Poor evidence for vaginal laser therapy

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Changed
Wed, 10/19/2022 - 12:20

Despite a lack of evidence and high cost, laser therapy continues to attract many women seeking “vaginal rejuvenation” to help reverse the physical symptoms of menopause.

Recent reviews of the medical literature continue to show that laser treatment appears to be less effective than estrogen at improving vaginal dryness and pain during sex, according to Cheryl B. Iglesia, MD, a professor of ob.gyn. and urology at Georgetown University, Washington.

Dr. Cheryl B. Iglesia

“Laser for GSM [genitourinary syndrome of menopause] is showing some promise, but patients need to be offered [Food and Drug Administration]–approved treatments prior to considering laser, and users need to know how to do speculum and pelvic exams and understand vulvovaginal anatomy and pathology,” Dr. Iglesia, who directs the section of female pelvic medicine and reconstructive surgery at MedStar Washington Hospital Center, said in an interview, adding that patients should avoid “vaginal rejuvenation” treatments offered at med-spas.

Dr. Iglesia reviewed how these lasers work and then discussed the controversy over their marketing and the evidence for their use at the annual meeting of the North American Menopause Society.

By 3 years after menopause, more than half of women experience atrophy in their vagina resulting from a lack of estrogen. Marked by a thinning of the epithelium, reduced blood supply, and loss of glycogen, vulvovaginal atrophy is to blame for GSM.

Vaginal laser therapy has been a popular option for women for the last decade, despite a lack of evidence supporting its use or approval from regulators.

The FDA has issued broad clearance for laser therapy for incision, ablation, vaporization, and coagulation of body soft tissues, such as dysplasia, vulvar or anal neoplasia, endometriosis, condylomas, and other disorders. However, the agency has not approved the use of laser therapy for vulvovaginal atrophy, GSM, vaginal dryness, or dyspareunia.
 

Evidence regarding vaginal laser therapy

According to Dr. Iglesia, the evidence for vaginal laser therapy is mixed and of generally low quality. A systematic review published in the Journal of Sexual Medicine (2022 Jan 29. doi: 10.1016/j.jsxm.2021.12.010) presented mostly low-quality evidence from 25 studies and found promising data for genitourinary symptoms but not enough to justify its use for genitourinary symptoms just yet. Dr. Iglesia discussed her own small, multisite study of 62 participants, which compared vaginal laser with vaginal estrogen and found no differences between the two for multiple outcomes. (The study would have been larger if not for interruption from an FDA warning for an Investigational Device Exemption.)

A JAMA study from Australia found no difference between laser therapy and sham laser therapy, but the most recent systematic review, from JAMA Network Open, found no significant difference between vaginal laser and vaginal estrogen for vaginal and sexual function symptoms. This review, however, covered only the six existing randomized controlled trials, including Dr. Iglesia’s, which were small and had a follow-up period of only 3-6 months.

Dr. Monica Christmas

“There have only been a few randomized controlled trials comparing laser to vaginal estrogen therapy, and most of those did not include a placebo or sham arm,” Monica Christmas, MD, director of the Center for Women’s Integrated Health at the University of Chicago Medicine, said in an interview. “This is extremely important, as most of the trials that did include a sham arm did not find that laser was better than the sham.” Dr. Christmas was not a part of the presentation but attended it at NAMS.

The bottom line, she said, is that “current evidence is not sufficient to make conclusions on long-term safety or sustainability, nor is there compelling evidence to make claims on equivalence to vaginal estrogen therapy.” Currently, committee opinions from a half-dozen medical societies, including NAMS, oppose using vaginal laser therapy until rigorous, robust trials on long-term safety and efficacy have been conducted. The International Continence Society and International Society for the Study of Vulvovaginal Disease issued a joint statement in 2018 that emphasized that histologic changes from lasers do not necessarily equate with changes in function. The statement noted the lack of evidence for laser treatment of incontinence and prolapse and stated that it should not be used for vulvodynia or lichen sclerosus.

A 2020 statement from NAMS found “insufficient placebo-controlled trials of energy-based therapies, including laser, to draw conclusions of efficacy or safety or to make treatment recommendations.” A slightly more optimistic statement from the American Urogynecologic Society concluded that energy-based devices have shown short-term efficacy for menopause-related vaginal atrophy and dyspareunia, including effects lasting up to 1 year from fractionated laser for treat dyspareunia, but also noted that studies up to that time were small and measure various outcomes.
 

 

 

Recommendations on vaginal laser therapy

Given this landscape of uneven and poor-quality evidence, Dr. Iglesia provided several “common sense” recommendations for energy-based therapies, starting with the need for any practitioner to have working knowledge of vulvovaginal anatomy. Contraindications for laser therapy include any malignancy – especially gynecologic – undiagnosed bleeding, active herpes or other infections, radiation, and vaginal mesh, particularly transvaginal mesh. The provider also must discuss the limited data on long-term function and treatment alternatives, including FDA-approved therapies like topical estrogen, dehydroepiandrosterone sulfate (DHEA-S), ospemifene, and moisturizers, Dr. Iglesia said.

Adverse events associated with laser therapy, such as scarring or burning, are rare but do occur, and cost remains an issue, Dr. Iglesia said.

“Vaginal estrogen therapy is well established as a safe and effective treatment option based on high quality evidence,” Dr. Christmas said. “This is not the case for laser therapy. Rare, but serious harms are reported with vaginal laser, including burns, scarring, dyspareunia, pain, and potential irreversible damage.”

Dr. Iglesia also cautioned that clinicians should take extra care with vulnerable populations, particularly cancer patients and others with contraindications for estrogen treatment.

For those in whom vaginal estrogen is contraindicated, Dr. Christmas recommended vaginal moisturizers, lubricants, dilators, and physical therapy for the pelvic floor.

“In patients who fail those nonhormonal approaches, short courses of vaginal estrogen therapy or DHEA-S suppository may be employed with approval from their oncologist,” Dr. Christmas said.

Dr. Iglesia finally reviewed the major research questions that remain with laser therapy:

  • What are outcomes for laser versus sham studies?
  • What are long-term outcomes (beyond 6 months)
  • What pretreatment is necessary?
  • Could laser be used as a drug delivery mechanism for estrogen, and could this provide a synergistic effect?
  • What is the optimal number and interval for laser treatments?

Dr. Iglesia had no industry disclosures but received honoraria for consulting at UpToDate. Dr. Christmas is a consultant for Materna. The presentation did not rely on any external funding.

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Despite a lack of evidence and high cost, laser therapy continues to attract many women seeking “vaginal rejuvenation” to help reverse the physical symptoms of menopause.

Recent reviews of the medical literature continue to show that laser treatment appears to be less effective than estrogen at improving vaginal dryness and pain during sex, according to Cheryl B. Iglesia, MD, a professor of ob.gyn. and urology at Georgetown University, Washington.

Dr. Cheryl B. Iglesia

“Laser for GSM [genitourinary syndrome of menopause] is showing some promise, but patients need to be offered [Food and Drug Administration]–approved treatments prior to considering laser, and users need to know how to do speculum and pelvic exams and understand vulvovaginal anatomy and pathology,” Dr. Iglesia, who directs the section of female pelvic medicine and reconstructive surgery at MedStar Washington Hospital Center, said in an interview, adding that patients should avoid “vaginal rejuvenation” treatments offered at med-spas.

Dr. Iglesia reviewed how these lasers work and then discussed the controversy over their marketing and the evidence for their use at the annual meeting of the North American Menopause Society.

By 3 years after menopause, more than half of women experience atrophy in their vagina resulting from a lack of estrogen. Marked by a thinning of the epithelium, reduced blood supply, and loss of glycogen, vulvovaginal atrophy is to blame for GSM.

Vaginal laser therapy has been a popular option for women for the last decade, despite a lack of evidence supporting its use or approval from regulators.

The FDA has issued broad clearance for laser therapy for incision, ablation, vaporization, and coagulation of body soft tissues, such as dysplasia, vulvar or anal neoplasia, endometriosis, condylomas, and other disorders. However, the agency has not approved the use of laser therapy for vulvovaginal atrophy, GSM, vaginal dryness, or dyspareunia.
 

Evidence regarding vaginal laser therapy

According to Dr. Iglesia, the evidence for vaginal laser therapy is mixed and of generally low quality. A systematic review published in the Journal of Sexual Medicine (2022 Jan 29. doi: 10.1016/j.jsxm.2021.12.010) presented mostly low-quality evidence from 25 studies and found promising data for genitourinary symptoms but not enough to justify its use for genitourinary symptoms just yet. Dr. Iglesia discussed her own small, multisite study of 62 participants, which compared vaginal laser with vaginal estrogen and found no differences between the two for multiple outcomes. (The study would have been larger if not for interruption from an FDA warning for an Investigational Device Exemption.)

A JAMA study from Australia found no difference between laser therapy and sham laser therapy, but the most recent systematic review, from JAMA Network Open, found no significant difference between vaginal laser and vaginal estrogen for vaginal and sexual function symptoms. This review, however, covered only the six existing randomized controlled trials, including Dr. Iglesia’s, which were small and had a follow-up period of only 3-6 months.

Dr. Monica Christmas

“There have only been a few randomized controlled trials comparing laser to vaginal estrogen therapy, and most of those did not include a placebo or sham arm,” Monica Christmas, MD, director of the Center for Women’s Integrated Health at the University of Chicago Medicine, said in an interview. “This is extremely important, as most of the trials that did include a sham arm did not find that laser was better than the sham.” Dr. Christmas was not a part of the presentation but attended it at NAMS.

The bottom line, she said, is that “current evidence is not sufficient to make conclusions on long-term safety or sustainability, nor is there compelling evidence to make claims on equivalence to vaginal estrogen therapy.” Currently, committee opinions from a half-dozen medical societies, including NAMS, oppose using vaginal laser therapy until rigorous, robust trials on long-term safety and efficacy have been conducted. The International Continence Society and International Society for the Study of Vulvovaginal Disease issued a joint statement in 2018 that emphasized that histologic changes from lasers do not necessarily equate with changes in function. The statement noted the lack of evidence for laser treatment of incontinence and prolapse and stated that it should not be used for vulvodynia or lichen sclerosus.

A 2020 statement from NAMS found “insufficient placebo-controlled trials of energy-based therapies, including laser, to draw conclusions of efficacy or safety or to make treatment recommendations.” A slightly more optimistic statement from the American Urogynecologic Society concluded that energy-based devices have shown short-term efficacy for menopause-related vaginal atrophy and dyspareunia, including effects lasting up to 1 year from fractionated laser for treat dyspareunia, but also noted that studies up to that time were small and measure various outcomes.
 

 

 

Recommendations on vaginal laser therapy

Given this landscape of uneven and poor-quality evidence, Dr. Iglesia provided several “common sense” recommendations for energy-based therapies, starting with the need for any practitioner to have working knowledge of vulvovaginal anatomy. Contraindications for laser therapy include any malignancy – especially gynecologic – undiagnosed bleeding, active herpes or other infections, radiation, and vaginal mesh, particularly transvaginal mesh. The provider also must discuss the limited data on long-term function and treatment alternatives, including FDA-approved therapies like topical estrogen, dehydroepiandrosterone sulfate (DHEA-S), ospemifene, and moisturizers, Dr. Iglesia said.

Adverse events associated with laser therapy, such as scarring or burning, are rare but do occur, and cost remains an issue, Dr. Iglesia said.

“Vaginal estrogen therapy is well established as a safe and effective treatment option based on high quality evidence,” Dr. Christmas said. “This is not the case for laser therapy. Rare, but serious harms are reported with vaginal laser, including burns, scarring, dyspareunia, pain, and potential irreversible damage.”

Dr. Iglesia also cautioned that clinicians should take extra care with vulnerable populations, particularly cancer patients and others with contraindications for estrogen treatment.

For those in whom vaginal estrogen is contraindicated, Dr. Christmas recommended vaginal moisturizers, lubricants, dilators, and physical therapy for the pelvic floor.

“In patients who fail those nonhormonal approaches, short courses of vaginal estrogen therapy or DHEA-S suppository may be employed with approval from their oncologist,” Dr. Christmas said.

Dr. Iglesia finally reviewed the major research questions that remain with laser therapy:

  • What are outcomes for laser versus sham studies?
  • What are long-term outcomes (beyond 6 months)
  • What pretreatment is necessary?
  • Could laser be used as a drug delivery mechanism for estrogen, and could this provide a synergistic effect?
  • What is the optimal number and interval for laser treatments?

Dr. Iglesia had no industry disclosures but received honoraria for consulting at UpToDate. Dr. Christmas is a consultant for Materna. The presentation did not rely on any external funding.

Despite a lack of evidence and high cost, laser therapy continues to attract many women seeking “vaginal rejuvenation” to help reverse the physical symptoms of menopause.

Recent reviews of the medical literature continue to show that laser treatment appears to be less effective than estrogen at improving vaginal dryness and pain during sex, according to Cheryl B. Iglesia, MD, a professor of ob.gyn. and urology at Georgetown University, Washington.

Dr. Cheryl B. Iglesia

“Laser for GSM [genitourinary syndrome of menopause] is showing some promise, but patients need to be offered [Food and Drug Administration]–approved treatments prior to considering laser, and users need to know how to do speculum and pelvic exams and understand vulvovaginal anatomy and pathology,” Dr. Iglesia, who directs the section of female pelvic medicine and reconstructive surgery at MedStar Washington Hospital Center, said in an interview, adding that patients should avoid “vaginal rejuvenation” treatments offered at med-spas.

Dr. Iglesia reviewed how these lasers work and then discussed the controversy over their marketing and the evidence for their use at the annual meeting of the North American Menopause Society.

By 3 years after menopause, more than half of women experience atrophy in their vagina resulting from a lack of estrogen. Marked by a thinning of the epithelium, reduced blood supply, and loss of glycogen, vulvovaginal atrophy is to blame for GSM.

Vaginal laser therapy has been a popular option for women for the last decade, despite a lack of evidence supporting its use or approval from regulators.

The FDA has issued broad clearance for laser therapy for incision, ablation, vaporization, and coagulation of body soft tissues, such as dysplasia, vulvar or anal neoplasia, endometriosis, condylomas, and other disorders. However, the agency has not approved the use of laser therapy for vulvovaginal atrophy, GSM, vaginal dryness, or dyspareunia.
 

Evidence regarding vaginal laser therapy

According to Dr. Iglesia, the evidence for vaginal laser therapy is mixed and of generally low quality. A systematic review published in the Journal of Sexual Medicine (2022 Jan 29. doi: 10.1016/j.jsxm.2021.12.010) presented mostly low-quality evidence from 25 studies and found promising data for genitourinary symptoms but not enough to justify its use for genitourinary symptoms just yet. Dr. Iglesia discussed her own small, multisite study of 62 participants, which compared vaginal laser with vaginal estrogen and found no differences between the two for multiple outcomes. (The study would have been larger if not for interruption from an FDA warning for an Investigational Device Exemption.)

A JAMA study from Australia found no difference between laser therapy and sham laser therapy, but the most recent systematic review, from JAMA Network Open, found no significant difference between vaginal laser and vaginal estrogen for vaginal and sexual function symptoms. This review, however, covered only the six existing randomized controlled trials, including Dr. Iglesia’s, which were small and had a follow-up period of only 3-6 months.

Dr. Monica Christmas

“There have only been a few randomized controlled trials comparing laser to vaginal estrogen therapy, and most of those did not include a placebo or sham arm,” Monica Christmas, MD, director of the Center for Women’s Integrated Health at the University of Chicago Medicine, said in an interview. “This is extremely important, as most of the trials that did include a sham arm did not find that laser was better than the sham.” Dr. Christmas was not a part of the presentation but attended it at NAMS.

The bottom line, she said, is that “current evidence is not sufficient to make conclusions on long-term safety or sustainability, nor is there compelling evidence to make claims on equivalence to vaginal estrogen therapy.” Currently, committee opinions from a half-dozen medical societies, including NAMS, oppose using vaginal laser therapy until rigorous, robust trials on long-term safety and efficacy have been conducted. The International Continence Society and International Society for the Study of Vulvovaginal Disease issued a joint statement in 2018 that emphasized that histologic changes from lasers do not necessarily equate with changes in function. The statement noted the lack of evidence for laser treatment of incontinence and prolapse and stated that it should not be used for vulvodynia or lichen sclerosus.

A 2020 statement from NAMS found “insufficient placebo-controlled trials of energy-based therapies, including laser, to draw conclusions of efficacy or safety or to make treatment recommendations.” A slightly more optimistic statement from the American Urogynecologic Society concluded that energy-based devices have shown short-term efficacy for menopause-related vaginal atrophy and dyspareunia, including effects lasting up to 1 year from fractionated laser for treat dyspareunia, but also noted that studies up to that time were small and measure various outcomes.
 

 

 

Recommendations on vaginal laser therapy

Given this landscape of uneven and poor-quality evidence, Dr. Iglesia provided several “common sense” recommendations for energy-based therapies, starting with the need for any practitioner to have working knowledge of vulvovaginal anatomy. Contraindications for laser therapy include any malignancy – especially gynecologic – undiagnosed bleeding, active herpes or other infections, radiation, and vaginal mesh, particularly transvaginal mesh. The provider also must discuss the limited data on long-term function and treatment alternatives, including FDA-approved therapies like topical estrogen, dehydroepiandrosterone sulfate (DHEA-S), ospemifene, and moisturizers, Dr. Iglesia said.

Adverse events associated with laser therapy, such as scarring or burning, are rare but do occur, and cost remains an issue, Dr. Iglesia said.

“Vaginal estrogen therapy is well established as a safe and effective treatment option based on high quality evidence,” Dr. Christmas said. “This is not the case for laser therapy. Rare, but serious harms are reported with vaginal laser, including burns, scarring, dyspareunia, pain, and potential irreversible damage.”

Dr. Iglesia also cautioned that clinicians should take extra care with vulnerable populations, particularly cancer patients and others with contraindications for estrogen treatment.

For those in whom vaginal estrogen is contraindicated, Dr. Christmas recommended vaginal moisturizers, lubricants, dilators, and physical therapy for the pelvic floor.

“In patients who fail those nonhormonal approaches, short courses of vaginal estrogen therapy or DHEA-S suppository may be employed with approval from their oncologist,” Dr. Christmas said.

Dr. Iglesia finally reviewed the major research questions that remain with laser therapy:

  • What are outcomes for laser versus sham studies?
  • What are long-term outcomes (beyond 6 months)
  • What pretreatment is necessary?
  • Could laser be used as a drug delivery mechanism for estrogen, and could this provide a synergistic effect?
  • What is the optimal number and interval for laser treatments?

Dr. Iglesia had no industry disclosures but received honoraria for consulting at UpToDate. Dr. Christmas is a consultant for Materna. The presentation did not rely on any external funding.

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Most pediatric myocarditis caused by viruses

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– A wide range of factors can cause myocarditis; most often viral infections cause myocarditis in children and teens, according to Ryan Butts, MD, medical director of the pediatric advanced cardiac care program at the University of Texas Southwestern Medical Center and Children’s Health of Texas.

Dr. Butts provided an overview of what pediatricians and other clinicians caring for children and teens should know about myocarditis at the annual meeting of the American Academy of Pediatrics.

The important new things that attendees may want to take away from this for their practice are improved recognition and diagnostic workup for acute viral myocarditis, making sure cardiology follow-up occurs after an admission for the condition, enhanced evaluation of the child before they return to competitive sports, and the availability of written or verbal education for patients relating to COVID vaccine–associated myocarditis, Dr. Butts said.

He also provided a set of key takeaways:

  • Myocarditis is rare.
  • The most common viruses causing myocarditis are always changing.
  • Myocarditis is most common in infants and teenagers but it has different clinical patterns in each population.
  • MRI is becoming the diagnostic tool of choice.
  • IVIG frequently is used but good evidence for the therapy is lacking.
  • Patients may go home on cardiac medications but have good long-term outcomes.
  • Patients must have a 6-month restriction on competitive sports after diagnosis.

Frank Han, MD, a pediatric cardiologist at OSF Medical Center and Children’s Hospital of Illinois in Peoria, said he found the most helpful parts of Dr. Butts’ presentation to be the diagnosis and triage of myocarditis in the major age groups.

“Myocarditis can have variable presentations, and its cause may influence how the myocarditis behaves,” Dr. Han said. Pediatric cardiologists, he said, are uniquely positioned to triage and diagnose myocarditis.
 

Epidemiology and presentation

Just 0.05% of admissions from 28.6 million U.S. pediatric ED visits every year are for myocarditis, Dr. Butts said. While viruses are the most common cause of myocarditis, bacterial infections and noninfectious causes, including hypersensitivity reactions, systemic disorders, and toxic substances, can also cause the condition. The dominant viruses causing myocarditis have shifted over the years as well. Coxsackie B was the most common cause in the 1980s, but adenovirus became more common in the 1990s and parvovirus B19 in the 2000s. Why some kids develop myocarditis while others don’t is unclear, but the host-immune response to the virus likely plays an important role.

Research has shown two substantial spikes in the incidence of myocarditis children: infants under 2 years old and teens aged 14-19. Although myocarditis refers to any inflammation of myocardium not caused by ischemia, the signs, symptoms, and lab results vary according to patient’s age group. The only constant is that diaphoresis is rare across all ages.

Infants are more likely to show respiratory distress (68%) and an enlarged liver (40%) but can also present with gastrointestinal symptoms (24%). Vomiting without fever or diarrhea should arouse clinical suspicion of myocarditis in infants, although fever and diarrhea can occur.

In young children, who have the lowest incidence, fatigue presents in about one-third, with 20% presenting with chest pain and 20% with hepatomegaly. The most common symptom in teens by far (80%) is chest pain. About one-third also have respiratory distress but gastrointestinal symptoms are less common (20%).

When should a clinician suspect myocarditis in a teen presenting with chest pain? “If the chest pain is reproducible and if you can localize it, they don’t need further evaluation,” Dr. Butts said. “After that, it’s a lot about the history.”

In terms of lab results, ventricular function measured by brain natriuretic peptide is significantly depressed in infants and young children but often near normal in teens. Inflammatory markers (C-reactive protein) tend to be low in infants but elevated in young children and teens. And troponin levels, denoting myocardial injury, are minimal in infants and young children but elevated in teens. Median ejection fraction on echocardiograms, about 55% in normal hearts, will often be low in infants and young children, around 30%-33%, but is near normal (54%) in teens.
 

 

 

Diagnosis and management

Cardiac MRI increasingly has been replacing endomyocardial biopsy for diagnosis, with MRI exceeding biopsy use between 2009 and 2010, Dr. Butts said. The advantage of endomyocardial biopsy is that it’s specific, if not very sensitive. The test is invasive, however, requiring sedation and carrying the risk of tricuspid injury. The most common finding on cardiac MRI is late gadolinium enhancement (80%) while early gadolinium enhancement is less common (55%).

Although Dr. Butts mentioned the Dallas diagnostic criteria from 1987, he advocated for the more recent Lake Louise Criteria, which require clinical suspicion of myocarditis and at least two of three findings on MRI: T2-weighted myocardial abnormalities, T1 early or late gadolinium enhancement, or regional wall motion abnormalities or evidence of pericarditis

Point-of-care ultrasound can be useful for detecting myocarditis, but its success depends on whether the user can pick up on the subtle changes in ventricular function. “Just because someone has a point-of-care ultrasound that’s normal or thought to be normal, it shouldn’t rule out the diagnosis,” he said.

Learning the etiology of viral myocarditis often is difficult, and etiology doesn’t affect management of the condition, Dr. Butts said. Even in cases of myocarditis confirmed by biopsy, the virus may be identified in only about 60%-70% of cases with myocardial polymerase chain reaction. In clinical cases, the virus can be determined only about 25%-30% of the time with serum PCR.

Prognosis is usually good, with 80%-90% of children and teens going home transplant free despite most arriving critically ill and 50%-80% initially being admitted to ICU. Two-thirds of those discharged go home with heart failure medications, but only one in six are readmitted within a year.

The strongest risk factors for poor prognosis are younger age and being critically ill at presentation but other risk factors include female sex, poor ventricular function, poor perfusion on exam, increased dilation on echocardiogram, and a need for ECMO or inotropes or mechanical ventilation.

That said, Dr. Butts cautioned attendees not to ignore normal function. In one study of 171 patients, among 75 who presented with normal function, 15% went home with inotropes, 12% required mechanical ventilation, 9% had arrhythmia, and 5% needed extracorporeal membrane oxygenation.

A big question in treatment is whether to give IVIG or not and the evidence is murky, Dr. Butts said. He reviewed a couple studies on IVIG, including one that suggested better ventricular functional recovery with the treatment but those who received IVIG were also more likely to be on an ACE inhibitor.

“Was it the ACE inhibitor or was it IVIG? We don’t know,” he said. Different cardiologists may give different opinions on IVIG. “It has nothing to do with the actual evidence behind it.”

IVIG has drawbacks: It’s very expensive and it involves risks that include serum sickness and interstitial nephritis.

“Pediatricians typically aren’t going to directly decide on giving or not giving IVIG,” Dr. Han said. “Typically, the ultimate choice comes from a group discussion between the hospital cardiologist – perhaps the hospitalist pediatrician if they are involved – and the family. We acknowledge the ambiguity of the evidence and decide based upon the severity of the initial disease process.”
 

 

 

Return to competitive sports; Follow-up critical

Experts are much more confident, however, about when teens admitted with viral myocarditis can return to competitive sports. But Dr. Butts said he suspects the guidelines for these children aren’t followed as closely as they should be. The American Heart Association recommends waiting 6 months after discharge and ensuring the athlete has a normal echocardiogram, Holter monitoring, and stress test.

“It’s incredibly important to have them come back and see the cardiologist 6 months after admission,” Dr. Butts said. “The only patient I’ve ever had who died 6-7 months post myocarditis is somebody who, during their stress test, had increasing ventricular ectopy. I told him not to do sports. He didn’t listen to me and unfortunately passed away – I’m assuming from arrhythmia.”
 

COVID and vaccine-associated myocarditis

Vaccine-associated myocarditis is substantially milder than viral myocarditis, Dr. Butts said. A small study from a single center in Atlanta found that ejection fraction at admission was normal, around 56%, in those with vaccine-associated myocarditis, compared with 45% with non-COVID viral myocarditis and 50% with multisystem inflammatory syndrome in children or myocarditis from COVID-19. All patients with vaccine-associated myocarditis had normal function at discharge, compared with 73% of those with viral myocarditis and 93% with COVID-associated myocarditis.

While 22% of those with vaccine-associated myocarditis were admitted to the ICU, twice as many (40%) with viral myocarditis were, and three times as many (68%) with COVID-associated myocarditis ended up in intensive care.

Dr. Butts also noted a Morbidity and Mortality Weekly Report from the Centers of Disease Control and Prevention that found teen boys had two to six times greater risk of heart complications after COVID-19 infection than after COVID vaccination.

In terms of direct comparisons, vaccine-related myocarditis occurred about 12-18 times per 100,000 doses for boys ages 5-11 years, compared with cardiac involvement in 93-133 cases out of 100,000 COVID-19 infections. Boys aged 12-17 years experienced 12-21 cases of myocarditis per 100,000 doses of the vaccine, compared with cardiac involvement in 50-64 out of 100,000 infections.

The bottom line, Dr. Butts said, is that cardiac involvement in MIS-C is common, but typically improves by discharge. “Vaccine-associated myocarditis is a mild clinical syndrome that has a very short duration, and, in my opinion, should never lead us to ever advise anybody not to get the vaccine. I’ve had many patients, even patients in their first year post transplant, who have gotten the COVID-19 vaccine and were just fine.”

Dr. Butts acknowledged that talking with families about the risk of myocarditis with the vaccine is challenging. He often starts these conversations by sharing the statistics, but he said relatable stories are the key. He will also relate the statistics to something the parents and teen will understand, whether it’s sports or another comparison. He does recommend that teens who develop vaccine-associated myocarditis complete the series and get the booster. Their chances of developing myocarditis again are extremely low, whereas “the likelihood of them being really ill from COVID-19 is much, much higher.”

Dr. Butts and Dr. Han had no disclosures. The presentation involved no external funding.

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– A wide range of factors can cause myocarditis; most often viral infections cause myocarditis in children and teens, according to Ryan Butts, MD, medical director of the pediatric advanced cardiac care program at the University of Texas Southwestern Medical Center and Children’s Health of Texas.

Dr. Butts provided an overview of what pediatricians and other clinicians caring for children and teens should know about myocarditis at the annual meeting of the American Academy of Pediatrics.

The important new things that attendees may want to take away from this for their practice are improved recognition and diagnostic workup for acute viral myocarditis, making sure cardiology follow-up occurs after an admission for the condition, enhanced evaluation of the child before they return to competitive sports, and the availability of written or verbal education for patients relating to COVID vaccine–associated myocarditis, Dr. Butts said.

He also provided a set of key takeaways:

  • Myocarditis is rare.
  • The most common viruses causing myocarditis are always changing.
  • Myocarditis is most common in infants and teenagers but it has different clinical patterns in each population.
  • MRI is becoming the diagnostic tool of choice.
  • IVIG frequently is used but good evidence for the therapy is lacking.
  • Patients may go home on cardiac medications but have good long-term outcomes.
  • Patients must have a 6-month restriction on competitive sports after diagnosis.

Frank Han, MD, a pediatric cardiologist at OSF Medical Center and Children’s Hospital of Illinois in Peoria, said he found the most helpful parts of Dr. Butts’ presentation to be the diagnosis and triage of myocarditis in the major age groups.

“Myocarditis can have variable presentations, and its cause may influence how the myocarditis behaves,” Dr. Han said. Pediatric cardiologists, he said, are uniquely positioned to triage and diagnose myocarditis.
 

Epidemiology and presentation

Just 0.05% of admissions from 28.6 million U.S. pediatric ED visits every year are for myocarditis, Dr. Butts said. While viruses are the most common cause of myocarditis, bacterial infections and noninfectious causes, including hypersensitivity reactions, systemic disorders, and toxic substances, can also cause the condition. The dominant viruses causing myocarditis have shifted over the years as well. Coxsackie B was the most common cause in the 1980s, but adenovirus became more common in the 1990s and parvovirus B19 in the 2000s. Why some kids develop myocarditis while others don’t is unclear, but the host-immune response to the virus likely plays an important role.

Research has shown two substantial spikes in the incidence of myocarditis children: infants under 2 years old and teens aged 14-19. Although myocarditis refers to any inflammation of myocardium not caused by ischemia, the signs, symptoms, and lab results vary according to patient’s age group. The only constant is that diaphoresis is rare across all ages.

Infants are more likely to show respiratory distress (68%) and an enlarged liver (40%) but can also present with gastrointestinal symptoms (24%). Vomiting without fever or diarrhea should arouse clinical suspicion of myocarditis in infants, although fever and diarrhea can occur.

In young children, who have the lowest incidence, fatigue presents in about one-third, with 20% presenting with chest pain and 20% with hepatomegaly. The most common symptom in teens by far (80%) is chest pain. About one-third also have respiratory distress but gastrointestinal symptoms are less common (20%).

When should a clinician suspect myocarditis in a teen presenting with chest pain? “If the chest pain is reproducible and if you can localize it, they don’t need further evaluation,” Dr. Butts said. “After that, it’s a lot about the history.”

In terms of lab results, ventricular function measured by brain natriuretic peptide is significantly depressed in infants and young children but often near normal in teens. Inflammatory markers (C-reactive protein) tend to be low in infants but elevated in young children and teens. And troponin levels, denoting myocardial injury, are minimal in infants and young children but elevated in teens. Median ejection fraction on echocardiograms, about 55% in normal hearts, will often be low in infants and young children, around 30%-33%, but is near normal (54%) in teens.
 

 

 

Diagnosis and management

Cardiac MRI increasingly has been replacing endomyocardial biopsy for diagnosis, with MRI exceeding biopsy use between 2009 and 2010, Dr. Butts said. The advantage of endomyocardial biopsy is that it’s specific, if not very sensitive. The test is invasive, however, requiring sedation and carrying the risk of tricuspid injury. The most common finding on cardiac MRI is late gadolinium enhancement (80%) while early gadolinium enhancement is less common (55%).

Although Dr. Butts mentioned the Dallas diagnostic criteria from 1987, he advocated for the more recent Lake Louise Criteria, which require clinical suspicion of myocarditis and at least two of three findings on MRI: T2-weighted myocardial abnormalities, T1 early or late gadolinium enhancement, or regional wall motion abnormalities or evidence of pericarditis

Point-of-care ultrasound can be useful for detecting myocarditis, but its success depends on whether the user can pick up on the subtle changes in ventricular function. “Just because someone has a point-of-care ultrasound that’s normal or thought to be normal, it shouldn’t rule out the diagnosis,” he said.

Learning the etiology of viral myocarditis often is difficult, and etiology doesn’t affect management of the condition, Dr. Butts said. Even in cases of myocarditis confirmed by biopsy, the virus may be identified in only about 60%-70% of cases with myocardial polymerase chain reaction. In clinical cases, the virus can be determined only about 25%-30% of the time with serum PCR.

Prognosis is usually good, with 80%-90% of children and teens going home transplant free despite most arriving critically ill and 50%-80% initially being admitted to ICU. Two-thirds of those discharged go home with heart failure medications, but only one in six are readmitted within a year.

The strongest risk factors for poor prognosis are younger age and being critically ill at presentation but other risk factors include female sex, poor ventricular function, poor perfusion on exam, increased dilation on echocardiogram, and a need for ECMO or inotropes or mechanical ventilation.

That said, Dr. Butts cautioned attendees not to ignore normal function. In one study of 171 patients, among 75 who presented with normal function, 15% went home with inotropes, 12% required mechanical ventilation, 9% had arrhythmia, and 5% needed extracorporeal membrane oxygenation.

A big question in treatment is whether to give IVIG or not and the evidence is murky, Dr. Butts said. He reviewed a couple studies on IVIG, including one that suggested better ventricular functional recovery with the treatment but those who received IVIG were also more likely to be on an ACE inhibitor.

“Was it the ACE inhibitor or was it IVIG? We don’t know,” he said. Different cardiologists may give different opinions on IVIG. “It has nothing to do with the actual evidence behind it.”

IVIG has drawbacks: It’s very expensive and it involves risks that include serum sickness and interstitial nephritis.

“Pediatricians typically aren’t going to directly decide on giving or not giving IVIG,” Dr. Han said. “Typically, the ultimate choice comes from a group discussion between the hospital cardiologist – perhaps the hospitalist pediatrician if they are involved – and the family. We acknowledge the ambiguity of the evidence and decide based upon the severity of the initial disease process.”
 

 

 

Return to competitive sports; Follow-up critical

Experts are much more confident, however, about when teens admitted with viral myocarditis can return to competitive sports. But Dr. Butts said he suspects the guidelines for these children aren’t followed as closely as they should be. The American Heart Association recommends waiting 6 months after discharge and ensuring the athlete has a normal echocardiogram, Holter monitoring, and stress test.

“It’s incredibly important to have them come back and see the cardiologist 6 months after admission,” Dr. Butts said. “The only patient I’ve ever had who died 6-7 months post myocarditis is somebody who, during their stress test, had increasing ventricular ectopy. I told him not to do sports. He didn’t listen to me and unfortunately passed away – I’m assuming from arrhythmia.”
 

COVID and vaccine-associated myocarditis

Vaccine-associated myocarditis is substantially milder than viral myocarditis, Dr. Butts said. A small study from a single center in Atlanta found that ejection fraction at admission was normal, around 56%, in those with vaccine-associated myocarditis, compared with 45% with non-COVID viral myocarditis and 50% with multisystem inflammatory syndrome in children or myocarditis from COVID-19. All patients with vaccine-associated myocarditis had normal function at discharge, compared with 73% of those with viral myocarditis and 93% with COVID-associated myocarditis.

While 22% of those with vaccine-associated myocarditis were admitted to the ICU, twice as many (40%) with viral myocarditis were, and three times as many (68%) with COVID-associated myocarditis ended up in intensive care.

Dr. Butts also noted a Morbidity and Mortality Weekly Report from the Centers of Disease Control and Prevention that found teen boys had two to six times greater risk of heart complications after COVID-19 infection than after COVID vaccination.

In terms of direct comparisons, vaccine-related myocarditis occurred about 12-18 times per 100,000 doses for boys ages 5-11 years, compared with cardiac involvement in 93-133 cases out of 100,000 COVID-19 infections. Boys aged 12-17 years experienced 12-21 cases of myocarditis per 100,000 doses of the vaccine, compared with cardiac involvement in 50-64 out of 100,000 infections.

The bottom line, Dr. Butts said, is that cardiac involvement in MIS-C is common, but typically improves by discharge. “Vaccine-associated myocarditis is a mild clinical syndrome that has a very short duration, and, in my opinion, should never lead us to ever advise anybody not to get the vaccine. I’ve had many patients, even patients in their first year post transplant, who have gotten the COVID-19 vaccine and were just fine.”

Dr. Butts acknowledged that talking with families about the risk of myocarditis with the vaccine is challenging. He often starts these conversations by sharing the statistics, but he said relatable stories are the key. He will also relate the statistics to something the parents and teen will understand, whether it’s sports or another comparison. He does recommend that teens who develop vaccine-associated myocarditis complete the series and get the booster. Their chances of developing myocarditis again are extremely low, whereas “the likelihood of them being really ill from COVID-19 is much, much higher.”

Dr. Butts and Dr. Han had no disclosures. The presentation involved no external funding.

– A wide range of factors can cause myocarditis; most often viral infections cause myocarditis in children and teens, according to Ryan Butts, MD, medical director of the pediatric advanced cardiac care program at the University of Texas Southwestern Medical Center and Children’s Health of Texas.

Dr. Butts provided an overview of what pediatricians and other clinicians caring for children and teens should know about myocarditis at the annual meeting of the American Academy of Pediatrics.

The important new things that attendees may want to take away from this for their practice are improved recognition and diagnostic workup for acute viral myocarditis, making sure cardiology follow-up occurs after an admission for the condition, enhanced evaluation of the child before they return to competitive sports, and the availability of written or verbal education for patients relating to COVID vaccine–associated myocarditis, Dr. Butts said.

He also provided a set of key takeaways:

  • Myocarditis is rare.
  • The most common viruses causing myocarditis are always changing.
  • Myocarditis is most common in infants and teenagers but it has different clinical patterns in each population.
  • MRI is becoming the diagnostic tool of choice.
  • IVIG frequently is used but good evidence for the therapy is lacking.
  • Patients may go home on cardiac medications but have good long-term outcomes.
  • Patients must have a 6-month restriction on competitive sports after diagnosis.

Frank Han, MD, a pediatric cardiologist at OSF Medical Center and Children’s Hospital of Illinois in Peoria, said he found the most helpful parts of Dr. Butts’ presentation to be the diagnosis and triage of myocarditis in the major age groups.

“Myocarditis can have variable presentations, and its cause may influence how the myocarditis behaves,” Dr. Han said. Pediatric cardiologists, he said, are uniquely positioned to triage and diagnose myocarditis.
 

Epidemiology and presentation

Just 0.05% of admissions from 28.6 million U.S. pediatric ED visits every year are for myocarditis, Dr. Butts said. While viruses are the most common cause of myocarditis, bacterial infections and noninfectious causes, including hypersensitivity reactions, systemic disorders, and toxic substances, can also cause the condition. The dominant viruses causing myocarditis have shifted over the years as well. Coxsackie B was the most common cause in the 1980s, but adenovirus became more common in the 1990s and parvovirus B19 in the 2000s. Why some kids develop myocarditis while others don’t is unclear, but the host-immune response to the virus likely plays an important role.

Research has shown two substantial spikes in the incidence of myocarditis children: infants under 2 years old and teens aged 14-19. Although myocarditis refers to any inflammation of myocardium not caused by ischemia, the signs, symptoms, and lab results vary according to patient’s age group. The only constant is that diaphoresis is rare across all ages.

Infants are more likely to show respiratory distress (68%) and an enlarged liver (40%) but can also present with gastrointestinal symptoms (24%). Vomiting without fever or diarrhea should arouse clinical suspicion of myocarditis in infants, although fever and diarrhea can occur.

In young children, who have the lowest incidence, fatigue presents in about one-third, with 20% presenting with chest pain and 20% with hepatomegaly. The most common symptom in teens by far (80%) is chest pain. About one-third also have respiratory distress but gastrointestinal symptoms are less common (20%).

When should a clinician suspect myocarditis in a teen presenting with chest pain? “If the chest pain is reproducible and if you can localize it, they don’t need further evaluation,” Dr. Butts said. “After that, it’s a lot about the history.”

In terms of lab results, ventricular function measured by brain natriuretic peptide is significantly depressed in infants and young children but often near normal in teens. Inflammatory markers (C-reactive protein) tend to be low in infants but elevated in young children and teens. And troponin levels, denoting myocardial injury, are minimal in infants and young children but elevated in teens. Median ejection fraction on echocardiograms, about 55% in normal hearts, will often be low in infants and young children, around 30%-33%, but is near normal (54%) in teens.
 

 

 

Diagnosis and management

Cardiac MRI increasingly has been replacing endomyocardial biopsy for diagnosis, with MRI exceeding biopsy use between 2009 and 2010, Dr. Butts said. The advantage of endomyocardial biopsy is that it’s specific, if not very sensitive. The test is invasive, however, requiring sedation and carrying the risk of tricuspid injury. The most common finding on cardiac MRI is late gadolinium enhancement (80%) while early gadolinium enhancement is less common (55%).

Although Dr. Butts mentioned the Dallas diagnostic criteria from 1987, he advocated for the more recent Lake Louise Criteria, which require clinical suspicion of myocarditis and at least two of three findings on MRI: T2-weighted myocardial abnormalities, T1 early or late gadolinium enhancement, or regional wall motion abnormalities or evidence of pericarditis

Point-of-care ultrasound can be useful for detecting myocarditis, but its success depends on whether the user can pick up on the subtle changes in ventricular function. “Just because someone has a point-of-care ultrasound that’s normal or thought to be normal, it shouldn’t rule out the diagnosis,” he said.

Learning the etiology of viral myocarditis often is difficult, and etiology doesn’t affect management of the condition, Dr. Butts said. Even in cases of myocarditis confirmed by biopsy, the virus may be identified in only about 60%-70% of cases with myocardial polymerase chain reaction. In clinical cases, the virus can be determined only about 25%-30% of the time with serum PCR.

Prognosis is usually good, with 80%-90% of children and teens going home transplant free despite most arriving critically ill and 50%-80% initially being admitted to ICU. Two-thirds of those discharged go home with heart failure medications, but only one in six are readmitted within a year.

The strongest risk factors for poor prognosis are younger age and being critically ill at presentation but other risk factors include female sex, poor ventricular function, poor perfusion on exam, increased dilation on echocardiogram, and a need for ECMO or inotropes or mechanical ventilation.

That said, Dr. Butts cautioned attendees not to ignore normal function. In one study of 171 patients, among 75 who presented with normal function, 15% went home with inotropes, 12% required mechanical ventilation, 9% had arrhythmia, and 5% needed extracorporeal membrane oxygenation.

A big question in treatment is whether to give IVIG or not and the evidence is murky, Dr. Butts said. He reviewed a couple studies on IVIG, including one that suggested better ventricular functional recovery with the treatment but those who received IVIG were also more likely to be on an ACE inhibitor.

“Was it the ACE inhibitor or was it IVIG? We don’t know,” he said. Different cardiologists may give different opinions on IVIG. “It has nothing to do with the actual evidence behind it.”

IVIG has drawbacks: It’s very expensive and it involves risks that include serum sickness and interstitial nephritis.

“Pediatricians typically aren’t going to directly decide on giving or not giving IVIG,” Dr. Han said. “Typically, the ultimate choice comes from a group discussion between the hospital cardiologist – perhaps the hospitalist pediatrician if they are involved – and the family. We acknowledge the ambiguity of the evidence and decide based upon the severity of the initial disease process.”
 

 

 

Return to competitive sports; Follow-up critical

Experts are much more confident, however, about when teens admitted with viral myocarditis can return to competitive sports. But Dr. Butts said he suspects the guidelines for these children aren’t followed as closely as they should be. The American Heart Association recommends waiting 6 months after discharge and ensuring the athlete has a normal echocardiogram, Holter monitoring, and stress test.

“It’s incredibly important to have them come back and see the cardiologist 6 months after admission,” Dr. Butts said. “The only patient I’ve ever had who died 6-7 months post myocarditis is somebody who, during their stress test, had increasing ventricular ectopy. I told him not to do sports. He didn’t listen to me and unfortunately passed away – I’m assuming from arrhythmia.”
 

COVID and vaccine-associated myocarditis

Vaccine-associated myocarditis is substantially milder than viral myocarditis, Dr. Butts said. A small study from a single center in Atlanta found that ejection fraction at admission was normal, around 56%, in those with vaccine-associated myocarditis, compared with 45% with non-COVID viral myocarditis and 50% with multisystem inflammatory syndrome in children or myocarditis from COVID-19. All patients with vaccine-associated myocarditis had normal function at discharge, compared with 73% of those with viral myocarditis and 93% with COVID-associated myocarditis.

While 22% of those with vaccine-associated myocarditis were admitted to the ICU, twice as many (40%) with viral myocarditis were, and three times as many (68%) with COVID-associated myocarditis ended up in intensive care.

Dr. Butts also noted a Morbidity and Mortality Weekly Report from the Centers of Disease Control and Prevention that found teen boys had two to six times greater risk of heart complications after COVID-19 infection than after COVID vaccination.

In terms of direct comparisons, vaccine-related myocarditis occurred about 12-18 times per 100,000 doses for boys ages 5-11 years, compared with cardiac involvement in 93-133 cases out of 100,000 COVID-19 infections. Boys aged 12-17 years experienced 12-21 cases of myocarditis per 100,000 doses of the vaccine, compared with cardiac involvement in 50-64 out of 100,000 infections.

The bottom line, Dr. Butts said, is that cardiac involvement in MIS-C is common, but typically improves by discharge. “Vaccine-associated myocarditis is a mild clinical syndrome that has a very short duration, and, in my opinion, should never lead us to ever advise anybody not to get the vaccine. I’ve had many patients, even patients in their first year post transplant, who have gotten the COVID-19 vaccine and were just fine.”

Dr. Butts acknowledged that talking with families about the risk of myocarditis with the vaccine is challenging. He often starts these conversations by sharing the statistics, but he said relatable stories are the key. He will also relate the statistics to something the parents and teen will understand, whether it’s sports or another comparison. He does recommend that teens who develop vaccine-associated myocarditis complete the series and get the booster. Their chances of developing myocarditis again are extremely low, whereas “the likelihood of them being really ill from COVID-19 is much, much higher.”

Dr. Butts and Dr. Han had no disclosures. The presentation involved no external funding.

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Pediatric faculty salaries have substantial racial, ethnic, gender disparities

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– Black and Hispanic pediatric faculty earn less than their White counterparts regardless of rank and degree, according to a study presented at the American Academy of Pediatrics National Conference.

“Our results demonstrated broad disparities in compensation by both gender and race/ethnicity,” Kimberly Montez, MD, MPH, of the department of pediatrics at Wake Forest University, Winston-Salem, N.C., told attendees.

Dr. Kimberly Montez

Arghavan Salles, MD, PhD, of Stanford (Calif.) University and a senior research scholar at the Clayman Institute for Gender Research, also in Stanford, was not involved in this study but conducts similar research and was unsurprised by these findings.

“It may surprise some people that these gender-based disparities persist in pediatrics, given it is a female-dominated specialty,” Dr. Salles said in an interview. “However, we see the same pattern in other female-dominated medical fields, such as obstetrics and gynecology and nursing.”

Dr. Montez, also the associate director of Wake Forest’s Maya Angelou Center for Health Equity and the associate editor for Diversity, Equity, Inclusion and Justice at the journal Pediatrics, told attendees that it’s important for academic medical centers to “identify, acknowledge, and address inequities in compensation models, including conducting transparent salary audits, standardizing new hire compensation benchmarks, and automatic review of salary outliers.”

Among the barriers to advancement that exist in academic medicine for individuals underrepresented in medicine are “racism, bias, discrimination, lack of mentorship, and the minority tax – extra responsibilities placed on individuals in the name of diversity,” Dr. Montez said. She drew attention to an article she coauthored in Pediatrics in August that highlighted how historically underrepresented individuals’ representation declined as rank increased and how the diversity of faculty pediatricians does not reflect that of the U.S. population.

Dr. Salles elaborated on the “minority tax” Dr. Montez referenced.

Faculty who are underrepresented in medicine “unfairly bear the majority of the responsibility to mentor [underrepresented] trainees and are more likely to be asked to serve in diversity, equity, and inclusion roles,” Dr. Salles said. “This work is too often uncompensated and undervalued, thereby affecting compensation.” This work also plays a role in gender salary disparities since women, especially women of color, are more likely to take on these roles, Dr. Salles added.

In this study, Dr. Montez and her colleagues aimed to investigate the differences in pediatric faculty salaries by race, ethnicity, and rank and then assess the association of median salary with race/ethnicity after adjustment for degree, rank, and gender. They conducted a cross-sectional study relying on 2020-2021 pediatric faculty median compensation data from the Association of American Medical Colleges annual Medical School Faculty Salary Survey report. The report had a response rate greater than 98% from the 152 medical schools queried.

For both the AAMC report and this study, individuals underrepresented in medicine included those who are African American/Black, Hispanic, American Indian/Alaska Native, or Native Hawaiian/Pacific Islander.

The survey included data on 26,548 pediatric faculty, 58% of whom were women, with a median salary of $216,289. Two-thirds of these faculty (67.2%) were White, 4.5% were Hispanic, and 4.4% were Black. Half (50%) were assistant professors, 25% were associate professors, and 17% were professors.

”Women were overly represented among instructors and assistant professors, while men were overly represented [among] associate professors, professors, chiefs, and chairs,” the authors reported. “Men consistently had higher median salaries among all ranks and races/ethnicities.”

For positions of associate professor, professor, chief, and chair, representation of those underrepresented in medicine decreased compared with their overall percentage, but the trend was the opposite for White faculty, who were overrepresented in higher positions relative to their overall percentage. Those with the lowest median salary across all ranks and races/ethnicities were Hispanic women.

Median salaries for those underrepresented in medicine were lower than salaries of White faculty even after adjustment for degree. Black, Hispanic, and American Indian or Alaska Native faculty also had lower median salaries than White faculty after adjusting for rank, but Asian faculty and those who self-identified as “other” race/ethnicity had slightly higher median salaries than White faculty.

Though the findings were not surprising overall, Dr. Montez did note a couple unexpected findings: Hispanic women earn the least across all ranks and Black men earn the most at the associate and professor levels – though Black men also represent a very tiny percentage of individuals at those ranks in the first place.

Dr. Salles noted that the gender wage gap appears widest for Hispanic physicians, compared with White or Black physicians. “It’s important to keep in mind, though, that due to structural racism, implicit bias, and many other factors, there are very few Black and Hispanic full professors of medicine,” Dr. Salles said.  

“Gender bias, sexism, and misogyny” are among the many factors that contribute to the gender pay gap,” Dr. Salles said, and ”the work of women is not valued in the same way as the work of men.”

She pointed to past research showing that CVs with male names at the top are judged as better than those with female names at the top.

”Similarly, it will be judged as being better if the name is Emily or Greg rather than Lakisha or Jamal,” Dr. Salles said. “These findings suggest we evaluate people’s work through the lens of who we think they are and we automatically judge women and other marginalized people to be less worthy.”

Dr. Montez agreed that discrimination is the most likely reason for the salary disparities between men and women and also noted additional factors.

“Women are more likely to shoulder the household and childcare responsibilities as compared to men and they may accept a lower salary for other benefits, such as flexible work hours [and] onsite childcare,” Dr. Montez said. In addition, she said, since most chairs in academic pediatrics are men, new women faculty may not feel able to negotiate higher salaries, or may feel different pressures than men.

Dr. Salles emphasized the importance of not blaming women for not negotiating enough since “women pay a social penalty when they do negotiate.” This problem is likely compounded for women of color, she added. “Offering equitable packages to begin with, rather than requiring applicants to negotiate, would be more equitable.”

Because the AAMC report data was disaggregated, it’s not possible to identify trends by institution, Dr. Montez said, but the August article specifically recommends “that future data be institution specific, and provide race, ethnicity, sex, and rank information, including hiring and promotion details,” including salary information.

In fact, a publicly available, institution-specific equity dashboard would be a “minimum starting point” for tracking and addressing disparities as well as the effect of any interventions, Dr. Montez said. She noted other potential policies that could ameliorate disparities.

“Given that caregiving responsibilities for women often lead to fewer hours worked, work interruptions, and less opportunity for advancement, restructuring jobs with more flexible work schedules without pay reduction and not limiting advancement based on part-time status could be considered,” Dr. Montez said. ”For promotion, given that individuals [underrepresented in medicine] often shoulder the minority tax, institutions should develop promotion criteria to account for this academic credit. Institutions could also implement an annual salary-monitoring system with corrections, should it reveal disparities.”

Dr. Salles consults for Intuitive Surgical and the Intuitive Foundation, but neither of these are related to diversity, equity, and inclusion. Dr. Montez had no disclosures. The study involved no external funding.

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– Black and Hispanic pediatric faculty earn less than their White counterparts regardless of rank and degree, according to a study presented at the American Academy of Pediatrics National Conference.

“Our results demonstrated broad disparities in compensation by both gender and race/ethnicity,” Kimberly Montez, MD, MPH, of the department of pediatrics at Wake Forest University, Winston-Salem, N.C., told attendees.

Dr. Kimberly Montez

Arghavan Salles, MD, PhD, of Stanford (Calif.) University and a senior research scholar at the Clayman Institute for Gender Research, also in Stanford, was not involved in this study but conducts similar research and was unsurprised by these findings.

“It may surprise some people that these gender-based disparities persist in pediatrics, given it is a female-dominated specialty,” Dr. Salles said in an interview. “However, we see the same pattern in other female-dominated medical fields, such as obstetrics and gynecology and nursing.”

Dr. Montez, also the associate director of Wake Forest’s Maya Angelou Center for Health Equity and the associate editor for Diversity, Equity, Inclusion and Justice at the journal Pediatrics, told attendees that it’s important for academic medical centers to “identify, acknowledge, and address inequities in compensation models, including conducting transparent salary audits, standardizing new hire compensation benchmarks, and automatic review of salary outliers.”

Among the barriers to advancement that exist in academic medicine for individuals underrepresented in medicine are “racism, bias, discrimination, lack of mentorship, and the minority tax – extra responsibilities placed on individuals in the name of diversity,” Dr. Montez said. She drew attention to an article she coauthored in Pediatrics in August that highlighted how historically underrepresented individuals’ representation declined as rank increased and how the diversity of faculty pediatricians does not reflect that of the U.S. population.

Dr. Salles elaborated on the “minority tax” Dr. Montez referenced.

Faculty who are underrepresented in medicine “unfairly bear the majority of the responsibility to mentor [underrepresented] trainees and are more likely to be asked to serve in diversity, equity, and inclusion roles,” Dr. Salles said. “This work is too often uncompensated and undervalued, thereby affecting compensation.” This work also plays a role in gender salary disparities since women, especially women of color, are more likely to take on these roles, Dr. Salles added.

In this study, Dr. Montez and her colleagues aimed to investigate the differences in pediatric faculty salaries by race, ethnicity, and rank and then assess the association of median salary with race/ethnicity after adjustment for degree, rank, and gender. They conducted a cross-sectional study relying on 2020-2021 pediatric faculty median compensation data from the Association of American Medical Colleges annual Medical School Faculty Salary Survey report. The report had a response rate greater than 98% from the 152 medical schools queried.

For both the AAMC report and this study, individuals underrepresented in medicine included those who are African American/Black, Hispanic, American Indian/Alaska Native, or Native Hawaiian/Pacific Islander.

The survey included data on 26,548 pediatric faculty, 58% of whom were women, with a median salary of $216,289. Two-thirds of these faculty (67.2%) were White, 4.5% were Hispanic, and 4.4% were Black. Half (50%) were assistant professors, 25% were associate professors, and 17% were professors.

”Women were overly represented among instructors and assistant professors, while men were overly represented [among] associate professors, professors, chiefs, and chairs,” the authors reported. “Men consistently had higher median salaries among all ranks and races/ethnicities.”

For positions of associate professor, professor, chief, and chair, representation of those underrepresented in medicine decreased compared with their overall percentage, but the trend was the opposite for White faculty, who were overrepresented in higher positions relative to their overall percentage. Those with the lowest median salary across all ranks and races/ethnicities were Hispanic women.

Median salaries for those underrepresented in medicine were lower than salaries of White faculty even after adjustment for degree. Black, Hispanic, and American Indian or Alaska Native faculty also had lower median salaries than White faculty after adjusting for rank, but Asian faculty and those who self-identified as “other” race/ethnicity had slightly higher median salaries than White faculty.

Though the findings were not surprising overall, Dr. Montez did note a couple unexpected findings: Hispanic women earn the least across all ranks and Black men earn the most at the associate and professor levels – though Black men also represent a very tiny percentage of individuals at those ranks in the first place.

Dr. Salles noted that the gender wage gap appears widest for Hispanic physicians, compared with White or Black physicians. “It’s important to keep in mind, though, that due to structural racism, implicit bias, and many other factors, there are very few Black and Hispanic full professors of medicine,” Dr. Salles said.  

“Gender bias, sexism, and misogyny” are among the many factors that contribute to the gender pay gap,” Dr. Salles said, and ”the work of women is not valued in the same way as the work of men.”

She pointed to past research showing that CVs with male names at the top are judged as better than those with female names at the top.

”Similarly, it will be judged as being better if the name is Emily or Greg rather than Lakisha or Jamal,” Dr. Salles said. “These findings suggest we evaluate people’s work through the lens of who we think they are and we automatically judge women and other marginalized people to be less worthy.”

Dr. Montez agreed that discrimination is the most likely reason for the salary disparities between men and women and also noted additional factors.

“Women are more likely to shoulder the household and childcare responsibilities as compared to men and they may accept a lower salary for other benefits, such as flexible work hours [and] onsite childcare,” Dr. Montez said. In addition, she said, since most chairs in academic pediatrics are men, new women faculty may not feel able to negotiate higher salaries, or may feel different pressures than men.

Dr. Salles emphasized the importance of not blaming women for not negotiating enough since “women pay a social penalty when they do negotiate.” This problem is likely compounded for women of color, she added. “Offering equitable packages to begin with, rather than requiring applicants to negotiate, would be more equitable.”

Because the AAMC report data was disaggregated, it’s not possible to identify trends by institution, Dr. Montez said, but the August article specifically recommends “that future data be institution specific, and provide race, ethnicity, sex, and rank information, including hiring and promotion details,” including salary information.

In fact, a publicly available, institution-specific equity dashboard would be a “minimum starting point” for tracking and addressing disparities as well as the effect of any interventions, Dr. Montez said. She noted other potential policies that could ameliorate disparities.

“Given that caregiving responsibilities for women often lead to fewer hours worked, work interruptions, and less opportunity for advancement, restructuring jobs with more flexible work schedules without pay reduction and not limiting advancement based on part-time status could be considered,” Dr. Montez said. ”For promotion, given that individuals [underrepresented in medicine] often shoulder the minority tax, institutions should develop promotion criteria to account for this academic credit. Institutions could also implement an annual salary-monitoring system with corrections, should it reveal disparities.”

Dr. Salles consults for Intuitive Surgical and the Intuitive Foundation, but neither of these are related to diversity, equity, and inclusion. Dr. Montez had no disclosures. The study involved no external funding.

– Black and Hispanic pediatric faculty earn less than their White counterparts regardless of rank and degree, according to a study presented at the American Academy of Pediatrics National Conference.

“Our results demonstrated broad disparities in compensation by both gender and race/ethnicity,” Kimberly Montez, MD, MPH, of the department of pediatrics at Wake Forest University, Winston-Salem, N.C., told attendees.

Dr. Kimberly Montez

Arghavan Salles, MD, PhD, of Stanford (Calif.) University and a senior research scholar at the Clayman Institute for Gender Research, also in Stanford, was not involved in this study but conducts similar research and was unsurprised by these findings.

“It may surprise some people that these gender-based disparities persist in pediatrics, given it is a female-dominated specialty,” Dr. Salles said in an interview. “However, we see the same pattern in other female-dominated medical fields, such as obstetrics and gynecology and nursing.”

Dr. Montez, also the associate director of Wake Forest’s Maya Angelou Center for Health Equity and the associate editor for Diversity, Equity, Inclusion and Justice at the journal Pediatrics, told attendees that it’s important for academic medical centers to “identify, acknowledge, and address inequities in compensation models, including conducting transparent salary audits, standardizing new hire compensation benchmarks, and automatic review of salary outliers.”

Among the barriers to advancement that exist in academic medicine for individuals underrepresented in medicine are “racism, bias, discrimination, lack of mentorship, and the minority tax – extra responsibilities placed on individuals in the name of diversity,” Dr. Montez said. She drew attention to an article she coauthored in Pediatrics in August that highlighted how historically underrepresented individuals’ representation declined as rank increased and how the diversity of faculty pediatricians does not reflect that of the U.S. population.

Dr. Salles elaborated on the “minority tax” Dr. Montez referenced.

Faculty who are underrepresented in medicine “unfairly bear the majority of the responsibility to mentor [underrepresented] trainees and are more likely to be asked to serve in diversity, equity, and inclusion roles,” Dr. Salles said. “This work is too often uncompensated and undervalued, thereby affecting compensation.” This work also plays a role in gender salary disparities since women, especially women of color, are more likely to take on these roles, Dr. Salles added.

In this study, Dr. Montez and her colleagues aimed to investigate the differences in pediatric faculty salaries by race, ethnicity, and rank and then assess the association of median salary with race/ethnicity after adjustment for degree, rank, and gender. They conducted a cross-sectional study relying on 2020-2021 pediatric faculty median compensation data from the Association of American Medical Colleges annual Medical School Faculty Salary Survey report. The report had a response rate greater than 98% from the 152 medical schools queried.

For both the AAMC report and this study, individuals underrepresented in medicine included those who are African American/Black, Hispanic, American Indian/Alaska Native, or Native Hawaiian/Pacific Islander.

The survey included data on 26,548 pediatric faculty, 58% of whom were women, with a median salary of $216,289. Two-thirds of these faculty (67.2%) were White, 4.5% were Hispanic, and 4.4% were Black. Half (50%) were assistant professors, 25% were associate professors, and 17% were professors.

”Women were overly represented among instructors and assistant professors, while men were overly represented [among] associate professors, professors, chiefs, and chairs,” the authors reported. “Men consistently had higher median salaries among all ranks and races/ethnicities.”

For positions of associate professor, professor, chief, and chair, representation of those underrepresented in medicine decreased compared with their overall percentage, but the trend was the opposite for White faculty, who were overrepresented in higher positions relative to their overall percentage. Those with the lowest median salary across all ranks and races/ethnicities were Hispanic women.

Median salaries for those underrepresented in medicine were lower than salaries of White faculty even after adjustment for degree. Black, Hispanic, and American Indian or Alaska Native faculty also had lower median salaries than White faculty after adjusting for rank, but Asian faculty and those who self-identified as “other” race/ethnicity had slightly higher median salaries than White faculty.

Though the findings were not surprising overall, Dr. Montez did note a couple unexpected findings: Hispanic women earn the least across all ranks and Black men earn the most at the associate and professor levels – though Black men also represent a very tiny percentage of individuals at those ranks in the first place.

Dr. Salles noted that the gender wage gap appears widest for Hispanic physicians, compared with White or Black physicians. “It’s important to keep in mind, though, that due to structural racism, implicit bias, and many other factors, there are very few Black and Hispanic full professors of medicine,” Dr. Salles said.  

“Gender bias, sexism, and misogyny” are among the many factors that contribute to the gender pay gap,” Dr. Salles said, and ”the work of women is not valued in the same way as the work of men.”

She pointed to past research showing that CVs with male names at the top are judged as better than those with female names at the top.

”Similarly, it will be judged as being better if the name is Emily or Greg rather than Lakisha or Jamal,” Dr. Salles said. “These findings suggest we evaluate people’s work through the lens of who we think they are and we automatically judge women and other marginalized people to be less worthy.”

Dr. Montez agreed that discrimination is the most likely reason for the salary disparities between men and women and also noted additional factors.

“Women are more likely to shoulder the household and childcare responsibilities as compared to men and they may accept a lower salary for other benefits, such as flexible work hours [and] onsite childcare,” Dr. Montez said. In addition, she said, since most chairs in academic pediatrics are men, new women faculty may not feel able to negotiate higher salaries, or may feel different pressures than men.

Dr. Salles emphasized the importance of not blaming women for not negotiating enough since “women pay a social penalty when they do negotiate.” This problem is likely compounded for women of color, she added. “Offering equitable packages to begin with, rather than requiring applicants to negotiate, would be more equitable.”

Because the AAMC report data was disaggregated, it’s not possible to identify trends by institution, Dr. Montez said, but the August article specifically recommends “that future data be institution specific, and provide race, ethnicity, sex, and rank information, including hiring and promotion details,” including salary information.

In fact, a publicly available, institution-specific equity dashboard would be a “minimum starting point” for tracking and addressing disparities as well as the effect of any interventions, Dr. Montez said. She noted other potential policies that could ameliorate disparities.

“Given that caregiving responsibilities for women often lead to fewer hours worked, work interruptions, and less opportunity for advancement, restructuring jobs with more flexible work schedules without pay reduction and not limiting advancement based on part-time status could be considered,” Dr. Montez said. ”For promotion, given that individuals [underrepresented in medicine] often shoulder the minority tax, institutions should develop promotion criteria to account for this academic credit. Institutions could also implement an annual salary-monitoring system with corrections, should it reveal disparities.”

Dr. Salles consults for Intuitive Surgical and the Intuitive Foundation, but neither of these are related to diversity, equity, and inclusion. Dr. Montez had no disclosures. The study involved no external funding.

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Mentorship key to improving GI, hepatology workforce diversity

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Wed, 11/23/2022 - 14:51

Increasing mentorship opportunities for gastroenterology and hepatology residents and medical students from populations underrepresented in medicine is essential to increase diversity in the specialty and improve health disparities among patients, according to a special report published simultaneously in Gastroenterology and three other journals.

“This study helps to establish priorities for diversity, equity and inclusion in our field and informs future interventions to improve workforce diversity and eliminate health care disparities among the patients we serve,” Folasade P. May, MD, PhD, MPhil, the study’s corresponding author and an associate professor of medicine at the University of California, Los Angeles, said in a prepared statement.

The report, the result of a partnership between researchers at UCLA and the Intersociety Group on Diversity, reveals the findings of a survey aimed at assessing current perspectives on individuals underrepresented in medicine and health equity within gastroenterology and hepatology. The collaboration involved five gastroenterology professional societies: the American Association for the Study of Liver Disease; American College of Gastroenterology; American Gastroenterological Association; American Society of Gastrointestinal Endoscopy; and North American Society for Pediatric Gastroenterology, Hepatology and Nutrition.

”The current racial and ethnic composition of the GI and hepatology workforce does not reflect the population of patients served or the current matriculants in medicine,” Harman K. Rahal, MD, of UCLA and Cedars-Sinai Medical Center, Los Angeles, and James H. Tabibian, MD, PhD, of UCLA and Olive View–UCLA Medical Center, and colleagues wrote. “As there are several conditions in GI and hepatology with disparities in incidence, treatment, and outcomes, representation of UIM [underrepresented in medicine] individuals is critical to address health disparities.”

The term “underrepresented in medicine” is defined by the Association of American Medical Colleges as “those racial and ethnic populations that are underrepresented in the medical profession relative to their numbers in the general population.” The authors explained that these groups “have traditionally included Latino (i.e., Latino/a/x), Black (or African American), Native American (namely, American Indian, Alaska Native, and Native Hawaiian), Pacific Islander, and mainland Puerto Rican individuals.”

The five gastroenterology and hepatology societies partnered with investigators at UCLA to develop a 33-question electronic survey “to determine perspectives of current racial, ethnic, and gender diversity within GI and hepatology; to assess current views on interventions needed to increase racial, ethnic, and gender diversity in the field; and to collect data on the experiences of UIM individuals and women in our field,” according to the report’s authors. The survey was then distributed to members of those societies, with 1,219 respondents.

The report found that inadequate representation of people from those underrepresented groups in the education and training pipeline was the most frequently reported barrier to improving racial and ethnic diversity in the field (35.4%), followed by insufficient racial and ethnic minority group representation in professional leadership (27.9%) and insufficient racial and ethnic minority group representation among practicing GI and hepatology professionals in the workplace (26.6%). Only 9% of fellows in GI and hepatology are from groups underrepresented in medicine, according to data from the Accreditation Council for Graduate Medical Education. Furthermore, one study has shown that the proportion of UIM in academic faculty has never exceeded 10% at each academic rank; there has even been a decline recently among junior academic faculty positions. That study also found that only 9% of academic gastroenterologists in the United states identify as underrepresented in medicine, with little change over the last decade.

Potential contributors to this low level of representation, the authors wrote, include “lack of racial and ethnic diversity in the medical training pipeline, nondiverse leadership, bias, racial discrimination, and the notion that UIM physicians may be less likely to promote themselves or be promoted.”

Another potential contributor, however, may be complacency within the field about the need to improve diversity and taking actions to do so.

 

 


A majority of White physicians (78%) were very or somewhat satisfied with current levels of workforce diversity, compared with a majority of Black physicians (63%) feeling very or somewhat unsatisfied.

This disconnect was not surprising to Aja McCutchen, MD, a partner at Atlanta Gastroenterology Associates who was not involved in the survey.

“One cannot discount the lived experience of a [person underrepresented in medicine] as it relates to recognizing conscious and unconscious biases, microaggression recognition, and absence of [underrepresented clinicians] in key positions. This is a reality that I do see on a daily basis,” Dr. McCutchen said in an interview.
Dr. Aja McCutchen

Only 35% of respondents felt there is “insufficient racial and ethnic representation in education and training,” and just over a quarter (28%) felt the same about representation in leadership. In fact, most respondents (59.7%) thought that racial and ethnic diversity had increased over the past 5 years even though data show no change, the authors noted.

Although Dr. McCutchen appreciated the broad recognition from respondents, regardless of background, to improve diversity in the pipeline, she noted that “retention of current talent and future talent would also require cultural shifts in understanding the challenges of the [underrepresented] members,” Dr. McCutchen said.

Again, however, the majority of the respondents (64.6%) were themselves not members of underrepresented groups. Nearly half the respondents (48.7%) were non-Hispanic White, and one in five (22.5%) were Asian, Native Hawaiian, or Pacific Islander. The remaining respondents, making up less than a third of the total, were Hispanic (10.6%), Black (9.1%), American Indian or Alaskan Native (0.2%), another race/ethnicity (3.3%), or preferred not to answer (5.7%).

Dr. McCutchen said she had mixed feelings about the survey overall.

“On the one hand, I was eager to read the perceptions of survey respondents as it relates to diversity, equity and inclusion in the GI space as very little cross-organizational data exists,” said Dr. McCutchen. “On the other hand, the responses reminded me that there is a lot of work to be done as I expected more dissatisfaction with the current GI workforce in both academia and private practice respondents.”

She was surprised, for example, that nearly three-quarters of the respondents were somewhat or very satisfied, and that a majority thought racial and ethnic diversity had increased.

Studies on provider-patient concordance have shown that patients feel it’s important to share common ground with their physicians particularly in terms of race, ethnicity and language, the authors noted.

“This patient preference underscores the need to recruit and train a more diverse cohort of trainees into GI and hepatology fellowships if the desired goal is to optimize patient care and combat health disparities,” they wrote. They pointed out that cultural understanding can influence how patients perceive their health, symptoms, and concerns, which can then affect providers’ diagnostic accuracy and treatment recommendations. In turn, patients may have better adherence to treatment recommendations when they share a similar background as their clinician.

“Diversity in medicine also leads to greater diversity in thoughts, better returns on investments, increased scholarly activities related to health equity to name a few,” Dr. McCutchen said.

The top recommendations from respondents for improving representation of currently underrepresented individuals in GI and hepatology were to increase mentorship opportunities for residents (45%) and medical students (43%) from these groups and to increase representation of professionals from these backgrounds in program and professional society leadership (39%). A third of respondents also recommended increasing shadowing opportunities for undergraduate students from these underrepresented populations.

Dr. McCutchen expressed optimism regarding the initiatives to improve diversity, equity and inclusion across the gastroenterology spectrum.

“It is incumbent upon all of us to continue to be the driving force of change, which will be a journey and not a destination,” McCutchen said. “In the future, diversity, equity and inclusion will be the expectation, and we will ultimately move closer to the goal of completely eliminating health care inequities.”

The research was funded by the National Cancer Institute, the UCLA Jonsson Comprehensive Cancer Center, and Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research Ablon Scholars Program. The authors reported no conflicts of interest. Dr. McCutchen disclosed relationships with Bristol-Myers Squibb and Redhill Biopharmaceuticals.
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Increasing mentorship opportunities for gastroenterology and hepatology residents and medical students from populations underrepresented in medicine is essential to increase diversity in the specialty and improve health disparities among patients, according to a special report published simultaneously in Gastroenterology and three other journals.

“This study helps to establish priorities for diversity, equity and inclusion in our field and informs future interventions to improve workforce diversity and eliminate health care disparities among the patients we serve,” Folasade P. May, MD, PhD, MPhil, the study’s corresponding author and an associate professor of medicine at the University of California, Los Angeles, said in a prepared statement.

The report, the result of a partnership between researchers at UCLA and the Intersociety Group on Diversity, reveals the findings of a survey aimed at assessing current perspectives on individuals underrepresented in medicine and health equity within gastroenterology and hepatology. The collaboration involved five gastroenterology professional societies: the American Association for the Study of Liver Disease; American College of Gastroenterology; American Gastroenterological Association; American Society of Gastrointestinal Endoscopy; and North American Society for Pediatric Gastroenterology, Hepatology and Nutrition.

”The current racial and ethnic composition of the GI and hepatology workforce does not reflect the population of patients served or the current matriculants in medicine,” Harman K. Rahal, MD, of UCLA and Cedars-Sinai Medical Center, Los Angeles, and James H. Tabibian, MD, PhD, of UCLA and Olive View–UCLA Medical Center, and colleagues wrote. “As there are several conditions in GI and hepatology with disparities in incidence, treatment, and outcomes, representation of UIM [underrepresented in medicine] individuals is critical to address health disparities.”

The term “underrepresented in medicine” is defined by the Association of American Medical Colleges as “those racial and ethnic populations that are underrepresented in the medical profession relative to their numbers in the general population.” The authors explained that these groups “have traditionally included Latino (i.e., Latino/a/x), Black (or African American), Native American (namely, American Indian, Alaska Native, and Native Hawaiian), Pacific Islander, and mainland Puerto Rican individuals.”

The five gastroenterology and hepatology societies partnered with investigators at UCLA to develop a 33-question electronic survey “to determine perspectives of current racial, ethnic, and gender diversity within GI and hepatology; to assess current views on interventions needed to increase racial, ethnic, and gender diversity in the field; and to collect data on the experiences of UIM individuals and women in our field,” according to the report’s authors. The survey was then distributed to members of those societies, with 1,219 respondents.

The report found that inadequate representation of people from those underrepresented groups in the education and training pipeline was the most frequently reported barrier to improving racial and ethnic diversity in the field (35.4%), followed by insufficient racial and ethnic minority group representation in professional leadership (27.9%) and insufficient racial and ethnic minority group representation among practicing GI and hepatology professionals in the workplace (26.6%). Only 9% of fellows in GI and hepatology are from groups underrepresented in medicine, according to data from the Accreditation Council for Graduate Medical Education. Furthermore, one study has shown that the proportion of UIM in academic faculty has never exceeded 10% at each academic rank; there has even been a decline recently among junior academic faculty positions. That study also found that only 9% of academic gastroenterologists in the United states identify as underrepresented in medicine, with little change over the last decade.

Potential contributors to this low level of representation, the authors wrote, include “lack of racial and ethnic diversity in the medical training pipeline, nondiverse leadership, bias, racial discrimination, and the notion that UIM physicians may be less likely to promote themselves or be promoted.”

Another potential contributor, however, may be complacency within the field about the need to improve diversity and taking actions to do so.

 

 


A majority of White physicians (78%) were very or somewhat satisfied with current levels of workforce diversity, compared with a majority of Black physicians (63%) feeling very or somewhat unsatisfied.

This disconnect was not surprising to Aja McCutchen, MD, a partner at Atlanta Gastroenterology Associates who was not involved in the survey.

“One cannot discount the lived experience of a [person underrepresented in medicine] as it relates to recognizing conscious and unconscious biases, microaggression recognition, and absence of [underrepresented clinicians] in key positions. This is a reality that I do see on a daily basis,” Dr. McCutchen said in an interview.
Dr. Aja McCutchen

Only 35% of respondents felt there is “insufficient racial and ethnic representation in education and training,” and just over a quarter (28%) felt the same about representation in leadership. In fact, most respondents (59.7%) thought that racial and ethnic diversity had increased over the past 5 years even though data show no change, the authors noted.

Although Dr. McCutchen appreciated the broad recognition from respondents, regardless of background, to improve diversity in the pipeline, she noted that “retention of current talent and future talent would also require cultural shifts in understanding the challenges of the [underrepresented] members,” Dr. McCutchen said.

Again, however, the majority of the respondents (64.6%) were themselves not members of underrepresented groups. Nearly half the respondents (48.7%) were non-Hispanic White, and one in five (22.5%) were Asian, Native Hawaiian, or Pacific Islander. The remaining respondents, making up less than a third of the total, were Hispanic (10.6%), Black (9.1%), American Indian or Alaskan Native (0.2%), another race/ethnicity (3.3%), or preferred not to answer (5.7%).

Dr. McCutchen said she had mixed feelings about the survey overall.

“On the one hand, I was eager to read the perceptions of survey respondents as it relates to diversity, equity and inclusion in the GI space as very little cross-organizational data exists,” said Dr. McCutchen. “On the other hand, the responses reminded me that there is a lot of work to be done as I expected more dissatisfaction with the current GI workforce in both academia and private practice respondents.”

She was surprised, for example, that nearly three-quarters of the respondents were somewhat or very satisfied, and that a majority thought racial and ethnic diversity had increased.

Studies on provider-patient concordance have shown that patients feel it’s important to share common ground with their physicians particularly in terms of race, ethnicity and language, the authors noted.

“This patient preference underscores the need to recruit and train a more diverse cohort of trainees into GI and hepatology fellowships if the desired goal is to optimize patient care and combat health disparities,” they wrote. They pointed out that cultural understanding can influence how patients perceive their health, symptoms, and concerns, which can then affect providers’ diagnostic accuracy and treatment recommendations. In turn, patients may have better adherence to treatment recommendations when they share a similar background as their clinician.

“Diversity in medicine also leads to greater diversity in thoughts, better returns on investments, increased scholarly activities related to health equity to name a few,” Dr. McCutchen said.

The top recommendations from respondents for improving representation of currently underrepresented individuals in GI and hepatology were to increase mentorship opportunities for residents (45%) and medical students (43%) from these groups and to increase representation of professionals from these backgrounds in program and professional society leadership (39%). A third of respondents also recommended increasing shadowing opportunities for undergraduate students from these underrepresented populations.

Dr. McCutchen expressed optimism regarding the initiatives to improve diversity, equity and inclusion across the gastroenterology spectrum.

“It is incumbent upon all of us to continue to be the driving force of change, which will be a journey and not a destination,” McCutchen said. “In the future, diversity, equity and inclusion will be the expectation, and we will ultimately move closer to the goal of completely eliminating health care inequities.”

The research was funded by the National Cancer Institute, the UCLA Jonsson Comprehensive Cancer Center, and Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research Ablon Scholars Program. The authors reported no conflicts of interest. Dr. McCutchen disclosed relationships with Bristol-Myers Squibb and Redhill Biopharmaceuticals.

Increasing mentorship opportunities for gastroenterology and hepatology residents and medical students from populations underrepresented in medicine is essential to increase diversity in the specialty and improve health disparities among patients, according to a special report published simultaneously in Gastroenterology and three other journals.

“This study helps to establish priorities for diversity, equity and inclusion in our field and informs future interventions to improve workforce diversity and eliminate health care disparities among the patients we serve,” Folasade P. May, MD, PhD, MPhil, the study’s corresponding author and an associate professor of medicine at the University of California, Los Angeles, said in a prepared statement.

The report, the result of a partnership between researchers at UCLA and the Intersociety Group on Diversity, reveals the findings of a survey aimed at assessing current perspectives on individuals underrepresented in medicine and health equity within gastroenterology and hepatology. The collaboration involved five gastroenterology professional societies: the American Association for the Study of Liver Disease; American College of Gastroenterology; American Gastroenterological Association; American Society of Gastrointestinal Endoscopy; and North American Society for Pediatric Gastroenterology, Hepatology and Nutrition.

”The current racial and ethnic composition of the GI and hepatology workforce does not reflect the population of patients served or the current matriculants in medicine,” Harman K. Rahal, MD, of UCLA and Cedars-Sinai Medical Center, Los Angeles, and James H. Tabibian, MD, PhD, of UCLA and Olive View–UCLA Medical Center, and colleagues wrote. “As there are several conditions in GI and hepatology with disparities in incidence, treatment, and outcomes, representation of UIM [underrepresented in medicine] individuals is critical to address health disparities.”

The term “underrepresented in medicine” is defined by the Association of American Medical Colleges as “those racial and ethnic populations that are underrepresented in the medical profession relative to their numbers in the general population.” The authors explained that these groups “have traditionally included Latino (i.e., Latino/a/x), Black (or African American), Native American (namely, American Indian, Alaska Native, and Native Hawaiian), Pacific Islander, and mainland Puerto Rican individuals.”

The five gastroenterology and hepatology societies partnered with investigators at UCLA to develop a 33-question electronic survey “to determine perspectives of current racial, ethnic, and gender diversity within GI and hepatology; to assess current views on interventions needed to increase racial, ethnic, and gender diversity in the field; and to collect data on the experiences of UIM individuals and women in our field,” according to the report’s authors. The survey was then distributed to members of those societies, with 1,219 respondents.

The report found that inadequate representation of people from those underrepresented groups in the education and training pipeline was the most frequently reported barrier to improving racial and ethnic diversity in the field (35.4%), followed by insufficient racial and ethnic minority group representation in professional leadership (27.9%) and insufficient racial and ethnic minority group representation among practicing GI and hepatology professionals in the workplace (26.6%). Only 9% of fellows in GI and hepatology are from groups underrepresented in medicine, according to data from the Accreditation Council for Graduate Medical Education. Furthermore, one study has shown that the proportion of UIM in academic faculty has never exceeded 10% at each academic rank; there has even been a decline recently among junior academic faculty positions. That study also found that only 9% of academic gastroenterologists in the United states identify as underrepresented in medicine, with little change over the last decade.

Potential contributors to this low level of representation, the authors wrote, include “lack of racial and ethnic diversity in the medical training pipeline, nondiverse leadership, bias, racial discrimination, and the notion that UIM physicians may be less likely to promote themselves or be promoted.”

Another potential contributor, however, may be complacency within the field about the need to improve diversity and taking actions to do so.

 

 


A majority of White physicians (78%) were very or somewhat satisfied with current levels of workforce diversity, compared with a majority of Black physicians (63%) feeling very or somewhat unsatisfied.

This disconnect was not surprising to Aja McCutchen, MD, a partner at Atlanta Gastroenterology Associates who was not involved in the survey.

“One cannot discount the lived experience of a [person underrepresented in medicine] as it relates to recognizing conscious and unconscious biases, microaggression recognition, and absence of [underrepresented clinicians] in key positions. This is a reality that I do see on a daily basis,” Dr. McCutchen said in an interview.
Dr. Aja McCutchen

Only 35% of respondents felt there is “insufficient racial and ethnic representation in education and training,” and just over a quarter (28%) felt the same about representation in leadership. In fact, most respondents (59.7%) thought that racial and ethnic diversity had increased over the past 5 years even though data show no change, the authors noted.

Although Dr. McCutchen appreciated the broad recognition from respondents, regardless of background, to improve diversity in the pipeline, she noted that “retention of current talent and future talent would also require cultural shifts in understanding the challenges of the [underrepresented] members,” Dr. McCutchen said.

Again, however, the majority of the respondents (64.6%) were themselves not members of underrepresented groups. Nearly half the respondents (48.7%) were non-Hispanic White, and one in five (22.5%) were Asian, Native Hawaiian, or Pacific Islander. The remaining respondents, making up less than a third of the total, were Hispanic (10.6%), Black (9.1%), American Indian or Alaskan Native (0.2%), another race/ethnicity (3.3%), or preferred not to answer (5.7%).

Dr. McCutchen said she had mixed feelings about the survey overall.

“On the one hand, I was eager to read the perceptions of survey respondents as it relates to diversity, equity and inclusion in the GI space as very little cross-organizational data exists,” said Dr. McCutchen. “On the other hand, the responses reminded me that there is a lot of work to be done as I expected more dissatisfaction with the current GI workforce in both academia and private practice respondents.”

She was surprised, for example, that nearly three-quarters of the respondents were somewhat or very satisfied, and that a majority thought racial and ethnic diversity had increased.

Studies on provider-patient concordance have shown that patients feel it’s important to share common ground with their physicians particularly in terms of race, ethnicity and language, the authors noted.

“This patient preference underscores the need to recruit and train a more diverse cohort of trainees into GI and hepatology fellowships if the desired goal is to optimize patient care and combat health disparities,” they wrote. They pointed out that cultural understanding can influence how patients perceive their health, symptoms, and concerns, which can then affect providers’ diagnostic accuracy and treatment recommendations. In turn, patients may have better adherence to treatment recommendations when they share a similar background as their clinician.

“Diversity in medicine also leads to greater diversity in thoughts, better returns on investments, increased scholarly activities related to health equity to name a few,” Dr. McCutchen said.

The top recommendations from respondents for improving representation of currently underrepresented individuals in GI and hepatology were to increase mentorship opportunities for residents (45%) and medical students (43%) from these groups and to increase representation of professionals from these backgrounds in program and professional society leadership (39%). A third of respondents also recommended increasing shadowing opportunities for undergraduate students from these underrepresented populations.

Dr. McCutchen expressed optimism regarding the initiatives to improve diversity, equity and inclusion across the gastroenterology spectrum.

“It is incumbent upon all of us to continue to be the driving force of change, which will be a journey and not a destination,” McCutchen said. “In the future, diversity, equity and inclusion will be the expectation, and we will ultimately move closer to the goal of completely eliminating health care inequities.”

The research was funded by the National Cancer Institute, the UCLA Jonsson Comprehensive Cancer Center, and Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research Ablon Scholars Program. The authors reported no conflicts of interest. Dr. McCutchen disclosed relationships with Bristol-Myers Squibb and Redhill Biopharmaceuticals.
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Digital mental health training acceptable to boarding teens

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Wed, 10/12/2022 - 13:45

– A modular digital intervention to teach mental health skills to youth awaiting transfer to psychiatric care appeared feasible to implement and acceptable to teens and their parents, according to a study presented at the American Academy of Pediatrics National Conference.

“This program has the potential to teach evidence-based mental health skills to youth during boarding, providing a head start on recovery prior to psychiatric hospitalization,” study coauthor Samantha House, DO, MPH, section chief of pediatric hospital medicine at Dartmouth Hitchcock Medical Center, Lebanon, N.H., told attendees.

Dr. Samantha House

Mental health boarding has become increasingly common as psychiatric care resources have been stretched by a crisis in pediatric mental health that began even before the COVID pandemic. Since youth often don’t receive evidence-based therapies while boarding, Dr. House and her coauthor, JoAnna K. Leyenaar, MD, PhD, MPH, developed a pilot program called I-CARE, which stands for Improving Care, Accelerating Recovery and Education.

I-CARE is a digital health intervention that combines videos on a tablet with workbook exercises that teach mental health skills. The seven modules include an introduction and one each on schedule-making, safety planning, psychoeducation, behavioral activation, relaxation skills, and mindfulness skills. Licensed nursing assistants who have received a 6-hour training from a clinical psychologist administer the program and provide safety supervision during boarding.

Dr. JoAnna K. Leyenaar

“I-CARE was designed to be largely self-directed, supported by ‘coaches’ who are not mental health professionals,” Dr. Leyenaar, vice chair of research in the department of pediatrics and an associate professor of pediatrics at Geisel School of Medicine at Dartmouth, Hanover, N.H., said in an interview. With this model, the program requires minimal additional resources beyond the tablets and workbooks, and is designed for implementation in settings with few or no mental health professionals, she said.

Cora Breuner, MD, MPH, a professor of pediatrics at the University of Washington, Seattle, and an attending physician at Seattle Children’s Hospital, was not involved in the study but was excited to see it.

“I think it’s a really good idea, and I like that it’s being studied,” Dr. Breuner said in an interview. She said the health care and public health system has let down an entire population who data had shown were experiencing mental health problems.

“We knew before the pandemic that behavioral health issues were creeping up slowly with anxiety, depression, suicidal ideation, and, of course, substance use disorders and eating disorders, and not a lot was being done about it,” Dr. Breuner said, and the pandemic exacerbated those issues. ”I don’t know why no one realized that this was going to be the downstream effect of having no socialization for kids for 18 months and limited resources for those who we need desperately to provide care for,” especially BIPOC [Black, Indigenous, and people of color] kids and underresourced kids.

That sentiment is exactly what inspired the creation of the program, according to Dr. Leyenaar.

The I-CARE program was implemented at Dartmouth Hitchcock Medical Center in November 2021 for adolescents aged 12-17 who were boarding because of suicidality or self-harm. The program and study excluded youth with psychosis and other cognitive or behavioral conditions that didn’t fit with the skills taught by the module training.

The researchers qualitatively evaluated the I-CARE program in youth who were offered at least two I-CARE modules and with parents present during boarding.

Twenty-four youth, with a median age of 14, were offered the I-CARE program between November 2021 and April 2022 while boarding for a median 8 days. Most of the patients were female (79%), and a third were transgender or gender diverse. Most were White (83%), and about two-thirds had Medicaid (62.5%). The most common diagnoses among the participants were major depressive disorder (71%) and generalized anxiety disorder (46%). Others included PTSD (29%), restrictive eating disorder (21%), and bipolar disorder (12.5%).

All offered the program completed the first module, and 79% participated in additional modules. The main reason for discontinuation was transfer to another facility, but a few youth either refused to engage with the program or felt they knew the material well enough that they weren’t benefiting from it.

The evaluation involved 16 youth, seven parents, and 17 clinicians. On a Likert scale, the composite score for the program’s appropriateness – suitability, applicability, and meeting needs – was an average 3.7, with a higher rating from clinicians (4.3) and caregivers (3.5) than youth (2.8).

“Some youth felt the intervention was better suited for a younger audience or those with less familiarity with mental health skills, but they acknowledged that the intervention would be helpful and appropriate for others,” Dr. House, who is also an assistant professor of pediatrics at Geisel School of Medicine, said.

Youth rated the acceptability of the program more highly (3.6) and all three groups found it easy to use, with an average feasibility score of 4 across the board. The program’s acceptability received an average score of 4 from parents and clinicians.

”Teens seem to particularly value the psychoeducation module that explains the relationship between thoughts and feelings, as well as the opportunity to develop a personalized safety plan,” Dr. Leyenaar said.

Among the challenges expressed by the participating teens were that the loud sounds and beeping in the hospital made it difficult to practice mindfulness and that they often had to wait for staff to be available to do I-CARE.

“I feel like not many people have been trained yet,” one teen said, “so to have more nurses available to do I-CARE would be helpful.”

Another participant found the coaches helpful. “Sometimes they were my nurse, sometimes they were someone I never met before. … and also, they were all really, really nice,” the teen said.

Another teen regarded the material as “really surface-level mental health stuff” that they thought “could be helpful to other people who are here for the first time.” But others found the content more beneficial.

“The videos were helpful. … I was worried that they weren’t going to be very informative, but they did make sense to me,” one participant said. “They weren’t overcomplicating things. … They weren’t saying anything I didn’t understand, so that was good.”

The researchers next plan to conduct a multisite study to determine the program’s effectiveness in improving health outcomes and reducing suicidal ideation. Dr. House and Dr. Leyenaar are looking at ways to refine the program.

”We may narrow the age range for participants, with an upper age limit of 16, since some older teens said that the modules were best suited for a younger audience,” Dr. Leyenaar said. “We are also discussing how to best support youth who are readmitted to our hospital and have participated in I-CARE previously.”

Dr. Breuner said she would be interested to see, in future studies of the program, whether it reduced the likelihood of inpatient psychiatric stay, the length of psychiatric stay after admission, or the risk of readmission. She also wondered if the program might be offered in languages other than English, whether a version might be specifically designed for BIPOC youth, and whether the researchers had considered offering the intervention to caregivers as well.

The modules are teaching the kids but should they also be teaching the parents? Dr. Breuner wondered. A lot of times, she said, the parents are bringing these kids in because they don’t know what to do and can’t deal with them anymore. Offering modules on the same skills to caregivers would also enable the caregivers to reinforce and reteach the skills to their children, especially if the youth struggled to really take in what the modules were trying to teach.

Dr. Leyenaar said she expects buy-in for a program like this would be high at other institutions, but it’s premature to scale it up until they’ve conducted at least another clinical trial on its effectiveness. The biggest potential barrier to buy-in that Dr. Breuner perceived would be cost.

“It’s always difficult when it costs money” since the hospital needs to train the clinicians who provide the care, Dr. Breuner said, but it’s possible those costs could be offset if the program reduces the risk of readmission or return to the emergency department.

While the overall risk of harms from the intervention are low, Dr. Breuner said it is important to be conscious that the intervention may not necessarily be appropriate for all youth.

“There’s always risk when there’s a trauma background, and you have to be very careful, especially with mindfulness training,” Dr. Breuner said. For those with a history of abuse or other adverse childhood experiences “for someone to get into a very calm, still place can actually be counterproductive.”

Dr. Breuner especially appreciated that the researchers involved the youth and caregivers in the evaluation process. “That the parents expressed positive attitudes is really incredible,” she said.

Dr. House, Dr. Leyenaar, and Dr. Breuner had no disclosures. No external funding was noted for the study.

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– A modular digital intervention to teach mental health skills to youth awaiting transfer to psychiatric care appeared feasible to implement and acceptable to teens and their parents, according to a study presented at the American Academy of Pediatrics National Conference.

“This program has the potential to teach evidence-based mental health skills to youth during boarding, providing a head start on recovery prior to psychiatric hospitalization,” study coauthor Samantha House, DO, MPH, section chief of pediatric hospital medicine at Dartmouth Hitchcock Medical Center, Lebanon, N.H., told attendees.

Dr. Samantha House

Mental health boarding has become increasingly common as psychiatric care resources have been stretched by a crisis in pediatric mental health that began even before the COVID pandemic. Since youth often don’t receive evidence-based therapies while boarding, Dr. House and her coauthor, JoAnna K. Leyenaar, MD, PhD, MPH, developed a pilot program called I-CARE, which stands for Improving Care, Accelerating Recovery and Education.

I-CARE is a digital health intervention that combines videos on a tablet with workbook exercises that teach mental health skills. The seven modules include an introduction and one each on schedule-making, safety planning, psychoeducation, behavioral activation, relaxation skills, and mindfulness skills. Licensed nursing assistants who have received a 6-hour training from a clinical psychologist administer the program and provide safety supervision during boarding.

Dr. JoAnna K. Leyenaar

“I-CARE was designed to be largely self-directed, supported by ‘coaches’ who are not mental health professionals,” Dr. Leyenaar, vice chair of research in the department of pediatrics and an associate professor of pediatrics at Geisel School of Medicine at Dartmouth, Hanover, N.H., said in an interview. With this model, the program requires minimal additional resources beyond the tablets and workbooks, and is designed for implementation in settings with few or no mental health professionals, she said.

Cora Breuner, MD, MPH, a professor of pediatrics at the University of Washington, Seattle, and an attending physician at Seattle Children’s Hospital, was not involved in the study but was excited to see it.

“I think it’s a really good idea, and I like that it’s being studied,” Dr. Breuner said in an interview. She said the health care and public health system has let down an entire population who data had shown were experiencing mental health problems.

“We knew before the pandemic that behavioral health issues were creeping up slowly with anxiety, depression, suicidal ideation, and, of course, substance use disorders and eating disorders, and not a lot was being done about it,” Dr. Breuner said, and the pandemic exacerbated those issues. ”I don’t know why no one realized that this was going to be the downstream effect of having no socialization for kids for 18 months and limited resources for those who we need desperately to provide care for,” especially BIPOC [Black, Indigenous, and people of color] kids and underresourced kids.

That sentiment is exactly what inspired the creation of the program, according to Dr. Leyenaar.

The I-CARE program was implemented at Dartmouth Hitchcock Medical Center in November 2021 for adolescents aged 12-17 who were boarding because of suicidality or self-harm. The program and study excluded youth with psychosis and other cognitive or behavioral conditions that didn’t fit with the skills taught by the module training.

The researchers qualitatively evaluated the I-CARE program in youth who were offered at least two I-CARE modules and with parents present during boarding.

Twenty-four youth, with a median age of 14, were offered the I-CARE program between November 2021 and April 2022 while boarding for a median 8 days. Most of the patients were female (79%), and a third were transgender or gender diverse. Most were White (83%), and about two-thirds had Medicaid (62.5%). The most common diagnoses among the participants were major depressive disorder (71%) and generalized anxiety disorder (46%). Others included PTSD (29%), restrictive eating disorder (21%), and bipolar disorder (12.5%).

All offered the program completed the first module, and 79% participated in additional modules. The main reason for discontinuation was transfer to another facility, but a few youth either refused to engage with the program or felt they knew the material well enough that they weren’t benefiting from it.

The evaluation involved 16 youth, seven parents, and 17 clinicians. On a Likert scale, the composite score for the program’s appropriateness – suitability, applicability, and meeting needs – was an average 3.7, with a higher rating from clinicians (4.3) and caregivers (3.5) than youth (2.8).

“Some youth felt the intervention was better suited for a younger audience or those with less familiarity with mental health skills, but they acknowledged that the intervention would be helpful and appropriate for others,” Dr. House, who is also an assistant professor of pediatrics at Geisel School of Medicine, said.

Youth rated the acceptability of the program more highly (3.6) and all three groups found it easy to use, with an average feasibility score of 4 across the board. The program’s acceptability received an average score of 4 from parents and clinicians.

”Teens seem to particularly value the psychoeducation module that explains the relationship between thoughts and feelings, as well as the opportunity to develop a personalized safety plan,” Dr. Leyenaar said.

Among the challenges expressed by the participating teens were that the loud sounds and beeping in the hospital made it difficult to practice mindfulness and that they often had to wait for staff to be available to do I-CARE.

“I feel like not many people have been trained yet,” one teen said, “so to have more nurses available to do I-CARE would be helpful.”

Another participant found the coaches helpful. “Sometimes they were my nurse, sometimes they were someone I never met before. … and also, they were all really, really nice,” the teen said.

Another teen regarded the material as “really surface-level mental health stuff” that they thought “could be helpful to other people who are here for the first time.” But others found the content more beneficial.

“The videos were helpful. … I was worried that they weren’t going to be very informative, but they did make sense to me,” one participant said. “They weren’t overcomplicating things. … They weren’t saying anything I didn’t understand, so that was good.”

The researchers next plan to conduct a multisite study to determine the program’s effectiveness in improving health outcomes and reducing suicidal ideation. Dr. House and Dr. Leyenaar are looking at ways to refine the program.

”We may narrow the age range for participants, with an upper age limit of 16, since some older teens said that the modules were best suited for a younger audience,” Dr. Leyenaar said. “We are also discussing how to best support youth who are readmitted to our hospital and have participated in I-CARE previously.”

Dr. Breuner said she would be interested to see, in future studies of the program, whether it reduced the likelihood of inpatient psychiatric stay, the length of psychiatric stay after admission, or the risk of readmission. She also wondered if the program might be offered in languages other than English, whether a version might be specifically designed for BIPOC youth, and whether the researchers had considered offering the intervention to caregivers as well.

The modules are teaching the kids but should they also be teaching the parents? Dr. Breuner wondered. A lot of times, she said, the parents are bringing these kids in because they don’t know what to do and can’t deal with them anymore. Offering modules on the same skills to caregivers would also enable the caregivers to reinforce and reteach the skills to their children, especially if the youth struggled to really take in what the modules were trying to teach.

Dr. Leyenaar said she expects buy-in for a program like this would be high at other institutions, but it’s premature to scale it up until they’ve conducted at least another clinical trial on its effectiveness. The biggest potential barrier to buy-in that Dr. Breuner perceived would be cost.

“It’s always difficult when it costs money” since the hospital needs to train the clinicians who provide the care, Dr. Breuner said, but it’s possible those costs could be offset if the program reduces the risk of readmission or return to the emergency department.

While the overall risk of harms from the intervention are low, Dr. Breuner said it is important to be conscious that the intervention may not necessarily be appropriate for all youth.

“There’s always risk when there’s a trauma background, and you have to be very careful, especially with mindfulness training,” Dr. Breuner said. For those with a history of abuse or other adverse childhood experiences “for someone to get into a very calm, still place can actually be counterproductive.”

Dr. Breuner especially appreciated that the researchers involved the youth and caregivers in the evaluation process. “That the parents expressed positive attitudes is really incredible,” she said.

Dr. House, Dr. Leyenaar, and Dr. Breuner had no disclosures. No external funding was noted for the study.

– A modular digital intervention to teach mental health skills to youth awaiting transfer to psychiatric care appeared feasible to implement and acceptable to teens and their parents, according to a study presented at the American Academy of Pediatrics National Conference.

“This program has the potential to teach evidence-based mental health skills to youth during boarding, providing a head start on recovery prior to psychiatric hospitalization,” study coauthor Samantha House, DO, MPH, section chief of pediatric hospital medicine at Dartmouth Hitchcock Medical Center, Lebanon, N.H., told attendees.

Dr. Samantha House

Mental health boarding has become increasingly common as psychiatric care resources have been stretched by a crisis in pediatric mental health that began even before the COVID pandemic. Since youth often don’t receive evidence-based therapies while boarding, Dr. House and her coauthor, JoAnna K. Leyenaar, MD, PhD, MPH, developed a pilot program called I-CARE, which stands for Improving Care, Accelerating Recovery and Education.

I-CARE is a digital health intervention that combines videos on a tablet with workbook exercises that teach mental health skills. The seven modules include an introduction and one each on schedule-making, safety planning, psychoeducation, behavioral activation, relaxation skills, and mindfulness skills. Licensed nursing assistants who have received a 6-hour training from a clinical psychologist administer the program and provide safety supervision during boarding.

Dr. JoAnna K. Leyenaar

“I-CARE was designed to be largely self-directed, supported by ‘coaches’ who are not mental health professionals,” Dr. Leyenaar, vice chair of research in the department of pediatrics and an associate professor of pediatrics at Geisel School of Medicine at Dartmouth, Hanover, N.H., said in an interview. With this model, the program requires minimal additional resources beyond the tablets and workbooks, and is designed for implementation in settings with few or no mental health professionals, she said.

Cora Breuner, MD, MPH, a professor of pediatrics at the University of Washington, Seattle, and an attending physician at Seattle Children’s Hospital, was not involved in the study but was excited to see it.

“I think it’s a really good idea, and I like that it’s being studied,” Dr. Breuner said in an interview. She said the health care and public health system has let down an entire population who data had shown were experiencing mental health problems.

“We knew before the pandemic that behavioral health issues were creeping up slowly with anxiety, depression, suicidal ideation, and, of course, substance use disorders and eating disorders, and not a lot was being done about it,” Dr. Breuner said, and the pandemic exacerbated those issues. ”I don’t know why no one realized that this was going to be the downstream effect of having no socialization for kids for 18 months and limited resources for those who we need desperately to provide care for,” especially BIPOC [Black, Indigenous, and people of color] kids and underresourced kids.

That sentiment is exactly what inspired the creation of the program, according to Dr. Leyenaar.

The I-CARE program was implemented at Dartmouth Hitchcock Medical Center in November 2021 for adolescents aged 12-17 who were boarding because of suicidality or self-harm. The program and study excluded youth with psychosis and other cognitive or behavioral conditions that didn’t fit with the skills taught by the module training.

The researchers qualitatively evaluated the I-CARE program in youth who were offered at least two I-CARE modules and with parents present during boarding.

Twenty-four youth, with a median age of 14, were offered the I-CARE program between November 2021 and April 2022 while boarding for a median 8 days. Most of the patients were female (79%), and a third were transgender or gender diverse. Most were White (83%), and about two-thirds had Medicaid (62.5%). The most common diagnoses among the participants were major depressive disorder (71%) and generalized anxiety disorder (46%). Others included PTSD (29%), restrictive eating disorder (21%), and bipolar disorder (12.5%).

All offered the program completed the first module, and 79% participated in additional modules. The main reason for discontinuation was transfer to another facility, but a few youth either refused to engage with the program or felt they knew the material well enough that they weren’t benefiting from it.

The evaluation involved 16 youth, seven parents, and 17 clinicians. On a Likert scale, the composite score for the program’s appropriateness – suitability, applicability, and meeting needs – was an average 3.7, with a higher rating from clinicians (4.3) and caregivers (3.5) than youth (2.8).

“Some youth felt the intervention was better suited for a younger audience or those with less familiarity with mental health skills, but they acknowledged that the intervention would be helpful and appropriate for others,” Dr. House, who is also an assistant professor of pediatrics at Geisel School of Medicine, said.

Youth rated the acceptability of the program more highly (3.6) and all three groups found it easy to use, with an average feasibility score of 4 across the board. The program’s acceptability received an average score of 4 from parents and clinicians.

”Teens seem to particularly value the psychoeducation module that explains the relationship between thoughts and feelings, as well as the opportunity to develop a personalized safety plan,” Dr. Leyenaar said.

Among the challenges expressed by the participating teens were that the loud sounds and beeping in the hospital made it difficult to practice mindfulness and that they often had to wait for staff to be available to do I-CARE.

“I feel like not many people have been trained yet,” one teen said, “so to have more nurses available to do I-CARE would be helpful.”

Another participant found the coaches helpful. “Sometimes they were my nurse, sometimes they were someone I never met before. … and also, they were all really, really nice,” the teen said.

Another teen regarded the material as “really surface-level mental health stuff” that they thought “could be helpful to other people who are here for the first time.” But others found the content more beneficial.

“The videos were helpful. … I was worried that they weren’t going to be very informative, but they did make sense to me,” one participant said. “They weren’t overcomplicating things. … They weren’t saying anything I didn’t understand, so that was good.”

The researchers next plan to conduct a multisite study to determine the program’s effectiveness in improving health outcomes and reducing suicidal ideation. Dr. House and Dr. Leyenaar are looking at ways to refine the program.

”We may narrow the age range for participants, with an upper age limit of 16, since some older teens said that the modules were best suited for a younger audience,” Dr. Leyenaar said. “We are also discussing how to best support youth who are readmitted to our hospital and have participated in I-CARE previously.”

Dr. Breuner said she would be interested to see, in future studies of the program, whether it reduced the likelihood of inpatient psychiatric stay, the length of psychiatric stay after admission, or the risk of readmission. She also wondered if the program might be offered in languages other than English, whether a version might be specifically designed for BIPOC youth, and whether the researchers had considered offering the intervention to caregivers as well.

The modules are teaching the kids but should they also be teaching the parents? Dr. Breuner wondered. A lot of times, she said, the parents are bringing these kids in because they don’t know what to do and can’t deal with them anymore. Offering modules on the same skills to caregivers would also enable the caregivers to reinforce and reteach the skills to their children, especially if the youth struggled to really take in what the modules were trying to teach.

Dr. Leyenaar said she expects buy-in for a program like this would be high at other institutions, but it’s premature to scale it up until they’ve conducted at least another clinical trial on its effectiveness. The biggest potential barrier to buy-in that Dr. Breuner perceived would be cost.

“It’s always difficult when it costs money” since the hospital needs to train the clinicians who provide the care, Dr. Breuner said, but it’s possible those costs could be offset if the program reduces the risk of readmission or return to the emergency department.

While the overall risk of harms from the intervention are low, Dr. Breuner said it is important to be conscious that the intervention may not necessarily be appropriate for all youth.

“There’s always risk when there’s a trauma background, and you have to be very careful, especially with mindfulness training,” Dr. Breuner said. For those with a history of abuse or other adverse childhood experiences “for someone to get into a very calm, still place can actually be counterproductive.”

Dr. Breuner especially appreciated that the researchers involved the youth and caregivers in the evaluation process. “That the parents expressed positive attitudes is really incredible,” she said.

Dr. House, Dr. Leyenaar, and Dr. Breuner had no disclosures. No external funding was noted for the study.

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Opioids leading cause of poisoning deaths in young children

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– Opioids are the most common cause of fatal poisonings in young children, and their contribution to children’s deaths has been increasing, according to research presented at the American Academy of Pediatrics National Conference.

The study found that the proportion of deaths in U.S. children linked to opioids has doubled since the mid-2000s, tracking the course of the epidemic in adults in this country.

Dr. Christopher Gaw

“What is striking about our study is how the opioid epidemic has not spared our nation’s infants or young children,” Christopher Gaw, MD, MA, a pediatric emergency medicine fellow physician at Children’s Hospital of Philadelphia, said in an interview. “There is important work being done to reduce unnecessary opioid prescribing, drug diversion, and treatment of substance use disorders. These efforts – though not directly related to children – also help protect them, since they can reduce the chance of exposure to opioids in the home.”

Dr. Gaw and his colleagues analyzed data in Child Death Reviews from 40 states that participate in the National Fatality Review Case Reporting System, focusing on children aged 5 years and younger who died from a poisoning between 2005 and 2018. During that time, 731 child poisoning deaths were reported to the system – of which nearly half (47%) involved opioids as the poisoning agent – up from 24% in 2005. More than 4 in 10 deaths (42%) involved children under age 1.

Most of the deaths (61%) occurred in the child’s home, and in even more cases (71%) the child was being supervised when the poisoning occurred, most often by a parent (58.5%). The others supervising children were usually a grandparent (11%) or another relative (5.5%). The child was in view of the supervising individual in 28.5% of the deaths. A child protective services case was opened in 13% of the cases.

“Supervising a child is hard. Kids are constantly exploring and moving,” Dr. Gaw said. “A child may find a dropped medication on the floor that a caregiver doesn’t see, or a child may get into a bag or a purse when a caregiver is looking the other way. Poisonings can happen in a split second.”

Expecting caregivers to be able to watch kids every moment and always be within arm’s reach to prevent an accident is unrealistic, Dr. Gaw said, so families should focus on preparedness.

“Young children can’t tell the difference between a deadly substance versus a substance that is harmless or would only cause some harm. The best way to protect children is to prevent the poisoning from happening in the first place,” Dr. Gaw said. ”

It is recommended that caregivers keep the Poison Control Center’s national 24/7 hotline in their phones: (800) 222-1222.

Two-thirds of the cases Dr. Gaw examined did not involve a call to a poison control center, but most did involve a call to 911.

“My guess is that caregivers likely called 911 instead of poison control because the child was likely critically ill or deceased when found,” Dr. Gaw said, noting that his group did not have access to descriptive information about 911 calls. “If a child is critically ill and a caregiver called poison control first, they would be referred to 911.”

If a child looks healthy but has just swallowed something dangerous or deadly, Dr. Gaw said poison control can guide the family to getting prompt medical attention that could be lifesaving.

“We don’t expect the public to know what substances are harmless, harmful, or deadly,” he said. “People should always call poison control if there is any concern, even if the child looks well.”

Some poison control centers are working to increase the ways people can reach them, including through texting, apps, or online chat, he added.

Dr. Gary A. Smith

Gary A. Smith, MD, DrPH, president of the nonprofit Child Injury Prevention Alliance in Columbus, Ohio, and director of the Center for Injury Research and Policy at Nationwide Children’s Hospital, said the high level of supervision in these cases was not surprising.

”We have shown that most children are being directly supervised at the moment of injury for baby walker–related injuries, firework-related injuries, and other types of injuries that we have studied,” Dr. Smith said in an interview. “Injuries happen quickly and generally do not give a parent or caregiver time to react.”

“This dispels the myth that parental supervision is the key to injury prevention,” Dr. Smith said. “Although supervision helps, it is not adequate. These injuries occur to children of good and caring parents. The message for pediatricians is that we must create safe environments for children and design hazards out of existence to effectively prevent poisoning and other injuries.”

That preventive approach has been used for infectious disease and other public health problems, he added.

“Prescription opioids must be kept in their original containers with children-resistant closures and be stored up, away, and out of sight of children, preferably in a locked location,” Dr. Smith said. “If adults use illicit opioids or any other illicit substances – which are commonly laced with fentanyl – they should not use or store them in the home where children can access them.”

Over-the-counter pain, cold, and allergy medications were the second most common cause of death, occurring in 15% of cases.

“There has been a lot of work over the years among health care providers to counsel families on the proper dosing and use of medications such as Tylenol, Motrin, and Benadryl,” Dr. Gaw said. “There has also been a push to educate families that using antihistamines, such as Benadryl, to sedate their children can be dangerous and, depending on the dose, potentially deadly.”

Another 14% of cases were an unspecified illicit drug, and 10% were an unspecified over-the-counter or prescription medication. Carbon monoxide poisoning made up 6% of cases, and the remaining substances included amphetamines, antidepressants, cocaine, and alcohol.

Over half the deaths in 1-year-olds (61%) and children aged 2-5 (54%) were due to opioid poisoning, as were a third of deaths in infants (34%). Most of the poisonings involving amphetamines (81%), cocaine (84%), and alcohol (61.5%) occurred in infants under age 1.

Dr. Smith said that harm-reduction strategies, such as having naloxone on hand and using fentanyl test strips, can reduce the likelihood of death from illicit drugs.
 

Reducing stigma can save lives

“Referring parents to services for individuals who use drugs is key,” Dr. Smith said. “Treating this as a public health problem without stigmatizing the behavior is something that pediatricians and other health care professionals must remember.” As a resource for other pediatricians, Dr. Gaw noted that CHOP’s poison control center medical director Kevin Osterhoudt, MD produced a 25-minute podcast that covers common causes of poisonings, use of naloxone in children, and prevention tips.

“Naloxone is an effective antidote to opioid poisonings,” Dr. Gaw said. “We often think of using it in adults, but this is also a lifesaving medication for children poisoned by opioids. Educating people on recognizing the signs and symptoms of opioid poisoning and helping them feel empowered to use naloxone is something the public health world is working on.”

Dr. Gaw and Dr. Smith had no relevant disclosures. No external funding was noted for the study.

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– Opioids are the most common cause of fatal poisonings in young children, and their contribution to children’s deaths has been increasing, according to research presented at the American Academy of Pediatrics National Conference.

The study found that the proportion of deaths in U.S. children linked to opioids has doubled since the mid-2000s, tracking the course of the epidemic in adults in this country.

Dr. Christopher Gaw

“What is striking about our study is how the opioid epidemic has not spared our nation’s infants or young children,” Christopher Gaw, MD, MA, a pediatric emergency medicine fellow physician at Children’s Hospital of Philadelphia, said in an interview. “There is important work being done to reduce unnecessary opioid prescribing, drug diversion, and treatment of substance use disorders. These efforts – though not directly related to children – also help protect them, since they can reduce the chance of exposure to opioids in the home.”

Dr. Gaw and his colleagues analyzed data in Child Death Reviews from 40 states that participate in the National Fatality Review Case Reporting System, focusing on children aged 5 years and younger who died from a poisoning between 2005 and 2018. During that time, 731 child poisoning deaths were reported to the system – of which nearly half (47%) involved opioids as the poisoning agent – up from 24% in 2005. More than 4 in 10 deaths (42%) involved children under age 1.

Most of the deaths (61%) occurred in the child’s home, and in even more cases (71%) the child was being supervised when the poisoning occurred, most often by a parent (58.5%). The others supervising children were usually a grandparent (11%) or another relative (5.5%). The child was in view of the supervising individual in 28.5% of the deaths. A child protective services case was opened in 13% of the cases.

“Supervising a child is hard. Kids are constantly exploring and moving,” Dr. Gaw said. “A child may find a dropped medication on the floor that a caregiver doesn’t see, or a child may get into a bag or a purse when a caregiver is looking the other way. Poisonings can happen in a split second.”

Expecting caregivers to be able to watch kids every moment and always be within arm’s reach to prevent an accident is unrealistic, Dr. Gaw said, so families should focus on preparedness.

“Young children can’t tell the difference between a deadly substance versus a substance that is harmless or would only cause some harm. The best way to protect children is to prevent the poisoning from happening in the first place,” Dr. Gaw said. ”

It is recommended that caregivers keep the Poison Control Center’s national 24/7 hotline in their phones: (800) 222-1222.

Two-thirds of the cases Dr. Gaw examined did not involve a call to a poison control center, but most did involve a call to 911.

“My guess is that caregivers likely called 911 instead of poison control because the child was likely critically ill or deceased when found,” Dr. Gaw said, noting that his group did not have access to descriptive information about 911 calls. “If a child is critically ill and a caregiver called poison control first, they would be referred to 911.”

If a child looks healthy but has just swallowed something dangerous or deadly, Dr. Gaw said poison control can guide the family to getting prompt medical attention that could be lifesaving.

“We don’t expect the public to know what substances are harmless, harmful, or deadly,” he said. “People should always call poison control if there is any concern, even if the child looks well.”

Some poison control centers are working to increase the ways people can reach them, including through texting, apps, or online chat, he added.

Dr. Gary A. Smith

Gary A. Smith, MD, DrPH, president of the nonprofit Child Injury Prevention Alliance in Columbus, Ohio, and director of the Center for Injury Research and Policy at Nationwide Children’s Hospital, said the high level of supervision in these cases was not surprising.

”We have shown that most children are being directly supervised at the moment of injury for baby walker–related injuries, firework-related injuries, and other types of injuries that we have studied,” Dr. Smith said in an interview. “Injuries happen quickly and generally do not give a parent or caregiver time to react.”

“This dispels the myth that parental supervision is the key to injury prevention,” Dr. Smith said. “Although supervision helps, it is not adequate. These injuries occur to children of good and caring parents. The message for pediatricians is that we must create safe environments for children and design hazards out of existence to effectively prevent poisoning and other injuries.”

That preventive approach has been used for infectious disease and other public health problems, he added.

“Prescription opioids must be kept in their original containers with children-resistant closures and be stored up, away, and out of sight of children, preferably in a locked location,” Dr. Smith said. “If adults use illicit opioids or any other illicit substances – which are commonly laced with fentanyl – they should not use or store them in the home where children can access them.”

Over-the-counter pain, cold, and allergy medications were the second most common cause of death, occurring in 15% of cases.

“There has been a lot of work over the years among health care providers to counsel families on the proper dosing and use of medications such as Tylenol, Motrin, and Benadryl,” Dr. Gaw said. “There has also been a push to educate families that using antihistamines, such as Benadryl, to sedate their children can be dangerous and, depending on the dose, potentially deadly.”

Another 14% of cases were an unspecified illicit drug, and 10% were an unspecified over-the-counter or prescription medication. Carbon monoxide poisoning made up 6% of cases, and the remaining substances included amphetamines, antidepressants, cocaine, and alcohol.

Over half the deaths in 1-year-olds (61%) and children aged 2-5 (54%) were due to opioid poisoning, as were a third of deaths in infants (34%). Most of the poisonings involving amphetamines (81%), cocaine (84%), and alcohol (61.5%) occurred in infants under age 1.

Dr. Smith said that harm-reduction strategies, such as having naloxone on hand and using fentanyl test strips, can reduce the likelihood of death from illicit drugs.
 

Reducing stigma can save lives

“Referring parents to services for individuals who use drugs is key,” Dr. Smith said. “Treating this as a public health problem without stigmatizing the behavior is something that pediatricians and other health care professionals must remember.” As a resource for other pediatricians, Dr. Gaw noted that CHOP’s poison control center medical director Kevin Osterhoudt, MD produced a 25-minute podcast that covers common causes of poisonings, use of naloxone in children, and prevention tips.

“Naloxone is an effective antidote to opioid poisonings,” Dr. Gaw said. “We often think of using it in adults, but this is also a lifesaving medication for children poisoned by opioids. Educating people on recognizing the signs and symptoms of opioid poisoning and helping them feel empowered to use naloxone is something the public health world is working on.”

Dr. Gaw and Dr. Smith had no relevant disclosures. No external funding was noted for the study.

– Opioids are the most common cause of fatal poisonings in young children, and their contribution to children’s deaths has been increasing, according to research presented at the American Academy of Pediatrics National Conference.

The study found that the proportion of deaths in U.S. children linked to opioids has doubled since the mid-2000s, tracking the course of the epidemic in adults in this country.

Dr. Christopher Gaw

“What is striking about our study is how the opioid epidemic has not spared our nation’s infants or young children,” Christopher Gaw, MD, MA, a pediatric emergency medicine fellow physician at Children’s Hospital of Philadelphia, said in an interview. “There is important work being done to reduce unnecessary opioid prescribing, drug diversion, and treatment of substance use disorders. These efforts – though not directly related to children – also help protect them, since they can reduce the chance of exposure to opioids in the home.”

Dr. Gaw and his colleagues analyzed data in Child Death Reviews from 40 states that participate in the National Fatality Review Case Reporting System, focusing on children aged 5 years and younger who died from a poisoning between 2005 and 2018. During that time, 731 child poisoning deaths were reported to the system – of which nearly half (47%) involved opioids as the poisoning agent – up from 24% in 2005. More than 4 in 10 deaths (42%) involved children under age 1.

Most of the deaths (61%) occurred in the child’s home, and in even more cases (71%) the child was being supervised when the poisoning occurred, most often by a parent (58.5%). The others supervising children were usually a grandparent (11%) or another relative (5.5%). The child was in view of the supervising individual in 28.5% of the deaths. A child protective services case was opened in 13% of the cases.

“Supervising a child is hard. Kids are constantly exploring and moving,” Dr. Gaw said. “A child may find a dropped medication on the floor that a caregiver doesn’t see, or a child may get into a bag or a purse when a caregiver is looking the other way. Poisonings can happen in a split second.”

Expecting caregivers to be able to watch kids every moment and always be within arm’s reach to prevent an accident is unrealistic, Dr. Gaw said, so families should focus on preparedness.

“Young children can’t tell the difference between a deadly substance versus a substance that is harmless or would only cause some harm. The best way to protect children is to prevent the poisoning from happening in the first place,” Dr. Gaw said. ”

It is recommended that caregivers keep the Poison Control Center’s national 24/7 hotline in their phones: (800) 222-1222.

Two-thirds of the cases Dr. Gaw examined did not involve a call to a poison control center, but most did involve a call to 911.

“My guess is that caregivers likely called 911 instead of poison control because the child was likely critically ill or deceased when found,” Dr. Gaw said, noting that his group did not have access to descriptive information about 911 calls. “If a child is critically ill and a caregiver called poison control first, they would be referred to 911.”

If a child looks healthy but has just swallowed something dangerous or deadly, Dr. Gaw said poison control can guide the family to getting prompt medical attention that could be lifesaving.

“We don’t expect the public to know what substances are harmless, harmful, or deadly,” he said. “People should always call poison control if there is any concern, even if the child looks well.”

Some poison control centers are working to increase the ways people can reach them, including through texting, apps, or online chat, he added.

Dr. Gary A. Smith

Gary A. Smith, MD, DrPH, president of the nonprofit Child Injury Prevention Alliance in Columbus, Ohio, and director of the Center for Injury Research and Policy at Nationwide Children’s Hospital, said the high level of supervision in these cases was not surprising.

”We have shown that most children are being directly supervised at the moment of injury for baby walker–related injuries, firework-related injuries, and other types of injuries that we have studied,” Dr. Smith said in an interview. “Injuries happen quickly and generally do not give a parent or caregiver time to react.”

“This dispels the myth that parental supervision is the key to injury prevention,” Dr. Smith said. “Although supervision helps, it is not adequate. These injuries occur to children of good and caring parents. The message for pediatricians is that we must create safe environments for children and design hazards out of existence to effectively prevent poisoning and other injuries.”

That preventive approach has been used for infectious disease and other public health problems, he added.

“Prescription opioids must be kept in their original containers with children-resistant closures and be stored up, away, and out of sight of children, preferably in a locked location,” Dr. Smith said. “If adults use illicit opioids or any other illicit substances – which are commonly laced with fentanyl – they should not use or store them in the home where children can access them.”

Over-the-counter pain, cold, and allergy medications were the second most common cause of death, occurring in 15% of cases.

“There has been a lot of work over the years among health care providers to counsel families on the proper dosing and use of medications such as Tylenol, Motrin, and Benadryl,” Dr. Gaw said. “There has also been a push to educate families that using antihistamines, such as Benadryl, to sedate their children can be dangerous and, depending on the dose, potentially deadly.”

Another 14% of cases were an unspecified illicit drug, and 10% were an unspecified over-the-counter or prescription medication. Carbon monoxide poisoning made up 6% of cases, and the remaining substances included amphetamines, antidepressants, cocaine, and alcohol.

Over half the deaths in 1-year-olds (61%) and children aged 2-5 (54%) were due to opioid poisoning, as were a third of deaths in infants (34%). Most of the poisonings involving amphetamines (81%), cocaine (84%), and alcohol (61.5%) occurred in infants under age 1.

Dr. Smith said that harm-reduction strategies, such as having naloxone on hand and using fentanyl test strips, can reduce the likelihood of death from illicit drugs.
 

Reducing stigma can save lives

“Referring parents to services for individuals who use drugs is key,” Dr. Smith said. “Treating this as a public health problem without stigmatizing the behavior is something that pediatricians and other health care professionals must remember.” As a resource for other pediatricians, Dr. Gaw noted that CHOP’s poison control center medical director Kevin Osterhoudt, MD produced a 25-minute podcast that covers common causes of poisonings, use of naloxone in children, and prevention tips.

“Naloxone is an effective antidote to opioid poisonings,” Dr. Gaw said. “We often think of using it in adults, but this is also a lifesaving medication for children poisoned by opioids. Educating people on recognizing the signs and symptoms of opioid poisoning and helping them feel empowered to use naloxone is something the public health world is working on.”

Dr. Gaw and Dr. Smith had no relevant disclosures. No external funding was noted for the study.

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Mother-to-child transmission of SARS-CoV-2 may be underestimated

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Tue, 10/11/2022 - 16:12

 

ANAHEIM, CALIF. – The rate of mother-to-child transmission of SARS-CoV-2 infection is likely higher than the current estimate of 2%-8%, suggests a recent study using cord blood serology to determine incidence. The study was presented at the American Academy of Pediatrics National Conference.  

“Cord blood screening is a potential tool to identify SARS-CoV-2 infected and/or exposed neonates who should then be followed for long-term consequences of mother-to-child transmission,” Amy Yeh, MD, an assistant professor of clinical pediatrics at the University of Southern California, Los Angeles, told attendees at the meeting.

Dr. Yeh and her colleagues collected cord blood from more than 500 mothers at LAC+USC Medical Center from October 2021 to April 2022 and tested them for IgG antibodies against three SARS-CoV-2 antigens: nucleoprotein (N), receptor-binding domain (RBD), and spike protein (S1). Results with an IgG mean fluorescence intensity (MFI) above 700 were considered positive for IgG antibodies. A positive result for N as well as RBD or S1 indicated a natural infection while a positive result for only RBD or S1 indicated a vaccine response or past infection. 

The researchers also tested a subset of the IgG positive samples for IgM and IgA antibodies against N, S1, and RBD, with an IgM MFI greater than 24 and an IgA MFI greater than 102 used as the thresholds for positive results.

Among 384 cord blood samples analyzed, 85.4% were positive for IgG against RBD, indicating that the mother had SARS-CoV-2 immunity from either a past infection or vaccination. Of these anti-RBD positive samples, 60.7% were anti-N IgG negative, suggesting that N had waned since vaccination or the past infection. 

Since the other 39.3% that were anti-N IgG positive suggest a past maternal infection, the researchers assessed these 129 samples for IgM and IgA antibodies against RBD. They found that 16 of them had high levels of anti-RBD IgA and/or IgM antibodies, pointing to a rate of mother-to-child-transmission of up to 12.4%.

Dr. Sallie Permar

Sallie Permar, MD, PhD, a professor and the chair of pediatrics at Weill Cornell Medicine in New York, who was not involved in the research, said most studies of placental transmission have focused on virologic testing, such as PCR. “Serologic tests for congenital infections are inherently challenged by the transfer of maternal IgG across the placenta and therefore must rely on non-IgG isotype response detection, which have inherently been more susceptible to false-positive results than IgG-based tests,” Dr. Permar said.

Also, “it is unclear if virologic testing was performed in the infants, which, if positive in the same infants for which cord blood IgM/IgA responses were identified, could further validate positive serologic findings,” added Dr. Permar, who is also pediatrician-in-chief at New York-Presbyterian Komansky Children’s Hospital.

Given these limitations, Dr. Permar reiterated that diagnostics for congenital SARS-CoV-2 continue to evolve, even if congenital SARS-CoV-2 infection currently appears rare. Dr. Permar said she agreed with Dr. Yeh that following those who do develop this infection is important.  

“There have been initial reports of neurodevelopmental and other outcomes from long-term follow-up cohorts of infants exposed to SARS-CoV-2 infection in utero with variable results and it should continue to be pursued using cohorts both enrolled early in the pandemic and those enrolled more recently after population-level immunity to SARS-CoV-2 was achieved,” said Dr. Permar.

Dr. Permar serves as a consultant to Moderna, Pfizer, Merck, Dynavax, and Hoopika on their CMV vaccine programs and has led sponsored research programs with Moderna and Merck. Information on study funding and on disclosures for Dr. Yeh was unavailable.

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ANAHEIM, CALIF. – The rate of mother-to-child transmission of SARS-CoV-2 infection is likely higher than the current estimate of 2%-8%, suggests a recent study using cord blood serology to determine incidence. The study was presented at the American Academy of Pediatrics National Conference.  

“Cord blood screening is a potential tool to identify SARS-CoV-2 infected and/or exposed neonates who should then be followed for long-term consequences of mother-to-child transmission,” Amy Yeh, MD, an assistant professor of clinical pediatrics at the University of Southern California, Los Angeles, told attendees at the meeting.

Dr. Yeh and her colleagues collected cord blood from more than 500 mothers at LAC+USC Medical Center from October 2021 to April 2022 and tested them for IgG antibodies against three SARS-CoV-2 antigens: nucleoprotein (N), receptor-binding domain (RBD), and spike protein (S1). Results with an IgG mean fluorescence intensity (MFI) above 700 were considered positive for IgG antibodies. A positive result for N as well as RBD or S1 indicated a natural infection while a positive result for only RBD or S1 indicated a vaccine response or past infection. 

The researchers also tested a subset of the IgG positive samples for IgM and IgA antibodies against N, S1, and RBD, with an IgM MFI greater than 24 and an IgA MFI greater than 102 used as the thresholds for positive results.

Among 384 cord blood samples analyzed, 85.4% were positive for IgG against RBD, indicating that the mother had SARS-CoV-2 immunity from either a past infection or vaccination. Of these anti-RBD positive samples, 60.7% were anti-N IgG negative, suggesting that N had waned since vaccination or the past infection. 

Since the other 39.3% that were anti-N IgG positive suggest a past maternal infection, the researchers assessed these 129 samples for IgM and IgA antibodies against RBD. They found that 16 of them had high levels of anti-RBD IgA and/or IgM antibodies, pointing to a rate of mother-to-child-transmission of up to 12.4%.

Dr. Sallie Permar

Sallie Permar, MD, PhD, a professor and the chair of pediatrics at Weill Cornell Medicine in New York, who was not involved in the research, said most studies of placental transmission have focused on virologic testing, such as PCR. “Serologic tests for congenital infections are inherently challenged by the transfer of maternal IgG across the placenta and therefore must rely on non-IgG isotype response detection, which have inherently been more susceptible to false-positive results than IgG-based tests,” Dr. Permar said.

Also, “it is unclear if virologic testing was performed in the infants, which, if positive in the same infants for which cord blood IgM/IgA responses were identified, could further validate positive serologic findings,” added Dr. Permar, who is also pediatrician-in-chief at New York-Presbyterian Komansky Children’s Hospital.

Given these limitations, Dr. Permar reiterated that diagnostics for congenital SARS-CoV-2 continue to evolve, even if congenital SARS-CoV-2 infection currently appears rare. Dr. Permar said she agreed with Dr. Yeh that following those who do develop this infection is important.  

“There have been initial reports of neurodevelopmental and other outcomes from long-term follow-up cohorts of infants exposed to SARS-CoV-2 infection in utero with variable results and it should continue to be pursued using cohorts both enrolled early in the pandemic and those enrolled more recently after population-level immunity to SARS-CoV-2 was achieved,” said Dr. Permar.

Dr. Permar serves as a consultant to Moderna, Pfizer, Merck, Dynavax, and Hoopika on their CMV vaccine programs and has led sponsored research programs with Moderna and Merck. Information on study funding and on disclosures for Dr. Yeh was unavailable.

 

ANAHEIM, CALIF. – The rate of mother-to-child transmission of SARS-CoV-2 infection is likely higher than the current estimate of 2%-8%, suggests a recent study using cord blood serology to determine incidence. The study was presented at the American Academy of Pediatrics National Conference.  

“Cord blood screening is a potential tool to identify SARS-CoV-2 infected and/or exposed neonates who should then be followed for long-term consequences of mother-to-child transmission,” Amy Yeh, MD, an assistant professor of clinical pediatrics at the University of Southern California, Los Angeles, told attendees at the meeting.

Dr. Yeh and her colleagues collected cord blood from more than 500 mothers at LAC+USC Medical Center from October 2021 to April 2022 and tested them for IgG antibodies against three SARS-CoV-2 antigens: nucleoprotein (N), receptor-binding domain (RBD), and spike protein (S1). Results with an IgG mean fluorescence intensity (MFI) above 700 were considered positive for IgG antibodies. A positive result for N as well as RBD or S1 indicated a natural infection while a positive result for only RBD or S1 indicated a vaccine response or past infection. 

The researchers also tested a subset of the IgG positive samples for IgM and IgA antibodies against N, S1, and RBD, with an IgM MFI greater than 24 and an IgA MFI greater than 102 used as the thresholds for positive results.

Among 384 cord blood samples analyzed, 85.4% were positive for IgG against RBD, indicating that the mother had SARS-CoV-2 immunity from either a past infection or vaccination. Of these anti-RBD positive samples, 60.7% were anti-N IgG negative, suggesting that N had waned since vaccination or the past infection. 

Since the other 39.3% that were anti-N IgG positive suggest a past maternal infection, the researchers assessed these 129 samples for IgM and IgA antibodies against RBD. They found that 16 of them had high levels of anti-RBD IgA and/or IgM antibodies, pointing to a rate of mother-to-child-transmission of up to 12.4%.

Dr. Sallie Permar

Sallie Permar, MD, PhD, a professor and the chair of pediatrics at Weill Cornell Medicine in New York, who was not involved in the research, said most studies of placental transmission have focused on virologic testing, such as PCR. “Serologic tests for congenital infections are inherently challenged by the transfer of maternal IgG across the placenta and therefore must rely on non-IgG isotype response detection, which have inherently been more susceptible to false-positive results than IgG-based tests,” Dr. Permar said.

Also, “it is unclear if virologic testing was performed in the infants, which, if positive in the same infants for which cord blood IgM/IgA responses were identified, could further validate positive serologic findings,” added Dr. Permar, who is also pediatrician-in-chief at New York-Presbyterian Komansky Children’s Hospital.

Given these limitations, Dr. Permar reiterated that diagnostics for congenital SARS-CoV-2 continue to evolve, even if congenital SARS-CoV-2 infection currently appears rare. Dr. Permar said she agreed with Dr. Yeh that following those who do develop this infection is important.  

“There have been initial reports of neurodevelopmental and other outcomes from long-term follow-up cohorts of infants exposed to SARS-CoV-2 infection in utero with variable results and it should continue to be pursued using cohorts both enrolled early in the pandemic and those enrolled more recently after population-level immunity to SARS-CoV-2 was achieved,” said Dr. Permar.

Dr. Permar serves as a consultant to Moderna, Pfizer, Merck, Dynavax, and Hoopika on their CMV vaccine programs and has led sponsored research programs with Moderna and Merck. Information on study funding and on disclosures for Dr. Yeh was unavailable.

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UC reaches remission with FMT plus anti-inflammatory diet: Study

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Tue, 10/11/2022 - 11:05

 

The combination of fecal microbiota transplantation (FMT) and an anti-inflammatory diet (AID) successfully induced and sustained remission of ulcerative colitis (UC) more effectively than optimizing medications for the condition did, according to a randomized controlled trial published in the journal Gut.

”Deep remission at 48 weeks was also significantly better in the FMT-AID arm, suggesting that the anti-inflammatory diet could sustain the FMT-AID–induced endoscopic and clinical remission,” wrote Saurabh Kedia, MD, of the All India Institute of Medical Sciences in New Delhi, and colleagues. “The adherence to modified diet was maintained until 48 weeks, suggesting the acceptability of this approach to patients.”

The open-label trial involved 66 patients with mild to moderate UC, based on a Simple Clinical Colitis Activity Index (SCCAI) score in the range of 3-9 and a score above 1 on the Ulcerative Colitis Endoscopic Index of Severity (UCEIS). Their average age was 35, and 34.8% of the participants had pancolitis. Their median SCCAI score was 6 (interquartile range, 5-7), and their median UCEIS score was 4 (IQR, 3-5) at enrollment.

The control group of 31 patients received standard medical therapy, which meant continuing on their baseline medications along with optimization of their therapy. The optimization involved increasing 5-aminosalicylic acid and/or adding topical therapy (topical 5-ASA or topical steroids in those already on topical 5-ASA); steroid dose was increased in patients already on topical steroids and 5-ASA.

The 35 patients randomized to the FMT-AID arm received seven weekly colonoscopic infusions of FMT from multiple donors, drawn from healthy rural adults aged 18-45, and were instructed to follow an anti-inflammatory diet. The anti-inflammatory diet was “rich in dietary constituents that expand T-regulatory cells, promote healthy microbiota, and improve the intestinal barrier, and poor in dietary constituents that cause dysbiosis or have negative effect on intestinal barrier,” the authors wrote. Foods to avoid included gluten-based grains, dairy products, processed and red meat, food additives, and refined sugars. Participants were encouraged to increase their intake of fresh fruit and vegetables, fermented foods, cruciferous vegetables, and polyphenols. The patients received a diet chart to follow, and a dietitian called every 2 weeks during the first 2 months to assess diet compliance.

The patients’ outcomes were assessed at 8 weeks with blood and stool samples and endoscopy, scored by an assignment-blinded physician. The primary outcome consisted of both clinical remission (SCCAI score of 2 or less) and endoscopic remission (UCEIS score of 1 or less), which the investigators considered deep remission. They also looked at those who clinically responded – a decline in SCCAI of at least 3 points – even if they didn’t reach remission. The researchers defined treatment failure as either an increase in SCCAI of at least 3 points with a rectal bleeding score of at least 1, or a need for oral steroids without improvement of at least 3 points in their SCCAI score.

At 8 weeks, patients in the FMT-AID arm were more than three times more likely to achieve remission or clinically respond than those receiving standard medical therapy. Two-thirds of those in the FMT-AID arm (65.7%) clinically responded, compared with 35.5% of those receiving standard therapy (odds ratio, 3.5; 95% confidence interval, 1.3-9.6). Clinical remission occurred in 60% of those in the FMT-AID arm, compared with 32.3% of the standard therapy arm (OR, 3.2; 95% CI, 1.1-8.7). Just over half the FMT-AID arm participants (51.5%) showed endoscopic response, compared with 17.4% of those with standard therapy (OR, 5.0; 95% CI, 1.4-18.1). Endoscopic remission was also greater in the FMT-AID group (36.4%) than the standard therapy group (17.4%) but without statistical significance (P = .15). Finally, about a third of the FMT-AID arm experienced deep remission (36.4%), compared with 8.7% of the standard therapy arm (OR, 6.0; 95% CI, 1.2-30.2). Those in the FMT-AID arm with milder disease or left-sided colitis were significantly more likely to reach clinical remission, and all the patients who hadn’t taken steroids had remission.

Those with clinical response or remission at 8 weeks – 23 people in the FMT-AID arm and 11 in the standard therapy arm – were then followed for the next 40 weeks. During that period, participants in the FMT-AID arm continued their anti-inflammatory diet and medications while the standard medical care group took only their medications.

At 48 weeks, half the original cohort of FMT-AID patients had maintained clinical remission or response, compared with a third of the standard care group, but the difference between the groups didn’t reach significance. However, a quarter of FMT-AID participants (25%) had maintained endoscopic remission, compared with none in the standard therapy arm (P = .007), and the same was true for deep remission (25% vs. 0%; P = .007).

Adverse events were similar in the FMT-AID (74%) and standard care (87%) arms and mild or moderate, mainly abdominal pain, bloating, gas, diarrhea, and worsened disease activity.

A substantial challenge in the trial came from interruptions because of the COVID-19 pandemic. Among the 66 trial participants, 52 were recruited between September 2019 and March 2020, when the pandemic prevented further recruitment. The remaining 14 participants were recruited between August and November 2021.

“The major strength of our study was a unique protocol combining two microbiome manipulation strategies: FMT and diet,” the authors wrote. “While both were used for induction of remission, the effect was maintained only with diet, which adds novelty to the study design.”

Vineet Ahuja, MD, DM, the paper’s senior author and a professor of gastroenterology at the All India Institute of Medical Sciences, said there likely wasn’t any major impact from the pandemic on participants’ ability to follow the diet given that none mentioned it during the dietitian calls.

”There are less possible chances of recall bias since we had a dedicated IBD dietician who would contact patients regularly for recalling the diet,” Dr. Ahuja said in an interview. “We also have created a diet app, IBD Nutricare, in which real-time recording of daily diet can be done by the patient and the input is analyzable at the web end.”

Most in the FMT-AID arm (84.6%) were qualitatively highly adherent to the diet at 8 weeks, with the other 15.4% moderately adherent. The highly adherent rate fell to 66.7% at 48 weeks, with the other third remaining moderately adherent. No patients were poorly or nonadherent during the study. At 8 weeks, 92.3% of patients were avoiding prohibited foods, which fell to 71.4% at 48 weeks.

Ashwin Ananthakrishnan, MBBS, MPH, an associate professor of medicine at Massachusetts General Hospital and director of the MGH Crohn’s and Colitis center in Boston, found the study design “intriguing and practical.”

”Prior studies of FMT in UC examined UC alone – they required fairly high intensity of FMT treatment for the entire duration of the trial – consequently they may not be sustainable in real world practice,” Dr. Ananthakrishnan said in an interview. “This is a more practically applicable study where the dietary intervention could be continued for a longer period of time. So in all, it’s a very promising study and provides a lot of guidance into how to practically position these treatments.”

The authors similarly noted that the two-intervention approach is ”practical for patients as they can practice the modified diet at home and avoid hospital visits for repeat FMTs.” The authors also noted that their study “provides a low-cost, safe alternative for IBD physicians in resource-limited settings.”

That said, Dr. Ananthakrishnan drew attention to the small size of the study as a limitation.

”To what degree the sustained benefit was due to AID vs. FMT cannot be established,” Dr. Ananthakrishnan said. “The optimized standard medical therapy arm had patients with mild disease who had only minor adjustments to their baseline treatment. Whether they would have had similar benefit if they had been treated with a short course of systemic steroids and continued their optimized treatment is unclear.”

The research was funded by a grant from the Indian Council of Medical Research. The authors and Dr. Ananthakrishnan reported no conflicts of interest.

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The combination of fecal microbiota transplantation (FMT) and an anti-inflammatory diet (AID) successfully induced and sustained remission of ulcerative colitis (UC) more effectively than optimizing medications for the condition did, according to a randomized controlled trial published in the journal Gut.

”Deep remission at 48 weeks was also significantly better in the FMT-AID arm, suggesting that the anti-inflammatory diet could sustain the FMT-AID–induced endoscopic and clinical remission,” wrote Saurabh Kedia, MD, of the All India Institute of Medical Sciences in New Delhi, and colleagues. “The adherence to modified diet was maintained until 48 weeks, suggesting the acceptability of this approach to patients.”

The open-label trial involved 66 patients with mild to moderate UC, based on a Simple Clinical Colitis Activity Index (SCCAI) score in the range of 3-9 and a score above 1 on the Ulcerative Colitis Endoscopic Index of Severity (UCEIS). Their average age was 35, and 34.8% of the participants had pancolitis. Their median SCCAI score was 6 (interquartile range, 5-7), and their median UCEIS score was 4 (IQR, 3-5) at enrollment.

The control group of 31 patients received standard medical therapy, which meant continuing on their baseline medications along with optimization of their therapy. The optimization involved increasing 5-aminosalicylic acid and/or adding topical therapy (topical 5-ASA or topical steroids in those already on topical 5-ASA); steroid dose was increased in patients already on topical steroids and 5-ASA.

The 35 patients randomized to the FMT-AID arm received seven weekly colonoscopic infusions of FMT from multiple donors, drawn from healthy rural adults aged 18-45, and were instructed to follow an anti-inflammatory diet. The anti-inflammatory diet was “rich in dietary constituents that expand T-regulatory cells, promote healthy microbiota, and improve the intestinal barrier, and poor in dietary constituents that cause dysbiosis or have negative effect on intestinal barrier,” the authors wrote. Foods to avoid included gluten-based grains, dairy products, processed and red meat, food additives, and refined sugars. Participants were encouraged to increase their intake of fresh fruit and vegetables, fermented foods, cruciferous vegetables, and polyphenols. The patients received a diet chart to follow, and a dietitian called every 2 weeks during the first 2 months to assess diet compliance.

The patients’ outcomes were assessed at 8 weeks with blood and stool samples and endoscopy, scored by an assignment-blinded physician. The primary outcome consisted of both clinical remission (SCCAI score of 2 or less) and endoscopic remission (UCEIS score of 1 or less), which the investigators considered deep remission. They also looked at those who clinically responded – a decline in SCCAI of at least 3 points – even if they didn’t reach remission. The researchers defined treatment failure as either an increase in SCCAI of at least 3 points with a rectal bleeding score of at least 1, or a need for oral steroids without improvement of at least 3 points in their SCCAI score.

At 8 weeks, patients in the FMT-AID arm were more than three times more likely to achieve remission or clinically respond than those receiving standard medical therapy. Two-thirds of those in the FMT-AID arm (65.7%) clinically responded, compared with 35.5% of those receiving standard therapy (odds ratio, 3.5; 95% confidence interval, 1.3-9.6). Clinical remission occurred in 60% of those in the FMT-AID arm, compared with 32.3% of the standard therapy arm (OR, 3.2; 95% CI, 1.1-8.7). Just over half the FMT-AID arm participants (51.5%) showed endoscopic response, compared with 17.4% of those with standard therapy (OR, 5.0; 95% CI, 1.4-18.1). Endoscopic remission was also greater in the FMT-AID group (36.4%) than the standard therapy group (17.4%) but without statistical significance (P = .15). Finally, about a third of the FMT-AID arm experienced deep remission (36.4%), compared with 8.7% of the standard therapy arm (OR, 6.0; 95% CI, 1.2-30.2). Those in the FMT-AID arm with milder disease or left-sided colitis were significantly more likely to reach clinical remission, and all the patients who hadn’t taken steroids had remission.

Those with clinical response or remission at 8 weeks – 23 people in the FMT-AID arm and 11 in the standard therapy arm – were then followed for the next 40 weeks. During that period, participants in the FMT-AID arm continued their anti-inflammatory diet and medications while the standard medical care group took only their medications.

At 48 weeks, half the original cohort of FMT-AID patients had maintained clinical remission or response, compared with a third of the standard care group, but the difference between the groups didn’t reach significance. However, a quarter of FMT-AID participants (25%) had maintained endoscopic remission, compared with none in the standard therapy arm (P = .007), and the same was true for deep remission (25% vs. 0%; P = .007).

Adverse events were similar in the FMT-AID (74%) and standard care (87%) arms and mild or moderate, mainly abdominal pain, bloating, gas, diarrhea, and worsened disease activity.

A substantial challenge in the trial came from interruptions because of the COVID-19 pandemic. Among the 66 trial participants, 52 were recruited between September 2019 and March 2020, when the pandemic prevented further recruitment. The remaining 14 participants were recruited between August and November 2021.

“The major strength of our study was a unique protocol combining two microbiome manipulation strategies: FMT and diet,” the authors wrote. “While both were used for induction of remission, the effect was maintained only with diet, which adds novelty to the study design.”

Vineet Ahuja, MD, DM, the paper’s senior author and a professor of gastroenterology at the All India Institute of Medical Sciences, said there likely wasn’t any major impact from the pandemic on participants’ ability to follow the diet given that none mentioned it during the dietitian calls.

”There are less possible chances of recall bias since we had a dedicated IBD dietician who would contact patients regularly for recalling the diet,” Dr. Ahuja said in an interview. “We also have created a diet app, IBD Nutricare, in which real-time recording of daily diet can be done by the patient and the input is analyzable at the web end.”

Most in the FMT-AID arm (84.6%) were qualitatively highly adherent to the diet at 8 weeks, with the other 15.4% moderately adherent. The highly adherent rate fell to 66.7% at 48 weeks, with the other third remaining moderately adherent. No patients were poorly or nonadherent during the study. At 8 weeks, 92.3% of patients were avoiding prohibited foods, which fell to 71.4% at 48 weeks.

Ashwin Ananthakrishnan, MBBS, MPH, an associate professor of medicine at Massachusetts General Hospital and director of the MGH Crohn’s and Colitis center in Boston, found the study design “intriguing and practical.”

”Prior studies of FMT in UC examined UC alone – they required fairly high intensity of FMT treatment for the entire duration of the trial – consequently they may not be sustainable in real world practice,” Dr. Ananthakrishnan said in an interview. “This is a more practically applicable study where the dietary intervention could be continued for a longer period of time. So in all, it’s a very promising study and provides a lot of guidance into how to practically position these treatments.”

The authors similarly noted that the two-intervention approach is ”practical for patients as they can practice the modified diet at home and avoid hospital visits for repeat FMTs.” The authors also noted that their study “provides a low-cost, safe alternative for IBD physicians in resource-limited settings.”

That said, Dr. Ananthakrishnan drew attention to the small size of the study as a limitation.

”To what degree the sustained benefit was due to AID vs. FMT cannot be established,” Dr. Ananthakrishnan said. “The optimized standard medical therapy arm had patients with mild disease who had only minor adjustments to their baseline treatment. Whether they would have had similar benefit if they had been treated with a short course of systemic steroids and continued their optimized treatment is unclear.”

The research was funded by a grant from the Indian Council of Medical Research. The authors and Dr. Ananthakrishnan reported no conflicts of interest.

 

The combination of fecal microbiota transplantation (FMT) and an anti-inflammatory diet (AID) successfully induced and sustained remission of ulcerative colitis (UC) more effectively than optimizing medications for the condition did, according to a randomized controlled trial published in the journal Gut.

”Deep remission at 48 weeks was also significantly better in the FMT-AID arm, suggesting that the anti-inflammatory diet could sustain the FMT-AID–induced endoscopic and clinical remission,” wrote Saurabh Kedia, MD, of the All India Institute of Medical Sciences in New Delhi, and colleagues. “The adherence to modified diet was maintained until 48 weeks, suggesting the acceptability of this approach to patients.”

The open-label trial involved 66 patients with mild to moderate UC, based on a Simple Clinical Colitis Activity Index (SCCAI) score in the range of 3-9 and a score above 1 on the Ulcerative Colitis Endoscopic Index of Severity (UCEIS). Their average age was 35, and 34.8% of the participants had pancolitis. Their median SCCAI score was 6 (interquartile range, 5-7), and their median UCEIS score was 4 (IQR, 3-5) at enrollment.

The control group of 31 patients received standard medical therapy, which meant continuing on their baseline medications along with optimization of their therapy. The optimization involved increasing 5-aminosalicylic acid and/or adding topical therapy (topical 5-ASA or topical steroids in those already on topical 5-ASA); steroid dose was increased in patients already on topical steroids and 5-ASA.

The 35 patients randomized to the FMT-AID arm received seven weekly colonoscopic infusions of FMT from multiple donors, drawn from healthy rural adults aged 18-45, and were instructed to follow an anti-inflammatory diet. The anti-inflammatory diet was “rich in dietary constituents that expand T-regulatory cells, promote healthy microbiota, and improve the intestinal barrier, and poor in dietary constituents that cause dysbiosis or have negative effect on intestinal barrier,” the authors wrote. Foods to avoid included gluten-based grains, dairy products, processed and red meat, food additives, and refined sugars. Participants were encouraged to increase their intake of fresh fruit and vegetables, fermented foods, cruciferous vegetables, and polyphenols. The patients received a diet chart to follow, and a dietitian called every 2 weeks during the first 2 months to assess diet compliance.

The patients’ outcomes were assessed at 8 weeks with blood and stool samples and endoscopy, scored by an assignment-blinded physician. The primary outcome consisted of both clinical remission (SCCAI score of 2 or less) and endoscopic remission (UCEIS score of 1 or less), which the investigators considered deep remission. They also looked at those who clinically responded – a decline in SCCAI of at least 3 points – even if they didn’t reach remission. The researchers defined treatment failure as either an increase in SCCAI of at least 3 points with a rectal bleeding score of at least 1, or a need for oral steroids without improvement of at least 3 points in their SCCAI score.

At 8 weeks, patients in the FMT-AID arm were more than three times more likely to achieve remission or clinically respond than those receiving standard medical therapy. Two-thirds of those in the FMT-AID arm (65.7%) clinically responded, compared with 35.5% of those receiving standard therapy (odds ratio, 3.5; 95% confidence interval, 1.3-9.6). Clinical remission occurred in 60% of those in the FMT-AID arm, compared with 32.3% of the standard therapy arm (OR, 3.2; 95% CI, 1.1-8.7). Just over half the FMT-AID arm participants (51.5%) showed endoscopic response, compared with 17.4% of those with standard therapy (OR, 5.0; 95% CI, 1.4-18.1). Endoscopic remission was also greater in the FMT-AID group (36.4%) than the standard therapy group (17.4%) but without statistical significance (P = .15). Finally, about a third of the FMT-AID arm experienced deep remission (36.4%), compared with 8.7% of the standard therapy arm (OR, 6.0; 95% CI, 1.2-30.2). Those in the FMT-AID arm with milder disease or left-sided colitis were significantly more likely to reach clinical remission, and all the patients who hadn’t taken steroids had remission.

Those with clinical response or remission at 8 weeks – 23 people in the FMT-AID arm and 11 in the standard therapy arm – were then followed for the next 40 weeks. During that period, participants in the FMT-AID arm continued their anti-inflammatory diet and medications while the standard medical care group took only their medications.

At 48 weeks, half the original cohort of FMT-AID patients had maintained clinical remission or response, compared with a third of the standard care group, but the difference between the groups didn’t reach significance. However, a quarter of FMT-AID participants (25%) had maintained endoscopic remission, compared with none in the standard therapy arm (P = .007), and the same was true for deep remission (25% vs. 0%; P = .007).

Adverse events were similar in the FMT-AID (74%) and standard care (87%) arms and mild or moderate, mainly abdominal pain, bloating, gas, diarrhea, and worsened disease activity.

A substantial challenge in the trial came from interruptions because of the COVID-19 pandemic. Among the 66 trial participants, 52 were recruited between September 2019 and March 2020, when the pandemic prevented further recruitment. The remaining 14 participants were recruited between August and November 2021.

“The major strength of our study was a unique protocol combining two microbiome manipulation strategies: FMT and diet,” the authors wrote. “While both were used for induction of remission, the effect was maintained only with diet, which adds novelty to the study design.”

Vineet Ahuja, MD, DM, the paper’s senior author and a professor of gastroenterology at the All India Institute of Medical Sciences, said there likely wasn’t any major impact from the pandemic on participants’ ability to follow the diet given that none mentioned it during the dietitian calls.

”There are less possible chances of recall bias since we had a dedicated IBD dietician who would contact patients regularly for recalling the diet,” Dr. Ahuja said in an interview. “We also have created a diet app, IBD Nutricare, in which real-time recording of daily diet can be done by the patient and the input is analyzable at the web end.”

Most in the FMT-AID arm (84.6%) were qualitatively highly adherent to the diet at 8 weeks, with the other 15.4% moderately adherent. The highly adherent rate fell to 66.7% at 48 weeks, with the other third remaining moderately adherent. No patients were poorly or nonadherent during the study. At 8 weeks, 92.3% of patients were avoiding prohibited foods, which fell to 71.4% at 48 weeks.

Ashwin Ananthakrishnan, MBBS, MPH, an associate professor of medicine at Massachusetts General Hospital and director of the MGH Crohn’s and Colitis center in Boston, found the study design “intriguing and practical.”

”Prior studies of FMT in UC examined UC alone – they required fairly high intensity of FMT treatment for the entire duration of the trial – consequently they may not be sustainable in real world practice,” Dr. Ananthakrishnan said in an interview. “This is a more practically applicable study where the dietary intervention could be continued for a longer period of time. So in all, it’s a very promising study and provides a lot of guidance into how to practically position these treatments.”

The authors similarly noted that the two-intervention approach is ”practical for patients as they can practice the modified diet at home and avoid hospital visits for repeat FMTs.” The authors also noted that their study “provides a low-cost, safe alternative for IBD physicians in resource-limited settings.”

That said, Dr. Ananthakrishnan drew attention to the small size of the study as a limitation.

”To what degree the sustained benefit was due to AID vs. FMT cannot be established,” Dr. Ananthakrishnan said. “The optimized standard medical therapy arm had patients with mild disease who had only minor adjustments to their baseline treatment. Whether they would have had similar benefit if they had been treated with a short course of systemic steroids and continued their optimized treatment is unclear.”

The research was funded by a grant from the Indian Council of Medical Research. The authors and Dr. Ananthakrishnan reported no conflicts of interest.

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Temper tantrums, bullying colleagues: How to avert physician misbehavior?

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Daniel Freedman, DO, a pediatric neurologist in Austin, Tex., remembers being flabbergasted when a surgeon threw an instrument across the room in medical school.

“I remember thinking, ‘I can’t believe people actually do this, a grown man in his 50s having a temper tantrum,’” Dr. Freedman said in an interview. But it certainly wasn’t the last time he witnessed bad behavior by one of his peers.

The results of Medscape’s recent report, Physicians Behaving Badly: Stress and Hardship Trigger Misconduct, suggest he has plenty of company. More than 4 in 10 respondents (41%) observed inappropriate behavior in the workplace in 2022, an uptick from 35% in 2021, according to the report, which polled more than 1,500 physicians about inappropriate behavior on and off the clock.

Of course, 38% of respondents have not seen any instances of misbehavior; and many of the instances that were seen were mild or infrequent. Additionally, instances of bad behavior have declined significantly over the past 5 years.

Dr. Freedman said he learned a lesson from his mentor and program director during training that has stuck with him throughout his career. “If you couldn’t act that way at any job, whether at McDonald’s or any other possible place, you shouldn’t act that way in medicine.” But he recognizes one limitation of that advice. “A lot of the people that behave badly may not have ever worked in a different environment before,” he said.

“They only perceive that they’re at the top of the food chain, so they can behave badly without repercussions.”

What Dr. Freedman described is formally called disruptive physician behavior, one of several categories of inappropriate behavior in medicine, according to Charles Samenow, MD, MPH, an associate professor of psychiatry and behavioral sciences at George Washington University, Washington, who has studied this phenomenon for years.

“Disruptive physician behavior compromises the safety of the workplace,” Dr. Samenow explained. The behavior can occur at work, outside of work, or on social media. It can hinder operations, threaten patient and staff safety, and affect workplace morale.

“The question is trying to understand where that bad behavior is coming from and the impact of that bad behavior,” Dr. Samenow said in an interview.

One reason is fairly simple: doctors are human, and humans have a wide range of behavior. Plus, as the Medscape survey showed, the tension, stress, dangerous conditions during COVID, burnout, and other problems have made many physicians tired, frustrated, depressed, and more reactive to situations around them.
 

Self-selecting traits become an Achilles heel

“Any human put in a position of power over other humans has the potential to be disruptive, harass, etc, if they have certain personality traits,” said David Gorski, MD, a professor of surgery at Wayne State University, Detroit. That jibes with Dr. Samenow’s research.

Classic disruptive behavior isn’t usually associated with depression, mania, psychosis, or similar characteristics, Dr. Samenow explained. Rather, it tends to be personality driven. “Physicians are not immune to the normal problems every human being faces,” he said.

In the Medscape report, physicians cited personal arrogance as one of the leading reasons physicians engaged in inappropriate behavior (56%), followed closely by personal problems outside of work (52%), a social shift in accepting more casual behavior (50%), and job-related stress (46%). (Respondents could choose more than one answer).

One factor contributing to misbehavior that Dr. Samenow has consistently identified in his research is a history of adverse childhood experiences or family dysfunction: People who grew up in homes with physical or verbal abuse learned anger as a coping skill instead of positive, assertive communication. It’s likely that some physicians, as well as the overall population, learned anger as a coping skill for that reason.
 

 

 

How to help avert disruptive behavior in medical settings

Dr. Samenow said that coaching is a “wonderful tool” in teaching the interpersonal skills that medical school often doesn’t address.

In some case, interventions can be very helpful. For example, programs that teach effective communication strategies and teamwork through a combination of culturally sensitive dialectical and cognitive-behavioral therapy and other modalities have been successful, Dr. Samenow said. Although they are more about treating an illness than addressing “misbehavior,” programs for substance use that have been developed by and for doctors are very effective, too.

Fewer resources are available, however, for addressing racism, classism, misogyny, and other forms of bigotry, Dr. Samenow noted. “There’s implicit bias training, but not at the level of what exists for disruptive physicians and those with addiction. “That’s an area we need to work on.” Racist language was the third most commonly observed bad behavior cited in the Medscape survey, behind only bullying of staff and mocking or disparaging of patients. It was reported frequently outside of work as well.

The Medscape report found an increase in observed behavior at work and on social media, although it’s hard to determine prevalence trends over time, Dr. Samenow said. “The tolerance for this behavior has really gone down,” likely leading to more reporting, he said, and more systems for reporting bad behavior exist today than in the past.

However, Dr. Freedman said inadequate regulation, disciplinary action, and follow-through remain a problem.

“There are lots of limitations to our reporting system and to our follow-through with those reports,” including hospitals that, whether for fear of litigation or other reasons, allow physicians to quietly resign and move to another institution, even with positive recommendations, Dr. Freedman said.

Indeed, only a third of observed misbehavior in the Medscape report resulted in disciplinary action. Half the respondents believed a verbal warning was a necessary consequence, followed by a conversation from management and being reported to a supervisor or human resources. Though only 10% thought a report to the medical board was warranted, it likely depends on the offense and its frequency.

“I think going from paternalism to more patient-centered care and having patients involved in those conversations is a nice shift that makes doctors more human and relatable, and hopefully makes the public more forgiving, that we’re going to make mistakes and nobody’s perfect,” Freedman said. But he added that physicians should be held accountable when a mistake or two becomes a pattern.
 

Misinformation is professional misconduct

Sufficient accountability is especially absent, these doctors said, for a subset of professional misconduct: spreading misinformation.

While more “conventional” bad behaviors include fraud, dishonesty, abuse of underlings, and incompetence, bad behavior should also include “selling quackery and antivaccine misinformation, the way some doctors did with various nostrums for COVID-19,” said Dr. Gorski, who frequently blogs about doctors’ spreading misinformation.

Taylor Nichols, MD, an emergency medicine physician based in Sacramento, cites the desire for attention and clout as motivations. “Saying things that are wildly, provably false is professional misconduct,” Nichols said. He distinguished such statements from scientific, academic, or clinical disagreement that is necessary within medicine.

Yet there’s been a “long tradition of looking the other way or letting people with fancy titles get away with saying nonsense just because they’re respected,” Jonathan Howard, MD, an associate professor of psychiatry and neurology at New York University said in an interview.

“We have a duty to be trusted members of the community,” Dr. Howard said. “People listen when we say things, and we have an obligation to try to be accurate and humble and as honest as possible and admit mistakes when we inevitably make them.”

That extends to social media, which Dr. Nichols said has magnified the problem of promoting quackery and misinformation. He thinks medical boards and professional credentialing bodies should pay attention to what’s happening in the public conversation and understand that our professional responsibility extends beyond the walls of the hospital or clinic. Physicians must represent themselves professionally and uphold the standards that the profession expects.

On the one hand, Medscape respondents agreed: 70% said one doctor’s misbehavior taints the whole profession. Yet, at the same time, 58% of respondents believed physicians should be able to “keep their private lives private” in 2022. But that’s not the reality of the profession when the lines between private life and behavior away from work get blurred, Dr. Samenow said.

“The way a physician behaves in public represents you,” he said. “What happens in Vegas doesn’t always stay in Vegas.”

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

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Daniel Freedman, DO, a pediatric neurologist in Austin, Tex., remembers being flabbergasted when a surgeon threw an instrument across the room in medical school.

“I remember thinking, ‘I can’t believe people actually do this, a grown man in his 50s having a temper tantrum,’” Dr. Freedman said in an interview. But it certainly wasn’t the last time he witnessed bad behavior by one of his peers.

The results of Medscape’s recent report, Physicians Behaving Badly: Stress and Hardship Trigger Misconduct, suggest he has plenty of company. More than 4 in 10 respondents (41%) observed inappropriate behavior in the workplace in 2022, an uptick from 35% in 2021, according to the report, which polled more than 1,500 physicians about inappropriate behavior on and off the clock.

Of course, 38% of respondents have not seen any instances of misbehavior; and many of the instances that were seen were mild or infrequent. Additionally, instances of bad behavior have declined significantly over the past 5 years.

Dr. Freedman said he learned a lesson from his mentor and program director during training that has stuck with him throughout his career. “If you couldn’t act that way at any job, whether at McDonald’s or any other possible place, you shouldn’t act that way in medicine.” But he recognizes one limitation of that advice. “A lot of the people that behave badly may not have ever worked in a different environment before,” he said.

“They only perceive that they’re at the top of the food chain, so they can behave badly without repercussions.”

What Dr. Freedman described is formally called disruptive physician behavior, one of several categories of inappropriate behavior in medicine, according to Charles Samenow, MD, MPH, an associate professor of psychiatry and behavioral sciences at George Washington University, Washington, who has studied this phenomenon for years.

“Disruptive physician behavior compromises the safety of the workplace,” Dr. Samenow explained. The behavior can occur at work, outside of work, or on social media. It can hinder operations, threaten patient and staff safety, and affect workplace morale.

“The question is trying to understand where that bad behavior is coming from and the impact of that bad behavior,” Dr. Samenow said in an interview.

One reason is fairly simple: doctors are human, and humans have a wide range of behavior. Plus, as the Medscape survey showed, the tension, stress, dangerous conditions during COVID, burnout, and other problems have made many physicians tired, frustrated, depressed, and more reactive to situations around them.
 

Self-selecting traits become an Achilles heel

“Any human put in a position of power over other humans has the potential to be disruptive, harass, etc, if they have certain personality traits,” said David Gorski, MD, a professor of surgery at Wayne State University, Detroit. That jibes with Dr. Samenow’s research.

Classic disruptive behavior isn’t usually associated with depression, mania, psychosis, or similar characteristics, Dr. Samenow explained. Rather, it tends to be personality driven. “Physicians are not immune to the normal problems every human being faces,” he said.

In the Medscape report, physicians cited personal arrogance as one of the leading reasons physicians engaged in inappropriate behavior (56%), followed closely by personal problems outside of work (52%), a social shift in accepting more casual behavior (50%), and job-related stress (46%). (Respondents could choose more than one answer).

One factor contributing to misbehavior that Dr. Samenow has consistently identified in his research is a history of adverse childhood experiences or family dysfunction: People who grew up in homes with physical or verbal abuse learned anger as a coping skill instead of positive, assertive communication. It’s likely that some physicians, as well as the overall population, learned anger as a coping skill for that reason.
 

 

 

How to help avert disruptive behavior in medical settings

Dr. Samenow said that coaching is a “wonderful tool” in teaching the interpersonal skills that medical school often doesn’t address.

In some case, interventions can be very helpful. For example, programs that teach effective communication strategies and teamwork through a combination of culturally sensitive dialectical and cognitive-behavioral therapy and other modalities have been successful, Dr. Samenow said. Although they are more about treating an illness than addressing “misbehavior,” programs for substance use that have been developed by and for doctors are very effective, too.

Fewer resources are available, however, for addressing racism, classism, misogyny, and other forms of bigotry, Dr. Samenow noted. “There’s implicit bias training, but not at the level of what exists for disruptive physicians and those with addiction. “That’s an area we need to work on.” Racist language was the third most commonly observed bad behavior cited in the Medscape survey, behind only bullying of staff and mocking or disparaging of patients. It was reported frequently outside of work as well.

The Medscape report found an increase in observed behavior at work and on social media, although it’s hard to determine prevalence trends over time, Dr. Samenow said. “The tolerance for this behavior has really gone down,” likely leading to more reporting, he said, and more systems for reporting bad behavior exist today than in the past.

However, Dr. Freedman said inadequate regulation, disciplinary action, and follow-through remain a problem.

“There are lots of limitations to our reporting system and to our follow-through with those reports,” including hospitals that, whether for fear of litigation or other reasons, allow physicians to quietly resign and move to another institution, even with positive recommendations, Dr. Freedman said.

Indeed, only a third of observed misbehavior in the Medscape report resulted in disciplinary action. Half the respondents believed a verbal warning was a necessary consequence, followed by a conversation from management and being reported to a supervisor or human resources. Though only 10% thought a report to the medical board was warranted, it likely depends on the offense and its frequency.

“I think going from paternalism to more patient-centered care and having patients involved in those conversations is a nice shift that makes doctors more human and relatable, and hopefully makes the public more forgiving, that we’re going to make mistakes and nobody’s perfect,” Freedman said. But he added that physicians should be held accountable when a mistake or two becomes a pattern.
 

Misinformation is professional misconduct

Sufficient accountability is especially absent, these doctors said, for a subset of professional misconduct: spreading misinformation.

While more “conventional” bad behaviors include fraud, dishonesty, abuse of underlings, and incompetence, bad behavior should also include “selling quackery and antivaccine misinformation, the way some doctors did with various nostrums for COVID-19,” said Dr. Gorski, who frequently blogs about doctors’ spreading misinformation.

Taylor Nichols, MD, an emergency medicine physician based in Sacramento, cites the desire for attention and clout as motivations. “Saying things that are wildly, provably false is professional misconduct,” Nichols said. He distinguished such statements from scientific, academic, or clinical disagreement that is necessary within medicine.

Yet there’s been a “long tradition of looking the other way or letting people with fancy titles get away with saying nonsense just because they’re respected,” Jonathan Howard, MD, an associate professor of psychiatry and neurology at New York University said in an interview.

“We have a duty to be trusted members of the community,” Dr. Howard said. “People listen when we say things, and we have an obligation to try to be accurate and humble and as honest as possible and admit mistakes when we inevitably make them.”

That extends to social media, which Dr. Nichols said has magnified the problem of promoting quackery and misinformation. He thinks medical boards and professional credentialing bodies should pay attention to what’s happening in the public conversation and understand that our professional responsibility extends beyond the walls of the hospital or clinic. Physicians must represent themselves professionally and uphold the standards that the profession expects.

On the one hand, Medscape respondents agreed: 70% said one doctor’s misbehavior taints the whole profession. Yet, at the same time, 58% of respondents believed physicians should be able to “keep their private lives private” in 2022. But that’s not the reality of the profession when the lines between private life and behavior away from work get blurred, Dr. Samenow said.

“The way a physician behaves in public represents you,” he said. “What happens in Vegas doesn’t always stay in Vegas.”

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

Daniel Freedman, DO, a pediatric neurologist in Austin, Tex., remembers being flabbergasted when a surgeon threw an instrument across the room in medical school.

“I remember thinking, ‘I can’t believe people actually do this, a grown man in his 50s having a temper tantrum,’” Dr. Freedman said in an interview. But it certainly wasn’t the last time he witnessed bad behavior by one of his peers.

The results of Medscape’s recent report, Physicians Behaving Badly: Stress and Hardship Trigger Misconduct, suggest he has plenty of company. More than 4 in 10 respondents (41%) observed inappropriate behavior in the workplace in 2022, an uptick from 35% in 2021, according to the report, which polled more than 1,500 physicians about inappropriate behavior on and off the clock.

Of course, 38% of respondents have not seen any instances of misbehavior; and many of the instances that were seen were mild or infrequent. Additionally, instances of bad behavior have declined significantly over the past 5 years.

Dr. Freedman said he learned a lesson from his mentor and program director during training that has stuck with him throughout his career. “If you couldn’t act that way at any job, whether at McDonald’s or any other possible place, you shouldn’t act that way in medicine.” But he recognizes one limitation of that advice. “A lot of the people that behave badly may not have ever worked in a different environment before,” he said.

“They only perceive that they’re at the top of the food chain, so they can behave badly without repercussions.”

What Dr. Freedman described is formally called disruptive physician behavior, one of several categories of inappropriate behavior in medicine, according to Charles Samenow, MD, MPH, an associate professor of psychiatry and behavioral sciences at George Washington University, Washington, who has studied this phenomenon for years.

“Disruptive physician behavior compromises the safety of the workplace,” Dr. Samenow explained. The behavior can occur at work, outside of work, or on social media. It can hinder operations, threaten patient and staff safety, and affect workplace morale.

“The question is trying to understand where that bad behavior is coming from and the impact of that bad behavior,” Dr. Samenow said in an interview.

One reason is fairly simple: doctors are human, and humans have a wide range of behavior. Plus, as the Medscape survey showed, the tension, stress, dangerous conditions during COVID, burnout, and other problems have made many physicians tired, frustrated, depressed, and more reactive to situations around them.
 

Self-selecting traits become an Achilles heel

“Any human put in a position of power over other humans has the potential to be disruptive, harass, etc, if they have certain personality traits,” said David Gorski, MD, a professor of surgery at Wayne State University, Detroit. That jibes with Dr. Samenow’s research.

Classic disruptive behavior isn’t usually associated with depression, mania, psychosis, or similar characteristics, Dr. Samenow explained. Rather, it tends to be personality driven. “Physicians are not immune to the normal problems every human being faces,” he said.

In the Medscape report, physicians cited personal arrogance as one of the leading reasons physicians engaged in inappropriate behavior (56%), followed closely by personal problems outside of work (52%), a social shift in accepting more casual behavior (50%), and job-related stress (46%). (Respondents could choose more than one answer).

One factor contributing to misbehavior that Dr. Samenow has consistently identified in his research is a history of adverse childhood experiences or family dysfunction: People who grew up in homes with physical or verbal abuse learned anger as a coping skill instead of positive, assertive communication. It’s likely that some physicians, as well as the overall population, learned anger as a coping skill for that reason.
 

 

 

How to help avert disruptive behavior in medical settings

Dr. Samenow said that coaching is a “wonderful tool” in teaching the interpersonal skills that medical school often doesn’t address.

In some case, interventions can be very helpful. For example, programs that teach effective communication strategies and teamwork through a combination of culturally sensitive dialectical and cognitive-behavioral therapy and other modalities have been successful, Dr. Samenow said. Although they are more about treating an illness than addressing “misbehavior,” programs for substance use that have been developed by and for doctors are very effective, too.

Fewer resources are available, however, for addressing racism, classism, misogyny, and other forms of bigotry, Dr. Samenow noted. “There’s implicit bias training, but not at the level of what exists for disruptive physicians and those with addiction. “That’s an area we need to work on.” Racist language was the third most commonly observed bad behavior cited in the Medscape survey, behind only bullying of staff and mocking or disparaging of patients. It was reported frequently outside of work as well.

The Medscape report found an increase in observed behavior at work and on social media, although it’s hard to determine prevalence trends over time, Dr. Samenow said. “The tolerance for this behavior has really gone down,” likely leading to more reporting, he said, and more systems for reporting bad behavior exist today than in the past.

However, Dr. Freedman said inadequate regulation, disciplinary action, and follow-through remain a problem.

“There are lots of limitations to our reporting system and to our follow-through with those reports,” including hospitals that, whether for fear of litigation or other reasons, allow physicians to quietly resign and move to another institution, even with positive recommendations, Dr. Freedman said.

Indeed, only a third of observed misbehavior in the Medscape report resulted in disciplinary action. Half the respondents believed a verbal warning was a necessary consequence, followed by a conversation from management and being reported to a supervisor or human resources. Though only 10% thought a report to the medical board was warranted, it likely depends on the offense and its frequency.

“I think going from paternalism to more patient-centered care and having patients involved in those conversations is a nice shift that makes doctors more human and relatable, and hopefully makes the public more forgiving, that we’re going to make mistakes and nobody’s perfect,” Freedman said. But he added that physicians should be held accountable when a mistake or two becomes a pattern.
 

Misinformation is professional misconduct

Sufficient accountability is especially absent, these doctors said, for a subset of professional misconduct: spreading misinformation.

While more “conventional” bad behaviors include fraud, dishonesty, abuse of underlings, and incompetence, bad behavior should also include “selling quackery and antivaccine misinformation, the way some doctors did with various nostrums for COVID-19,” said Dr. Gorski, who frequently blogs about doctors’ spreading misinformation.

Taylor Nichols, MD, an emergency medicine physician based in Sacramento, cites the desire for attention and clout as motivations. “Saying things that are wildly, provably false is professional misconduct,” Nichols said. He distinguished such statements from scientific, academic, or clinical disagreement that is necessary within medicine.

Yet there’s been a “long tradition of looking the other way or letting people with fancy titles get away with saying nonsense just because they’re respected,” Jonathan Howard, MD, an associate professor of psychiatry and neurology at New York University said in an interview.

“We have a duty to be trusted members of the community,” Dr. Howard said. “People listen when we say things, and we have an obligation to try to be accurate and humble and as honest as possible and admit mistakes when we inevitably make them.”

That extends to social media, which Dr. Nichols said has magnified the problem of promoting quackery and misinformation. He thinks medical boards and professional credentialing bodies should pay attention to what’s happening in the public conversation and understand that our professional responsibility extends beyond the walls of the hospital or clinic. Physicians must represent themselves professionally and uphold the standards that the profession expects.

On the one hand, Medscape respondents agreed: 70% said one doctor’s misbehavior taints the whole profession. Yet, at the same time, 58% of respondents believed physicians should be able to “keep their private lives private” in 2022. But that’s not the reality of the profession when the lines between private life and behavior away from work get blurred, Dr. Samenow said.

“The way a physician behaves in public represents you,” he said. “What happens in Vegas doesn’t always stay in Vegas.”

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

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Breakthrough COVID studies lend support to use of new boosters in immunosuppressed patients

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Wed, 10/05/2022 - 11:35

People with immune-mediated inflammatory diseases who are taking immunosuppressants don’t mount as strong of an immune defense against the Omicron variant as they did against the original SARS-CoV-2 wild-type virus, according to two studies published in Annals of the Rheumatic Diseases. One of the studies further showed that vaccinated individuals taking immunosuppressants have poorer cross-neutralizing responses to Omicron than do healthy vaccinated individuals, even after three doses of the COVID-19 mRNA vaccines.

filadendron/E+/Getty Images

“We carefully suggest that if Omicron-specific vaccination can be administered, it may be an effective way to reduce the risk of breakthrough infections in patients with autoimmune rheumatic disease,” Sang Tae Choi, MD, PhD, of the University College of Medicine, Seoul, Korea, and one of the authors of the study on cross-neutralizing protection, told this news organization. “However, further research is needed on Omicron-specific vaccine effectiveness in patients with immune dysfunctions. We believe that these study results can be of great benefit in determining the strategy of vaccination in the future.”

The earlier study, published in July, examined the ability of COVID-19 vaccines to induce cross-reactive antibody responses against Omicron infections in patients with autoimmune rheumatic diseases (ARDs). The observational study involved 149 patients with ARDs and 94 health care workers as controls, all of whom provided blood samples a median 15 weeks after their second COVID vaccine dose or a median 8 weeks after their third dose. A little more than two-thirds of the patients (68.5%) had received a third mRNA vaccine dose. None of the participants previously had COVID-19.

The researchers compared the rate of breakthrough infections with the Omicron variant to the neutralizing responses in patients’ blood, specifically the cross-neutralizing antibody responses because the original mRNA vaccines targeted a different variant than Omicron. Breakthrough infections were assessed by survey questions.

“Our findings suggested that neither primary series vaccinations nor booster doses are sufficient to induce Omicron-neutralizing responses above the threshold in patients with ARDs, although responses were noticeably increased following the third dose of an mRNA vaccine,” write Woo-Joong Kim, of the Chung-Ang University College of Medicine, Seoul, Korea, and his colleagues. “This impairment of cross-neutralization responses across most of our patients contrasts starkly with a potent elicitation of the Omicron-neutralizing responses after the third vaccination in healthy recipients.”

The average neutralizing responses against the original SARS-CoV-2 strain were similar in both groups: 76% in patients with ARDs and 72% in health care workers after the second dose. The mean response after a third dose was 97% in health care workers and 88% in patients.

The average cross-neutralizing response against the Omicron variant was far lower, particularly in those with rheumatic disease: only 11.5%, which rose to 27% after the third dose. Only 39% of the patient sera showed neutralization of Omicron, even after the third dose. Meanwhile, the mean cross-neutralizing response in health care workers was 18% after the second dose and 50% after the third.

When the researchers compared seropositivity rates against the original virus to neutralizing responses against Omicron, the association between these was stronger in health care workers than in those with ARDs. In fact, among patients with ARDs who seroconverted, only 41% showed any response against Omicron. Among all the patients, most of those who didn’t respond to Omicron (93.5%) had initially seroconverted.



The researchers also looked at the ability to neutralize Omicron on the basis of disease in those who received three doses of the vaccine. About half of those with lupus (52%) showed any neutralization against Omicron, compared with 25% of those with rheumatoid arthritis, 37.5% of those with ankylosing spondylitis, 33% of those with Behçet snydrome, and all of those with adult-onset Still’s disease.

The rate of breakthrough infections was lower in patients (19%) than in health care workers (33%). A similar pattern was seen in the more recent study published Sept. 5. Researchers used data from a prospective cohort study in the Netherlands to examine incidence and severity of Omicron breakthrough infections in patients with immune-mediated inflammatory diseases. The researchers compared infection rates and severity among 1,593 vaccinated patients with inflammatory disease who were taking immunosuppressants and 579 vaccinated controls (418 patients with inflammatory disease not on immunosuppressants and 161 healthy controls).

One in five patients with inflammatory disease (21%) were taking immunosuppressants that substantially impair antibodies, such as anti-CD20 therapy, S1P modulators, or mycophenolate mofetil combination therapy, and 48% of these patients seroconverted after primary vaccination, compared with 96% of patients taking other immunosuppressants and 98% of controls.

Breakthrough infection rates were similar between the control group (31%) and those taking immunosuppressants (30%). Only three participants had severe disease requiring hospitalization: one control and two patients taking immunosuppressants.

“In both studies, the controls had similar or higher rates of breakthrough infections, compared with the immunosuppressed,” noted Alfred Kim, MD, an assistant professor of medicine at Washington University, St Louis, but he added, “one has to consider differences in mitigation strategies, such as masking, that may explain these findings.” That is, patients taking immunosuppressants may be taking fewer risks in the community or have fewer potential exposures, especially in the Korean study, wherein the controls were health care workers.

A greater disparity in infections occurred when considering seroconversion rates. Breakthrough incidence was 38% among those taking immunosuppressants who did not seroconvert, compared with 29% among those who did. A similar trend was seen in breakthrough incidence between those taking strongly antibody-impairing immunosuppressants (36% breakthrough rate) and those taking other immunosuppressants (28%).

Dr. Alfred Kim


Among those taking immunosuppressants who seroconverted, a primary series of vaccination reduced the risk of a breakthrough infection by 29%. Protection became more robust with a booster or prior infection, both of which reduced breakthrough infection risk by 39% in those taking immunosuppressants who seroconverted.

“We demonstrate in patients with immune-mediated inflammatory diseases on immunosuppressants that additional vaccinations are associated with decreased risk of SARS-CoV-2 Omicron breakthrough infections,” wrote Eileen W. Stalman, MD, PhD, of Amsterdam UMC in the Netherlands, and her colleagues.

Though neither study broke down immune response or breakthrough infection based on individual medications, Kim said that previous research allows one to extrapolate “that prior culprits of poor vaccine responses [such as B-cell depleting drugs, mycophenolate, and TNF [tumor necrosis factor] inhibitors will continue to bear the greatest burden in breakthrough infection, including Omicron.”

Overall, he found the data from both studies relatively consistent with one another.

“Those on immunosuppression, particularly mechanisms that have been established as risk factors for poor vaccine responses, are at risk of breakthrough infection during the era of Omicron,” Dr. Kim said.

The earlier study from Korea also found that “the median time between the third-dose vaccination and the date of confirmed breakthrough infection in patients with ARDs was significantly shorter, compared with that in health care workers” at just 93 days in patients versus 122 days in health care workers. They postulated that this population’s limited neutralization of Omicron explained this short-lived protection.

Most of the patients with breakthrough infections (74%) in that study showed no neutralization against Omicron, including the only two hospitalized patients, both of whom had strong responses against the original SARS-CoV-2 strain. The significant decline over time of neutralization against Omicron suggested “the potential for a substantial loss of the protection from breakthrough infection,” the authors write.

“The third dose of an mRNA vaccine could improve the cross-neutralization of the SARS-CoV-2 Omicron variant in patients with autoimmune rheumatic disease [although] more than half of the patients failed to generate Omicron-neutralizing antibodies,” Tae Choi said in an interview. “Our study sheds light on the relative deficiency of the Omicron-specific neutralizing responses in patients with autoimmune rheumatic disease and their anticipated vulnerability to breakthrough infection.”

The message for clinicians, Dr. Kim said, is to “continue to urge our patients to maintain additional and boosting doses per guidance, use pre-exposure prophylaxis such as Evusheld, and continue other mitigation strategies as they have done.”

The Dutch study was funded by The Netherlands Organization for Health Research and Development; the Korean study used no external funding.

The authors of the Korean study had no disclosures. The Dutch study’s authors reported a wide range of disclosures involving more than a dozen pharmaceutical companies but not including Pfizer or Moderna. Dr. Kim’s industry disclosures include Alexion, ANI, AstraZeneca, Aurinia, Exagen, Foghorn Therapeutics, GlaxoSmithKline, Kypha, and Pfizer.

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

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People with immune-mediated inflammatory diseases who are taking immunosuppressants don’t mount as strong of an immune defense against the Omicron variant as they did against the original SARS-CoV-2 wild-type virus, according to two studies published in Annals of the Rheumatic Diseases. One of the studies further showed that vaccinated individuals taking immunosuppressants have poorer cross-neutralizing responses to Omicron than do healthy vaccinated individuals, even after three doses of the COVID-19 mRNA vaccines.

filadendron/E+/Getty Images

“We carefully suggest that if Omicron-specific vaccination can be administered, it may be an effective way to reduce the risk of breakthrough infections in patients with autoimmune rheumatic disease,” Sang Tae Choi, MD, PhD, of the University College of Medicine, Seoul, Korea, and one of the authors of the study on cross-neutralizing protection, told this news organization. “However, further research is needed on Omicron-specific vaccine effectiveness in patients with immune dysfunctions. We believe that these study results can be of great benefit in determining the strategy of vaccination in the future.”

The earlier study, published in July, examined the ability of COVID-19 vaccines to induce cross-reactive antibody responses against Omicron infections in patients with autoimmune rheumatic diseases (ARDs). The observational study involved 149 patients with ARDs and 94 health care workers as controls, all of whom provided blood samples a median 15 weeks after their second COVID vaccine dose or a median 8 weeks after their third dose. A little more than two-thirds of the patients (68.5%) had received a third mRNA vaccine dose. None of the participants previously had COVID-19.

The researchers compared the rate of breakthrough infections with the Omicron variant to the neutralizing responses in patients’ blood, specifically the cross-neutralizing antibody responses because the original mRNA vaccines targeted a different variant than Omicron. Breakthrough infections were assessed by survey questions.

“Our findings suggested that neither primary series vaccinations nor booster doses are sufficient to induce Omicron-neutralizing responses above the threshold in patients with ARDs, although responses were noticeably increased following the third dose of an mRNA vaccine,” write Woo-Joong Kim, of the Chung-Ang University College of Medicine, Seoul, Korea, and his colleagues. “This impairment of cross-neutralization responses across most of our patients contrasts starkly with a potent elicitation of the Omicron-neutralizing responses after the third vaccination in healthy recipients.”

The average neutralizing responses against the original SARS-CoV-2 strain were similar in both groups: 76% in patients with ARDs and 72% in health care workers after the second dose. The mean response after a third dose was 97% in health care workers and 88% in patients.

The average cross-neutralizing response against the Omicron variant was far lower, particularly in those with rheumatic disease: only 11.5%, which rose to 27% after the third dose. Only 39% of the patient sera showed neutralization of Omicron, even after the third dose. Meanwhile, the mean cross-neutralizing response in health care workers was 18% after the second dose and 50% after the third.

When the researchers compared seropositivity rates against the original virus to neutralizing responses against Omicron, the association between these was stronger in health care workers than in those with ARDs. In fact, among patients with ARDs who seroconverted, only 41% showed any response against Omicron. Among all the patients, most of those who didn’t respond to Omicron (93.5%) had initially seroconverted.



The researchers also looked at the ability to neutralize Omicron on the basis of disease in those who received three doses of the vaccine. About half of those with lupus (52%) showed any neutralization against Omicron, compared with 25% of those with rheumatoid arthritis, 37.5% of those with ankylosing spondylitis, 33% of those with Behçet snydrome, and all of those with adult-onset Still’s disease.

The rate of breakthrough infections was lower in patients (19%) than in health care workers (33%). A similar pattern was seen in the more recent study published Sept. 5. Researchers used data from a prospective cohort study in the Netherlands to examine incidence and severity of Omicron breakthrough infections in patients with immune-mediated inflammatory diseases. The researchers compared infection rates and severity among 1,593 vaccinated patients with inflammatory disease who were taking immunosuppressants and 579 vaccinated controls (418 patients with inflammatory disease not on immunosuppressants and 161 healthy controls).

One in five patients with inflammatory disease (21%) were taking immunosuppressants that substantially impair antibodies, such as anti-CD20 therapy, S1P modulators, or mycophenolate mofetil combination therapy, and 48% of these patients seroconverted after primary vaccination, compared with 96% of patients taking other immunosuppressants and 98% of controls.

Breakthrough infection rates were similar between the control group (31%) and those taking immunosuppressants (30%). Only three participants had severe disease requiring hospitalization: one control and two patients taking immunosuppressants.

“In both studies, the controls had similar or higher rates of breakthrough infections, compared with the immunosuppressed,” noted Alfred Kim, MD, an assistant professor of medicine at Washington University, St Louis, but he added, “one has to consider differences in mitigation strategies, such as masking, that may explain these findings.” That is, patients taking immunosuppressants may be taking fewer risks in the community or have fewer potential exposures, especially in the Korean study, wherein the controls were health care workers.

A greater disparity in infections occurred when considering seroconversion rates. Breakthrough incidence was 38% among those taking immunosuppressants who did not seroconvert, compared with 29% among those who did. A similar trend was seen in breakthrough incidence between those taking strongly antibody-impairing immunosuppressants (36% breakthrough rate) and those taking other immunosuppressants (28%).

Dr. Alfred Kim


Among those taking immunosuppressants who seroconverted, a primary series of vaccination reduced the risk of a breakthrough infection by 29%. Protection became more robust with a booster or prior infection, both of which reduced breakthrough infection risk by 39% in those taking immunosuppressants who seroconverted.

“We demonstrate in patients with immune-mediated inflammatory diseases on immunosuppressants that additional vaccinations are associated with decreased risk of SARS-CoV-2 Omicron breakthrough infections,” wrote Eileen W. Stalman, MD, PhD, of Amsterdam UMC in the Netherlands, and her colleagues.

Though neither study broke down immune response or breakthrough infection based on individual medications, Kim said that previous research allows one to extrapolate “that prior culprits of poor vaccine responses [such as B-cell depleting drugs, mycophenolate, and TNF [tumor necrosis factor] inhibitors will continue to bear the greatest burden in breakthrough infection, including Omicron.”

Overall, he found the data from both studies relatively consistent with one another.

“Those on immunosuppression, particularly mechanisms that have been established as risk factors for poor vaccine responses, are at risk of breakthrough infection during the era of Omicron,” Dr. Kim said.

The earlier study from Korea also found that “the median time between the third-dose vaccination and the date of confirmed breakthrough infection in patients with ARDs was significantly shorter, compared with that in health care workers” at just 93 days in patients versus 122 days in health care workers. They postulated that this population’s limited neutralization of Omicron explained this short-lived protection.

Most of the patients with breakthrough infections (74%) in that study showed no neutralization against Omicron, including the only two hospitalized patients, both of whom had strong responses against the original SARS-CoV-2 strain. The significant decline over time of neutralization against Omicron suggested “the potential for a substantial loss of the protection from breakthrough infection,” the authors write.

“The third dose of an mRNA vaccine could improve the cross-neutralization of the SARS-CoV-2 Omicron variant in patients with autoimmune rheumatic disease [although] more than half of the patients failed to generate Omicron-neutralizing antibodies,” Tae Choi said in an interview. “Our study sheds light on the relative deficiency of the Omicron-specific neutralizing responses in patients with autoimmune rheumatic disease and their anticipated vulnerability to breakthrough infection.”

The message for clinicians, Dr. Kim said, is to “continue to urge our patients to maintain additional and boosting doses per guidance, use pre-exposure prophylaxis such as Evusheld, and continue other mitigation strategies as they have done.”

The Dutch study was funded by The Netherlands Organization for Health Research and Development; the Korean study used no external funding.

The authors of the Korean study had no disclosures. The Dutch study’s authors reported a wide range of disclosures involving more than a dozen pharmaceutical companies but not including Pfizer or Moderna. Dr. Kim’s industry disclosures include Alexion, ANI, AstraZeneca, Aurinia, Exagen, Foghorn Therapeutics, GlaxoSmithKline, Kypha, and Pfizer.

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

People with immune-mediated inflammatory diseases who are taking immunosuppressants don’t mount as strong of an immune defense against the Omicron variant as they did against the original SARS-CoV-2 wild-type virus, according to two studies published in Annals of the Rheumatic Diseases. One of the studies further showed that vaccinated individuals taking immunosuppressants have poorer cross-neutralizing responses to Omicron than do healthy vaccinated individuals, even after three doses of the COVID-19 mRNA vaccines.

filadendron/E+/Getty Images

“We carefully suggest that if Omicron-specific vaccination can be administered, it may be an effective way to reduce the risk of breakthrough infections in patients with autoimmune rheumatic disease,” Sang Tae Choi, MD, PhD, of the University College of Medicine, Seoul, Korea, and one of the authors of the study on cross-neutralizing protection, told this news organization. “However, further research is needed on Omicron-specific vaccine effectiveness in patients with immune dysfunctions. We believe that these study results can be of great benefit in determining the strategy of vaccination in the future.”

The earlier study, published in July, examined the ability of COVID-19 vaccines to induce cross-reactive antibody responses against Omicron infections in patients with autoimmune rheumatic diseases (ARDs). The observational study involved 149 patients with ARDs and 94 health care workers as controls, all of whom provided blood samples a median 15 weeks after their second COVID vaccine dose or a median 8 weeks after their third dose. A little more than two-thirds of the patients (68.5%) had received a third mRNA vaccine dose. None of the participants previously had COVID-19.

The researchers compared the rate of breakthrough infections with the Omicron variant to the neutralizing responses in patients’ blood, specifically the cross-neutralizing antibody responses because the original mRNA vaccines targeted a different variant than Omicron. Breakthrough infections were assessed by survey questions.

“Our findings suggested that neither primary series vaccinations nor booster doses are sufficient to induce Omicron-neutralizing responses above the threshold in patients with ARDs, although responses were noticeably increased following the third dose of an mRNA vaccine,” write Woo-Joong Kim, of the Chung-Ang University College of Medicine, Seoul, Korea, and his colleagues. “This impairment of cross-neutralization responses across most of our patients contrasts starkly with a potent elicitation of the Omicron-neutralizing responses after the third vaccination in healthy recipients.”

The average neutralizing responses against the original SARS-CoV-2 strain were similar in both groups: 76% in patients with ARDs and 72% in health care workers after the second dose. The mean response after a third dose was 97% in health care workers and 88% in patients.

The average cross-neutralizing response against the Omicron variant was far lower, particularly in those with rheumatic disease: only 11.5%, which rose to 27% after the third dose. Only 39% of the patient sera showed neutralization of Omicron, even after the third dose. Meanwhile, the mean cross-neutralizing response in health care workers was 18% after the second dose and 50% after the third.

When the researchers compared seropositivity rates against the original virus to neutralizing responses against Omicron, the association between these was stronger in health care workers than in those with ARDs. In fact, among patients with ARDs who seroconverted, only 41% showed any response against Omicron. Among all the patients, most of those who didn’t respond to Omicron (93.5%) had initially seroconverted.



The researchers also looked at the ability to neutralize Omicron on the basis of disease in those who received three doses of the vaccine. About half of those with lupus (52%) showed any neutralization against Omicron, compared with 25% of those with rheumatoid arthritis, 37.5% of those with ankylosing spondylitis, 33% of those with Behçet snydrome, and all of those with adult-onset Still’s disease.

The rate of breakthrough infections was lower in patients (19%) than in health care workers (33%). A similar pattern was seen in the more recent study published Sept. 5. Researchers used data from a prospective cohort study in the Netherlands to examine incidence and severity of Omicron breakthrough infections in patients with immune-mediated inflammatory diseases. The researchers compared infection rates and severity among 1,593 vaccinated patients with inflammatory disease who were taking immunosuppressants and 579 vaccinated controls (418 patients with inflammatory disease not on immunosuppressants and 161 healthy controls).

One in five patients with inflammatory disease (21%) were taking immunosuppressants that substantially impair antibodies, such as anti-CD20 therapy, S1P modulators, or mycophenolate mofetil combination therapy, and 48% of these patients seroconverted after primary vaccination, compared with 96% of patients taking other immunosuppressants and 98% of controls.

Breakthrough infection rates were similar between the control group (31%) and those taking immunosuppressants (30%). Only three participants had severe disease requiring hospitalization: one control and two patients taking immunosuppressants.

“In both studies, the controls had similar or higher rates of breakthrough infections, compared with the immunosuppressed,” noted Alfred Kim, MD, an assistant professor of medicine at Washington University, St Louis, but he added, “one has to consider differences in mitigation strategies, such as masking, that may explain these findings.” That is, patients taking immunosuppressants may be taking fewer risks in the community or have fewer potential exposures, especially in the Korean study, wherein the controls were health care workers.

A greater disparity in infections occurred when considering seroconversion rates. Breakthrough incidence was 38% among those taking immunosuppressants who did not seroconvert, compared with 29% among those who did. A similar trend was seen in breakthrough incidence between those taking strongly antibody-impairing immunosuppressants (36% breakthrough rate) and those taking other immunosuppressants (28%).

Dr. Alfred Kim


Among those taking immunosuppressants who seroconverted, a primary series of vaccination reduced the risk of a breakthrough infection by 29%. Protection became more robust with a booster or prior infection, both of which reduced breakthrough infection risk by 39% in those taking immunosuppressants who seroconverted.

“We demonstrate in patients with immune-mediated inflammatory diseases on immunosuppressants that additional vaccinations are associated with decreased risk of SARS-CoV-2 Omicron breakthrough infections,” wrote Eileen W. Stalman, MD, PhD, of Amsterdam UMC in the Netherlands, and her colleagues.

Though neither study broke down immune response or breakthrough infection based on individual medications, Kim said that previous research allows one to extrapolate “that prior culprits of poor vaccine responses [such as B-cell depleting drugs, mycophenolate, and TNF [tumor necrosis factor] inhibitors will continue to bear the greatest burden in breakthrough infection, including Omicron.”

Overall, he found the data from both studies relatively consistent with one another.

“Those on immunosuppression, particularly mechanisms that have been established as risk factors for poor vaccine responses, are at risk of breakthrough infection during the era of Omicron,” Dr. Kim said.

The earlier study from Korea also found that “the median time between the third-dose vaccination and the date of confirmed breakthrough infection in patients with ARDs was significantly shorter, compared with that in health care workers” at just 93 days in patients versus 122 days in health care workers. They postulated that this population’s limited neutralization of Omicron explained this short-lived protection.

Most of the patients with breakthrough infections (74%) in that study showed no neutralization against Omicron, including the only two hospitalized patients, both of whom had strong responses against the original SARS-CoV-2 strain. The significant decline over time of neutralization against Omicron suggested “the potential for a substantial loss of the protection from breakthrough infection,” the authors write.

“The third dose of an mRNA vaccine could improve the cross-neutralization of the SARS-CoV-2 Omicron variant in patients with autoimmune rheumatic disease [although] more than half of the patients failed to generate Omicron-neutralizing antibodies,” Tae Choi said in an interview. “Our study sheds light on the relative deficiency of the Omicron-specific neutralizing responses in patients with autoimmune rheumatic disease and their anticipated vulnerability to breakthrough infection.”

The message for clinicians, Dr. Kim said, is to “continue to urge our patients to maintain additional and boosting doses per guidance, use pre-exposure prophylaxis such as Evusheld, and continue other mitigation strategies as they have done.”

The Dutch study was funded by The Netherlands Organization for Health Research and Development; the Korean study used no external funding.

The authors of the Korean study had no disclosures. The Dutch study’s authors reported a wide range of disclosures involving more than a dozen pharmaceutical companies but not including Pfizer or Moderna. Dr. Kim’s industry disclosures include Alexion, ANI, AstraZeneca, Aurinia, Exagen, Foghorn Therapeutics, GlaxoSmithKline, Kypha, and Pfizer.

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

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