add-back therapy to the doses of elagolix. Concerns about bone loss from a health perspective and vasomotor symptoms from a quality-of-life perspective are not insignificant with elagolix-alone treatment, and proof that add-back therapy significantly diminishes or attenuates the efficacy of this entity is extremely important.

WHAT THIS EVIDENCE MEANS FOR PRACTICE

Elagolix is currently available (albeit not in the dosing regimen used in the current study or with built-in add-back therapy), and these study results offer an encouraging nonsurgical approach to HMB. The addition of add-back therapy to this oral GnRH antagonist will allow greater patient acceptance from a quality-of-life point of view because of diminution of vasomotor symptoms while maintaining BMD.

STEVEN R. GOLDSTEIN, MD

 

References
  1. Taylor HS, Giudice LC, Lessey BA, et al. Treatment of endometriosis-associated pain with elagolix, an oral GnRH antagonist. N Engl J Med. 2017;377:28-40.
     
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Steven R. Goldstein, MD, is Professor, Obstetrics and Gynecology, New York University School of Medicine, and Director of Gynecologic Ultrasound and Co-Director of Bone Densitometry, NYU Langone Medical Center, New York. He serves on the OBG Management Board of Editors.

The author reports being an advisory board member for AbbVie Inc.

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Steven R. Goldstein, MD, is Professor, Obstetrics and Gynecology, New York University School of Medicine, and Director of Gynecologic Ultrasound and Co-Director of Bone Densitometry, NYU Langone Medical Center, New York. He serves on the OBG Management Board of Editors.

The author reports being an advisory board member for AbbVie Inc.

Author and Disclosure Information

Steven R. Goldstein, MD, is Professor, Obstetrics and Gynecology, New York University School of Medicine, and Director of Gynecologic Ultrasound and Co-Director of Bone Densitometry, NYU Langone Medical Center, New York. He serves on the OBG Management Board of Editors.

The author reports being an advisory board member for AbbVie Inc.

Article PDF
Article PDF

Schlaff WD, Ackerman RT, Al-Hendy A, et al. Elagolix for heavy menstrual bleeding in women with uterine fibroids. N Engl J Med. 2020;382:328-340.

Expert Commentary

Any women’s health care provider is extremely aware of how common uterine fibroids (leiomyomas) are in reproductive-aged women. Bleeding associated with such fibroids is a common source of medical morbidity and reduced quality of life for many patients. The mainstay treatment approach for such patients has been surgical, which over time has become minimally invasive. Finding a nonsurgical treatment for patients with fibroid-associated HMB is of huge importance. The recent failure of the selective progesterone receptor modulator ulipristal acetate to be approved by the US Food and Drug Administration (FDA) was a significant setback to finding an excellent option for medical management. A gonadotropin-releasing hormone (GnRH) antagonist like elagolix could become an incredibly important “arrow in the quiver” of women’s health clinicians.

Details about elagolix

As mentioned, elagolix was FDA approved in 2-dose regimens for the treatment of dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia associated with endometriosis. One would expect that such a GnRH antagonist would reduce or eliminate HMB in patients with fibroids, although formal study had never been undertaken. Previous studies of elagolix had shown the most common adverse reaction to be vasomotor symptoms—hot flashes and night sweats. In addition, the drug shows a dose-dependent decrease in bone mineral density (BMD), although its effect on long-term bone health and future fracture risk is unknown.1

Study specifics. The current study by Schlaff and colleagues was performed including 3 arms: a placebo arm, an elagolix 300 mg twice daily arm, and a third arm that received elagolix 300 mg twice daily and hormonal “add-back” therapy in the form of estradiol 1 mg and norethindrone acetate 0.5 mg daily. The authors actually report on two phase 3 six-month trials that were identical, double-blind, and randomized in nature. Both trials involved approximately 400 women. About 70% of the study participants overall were black, and the average age was approximately 42 years (range, 18 to 51). At baseline, BMD scores were mostly in the normal range. HMB for inclusion was defined as a volume of more than 80 mL per month.

The primary end point was menstrual blood loss volume less than 80 mL in the final month and at least a 50% reduction in menstrual blood loss from baseline to the final month. In the placebo group, only 9% and 10%, respectively, met these criteria.

Continue to: Results...

 

 

Results. In the first study group, 84% of those receiving elagolix alone achieved the primary end point, while the group that received elagolix plus add-back therapy had 69% success.

In the second study, both the elagolix group and the add-back group showed that 77% of patients met the primary end point criteria.

The incidences of hot flashes in the elagolix-alone groups were 64% and 43%, respectively, while with add-back therapy, they were 20% in both trials. In the placebo groups, 9% and 4% of participants reported hot flashes. At 6 months, the elagolix-only groups in both trials lost more BMD than the placebo groups, while BMD loss in both add-back groups was not statistically significant from the placebo groups.

Study strengths

Schlaff and colleagues conducted a very well-designed study. The two phase 3 clinical trials in preparation for drug approval were thorough and well reported. The authors are to be commended for including nearly 70% black women as study participants, since this is a racial group known to be affected by HMB resulting from fibroids.

Another strength was the addition of add-back therapy to the doses of elagolix. Concerns about bone loss from a health perspective and vasomotor symptoms from a quality-of-life perspective are not insignificant with elagolix-alone treatment, and proof that add-back therapy significantly diminishes or attenuates the efficacy of this entity is extremely important.

WHAT THIS EVIDENCE MEANS FOR PRACTICE

Elagolix is currently available (albeit not in the dosing regimen used in the current study or with built-in add-back therapy), and these study results offer an encouraging nonsurgical approach to HMB. The addition of add-back therapy to this oral GnRH antagonist will allow greater patient acceptance from a quality-of-life point of view because of diminution of vasomotor symptoms while maintaining BMD.

STEVEN R. GOLDSTEIN, MD

 

Schlaff WD, Ackerman RT, Al-Hendy A, et al. Elagolix for heavy menstrual bleeding in women with uterine fibroids. N Engl J Med. 2020;382:328-340.

Expert Commentary

Any women’s health care provider is extremely aware of how common uterine fibroids (leiomyomas) are in reproductive-aged women. Bleeding associated with such fibroids is a common source of medical morbidity and reduced quality of life for many patients. The mainstay treatment approach for such patients has been surgical, which over time has become minimally invasive. Finding a nonsurgical treatment for patients with fibroid-associated HMB is of huge importance. The recent failure of the selective progesterone receptor modulator ulipristal acetate to be approved by the US Food and Drug Administration (FDA) was a significant setback to finding an excellent option for medical management. A gonadotropin-releasing hormone (GnRH) antagonist like elagolix could become an incredibly important “arrow in the quiver” of women’s health clinicians.

Details about elagolix

As mentioned, elagolix was FDA approved in 2-dose regimens for the treatment of dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia associated with endometriosis. One would expect that such a GnRH antagonist would reduce or eliminate HMB in patients with fibroids, although formal study had never been undertaken. Previous studies of elagolix had shown the most common adverse reaction to be vasomotor symptoms—hot flashes and night sweats. In addition, the drug shows a dose-dependent decrease in bone mineral density (BMD), although its effect on long-term bone health and future fracture risk is unknown.1

Study specifics. The current study by Schlaff and colleagues was performed including 3 arms: a placebo arm, an elagolix 300 mg twice daily arm, and a third arm that received elagolix 300 mg twice daily and hormonal “add-back” therapy in the form of estradiol 1 mg and norethindrone acetate 0.5 mg daily. The authors actually report on two phase 3 six-month trials that were identical, double-blind, and randomized in nature. Both trials involved approximately 400 women. About 70% of the study participants overall were black, and the average age was approximately 42 years (range, 18 to 51). At baseline, BMD scores were mostly in the normal range. HMB for inclusion was defined as a volume of more than 80 mL per month.

The primary end point was menstrual blood loss volume less than 80 mL in the final month and at least a 50% reduction in menstrual blood loss from baseline to the final month. In the placebo group, only 9% and 10%, respectively, met these criteria.

Continue to: Results...

 

 

Results. In the first study group, 84% of those receiving elagolix alone achieved the primary end point, while the group that received elagolix plus add-back therapy had 69% success.

In the second study, both the elagolix group and the add-back group showed that 77% of patients met the primary end point criteria.

The incidences of hot flashes in the elagolix-alone groups were 64% and 43%, respectively, while with add-back therapy, they were 20% in both trials. In the placebo groups, 9% and 4% of participants reported hot flashes. At 6 months, the elagolix-only groups in both trials lost more BMD than the placebo groups, while BMD loss in both add-back groups was not statistically significant from the placebo groups.

Study strengths

Schlaff and colleagues conducted a very well-designed study. The two phase 3 clinical trials in preparation for drug approval were thorough and well reported. The authors are to be commended for including nearly 70% black women as study participants, since this is a racial group known to be affected by HMB resulting from fibroids.

Another strength was the addition of add-back therapy to the doses of elagolix. Concerns about bone loss from a health perspective and vasomotor symptoms from a quality-of-life perspective are not insignificant with elagolix-alone treatment, and proof that add-back therapy significantly diminishes or attenuates the efficacy of this entity is extremely important.

WHAT THIS EVIDENCE MEANS FOR PRACTICE

Elagolix is currently available (albeit not in the dosing regimen used in the current study or with built-in add-back therapy), and these study results offer an encouraging nonsurgical approach to HMB. The addition of add-back therapy to this oral GnRH antagonist will allow greater patient acceptance from a quality-of-life point of view because of diminution of vasomotor symptoms while maintaining BMD.

STEVEN R. GOLDSTEIN, MD

 

References
  1. Taylor HS, Giudice LC, Lessey BA, et al. Treatment of endometriosis-associated pain with elagolix, an oral GnRH antagonist. N Engl J Med. 2017;377:28-40.
     
References
  1. Taylor HS, Giudice LC, Lessey BA, et al. Treatment of endometriosis-associated pain with elagolix, an oral GnRH antagonist. N Engl J Med. 2017;377:28-40.
     
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‘The kids will be all right,’ won’t they?

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Changed
Tue, 02/14/2023 - 13:03

Pediatric patients and COVID-19

The coronavirus disease 2019 (COVID-19) pandemic affects us in many ways. Pediatric patients, interestingly, are largely unaffected clinically by this disease. Less than 1% of documented infections occur in children under 10 years old, according to a review of over 72,000 cases from China.1 In that review, most children were asymptomatic or had mild illness, only three required intensive care, and only one death had been reported as of March 10, 2020. This is in stark contrast to the shocking morbidity and mortality statistics we are becoming all too familiar with on the adult side.

Dr. Andrea Hadley

From a social standpoint, however, our pediatric patients’ lives have been turned upside down. Their schedules and routines upended, their education and friendships interrupted, and many are likely experiencing real anxiety and fear.2 For countless children, school is a major source of social, emotional, and nutritional support that has been cut off. Some will lose parents, grandparents, or other loved ones to this disease. Parents will lose jobs and will be unable to afford necessities. Pediatric patients will experience delays of procedures or treatments because of the pandemic. Some have projected that rates of child abuse will increase as has been reported during natural disasters.3

Pediatricians around the country are coming together to tackle these issues in creative ways, including the rapid expansion of virtual/telehealth programs. The school systems are developing strategies to deliver online content, and even food, to their students’ homes. Hopefully these tactics will mitigate some of the potential effects on the mental and physical well-being of these patients.

How about my kids? Will they be all right? I am lucky that my husband and I will have jobs throughout this ordeal. Unfortunately, given my role as a hospitalist and my husband’s as a pulmonary/critical care physician, these same jobs that will keep our kids nourished and supported pose the greatest threat to them. As health care workers, we are worried about protecting our families, which may include vulnerable members. The Spanish health ministry announced that medical professionals account for approximately one in eight documented COVID-19 infections in Spain.4 With inadequate supplies of personal protective equipment (PPE) in our own nation, we are concerned that our statistics could be similar.

There are multiple strategies to protect ourselves and our families during this difficult time. First, appropriate PPE is essential and integrity with the process must be maintained always. Hospital leaders can protect us by tirelessly working to acquire PPE. In Grand Rapids, Mich., our health system has partnered with multiple local manufacturing companies, including Steelcase, who are producing PPE for our workforce.5 Leaders can diligently update their system’s PPE recommendations to be in line with the latest CDC recommendations and disseminate the information regularly. Hospitalists should frequently check with their Infection Prevention department to make sure they understand if there have been any changes to the recommendations. Innovative solutions for sterilization of PPE, stethoscopes, badges and other equipment, such as with the use of UV boxes or hydrogen peroxide vapor,6 should be explored to minimize contamination. Hospitalists should bring a set of clothes and shoes to change into upon arrival to work and to change out of prior to leaving the hospital.

We must also keep our heads strong. Currently the anxiety amongst physicians is palpable but there is solidarity. Hospital leaders must ensure that hospitalists have easy access to free mental health resources, such as virtual counseling. Wellness teams must rise to the occasion with innovative tactics to support us. For example, Spectrum Health’s wellness team is sponsoring a blog where physicians can discuss COVID-19–related challenges openly. Hospitalist leaders should ensure that there is a structure for debriefing after critical incidents, which are sure to increase in frequency. Email lists and discussion boards sponsored by professional society also provide a collaborative venue for some of these discussions. We must take advantage of these resources and communicate with each other.

For me, in the end it comes back to the kids. My kids and most pediatric patients are not likely to be hospitalized from COVID-19, but they are also not immune to the toll that fighting this pandemic will take on our families. We took an oath to protect our patients, but what do we owe to our own children? At a minimum we can optimize how we protect ourselves every day, both physically and mentally. As we come together as a strong community to fight this pandemic, in addition to saving lives, we are working to ensure that, in the end, the kids will be all right.
 

Dr. Hadley is chief of pediatric hospital medicine at Spectrum Health/Helen DeVos Children’s Hospital in Grand Rapids, Mich., and clinical assistant professor at Michigan State University, East Lansing.

References

1. Wu Z, McGoogan JM. Characteristics of and important lessons from the coronavirus disease 2019 (COVID-19) outbreak in China: Summary of a report of 72 314 cases from the Chinese Center for Disease Control and Prevention. JAMA. 2020 Feb 24. doi: 10.1001/jama.2020.2648.

2. Hagan JF Jr; American Academy of Pediatrics Committee on Psychosocial Aspects of Child and Family Health; Task Force on Terrorism. Psychosocial implications of disaster or terrorism on children: A guide for the pediatrician. Pediatrics. 2005;116(3):787-795.

3. Gearhart S et al. The impact of natural disasters on domestic violence: An analysis of reports of simple assault in Florida (1997-2007). Violence Gend. 2018 Jun. doi: 10.1089/vio.2017.0077.

4. Minder R, Peltier E. Virus knocks thousands of health workers out of action in Europe. The New York Times. March 24, 2020.

5. McVicar B. West Michigan businesses hustle to produce medical supplies amid coronavirus pandemic. MLive. March 25, 2020.

6. Kenney PA et al. Hydrogen Peroxide Vapor sterilization of N95 respirators for reuse. medRxiv preprint. 2020 Mar. doi: 10.1101/2020.03.24.20041087.
 

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Pediatric patients and COVID-19

Pediatric patients and COVID-19

The coronavirus disease 2019 (COVID-19) pandemic affects us in many ways. Pediatric patients, interestingly, are largely unaffected clinically by this disease. Less than 1% of documented infections occur in children under 10 years old, according to a review of over 72,000 cases from China.1 In that review, most children were asymptomatic or had mild illness, only three required intensive care, and only one death had been reported as of March 10, 2020. This is in stark contrast to the shocking morbidity and mortality statistics we are becoming all too familiar with on the adult side.

Dr. Andrea Hadley

From a social standpoint, however, our pediatric patients’ lives have been turned upside down. Their schedules and routines upended, their education and friendships interrupted, and many are likely experiencing real anxiety and fear.2 For countless children, school is a major source of social, emotional, and nutritional support that has been cut off. Some will lose parents, grandparents, or other loved ones to this disease. Parents will lose jobs and will be unable to afford necessities. Pediatric patients will experience delays of procedures or treatments because of the pandemic. Some have projected that rates of child abuse will increase as has been reported during natural disasters.3

Pediatricians around the country are coming together to tackle these issues in creative ways, including the rapid expansion of virtual/telehealth programs. The school systems are developing strategies to deliver online content, and even food, to their students’ homes. Hopefully these tactics will mitigate some of the potential effects on the mental and physical well-being of these patients.

How about my kids? Will they be all right? I am lucky that my husband and I will have jobs throughout this ordeal. Unfortunately, given my role as a hospitalist and my husband’s as a pulmonary/critical care physician, these same jobs that will keep our kids nourished and supported pose the greatest threat to them. As health care workers, we are worried about protecting our families, which may include vulnerable members. The Spanish health ministry announced that medical professionals account for approximately one in eight documented COVID-19 infections in Spain.4 With inadequate supplies of personal protective equipment (PPE) in our own nation, we are concerned that our statistics could be similar.

There are multiple strategies to protect ourselves and our families during this difficult time. First, appropriate PPE is essential and integrity with the process must be maintained always. Hospital leaders can protect us by tirelessly working to acquire PPE. In Grand Rapids, Mich., our health system has partnered with multiple local manufacturing companies, including Steelcase, who are producing PPE for our workforce.5 Leaders can diligently update their system’s PPE recommendations to be in line with the latest CDC recommendations and disseminate the information regularly. Hospitalists should frequently check with their Infection Prevention department to make sure they understand if there have been any changes to the recommendations. Innovative solutions for sterilization of PPE, stethoscopes, badges and other equipment, such as with the use of UV boxes or hydrogen peroxide vapor,6 should be explored to minimize contamination. Hospitalists should bring a set of clothes and shoes to change into upon arrival to work and to change out of prior to leaving the hospital.

We must also keep our heads strong. Currently the anxiety amongst physicians is palpable but there is solidarity. Hospital leaders must ensure that hospitalists have easy access to free mental health resources, such as virtual counseling. Wellness teams must rise to the occasion with innovative tactics to support us. For example, Spectrum Health’s wellness team is sponsoring a blog where physicians can discuss COVID-19–related challenges openly. Hospitalist leaders should ensure that there is a structure for debriefing after critical incidents, which are sure to increase in frequency. Email lists and discussion boards sponsored by professional society also provide a collaborative venue for some of these discussions. We must take advantage of these resources and communicate with each other.

For me, in the end it comes back to the kids. My kids and most pediatric patients are not likely to be hospitalized from COVID-19, but they are also not immune to the toll that fighting this pandemic will take on our families. We took an oath to protect our patients, but what do we owe to our own children? At a minimum we can optimize how we protect ourselves every day, both physically and mentally. As we come together as a strong community to fight this pandemic, in addition to saving lives, we are working to ensure that, in the end, the kids will be all right.
 

Dr. Hadley is chief of pediatric hospital medicine at Spectrum Health/Helen DeVos Children’s Hospital in Grand Rapids, Mich., and clinical assistant professor at Michigan State University, East Lansing.

References

1. Wu Z, McGoogan JM. Characteristics of and important lessons from the coronavirus disease 2019 (COVID-19) outbreak in China: Summary of a report of 72 314 cases from the Chinese Center for Disease Control and Prevention. JAMA. 2020 Feb 24. doi: 10.1001/jama.2020.2648.

2. Hagan JF Jr; American Academy of Pediatrics Committee on Psychosocial Aspects of Child and Family Health; Task Force on Terrorism. Psychosocial implications of disaster or terrorism on children: A guide for the pediatrician. Pediatrics. 2005;116(3):787-795.

3. Gearhart S et al. The impact of natural disasters on domestic violence: An analysis of reports of simple assault in Florida (1997-2007). Violence Gend. 2018 Jun. doi: 10.1089/vio.2017.0077.

4. Minder R, Peltier E. Virus knocks thousands of health workers out of action in Europe. The New York Times. March 24, 2020.

5. McVicar B. West Michigan businesses hustle to produce medical supplies amid coronavirus pandemic. MLive. March 25, 2020.

6. Kenney PA et al. Hydrogen Peroxide Vapor sterilization of N95 respirators for reuse. medRxiv preprint. 2020 Mar. doi: 10.1101/2020.03.24.20041087.
 

The coronavirus disease 2019 (COVID-19) pandemic affects us in many ways. Pediatric patients, interestingly, are largely unaffected clinically by this disease. Less than 1% of documented infections occur in children under 10 years old, according to a review of over 72,000 cases from China.1 In that review, most children were asymptomatic or had mild illness, only three required intensive care, and only one death had been reported as of March 10, 2020. This is in stark contrast to the shocking morbidity and mortality statistics we are becoming all too familiar with on the adult side.

Dr. Andrea Hadley

From a social standpoint, however, our pediatric patients’ lives have been turned upside down. Their schedules and routines upended, their education and friendships interrupted, and many are likely experiencing real anxiety and fear.2 For countless children, school is a major source of social, emotional, and nutritional support that has been cut off. Some will lose parents, grandparents, or other loved ones to this disease. Parents will lose jobs and will be unable to afford necessities. Pediatric patients will experience delays of procedures or treatments because of the pandemic. Some have projected that rates of child abuse will increase as has been reported during natural disasters.3

Pediatricians around the country are coming together to tackle these issues in creative ways, including the rapid expansion of virtual/telehealth programs. The school systems are developing strategies to deliver online content, and even food, to their students’ homes. Hopefully these tactics will mitigate some of the potential effects on the mental and physical well-being of these patients.

How about my kids? Will they be all right? I am lucky that my husband and I will have jobs throughout this ordeal. Unfortunately, given my role as a hospitalist and my husband’s as a pulmonary/critical care physician, these same jobs that will keep our kids nourished and supported pose the greatest threat to them. As health care workers, we are worried about protecting our families, which may include vulnerable members. The Spanish health ministry announced that medical professionals account for approximately one in eight documented COVID-19 infections in Spain.4 With inadequate supplies of personal protective equipment (PPE) in our own nation, we are concerned that our statistics could be similar.

There are multiple strategies to protect ourselves and our families during this difficult time. First, appropriate PPE is essential and integrity with the process must be maintained always. Hospital leaders can protect us by tirelessly working to acquire PPE. In Grand Rapids, Mich., our health system has partnered with multiple local manufacturing companies, including Steelcase, who are producing PPE for our workforce.5 Leaders can diligently update their system’s PPE recommendations to be in line with the latest CDC recommendations and disseminate the information regularly. Hospitalists should frequently check with their Infection Prevention department to make sure they understand if there have been any changes to the recommendations. Innovative solutions for sterilization of PPE, stethoscopes, badges and other equipment, such as with the use of UV boxes or hydrogen peroxide vapor,6 should be explored to minimize contamination. Hospitalists should bring a set of clothes and shoes to change into upon arrival to work and to change out of prior to leaving the hospital.

We must also keep our heads strong. Currently the anxiety amongst physicians is palpable but there is solidarity. Hospital leaders must ensure that hospitalists have easy access to free mental health resources, such as virtual counseling. Wellness teams must rise to the occasion with innovative tactics to support us. For example, Spectrum Health’s wellness team is sponsoring a blog where physicians can discuss COVID-19–related challenges openly. Hospitalist leaders should ensure that there is a structure for debriefing after critical incidents, which are sure to increase in frequency. Email lists and discussion boards sponsored by professional society also provide a collaborative venue for some of these discussions. We must take advantage of these resources and communicate with each other.

For me, in the end it comes back to the kids. My kids and most pediatric patients are not likely to be hospitalized from COVID-19, but they are also not immune to the toll that fighting this pandemic will take on our families. We took an oath to protect our patients, but what do we owe to our own children? At a minimum we can optimize how we protect ourselves every day, both physically and mentally. As we come together as a strong community to fight this pandemic, in addition to saving lives, we are working to ensure that, in the end, the kids will be all right.
 

Dr. Hadley is chief of pediatric hospital medicine at Spectrum Health/Helen DeVos Children’s Hospital in Grand Rapids, Mich., and clinical assistant professor at Michigan State University, East Lansing.

References

1. Wu Z, McGoogan JM. Characteristics of and important lessons from the coronavirus disease 2019 (COVID-19) outbreak in China: Summary of a report of 72 314 cases from the Chinese Center for Disease Control and Prevention. JAMA. 2020 Feb 24. doi: 10.1001/jama.2020.2648.

2. Hagan JF Jr; American Academy of Pediatrics Committee on Psychosocial Aspects of Child and Family Health; Task Force on Terrorism. Psychosocial implications of disaster or terrorism on children: A guide for the pediatrician. Pediatrics. 2005;116(3):787-795.

3. Gearhart S et al. The impact of natural disasters on domestic violence: An analysis of reports of simple assault in Florida (1997-2007). Violence Gend. 2018 Jun. doi: 10.1089/vio.2017.0077.

4. Minder R, Peltier E. Virus knocks thousands of health workers out of action in Europe. The New York Times. March 24, 2020.

5. McVicar B. West Michigan businesses hustle to produce medical supplies amid coronavirus pandemic. MLive. March 25, 2020.

6. Kenney PA et al. Hydrogen Peroxide Vapor sterilization of N95 respirators for reuse. medRxiv preprint. 2020 Mar. doi: 10.1101/2020.03.24.20041087.
 

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Many children with COVID-19 don’t have cough or fever

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Tue, 02/14/2023 - 13:03

The characteristic COVID-19 symptoms of cough, fever, and shortness of breath are less common in children than adults, according to the Centers for Disease and Prevention Control.

Among pediatric patients younger than 18 years in the United States, 73% had at least one of the trio of symptoms, compared with 93% of adults aged 18-64, noted Lucy A. McNamara, PhD, and the CDC’s COVID-19 response team, based on a preliminary analysis of the 149,082 cases reported as of April 2.

By a small margin, fever – present in 58% of pediatric patients – was the most common sign or symptom of COVID-19, compared with cough at 54% and shortness of breath in 13%. In adults, cough (81%) was seen most often, followed by fever (71%) and shortness of breath (43%), the investigators reported in the MMWR.

In both children and adults, headache and myalgia were more common than shortness of breath, as was sore throat in children, the team added.

“These findings are largely consistent with a report on pediatric COVID-19 patients aged <16 years in China, which found that only 41.5% of pediatric patients had fever [and] 48.5% had cough,” they wrote.

The CDC analysis of pediatric patients was limited by its small sample size, with data on signs and symptoms available for only 11% (291) of the 2,572 children known to have COVID-19 as of April 2. The adult population included 10,944 individuals, who represented 9.6% of the 113,985 U.S. patients aged 18-65, the response team said.

“As the number of COVID-19 cases continues to increase in many parts of the United States, it will be important to adapt COVID-19 surveillance strategies to maintain collection of critical case information without overburdening jurisdiction health departments,” they said.

SOURCE: McNamara LA et al. MMWR 2020 Apr 6;69(early release):1-5.

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The characteristic COVID-19 symptoms of cough, fever, and shortness of breath are less common in children than adults, according to the Centers for Disease and Prevention Control.

Among pediatric patients younger than 18 years in the United States, 73% had at least one of the trio of symptoms, compared with 93% of adults aged 18-64, noted Lucy A. McNamara, PhD, and the CDC’s COVID-19 response team, based on a preliminary analysis of the 149,082 cases reported as of April 2.

By a small margin, fever – present in 58% of pediatric patients – was the most common sign or symptom of COVID-19, compared with cough at 54% and shortness of breath in 13%. In adults, cough (81%) was seen most often, followed by fever (71%) and shortness of breath (43%), the investigators reported in the MMWR.

In both children and adults, headache and myalgia were more common than shortness of breath, as was sore throat in children, the team added.

“These findings are largely consistent with a report on pediatric COVID-19 patients aged <16 years in China, which found that only 41.5% of pediatric patients had fever [and] 48.5% had cough,” they wrote.

The CDC analysis of pediatric patients was limited by its small sample size, with data on signs and symptoms available for only 11% (291) of the 2,572 children known to have COVID-19 as of April 2. The adult population included 10,944 individuals, who represented 9.6% of the 113,985 U.S. patients aged 18-65, the response team said.

“As the number of COVID-19 cases continues to increase in many parts of the United States, it will be important to adapt COVID-19 surveillance strategies to maintain collection of critical case information without overburdening jurisdiction health departments,” they said.

SOURCE: McNamara LA et al. MMWR 2020 Apr 6;69(early release):1-5.

The characteristic COVID-19 symptoms of cough, fever, and shortness of breath are less common in children than adults, according to the Centers for Disease and Prevention Control.

Among pediatric patients younger than 18 years in the United States, 73% had at least one of the trio of symptoms, compared with 93% of adults aged 18-64, noted Lucy A. McNamara, PhD, and the CDC’s COVID-19 response team, based on a preliminary analysis of the 149,082 cases reported as of April 2.

By a small margin, fever – present in 58% of pediatric patients – was the most common sign or symptom of COVID-19, compared with cough at 54% and shortness of breath in 13%. In adults, cough (81%) was seen most often, followed by fever (71%) and shortness of breath (43%), the investigators reported in the MMWR.

In both children and adults, headache and myalgia were more common than shortness of breath, as was sore throat in children, the team added.

“These findings are largely consistent with a report on pediatric COVID-19 patients aged <16 years in China, which found that only 41.5% of pediatric patients had fever [and] 48.5% had cough,” they wrote.

The CDC analysis of pediatric patients was limited by its small sample size, with data on signs and symptoms available for only 11% (291) of the 2,572 children known to have COVID-19 as of April 2. The adult population included 10,944 individuals, who represented 9.6% of the 113,985 U.S. patients aged 18-65, the response team said.

“As the number of COVID-19 cases continues to increase in many parts of the United States, it will be important to adapt COVID-19 surveillance strategies to maintain collection of critical case information without overburdening jurisdiction health departments,” they said.

SOURCE: McNamara LA et al. MMWR 2020 Apr 6;69(early release):1-5.

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AAP issues guidance on managing infants born to mothers with COVID-19

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Tue, 02/14/2023 - 13:04

As clinicians grapple with the COVID-19 pandemic, the American Academy of Pediatrics has released interim guidance on managing infants born of infected mothers.

CDC/ Dr. Fred Murphy; Sylvia Whitfield

“Pediatric cases of COVID-19 are so far reported as less severe than disease occurring among older individuals,” Karen M. Puopolo, MD, PhD, a neonatologist and chief of the section on newborn pediatrics at Pennsylvania Hospital, Philadelphia, and coauthors wrote in the 18-page document, which was released on April 2, 2020, along with an abbreviated “Frequently Asked Questions” summary. However, one study of children with COVID-19 in China found that 12% of confirmed cases occurred among 731 infants aged less than 1 year; 24% of those 86 infants “suffered severe or critical illness” (Pediatrics. 2020 March. doi: 10.1542/peds.2020-0702). There were no deaths reported among these infants. Other case reports have documented COVID-19 in children aged as young as 2 days.

The document, which was assembled by members of the AAP Committee on Fetus and Newborn, Section on Neonatal Perinatal Medicine, and Committee on Infectious Diseases, pointed out that “considerable uncertainty” exists about the possibility for vertical transmission of SARS-CoV-2 from infected pregnant women to their newborns. “Evidence-based guidelines for managing antenatal, intrapartum, and neonatal care around COVID-19 would require an understanding of whether the virus can be transmitted transplacentally; a determination of which maternal body fluids may be infectious; and data of adequate statistical power that describe which maternal, intrapartum, and neonatal factors influence perinatal transmission,” according to the document. “In the midst of the pandemic these data do not exist, with only limited information currently available to address these issues.”

Based on the best available evidence, the guidance authors recommend that clinicians temporarily separate newborns from affected mothers to minimize the risk of postnatal infant infection from maternal respiratory secretions. “Newborns should be bathed as soon as reasonably possible after birth to remove virus potentially present on skin surfaces,” they wrote. “Clinical staff should use airborne, droplet, and contact precautions until newborn virologic status is known to be negative by SARS-CoV-2 [polymerase chain reaction] testing.”



While SARS-CoV-2 has not been detected in breast milk to date, the authors noted that mothers with COVID-19 can express breast milk to be fed to their infants by uninfected caregivers until specific maternal criteria are met. In addition, infants born to mothers with COVID-19 should be tested for SARS-CoV-2 at 24 hours and, if still in the birth facility, at 48 hours after birth. Centers with limited resources for testing may make individual risk/benefit decisions regarding testing.

For infants infected with SARS-CoV-2 but have no symptoms of the disease, they “may be discharged home on a case-by-case basis with appropriate precautions and plans for frequent outpatient follow-up contacts (either by phone, telemedicine, or in office) through 14 days after birth,” according to the document.

If both infant and mother are discharged from the hospital and the mother still has COVID-19 symptoms, she should maintain at least 6 feet of distance from the baby; if she is in closer proximity she should use a mask and hand hygiene. The mother can stop such precautions until she is afebrile without the use of antipyretics for at least 72 hours, and it is at least 7 days since her symptoms first occurred.

In cases where infants require ongoing neonatal intensive care, mothers infected with COVID-19 should not visit their newborn until she is afebrile without the use of antipyretics for at least 72 hours, her respiratory symptoms are improved, and she has negative results of a molecular assay for detection of SARS-CoV-2 from at least two consecutive nasopharyngeal swab specimens collected at least 24 hours apart.

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As clinicians grapple with the COVID-19 pandemic, the American Academy of Pediatrics has released interim guidance on managing infants born of infected mothers.

CDC/ Dr. Fred Murphy; Sylvia Whitfield

“Pediatric cases of COVID-19 are so far reported as less severe than disease occurring among older individuals,” Karen M. Puopolo, MD, PhD, a neonatologist and chief of the section on newborn pediatrics at Pennsylvania Hospital, Philadelphia, and coauthors wrote in the 18-page document, which was released on April 2, 2020, along with an abbreviated “Frequently Asked Questions” summary. However, one study of children with COVID-19 in China found that 12% of confirmed cases occurred among 731 infants aged less than 1 year; 24% of those 86 infants “suffered severe or critical illness” (Pediatrics. 2020 March. doi: 10.1542/peds.2020-0702). There were no deaths reported among these infants. Other case reports have documented COVID-19 in children aged as young as 2 days.

The document, which was assembled by members of the AAP Committee on Fetus and Newborn, Section on Neonatal Perinatal Medicine, and Committee on Infectious Diseases, pointed out that “considerable uncertainty” exists about the possibility for vertical transmission of SARS-CoV-2 from infected pregnant women to their newborns. “Evidence-based guidelines for managing antenatal, intrapartum, and neonatal care around COVID-19 would require an understanding of whether the virus can be transmitted transplacentally; a determination of which maternal body fluids may be infectious; and data of adequate statistical power that describe which maternal, intrapartum, and neonatal factors influence perinatal transmission,” according to the document. “In the midst of the pandemic these data do not exist, with only limited information currently available to address these issues.”

Based on the best available evidence, the guidance authors recommend that clinicians temporarily separate newborns from affected mothers to minimize the risk of postnatal infant infection from maternal respiratory secretions. “Newborns should be bathed as soon as reasonably possible after birth to remove virus potentially present on skin surfaces,” they wrote. “Clinical staff should use airborne, droplet, and contact precautions until newborn virologic status is known to be negative by SARS-CoV-2 [polymerase chain reaction] testing.”



While SARS-CoV-2 has not been detected in breast milk to date, the authors noted that mothers with COVID-19 can express breast milk to be fed to their infants by uninfected caregivers until specific maternal criteria are met. In addition, infants born to mothers with COVID-19 should be tested for SARS-CoV-2 at 24 hours and, if still in the birth facility, at 48 hours after birth. Centers with limited resources for testing may make individual risk/benefit decisions regarding testing.

For infants infected with SARS-CoV-2 but have no symptoms of the disease, they “may be discharged home on a case-by-case basis with appropriate precautions and plans for frequent outpatient follow-up contacts (either by phone, telemedicine, or in office) through 14 days after birth,” according to the document.

If both infant and mother are discharged from the hospital and the mother still has COVID-19 symptoms, she should maintain at least 6 feet of distance from the baby; if she is in closer proximity she should use a mask and hand hygiene. The mother can stop such precautions until she is afebrile without the use of antipyretics for at least 72 hours, and it is at least 7 days since her symptoms first occurred.

In cases where infants require ongoing neonatal intensive care, mothers infected with COVID-19 should not visit their newborn until she is afebrile without the use of antipyretics for at least 72 hours, her respiratory symptoms are improved, and she has negative results of a molecular assay for detection of SARS-CoV-2 from at least two consecutive nasopharyngeal swab specimens collected at least 24 hours apart.

[email protected]
 

As clinicians grapple with the COVID-19 pandemic, the American Academy of Pediatrics has released interim guidance on managing infants born of infected mothers.

CDC/ Dr. Fred Murphy; Sylvia Whitfield

“Pediatric cases of COVID-19 are so far reported as less severe than disease occurring among older individuals,” Karen M. Puopolo, MD, PhD, a neonatologist and chief of the section on newborn pediatrics at Pennsylvania Hospital, Philadelphia, and coauthors wrote in the 18-page document, which was released on April 2, 2020, along with an abbreviated “Frequently Asked Questions” summary. However, one study of children with COVID-19 in China found that 12% of confirmed cases occurred among 731 infants aged less than 1 year; 24% of those 86 infants “suffered severe or critical illness” (Pediatrics. 2020 March. doi: 10.1542/peds.2020-0702). There were no deaths reported among these infants. Other case reports have documented COVID-19 in children aged as young as 2 days.

The document, which was assembled by members of the AAP Committee on Fetus and Newborn, Section on Neonatal Perinatal Medicine, and Committee on Infectious Diseases, pointed out that “considerable uncertainty” exists about the possibility for vertical transmission of SARS-CoV-2 from infected pregnant women to their newborns. “Evidence-based guidelines for managing antenatal, intrapartum, and neonatal care around COVID-19 would require an understanding of whether the virus can be transmitted transplacentally; a determination of which maternal body fluids may be infectious; and data of adequate statistical power that describe which maternal, intrapartum, and neonatal factors influence perinatal transmission,” according to the document. “In the midst of the pandemic these data do not exist, with only limited information currently available to address these issues.”

Based on the best available evidence, the guidance authors recommend that clinicians temporarily separate newborns from affected mothers to minimize the risk of postnatal infant infection from maternal respiratory secretions. “Newborns should be bathed as soon as reasonably possible after birth to remove virus potentially present on skin surfaces,” they wrote. “Clinical staff should use airborne, droplet, and contact precautions until newborn virologic status is known to be negative by SARS-CoV-2 [polymerase chain reaction] testing.”



While SARS-CoV-2 has not been detected in breast milk to date, the authors noted that mothers with COVID-19 can express breast milk to be fed to their infants by uninfected caregivers until specific maternal criteria are met. In addition, infants born to mothers with COVID-19 should be tested for SARS-CoV-2 at 24 hours and, if still in the birth facility, at 48 hours after birth. Centers with limited resources for testing may make individual risk/benefit decisions regarding testing.

For infants infected with SARS-CoV-2 but have no symptoms of the disease, they “may be discharged home on a case-by-case basis with appropriate precautions and plans for frequent outpatient follow-up contacts (either by phone, telemedicine, or in office) through 14 days after birth,” according to the document.

If both infant and mother are discharged from the hospital and the mother still has COVID-19 symptoms, she should maintain at least 6 feet of distance from the baby; if she is in closer proximity she should use a mask and hand hygiene. The mother can stop such precautions until she is afebrile without the use of antipyretics for at least 72 hours, and it is at least 7 days since her symptoms first occurred.

In cases where infants require ongoing neonatal intensive care, mothers infected with COVID-19 should not visit their newborn until she is afebrile without the use of antipyretics for at least 72 hours, her respiratory symptoms are improved, and she has negative results of a molecular assay for detection of SARS-CoV-2 from at least two consecutive nasopharyngeal swab specimens collected at least 24 hours apart.

[email protected]
 

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