MDedge Rheumatology

In early April, Maura Quinlan, MD, was working nights on the labor and delivery unit at Northwestern Medicine Prentice Women’s Hospital in Chicago. At the time, hospital policy was to test only patients with known COVID-19 symptoms for SARS-CoV-2. Women in labor wore N95 masks, but only while pushing – and practitioners didn’t always don proper protection in time.

Babies came and families rejoiced. But Dr. Quinlan looks back on those weeks with a degree of horror. “We were laboring a bunch of patients that probably had COVID,” she said, and they were doing so without proper protection.

She’s probably right. According to one study in the New England Journal of Medicine, 13.7% of 211 women who came into the labor and delivery unit at one New York City hospital between March 22 and April 2 were asymptomatic but infected, potentially putting staff and doctors at risk.

Dr. Quinlan already knew she and her fellow ob.gyns. had been walking a thin line and, upon seeing that research, her heart sank. In the middle of a pandemic, they had been racing to keep up with the reality of delivering babies. But despite their efforts to protect both practitioners and patients, some aspects slipped through the cracks. Today, every laboring patient admitted to Northwestern is now tested for the novel coronavirus.

Across the country, hospital labor and delivery wards have been working to find a careful and informed balance among multiple competing interests: the safety of their health care workers, the health of tiny and vulnerable new humans, and the stability of a birthing mother. Each hospital has been making the best decisions it can based on available data. The result is a patchwork of policies, but all of them center around rapid testing and appropriate protection.
 

Shifting recommendations

One case study of women in a New York City hospital during the height of the city’s surge found that, of seven confirmed COVID-19–positive patients, two were asymptomatic upon admission to the obstetrical service, and these same two patients ultimately required unplanned ICU admission. The women’s care prior to their positive diagnosis had exposed multiple health care workers, all of whom lacked appropriate personal protective equipment (PPE), the study authors wrote. “Further, five of seven confirmed COVID-19–positive women were afebrile on initial screen, and four did not first report a cough. In some locations where testing availability remains limited, the minimal symptoms reported for some of these cases might have been insufficient to prompt COVID-19 testing.”

As studies like this pour in, societies continue to update their recommendations accordingly. The latest guidance from the American College of Obstetricians and Gynecologists came on July 1. The group suggests testing all labor and delivery patients, particularly in high-prevalence areas. If tests are in short supply, it recommends prioritizing testing pregnant women with suspected COVID-19 and those who develop symptoms during admission.

At Northwestern, the hospital requests patients stay home and quarantine for the weeks leading up to their delivery date. Then, they rapidly test every patient who comes in for delivery and aim to have results available within a few hours.

The hospital’s 30-room labor and delivery wing remains reserved for patients who test negative. Those with positive COVID-19 results are sent to a 6-bed COVID labor and delivery unit elsewhere in the hospital. “We were lucky we had the space to do that, because smaller community hospitals wouldn’t have a separate unused unit where they could put these women,” Dr. Quinlan said.

In the COVID unit, women deliver without a support person – no partner, doula, or family member can join. Doctors and nurses wear full PPE and work only in that ward. And because some research shows that pregnant women who are asymptomatic or presymptomatic may develop symptoms quickly after starting labor with no measurable illness, Dr. Quinlan must decide on a case-by-case basis what to do, if anything at all.

Delaying an induction could allow the infection to resolve or it could result in her patient moving from presymptomatic disease to full-blown pneumonia. Accelerating labor could bring on symptoms or it could allow a mother to deliver safely and get out of the hospital as quickly as possible. “There is an advantage to having the baby now if you feel okay – even if it’s alone – and getting home,” Dr. Quinlan said.

The hospital also tests the partners of women who are COVID-19 positive. Those with negative results can take the newborn home and try to maintain distance until the mother is no longer symptomatic.

In different parts of the country, hospitals have developed different approaches. Southern California is experiencing its own surge, but at the Ronald Reagan University of California, Los Angeles, Medical Center there still haven’t been enough COVID-19 patients to warrant a separate labor and delivery unit.

At UCLA, staff swab patients when they enter the labor and delivery ward — those who test positive have specific room designations. For both COVID-19–positive patients and women who progress faster than test results can be returned, the goals are the same, said Rashmi Rao, MD, an ob.gyn. at UCLA: Deliver in the safest way possible for both mother and baby.

All women, positive or negative, must wear masks during labor – as much as they can tolerate, at least. For patients who are only mildly ill or asymptomatic, the only difference is that everyone wears protective gear. But if a patient’s oxygen levels dip, or her baby is in distress, the team moves more quickly to a cesarean delivery than they’d do with a healthy patient.

Just as hospital policies have been evolving, rules for visitors have been constantly changing too. Initially, UCLA allowed a support person to be present during delivery but had to leave immediately following. Now, each new mother is allowed one visitor for the duration of their stay. And the hospital suggests that patients who are COVID-19 positive recover in separate rooms from their babies and encourages them to maintain distance from their infants, except when breastfeeding.

“We respect and understand that this is a joyous occasion and we’re trying to keep families together as much as possible,” Dr. Rao said.
 

Care conundrums

How hospitals protect their smallest charges keeps changing too. Reports have been circulating about newborns being taken away from COVID-19-positive mothers, especially in marginalized communities. The stories have led many to worry they’d be forcibly separated from their babies. Most hospitals, however, leave it up to the woman and her doctors to decide how much separation is needed. “After delivery, it depends on how someone is feeling,” Dr. Rao said.

The American Academy of Pediatrics recommends that mothers who are COVID-19–positive pump breast milk and have a healthy caregiver use that milk, or formula, to bottle-feed the baby, with the new mother remaining 6 feet away from the child as much as she can. If that’s not possible, she should wear gloves and a mask while breastfeeding until she has been naturally afebrile for 72 hours and at least 1 week removed from the first appearance of her symptoms.

“It’s tragically hard,” said Dr. Quinlan, to keep a COVID-19–positive mother even 6 feet away from her newborn baby. “If a mother declines separation, we ask the acting pediatric team to discuss the theoretical risks and paucity of data.”

Until recently, research indicated that SARS-CoV-2 wasn’t being transmitted through the uterus from mothers to their babies. And despite a recent case study reporting transplacental transmission between a mother and her fetus in France, researchers still say that the risk of transference is low. To ensure newborn risk remains as low as possible, UCLA’s policy is to swab the baby when he/she is 24 hours old and keep watch for signs of infection: increased lethargy, difficulty waking, or gastrointestinal symptoms like vomiting.

Transmission via breast milk has also, to date, proven relatively unlikely. One study in The Lancet detected the novel coronavirus in breast milk, although it’s not clear that the virus can be passed on in the fluid, says Christina Chambers, PhD, a professor of pediatrics at the University of California, San Diego. Dr. Chambers is studying breast milk to see if the virus or antibodies to it are present. She is also investigating how infection with SARS-CoV-2 impacts women at different times in pregnancy, something that’s still an open question.

“[In] pregnant women with a deteriorating infection, the decisions are the same you would make with any delivery: Save the mom and save the baby,” Dr. Chambers said. “Beyond that, I am encouraged to see that pregnant women are prioritized to being tested,” something that will help researchers understand prevalence of disease in order to better understand whether some symptoms are more dangerous than others.

The situation is evolving so quickly that hospitals and providers are simply trying to stay abreast of the flood of new research. In the absence of definitive answers, they are using the information available and adjusting on the fly. “We are cautiously waiting for more data,” said Dr. Rao. “With the information we have we are doing the best we can to keep our patients safe. And we’re just going to keep at it.”

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

In early April, Maura Quinlan, MD, was working nights on the labor and delivery unit at Northwestern Medicine Prentice Women’s Hospital in Chicago. At the time, hospital policy was to test only patients with known COVID-19 symptoms for SARS-CoV-2. Women in labor wore N95 masks, but only while pushing – and practitioners didn’t always don proper protection in time.

Babies came and families rejoiced. But Dr. Quinlan looks back on those weeks with a degree of horror. “We were laboring a bunch of patients that probably had COVID,” she said, and they were doing so without proper protection.

She’s probably right. According to one study in the New England Journal of Medicine, 13.7% of 211 women who came into the labor and delivery unit at one New York City hospital between March 22 and April 2 were asymptomatic but infected, potentially putting staff and doctors at risk.

Dr. Quinlan already knew she and her fellow ob.gyns. had been walking a thin line and, upon seeing that research, her heart sank. In the middle of a pandemic, they had been racing to keep up with the reality of delivering babies. But despite their efforts to protect both practitioners and patients, some aspects slipped through the cracks. Today, every laboring patient admitted to Northwestern is now tested for the novel coronavirus.

Across the country, hospital labor and delivery wards have been working to find a careful and informed balance among multiple competing interests: the safety of their health care workers, the health of tiny and vulnerable new humans, and the stability of a birthing mother. Each hospital has been making the best decisions it can based on available data. The result is a patchwork of policies, but all of them center around rapid testing and appropriate protection.
 

Shifting recommendations

One case study of women in a New York City hospital during the height of the city’s surge found that, of seven confirmed COVID-19–positive patients, two were asymptomatic upon admission to the obstetrical service, and these same two patients ultimately required unplanned ICU admission. The women’s care prior to their positive diagnosis had exposed multiple health care workers, all of whom lacked appropriate personal protective equipment (PPE), the study authors wrote. “Further, five of seven confirmed COVID-19–positive women were afebrile on initial screen, and four did not first report a cough. In some locations where testing availability remains limited, the minimal symptoms reported for some of these cases might have been insufficient to prompt COVID-19 testing.”

As studies like this pour in, societies continue to update their recommendations accordingly. The latest guidance from the American College of Obstetricians and Gynecologists came on July 1. The group suggests testing all labor and delivery patients, particularly in high-prevalence areas. If tests are in short supply, it recommends prioritizing testing pregnant women with suspected COVID-19 and those who develop symptoms during admission.

At Northwestern, the hospital requests patients stay home and quarantine for the weeks leading up to their delivery date. Then, they rapidly test every patient who comes in for delivery and aim to have results available within a few hours.

The hospital’s 30-room labor and delivery wing remains reserved for patients who test negative. Those with positive COVID-19 results are sent to a 6-bed COVID labor and delivery unit elsewhere in the hospital. “We were lucky we had the space to do that, because smaller community hospitals wouldn’t have a separate unused unit where they could put these women,” Dr. Quinlan said.

In the COVID unit, women deliver without a support person – no partner, doula, or family member can join. Doctors and nurses wear full PPE and work only in that ward. And because some research shows that pregnant women who are asymptomatic or presymptomatic may develop symptoms quickly after starting labor with no measurable illness, Dr. Quinlan must decide on a case-by-case basis what to do, if anything at all.

Delaying an induction could allow the infection to resolve or it could result in her patient moving from presymptomatic disease to full-blown pneumonia. Accelerating labor could bring on symptoms or it could allow a mother to deliver safely and get out of the hospital as quickly as possible. “There is an advantage to having the baby now if you feel okay – even if it’s alone – and getting home,” Dr. Quinlan said.

The hospital also tests the partners of women who are COVID-19 positive. Those with negative results can take the newborn home and try to maintain distance until the mother is no longer symptomatic.

In different parts of the country, hospitals have developed different approaches. Southern California is experiencing its own surge, but at the Ronald Reagan University of California, Los Angeles, Medical Center there still haven’t been enough COVID-19 patients to warrant a separate labor and delivery unit.

At UCLA, staff swab patients when they enter the labor and delivery ward — those who test positive have specific room designations. For both COVID-19–positive patients and women who progress faster than test results can be returned, the goals are the same, said Rashmi Rao, MD, an ob.gyn. at UCLA: Deliver in the safest way possible for both mother and baby.

All women, positive or negative, must wear masks during labor – as much as they can tolerate, at least. For patients who are only mildly ill or asymptomatic, the only difference is that everyone wears protective gear. But if a patient’s oxygen levels dip, or her baby is in distress, the team moves more quickly to a cesarean delivery than they’d do with a healthy patient.

Just as hospital policies have been evolving, rules for visitors have been constantly changing too. Initially, UCLA allowed a support person to be present during delivery but had to leave immediately following. Now, each new mother is allowed one visitor for the duration of their stay. And the hospital suggests that patients who are COVID-19 positive recover in separate rooms from their babies and encourages them to maintain distance from their infants, except when breastfeeding.

“We respect and understand that this is a joyous occasion and we’re trying to keep families together as much as possible,” Dr. Rao said.
 

Care conundrums

How hospitals protect their smallest charges keeps changing too. Reports have been circulating about newborns being taken away from COVID-19-positive mothers, especially in marginalized communities. The stories have led many to worry they’d be forcibly separated from their babies. Most hospitals, however, leave it up to the woman and her doctors to decide how much separation is needed. “After delivery, it depends on how someone is feeling,” Dr. Rao said.

The American Academy of Pediatrics recommends that mothers who are COVID-19–positive pump breast milk and have a healthy caregiver use that milk, or formula, to bottle-feed the baby, with the new mother remaining 6 feet away from the child as much as she can. If that’s not possible, she should wear gloves and a mask while breastfeeding until she has been naturally afebrile for 72 hours and at least 1 week removed from the first appearance of her symptoms.

“It’s tragically hard,” said Dr. Quinlan, to keep a COVID-19–positive mother even 6 feet away from her newborn baby. “If a mother declines separation, we ask the acting pediatric team to discuss the theoretical risks and paucity of data.”

Until recently, research indicated that SARS-CoV-2 wasn’t being transmitted through the uterus from mothers to their babies. And despite a recent case study reporting transplacental transmission between a mother and her fetus in France, researchers still say that the risk of transference is low. To ensure newborn risk remains as low as possible, UCLA’s policy is to swab the baby when he/she is 24 hours old and keep watch for signs of infection: increased lethargy, difficulty waking, or gastrointestinal symptoms like vomiting.

Transmission via breast milk has also, to date, proven relatively unlikely. One study in The Lancet detected the novel coronavirus in breast milk, although it’s not clear that the virus can be passed on in the fluid, says Christina Chambers, PhD, a professor of pediatrics at the University of California, San Diego. Dr. Chambers is studying breast milk to see if the virus or antibodies to it are present. She is also investigating how infection with SARS-CoV-2 impacts women at different times in pregnancy, something that’s still an open question.

“[In] pregnant women with a deteriorating infection, the decisions are the same you would make with any delivery: Save the mom and save the baby,” Dr. Chambers said. “Beyond that, I am encouraged to see that pregnant women are prioritized to being tested,” something that will help researchers understand prevalence of disease in order to better understand whether some symptoms are more dangerous than others.

The situation is evolving so quickly that hospitals and providers are simply trying to stay abreast of the flood of new research. In the absence of definitive answers, they are using the information available and adjusting on the fly. “We are cautiously waiting for more data,” said Dr. Rao. “With the information we have we are doing the best we can to keep our patients safe. And we’re just going to keep at it.”

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

In early April, Maura Quinlan, MD, was working nights on the labor and delivery unit at Northwestern Medicine Prentice Women’s Hospital in Chicago. At the time, hospital policy was to test only patients with known COVID-19 symptoms for SARS-CoV-2. Women in labor wore N95 masks, but only while pushing – and practitioners didn’t always don proper protection in time.

Babies came and families rejoiced. But Dr. Quinlan looks back on those weeks with a degree of horror. “We were laboring a bunch of patients that probably had COVID,” she said, and they were doing so without proper protection.

She’s probably right. According to one study in the New England Journal of Medicine, 13.7% of 211 women who came into the labor and delivery unit at one New York City hospital between March 22 and April 2 were asymptomatic but infected, potentially putting staff and doctors at risk.

Dr. Quinlan already knew she and her fellow ob.gyns. had been walking a thin line and, upon seeing that research, her heart sank. In the middle of a pandemic, they had been racing to keep up with the reality of delivering babies. But despite their efforts to protect both practitioners and patients, some aspects slipped through the cracks. Today, every laboring patient admitted to Northwestern is now tested for the novel coronavirus.

Across the country, hospital labor and delivery wards have been working to find a careful and informed balance among multiple competing interests: the safety of their health care workers, the health of tiny and vulnerable new humans, and the stability of a birthing mother. Each hospital has been making the best decisions it can based on available data. The result is a patchwork of policies, but all of them center around rapid testing and appropriate protection.
 

Shifting recommendations

One case study of women in a New York City hospital during the height of the city’s surge found that, of seven confirmed COVID-19–positive patients, two were asymptomatic upon admission to the obstetrical service, and these same two patients ultimately required unplanned ICU admission. The women’s care prior to their positive diagnosis had exposed multiple health care workers, all of whom lacked appropriate personal protective equipment (PPE), the study authors wrote. “Further, five of seven confirmed COVID-19–positive women were afebrile on initial screen, and four did not first report a cough. In some locations where testing availability remains limited, the minimal symptoms reported for some of these cases might have been insufficient to prompt COVID-19 testing.”

As studies like this pour in, societies continue to update their recommendations accordingly. The latest guidance from the American College of Obstetricians and Gynecologists came on July 1. The group suggests testing all labor and delivery patients, particularly in high-prevalence areas. If tests are in short supply, it recommends prioritizing testing pregnant women with suspected COVID-19 and those who develop symptoms during admission.

At Northwestern, the hospital requests patients stay home and quarantine for the weeks leading up to their delivery date. Then, they rapidly test every patient who comes in for delivery and aim to have results available within a few hours.

The hospital’s 30-room labor and delivery wing remains reserved for patients who test negative. Those with positive COVID-19 results are sent to a 6-bed COVID labor and delivery unit elsewhere in the hospital. “We were lucky we had the space to do that, because smaller community hospitals wouldn’t have a separate unused unit where they could put these women,” Dr. Quinlan said.

In the COVID unit, women deliver without a support person – no partner, doula, or family member can join. Doctors and nurses wear full PPE and work only in that ward. And because some research shows that pregnant women who are asymptomatic or presymptomatic may develop symptoms quickly after starting labor with no measurable illness, Dr. Quinlan must decide on a case-by-case basis what to do, if anything at all.

Delaying an induction could allow the infection to resolve or it could result in her patient moving from presymptomatic disease to full-blown pneumonia. Accelerating labor could bring on symptoms or it could allow a mother to deliver safely and get out of the hospital as quickly as possible. “There is an advantage to having the baby now if you feel okay – even if it’s alone – and getting home,” Dr. Quinlan said.

The hospital also tests the partners of women who are COVID-19 positive. Those with negative results can take the newborn home and try to maintain distance until the mother is no longer symptomatic.

In different parts of the country, hospitals have developed different approaches. Southern California is experiencing its own surge, but at the Ronald Reagan University of California, Los Angeles, Medical Center there still haven’t been enough COVID-19 patients to warrant a separate labor and delivery unit.

At UCLA, staff swab patients when they enter the labor and delivery ward — those who test positive have specific room designations. For both COVID-19–positive patients and women who progress faster than test results can be returned, the goals are the same, said Rashmi Rao, MD, an ob.gyn. at UCLA: Deliver in the safest way possible for both mother and baby.

All women, positive or negative, must wear masks during labor – as much as they can tolerate, at least. For patients who are only mildly ill or asymptomatic, the only difference is that everyone wears protective gear. But if a patient’s oxygen levels dip, or her baby is in distress, the team moves more quickly to a cesarean delivery than they’d do with a healthy patient.

Just as hospital policies have been evolving, rules for visitors have been constantly changing too. Initially, UCLA allowed a support person to be present during delivery but had to leave immediately following. Now, each new mother is allowed one visitor for the duration of their stay. And the hospital suggests that patients who are COVID-19 positive recover in separate rooms from their babies and encourages them to maintain distance from their infants, except when breastfeeding.

“We respect and understand that this is a joyous occasion and we’re trying to keep families together as much as possible,” Dr. Rao said.
 

Care conundrums

How hospitals protect their smallest charges keeps changing too. Reports have been circulating about newborns being taken away from COVID-19-positive mothers, especially in marginalized communities. The stories have led many to worry they’d be forcibly separated from their babies. Most hospitals, however, leave it up to the woman and her doctors to decide how much separation is needed. “After delivery, it depends on how someone is feeling,” Dr. Rao said.

The American Academy of Pediatrics recommends that mothers who are COVID-19–positive pump breast milk and have a healthy caregiver use that milk, or formula, to bottle-feed the baby, with the new mother remaining 6 feet away from the child as much as she can. If that’s not possible, she should wear gloves and a mask while breastfeeding until she has been naturally afebrile for 72 hours and at least 1 week removed from the first appearance of her symptoms.

“It’s tragically hard,” said Dr. Quinlan, to keep a COVID-19–positive mother even 6 feet away from her newborn baby. “If a mother declines separation, we ask the acting pediatric team to discuss the theoretical risks and paucity of data.”

Until recently, research indicated that SARS-CoV-2 wasn’t being transmitted through the uterus from mothers to their babies. And despite a recent case study reporting transplacental transmission between a mother and her fetus in France, researchers still say that the risk of transference is low. To ensure newborn risk remains as low as possible, UCLA’s policy is to swab the baby when he/she is 24 hours old and keep watch for signs of infection: increased lethargy, difficulty waking, or gastrointestinal symptoms like vomiting.

Transmission via breast milk has also, to date, proven relatively unlikely. One study in The Lancet detected the novel coronavirus in breast milk, although it’s not clear that the virus can be passed on in the fluid, says Christina Chambers, PhD, a professor of pediatrics at the University of California, San Diego. Dr. Chambers is studying breast milk to see if the virus or antibodies to it are present. She is also investigating how infection with SARS-CoV-2 impacts women at different times in pregnancy, something that’s still an open question.

“[In] pregnant women with a deteriorating infection, the decisions are the same you would make with any delivery: Save the mom and save the baby,” Dr. Chambers said. “Beyond that, I am encouraged to see that pregnant women are prioritized to being tested,” something that will help researchers understand prevalence of disease in order to better understand whether some symptoms are more dangerous than others.

The situation is evolving so quickly that hospitals and providers are simply trying to stay abreast of the flood of new research. In the absence of definitive answers, they are using the information available and adjusting on the fly. “We are cautiously waiting for more data,” said Dr. Rao. “With the information we have we are doing the best we can to keep our patients safe. And we’re just going to keep at it.”

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

As more and more reopened medical practices ramp up toward normal activity, the safety of patients and health care workers alike remains paramount. As always, the responsibility for enforcing all the new safety guidelines ultimately rests with the Occupational Health and Safety Administration (OSHA).

Most of the modified guidelines are already familiar: wear masks (and other personal protective equipment as necessary); maintain social distancing; have hand cleaner, soap, and water readily available; and sanitize between patient examinations.

It is also important to remember that COVID-19 is now a reportable disease; check with your local health authorities as to where and how. Also remember that, if you decide to screen employees and/or patients for fevers and other symptoms of COVID-19, those data are subject to HIPAA rules and must be kept confidential.

Now might be a good time to confirm that you remain in compliance with both the new and old regulations. Even if you hold regular safety meetings – which often is not the case – it is always a good idea to occasionally conduct a comprehensive review, which could save you a lot in fines.

So get your OSHA logs out, and walk through your office. Start by making sure you have an official OSHA poster, which enumerates employee rights and explains how to file complaints. Every office must have one posted in plain site, and is what an OSHA inspector will look for first. They are available for free at OSHA’s website or you can order one by calling 800-321-OSHA.

How long have you had your written exposure control plan for blood-borne pathogens? This plan should document your use of such protective equipment as gloves, face and eye protection, needle guards, and gowns, as well as your implementation of universal precautions. It should be updated annually to reflect changes in technology – and new threats, such as COVID-19.

Review your list of hazardous substances, which all employees have a right to know about. OSHA’s list includes alcohol, hydrogen peroxide, acetone, liquid nitrogen, and other substances that you might not consider particularly dangerous, but are classified as “hazardous.” Also remember that you’re probably using new disinfectants, which may need to be added to your list. For each substance, your employees must have access to the manufacturer-supplied Material Safety Data Sheet, which outlines the proper procedures for working with a specific material, and for handling and containing it in a spill or other emergency.

It is not necessary to adopt every new safety device as it comes on the market, but you should document which ones you are using and which ones you decide not to use – and why. For example, if you and your employees decide against buying a new safety needle because you don’t think it will improve safety, or that it will be more trouble than it is worth, you still should document how you made that decision and why you believe that your current protocol is as good or better.

All at-risk employees should be provided with hepatitis B vaccine at no cost to them. And after any exposure to dangerous pathogens – which now include COVID-19 – you also must provide and pay for appropriate medical treatment and follow-up.

Another important consideration in your review: Electrical devices and their power sources in the office. All electrically powered equipment – medical or clerical – must operate safely and should all be examined. It is particularly important to check how wall outlets are set up. Make sure each outlet has sufficient power to run the equipment plugged into it and that circuit breakers are present and functioning.

Other components of the rule include proper containment of regulated medical waste, identification of regulated-waste containers, sharps disposal boxes, and periodic employee training regarding all of these things.

Medical and dental offices are not required to keep an injury and illness log under federal OSHA regulations, which other businesses must. However, your state may have a requirement that supersedes the federal law so you should check with your state, or with your local OSHA office, regarding any such requirements.

It is important to take OSHA regulations seriously because failure to comply with them can result in stiff penalties running into many thousands of dollars.

To be certain you are complying with all the rules, you can call your local OSHA office and request an inspection. This is the easiest and cheapest way because OSHA issues no citations during voluntary inspections as long as you agree to remedy any violations they discover.
 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

As more and more reopened medical practices ramp up toward normal activity, the safety of patients and health care workers alike remains paramount. As always, the responsibility for enforcing all the new safety guidelines ultimately rests with the Occupational Health and Safety Administration (OSHA).

Most of the modified guidelines are already familiar: wear masks (and other personal protective equipment as necessary); maintain social distancing; have hand cleaner, soap, and water readily available; and sanitize between patient examinations.

It is also important to remember that COVID-19 is now a reportable disease; check with your local health authorities as to where and how. Also remember that, if you decide to screen employees and/or patients for fevers and other symptoms of COVID-19, those data are subject to HIPAA rules and must be kept confidential.

Now might be a good time to confirm that you remain in compliance with both the new and old regulations. Even if you hold regular safety meetings – which often is not the case – it is always a good idea to occasionally conduct a comprehensive review, which could save you a lot in fines.

So get your OSHA logs out, and walk through your office. Start by making sure you have an official OSHA poster, which enumerates employee rights and explains how to file complaints. Every office must have one posted in plain site, and is what an OSHA inspector will look for first. They are available for free at OSHA’s website or you can order one by calling 800-321-OSHA.

How long have you had your written exposure control plan for blood-borne pathogens? This plan should document your use of such protective equipment as gloves, face and eye protection, needle guards, and gowns, as well as your implementation of universal precautions. It should be updated annually to reflect changes in technology – and new threats, such as COVID-19.

Review your list of hazardous substances, which all employees have a right to know about. OSHA’s list includes alcohol, hydrogen peroxide, acetone, liquid nitrogen, and other substances that you might not consider particularly dangerous, but are classified as “hazardous.” Also remember that you’re probably using new disinfectants, which may need to be added to your list. For each substance, your employees must have access to the manufacturer-supplied Material Safety Data Sheet, which outlines the proper procedures for working with a specific material, and for handling and containing it in a spill or other emergency.

It is not necessary to adopt every new safety device as it comes on the market, but you should document which ones you are using and which ones you decide not to use – and why. For example, if you and your employees decide against buying a new safety needle because you don’t think it will improve safety, or that it will be more trouble than it is worth, you still should document how you made that decision and why you believe that your current protocol is as good or better.

All at-risk employees should be provided with hepatitis B vaccine at no cost to them. And after any exposure to dangerous pathogens – which now include COVID-19 – you also must provide and pay for appropriate medical treatment and follow-up.

Another important consideration in your review: Electrical devices and their power sources in the office. All electrically powered equipment – medical or clerical – must operate safely and should all be examined. It is particularly important to check how wall outlets are set up. Make sure each outlet has sufficient power to run the equipment plugged into it and that circuit breakers are present and functioning.

Other components of the rule include proper containment of regulated medical waste, identification of regulated-waste containers, sharps disposal boxes, and periodic employee training regarding all of these things.

Medical and dental offices are not required to keep an injury and illness log under federal OSHA regulations, which other businesses must. However, your state may have a requirement that supersedes the federal law so you should check with your state, or with your local OSHA office, regarding any such requirements.

It is important to take OSHA regulations seriously because failure to comply with them can result in stiff penalties running into many thousands of dollars.

To be certain you are complying with all the rules, you can call your local OSHA office and request an inspection. This is the easiest and cheapest way because OSHA issues no citations during voluntary inspections as long as you agree to remedy any violations they discover.
 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

As more and more reopened medical practices ramp up toward normal activity, the safety of patients and health care workers alike remains paramount. As always, the responsibility for enforcing all the new safety guidelines ultimately rests with the Occupational Health and Safety Administration (OSHA).

Most of the modified guidelines are already familiar: wear masks (and other personal protective equipment as necessary); maintain social distancing; have hand cleaner, soap, and water readily available; and sanitize between patient examinations.

It is also important to remember that COVID-19 is now a reportable disease; check with your local health authorities as to where and how. Also remember that, if you decide to screen employees and/or patients for fevers and other symptoms of COVID-19, those data are subject to HIPAA rules and must be kept confidential.

Now might be a good time to confirm that you remain in compliance with both the new and old regulations. Even if you hold regular safety meetings – which often is not the case – it is always a good idea to occasionally conduct a comprehensive review, which could save you a lot in fines.

So get your OSHA logs out, and walk through your office. Start by making sure you have an official OSHA poster, which enumerates employee rights and explains how to file complaints. Every office must have one posted in plain site, and is what an OSHA inspector will look for first. They are available for free at OSHA’s website or you can order one by calling 800-321-OSHA.

How long have you had your written exposure control plan for blood-borne pathogens? This plan should document your use of such protective equipment as gloves, face and eye protection, needle guards, and gowns, as well as your implementation of universal precautions. It should be updated annually to reflect changes in technology – and new threats, such as COVID-19.

Review your list of hazardous substances, which all employees have a right to know about. OSHA’s list includes alcohol, hydrogen peroxide, acetone, liquid nitrogen, and other substances that you might not consider particularly dangerous, but are classified as “hazardous.” Also remember that you’re probably using new disinfectants, which may need to be added to your list. For each substance, your employees must have access to the manufacturer-supplied Material Safety Data Sheet, which outlines the proper procedures for working with a specific material, and for handling and containing it in a spill or other emergency.

It is not necessary to adopt every new safety device as it comes on the market, but you should document which ones you are using and which ones you decide not to use – and why. For example, if you and your employees decide against buying a new safety needle because you don’t think it will improve safety, or that it will be more trouble than it is worth, you still should document how you made that decision and why you believe that your current protocol is as good or better.

All at-risk employees should be provided with hepatitis B vaccine at no cost to them. And after any exposure to dangerous pathogens – which now include COVID-19 – you also must provide and pay for appropriate medical treatment and follow-up.

Another important consideration in your review: Electrical devices and their power sources in the office. All electrically powered equipment – medical or clerical – must operate safely and should all be examined. It is particularly important to check how wall outlets are set up. Make sure each outlet has sufficient power to run the equipment plugged into it and that circuit breakers are present and functioning.

Other components of the rule include proper containment of regulated medical waste, identification of regulated-waste containers, sharps disposal boxes, and periodic employee training regarding all of these things.

Medical and dental offices are not required to keep an injury and illness log under federal OSHA regulations, which other businesses must. However, your state may have a requirement that supersedes the federal law so you should check with your state, or with your local OSHA office, regarding any such requirements.

It is important to take OSHA regulations seriously because failure to comply with them can result in stiff penalties running into many thousands of dollars.

To be certain you are complying with all the rules, you can call your local OSHA office and request an inspection. This is the easiest and cheapest way because OSHA issues no citations during voluntary inspections as long as you agree to remedy any violations they discover.
 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

Osteoporosis treatment with abaloparatide in postmenopausal women does not lead to increased cardiovascular risk, according to a post hoc analysis of the pivotal ACTIVE and ACTIVExtend trials.

iStock/Thinkstock

“Neither treatment with abaloparatide or teriparatide was associated with an increase in serious cardiac [adverse events],” wrote Felicia Cosman, MD, of Columbia University, New York, and coauthors. The study was published in the Journal of Clinical Endocrinology.

To assess the cardiovascular safety profile of abaloparatide, a synthetic analogue of parathyroid hormone–related peptide, the researchers analyzed data on heart rate, blood pressure and cardiovascular-related adverse events (AEs) from patients taking part in the Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) trial and its ACTIVExtend extension study.

The 2,460 participants in the ACTIVE trial were postmenopausal women between the ages of 49 and 86 years with osteoporosis; they were given 80 mcg of daily subcutaneous abaloparatide, 20 mcg of open-label daily subcutaneous teriparatide, or placebo in roughly equal numbers for 18 months. After a 1-month treatment-free period, 1,133 eligible participants from either the abaloparatide or placebo groups were enrolled in ACTIVExtend and given 70 mg of open-label alendronate once a week for 24 months. Because heart rate was only assessed pre- and post dose in the ACTIVE trial, an additional pharmacology study of abaloparatide involving 55 healthy volunteers (32 men and 23 women) was undertaken. After a dose of either abaloparatide or placebo, heart rate was measured at 15, 30, and 45 minutes and 1, 1.5, 2, 2.5, 4, 6, 8, and 12 hours.

Overall, treatment-emergent AEs were higher in the abaloparatide (165, 20.1%) and teriparatide (106, 13%) groups, compared with placebo (74, 9%), as were AEs that led to discontinuation of the study and were potentially associated with changes in heart rate or BP (27 in abaloparatide, 11 in teriparatide, and 5 in placebo). However, the percentage of patients with serious cardiac AEs was similar across groups (1%, 1%, and 0.9%, respectively).

During the ACTIVE trial, major cardiac adverse events plus heart failure were more common in the placebo group (1.7%) than the abaloparatide (0.5%) or teriparatide (0.6%) groups. During ACTIVExtend, major cardiac adverse plus heart failure were similarly common in the abaloparatide/alendronate (1.6%) and the placebo/alendronate (1.6%) groups.

On day 1 of treatment during ACTIVE, the mean change in heart rate from pretreatment to an hour post treatment was 7.9 bpm, 5.3 bpm, and 1.2 bpm for abaloparatide, teriparatide, and placebo, respectively (P < .0001 for abaloparatide and teriparatide vs. placebo; P < .05 for abaloparatide vs. teriparatide).

Subsequent visits saw similar changes. The mean maximum heart rate at 1 hour post dose was 80.7 bpm for abaloparatide, 79.0 bpm for teriparatide, and 73.7 bpm for placebo (P < .0001 for abaloparatide and teriparatide vs. placebo; P < .01 for abaloparatide vs. teriparatide). In the study of healthy volunteers, HR peaked at 15 minutes after dosing and then declined, resolving within 2.5-4 hours.

From predose to 1 hour post dose, small but significant decreases were observed in mean supine systolic and diastolic BP across groups (–2.7/–3.6 mm Hg with abaloparatide, –2.0/–3.6 with teriparatide, –1.5/–2.3 with placebo). During the first year of ACTIVE, the mean maximal decrease in BP from predose to 1 hour post dose was slightly higher (1-2 mm Hg) in the abaloparatide and teriparatide groups, compared with the placebo group (P < .05).

The authors acknowledged their study’s limitations, including the analysis of major cardiac adverse plus heart failure in ACTIVE being limited because of a low number of events and the trial not being designed in that regard.

Abaloparatide was approved by the Food and Drug Administration in 2017 on the basis of results from the ACTIVE and ACTIVExtend trials showing significant reductions in new vertebral and nonvertebral fractures, compared with placebo.

The analysis was partially funded by Radius Health. Its authors acknowledged numerous potential conflicts of interest, including receiving grants and research support from various organizations and pharmaceutical companies.

SOURCE: Cosman F et al. J Clin Endocrinol Metab. 2020 Jul 13. doi: 10.1210/clinem/dgaa450.

Osteoporosis treatment with abaloparatide in postmenopausal women does not lead to increased cardiovascular risk, according to a post hoc analysis of the pivotal ACTIVE and ACTIVExtend trials.

iStock/Thinkstock

“Neither treatment with abaloparatide or teriparatide was associated with an increase in serious cardiac [adverse events],” wrote Felicia Cosman, MD, of Columbia University, New York, and coauthors. The study was published in the Journal of Clinical Endocrinology.

To assess the cardiovascular safety profile of abaloparatide, a synthetic analogue of parathyroid hormone–related peptide, the researchers analyzed data on heart rate, blood pressure and cardiovascular-related adverse events (AEs) from patients taking part in the Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) trial and its ACTIVExtend extension study.

The 2,460 participants in the ACTIVE trial were postmenopausal women between the ages of 49 and 86 years with osteoporosis; they were given 80 mcg of daily subcutaneous abaloparatide, 20 mcg of open-label daily subcutaneous teriparatide, or placebo in roughly equal numbers for 18 months. After a 1-month treatment-free period, 1,133 eligible participants from either the abaloparatide or placebo groups were enrolled in ACTIVExtend and given 70 mg of open-label alendronate once a week for 24 months. Because heart rate was only assessed pre- and post dose in the ACTIVE trial, an additional pharmacology study of abaloparatide involving 55 healthy volunteers (32 men and 23 women) was undertaken. After a dose of either abaloparatide or placebo, heart rate was measured at 15, 30, and 45 minutes and 1, 1.5, 2, 2.5, 4, 6, 8, and 12 hours.

Overall, treatment-emergent AEs were higher in the abaloparatide (165, 20.1%) and teriparatide (106, 13%) groups, compared with placebo (74, 9%), as were AEs that led to discontinuation of the study and were potentially associated with changes in heart rate or BP (27 in abaloparatide, 11 in teriparatide, and 5 in placebo). However, the percentage of patients with serious cardiac AEs was similar across groups (1%, 1%, and 0.9%, respectively).

During the ACTIVE trial, major cardiac adverse events plus heart failure were more common in the placebo group (1.7%) than the abaloparatide (0.5%) or teriparatide (0.6%) groups. During ACTIVExtend, major cardiac adverse plus heart failure were similarly common in the abaloparatide/alendronate (1.6%) and the placebo/alendronate (1.6%) groups.

On day 1 of treatment during ACTIVE, the mean change in heart rate from pretreatment to an hour post treatment was 7.9 bpm, 5.3 bpm, and 1.2 bpm for abaloparatide, teriparatide, and placebo, respectively (P < .0001 for abaloparatide and teriparatide vs. placebo; P < .05 for abaloparatide vs. teriparatide).

Subsequent visits saw similar changes. The mean maximum heart rate at 1 hour post dose was 80.7 bpm for abaloparatide, 79.0 bpm for teriparatide, and 73.7 bpm for placebo (P < .0001 for abaloparatide and teriparatide vs. placebo; P < .01 for abaloparatide vs. teriparatide). In the study of healthy volunteers, HR peaked at 15 minutes after dosing and then declined, resolving within 2.5-4 hours.

From predose to 1 hour post dose, small but significant decreases were observed in mean supine systolic and diastolic BP across groups (–2.7/–3.6 mm Hg with abaloparatide, –2.0/–3.6 with teriparatide, –1.5/–2.3 with placebo). During the first year of ACTIVE, the mean maximal decrease in BP from predose to 1 hour post dose was slightly higher (1-2 mm Hg) in the abaloparatide and teriparatide groups, compared with the placebo group (P < .05).

The authors acknowledged their study’s limitations, including the analysis of major cardiac adverse plus heart failure in ACTIVE being limited because of a low number of events and the trial not being designed in that regard.

Abaloparatide was approved by the Food and Drug Administration in 2017 on the basis of results from the ACTIVE and ACTIVExtend trials showing significant reductions in new vertebral and nonvertebral fractures, compared with placebo.

The analysis was partially funded by Radius Health. Its authors acknowledged numerous potential conflicts of interest, including receiving grants and research support from various organizations and pharmaceutical companies.

SOURCE: Cosman F et al. J Clin Endocrinol Metab. 2020 Jul 13. doi: 10.1210/clinem/dgaa450.

Osteoporosis treatment with abaloparatide in postmenopausal women does not lead to increased cardiovascular risk, according to a post hoc analysis of the pivotal ACTIVE and ACTIVExtend trials.

iStock/Thinkstock

“Neither treatment with abaloparatide or teriparatide was associated with an increase in serious cardiac [adverse events],” wrote Felicia Cosman, MD, of Columbia University, New York, and coauthors. The study was published in the Journal of Clinical Endocrinology.

To assess the cardiovascular safety profile of abaloparatide, a synthetic analogue of parathyroid hormone–related peptide, the researchers analyzed data on heart rate, blood pressure and cardiovascular-related adverse events (AEs) from patients taking part in the Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) trial and its ACTIVExtend extension study.

The 2,460 participants in the ACTIVE trial were postmenopausal women between the ages of 49 and 86 years with osteoporosis; they were given 80 mcg of daily subcutaneous abaloparatide, 20 mcg of open-label daily subcutaneous teriparatide, or placebo in roughly equal numbers for 18 months. After a 1-month treatment-free period, 1,133 eligible participants from either the abaloparatide or placebo groups were enrolled in ACTIVExtend and given 70 mg of open-label alendronate once a week for 24 months. Because heart rate was only assessed pre- and post dose in the ACTIVE trial, an additional pharmacology study of abaloparatide involving 55 healthy volunteers (32 men and 23 women) was undertaken. After a dose of either abaloparatide or placebo, heart rate was measured at 15, 30, and 45 minutes and 1, 1.5, 2, 2.5, 4, 6, 8, and 12 hours.

Overall, treatment-emergent AEs were higher in the abaloparatide (165, 20.1%) and teriparatide (106, 13%) groups, compared with placebo (74, 9%), as were AEs that led to discontinuation of the study and were potentially associated with changes in heart rate or BP (27 in abaloparatide, 11 in teriparatide, and 5 in placebo). However, the percentage of patients with serious cardiac AEs was similar across groups (1%, 1%, and 0.9%, respectively).

During the ACTIVE trial, major cardiac adverse events plus heart failure were more common in the placebo group (1.7%) than the abaloparatide (0.5%) or teriparatide (0.6%) groups. During ACTIVExtend, major cardiac adverse plus heart failure were similarly common in the abaloparatide/alendronate (1.6%) and the placebo/alendronate (1.6%) groups.

On day 1 of treatment during ACTIVE, the mean change in heart rate from pretreatment to an hour post treatment was 7.9 bpm, 5.3 bpm, and 1.2 bpm for abaloparatide, teriparatide, and placebo, respectively (P < .0001 for abaloparatide and teriparatide vs. placebo; P < .05 for abaloparatide vs. teriparatide).

Subsequent visits saw similar changes. The mean maximum heart rate at 1 hour post dose was 80.7 bpm for abaloparatide, 79.0 bpm for teriparatide, and 73.7 bpm for placebo (P < .0001 for abaloparatide and teriparatide vs. placebo; P < .01 for abaloparatide vs. teriparatide). In the study of healthy volunteers, HR peaked at 15 minutes after dosing and then declined, resolving within 2.5-4 hours.

From predose to 1 hour post dose, small but significant decreases were observed in mean supine systolic and diastolic BP across groups (–2.7/–3.6 mm Hg with abaloparatide, –2.0/–3.6 with teriparatide, –1.5/–2.3 with placebo). During the first year of ACTIVE, the mean maximal decrease in BP from predose to 1 hour post dose was slightly higher (1-2 mm Hg) in the abaloparatide and teriparatide groups, compared with the placebo group (P < .05).

The authors acknowledged their study’s limitations, including the analysis of major cardiac adverse plus heart failure in ACTIVE being limited because of a low number of events and the trial not being designed in that regard.

Abaloparatide was approved by the Food and Drug Administration in 2017 on the basis of results from the ACTIVE and ACTIVExtend trials showing significant reductions in new vertebral and nonvertebral fractures, compared with placebo.

The analysis was partially funded by Radius Health. Its authors acknowledged numerous potential conflicts of interest, including receiving grants and research support from various organizations and pharmaceutical companies.

SOURCE: Cosman F et al. J Clin Endocrinol Metab. 2020 Jul 13. doi: 10.1210/clinem/dgaa450.

Work-life balance was the top concern for female physicians who responded to a new Medscape survey, far outpacing concerns about pay.

A psychiatrist who responded to the survey commented, “I’ve been trying to use all my vacation to spend time with my spouse. I’m always apologizing for being late, not being able to go to an event due to my work schedule, and missing out on life with my husband.”

Nearly two thirds (64%) said the balance was their top concern whereas 43% put pay at the top.

Medscape surveyed more than 3,000 women physicians about how they deal with parenthood, work pressures, and relationships in Women Physicians 2020: The Issues They Care About.
 

Almost all are making personal trade-offs

An overwhelming percentage (94%) said they have had to make personal trade-offs for work obligations.

“Women are more likely to make work compromises to benefit their families,” a cardiologist responded. “I won’t/can’t take a position that would disrupt my husband’s community ties, my children’s schooling, and relationships with family.”

More than one-third of women (36%) said that being a woman had a negative or very negative impact on their compensation. Only 4% said their gender had a positive or very positive impact on pay and 59% said gender had no effect.

The Medscape Physician Compensation Report 2020 showed male specialists made 31% more than their female counterparts and male primary care physicians earned 25% more.

Some factors may help explain some of the difference, but others remain unclear.

Poor negotiating skills have long been cited as a reason women get paid less; in this survey 39% said they were unskilled or very unskilled in salary negotiations, compared with 28% who said they were skilled or very skilled in those talks.

Katie Donovan, founder of Equal Pay Negotiations, reports that only 30% of women negotiate pay at all, compared with 46% of men.

Additionally, women tend to gravitate in specialties that don’t pay as well.

They are poorly represented in some of the highest-paying specialties: orthopedics (9%), urology (12%), and cardiology (14%).

“Society’s view of women as caretaker is powerful,” a radiologist commented. “Women feel like they need to choose specialties where they can work part-time or flexible time in order to be the primary caretaker at home.”
 

Confidence high in leadership abilities

The survey asked women about their confidence in taking a leadership role, and 90% answered that they were confident about taking such a role. However, only half said they had a leadership or supervisory role.

According to the American Medical Association, women make up 3% of healthcare chief medical officers, 6% of department chairs, and 9% of division leaders.

Asked whether women have experienced gender inequity in the workplace, respondents were almost evenly split, but hospital-based physicians at 61% were more likely to report inequity than were 42% of office-based physicians.

A family physician responded, “I have experienced gender inequality more from administrators than from my male colleagues. I think it’s coming from corporate more than from medical professionals.”

In this survey, 3% said their male colleagues were unsupportive of gender equality in the workplace.

The survey responses indicate most women physicians who have children are also conflicted as parents regarding their careers. Almost two-thirds (64%) said they were always or often conflicted with these dueling priorities; only 8% said they sometimes or rarely are.

Those conflicts start even before having children. More than half in this survey (52%) said their career influenced the number of children they have.

A family physician said, “I delayed starting a family because of my career. That affected my fertility and made it hard to complete [in-vitro fertilization].”
 

Family responsibilities meet stigma

Half of the respondents said women physicians are stigmatized for taking a full maternity leave (6 weeks or longer). An even higher percentage (65%) said women are stigmatized for taking more flexible or fewer hours to accommodate family responsibilities.

A 2019 survey of 844 physician mothers found that physicians who took maternity leave received lower peer evaluation scores, lost potential income, and reported experiencing discrimination. One-quarter of the participants (25.8%) reported experiencing discrimination related to breastfeeding or breast milk pumping upon their return to work.

Burnout at work puts stress on primary relationships, 63% of respondents said, although 24% said it did not strain those relationships. Thirteen percent of women gave the response “not applicable.”

“I try to be present when I’m home, but to be honest, I don’t deal with it very well,” a family physician commented.

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

Work-life balance was the top concern for female physicians who responded to a new Medscape survey, far outpacing concerns about pay.

A psychiatrist who responded to the survey commented, “I’ve been trying to use all my vacation to spend time with my spouse. I’m always apologizing for being late, not being able to go to an event due to my work schedule, and missing out on life with my husband.”

Nearly two thirds (64%) said the balance was their top concern whereas 43% put pay at the top.

Medscape surveyed more than 3,000 women physicians about how they deal with parenthood, work pressures, and relationships in Women Physicians 2020: The Issues They Care About.
 

Almost all are making personal trade-offs

An overwhelming percentage (94%) said they have had to make personal trade-offs for work obligations.

“Women are more likely to make work compromises to benefit their families,” a cardiologist responded. “I won’t/can’t take a position that would disrupt my husband’s community ties, my children’s schooling, and relationships with family.”

More than one-third of women (36%) said that being a woman had a negative or very negative impact on their compensation. Only 4% said their gender had a positive or very positive impact on pay and 59% said gender had no effect.

The Medscape Physician Compensation Report 2020 showed male specialists made 31% more than their female counterparts and male primary care physicians earned 25% more.

Some factors may help explain some of the difference, but others remain unclear.

Poor negotiating skills have long been cited as a reason women get paid less; in this survey 39% said they were unskilled or very unskilled in salary negotiations, compared with 28% who said they were skilled or very skilled in those talks.

Katie Donovan, founder of Equal Pay Negotiations, reports that only 30% of women negotiate pay at all, compared with 46% of men.

Additionally, women tend to gravitate in specialties that don’t pay as well.

They are poorly represented in some of the highest-paying specialties: orthopedics (9%), urology (12%), and cardiology (14%).

“Society’s view of women as caretaker is powerful,” a radiologist commented. “Women feel like they need to choose specialties where they can work part-time or flexible time in order to be the primary caretaker at home.”
 

Confidence high in leadership abilities

The survey asked women about their confidence in taking a leadership role, and 90% answered that they were confident about taking such a role. However, only half said they had a leadership or supervisory role.

According to the American Medical Association, women make up 3% of healthcare chief medical officers, 6% of department chairs, and 9% of division leaders.

Asked whether women have experienced gender inequity in the workplace, respondents were almost evenly split, but hospital-based physicians at 61% were more likely to report inequity than were 42% of office-based physicians.

A family physician responded, “I have experienced gender inequality more from administrators than from my male colleagues. I think it’s coming from corporate more than from medical professionals.”

In this survey, 3% said their male colleagues were unsupportive of gender equality in the workplace.

The survey responses indicate most women physicians who have children are also conflicted as parents regarding their careers. Almost two-thirds (64%) said they were always or often conflicted with these dueling priorities; only 8% said they sometimes or rarely are.

Those conflicts start even before having children. More than half in this survey (52%) said their career influenced the number of children they have.

A family physician said, “I delayed starting a family because of my career. That affected my fertility and made it hard to complete [in-vitro fertilization].”
 

Family responsibilities meet stigma

Half of the respondents said women physicians are stigmatized for taking a full maternity leave (6 weeks or longer). An even higher percentage (65%) said women are stigmatized for taking more flexible or fewer hours to accommodate family responsibilities.

A 2019 survey of 844 physician mothers found that physicians who took maternity leave received lower peer evaluation scores, lost potential income, and reported experiencing discrimination. One-quarter of the participants (25.8%) reported experiencing discrimination related to breastfeeding or breast milk pumping upon their return to work.

Burnout at work puts stress on primary relationships, 63% of respondents said, although 24% said it did not strain those relationships. Thirteen percent of women gave the response “not applicable.”

“I try to be present when I’m home, but to be honest, I don’t deal with it very well,” a family physician commented.

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

Work-life balance was the top concern for female physicians who responded to a new Medscape survey, far outpacing concerns about pay.

A psychiatrist who responded to the survey commented, “I’ve been trying to use all my vacation to spend time with my spouse. I’m always apologizing for being late, not being able to go to an event due to my work schedule, and missing out on life with my husband.”

Nearly two thirds (64%) said the balance was their top concern whereas 43% put pay at the top.

Medscape surveyed more than 3,000 women physicians about how they deal with parenthood, work pressures, and relationships in Women Physicians 2020: The Issues They Care About.
 

Almost all are making personal trade-offs

An overwhelming percentage (94%) said they have had to make personal trade-offs for work obligations.

“Women are more likely to make work compromises to benefit their families,” a cardiologist responded. “I won’t/can’t take a position that would disrupt my husband’s community ties, my children’s schooling, and relationships with family.”

More than one-third of women (36%) said that being a woman had a negative or very negative impact on their compensation. Only 4% said their gender had a positive or very positive impact on pay and 59% said gender had no effect.

The Medscape Physician Compensation Report 2020 showed male specialists made 31% more than their female counterparts and male primary care physicians earned 25% more.

Some factors may help explain some of the difference, but others remain unclear.

Poor negotiating skills have long been cited as a reason women get paid less; in this survey 39% said they were unskilled or very unskilled in salary negotiations, compared with 28% who said they were skilled or very skilled in those talks.

Katie Donovan, founder of Equal Pay Negotiations, reports that only 30% of women negotiate pay at all, compared with 46% of men.

Additionally, women tend to gravitate in specialties that don’t pay as well.

They are poorly represented in some of the highest-paying specialties: orthopedics (9%), urology (12%), and cardiology (14%).

“Society’s view of women as caretaker is powerful,” a radiologist commented. “Women feel like they need to choose specialties where they can work part-time or flexible time in order to be the primary caretaker at home.”
 

Confidence high in leadership abilities

The survey asked women about their confidence in taking a leadership role, and 90% answered that they were confident about taking such a role. However, only half said they had a leadership or supervisory role.

According to the American Medical Association, women make up 3% of healthcare chief medical officers, 6% of department chairs, and 9% of division leaders.

Asked whether women have experienced gender inequity in the workplace, respondents were almost evenly split, but hospital-based physicians at 61% were more likely to report inequity than were 42% of office-based physicians.

A family physician responded, “I have experienced gender inequality more from administrators than from my male colleagues. I think it’s coming from corporate more than from medical professionals.”

In this survey, 3% said their male colleagues were unsupportive of gender equality in the workplace.

The survey responses indicate most women physicians who have children are also conflicted as parents regarding their careers. Almost two-thirds (64%) said they were always or often conflicted with these dueling priorities; only 8% said they sometimes or rarely are.

Those conflicts start even before having children. More than half in this survey (52%) said their career influenced the number of children they have.

A family physician said, “I delayed starting a family because of my career. That affected my fertility and made it hard to complete [in-vitro fertilization].”
 

Family responsibilities meet stigma

Half of the respondents said women physicians are stigmatized for taking a full maternity leave (6 weeks or longer). An even higher percentage (65%) said women are stigmatized for taking more flexible or fewer hours to accommodate family responsibilities.

A 2019 survey of 844 physician mothers found that physicians who took maternity leave received lower peer evaluation scores, lost potential income, and reported experiencing discrimination. One-quarter of the participants (25.8%) reported experiencing discrimination related to breastfeeding or breast milk pumping upon their return to work.

Burnout at work puts stress on primary relationships, 63% of respondents said, although 24% said it did not strain those relationships. Thirteen percent of women gave the response “not applicable.”

“I try to be present when I’m home, but to be honest, I don’t deal with it very well,” a family physician commented.

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

“The sewer is the conscience of the city. Everything there converges and confronts everything else. In that livid spot there are shades, but there are no longer any secrets.” Victor Hugo – “Les Miserables”

To get a sense of the prevalence of COVID-19 in a community you need to test hundreds to thousands of people. This is difficult, resource intensive, and requires cooperation for testing among people both with and without symptoms. It turns out that Sewage Chemical Information Mining (SCIM), a technology that has been in development for over a decade, is now being developed to track COVID-19.

In various locations from China to medieval London, there have been attempts to utilize human excrement for the betterment of mankind, from employing it as fertilizer to processing it to make gunpowder. Such attempts did not always work as planned. The use of sewage for fertilizer in Europe and the United States in the 1840s and 1850s led to the spread of waterborne diseases, including cholera and typhoid. As the importance of sanitary elimination of human waste became ever clearer, ideas and technology for our modern system of sewage management evolved. We have since advanced a great deal, so that all industrialized nations now have a well-developed system for clean water entry, as well as sewage treatment and disposal. Nonetheless, there remains a nagging question of whether human waste could be used for something productive.¹

In the early 2000s, SCIM was developed as a technique to assess population-level human health and disease. In SCIM, untreated sewage is tested for a chemical of interest which reflects a health parameter for a community. Chemicals of interest and usage rates can be calculated for substances as varied as opioids, tobacco, pesticides, and even nonnutritive sweeteners. For instance, relative opioid use can be calculated over time for a given “sewershed” or sewage catchment area. The calculation of community-wide exposure to substances as a means of getting real-time data on shifts of usage without having to collect and collate data from thousands of individuals has been termed wastewater-based epidemiology.

We use urine and stool testing in so many other areas, such as urinalysis, urine drug testing, urine Legionella antigen testing, and stool testing for common pathogens. What a rich source of information is present in the combination of urine and stool that collectively make up sewage! With the average volume of urine per adult being approximately 1 liter daily (and with urine calculated to be approximately 1% of wastewater), accurate analytic techniques can estimate per capita exposure to different substances. Applications of wastewater-based epidemiology have included tracking community prevalence of enteric viral infections, opioid and tobacco use, and many other indicators of health and disease.²

Given the enormous work in the field over the last 2 decades and that SARS-CoV-2 RNA has been detected in feces of both symptomatic and asymptomatic patients, it was only a short conceptual step for those familiar with sewage epidemiology to consider adapting it to assess the prevalence of COVID-19 in a community.

An elegant study collected untreated sewage from southeast Queensland, Australia. The sewage was processed, concentrated, and then tested with reverse transcriptase polymerase chain reaction analysis for SARS-CoV-2 RNA. The number of RNA copies was then entered into an equation that included the population served by the sewage encatchment area, as well as the measured liters of wastewater and grams of feces per day. This provided an estimate of the number of persons infected in the community, and the researchers were able to show reasonable agreement between the numbers estimated by sewage analysis and that found in traditional clinical testing.^3,4

The promise of wastewater-based epidemiology is large. Early research indicates that quantification of viral particles in sewage can be accurately assessed and correlated with the prevalence of the infection in the community. Such levels can then be used to track infection rates of COVID-19 over time, as well as to compare the relative rates in different communities.

Our sewage may hold the answer to accurately and easily tracking COVID-19, and ultimately help us gain a better hold on this disease.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. History of water supply and sanitation. Wikipedia, https://en.wikipedia.org/wiki/History_of_water_supply_and_sanitation.

2. Daughton C. Monitoring wastewater for assessing community health: Sewage Chemical-Information Mining (SCIM). Sci Total Environ. 2017 Nov 29. doi: 10.1016/j.scitotenv.2017.11.102.

3. Ahmed W et al. First confirmed detection of SARS-CoV-2 in untreated wastewater in Australia: A proof of concept for the wastewater surveillance of COVID-19 in the community. Sci Total Environ. 2020 Apr 18. doi: doi.org/10.1016/j.scitotenv.2020.138764.

4. Daughton C. The international imperative to rapidly and inexpensively monitor community-wide COVID-19 infection status and trends. Sci Total Environ. 2020 Mar 23. doi: 10.1016/j.scitotenv.2020.138149.

“The sewer is the conscience of the city. Everything there converges and confronts everything else. In that livid spot there are shades, but there are no longer any secrets.” Victor Hugo – “Les Miserables”

To get a sense of the prevalence of COVID-19 in a community you need to test hundreds to thousands of people. This is difficult, resource intensive, and requires cooperation for testing among people both with and without symptoms. It turns out that Sewage Chemical Information Mining (SCIM), a technology that has been in development for over a decade, is now being developed to track COVID-19.

In various locations from China to medieval London, there have been attempts to utilize human excrement for the betterment of mankind, from employing it as fertilizer to processing it to make gunpowder. Such attempts did not always work as planned. The use of sewage for fertilizer in Europe and the United States in the 1840s and 1850s led to the spread of waterborne diseases, including cholera and typhoid. As the importance of sanitary elimination of human waste became ever clearer, ideas and technology for our modern system of sewage management evolved. We have since advanced a great deal, so that all industrialized nations now have a well-developed system for clean water entry, as well as sewage treatment and disposal. Nonetheless, there remains a nagging question of whether human waste could be used for something productive.¹

In the early 2000s, SCIM was developed as a technique to assess population-level human health and disease. In SCIM, untreated sewage is tested for a chemical of interest which reflects a health parameter for a community. Chemicals of interest and usage rates can be calculated for substances as varied as opioids, tobacco, pesticides, and even nonnutritive sweeteners. For instance, relative opioid use can be calculated over time for a given “sewershed” or sewage catchment area. The calculation of community-wide exposure to substances as a means of getting real-time data on shifts of usage without having to collect and collate data from thousands of individuals has been termed wastewater-based epidemiology.

We use urine and stool testing in so many other areas, such as urinalysis, urine drug testing, urine Legionella antigen testing, and stool testing for common pathogens. What a rich source of information is present in the combination of urine and stool that collectively make up sewage! With the average volume of urine per adult being approximately 1 liter daily (and with urine calculated to be approximately 1% of wastewater), accurate analytic techniques can estimate per capita exposure to different substances. Applications of wastewater-based epidemiology have included tracking community prevalence of enteric viral infections, opioid and tobacco use, and many other indicators of health and disease.²

Given the enormous work in the field over the last 2 decades and that SARS-CoV-2 RNA has been detected in feces of both symptomatic and asymptomatic patients, it was only a short conceptual step for those familiar with sewage epidemiology to consider adapting it to assess the prevalence of COVID-19 in a community.

An elegant study collected untreated sewage from southeast Queensland, Australia. The sewage was processed, concentrated, and then tested with reverse transcriptase polymerase chain reaction analysis for SARS-CoV-2 RNA. The number of RNA copies was then entered into an equation that included the population served by the sewage encatchment area, as well as the measured liters of wastewater and grams of feces per day. This provided an estimate of the number of persons infected in the community, and the researchers were able to show reasonable agreement between the numbers estimated by sewage analysis and that found in traditional clinical testing.^3,4

The promise of wastewater-based epidemiology is large. Early research indicates that quantification of viral particles in sewage can be accurately assessed and correlated with the prevalence of the infection in the community. Such levels can then be used to track infection rates of COVID-19 over time, as well as to compare the relative rates in different communities.

Our sewage may hold the answer to accurately and easily tracking COVID-19, and ultimately help us gain a better hold on this disease.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. History of water supply and sanitation. Wikipedia, https://en.wikipedia.org/wiki/History_of_water_supply_and_sanitation.

2. Daughton C. Monitoring wastewater for assessing community health: Sewage Chemical-Information Mining (SCIM). Sci Total Environ. 2017 Nov 29. doi: 10.1016/j.scitotenv.2017.11.102.

3. Ahmed W et al. First confirmed detection of SARS-CoV-2 in untreated wastewater in Australia: A proof of concept for the wastewater surveillance of COVID-19 in the community. Sci Total Environ. 2020 Apr 18. doi: doi.org/10.1016/j.scitotenv.2020.138764.

4. Daughton C. The international imperative to rapidly and inexpensively monitor community-wide COVID-19 infection status and trends. Sci Total Environ. 2020 Mar 23. doi: 10.1016/j.scitotenv.2020.138149.

“The sewer is the conscience of the city. Everything there converges and confronts everything else. In that livid spot there are shades, but there are no longer any secrets.” Victor Hugo – “Les Miserables”

To get a sense of the prevalence of COVID-19 in a community you need to test hundreds to thousands of people. This is difficult, resource intensive, and requires cooperation for testing among people both with and without symptoms. It turns out that Sewage Chemical Information Mining (SCIM), a technology that has been in development for over a decade, is now being developed to track COVID-19.

In various locations from China to medieval London, there have been attempts to utilize human excrement for the betterment of mankind, from employing it as fertilizer to processing it to make gunpowder. Such attempts did not always work as planned. The use of sewage for fertilizer in Europe and the United States in the 1840s and 1850s led to the spread of waterborne diseases, including cholera and typhoid. As the importance of sanitary elimination of human waste became ever clearer, ideas and technology for our modern system of sewage management evolved. We have since advanced a great deal, so that all industrialized nations now have a well-developed system for clean water entry, as well as sewage treatment and disposal. Nonetheless, there remains a nagging question of whether human waste could be used for something productive.¹

In the early 2000s, SCIM was developed as a technique to assess population-level human health and disease. In SCIM, untreated sewage is tested for a chemical of interest which reflects a health parameter for a community. Chemicals of interest and usage rates can be calculated for substances as varied as opioids, tobacco, pesticides, and even nonnutritive sweeteners. For instance, relative opioid use can be calculated over time for a given “sewershed” or sewage catchment area. The calculation of community-wide exposure to substances as a means of getting real-time data on shifts of usage without having to collect and collate data from thousands of individuals has been termed wastewater-based epidemiology.

We use urine and stool testing in so many other areas, such as urinalysis, urine drug testing, urine Legionella antigen testing, and stool testing for common pathogens. What a rich source of information is present in the combination of urine and stool that collectively make up sewage! With the average volume of urine per adult being approximately 1 liter daily (and with urine calculated to be approximately 1% of wastewater), accurate analytic techniques can estimate per capita exposure to different substances. Applications of wastewater-based epidemiology have included tracking community prevalence of enteric viral infections, opioid and tobacco use, and many other indicators of health and disease.²

Given the enormous work in the field over the last 2 decades and that SARS-CoV-2 RNA has been detected in feces of both symptomatic and asymptomatic patients, it was only a short conceptual step for those familiar with sewage epidemiology to consider adapting it to assess the prevalence of COVID-19 in a community.

An elegant study collected untreated sewage from southeast Queensland, Australia. The sewage was processed, concentrated, and then tested with reverse transcriptase polymerase chain reaction analysis for SARS-CoV-2 RNA. The number of RNA copies was then entered into an equation that included the population served by the sewage encatchment area, as well as the measured liters of wastewater and grams of feces per day. This provided an estimate of the number of persons infected in the community, and the researchers were able to show reasonable agreement between the numbers estimated by sewage analysis and that found in traditional clinical testing.^3,4

The promise of wastewater-based epidemiology is large. Early research indicates that quantification of viral particles in sewage can be accurately assessed and correlated with the prevalence of the infection in the community. Such levels can then be used to track infection rates of COVID-19 over time, as well as to compare the relative rates in different communities.

Our sewage may hold the answer to accurately and easily tracking COVID-19, and ultimately help us gain a better hold on this disease.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. History of water supply and sanitation. Wikipedia, https://en.wikipedia.org/wiki/History_of_water_supply_and_sanitation.

2. Daughton C. Monitoring wastewater for assessing community health: Sewage Chemical-Information Mining (SCIM). Sci Total Environ. 2017 Nov 29. doi: 10.1016/j.scitotenv.2017.11.102.

3. Ahmed W et al. First confirmed detection of SARS-CoV-2 in untreated wastewater in Australia: A proof of concept for the wastewater surveillance of COVID-19 in the community. Sci Total Environ. 2020 Apr 18. doi: doi.org/10.1016/j.scitotenv.2020.138764.

4. Daughton C. The international imperative to rapidly and inexpensively monitor community-wide COVID-19 infection status and trends. Sci Total Environ. 2020 Mar 23. doi: 10.1016/j.scitotenv.2020.138149.

Bicycling has always been part of who I am because it offered me the freedom to explore as a preteen. As an adult I have always been a bicycle commuter and a very visible part of the community as I pedal around town to do my errands. But, I didn’t always wear a helmet ... because well, I just didn’t. I saw the helmet as a nuisance with very little benefit to myself. Eventually, when bike races required helmets I bought one just for the competitions. Until one day about 30 years ago when the mother of a child I was seeing in the office said, “Dr. Wilkoff, you know as an influential member of this community, particularly its children, you should be wearing a helmet.” My wife had been badgering me for years but this woman’s courage to speak up embarrassed me into changing my ways.

For some, maybe many, people, wearing a mask during the COVID-19 pandemic is a nuisance and an assault on their independence just as I viewed a bicycle helmet. Initially there was some information being circulated that any mask less robust than a N-95 had very little if any effect, either as protection or as way to decrease spread. I certainly had my doubts about the value of mask other than as a statement of solidarity. However, we are now learning that masks can serve an important role along with social distancing in a comprehensive community effort to minimize contagion.

In light of this new information, why are there are still people who won’t wear a mask? It may be that they are receiving their news filtered through a lens that discredits science. But, it is more likely the result of the same mindset that permeates the anti-vaccine faction that the common good is less important than personal freedom to follow their beliefs.

Do we have any tools at our disposal to increase the number of folks wearing masks? Based on our experience with attempts to convince those who are anti-vaccine, education will be ineffective in shifting the focus from personal freedom to a commitment to the welfare of the community at large. Shaming might be effective, but it runs the risk of igniting conflicts and further widening the gaps in our society. Some establishments have been effective in simply saying “no mask, no entry,” but this runs the same risk of creating friction depending on the community and the situation.

The ship may have already sailed on our best opportunity to achieve community compliance when the leaders of our national government have chosen to ignore their obligation to set an example by refusing to wear masks. I fear that the wedge has already been set and the widening of the gap between those who see their responsibility to the community at large and those who do not will continue to grow.

I am fortunate to live in a town whose residents look out for each other and have relied on local leaders to set an example in the absence of leadership on a national level.
 

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 pdnews@mdedge.com.

Bicycling has always been part of who I am because it offered me the freedom to explore as a preteen. As an adult I have always been a bicycle commuter and a very visible part of the community as I pedal around town to do my errands. But, I didn’t always wear a helmet ... because well, I just didn’t. I saw the helmet as a nuisance with very little benefit to myself. Eventually, when bike races required helmets I bought one just for the competitions. Until one day about 30 years ago when the mother of a child I was seeing in the office said, “Dr. Wilkoff, you know as an influential member of this community, particularly its children, you should be wearing a helmet.” My wife had been badgering me for years but this woman’s courage to speak up embarrassed me into changing my ways.

For some, maybe many, people, wearing a mask during the COVID-19 pandemic is a nuisance and an assault on their independence just as I viewed a bicycle helmet. Initially there was some information being circulated that any mask less robust than a N-95 had very little if any effect, either as protection or as way to decrease spread. I certainly had my doubts about the value of mask other than as a statement of solidarity. However, we are now learning that masks can serve an important role along with social distancing in a comprehensive community effort to minimize contagion.

In light of this new information, why are there are still people who won’t wear a mask? It may be that they are receiving their news filtered through a lens that discredits science. But, it is more likely the result of the same mindset that permeates the anti-vaccine faction that the common good is less important than personal freedom to follow their beliefs.

Do we have any tools at our disposal to increase the number of folks wearing masks? Based on our experience with attempts to convince those who are anti-vaccine, education will be ineffective in shifting the focus from personal freedom to a commitment to the welfare of the community at large. Shaming might be effective, but it runs the risk of igniting conflicts and further widening the gaps in our society. Some establishments have been effective in simply saying “no mask, no entry,” but this runs the same risk of creating friction depending on the community and the situation.

The ship may have already sailed on our best opportunity to achieve community compliance when the leaders of our national government have chosen to ignore their obligation to set an example by refusing to wear masks. I fear that the wedge has already been set and the widening of the gap between those who see their responsibility to the community at large and those who do not will continue to grow.

I am fortunate to live in a town whose residents look out for each other and have relied on local leaders to set an example in the absence of leadership on a national level.
 

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 pdnews@mdedge.com.

Bicycling has always been part of who I am because it offered me the freedom to explore as a preteen. As an adult I have always been a bicycle commuter and a very visible part of the community as I pedal around town to do my errands. But, I didn’t always wear a helmet ... because well, I just didn’t. I saw the helmet as a nuisance with very little benefit to myself. Eventually, when bike races required helmets I bought one just for the competitions. Until one day about 30 years ago when the mother of a child I was seeing in the office said, “Dr. Wilkoff, you know as an influential member of this community, particularly its children, you should be wearing a helmet.” My wife had been badgering me for years but this woman’s courage to speak up embarrassed me into changing my ways.

For some, maybe many, people, wearing a mask during the COVID-19 pandemic is a nuisance and an assault on their independence just as I viewed a bicycle helmet. Initially there was some information being circulated that any mask less robust than a N-95 had very little if any effect, either as protection or as way to decrease spread. I certainly had my doubts about the value of mask other than as a statement of solidarity. However, we are now learning that masks can serve an important role along with social distancing in a comprehensive community effort to minimize contagion.

In light of this new information, why are there are still people who won’t wear a mask? It may be that they are receiving their news filtered through a lens that discredits science. But, it is more likely the result of the same mindset that permeates the anti-vaccine faction that the common good is less important than personal freedom to follow their beliefs.

Do we have any tools at our disposal to increase the number of folks wearing masks? Based on our experience with attempts to convince those who are anti-vaccine, education will be ineffective in shifting the focus from personal freedom to a commitment to the welfare of the community at large. Shaming might be effective, but it runs the risk of igniting conflicts and further widening the gaps in our society. Some establishments have been effective in simply saying “no mask, no entry,” but this runs the same risk of creating friction depending on the community and the situation.

The ship may have already sailed on our best opportunity to achieve community compliance when the leaders of our national government have chosen to ignore their obligation to set an example by refusing to wear masks. I fear that the wedge has already been set and the widening of the gap between those who see their responsibility to the community at large and those who do not will continue to grow.

I am fortunate to live in a town whose residents look out for each other and have relied on local leaders to set an example in the absence of leadership on a national level.
 

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 pdnews@mdedge.com.

A phase 1/2 trial of a vaccine against SARS-CoV-2 being developed by the University of Oxford has found that the vaccine is safe, causes few side effects, and induces strong immune responses.

The early stage results, published in The Lancet, found that the candidate vaccine, known as ChAdOx1 nCoV-19, provoked a T-cell response peaking 14 days after vaccination, and an antibody response within 28 days.

Andrew Pollard, chief investigator on the study, and professor of pediatric infection and immunity at Oxford University, described the results as “encouraging”. He told a briefing convened by the Science Media Centre on Monday that it was “a really important milestone on the path to the development of the vaccine”.

In the Commons, the Health Secretary, Matt Hancock, hailed the results for taking us “one step closer to finding a vaccine that can potentially save lives, all around the world”.

The trial, which has so far involved 1,077 healthy adults, caused minor side effects when compared with a control group given a meningitis vaccine. Fatigue and headache were the most commonly reported reactions.

However, there were no serious adverse events from the vaccine, the researchers said.
 

‘Still a long way to go’

Sarah Gilbert, lead researcher of the vaccine development program, and professor of vaccinology at Oxford, cautioned that there was still a long way to go before the team could confirm that the vaccine could protect against developing COVID-19.

“The difficulty that we have, and that all vaccine developers have in trying to make a vaccine against this particular virus, is that we don’t know how strong that immune response needs to be,” she said.

“So, we can’t say just by looking at immune responses whether this is going to protect people or not. And the only way we’re going to find out is by doing the large phase 3 trials and wait for people to be infected as part of that trial before we know if the vaccine can work.”

The authors noted some limitations to their findings. They said more research was needed to confirm their results in different groups of people – including older age groups, those with other health conditions, and in ethnically and geographically diverse populations.

A notable result of the trial was that participants given a second dose of the vaccine appeared to display a stronger immune response, a finding that had influenced plans to “look at two dose regimes as well as one dose regimes in the phase 3 trial”, Prof Adrian Hill, director of Oxford’s Jenner Institute, confirmed.

ChAdOx1 nCoV-19 is made from a weakened version of an adenovirus that causes infections in chimpanzees. The virus has been genetically modified so that it cannot grow in humans.

On Monday, the government announced that it had struck a deal with AstraZeneca for access to 100 million doses of the Oxford vaccine, in addition to millions of doses of other promising candidate vaccines.
 

Expert reaction to the findings

The Medical Research Council helped to fund the trial. Executive Chair Professor Fiona Watt commented: “It is truly remarkable how fast this vaccine has progressed, with our support, through early clinical trials, and it is very encouraging that it shows no safety concerns and evokes strong immune responses.

“There is a lot that we don’t yet know about immunity to the virus that causes COVID-19. However, it seems that both antibody and T cell immunity are important, and this vaccine triggers both responses. The much anticipated next milestone will be the results of the larger trials that are happening now to find out if the vaccine will protect people from the virus.”

Jonathan Ball, professor of molecular virology at the University of Nottingham, told the SMC: “The results of the Oxford chimp adenovirus vaccine candidate show that the vaccine is able to generate antibodies and T cells in humans and these persisted for several weeks. Whilst encouraging there is still a long way to go before we can herald the arrival of a successful coronavirus vaccine.

“It is unclear whether the levels of immunity can protect against infection – that’s what the larger ongoing phase III trials are designed to test. Nor do we know if this vaccine can protect those most vulnerable to severe COVID-19 disease.”

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, commented: “For the vaccine to be really useful, we not only need the larger studies conducted where COVID-19 is still occurring at a high rate, but we need to be reasonably sure that the protection lasts for a considerable time.”

He said it was also vital that people older than 55 were included in later trials.

Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry, said: “Developing a vaccine is an incredibly difficult challenge; the fact that there are multiple candidates in development is hopefully a sign that the hard work will ultimately pay off.

“But we must be patient. Proving that a vaccine is safe and effective is a long process and we could still be many months away.”

This article first appeared on Medscape.com.

A phase 1/2 trial of a vaccine against SARS-CoV-2 being developed by the University of Oxford has found that the vaccine is safe, causes few side effects, and induces strong immune responses.

The early stage results, published in The Lancet, found that the candidate vaccine, known as ChAdOx1 nCoV-19, provoked a T-cell response peaking 14 days after vaccination, and an antibody response within 28 days.

Andrew Pollard, chief investigator on the study, and professor of pediatric infection and immunity at Oxford University, described the results as “encouraging”. He told a briefing convened by the Science Media Centre on Monday that it was “a really important milestone on the path to the development of the vaccine”.

In the Commons, the Health Secretary, Matt Hancock, hailed the results for taking us “one step closer to finding a vaccine that can potentially save lives, all around the world”.

The trial, which has so far involved 1,077 healthy adults, caused minor side effects when compared with a control group given a meningitis vaccine. Fatigue and headache were the most commonly reported reactions.

However, there were no serious adverse events from the vaccine, the researchers said.
 

‘Still a long way to go’

Sarah Gilbert, lead researcher of the vaccine development program, and professor of vaccinology at Oxford, cautioned that there was still a long way to go before the team could confirm that the vaccine could protect against developing COVID-19.

“The difficulty that we have, and that all vaccine developers have in trying to make a vaccine against this particular virus, is that we don’t know how strong that immune response needs to be,” she said.

“So, we can’t say just by looking at immune responses whether this is going to protect people or not. And the only way we’re going to find out is by doing the large phase 3 trials and wait for people to be infected as part of that trial before we know if the vaccine can work.”

The authors noted some limitations to their findings. They said more research was needed to confirm their results in different groups of people – including older age groups, those with other health conditions, and in ethnically and geographically diverse populations.

A notable result of the trial was that participants given a second dose of the vaccine appeared to display a stronger immune response, a finding that had influenced plans to “look at two dose regimes as well as one dose regimes in the phase 3 trial”, Prof Adrian Hill, director of Oxford’s Jenner Institute, confirmed.

ChAdOx1 nCoV-19 is made from a weakened version of an adenovirus that causes infections in chimpanzees. The virus has been genetically modified so that it cannot grow in humans.

On Monday, the government announced that it had struck a deal with AstraZeneca for access to 100 million doses of the Oxford vaccine, in addition to millions of doses of other promising candidate vaccines.
 

Expert reaction to the findings

The Medical Research Council helped to fund the trial. Executive Chair Professor Fiona Watt commented: “It is truly remarkable how fast this vaccine has progressed, with our support, through early clinical trials, and it is very encouraging that it shows no safety concerns and evokes strong immune responses.

“There is a lot that we don’t yet know about immunity to the virus that causes COVID-19. However, it seems that both antibody and T cell immunity are important, and this vaccine triggers both responses. The much anticipated next milestone will be the results of the larger trials that are happening now to find out if the vaccine will protect people from the virus.”

Jonathan Ball, professor of molecular virology at the University of Nottingham, told the SMC: “The results of the Oxford chimp adenovirus vaccine candidate show that the vaccine is able to generate antibodies and T cells in humans and these persisted for several weeks. Whilst encouraging there is still a long way to go before we can herald the arrival of a successful coronavirus vaccine.

“It is unclear whether the levels of immunity can protect against infection – that’s what the larger ongoing phase III trials are designed to test. Nor do we know if this vaccine can protect those most vulnerable to severe COVID-19 disease.”

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, commented: “For the vaccine to be really useful, we not only need the larger studies conducted where COVID-19 is still occurring at a high rate, but we need to be reasonably sure that the protection lasts for a considerable time.”

He said it was also vital that people older than 55 were included in later trials.

Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry, said: “Developing a vaccine is an incredibly difficult challenge; the fact that there are multiple candidates in development is hopefully a sign that the hard work will ultimately pay off.

“But we must be patient. Proving that a vaccine is safe and effective is a long process and we could still be many months away.”

This article first appeared on Medscape.com.

A phase 1/2 trial of a vaccine against SARS-CoV-2 being developed by the University of Oxford has found that the vaccine is safe, causes few side effects, and induces strong immune responses.

The early stage results, published in The Lancet, found that the candidate vaccine, known as ChAdOx1 nCoV-19, provoked a T-cell response peaking 14 days after vaccination, and an antibody response within 28 days.

Andrew Pollard, chief investigator on the study, and professor of pediatric infection and immunity at Oxford University, described the results as “encouraging”. He told a briefing convened by the Science Media Centre on Monday that it was “a really important milestone on the path to the development of the vaccine”.

In the Commons, the Health Secretary, Matt Hancock, hailed the results for taking us “one step closer to finding a vaccine that can potentially save lives, all around the world”.

The trial, which has so far involved 1,077 healthy adults, caused minor side effects when compared with a control group given a meningitis vaccine. Fatigue and headache were the most commonly reported reactions.

However, there were no serious adverse events from the vaccine, the researchers said.
 

‘Still a long way to go’

Sarah Gilbert, lead researcher of the vaccine development program, and professor of vaccinology at Oxford, cautioned that there was still a long way to go before the team could confirm that the vaccine could protect against developing COVID-19.

“The difficulty that we have, and that all vaccine developers have in trying to make a vaccine against this particular virus, is that we don’t know how strong that immune response needs to be,” she said.

“So, we can’t say just by looking at immune responses whether this is going to protect people or not. And the only way we’re going to find out is by doing the large phase 3 trials and wait for people to be infected as part of that trial before we know if the vaccine can work.”

The authors noted some limitations to their findings. They said more research was needed to confirm their results in different groups of people – including older age groups, those with other health conditions, and in ethnically and geographically diverse populations.

A notable result of the trial was that participants given a second dose of the vaccine appeared to display a stronger immune response, a finding that had influenced plans to “look at two dose regimes as well as one dose regimes in the phase 3 trial”, Prof Adrian Hill, director of Oxford’s Jenner Institute, confirmed.

ChAdOx1 nCoV-19 is made from a weakened version of an adenovirus that causes infections in chimpanzees. The virus has been genetically modified so that it cannot grow in humans.

On Monday, the government announced that it had struck a deal with AstraZeneca for access to 100 million doses of the Oxford vaccine, in addition to millions of doses of other promising candidate vaccines.
 

Expert reaction to the findings

The Medical Research Council helped to fund the trial. Executive Chair Professor Fiona Watt commented: “It is truly remarkable how fast this vaccine has progressed, with our support, through early clinical trials, and it is very encouraging that it shows no safety concerns and evokes strong immune responses.

“There is a lot that we don’t yet know about immunity to the virus that causes COVID-19. However, it seems that both antibody and T cell immunity are important, and this vaccine triggers both responses. The much anticipated next milestone will be the results of the larger trials that are happening now to find out if the vaccine will protect people from the virus.”

Jonathan Ball, professor of molecular virology at the University of Nottingham, told the SMC: “The results of the Oxford chimp adenovirus vaccine candidate show that the vaccine is able to generate antibodies and T cells in humans and these persisted for several weeks. Whilst encouraging there is still a long way to go before we can herald the arrival of a successful coronavirus vaccine.

“It is unclear whether the levels of immunity can protect against infection – that’s what the larger ongoing phase III trials are designed to test. Nor do we know if this vaccine can protect those most vulnerable to severe COVID-19 disease.”

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, commented: “For the vaccine to be really useful, we not only need the larger studies conducted where COVID-19 is still occurring at a high rate, but we need to be reasonably sure that the protection lasts for a considerable time.”

He said it was also vital that people older than 55 were included in later trials.

Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry, said: “Developing a vaccine is an incredibly difficult challenge; the fact that there are multiple candidates in development is hopefully a sign that the hard work will ultimately pay off.

“But we must be patient. Proving that a vaccine is safe and effective is a long process and we could still be many months away.”

This article first appeared on Medscape.com.

Every person who received Moderna’s COVID-19 vaccine, mRNA-1273, developed an immune response to the virus that causes it, the company says in a news release.

Researchers also reported some side effects in the 45 people in the phase I study, but no significant safety issues, the news release says.

The vaccine is among hundreds being tested worldwide in an effort to halt the pandemic that has killed nearly 600,000 worldwide.

A researcher testing the vaccine called the results encouraging but cautioned more study is needed. “Importantly, the vaccine resulted in a robust immune response,” Evan Anderson, MD, principal investigator for the trial at Emory University, says in a news release. Emory and Kaiser Permanente Washington Health Research Institute were the two sites for the study.

The company is already testing the vaccine in a larger group of people, known as a phase II trial. It plans to begin phase III trials in late July. Phase III trials involve testing the vaccine on an even larger group and are the final step before FDA approval.

The study results are published in The New England Journal of Medicine. The study was led by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.

Moderna’s vaccine uses messenger RNA, also called mRNA. It carries the instruction for making the spike protein, a key protein on the surface of the virus that allows it to enter cells when a person is infected. After it’s injected, it goes to the immune cells and instructs them to make copies of the spike protein, acting as if the cells have been infected with the actual coronavirus. This allows other immune cells to develop immunity.

In the study, participants were divided into three groups of 15 people each. All groups received two vaccinations 28 days apart. Each group received a different strength of the vaccine – either 25, 100, or 250 micrograms.

Every person in the study developed antibodies that can block the infection. Most commonly reported side effects after the second vaccination in the 100-microgram group were fatigue, chills, headache, and muscle pains, ranging from mild to moderately severe.

The phase II study has 300 heathy adults ages 18-55, along with another 300 ages 55 and older

Moderna says it hopes to include about 30,000 participants at the 100-microgram dose level in the U.S. for the phase III trial. The estimated start date is July 27.

This article first appeared on WebMD.com.

Every person who received Moderna’s COVID-19 vaccine, mRNA-1273, developed an immune response to the virus that causes it, the company says in a news release.

Researchers also reported some side effects in the 45 people in the phase I study, but no significant safety issues, the news release says.

The vaccine is among hundreds being tested worldwide in an effort to halt the pandemic that has killed nearly 600,000 worldwide.

A researcher testing the vaccine called the results encouraging but cautioned more study is needed. “Importantly, the vaccine resulted in a robust immune response,” Evan Anderson, MD, principal investigator for the trial at Emory University, says in a news release. Emory and Kaiser Permanente Washington Health Research Institute were the two sites for the study.

The company is already testing the vaccine in a larger group of people, known as a phase II trial. It plans to begin phase III trials in late July. Phase III trials involve testing the vaccine on an even larger group and are the final step before FDA approval.

The study results are published in The New England Journal of Medicine. The study was led by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.

Moderna’s vaccine uses messenger RNA, also called mRNA. It carries the instruction for making the spike protein, a key protein on the surface of the virus that allows it to enter cells when a person is infected. After it’s injected, it goes to the immune cells and instructs them to make copies of the spike protein, acting as if the cells have been infected with the actual coronavirus. This allows other immune cells to develop immunity.

In the study, participants were divided into three groups of 15 people each. All groups received two vaccinations 28 days apart. Each group received a different strength of the vaccine – either 25, 100, or 250 micrograms.

Every person in the study developed antibodies that can block the infection. Most commonly reported side effects after the second vaccination in the 100-microgram group were fatigue, chills, headache, and muscle pains, ranging from mild to moderately severe.

The phase II study has 300 heathy adults ages 18-55, along with another 300 ages 55 and older

Moderna says it hopes to include about 30,000 participants at the 100-microgram dose level in the U.S. for the phase III trial. The estimated start date is July 27.

This article first appeared on WebMD.com.

Every person who received Moderna’s COVID-19 vaccine, mRNA-1273, developed an immune response to the virus that causes it, the company says in a news release.

Researchers also reported some side effects in the 45 people in the phase I study, but no significant safety issues, the news release says.

The vaccine is among hundreds being tested worldwide in an effort to halt the pandemic that has killed nearly 600,000 worldwide.

A researcher testing the vaccine called the results encouraging but cautioned more study is needed. “Importantly, the vaccine resulted in a robust immune response,” Evan Anderson, MD, principal investigator for the trial at Emory University, says in a news release. Emory and Kaiser Permanente Washington Health Research Institute were the two sites for the study.

The company is already testing the vaccine in a larger group of people, known as a phase II trial. It plans to begin phase III trials in late July. Phase III trials involve testing the vaccine on an even larger group and are the final step before FDA approval.

The study results are published in The New England Journal of Medicine. The study was led by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.

Moderna’s vaccine uses messenger RNA, also called mRNA. It carries the instruction for making the spike protein, a key protein on the surface of the virus that allows it to enter cells when a person is infected. After it’s injected, it goes to the immune cells and instructs them to make copies of the spike protein, acting as if the cells have been infected with the actual coronavirus. This allows other immune cells to develop immunity.

In the study, participants were divided into three groups of 15 people each. All groups received two vaccinations 28 days apart. Each group received a different strength of the vaccine – either 25, 100, or 250 micrograms.

Every person in the study developed antibodies that can block the infection. Most commonly reported side effects after the second vaccination in the 100-microgram group were fatigue, chills, headache, and muscle pains, ranging from mild to moderately severe.

The phase II study has 300 heathy adults ages 18-55, along with another 300 ages 55 and older

Moderna says it hopes to include about 30,000 participants at the 100-microgram dose level in the U.S. for the phase III trial. The estimated start date is July 27.

This article first appeared on WebMD.com.

We live in historic times. A worldwide pandemic is surging in the United States, with millions infected and the world’s highest death rate. Many of our hospitals are overwhelmed. Schools have been closed for months. Businesses are struggling, and unemployment is at record levels. The murder of George Floyd unleashed an outpouring of grief and rage over police brutality and structural racism.

Thinkstock

The value of knowing about these risk factors would seem self-evident; it would inform a patient’s health care from screening for cancer or heart disease, referral for mild depressive symptoms, and counseling about alcohol consumption. But this research did not lead to the establishment of routine screening for childhood adversity in primary care practices. There are multiple reasons for this, including growing pressure on physician time and discomfort with starting conversations about potentially traumatic material. But perhaps the greatest obstacle has been uncertainty about what to offer patients who screened in. What is the treatment for a high ACE score?

Even without treatments, we have learned much about childhood adversity since Dr. Anda and Dr. Felitti published their landmark study. Other more chronic adverse childhood experiences also contribute to adult health risk, such as poverty, homelessness, discrimination, community violence, parental chronic illness, or disability or placement in foster care. Having a high ACE score does not only affect health in adulthood. Children with an ACE score of 4 are 2 times as likely to have asthma^2,3 and allergies³, 2 times as likely to be obese⁴, 3 times as likely to have headaches³ and dental problems^5,6, 4 times as likely to have depression^7,8, 5 times as likely to have ADHD^8,9, 7 times as likely to have high rates of school absenteeism³ and aggression¹⁰, and over 30 times as likely to have learning or behavioral problems at school⁴. There is a growing body of knowledge about how chronic, severe stress in childhood affects can lead to pathological alterations in neuroendocrine and immune function. But this has not led to any concrete treatments that may be preventive or reparative.

Movement toward expanding screening nonetheless has accelerated. In California, Nadine Burke-Harris, MD, a pediatrician who studied ACEs and children’s health was named the state’s first Surgeon General in 2019 and spearheaded an effort to make screening for ACEs easier. Starting in 2020, MediCal will pay for annual screenings, and the state is offering training and resources on how to screen and what to do with the information to help patients and families.

The coronavirus pandemic has only highlighted the risks of childhood adversity. The burden of infection and mortality has been borne disproportionately by people of color and those with multiple chronic medical conditions (obesity, cardiovascular disease, diabetes, etc.). While viruses do not discriminate, they are more likely to infect those with higher risk of exposure and to kill those who are physiologically vulnerable.

And the pandemic increases the risk for adversity for today’s children and families. When children cannot attend school, financially vulnerable parents may have to choose between supervising them or feeding them. Families who suddenly are all in a small apartment together without school or other outside supports may be at higher risk for domestic violence and child abuse. Unemployment and financial uncertainty will increase the rates of substance abuse and depression amongst parents. And the serious illness or death of a parent will be a more common event for children in the year ahead. One of these risk factors may increase the likelihood of others.

Beyond the obvious need for substantial policy changes focused on housing, education, and health care, there are immediate and concrete strategies that can build resilience in children and their families. And resilience can build on itself, as children face subsequent challenges with the support of caring connected adults.

The critical first step is asking. Then listen calmly and supportively, normalizing for parents and children how common these experiences are. Explain how they affect health and well-being. Explain that adversity and its consequences are not their fault. Then educate them about what is in their control: the skills they can practice to buffer against the consequences of adversity and build resilience. They sound simple, but still require effort and work. And the pandemic has created some difficulty (social distancing) and opportunity (more family time, fewer school demands).
 

Sleep

Help parents establish and protect consistent, restful sleep for their children. They can set a consistent bedtime and a calm routine, with screens all off at least 30 minutes before sleep and reading before sleep. Restful sleep is physiologically and psychologically protective to everyone in a family.

Movement

Beyond directly improving physical health, establishing habits of exercise – especially outside – every day can effectively manage ongoing stress, build skills of self-regulation, and help with sleep.

Find out what parents and their children like to do together (walking the dog, shooting hoops, even dancing) and help them devise ways to create family routines around exercise.
 

Nutrition

Food should be a source of pleasure, but stress can make food into a source of comfort or escape. Help parents to create realistic ways to consistently offer healthy family meals and discourage unhealthy habits.

Even small changes like water instead of soda can help, and there are nutritional and emotional benefits to eating a healthy breakfast or dinner together as a family.
 

Connections

Nourishing social connections are protective. Help parents think about protecting time to spend with their children for talking, playing games, or even singing.

They should support their children’s connections to other caring adults, through community organizations (church, community centers, or sports), and they should know who their children’s reliable friends are. Parents will benefit from these supports for themselves, which in turn will benefit the full family.
 

Self-awareness

Activities that cultivate mindfulness are protective. Parents can simply ask how their children are feeling, physically or emotionally, and be able to bear it when it is uncomfortable. Work towards nonjudgmental awareness of how they are feeling. Learning what is relaxing or recharging for them (exercise, music, a hot bath, a good book, time with a friend) will protect against defaulting into maladaptive coping such as escape, numbing, or avoidance.

Of course, if you learn about symptoms that suggest PTSD, depression, or addiction, you should help your patient connect with effective treatment. The difficulty of referring to a mental health provider does not mean you should not try and bring as many people onto the team and into the orbit of the child and family at risk. It may be easier to access some therapy given the new availability of telemedicine visits across many more systems of care. Although the heaviest burdens of adversity are not being borne equally, the fact that adversity is currently a shared experience makes this a moment of promise.

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Dr. Swick and Dr. Jellinek had no relevant financial disclosures. Email them at pdnews@mdedge.com.

References
1. Am J Prev Med. 1998 May;14(4):245-58.
2. Ann Allergy Asthma Immunol. 2015;114: 379-84.
3. BMC Public Health. 2018. doi: 10.1186/s12889-018-5699-8.
4. Child Abuse Negl. 2011 Jun;35(6):408-13.
5. Community Dent Oral Epidemiol. 2015;43:193-9.
6. Community Dent Oral Epidemiol. 2018 Oct;46(5): 442-8.
7. Pediatrics 2016 Apr. doi: 10.1542/peds.2015-4016.
8. Matern Child Health J. 2016 Apr. doi: 10.1007/s10995-015-1915-7.
9. Acad Pediatr. 2017 May-Jun. doi: 10.1016/j.acap.2016.08.013.
10. Pediatrics. 2010 Apr. doi: 10.1542/peds.2009-0597.
 

This article was updated 7/27/2020.

We live in historic times. A worldwide pandemic is surging in the United States, with millions infected and the world’s highest death rate. Many of our hospitals are overwhelmed. Schools have been closed for months. Businesses are struggling, and unemployment is at record levels. The murder of George Floyd unleashed an outpouring of grief and rage over police brutality and structural racism.

Thinkstock

The value of knowing about these risk factors would seem self-evident; it would inform a patient’s health care from screening for cancer or heart disease, referral for mild depressive symptoms, and counseling about alcohol consumption. But this research did not lead to the establishment of routine screening for childhood adversity in primary care practices. There are multiple reasons for this, including growing pressure on physician time and discomfort with starting conversations about potentially traumatic material. But perhaps the greatest obstacle has been uncertainty about what to offer patients who screened in. What is the treatment for a high ACE score?

Even without treatments, we have learned much about childhood adversity since Dr. Anda and Dr. Felitti published their landmark study. Other more chronic adverse childhood experiences also contribute to adult health risk, such as poverty, homelessness, discrimination, community violence, parental chronic illness, or disability or placement in foster care. Having a high ACE score does not only affect health in adulthood. Children with an ACE score of 4 are 2 times as likely to have asthma^2,3 and allergies³, 2 times as likely to be obese⁴, 3 times as likely to have headaches³ and dental problems^5,6, 4 times as likely to have depression^7,8, 5 times as likely to have ADHD^8,9, 7 times as likely to have high rates of school absenteeism³ and aggression¹⁰, and over 30 times as likely to have learning or behavioral problems at school⁴. There is a growing body of knowledge about how chronic, severe stress in childhood affects can lead to pathological alterations in neuroendocrine and immune function. But this has not led to any concrete treatments that may be preventive or reparative.

Movement toward expanding screening nonetheless has accelerated. In California, Nadine Burke-Harris, MD, a pediatrician who studied ACEs and children’s health was named the state’s first Surgeon General in 2019 and spearheaded an effort to make screening for ACEs easier. Starting in 2020, MediCal will pay for annual screenings, and the state is offering training and resources on how to screen and what to do with the information to help patients and families.

The coronavirus pandemic has only highlighted the risks of childhood adversity. The burden of infection and mortality has been borne disproportionately by people of color and those with multiple chronic medical conditions (obesity, cardiovascular disease, diabetes, etc.). While viruses do not discriminate, they are more likely to infect those with higher risk of exposure and to kill those who are physiologically vulnerable.

And the pandemic increases the risk for adversity for today’s children and families. When children cannot attend school, financially vulnerable parents may have to choose between supervising them or feeding them. Families who suddenly are all in a small apartment together without school or other outside supports may be at higher risk for domestic violence and child abuse. Unemployment and financial uncertainty will increase the rates of substance abuse and depression amongst parents. And the serious illness or death of a parent will be a more common event for children in the year ahead. One of these risk factors may increase the likelihood of others.

Beyond the obvious need for substantial policy changes focused on housing, education, and health care, there are immediate and concrete strategies that can build resilience in children and their families. And resilience can build on itself, as children face subsequent challenges with the support of caring connected adults.

The critical first step is asking. Then listen calmly and supportively, normalizing for parents and children how common these experiences are. Explain how they affect health and well-being. Explain that adversity and its consequences are not their fault. Then educate them about what is in their control: the skills they can practice to buffer against the consequences of adversity and build resilience. They sound simple, but still require effort and work. And the pandemic has created some difficulty (social distancing) and opportunity (more family time, fewer school demands).
 

Sleep

Help parents establish and protect consistent, restful sleep for their children. They can set a consistent bedtime and a calm routine, with screens all off at least 30 minutes before sleep and reading before sleep. Restful sleep is physiologically and psychologically protective to everyone in a family.

Movement

Beyond directly improving physical health, establishing habits of exercise – especially outside – every day can effectively manage ongoing stress, build skills of self-regulation, and help with sleep.

Find out what parents and their children like to do together (walking the dog, shooting hoops, even dancing) and help them devise ways to create family routines around exercise.
 

Nutrition

Food should be a source of pleasure, but stress can make food into a source of comfort or escape. Help parents to create realistic ways to consistently offer healthy family meals and discourage unhealthy habits.

Even small changes like water instead of soda can help, and there are nutritional and emotional benefits to eating a healthy breakfast or dinner together as a family.
 

Connections

Nourishing social connections are protective. Help parents think about protecting time to spend with their children for talking, playing games, or even singing.

They should support their children’s connections to other caring adults, through community organizations (church, community centers, or sports), and they should know who their children’s reliable friends are. Parents will benefit from these supports for themselves, which in turn will benefit the full family.
 

Self-awareness

Activities that cultivate mindfulness are protective. Parents can simply ask how their children are feeling, physically or emotionally, and be able to bear it when it is uncomfortable. Work towards nonjudgmental awareness of how they are feeling. Learning what is relaxing or recharging for them (exercise, music, a hot bath, a good book, time with a friend) will protect against defaulting into maladaptive coping such as escape, numbing, or avoidance.

Of course, if you learn about symptoms that suggest PTSD, depression, or addiction, you should help your patient connect with effective treatment. The difficulty of referring to a mental health provider does not mean you should not try and bring as many people onto the team and into the orbit of the child and family at risk. It may be easier to access some therapy given the new availability of telemedicine visits across many more systems of care. Although the heaviest burdens of adversity are not being borne equally, the fact that adversity is currently a shared experience makes this a moment of promise.

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Dr. Swick and Dr. Jellinek had no relevant financial disclosures. Email them at pdnews@mdedge.com.

References
1. Am J Prev Med. 1998 May;14(4):245-58.
2. Ann Allergy Asthma Immunol. 2015;114: 379-84.
3. BMC Public Health. 2018. doi: 10.1186/s12889-018-5699-8.
4. Child Abuse Negl. 2011 Jun;35(6):408-13.
5. Community Dent Oral Epidemiol. 2015;43:193-9.
6. Community Dent Oral Epidemiol. 2018 Oct;46(5): 442-8.
7. Pediatrics 2016 Apr. doi: 10.1542/peds.2015-4016.
8. Matern Child Health J. 2016 Apr. doi: 10.1007/s10995-015-1915-7.
9. Acad Pediatr. 2017 May-Jun. doi: 10.1016/j.acap.2016.08.013.
10. Pediatrics. 2010 Apr. doi: 10.1542/peds.2009-0597.
 

This article was updated 7/27/2020.

We live in historic times. A worldwide pandemic is surging in the United States, with millions infected and the world’s highest death rate. Many of our hospitals are overwhelmed. Schools have been closed for months. Businesses are struggling, and unemployment is at record levels. The murder of George Floyd unleashed an outpouring of grief and rage over police brutality and structural racism.

Thinkstock

The value of knowing about these risk factors would seem self-evident; it would inform a patient’s health care from screening for cancer or heart disease, referral for mild depressive symptoms, and counseling about alcohol consumption. But this research did not lead to the establishment of routine screening for childhood adversity in primary care practices. There are multiple reasons for this, including growing pressure on physician time and discomfort with starting conversations about potentially traumatic material. But perhaps the greatest obstacle has been uncertainty about what to offer patients who screened in. What is the treatment for a high ACE score?

Even without treatments, we have learned much about childhood adversity since Dr. Anda and Dr. Felitti published their landmark study. Other more chronic adverse childhood experiences also contribute to adult health risk, such as poverty, homelessness, discrimination, community violence, parental chronic illness, or disability or placement in foster care. Having a high ACE score does not only affect health in adulthood. Children with an ACE score of 4 are 2 times as likely to have asthma^2,3 and allergies³, 2 times as likely to be obese⁴, 3 times as likely to have headaches³ and dental problems^5,6, 4 times as likely to have depression^7,8, 5 times as likely to have ADHD^8,9, 7 times as likely to have high rates of school absenteeism³ and aggression¹⁰, and over 30 times as likely to have learning or behavioral problems at school⁴. There is a growing body of knowledge about how chronic, severe stress in childhood affects can lead to pathological alterations in neuroendocrine and immune function. But this has not led to any concrete treatments that may be preventive or reparative.

Movement toward expanding screening nonetheless has accelerated. In California, Nadine Burke-Harris, MD, a pediatrician who studied ACEs and children’s health was named the state’s first Surgeon General in 2019 and spearheaded an effort to make screening for ACEs easier. Starting in 2020, MediCal will pay for annual screenings, and the state is offering training and resources on how to screen and what to do with the information to help patients and families.

The coronavirus pandemic has only highlighted the risks of childhood adversity. The burden of infection and mortality has been borne disproportionately by people of color and those with multiple chronic medical conditions (obesity, cardiovascular disease, diabetes, etc.). While viruses do not discriminate, they are more likely to infect those with higher risk of exposure and to kill those who are physiologically vulnerable.

And the pandemic increases the risk for adversity for today’s children and families. When children cannot attend school, financially vulnerable parents may have to choose between supervising them or feeding them. Families who suddenly are all in a small apartment together without school or other outside supports may be at higher risk for domestic violence and child abuse. Unemployment and financial uncertainty will increase the rates of substance abuse and depression amongst parents. And the serious illness or death of a parent will be a more common event for children in the year ahead. One of these risk factors may increase the likelihood of others.

Beyond the obvious need for substantial policy changes focused on housing, education, and health care, there are immediate and concrete strategies that can build resilience in children and their families. And resilience can build on itself, as children face subsequent challenges with the support of caring connected adults.

The critical first step is asking. Then listen calmly and supportively, normalizing for parents and children how common these experiences are. Explain how they affect health and well-being. Explain that adversity and its consequences are not their fault. Then educate them about what is in their control: the skills they can practice to buffer against the consequences of adversity and build resilience. They sound simple, but still require effort and work. And the pandemic has created some difficulty (social distancing) and opportunity (more family time, fewer school demands).
 

Sleep

Help parents establish and protect consistent, restful sleep for their children. They can set a consistent bedtime and a calm routine, with screens all off at least 30 minutes before sleep and reading before sleep. Restful sleep is physiologically and psychologically protective to everyone in a family.

Movement

Beyond directly improving physical health, establishing habits of exercise – especially outside – every day can effectively manage ongoing stress, build skills of self-regulation, and help with sleep.

Find out what parents and their children like to do together (walking the dog, shooting hoops, even dancing) and help them devise ways to create family routines around exercise.
 

Nutrition

Food should be a source of pleasure, but stress can make food into a source of comfort or escape. Help parents to create realistic ways to consistently offer healthy family meals and discourage unhealthy habits.

Even small changes like water instead of soda can help, and there are nutritional and emotional benefits to eating a healthy breakfast or dinner together as a family.
 

Connections

Nourishing social connections are protective. Help parents think about protecting time to spend with their children for talking, playing games, or even singing.

They should support their children’s connections to other caring adults, through community organizations (church, community centers, or sports), and they should know who their children’s reliable friends are. Parents will benefit from these supports for themselves, which in turn will benefit the full family.
 

Self-awareness

Activities that cultivate mindfulness are protective. Parents can simply ask how their children are feeling, physically or emotionally, and be able to bear it when it is uncomfortable. Work towards nonjudgmental awareness of how they are feeling. Learning what is relaxing or recharging for them (exercise, music, a hot bath, a good book, time with a friend) will protect against defaulting into maladaptive coping such as escape, numbing, or avoidance.

Of course, if you learn about symptoms that suggest PTSD, depression, or addiction, you should help your patient connect with effective treatment. The difficulty of referring to a mental health provider does not mean you should not try and bring as many people onto the team and into the orbit of the child and family at risk. It may be easier to access some therapy given the new availability of telemedicine visits across many more systems of care. Although the heaviest burdens of adversity are not being borne equally, the fact that adversity is currently a shared experience makes this a moment of promise.

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Dr. Swick and Dr. Jellinek had no relevant financial disclosures. Email them at pdnews@mdedge.com.

References
1. Am J Prev Med. 1998 May;14(4):245-58.
2. Ann Allergy Asthma Immunol. 2015;114: 379-84.
3. BMC Public Health. 2018. doi: 10.1186/s12889-018-5699-8.
4. Child Abuse Negl. 2011 Jun;35(6):408-13.
5. Community Dent Oral Epidemiol. 2015;43:193-9.
6. Community Dent Oral Epidemiol. 2018 Oct;46(5): 442-8.
7. Pediatrics 2016 Apr. doi: 10.1542/peds.2015-4016.
8. Matern Child Health J. 2016 Apr. doi: 10.1007/s10995-015-1915-7.
9. Acad Pediatr. 2017 May-Jun. doi: 10.1016/j.acap.2016.08.013.
10. Pediatrics. 2010 Apr. doi: 10.1542/peds.2009-0597.
 

This article was updated 7/27/2020.

Three autoantibodies to newly discovered axial spondyloarthritis peptides may improve early diagnosis of the disease, according to a cross-sectional cohort study reported in Arthritis & Rheumatology.

The Assessment in SpondyloArthritis International Society (ASAS) classification criteria were not intended for diagnosis and do not differentiate well between patients with early axial spondyloarthritis (axSpA) and patients with nonspecific chronic low back pain, note the investigators, who conducted their research under senior investigator Veerle Somers, PhD, professor of molecular biology at Hasselt (Belgium) University and vice dean of the School of Life Sciences at Transnationale Universiteit Limburg, also in Hasselt.

“Therefore, for many patients, axSpA diagnosis may be challenging and is often delayed by several years after the occurrence of first clinical symptoms, posing a problem for early treatment initiation,” they wrote.

The investigators used plasma samples from patients with early disease and an axSpA complementary DNA phage display library developed with synovial tissue to screen for IgG antibodies that displayed significantly higher reactivity to plasma pools from the early axSpA patients than healthy controls.

They then assessed presence of the antibodies with enzyme-linked immunosorbent assays in a mixed cohort (76 patients with early axSpA having mean disease duration of 2.8 years, 75 control patients with nonspecific chronic low back pain, 60 patients with RA, and 94 healthy controls) and in an axSpA-only cohort (174 patients, 79 of whom had early disease with mean disease duration of 1.4 years).

Screening identified antibodies to nine novel peptides – eight peptides showing partial homology to human proteins and one novel axSpA autoantigen, double homeobox protein 4 (DUX4) – that were more commonly present in patients with early axSpA than in healthy controls, Dr. Somers and coinvestigators reported.

Subsequent analyses focused on the three antibodies having the highest positive likelihood ratios for differentiating axSpA from chronic low back pain.

Some 14.2% of the combined group of all patients with early axSpA had at least one antibody in this panel, compared with just 5.3% of the patients with chronic low back pain (P = .0484), corresponding to 95% specificity.

Prevalence did not differ significantly from that in patients with RA (10.0%; P = .5025) or healthy controls (8.4%; P = .2292).

The positive likelihood ratio for confirming early axSpA using the three antibodies was 2.7, on par with the historical ratio of 2.5 seen for C-reactive protein (CRP), the currently used laboratory marker, the investigators noted.

Among the patients with chronic low back pain, the posttest probability for axSpA increased from 79% with presence of inflammatory back pain and positive test results for HLA-B27 and CRP to 91% with addition of testing for the three antibodies.

The researchers proposed that, “in combination with other laboratory markers such as HLA-B27 and CRP, antibodies against our [three peptides] ... could provide a novel tool for the diagnosis of a subset of axSpA patients,” but the three-peptide panel needs to be studied more in larger cohorts of early axSpA patients and controls with low back pain.

Findings in context

“The authors did a number of steps laudably,” James T. Rosenbaum, MD, chair of the division of arthritis and rheumatic diseases and the Edward E. Rosenbaum Professor of Inflammation Research at Oregon Health & Science University, Portland, commented in an interview. Specifically, they used a variety of appropriate controls, had discovery and validation sets, achieved a fairly good sample size, and applied the phage library technique.

“Despite this technological tour de force and the need for a sensitive and specific blood test to diagnose nonradiographic axSpA, this study is preliminary,” he cautioned. “For example, the authors found antibodies to DUX4 in 8% of axSpA patients versus 3% of healthy controls, 4% of patients with chronic low back pain, and 7% with RA. It took a combination of antigens to enhance the diagnostic accuracy of the ASAS criteria to diagnose axSpA. For each antigen that was studied, more than 80% of the axSpA patients had no detectable antibodies.”

Importantly, rheumatic diseases are often immune mediated without being autoimmune, calling into question the role of the antibodies, according to Dr. Rosenbaum.

“Even if further studies validate these observations, additional research needs to be done to support the concept that these antibodies cause disease as opposed to being mere epiphenomena as is suggested by the low prevalence,” he concluded. “Current hypotheses as to the cause of ankylosing spondylitis now point to the microbiome and autoinflammatory rather than autoimmune pathways, but the jury is still out.”

Dr. Somers and three coauthors disclosed having a patent pending on the markers. The study was funded by a personal grant from the Agency for Innovation by Science and Technology Flanders. Dr. Rosenbaum disclosed that he consults for AbbVie, Gilead, Novartis, Pfizer, Roche, and UCB.

SOURCE: Quaden D et al. Arthritis Rheumatol. 2020 Jul 8. doi: 10.1002/art.41427.

Three autoantibodies to newly discovered axial spondyloarthritis peptides may improve early diagnosis of the disease, according to a cross-sectional cohort study reported in Arthritis & Rheumatology.

The Assessment in SpondyloArthritis International Society (ASAS) classification criteria were not intended for diagnosis and do not differentiate well between patients with early axial spondyloarthritis (axSpA) and patients with nonspecific chronic low back pain, note the investigators, who conducted their research under senior investigator Veerle Somers, PhD, professor of molecular biology at Hasselt (Belgium) University and vice dean of the School of Life Sciences at Transnationale Universiteit Limburg, also in Hasselt.

“Therefore, for many patients, axSpA diagnosis may be challenging and is often delayed by several years after the occurrence of first clinical symptoms, posing a problem for early treatment initiation,” they wrote.

The investigators used plasma samples from patients with early disease and an axSpA complementary DNA phage display library developed with synovial tissue to screen for IgG antibodies that displayed significantly higher reactivity to plasma pools from the early axSpA patients than healthy controls.

They then assessed presence of the antibodies with enzyme-linked immunosorbent assays in a mixed cohort (76 patients with early axSpA having mean disease duration of 2.8 years, 75 control patients with nonspecific chronic low back pain, 60 patients with RA, and 94 healthy controls) and in an axSpA-only cohort (174 patients, 79 of whom had early disease with mean disease duration of 1.4 years).

Screening identified antibodies to nine novel peptides – eight peptides showing partial homology to human proteins and one novel axSpA autoantigen, double homeobox protein 4 (DUX4) – that were more commonly present in patients with early axSpA than in healthy controls, Dr. Somers and coinvestigators reported.

Subsequent analyses focused on the three antibodies having the highest positive likelihood ratios for differentiating axSpA from chronic low back pain.

Some 14.2% of the combined group of all patients with early axSpA had at least one antibody in this panel, compared with just 5.3% of the patients with chronic low back pain (P = .0484), corresponding to 95% specificity.

Prevalence did not differ significantly from that in patients with RA (10.0%; P = .5025) or healthy controls (8.4%; P = .2292).

The positive likelihood ratio for confirming early axSpA using the three antibodies was 2.7, on par with the historical ratio of 2.5 seen for C-reactive protein (CRP), the currently used laboratory marker, the investigators noted.

Among the patients with chronic low back pain, the posttest probability for axSpA increased from 79% with presence of inflammatory back pain and positive test results for HLA-B27 and CRP to 91% with addition of testing for the three antibodies.

The researchers proposed that, “in combination with other laboratory markers such as HLA-B27 and CRP, antibodies against our [three peptides] ... could provide a novel tool for the diagnosis of a subset of axSpA patients,” but the three-peptide panel needs to be studied more in larger cohorts of early axSpA patients and controls with low back pain.

Findings in context

“The authors did a number of steps laudably,” James T. Rosenbaum, MD, chair of the division of arthritis and rheumatic diseases and the Edward E. Rosenbaum Professor of Inflammation Research at Oregon Health & Science University, Portland, commented in an interview. Specifically, they used a variety of appropriate controls, had discovery and validation sets, achieved a fairly good sample size, and applied the phage library technique.

“Despite this technological tour de force and the need for a sensitive and specific blood test to diagnose nonradiographic axSpA, this study is preliminary,” he cautioned. “For example, the authors found antibodies to DUX4 in 8% of axSpA patients versus 3% of healthy controls, 4% of patients with chronic low back pain, and 7% with RA. It took a combination of antigens to enhance the diagnostic accuracy of the ASAS criteria to diagnose axSpA. For each antigen that was studied, more than 80% of the axSpA patients had no detectable antibodies.”

Importantly, rheumatic diseases are often immune mediated without being autoimmune, calling into question the role of the antibodies, according to Dr. Rosenbaum.

“Even if further studies validate these observations, additional research needs to be done to support the concept that these antibodies cause disease as opposed to being mere epiphenomena as is suggested by the low prevalence,” he concluded. “Current hypotheses as to the cause of ankylosing spondylitis now point to the microbiome and autoinflammatory rather than autoimmune pathways, but the jury is still out.”

Dr. Somers and three coauthors disclosed having a patent pending on the markers. The study was funded by a personal grant from the Agency for Innovation by Science and Technology Flanders. Dr. Rosenbaum disclosed that he consults for AbbVie, Gilead, Novartis, Pfizer, Roche, and UCB.

SOURCE: Quaden D et al. Arthritis Rheumatol. 2020 Jul 8. doi: 10.1002/art.41427.

Three autoantibodies to newly discovered axial spondyloarthritis peptides may improve early diagnosis of the disease, according to a cross-sectional cohort study reported in Arthritis & Rheumatology.

The Assessment in SpondyloArthritis International Society (ASAS) classification criteria were not intended for diagnosis and do not differentiate well between patients with early axial spondyloarthritis (axSpA) and patients with nonspecific chronic low back pain, note the investigators, who conducted their research under senior investigator Veerle Somers, PhD, professor of molecular biology at Hasselt (Belgium) University and vice dean of the School of Life Sciences at Transnationale Universiteit Limburg, also in Hasselt.

“Therefore, for many patients, axSpA diagnosis may be challenging and is often delayed by several years after the occurrence of first clinical symptoms, posing a problem for early treatment initiation,” they wrote.

The investigators used plasma samples from patients with early disease and an axSpA complementary DNA phage display library developed with synovial tissue to screen for IgG antibodies that displayed significantly higher reactivity to plasma pools from the early axSpA patients than healthy controls.

They then assessed presence of the antibodies with enzyme-linked immunosorbent assays in a mixed cohort (76 patients with early axSpA having mean disease duration of 2.8 years, 75 control patients with nonspecific chronic low back pain, 60 patients with RA, and 94 healthy controls) and in an axSpA-only cohort (174 patients, 79 of whom had early disease with mean disease duration of 1.4 years).

Screening identified antibodies to nine novel peptides – eight peptides showing partial homology to human proteins and one novel axSpA autoantigen, double homeobox protein 4 (DUX4) – that were more commonly present in patients with early axSpA than in healthy controls, Dr. Somers and coinvestigators reported.

Subsequent analyses focused on the three antibodies having the highest positive likelihood ratios for differentiating axSpA from chronic low back pain.

Some 14.2% of the combined group of all patients with early axSpA had at least one antibody in this panel, compared with just 5.3% of the patients with chronic low back pain (P = .0484), corresponding to 95% specificity.

Prevalence did not differ significantly from that in patients with RA (10.0%; P = .5025) or healthy controls (8.4%; P = .2292).

The positive likelihood ratio for confirming early axSpA using the three antibodies was 2.7, on par with the historical ratio of 2.5 seen for C-reactive protein (CRP), the currently used laboratory marker, the investigators noted.

Among the patients with chronic low back pain, the posttest probability for axSpA increased from 79% with presence of inflammatory back pain and positive test results for HLA-B27 and CRP to 91% with addition of testing for the three antibodies.

The researchers proposed that, “in combination with other laboratory markers such as HLA-B27 and CRP, antibodies against our [three peptides] ... could provide a novel tool for the diagnosis of a subset of axSpA patients,” but the three-peptide panel needs to be studied more in larger cohorts of early axSpA patients and controls with low back pain.

Findings in context

“The authors did a number of steps laudably,” James T. Rosenbaum, MD, chair of the division of arthritis and rheumatic diseases and the Edward E. Rosenbaum Professor of Inflammation Research at Oregon Health & Science University, Portland, commented in an interview. Specifically, they used a variety of appropriate controls, had discovery and validation sets, achieved a fairly good sample size, and applied the phage library technique.

“Despite this technological tour de force and the need for a sensitive and specific blood test to diagnose nonradiographic axSpA, this study is preliminary,” he cautioned. “For example, the authors found antibodies to DUX4 in 8% of axSpA patients versus 3% of healthy controls, 4% of patients with chronic low back pain, and 7% with RA. It took a combination of antigens to enhance the diagnostic accuracy of the ASAS criteria to diagnose axSpA. For each antigen that was studied, more than 80% of the axSpA patients had no detectable antibodies.”

Importantly, rheumatic diseases are often immune mediated without being autoimmune, calling into question the role of the antibodies, according to Dr. Rosenbaum.

“Even if further studies validate these observations, additional research needs to be done to support the concept that these antibodies cause disease as opposed to being mere epiphenomena as is suggested by the low prevalence,” he concluded. “Current hypotheses as to the cause of ankylosing spondylitis now point to the microbiome and autoinflammatory rather than autoimmune pathways, but the jury is still out.”

Dr. Somers and three coauthors disclosed having a patent pending on the markers. The study was funded by a personal grant from the Agency for Innovation by Science and Technology Flanders. Dr. Rosenbaum disclosed that he consults for AbbVie, Gilead, Novartis, Pfizer, Roche, and UCB.

SOURCE: Quaden D et al. Arthritis Rheumatol. 2020 Jul 8. doi: 10.1002/art.41427.