It’s important for clinicians to ask women whether they are experiencing symptoms of genitourinary syndrome of menopause (GSM) before and after menopause, according to a new statement from the North American Menopause Society.

Stephanie Faubion, MD, MBA, medical director of NAMS, presented the updated statement at the virtual annual meeting of the North American Menopause Society.

“The one thing we tried to emphasize is proactive counseling and proactive inquiry, educating women when they hit perimenopause that this is a thing and that there are treatments,” Dr. Faubion said in an interview.

“I think women sometimes think there’s nothing they can do, which is not true. There’s the misperception that it’s just part of getting old, which it’s not,” said Dr. Faubion, who is also director of the Mayo Clinic Center for Women’s Health in Rochester, Minn., and chair of the department of medicine at the Mayo Clinic in Jacksonville, Fla.
 

Changes from previous statement

The GSM statement describes the symptoms and signs resulting from estrogen deficiency on the genitourinary tract, Dr. Faubion explained. The biggest change from the earlier version, published in 2013, is the condition’s new name. Formerly known as vulvovaginal atrophy, the condition’s new term was developed in 2014 and is now preferred by NAMS and the American College of Obstetricians and Gynecologists because it’s more comprehensive. Rather than just a physical description of the condition, GSM encompasses the many related symptoms and the urinary tract changes that occur, and it clearly associates the condition with menopause.

“Women don’t always associate these changes with menopause and don’t recognize that there’s something that can be done about it,” Dr. Faubion said. “We like to emphasize that sex should never be painful, but it’s not just about sex. It’s about comfort.”

Other changes include a review of evidence related to vaginal laser therapy for GSM and the availability of Imvexxy vaginal inserts with lower doses (4 mcg and 10 mpg) of estrogen.
 

Etiology and diagnosis of GSM

The presence of endogenous estrogen keeps the vaginal lining thick, rugated, well vascularized, and lubricated. As estrogen levels decline during postmenopause, the epithelial lining becomes thinner, with reduced blood supply and loss of glycogen.

The most common symptoms of GSM include irritation of the vulva, inadequate vaginal lubrication, burning, dysuria, dyspareunia, and vaginal discharge, but the symptoms may not always correlate with physical findings. In women with surgical menopause, the symptoms tend to be more severe. The most distressing symptoms to women are often those that affect sexual function.

“Clinicians must be proactive in asking menopausal women if GSM symptoms are present, even before menopause begins,” Dr. Faubion said.

Taking a women’s history during evaluation may help identify contributing factors, other causes, or potentially effective treatments based on what has worked in the past. History should include a description of symptoms, their onset and duration, how distressing they are, and their effect on the woman’s quality of life. A sexual history, such as lubricants the woman has used, can also be useful in determining management strategies.

Signs of GSM include labial atrophy, vaginal dryness, introital stenosis, clitoral atrophy, phimosis of the prepuce, reduced mons pubis and labia majora bulk, reduced labia minora tissue and pigmentation, and changes in the urethra, including erythema of the urethral meatus and commonly a urethral caruncle, a benign outgrown of inflammatory tissue that likely results from low estrogen levels and can be treated effectively with topical hormonal therapies.

A diagnosis of GSM requires both physical findings and bothersome symptoms, though not necessarily specific vaginal maturation index or vaginal pH values. The differential diagnosis speaks to the importance of taking a good history: allergic or inflammatory conditions, infection, trauma, presence of a foreign body, malignancy, vulvodynia, chronic pelvic pain, or provoked pelvic floor hypertonia.

If first-line therapies of over-the-counter lubricants do not sufficiently treat GSM, other effective treatments include low-dose vaginal estrogen therapy, systemic estrogen therapy if other menopause symptoms are present, vaginal dehydroepiandrosterone (DHEA), and ospemifene.
 

Management of GSM

First-line therapy of GSM involves over-the-counter lubricants and moisturizers, which are often adequate to alleviate or eliminate women’s symptoms. However, the panel that developed the statement found no evidence that hyaluronic acid was any more effective than other lubricants or moisturizers, and no herbal products were found to effectively treat GSM.

While emerging evidence suggests that energy-based therapies, such as treatments with vaginal laser or radiofrequency devices, show some promise, more evidence is needed to show safety and efficacy before the panel can recommend routine use.

When over-the-counter therapies are not effective, vaginal estrogen usually relieves GSM with little absorption and is preferred over systemic therapy if GSM is the only bothersome menopausal symptom. Options include topical creams, a slow-release estradiol intravaginal ring, and estradiol vaginal tablets and inserts.

“However, when systemic hormone therapy is needed to treat other menopause symptoms, usually a woman will derive benefit and resolution of the GSM at the same time,” Dr. Faubion said. “However, for some women, additional low-dose vaginal estrogen may be added to systemic estrogen if needed, and that could include vaginal DHEA.”

All the approved vaginal products have shown efficacy, compared with placebo in clinical trials, and a Cochrane review comparing the different therapies found them to be similarly efficacious in treating vaginal dryness and dyspareunia with no significant differences in adverse events.
 

Preparing patients for the boxed warning

As vaginal estrogen doses are significantly lower than systemic estrogen, their safety profile is better, with serum estrogen levels remaining within the postmenopausal range when low-dose vaginal estrogen therapy is used. That said, some studies have shown that vaginal estrogen cream can be a large enough dose to involve systemic absorption and lead to symptoms such as vaginal bleeding, breast pain, and nausea.

However, package inserts for vaginal estrogen have the same boxed warning as seen in systemic hormone therapy inserts regarding risk of endometrial cancer, breast cancer, cardiovascular disorders, and “probable dementia” despite these conditions not being linked to vaginal estrogen in trials. Neither has venous thromboembolism been linked to vaginal estrogen.

“The panel felt it was very important that women be educated about the differences between low-dose vaginal estrogen and systemic estrogen therapy and be prepared for this boxed warning,” Dr. Faubion told attendees. “It’s really important to say: ‘You’re going to get this, it’s going to look scary, and there’s no evidence these same warnings apply to the low-dose vaginal estrogen products.’ ”

This point particularly resonated with NAMS attendee Juliana (Jewel) Kling, MD, MPH, an associate professor of medicine at the Mayo Clinic Arizona, Scottsdale.

“The point about educating women about the differences between low-dose vaginal estrogen products and systemic treatments and being prepared for the boxed warning is important and I hope reaches many practitioners,” Dr. Kling said in an interview.

The panel did not recommend using progestogen with low-dose vaginal estrogen therapy or doing routine endometrial surveillance in women using vaginal estrogen. But endometrial surveillance may be worth considering in women with increased risk of endometrial cancer.

Estrogen insufficiency from premature menopause or primary ovarian insufficiency is linked to more severe sexual dysfunction, which can be particularly upsetting for younger women with vaginal atrophy and dyspareunia. A meta-analysis showed that vaginal estrogen appeared to slightly outperform over-the-counter lubricants in bringing back sexual function.

Undiagnosed vaginal or uterine bleeding is a contraindication for vaginal estrogen until the cause has been determined, and providers should use caution in prescribing vaginal estrogen to women with estrogen-dependent neoplasia. Dr. Faubion noted that GSM is common in women with breast cancer, especially if they are receiving endocrine treatments or aromatase inhibitors.

“For women with a hormone-dependent cancer, GSM management depends on each woman’s preference in consultants with her oncologist,” she said. GSM management in women with a nonhormone-dependent cancer, however, is no different than in women without cancer.

DHEA is a steroid that effectively improves vaginal maturation index, vaginal pH, dyspareunia, and vaginal dryness. The most common side effect is vaginal discharge.

Ospemifene, an estrogen agonist available in the United States but not in Canada, is the only oral product approved to treat vaginal dryness and dyspareunia. An observational study also found it effective in reducing recurrent UTIs. The most common side effect is vasomotor symptoms, and it should not be used in patients with breast cancer because it hasn’t been studied in this population.

“This updated information and position statement was needed and will be very clinically relevant in treating midlife women,” Dr. Kling said in an interview. “Dr. Faubion presented a high-level overview of the position statement with clinically relevant points, including treatment for sexual dysfunction related to GSM, GSM treatment in cancer patients, and emphasized the efficacy and low-risk safety profile of low-dose vaginal estrogen, compared to systemic [hormone therapy], for treatment of GSM.”

Dr. Faubion and Dr. Kling disclosed no relevant financial relationships.

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

It’s important for clinicians to ask women whether they are experiencing symptoms of genitourinary syndrome of menopause (GSM) before and after menopause, according to a new statement from the North American Menopause Society.

Stephanie Faubion, MD, MBA, medical director of NAMS, presented the updated statement at the virtual annual meeting of the North American Menopause Society.

“The one thing we tried to emphasize is proactive counseling and proactive inquiry, educating women when they hit perimenopause that this is a thing and that there are treatments,” Dr. Faubion said in an interview.

“I think women sometimes think there’s nothing they can do, which is not true. There’s the misperception that it’s just part of getting old, which it’s not,” said Dr. Faubion, who is also director of the Mayo Clinic Center for Women’s Health in Rochester, Minn., and chair of the department of medicine at the Mayo Clinic in Jacksonville, Fla.
 

Changes from previous statement

The GSM statement describes the symptoms and signs resulting from estrogen deficiency on the genitourinary tract, Dr. Faubion explained. The biggest change from the earlier version, published in 2013, is the condition’s new name. Formerly known as vulvovaginal atrophy, the condition’s new term was developed in 2014 and is now preferred by NAMS and the American College of Obstetricians and Gynecologists because it’s more comprehensive. Rather than just a physical description of the condition, GSM encompasses the many related symptoms and the urinary tract changes that occur, and it clearly associates the condition with menopause.

“Women don’t always associate these changes with menopause and don’t recognize that there’s something that can be done about it,” Dr. Faubion said. “We like to emphasize that sex should never be painful, but it’s not just about sex. It’s about comfort.”

Other changes include a review of evidence related to vaginal laser therapy for GSM and the availability of Imvexxy vaginal inserts with lower doses (4 mcg and 10 mpg) of estrogen.
 

Etiology and diagnosis of GSM

The presence of endogenous estrogen keeps the vaginal lining thick, rugated, well vascularized, and lubricated. As estrogen levels decline during postmenopause, the epithelial lining becomes thinner, with reduced blood supply and loss of glycogen.

The most common symptoms of GSM include irritation of the vulva, inadequate vaginal lubrication, burning, dysuria, dyspareunia, and vaginal discharge, but the symptoms may not always correlate with physical findings. In women with surgical menopause, the symptoms tend to be more severe. The most distressing symptoms to women are often those that affect sexual function.

“Clinicians must be proactive in asking menopausal women if GSM symptoms are present, even before menopause begins,” Dr. Faubion said.

Taking a women’s history during evaluation may help identify contributing factors, other causes, or potentially effective treatments based on what has worked in the past. History should include a description of symptoms, their onset and duration, how distressing they are, and their effect on the woman’s quality of life. A sexual history, such as lubricants the woman has used, can also be useful in determining management strategies.

Signs of GSM include labial atrophy, vaginal dryness, introital stenosis, clitoral atrophy, phimosis of the prepuce, reduced mons pubis and labia majora bulk, reduced labia minora tissue and pigmentation, and changes in the urethra, including erythema of the urethral meatus and commonly a urethral caruncle, a benign outgrown of inflammatory tissue that likely results from low estrogen levels and can be treated effectively with topical hormonal therapies.

A diagnosis of GSM requires both physical findings and bothersome symptoms, though not necessarily specific vaginal maturation index or vaginal pH values. The differential diagnosis speaks to the importance of taking a good history: allergic or inflammatory conditions, infection, trauma, presence of a foreign body, malignancy, vulvodynia, chronic pelvic pain, or provoked pelvic floor hypertonia.

If first-line therapies of over-the-counter lubricants do not sufficiently treat GSM, other effective treatments include low-dose vaginal estrogen therapy, systemic estrogen therapy if other menopause symptoms are present, vaginal dehydroepiandrosterone (DHEA), and ospemifene.
 

Management of GSM

First-line therapy of GSM involves over-the-counter lubricants and moisturizers, which are often adequate to alleviate or eliminate women’s symptoms. However, the panel that developed the statement found no evidence that hyaluronic acid was any more effective than other lubricants or moisturizers, and no herbal products were found to effectively treat GSM.

While emerging evidence suggests that energy-based therapies, such as treatments with vaginal laser or radiofrequency devices, show some promise, more evidence is needed to show safety and efficacy before the panel can recommend routine use.

When over-the-counter therapies are not effective, vaginal estrogen usually relieves GSM with little absorption and is preferred over systemic therapy if GSM is the only bothersome menopausal symptom. Options include topical creams, a slow-release estradiol intravaginal ring, and estradiol vaginal tablets and inserts.

“However, when systemic hormone therapy is needed to treat other menopause symptoms, usually a woman will derive benefit and resolution of the GSM at the same time,” Dr. Faubion said. “However, for some women, additional low-dose vaginal estrogen may be added to systemic estrogen if needed, and that could include vaginal DHEA.”

All the approved vaginal products have shown efficacy, compared with placebo in clinical trials, and a Cochrane review comparing the different therapies found them to be similarly efficacious in treating vaginal dryness and dyspareunia with no significant differences in adverse events.
 

Preparing patients for the boxed warning

As vaginal estrogen doses are significantly lower than systemic estrogen, their safety profile is better, with serum estrogen levels remaining within the postmenopausal range when low-dose vaginal estrogen therapy is used. That said, some studies have shown that vaginal estrogen cream can be a large enough dose to involve systemic absorption and lead to symptoms such as vaginal bleeding, breast pain, and nausea.

However, package inserts for vaginal estrogen have the same boxed warning as seen in systemic hormone therapy inserts regarding risk of endometrial cancer, breast cancer, cardiovascular disorders, and “probable dementia” despite these conditions not being linked to vaginal estrogen in trials. Neither has venous thromboembolism been linked to vaginal estrogen.

“The panel felt it was very important that women be educated about the differences between low-dose vaginal estrogen and systemic estrogen therapy and be prepared for this boxed warning,” Dr. Faubion told attendees. “It’s really important to say: ‘You’re going to get this, it’s going to look scary, and there’s no evidence these same warnings apply to the low-dose vaginal estrogen products.’ ”

This point particularly resonated with NAMS attendee Juliana (Jewel) Kling, MD, MPH, an associate professor of medicine at the Mayo Clinic Arizona, Scottsdale.

“The point about educating women about the differences between low-dose vaginal estrogen products and systemic treatments and being prepared for the boxed warning is important and I hope reaches many practitioners,” Dr. Kling said in an interview.

The panel did not recommend using progestogen with low-dose vaginal estrogen therapy or doing routine endometrial surveillance in women using vaginal estrogen. But endometrial surveillance may be worth considering in women with increased risk of endometrial cancer.

Estrogen insufficiency from premature menopause or primary ovarian insufficiency is linked to more severe sexual dysfunction, which can be particularly upsetting for younger women with vaginal atrophy and dyspareunia. A meta-analysis showed that vaginal estrogen appeared to slightly outperform over-the-counter lubricants in bringing back sexual function.

Undiagnosed vaginal or uterine bleeding is a contraindication for vaginal estrogen until the cause has been determined, and providers should use caution in prescribing vaginal estrogen to women with estrogen-dependent neoplasia. Dr. Faubion noted that GSM is common in women with breast cancer, especially if they are receiving endocrine treatments or aromatase inhibitors.

“For women with a hormone-dependent cancer, GSM management depends on each woman’s preference in consultants with her oncologist,” she said. GSM management in women with a nonhormone-dependent cancer, however, is no different than in women without cancer.

DHEA is a steroid that effectively improves vaginal maturation index, vaginal pH, dyspareunia, and vaginal dryness. The most common side effect is vaginal discharge.

Ospemifene, an estrogen agonist available in the United States but not in Canada, is the only oral product approved to treat vaginal dryness and dyspareunia. An observational study also found it effective in reducing recurrent UTIs. The most common side effect is vasomotor symptoms, and it should not be used in patients with breast cancer because it hasn’t been studied in this population.

“This updated information and position statement was needed and will be very clinically relevant in treating midlife women,” Dr. Kling said in an interview. “Dr. Faubion presented a high-level overview of the position statement with clinically relevant points, including treatment for sexual dysfunction related to GSM, GSM treatment in cancer patients, and emphasized the efficacy and low-risk safety profile of low-dose vaginal estrogen, compared to systemic [hormone therapy], for treatment of GSM.”

Dr. Faubion and Dr. Kling disclosed no relevant financial relationships.

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

It’s important for clinicians to ask women whether they are experiencing symptoms of genitourinary syndrome of menopause (GSM) before and after menopause, according to a new statement from the North American Menopause Society.

Stephanie Faubion, MD, MBA, medical director of NAMS, presented the updated statement at the virtual annual meeting of the North American Menopause Society.

“The one thing we tried to emphasize is proactive counseling and proactive inquiry, educating women when they hit perimenopause that this is a thing and that there are treatments,” Dr. Faubion said in an interview.

“I think women sometimes think there’s nothing they can do, which is not true. There’s the misperception that it’s just part of getting old, which it’s not,” said Dr. Faubion, who is also director of the Mayo Clinic Center for Women’s Health in Rochester, Minn., and chair of the department of medicine at the Mayo Clinic in Jacksonville, Fla.
 

Changes from previous statement

The GSM statement describes the symptoms and signs resulting from estrogen deficiency on the genitourinary tract, Dr. Faubion explained. The biggest change from the earlier version, published in 2013, is the condition’s new name. Formerly known as vulvovaginal atrophy, the condition’s new term was developed in 2014 and is now preferred by NAMS and the American College of Obstetricians and Gynecologists because it’s more comprehensive. Rather than just a physical description of the condition, GSM encompasses the many related symptoms and the urinary tract changes that occur, and it clearly associates the condition with menopause.

“Women don’t always associate these changes with menopause and don’t recognize that there’s something that can be done about it,” Dr. Faubion said. “We like to emphasize that sex should never be painful, but it’s not just about sex. It’s about comfort.”

Other changes include a review of evidence related to vaginal laser therapy for GSM and the availability of Imvexxy vaginal inserts with lower doses (4 mcg and 10 mpg) of estrogen.
 

Etiology and diagnosis of GSM

The presence of endogenous estrogen keeps the vaginal lining thick, rugated, well vascularized, and lubricated. As estrogen levels decline during postmenopause, the epithelial lining becomes thinner, with reduced blood supply and loss of glycogen.

The most common symptoms of GSM include irritation of the vulva, inadequate vaginal lubrication, burning, dysuria, dyspareunia, and vaginal discharge, but the symptoms may not always correlate with physical findings. In women with surgical menopause, the symptoms tend to be more severe. The most distressing symptoms to women are often those that affect sexual function.

“Clinicians must be proactive in asking menopausal women if GSM symptoms are present, even before menopause begins,” Dr. Faubion said.

Taking a women’s history during evaluation may help identify contributing factors, other causes, or potentially effective treatments based on what has worked in the past. History should include a description of symptoms, their onset and duration, how distressing they are, and their effect on the woman’s quality of life. A sexual history, such as lubricants the woman has used, can also be useful in determining management strategies.

Signs of GSM include labial atrophy, vaginal dryness, introital stenosis, clitoral atrophy, phimosis of the prepuce, reduced mons pubis and labia majora bulk, reduced labia minora tissue and pigmentation, and changes in the urethra, including erythema of the urethral meatus and commonly a urethral caruncle, a benign outgrown of inflammatory tissue that likely results from low estrogen levels and can be treated effectively with topical hormonal therapies.

A diagnosis of GSM requires both physical findings and bothersome symptoms, though not necessarily specific vaginal maturation index or vaginal pH values. The differential diagnosis speaks to the importance of taking a good history: allergic or inflammatory conditions, infection, trauma, presence of a foreign body, malignancy, vulvodynia, chronic pelvic pain, or provoked pelvic floor hypertonia.

If first-line therapies of over-the-counter lubricants do not sufficiently treat GSM, other effective treatments include low-dose vaginal estrogen therapy, systemic estrogen therapy if other menopause symptoms are present, vaginal dehydroepiandrosterone (DHEA), and ospemifene.
 

Management of GSM

First-line therapy of GSM involves over-the-counter lubricants and moisturizers, which are often adequate to alleviate or eliminate women’s symptoms. However, the panel that developed the statement found no evidence that hyaluronic acid was any more effective than other lubricants or moisturizers, and no herbal products were found to effectively treat GSM.

While emerging evidence suggests that energy-based therapies, such as treatments with vaginal laser or radiofrequency devices, show some promise, more evidence is needed to show safety and efficacy before the panel can recommend routine use.

When over-the-counter therapies are not effective, vaginal estrogen usually relieves GSM with little absorption and is preferred over systemic therapy if GSM is the only bothersome menopausal symptom. Options include topical creams, a slow-release estradiol intravaginal ring, and estradiol vaginal tablets and inserts.

“However, when systemic hormone therapy is needed to treat other menopause symptoms, usually a woman will derive benefit and resolution of the GSM at the same time,” Dr. Faubion said. “However, for some women, additional low-dose vaginal estrogen may be added to systemic estrogen if needed, and that could include vaginal DHEA.”

All the approved vaginal products have shown efficacy, compared with placebo in clinical trials, and a Cochrane review comparing the different therapies found them to be similarly efficacious in treating vaginal dryness and dyspareunia with no significant differences in adverse events.
 

Preparing patients for the boxed warning

As vaginal estrogen doses are significantly lower than systemic estrogen, their safety profile is better, with serum estrogen levels remaining within the postmenopausal range when low-dose vaginal estrogen therapy is used. That said, some studies have shown that vaginal estrogen cream can be a large enough dose to involve systemic absorption and lead to symptoms such as vaginal bleeding, breast pain, and nausea.

However, package inserts for vaginal estrogen have the same boxed warning as seen in systemic hormone therapy inserts regarding risk of endometrial cancer, breast cancer, cardiovascular disorders, and “probable dementia” despite these conditions not being linked to vaginal estrogen in trials. Neither has venous thromboembolism been linked to vaginal estrogen.

“The panel felt it was very important that women be educated about the differences between low-dose vaginal estrogen and systemic estrogen therapy and be prepared for this boxed warning,” Dr. Faubion told attendees. “It’s really important to say: ‘You’re going to get this, it’s going to look scary, and there’s no evidence these same warnings apply to the low-dose vaginal estrogen products.’ ”

This point particularly resonated with NAMS attendee Juliana (Jewel) Kling, MD, MPH, an associate professor of medicine at the Mayo Clinic Arizona, Scottsdale.

“The point about educating women about the differences between low-dose vaginal estrogen products and systemic treatments and being prepared for the boxed warning is important and I hope reaches many practitioners,” Dr. Kling said in an interview.

The panel did not recommend using progestogen with low-dose vaginal estrogen therapy or doing routine endometrial surveillance in women using vaginal estrogen. But endometrial surveillance may be worth considering in women with increased risk of endometrial cancer.

Estrogen insufficiency from premature menopause or primary ovarian insufficiency is linked to more severe sexual dysfunction, which can be particularly upsetting for younger women with vaginal atrophy and dyspareunia. A meta-analysis showed that vaginal estrogen appeared to slightly outperform over-the-counter lubricants in bringing back sexual function.

Undiagnosed vaginal or uterine bleeding is a contraindication for vaginal estrogen until the cause has been determined, and providers should use caution in prescribing vaginal estrogen to women with estrogen-dependent neoplasia. Dr. Faubion noted that GSM is common in women with breast cancer, especially if they are receiving endocrine treatments or aromatase inhibitors.

“For women with a hormone-dependent cancer, GSM management depends on each woman’s preference in consultants with her oncologist,” she said. GSM management in women with a nonhormone-dependent cancer, however, is no different than in women without cancer.

DHEA is a steroid that effectively improves vaginal maturation index, vaginal pH, dyspareunia, and vaginal dryness. The most common side effect is vaginal discharge.

Ospemifene, an estrogen agonist available in the United States but not in Canada, is the only oral product approved to treat vaginal dryness and dyspareunia. An observational study also found it effective in reducing recurrent UTIs. The most common side effect is vasomotor symptoms, and it should not be used in patients with breast cancer because it hasn’t been studied in this population.

“This updated information and position statement was needed and will be very clinically relevant in treating midlife women,” Dr. Kling said in an interview. “Dr. Faubion presented a high-level overview of the position statement with clinically relevant points, including treatment for sexual dysfunction related to GSM, GSM treatment in cancer patients, and emphasized the efficacy and low-risk safety profile of low-dose vaginal estrogen, compared to systemic [hormone therapy], for treatment of GSM.”

Dr. Faubion and Dr. Kling disclosed no relevant financial relationships.

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

Fifteen days. That’s how much time the American College of Cardiology (ACC) had to convert its annual conference, scheduled for the end of March this year in Chicago, into a virtual meeting for the estimated 17,000 people who had planned to attend.

Because of the coronavirus pandemic, Illinois announced restrictions on the size of gatherings on March 13, causing the ACC to pivot to an online-only model.

“One big advantage was that we already had all of our content planned,” Janice Sibley, the ACC’s executive vice president of education, told Medscape Medical News. “We knew who the faculty would be for different sessions, and many of them had already planned their slides.”

But determining how to present those hundreds of presentations at an online conference, not to mention addressing the logistics related to registrations, tech platforms, exhibit hall sponsors, and other aspects of an annual meeting, would be no small task.

As medical societies have pivoted from in-person annual conferences to online meetings during the COVID-19 pandemic, they have found that they are mostly up to the challenge of disseminating research results and clinical education on par with in-person presentations. But according to a Medscape poll, many physicians think that, while the virtual experience is worthwhile and getting better, it’s never going to be the same as spending several days on site, immersed in the experience of an annual meeting.

As one respondent commented, “I miss the intellectual excitement, the electricity in the room, when there is a live presentation that announces a major breakthrough.”
 

Large medical societies have an advantage

As ACC rapidly prepared for its virtual conference, the society first refunded all registration and expo fees and worked with the vendor partners to resolve the cancellation of rental space, food and beverage services, and decorating. Then they organized a team of 15 people split into three groups. One group focused on the intellectual, scientific, and educational elements of the virtual conference. They chose 24 sessions to livestream and decided to prerecord the rest for on-demand access, limiting the number of presenters they needed to train for online presentation.

A second team focused on business and worked with industry partners on how to translate a large expo into digital offerings. They developed virtual pages, advertisements, promotions, and industry-sponsored education.

The third team’s focus, Ms. Sibley said, was most critical, and the hardest: addressing socio-emotional needs.

“That group was responsible for trying to create the buzz and excitement we would have had at the event,” she said, “pivoting that experience we would have had in a live event to a virtual environment. What we were worried about was, would anyone even come?”

But ACC built it, and they did indeed come. Within a half hour of the opening session, nearly 13,000 people logged on from around the world. “It worked beautifully,” Ms. Sibley said.

By the end of the 3-day event, approximately 34,000 unique visitors had logged in for live or prerecorded sessions. Although ACC worried at first about technical glitches and bandwidth needs, everything ran smoothly. By 90 days after the meeting, 63,000 unique users had logged in to access the conference content.

ACC was among the first organizations forced to switch from an in-person to all-online meeting, but dozens of other organizations have now done the same, discovering the benefits and drawbacks of a virtual environment while experimenting with different formats and offerings. Talks with a few large medical societies about the experience revealed several common themes, including the following:

• Finding new ways to attract and measure attendance.
• Ensuring the actual scientific content was as robust online as in person.
• Realizing the value of social media in enhancing the socio-emotional experience.
• Believing that virtual meetings will become a permanent fixture in a future of “hybrid” conferences.

New ways of attracting and measuring attendance

Previous ways to measure meeting attendance were straightforward: number of registrations and number of people physically walking into sessions. An online conference, however, offers dozens of ways to measure attendance. While the number of registrations remained one tool – and all the organizations interviewed reported record numbers of registrations – organizations also used other metrics to measure success, such as “participation,” “engagement,” and “viewing time.”

ACC defined “participation” as a unique user logging in, and it defined “engagement” as sticking around for a while, possibly using chat functions or discussing the content on social media. The American Society of Clinical Oncology (ASCO) annual conference in May, which attracted more than 44,000 registered attendees, also measured total content views – more than 2.5 million during the meeting – and monitored social media. More than 8,800 Twitter users posted more than 45,000 tweets with the #ASCO20 hashtag during the meeting, generating 750 million likes, shares, and comments. The European League Against Rheumatism (EULAR) annual congress registered a record 18,700 delegates – up from 14,500 in 2019 – but it also measured attendance by average viewing time and visits by congress day and by category.

Organizations shifted fee structures as well. While ACC refunded fees for its first online meeting, it has since developed tiers to match fees to anticipated value, such as charging more for livestreamed sessions that allow interactivity than for viewing recordings. ASCO offered a one-time fee waiver for members plus free registration to cancer survivors and caregivers, discounted registration for patient advocates, and reduced fees for other categories. But adjusting how to measure attendance and charge for events were the easy parts of transitioning to online.
 

Priority for having robust content

The biggest difficulty for most organizations was the short time they had to move online, with a host of challenges accompanying the switch, said the executive director of EULAR, Julia Rautenstrauch, DrMed. These included technical requirements, communication, training, finances, legal issues, compliance rules, and other logistics.

“The year 2020 will be remembered for being the year of unexpected transformation,” said a spokesperson from European Society for Medical Oncology (ESMO), who declined to be named. “The number of fundamental questions we had to ask ourselves is pages long. The solutions we have implemented so far have been successful, but we won’t rest on our laurels.”

ASCO had an advantage in the pivot, despite only 6 weeks to make the switch, because they already had a robust online platform to build on. “We weren’t starting from scratch, but we were sure changing the way we prepared,” ASCO CEO Clifford Hudis, MD, said.

All of the organizations made the breadth and quality of scientific and educational content a top priority, and those who have already hosted meetings this year report positive feedback.

“The rating of the scientific content was excellent, and the event did indeed fulfill the educational goals and expected learning outcomes for the vast majority of delegates,” EULAR’s Dr. Rautenstrauch said.

“Our goal, when we went into this, was that, in the future when somebody looks back at ASCO20, they should not be able to tell that it was a different year from any other in terms of the science,” Dr. Hudis said.
 

Missing out on networking and social interaction

Even when logistics run smoothly, virtual conferences must overcome two other challenges: the loss of in-person interactions and the potential for “Zoom burnout.”

“You do miss that human contact, the unsaid reactions in the room when you’re speaking or providing a controversial statement, even the facial expression or seeing people lean in or being distracted,” Ms. Sibley said.

Taher Modarressi, MD, an endocrinologist with Diabetes and Endocrine Associates of Hunterdon in Flemington, N.J., said all the digital conferences he has attended were missing those key social elements: “seeing old friends, sideline discussions that generate new ideas, and meeting new colleagues. However, this has been partly alleviated with the robust rise of social media and ‘MedTwitter,’ in particular, where these discussions and interactions continue.”

To attempt to meet that need for social interaction, societies came up with a variety of options. EULAR offered chatrooms, “Meet the Expert” sessions, and other virtual opportunities for live interaction. ASCO hosted discussion groups with subsets of participants, such as virtual meetings with oncology fellows, and it plans to offer networking sessions and “poster walks” during future meetings.

“The value of an in-person meeting is connecting with people, exchanging ideas over coffee, and making new contacts,” ASCO’s Dr. Hudis said. While virtual meetings lose many of those personal interactions, knowledge can also be shared with more people, he said.

The key to combating digital fatigue is focusing on opportunities for interactivity, ACC’s Ms. Sibley said. “When you are creating a virtual environment, it’s important that you offer choices.” Online learners tend to have shorter attention spans than in-person learners, so people need opportunities to flip between sessions, like flipping between TV channels. Different engagement options are also essential, such as chat functions on the video platforms, asking questions of presenters orally or in writing, and using the familiar hashtags for social media discussion.

“We set up all those different ways to interact, and you allow the user to choose,” Ms. Sibley said.

Some conferences, however, had less time or fewer resources to adjust to a virtual format and couldn’t make up for the lost social interaction. Andy Bowman, MD, a neonatologist in Lubbock, Tex., was supposed to attend the Neonatal & Pediatric Airborne Transport Conference sponsored by International Biomed in the spring, but it was canceled at the last minute. Several weeks later, the organizers released videos of scheduled speakers giving their talks, but it was less engaging and too easy to get distracted, Dr. Bowman said.

“There is a noticeable decrease in energy – you can’t look around to feed off other’s reactions when a speaker says something off the wall, or new, or contrary to expectations,” he said. He also especially missed the social interactions, such as “missing out on the chance encounters in the hallway or seeing the same face in back-to-back sessions and figuring out you have shared interest.” He was also sorry to miss the expo because neonatal transport requires a lot of specialty equipment, and he appreciates the chance to actually touch and see it in person.
 

Advantages of an online meeting

Despite the challenges, online meetings can overcome obstacles of in-person meetings, particularly for those in low- and middle-income countries, such as travel and registration costs, the hardships of being away from practice, and visa restrictions.

“You really have the potential to broaden your reach,” Ms. Sibley said, noting that people in 157 countries participated in ACC.20.

Another advantage is keeping the experience available to people after the livestreamed event.

“Virtual events have demonstrated the potential for a more democratic conference world, expanding the dissemination of information to a much wider community of stakeholders,” ESMO’s spokesperson said.

Not traveling can actually mean getting more out of the conference, said Atisha Patel Manhas, MD, a hematologist/oncologist in Dallas, who attended ASCO. “I have really enjoyed the access aspect – on the virtual platform there is so much more content available to you, and travel time doesn’t cut into conference time,” she said, though she also missed the interaction with colleagues.

Others found that virtual conferences provided more engagement than in-person conferences. Marwah Abdalla, MD, MPH, an assistant professor of medicine and director of education for the Cardiac Intensive Care Unit at Columbia University Medical Center, New York, felt that moderated Q&A sessions offered more interaction among participants. She attended and spoke on a panel during virtual SLEEP 2020, a joint meeting of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS).

“Usually during in-person sessions, only a few questions are possible, and participants rarely have an opportunity to discuss the presentations within the session due to time limits,” Dr. Abdalla said. “Because the conference presentations can also be viewed asynchronously, participants have been able to comment on lectures and continue the discussion offline, either via social media or via email.” She acknowledged drawbacks of the virtual experience, such as an inability to socialize in person and participate in activities but appreciated the new opportunities to network and learn from international colleagues who would not have been able to attend in person.

Ritu Thamman, MD, assistant professor of medicine at the University of Pittsburgh School of Medicine, pointed out that many institutions have cut their travel budgets, and physicians would be unable to attend in-person conferences for financial or other reasons. She especially appreciated that the European Society of Cardiology had no registration fee for ESC 2020 and made their content free for all of September, which led to more than 100,000 participants.

“That meant anyone anywhere could learn,” she said. “It makes it much more diverse and more egalitarian. That feels like a good step in the right direction for all of us.”

Dr. Modarressi, who found ESC “exhilarating,” similarly noted the benefit of such an equitably accessible conference. “Decreasing barriers and improving access to top-line results and up-to-date information has always been a challenge to the global health community,” he said, noting that the map of attendance for the virtual meeting was “astonishing.”

Given these benefits, organizers said they expect a future of hybrid conferences: physical meetings for those able to attend in person and virtual ones for those who cannot.

“We also expect that the hybrid congress will cater to the needs of people on-site by allowing them additional access to more scientific content than by physical attendance alone,” Dr. Rautenstrauch said.

Everyone has been in reactive mode this year, Ms. Sibley said, but the future looks bright as they seek ways to overcome challenges such as socio-emotional needs and virtual expo spaces.

“We’ve been thrust into the virtual world much faster than we expected, but we’re finding it’s opening more opportunities than we had live,” Ms. Sibley said. “This has catapulted us, for better or worse, into a new way to deliver education and other types of information.

“I think, if we’re smart, we’ll continue to think of ways this can augment our live environment and not replace it.”
 

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

Fifteen days. That’s how much time the American College of Cardiology (ACC) had to convert its annual conference, scheduled for the end of March this year in Chicago, into a virtual meeting for the estimated 17,000 people who had planned to attend.

Because of the coronavirus pandemic, Illinois announced restrictions on the size of gatherings on March 13, causing the ACC to pivot to an online-only model.

“One big advantage was that we already had all of our content planned,” Janice Sibley, the ACC’s executive vice president of education, told Medscape Medical News. “We knew who the faculty would be for different sessions, and many of them had already planned their slides.”

But determining how to present those hundreds of presentations at an online conference, not to mention addressing the logistics related to registrations, tech platforms, exhibit hall sponsors, and other aspects of an annual meeting, would be no small task.

As medical societies have pivoted from in-person annual conferences to online meetings during the COVID-19 pandemic, they have found that they are mostly up to the challenge of disseminating research results and clinical education on par with in-person presentations. But according to a Medscape poll, many physicians think that, while the virtual experience is worthwhile and getting better, it’s never going to be the same as spending several days on site, immersed in the experience of an annual meeting.

As one respondent commented, “I miss the intellectual excitement, the electricity in the room, when there is a live presentation that announces a major breakthrough.”
 

Large medical societies have an advantage

As ACC rapidly prepared for its virtual conference, the society first refunded all registration and expo fees and worked with the vendor partners to resolve the cancellation of rental space, food and beverage services, and decorating. Then they organized a team of 15 people split into three groups. One group focused on the intellectual, scientific, and educational elements of the virtual conference. They chose 24 sessions to livestream and decided to prerecord the rest for on-demand access, limiting the number of presenters they needed to train for online presentation.

A second team focused on business and worked with industry partners on how to translate a large expo into digital offerings. They developed virtual pages, advertisements, promotions, and industry-sponsored education.

The third team’s focus, Ms. Sibley said, was most critical, and the hardest: addressing socio-emotional needs.

“That group was responsible for trying to create the buzz and excitement we would have had at the event,” she said, “pivoting that experience we would have had in a live event to a virtual environment. What we were worried about was, would anyone even come?”

But ACC built it, and they did indeed come. Within a half hour of the opening session, nearly 13,000 people logged on from around the world. “It worked beautifully,” Ms. Sibley said.

By the end of the 3-day event, approximately 34,000 unique visitors had logged in for live or prerecorded sessions. Although ACC worried at first about technical glitches and bandwidth needs, everything ran smoothly. By 90 days after the meeting, 63,000 unique users had logged in to access the conference content.

ACC was among the first organizations forced to switch from an in-person to all-online meeting, but dozens of other organizations have now done the same, discovering the benefits and drawbacks of a virtual environment while experimenting with different formats and offerings. Talks with a few large medical societies about the experience revealed several common themes, including the following:

• Finding new ways to attract and measure attendance.
• Ensuring the actual scientific content was as robust online as in person.
• Realizing the value of social media in enhancing the socio-emotional experience.
• Believing that virtual meetings will become a permanent fixture in a future of “hybrid” conferences.

New ways of attracting and measuring attendance

Previous ways to measure meeting attendance were straightforward: number of registrations and number of people physically walking into sessions. An online conference, however, offers dozens of ways to measure attendance. While the number of registrations remained one tool – and all the organizations interviewed reported record numbers of registrations – organizations also used other metrics to measure success, such as “participation,” “engagement,” and “viewing time.”

ACC defined “participation” as a unique user logging in, and it defined “engagement” as sticking around for a while, possibly using chat functions or discussing the content on social media. The American Society of Clinical Oncology (ASCO) annual conference in May, which attracted more than 44,000 registered attendees, also measured total content views – more than 2.5 million during the meeting – and monitored social media. More than 8,800 Twitter users posted more than 45,000 tweets with the #ASCO20 hashtag during the meeting, generating 750 million likes, shares, and comments. The European League Against Rheumatism (EULAR) annual congress registered a record 18,700 delegates – up from 14,500 in 2019 – but it also measured attendance by average viewing time and visits by congress day and by category.

Organizations shifted fee structures as well. While ACC refunded fees for its first online meeting, it has since developed tiers to match fees to anticipated value, such as charging more for livestreamed sessions that allow interactivity than for viewing recordings. ASCO offered a one-time fee waiver for members plus free registration to cancer survivors and caregivers, discounted registration for patient advocates, and reduced fees for other categories. But adjusting how to measure attendance and charge for events were the easy parts of transitioning to online.
 

Priority for having robust content

The biggest difficulty for most organizations was the short time they had to move online, with a host of challenges accompanying the switch, said the executive director of EULAR, Julia Rautenstrauch, DrMed. These included technical requirements, communication, training, finances, legal issues, compliance rules, and other logistics.

“The year 2020 will be remembered for being the year of unexpected transformation,” said a spokesperson from European Society for Medical Oncology (ESMO), who declined to be named. “The number of fundamental questions we had to ask ourselves is pages long. The solutions we have implemented so far have been successful, but we won’t rest on our laurels.”

ASCO had an advantage in the pivot, despite only 6 weeks to make the switch, because they already had a robust online platform to build on. “We weren’t starting from scratch, but we were sure changing the way we prepared,” ASCO CEO Clifford Hudis, MD, said.

All of the organizations made the breadth and quality of scientific and educational content a top priority, and those who have already hosted meetings this year report positive feedback.

“The rating of the scientific content was excellent, and the event did indeed fulfill the educational goals and expected learning outcomes for the vast majority of delegates,” EULAR’s Dr. Rautenstrauch said.

“Our goal, when we went into this, was that, in the future when somebody looks back at ASCO20, they should not be able to tell that it was a different year from any other in terms of the science,” Dr. Hudis said.
 

Missing out on networking and social interaction

Even when logistics run smoothly, virtual conferences must overcome two other challenges: the loss of in-person interactions and the potential for “Zoom burnout.”

“You do miss that human contact, the unsaid reactions in the room when you’re speaking or providing a controversial statement, even the facial expression or seeing people lean in or being distracted,” Ms. Sibley said.

Taher Modarressi, MD, an endocrinologist with Diabetes and Endocrine Associates of Hunterdon in Flemington, N.J., said all the digital conferences he has attended were missing those key social elements: “seeing old friends, sideline discussions that generate new ideas, and meeting new colleagues. However, this has been partly alleviated with the robust rise of social media and ‘MedTwitter,’ in particular, where these discussions and interactions continue.”

To attempt to meet that need for social interaction, societies came up with a variety of options. EULAR offered chatrooms, “Meet the Expert” sessions, and other virtual opportunities for live interaction. ASCO hosted discussion groups with subsets of participants, such as virtual meetings with oncology fellows, and it plans to offer networking sessions and “poster walks” during future meetings.

“The value of an in-person meeting is connecting with people, exchanging ideas over coffee, and making new contacts,” ASCO’s Dr. Hudis said. While virtual meetings lose many of those personal interactions, knowledge can also be shared with more people, he said.

The key to combating digital fatigue is focusing on opportunities for interactivity, ACC’s Ms. Sibley said. “When you are creating a virtual environment, it’s important that you offer choices.” Online learners tend to have shorter attention spans than in-person learners, so people need opportunities to flip between sessions, like flipping between TV channels. Different engagement options are also essential, such as chat functions on the video platforms, asking questions of presenters orally or in writing, and using the familiar hashtags for social media discussion.

“We set up all those different ways to interact, and you allow the user to choose,” Ms. Sibley said.

Some conferences, however, had less time or fewer resources to adjust to a virtual format and couldn’t make up for the lost social interaction. Andy Bowman, MD, a neonatologist in Lubbock, Tex., was supposed to attend the Neonatal & Pediatric Airborne Transport Conference sponsored by International Biomed in the spring, but it was canceled at the last minute. Several weeks later, the organizers released videos of scheduled speakers giving their talks, but it was less engaging and too easy to get distracted, Dr. Bowman said.

“There is a noticeable decrease in energy – you can’t look around to feed off other’s reactions when a speaker says something off the wall, or new, or contrary to expectations,” he said. He also especially missed the social interactions, such as “missing out on the chance encounters in the hallway or seeing the same face in back-to-back sessions and figuring out you have shared interest.” He was also sorry to miss the expo because neonatal transport requires a lot of specialty equipment, and he appreciates the chance to actually touch and see it in person.
 

Advantages of an online meeting

Despite the challenges, online meetings can overcome obstacles of in-person meetings, particularly for those in low- and middle-income countries, such as travel and registration costs, the hardships of being away from practice, and visa restrictions.

“You really have the potential to broaden your reach,” Ms. Sibley said, noting that people in 157 countries participated in ACC.20.

Another advantage is keeping the experience available to people after the livestreamed event.

“Virtual events have demonstrated the potential for a more democratic conference world, expanding the dissemination of information to a much wider community of stakeholders,” ESMO’s spokesperson said.

Not traveling can actually mean getting more out of the conference, said Atisha Patel Manhas, MD, a hematologist/oncologist in Dallas, who attended ASCO. “I have really enjoyed the access aspect – on the virtual platform there is so much more content available to you, and travel time doesn’t cut into conference time,” she said, though she also missed the interaction with colleagues.

Others found that virtual conferences provided more engagement than in-person conferences. Marwah Abdalla, MD, MPH, an assistant professor of medicine and director of education for the Cardiac Intensive Care Unit at Columbia University Medical Center, New York, felt that moderated Q&A sessions offered more interaction among participants. She attended and spoke on a panel during virtual SLEEP 2020, a joint meeting of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS).

“Usually during in-person sessions, only a few questions are possible, and participants rarely have an opportunity to discuss the presentations within the session due to time limits,” Dr. Abdalla said. “Because the conference presentations can also be viewed asynchronously, participants have been able to comment on lectures and continue the discussion offline, either via social media or via email.” She acknowledged drawbacks of the virtual experience, such as an inability to socialize in person and participate in activities but appreciated the new opportunities to network and learn from international colleagues who would not have been able to attend in person.

Ritu Thamman, MD, assistant professor of medicine at the University of Pittsburgh School of Medicine, pointed out that many institutions have cut their travel budgets, and physicians would be unable to attend in-person conferences for financial or other reasons. She especially appreciated that the European Society of Cardiology had no registration fee for ESC 2020 and made their content free for all of September, which led to more than 100,000 participants.

“That meant anyone anywhere could learn,” she said. “It makes it much more diverse and more egalitarian. That feels like a good step in the right direction for all of us.”

Dr. Modarressi, who found ESC “exhilarating,” similarly noted the benefit of such an equitably accessible conference. “Decreasing barriers and improving access to top-line results and up-to-date information has always been a challenge to the global health community,” he said, noting that the map of attendance for the virtual meeting was “astonishing.”

Given these benefits, organizers said they expect a future of hybrid conferences: physical meetings for those able to attend in person and virtual ones for those who cannot.

“We also expect that the hybrid congress will cater to the needs of people on-site by allowing them additional access to more scientific content than by physical attendance alone,” Dr. Rautenstrauch said.

Everyone has been in reactive mode this year, Ms. Sibley said, but the future looks bright as they seek ways to overcome challenges such as socio-emotional needs and virtual expo spaces.

“We’ve been thrust into the virtual world much faster than we expected, but we’re finding it’s opening more opportunities than we had live,” Ms. Sibley said. “This has catapulted us, for better or worse, into a new way to deliver education and other types of information.

“I think, if we’re smart, we’ll continue to think of ways this can augment our live environment and not replace it.”
 

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

Fifteen days. That’s how much time the American College of Cardiology (ACC) had to convert its annual conference, scheduled for the end of March this year in Chicago, into a virtual meeting for the estimated 17,000 people who had planned to attend.

Because of the coronavirus pandemic, Illinois announced restrictions on the size of gatherings on March 13, causing the ACC to pivot to an online-only model.

“One big advantage was that we already had all of our content planned,” Janice Sibley, the ACC’s executive vice president of education, told Medscape Medical News. “We knew who the faculty would be for different sessions, and many of them had already planned their slides.”

But determining how to present those hundreds of presentations at an online conference, not to mention addressing the logistics related to registrations, tech platforms, exhibit hall sponsors, and other aspects of an annual meeting, would be no small task.

As medical societies have pivoted from in-person annual conferences to online meetings during the COVID-19 pandemic, they have found that they are mostly up to the challenge of disseminating research results and clinical education on par with in-person presentations. But according to a Medscape poll, many physicians think that, while the virtual experience is worthwhile and getting better, it’s never going to be the same as spending several days on site, immersed in the experience of an annual meeting.

As one respondent commented, “I miss the intellectual excitement, the electricity in the room, when there is a live presentation that announces a major breakthrough.”
 

Large medical societies have an advantage

As ACC rapidly prepared for its virtual conference, the society first refunded all registration and expo fees and worked with the vendor partners to resolve the cancellation of rental space, food and beverage services, and decorating. Then they organized a team of 15 people split into three groups. One group focused on the intellectual, scientific, and educational elements of the virtual conference. They chose 24 sessions to livestream and decided to prerecord the rest for on-demand access, limiting the number of presenters they needed to train for online presentation.

A second team focused on business and worked with industry partners on how to translate a large expo into digital offerings. They developed virtual pages, advertisements, promotions, and industry-sponsored education.

The third team’s focus, Ms. Sibley said, was most critical, and the hardest: addressing socio-emotional needs.

“That group was responsible for trying to create the buzz and excitement we would have had at the event,” she said, “pivoting that experience we would have had in a live event to a virtual environment. What we were worried about was, would anyone even come?”

But ACC built it, and they did indeed come. Within a half hour of the opening session, nearly 13,000 people logged on from around the world. “It worked beautifully,” Ms. Sibley said.

By the end of the 3-day event, approximately 34,000 unique visitors had logged in for live or prerecorded sessions. Although ACC worried at first about technical glitches and bandwidth needs, everything ran smoothly. By 90 days after the meeting, 63,000 unique users had logged in to access the conference content.

ACC was among the first organizations forced to switch from an in-person to all-online meeting, but dozens of other organizations have now done the same, discovering the benefits and drawbacks of a virtual environment while experimenting with different formats and offerings. Talks with a few large medical societies about the experience revealed several common themes, including the following:

• Finding new ways to attract and measure attendance.
• Ensuring the actual scientific content was as robust online as in person.
• Realizing the value of social media in enhancing the socio-emotional experience.
• Believing that virtual meetings will become a permanent fixture in a future of “hybrid” conferences.

New ways of attracting and measuring attendance

Previous ways to measure meeting attendance were straightforward: number of registrations and number of people physically walking into sessions. An online conference, however, offers dozens of ways to measure attendance. While the number of registrations remained one tool – and all the organizations interviewed reported record numbers of registrations – organizations also used other metrics to measure success, such as “participation,” “engagement,” and “viewing time.”

ACC defined “participation” as a unique user logging in, and it defined “engagement” as sticking around for a while, possibly using chat functions or discussing the content on social media. The American Society of Clinical Oncology (ASCO) annual conference in May, which attracted more than 44,000 registered attendees, also measured total content views – more than 2.5 million during the meeting – and monitored social media. More than 8,800 Twitter users posted more than 45,000 tweets with the #ASCO20 hashtag during the meeting, generating 750 million likes, shares, and comments. The European League Against Rheumatism (EULAR) annual congress registered a record 18,700 delegates – up from 14,500 in 2019 – but it also measured attendance by average viewing time and visits by congress day and by category.

Organizations shifted fee structures as well. While ACC refunded fees for its first online meeting, it has since developed tiers to match fees to anticipated value, such as charging more for livestreamed sessions that allow interactivity than for viewing recordings. ASCO offered a one-time fee waiver for members plus free registration to cancer survivors and caregivers, discounted registration for patient advocates, and reduced fees for other categories. But adjusting how to measure attendance and charge for events were the easy parts of transitioning to online.
 

Priority for having robust content

The biggest difficulty for most organizations was the short time they had to move online, with a host of challenges accompanying the switch, said the executive director of EULAR, Julia Rautenstrauch, DrMed. These included technical requirements, communication, training, finances, legal issues, compliance rules, and other logistics.

“The year 2020 will be remembered for being the year of unexpected transformation,” said a spokesperson from European Society for Medical Oncology (ESMO), who declined to be named. “The number of fundamental questions we had to ask ourselves is pages long. The solutions we have implemented so far have been successful, but we won’t rest on our laurels.”

ASCO had an advantage in the pivot, despite only 6 weeks to make the switch, because they already had a robust online platform to build on. “We weren’t starting from scratch, but we were sure changing the way we prepared,” ASCO CEO Clifford Hudis, MD, said.

All of the organizations made the breadth and quality of scientific and educational content a top priority, and those who have already hosted meetings this year report positive feedback.

“The rating of the scientific content was excellent, and the event did indeed fulfill the educational goals and expected learning outcomes for the vast majority of delegates,” EULAR’s Dr. Rautenstrauch said.

“Our goal, when we went into this, was that, in the future when somebody looks back at ASCO20, they should not be able to tell that it was a different year from any other in terms of the science,” Dr. Hudis said.
 

Missing out on networking and social interaction

Even when logistics run smoothly, virtual conferences must overcome two other challenges: the loss of in-person interactions and the potential for “Zoom burnout.”

“You do miss that human contact, the unsaid reactions in the room when you’re speaking or providing a controversial statement, even the facial expression or seeing people lean in or being distracted,” Ms. Sibley said.

Taher Modarressi, MD, an endocrinologist with Diabetes and Endocrine Associates of Hunterdon in Flemington, N.J., said all the digital conferences he has attended were missing those key social elements: “seeing old friends, sideline discussions that generate new ideas, and meeting new colleagues. However, this has been partly alleviated with the robust rise of social media and ‘MedTwitter,’ in particular, where these discussions and interactions continue.”

To attempt to meet that need for social interaction, societies came up with a variety of options. EULAR offered chatrooms, “Meet the Expert” sessions, and other virtual opportunities for live interaction. ASCO hosted discussion groups with subsets of participants, such as virtual meetings with oncology fellows, and it plans to offer networking sessions and “poster walks” during future meetings.

“The value of an in-person meeting is connecting with people, exchanging ideas over coffee, and making new contacts,” ASCO’s Dr. Hudis said. While virtual meetings lose many of those personal interactions, knowledge can also be shared with more people, he said.

The key to combating digital fatigue is focusing on opportunities for interactivity, ACC’s Ms. Sibley said. “When you are creating a virtual environment, it’s important that you offer choices.” Online learners tend to have shorter attention spans than in-person learners, so people need opportunities to flip between sessions, like flipping between TV channels. Different engagement options are also essential, such as chat functions on the video platforms, asking questions of presenters orally or in writing, and using the familiar hashtags for social media discussion.

“We set up all those different ways to interact, and you allow the user to choose,” Ms. Sibley said.

Some conferences, however, had less time or fewer resources to adjust to a virtual format and couldn’t make up for the lost social interaction. Andy Bowman, MD, a neonatologist in Lubbock, Tex., was supposed to attend the Neonatal & Pediatric Airborne Transport Conference sponsored by International Biomed in the spring, but it was canceled at the last minute. Several weeks later, the organizers released videos of scheduled speakers giving their talks, but it was less engaging and too easy to get distracted, Dr. Bowman said.

“There is a noticeable decrease in energy – you can’t look around to feed off other’s reactions when a speaker says something off the wall, or new, or contrary to expectations,” he said. He also especially missed the social interactions, such as “missing out on the chance encounters in the hallway or seeing the same face in back-to-back sessions and figuring out you have shared interest.” He was also sorry to miss the expo because neonatal transport requires a lot of specialty equipment, and he appreciates the chance to actually touch and see it in person.
 

Advantages of an online meeting

Despite the challenges, online meetings can overcome obstacles of in-person meetings, particularly for those in low- and middle-income countries, such as travel and registration costs, the hardships of being away from practice, and visa restrictions.

“You really have the potential to broaden your reach,” Ms. Sibley said, noting that people in 157 countries participated in ACC.20.

Another advantage is keeping the experience available to people after the livestreamed event.

“Virtual events have demonstrated the potential for a more democratic conference world, expanding the dissemination of information to a much wider community of stakeholders,” ESMO’s spokesperson said.

Not traveling can actually mean getting more out of the conference, said Atisha Patel Manhas, MD, a hematologist/oncologist in Dallas, who attended ASCO. “I have really enjoyed the access aspect – on the virtual platform there is so much more content available to you, and travel time doesn’t cut into conference time,” she said, though she also missed the interaction with colleagues.

Others found that virtual conferences provided more engagement than in-person conferences. Marwah Abdalla, MD, MPH, an assistant professor of medicine and director of education for the Cardiac Intensive Care Unit at Columbia University Medical Center, New York, felt that moderated Q&A sessions offered more interaction among participants. She attended and spoke on a panel during virtual SLEEP 2020, a joint meeting of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS).

“Usually during in-person sessions, only a few questions are possible, and participants rarely have an opportunity to discuss the presentations within the session due to time limits,” Dr. Abdalla said. “Because the conference presentations can also be viewed asynchronously, participants have been able to comment on lectures and continue the discussion offline, either via social media or via email.” She acknowledged drawbacks of the virtual experience, such as an inability to socialize in person and participate in activities but appreciated the new opportunities to network and learn from international colleagues who would not have been able to attend in person.

Ritu Thamman, MD, assistant professor of medicine at the University of Pittsburgh School of Medicine, pointed out that many institutions have cut their travel budgets, and physicians would be unable to attend in-person conferences for financial or other reasons. She especially appreciated that the European Society of Cardiology had no registration fee for ESC 2020 and made their content free for all of September, which led to more than 100,000 participants.

“That meant anyone anywhere could learn,” she said. “It makes it much more diverse and more egalitarian. That feels like a good step in the right direction for all of us.”

Dr. Modarressi, who found ESC “exhilarating,” similarly noted the benefit of such an equitably accessible conference. “Decreasing barriers and improving access to top-line results and up-to-date information has always been a challenge to the global health community,” he said, noting that the map of attendance for the virtual meeting was “astonishing.”

Given these benefits, organizers said they expect a future of hybrid conferences: physical meetings for those able to attend in person and virtual ones for those who cannot.

“We also expect that the hybrid congress will cater to the needs of people on-site by allowing them additional access to more scientific content than by physical attendance alone,” Dr. Rautenstrauch said.

Everyone has been in reactive mode this year, Ms. Sibley said, but the future looks bright as they seek ways to overcome challenges such as socio-emotional needs and virtual expo spaces.

“We’ve been thrust into the virtual world much faster than we expected, but we’re finding it’s opening more opportunities than we had live,” Ms. Sibley said. “This has catapulted us, for better or worse, into a new way to deliver education and other types of information.

“I think, if we’re smart, we’ll continue to think of ways this can augment our live environment and not replace it.”
 

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

Pediatricians and other health care professionals who care for children are uniquely situated and qualified to educate the rest of the nation on how police brutality and overpolicing traumatizes children and teens and why those issues must be addressed, said Cornell William Brooks, JD, MDiv, a professor of public leadership and social justice at the Harvard Kennedy School of Government in Cambridge, Mass.

Mr. Brooks, also former president and CEO of the National Association for the Advancement of Colored People (NAACP), delivered an impassioned call to action during a plenary session at the annual meeting of the American Academy of Pediatrics, held virtually this year.

“In this moment, you enjoy an extraordinary measure of trust,” Mr. Brooks said. “As a consequence, I would argue that history and circumstance call upon to you to speak to this moment with a voice that is distinctive as a measure of expertise and unique as a measure of trust and credibility.”

The flood of comments throughout his live talk testified to how inspirational the AAP attendees found his words.

“We, as pediatricians, have a very powerful voice together,” wrote AAP President-elect Lee Savio Beers, MD.

“As pediatric staff we need to have our voices heard beyond the walls of our clinics, in our schools, in our legislative bodies and communities as a whole!” wrote Michelle Bucknor, MD, MBA, chief medical officer of United Healthcare of North Carolina.

Mr. Brooks opened his talk with images of Tamir Rice, Emmett Till, and George Floyd, explaining how images of Emmett Till’s dead body galvanized a movement in the same way that Rice, Floyd, Breonna Taylor, and other victims of police brutality are doing today.

“Emmett Till was killed by white racists in 1955 in Mississippi on the eve of the Montgomery boycott, and his death and his tragic image in death animated and inspired the Civil Rights movement,” Mr. Brooks said. Now “the country is divided along the fissures of class and the fault lines of race in a moment of generationally unprecedented policing. These images, tragic as they are, represent the countenance, the face of police brutality in this moment. “
 

How police brutality affects children

Since the death of George Floyd, at least 27 million Americans have participated in protests and demonstrations throughout at least 550 jurisdictions in the United States and throughout the world, Mr. Brooks said. But the harm of police brutality extends beyond police homicide victims.

“The harm is a matter of overpoliced patients and untreated children,” he said. Children are watching and listening as the nation grapples with police brutality and overpolicing, and the experience is traumatizing them in ways that shows up in school performance and health.

He shared findings from multiple different studies showing that exposure to police violence in the community is associated with declines in grade point averages, lower test scores, and poorer attendance. Risk of emotional disturbance is 15% greater in children exposed to police violence, and youth who have had contact with the police have reported worse health than those who hadn’t. Some of these effects increased with age, and they disproportionately fell almost entirely on Black and Hispanic students.

“Because of this trauma, school attendance and college enrollment declines,” Mr. Brooks said. “Police brutality has an impact on your patients, and beyond the patients who are right in front of you, there is a sea of millions of untreated, unattended children, and this trauma is reflected in the tremor of their voices, the trepidation, the apprehension, the fear that can be discerned in their spirits.”

Mr. Brooks shared several quotes from two qualitative studies that attempted to capture the experience of youths living in overpoliced communities and whose daily routines are criminalized. One respondent in this research said, “Sometimes I think to myself that I probably look suspicious, but I, like, shouldn’t think like that ‘cause I’m a human being.” Another said when he sees the police come around when there are groups of boys out, “I have my phone ready to record. I’m just waiting for something to happen.”
 

The voice of pediatricians

The voices of pediatric providers have a key role in the national discussion about this issue, Mr. Brooks said, because medical professionals have so much of America’s truth. One Pew Research Center survey found that 74% of Americans had a mostly positive view of medical doctors, compared with only 35% with a positive view of elected officials and 47% of the news media.

“As health care professionals dedicated to pediatrics, you are uniquely qualified, circumstantially and historically called in this moment to respond to this tragedy and trauma of police brutality as visited upon our children because you have been entrusted with America’s trust and credibility,” Mr. Brooks said.

He described several ways pediatricians can use storytelling to shift how the country perceives the issue of police brutality and the impact on children. Pediatricians can emphasize the humanity of children who are victimized, particularly when a different narrative competes for the public’s attention.

“Some children we deem to be sufficiently perfect that we can have sympathy and empathy for them,” Mr. Brooks said. “Other children are deemed to be so imperfect that we cannot have sympathy and empathy for them.” Within days of Michael Brown’s death by police in Ferguson, Mo., for example, a “post mortem character assassination” deemed Mr. Brown “too imperfect for empathy,” Mr. Brooks said.

“Dr. Brooks hit the nail on the head,” attendee Jeanette Callahan, MD, a pediatrician with Cambridge Health Alliance in Massachusetts, wrote during the session. “We must tell the stories that we hear every day from our patients.”

Pediatricians also can bring science and research into the public conversation to help people better understand children, just as the amicus briefs of pediatricians and neuroscientists in U.S. Supreme Court cases led the court to declare the death penalty and life sentences without parole as unconstitutional for minors.

“You as pediatricians, as physicians, as nurses, as health care professionals have the ability to cast doubt on things that people believe to be true and give them conviction with respect to things we know to be true as a consequence of data and our moral understanding,” Mr. Brooks said. He encouraged pediatricians to “engage in storytelling and justice-seeking by expanding and diversifying the resources we bring to public policy,” including science, data, and expertise.

Two recent examples of this professional activism include Massachusetts pediatrician Fiona Danaher’s testimony to the U.S. House of Representatives regarding current immigration policies’ impact on children and the work of Michigan pediatrician Mona Hanna-Attisha’s in exposing the Flint water crisis. Mr. Brooks shared a quote from Dr. Danaher: “For me, treating children humanely is a question of basic morality. I knew I couldn’t sit on the sidelines.”

Neither can pediatricians sit on the sidelines now with the issue of police brutality, Mr. Brooks said.

“You as pediatricians can call on America to engage in a Hippocratic approach to policing, that is to say, do no harm,” he said. “It’s not enough for us to content ourselves with children not becoming hashtags, not becoming police homicides. We have to also consider the trauma of overpolicing and oversurveilling our communities of color.”

He also recommended pediatricians remind the country that addressing social determinants of health also addresses social determinants of crime, providing an opportunity to disrupt the school-to-prison pipeline.

In the comments, attendees shared other ways pediatricians can influence policy in favor of children.

“Pediatricians can reach out to police departments, prosecutors, and public defender offices, the local judiciary, and local attorney associations, etc., to describe and explain the effects of policing on children and adolescents,” wrote Trina Anglin, MD, PhD, who retired in August 2019 as chief of the Adolescent Health Branch in the Health Resources and Services Administration’s Maternal and Child Health Bureau. “We can bring the voices of young people to others. At the community level, each professional group meets on a regular basis; each group also talks to the other groups.”

Others echoed these suggestions. “Expand your voice outside your office,” wrote Jimmell Felder, MD, of Pediatric Associates Greenwood in South Carolina. “Attend city council meetings and discuss the stories of our patients with the people who make the policies. It is part of our job to advocate for our patients.”

Joanna Betancourt, MD, a pediatrician with Salud Pediatrics in Algonquin, Ill., encouraged fellow attendees to “vote locally and nationally for people that are open to change legislation that supports the well-being of all children.”

Given all the trauma of 2020, Patricia Deffer-Valley, MD, of the University of Wisconsin School of Medicine and Public Health in Madison, said pediatricians cannot have “moral paralysis.”

Mr. Brooks had no relevant financial disclosures. Disclosure information was unavailable for others quoted in this article

Pediatricians and other health care professionals who care for children are uniquely situated and qualified to educate the rest of the nation on how police brutality and overpolicing traumatizes children and teens and why those issues must be addressed, said Cornell William Brooks, JD, MDiv, a professor of public leadership and social justice at the Harvard Kennedy School of Government in Cambridge, Mass.

Mr. Brooks, also former president and CEO of the National Association for the Advancement of Colored People (NAACP), delivered an impassioned call to action during a plenary session at the annual meeting of the American Academy of Pediatrics, held virtually this year.

“In this moment, you enjoy an extraordinary measure of trust,” Mr. Brooks said. “As a consequence, I would argue that history and circumstance call upon to you to speak to this moment with a voice that is distinctive as a measure of expertise and unique as a measure of trust and credibility.”

The flood of comments throughout his live talk testified to how inspirational the AAP attendees found his words.

“We, as pediatricians, have a very powerful voice together,” wrote AAP President-elect Lee Savio Beers, MD.

“As pediatric staff we need to have our voices heard beyond the walls of our clinics, in our schools, in our legislative bodies and communities as a whole!” wrote Michelle Bucknor, MD, MBA, chief medical officer of United Healthcare of North Carolina.

Mr. Brooks opened his talk with images of Tamir Rice, Emmett Till, and George Floyd, explaining how images of Emmett Till’s dead body galvanized a movement in the same way that Rice, Floyd, Breonna Taylor, and other victims of police brutality are doing today.

“Emmett Till was killed by white racists in 1955 in Mississippi on the eve of the Montgomery boycott, and his death and his tragic image in death animated and inspired the Civil Rights movement,” Mr. Brooks said. Now “the country is divided along the fissures of class and the fault lines of race in a moment of generationally unprecedented policing. These images, tragic as they are, represent the countenance, the face of police brutality in this moment. “
 

How police brutality affects children

Since the death of George Floyd, at least 27 million Americans have participated in protests and demonstrations throughout at least 550 jurisdictions in the United States and throughout the world, Mr. Brooks said. But the harm of police brutality extends beyond police homicide victims.

“The harm is a matter of overpoliced patients and untreated children,” he said. Children are watching and listening as the nation grapples with police brutality and overpolicing, and the experience is traumatizing them in ways that shows up in school performance and health.

He shared findings from multiple different studies showing that exposure to police violence in the community is associated with declines in grade point averages, lower test scores, and poorer attendance. Risk of emotional disturbance is 15% greater in children exposed to police violence, and youth who have had contact with the police have reported worse health than those who hadn’t. Some of these effects increased with age, and they disproportionately fell almost entirely on Black and Hispanic students.

“Because of this trauma, school attendance and college enrollment declines,” Mr. Brooks said. “Police brutality has an impact on your patients, and beyond the patients who are right in front of you, there is a sea of millions of untreated, unattended children, and this trauma is reflected in the tremor of their voices, the trepidation, the apprehension, the fear that can be discerned in their spirits.”

Mr. Brooks shared several quotes from two qualitative studies that attempted to capture the experience of youths living in overpoliced communities and whose daily routines are criminalized. One respondent in this research said, “Sometimes I think to myself that I probably look suspicious, but I, like, shouldn’t think like that ‘cause I’m a human being.” Another said when he sees the police come around when there are groups of boys out, “I have my phone ready to record. I’m just waiting for something to happen.”
 

The voice of pediatricians

The voices of pediatric providers have a key role in the national discussion about this issue, Mr. Brooks said, because medical professionals have so much of America’s truth. One Pew Research Center survey found that 74% of Americans had a mostly positive view of medical doctors, compared with only 35% with a positive view of elected officials and 47% of the news media.

“As health care professionals dedicated to pediatrics, you are uniquely qualified, circumstantially and historically called in this moment to respond to this tragedy and trauma of police brutality as visited upon our children because you have been entrusted with America’s trust and credibility,” Mr. Brooks said.

He described several ways pediatricians can use storytelling to shift how the country perceives the issue of police brutality and the impact on children. Pediatricians can emphasize the humanity of children who are victimized, particularly when a different narrative competes for the public’s attention.

“Some children we deem to be sufficiently perfect that we can have sympathy and empathy for them,” Mr. Brooks said. “Other children are deemed to be so imperfect that we cannot have sympathy and empathy for them.” Within days of Michael Brown’s death by police in Ferguson, Mo., for example, a “post mortem character assassination” deemed Mr. Brown “too imperfect for empathy,” Mr. Brooks said.

“Dr. Brooks hit the nail on the head,” attendee Jeanette Callahan, MD, a pediatrician with Cambridge Health Alliance in Massachusetts, wrote during the session. “We must tell the stories that we hear every day from our patients.”

Pediatricians also can bring science and research into the public conversation to help people better understand children, just as the amicus briefs of pediatricians and neuroscientists in U.S. Supreme Court cases led the court to declare the death penalty and life sentences without parole as unconstitutional for minors.

“You as pediatricians, as physicians, as nurses, as health care professionals have the ability to cast doubt on things that people believe to be true and give them conviction with respect to things we know to be true as a consequence of data and our moral understanding,” Mr. Brooks said. He encouraged pediatricians to “engage in storytelling and justice-seeking by expanding and diversifying the resources we bring to public policy,” including science, data, and expertise.

Two recent examples of this professional activism include Massachusetts pediatrician Fiona Danaher’s testimony to the U.S. House of Representatives regarding current immigration policies’ impact on children and the work of Michigan pediatrician Mona Hanna-Attisha’s in exposing the Flint water crisis. Mr. Brooks shared a quote from Dr. Danaher: “For me, treating children humanely is a question of basic morality. I knew I couldn’t sit on the sidelines.”

Neither can pediatricians sit on the sidelines now with the issue of police brutality, Mr. Brooks said.

“You as pediatricians can call on America to engage in a Hippocratic approach to policing, that is to say, do no harm,” he said. “It’s not enough for us to content ourselves with children not becoming hashtags, not becoming police homicides. We have to also consider the trauma of overpolicing and oversurveilling our communities of color.”

He also recommended pediatricians remind the country that addressing social determinants of health also addresses social determinants of crime, providing an opportunity to disrupt the school-to-prison pipeline.

In the comments, attendees shared other ways pediatricians can influence policy in favor of children.

“Pediatricians can reach out to police departments, prosecutors, and public defender offices, the local judiciary, and local attorney associations, etc., to describe and explain the effects of policing on children and adolescents,” wrote Trina Anglin, MD, PhD, who retired in August 2019 as chief of the Adolescent Health Branch in the Health Resources and Services Administration’s Maternal and Child Health Bureau. “We can bring the voices of young people to others. At the community level, each professional group meets on a regular basis; each group also talks to the other groups.”

Others echoed these suggestions. “Expand your voice outside your office,” wrote Jimmell Felder, MD, of Pediatric Associates Greenwood in South Carolina. “Attend city council meetings and discuss the stories of our patients with the people who make the policies. It is part of our job to advocate for our patients.”

Joanna Betancourt, MD, a pediatrician with Salud Pediatrics in Algonquin, Ill., encouraged fellow attendees to “vote locally and nationally for people that are open to change legislation that supports the well-being of all children.”

Given all the trauma of 2020, Patricia Deffer-Valley, MD, of the University of Wisconsin School of Medicine and Public Health in Madison, said pediatricians cannot have “moral paralysis.”

Mr. Brooks had no relevant financial disclosures. Disclosure information was unavailable for others quoted in this article

Pediatricians and other health care professionals who care for children are uniquely situated and qualified to educate the rest of the nation on how police brutality and overpolicing traumatizes children and teens and why those issues must be addressed, said Cornell William Brooks, JD, MDiv, a professor of public leadership and social justice at the Harvard Kennedy School of Government in Cambridge, Mass.

Mr. Brooks, also former president and CEO of the National Association for the Advancement of Colored People (NAACP), delivered an impassioned call to action during a plenary session at the annual meeting of the American Academy of Pediatrics, held virtually this year.

“In this moment, you enjoy an extraordinary measure of trust,” Mr. Brooks said. “As a consequence, I would argue that history and circumstance call upon to you to speak to this moment with a voice that is distinctive as a measure of expertise and unique as a measure of trust and credibility.”

The flood of comments throughout his live talk testified to how inspirational the AAP attendees found his words.

“We, as pediatricians, have a very powerful voice together,” wrote AAP President-elect Lee Savio Beers, MD.

“As pediatric staff we need to have our voices heard beyond the walls of our clinics, in our schools, in our legislative bodies and communities as a whole!” wrote Michelle Bucknor, MD, MBA, chief medical officer of United Healthcare of North Carolina.

Mr. Brooks opened his talk with images of Tamir Rice, Emmett Till, and George Floyd, explaining how images of Emmett Till’s dead body galvanized a movement in the same way that Rice, Floyd, Breonna Taylor, and other victims of police brutality are doing today.

“Emmett Till was killed by white racists in 1955 in Mississippi on the eve of the Montgomery boycott, and his death and his tragic image in death animated and inspired the Civil Rights movement,” Mr. Brooks said. Now “the country is divided along the fissures of class and the fault lines of race in a moment of generationally unprecedented policing. These images, tragic as they are, represent the countenance, the face of police brutality in this moment. “
 

How police brutality affects children

Since the death of George Floyd, at least 27 million Americans have participated in protests and demonstrations throughout at least 550 jurisdictions in the United States and throughout the world, Mr. Brooks said. But the harm of police brutality extends beyond police homicide victims.

“The harm is a matter of overpoliced patients and untreated children,” he said. Children are watching and listening as the nation grapples with police brutality and overpolicing, and the experience is traumatizing them in ways that shows up in school performance and health.

He shared findings from multiple different studies showing that exposure to police violence in the community is associated with declines in grade point averages, lower test scores, and poorer attendance. Risk of emotional disturbance is 15% greater in children exposed to police violence, and youth who have had contact with the police have reported worse health than those who hadn’t. Some of these effects increased with age, and they disproportionately fell almost entirely on Black and Hispanic students.

“Because of this trauma, school attendance and college enrollment declines,” Mr. Brooks said. “Police brutality has an impact on your patients, and beyond the patients who are right in front of you, there is a sea of millions of untreated, unattended children, and this trauma is reflected in the tremor of their voices, the trepidation, the apprehension, the fear that can be discerned in their spirits.”

Mr. Brooks shared several quotes from two qualitative studies that attempted to capture the experience of youths living in overpoliced communities and whose daily routines are criminalized. One respondent in this research said, “Sometimes I think to myself that I probably look suspicious, but I, like, shouldn’t think like that ‘cause I’m a human being.” Another said when he sees the police come around when there are groups of boys out, “I have my phone ready to record. I’m just waiting for something to happen.”
 

The voice of pediatricians

The voices of pediatric providers have a key role in the national discussion about this issue, Mr. Brooks said, because medical professionals have so much of America’s truth. One Pew Research Center survey found that 74% of Americans had a mostly positive view of medical doctors, compared with only 35% with a positive view of elected officials and 47% of the news media.

“As health care professionals dedicated to pediatrics, you are uniquely qualified, circumstantially and historically called in this moment to respond to this tragedy and trauma of police brutality as visited upon our children because you have been entrusted with America’s trust and credibility,” Mr. Brooks said.

He described several ways pediatricians can use storytelling to shift how the country perceives the issue of police brutality and the impact on children. Pediatricians can emphasize the humanity of children who are victimized, particularly when a different narrative competes for the public’s attention.

“Some children we deem to be sufficiently perfect that we can have sympathy and empathy for them,” Mr. Brooks said. “Other children are deemed to be so imperfect that we cannot have sympathy and empathy for them.” Within days of Michael Brown’s death by police in Ferguson, Mo., for example, a “post mortem character assassination” deemed Mr. Brown “too imperfect for empathy,” Mr. Brooks said.

“Dr. Brooks hit the nail on the head,” attendee Jeanette Callahan, MD, a pediatrician with Cambridge Health Alliance in Massachusetts, wrote during the session. “We must tell the stories that we hear every day from our patients.”

Pediatricians also can bring science and research into the public conversation to help people better understand children, just as the amicus briefs of pediatricians and neuroscientists in U.S. Supreme Court cases led the court to declare the death penalty and life sentences without parole as unconstitutional for minors.

“You as pediatricians, as physicians, as nurses, as health care professionals have the ability to cast doubt on things that people believe to be true and give them conviction with respect to things we know to be true as a consequence of data and our moral understanding,” Mr. Brooks said. He encouraged pediatricians to “engage in storytelling and justice-seeking by expanding and diversifying the resources we bring to public policy,” including science, data, and expertise.

Two recent examples of this professional activism include Massachusetts pediatrician Fiona Danaher’s testimony to the U.S. House of Representatives regarding current immigration policies’ impact on children and the work of Michigan pediatrician Mona Hanna-Attisha’s in exposing the Flint water crisis. Mr. Brooks shared a quote from Dr. Danaher: “For me, treating children humanely is a question of basic morality. I knew I couldn’t sit on the sidelines.”

Neither can pediatricians sit on the sidelines now with the issue of police brutality, Mr. Brooks said.

“You as pediatricians can call on America to engage in a Hippocratic approach to policing, that is to say, do no harm,” he said. “It’s not enough for us to content ourselves with children not becoming hashtags, not becoming police homicides. We have to also consider the trauma of overpolicing and oversurveilling our communities of color.”

He also recommended pediatricians remind the country that addressing social determinants of health also addresses social determinants of crime, providing an opportunity to disrupt the school-to-prison pipeline.

In the comments, attendees shared other ways pediatricians can influence policy in favor of children.

“Pediatricians can reach out to police departments, prosecutors, and public defender offices, the local judiciary, and local attorney associations, etc., to describe and explain the effects of policing on children and adolescents,” wrote Trina Anglin, MD, PhD, who retired in August 2019 as chief of the Adolescent Health Branch in the Health Resources and Services Administration’s Maternal and Child Health Bureau. “We can bring the voices of young people to others. At the community level, each professional group meets on a regular basis; each group also talks to the other groups.”

Others echoed these suggestions. “Expand your voice outside your office,” wrote Jimmell Felder, MD, of Pediatric Associates Greenwood in South Carolina. “Attend city council meetings and discuss the stories of our patients with the people who make the policies. It is part of our job to advocate for our patients.”

Joanna Betancourt, MD, a pediatrician with Salud Pediatrics in Algonquin, Ill., encouraged fellow attendees to “vote locally and nationally for people that are open to change legislation that supports the well-being of all children.”

Given all the trauma of 2020, Patricia Deffer-Valley, MD, of the University of Wisconsin School of Medicine and Public Health in Madison, said pediatricians cannot have “moral paralysis.”

Mr. Brooks had no relevant financial disclosures. Disclosure information was unavailable for others quoted in this article

Hormone therapy for menopausal symptoms has come a long way in the past decade, but some low risks remain, particularly for certain groups of women. But new naturally occurring estrogens are on the horizon and may provide safer options with similar efficacy for treating hot flashes and other symptoms, researchers report.

“Unfortunately, there is no such thing as the perfect estrogen that has all the things that makes it favorable and none of the negative,” Hugh S. Taylor, MD, told attendees at the virtual annual meeting of the North American Menopause Society. “It probably doesn’t exist. But there’s an opportunity for us to design better estrogens or take advantage of other naturally occurring estrogens that come closer to that goal of the ideal estrogen,” said Dr. Taylor, professor and chair of ob.gyn. and reproductive sciences at Yale University, New Haven, Conn.

Those naturally occurring estrogens are the fetal estrogens, estetrol and estriol, which are produced almost exclusively during pregnancy. Only estetrol has been investigated in clinical trials, and it does show some promise, Dr. Taylor said.

“If there’s a better cardiovascular effect without the breast cancer risk, this could be something everyone would want to take,” Dr. Taylor said in an interview. “It’s the first new estrogen we’ve had in many years, and it makes so much sense that we go back to a naturally occurring estrogen. We’ve never really been able to get a synthetic estrogen [that works].”
 

Hormone therapy still most effective for vasomotor symptoms

The primary benefits of hormone therapy for postmenopausal women are decreased hot flashes and night sweats and the prevention of bone loss, vaginal dryness, and vaginal atrophy. But as women age, particularly past age 70 years, the risks for stroke, heart disease, and breast cancer associated with hormone therapy begin to outweigh the benefits.

That leaves women who are still experiencing those symptoms in a quandary.

“Some people will take on substantial risks because they want to continue taking hormones,” Nanette F. Santoro, MD, a professor of ob.gyn. at the University of Colorado at Denver, Aurora, said in an interview. “If they understand what they’re doing and they tell me that they are that miserable, then I will continue their hormones.”

Dr. Santoro, who was not involved in Taylor’s work, said some patients have seen her because their primary care providers refused to continue prescribing them hormones at their age, despite serious vasomotor symptoms that interfered with their daily life.

“Women are sometimes not taken seriously, and I think that’s a problem,” Dr. Santoro said. “Women need to be able to make an informed choice about what kinds of risk they’re taking on. Many physicians’ rationales are that hot flashes never killed anybody. Well, they can sure make you miserable.”

Dr. Taylor echoed the importance of taking women’s symptoms seriously and helping them choose the most effective treatments to manage their symptoms.

“The rush of adrenaline, the anxiety, the palpitations, the heart racing, the sweating, all the night sweats [that mean] you can’t sleep at night, and the lack of adequate REM sleep – all these things add up and can really be disruptive to someone’s life,” Dr. Taylor said in an interview. “I think it’s important that we raise awareness of how severe it can be, about just how low the risks [of hormone therapy] are, and get people more comfortable using hormone therapy, but also continue to search for safer, better products that will eliminate even those low risks.”

A major development toward that goal in the past decade has been therapies that combine an estrogen with a selective estrogen receptor modulator (SERM), which have antiestrogen effects in the endometrium and breast without blocking estrogen in the bones and brain.

One such tissue-selective estrogen complex (TSEC) is the combination of bazedoxifene (20 mg) and conjugated estrogens (0.45 mg). Clinical trials showed that this TSEC reduced the frequency of hot flashes by 74%, compared with 47% with placebo. In addition, TSEC reduced the severity of hot flashes by 39%, compared with 13% with placebo. The combination also improved bone density at the spine and hip without promoting endometrial hyperplasia.

“It looks like it does exactly what we want,” Dr. Taylor told NAMS attendees. “The SERM is antagonizing the effects of the estrogens in the endometrium but not in the bone or brain.” It also led to a decrease in total cholesterol, and there was no increase in breast stimulation or density.

Another advance in recent years has been more choices and more precision with dosing, Dr. Santoro said.

“Where inroads have been made is in having women be aware of all the options they have and in getting the most convenient compounds to people,” she said, despite the confusion and misinformation that have arisen from the proliferation of bioidenticals. “You can dial in a dose for just about anybody.”
 

New estrogens in the pipeline

Neither of these developments, however, have eliminated the risks associated with hormone therapy for women of older age or for women at high risk for breast cancer. Although total elimination of risk may not be possible, recent research suggests that the naturally occurring fetal estrogens estriol and estetrol appear to have SERM-like properties, Dr. Taylor said. These estrogens are made only in pregnancy and appear to have evolved for a purpose different from that of estrone and estradiol.

“While both are weak estrogens by traditional standards, both have unique properties that make them very interesting for therapeutic use,” Dr. Taylor said. In particular, estetrol has a much longer half-life than estriol, making it more appropriate for therapeutic investigation.

A study of estetrol that was published in Menopause in August 2020 showed encouraging results. Despite a fairly sizable placebo effect, there was also a dose-response effect from estetrol on vasomotor symptoms. Low doses did not have much effect, but with higher doses (15 mg), there was a robust, significant improvement in the frequency and severity of hot flashes. So far, Dr. Taylor said, it looks like estetrol can be a highly effective treatment for vasomotor symptoms.

In addition, preclinical research suggests that estetrol may have a better safety profile than currently available therapies, though much more work is needed to know for sure. For example, a 2015 study found that it requires extremely high doses – well above therapeutic levels – for tumor growth to occur. Similarly, a 2019 study found that very high doses of estetrol or estriol were needed before it would stimulate breast cancer cell growth, likely because these are such weak estrogens, compared with estradiol, Dr. Taylor said.

There is currently less information on estetrol’s potential cardiovascular effects, but an animal model suggests positive effects, he said. Giving a mouse estetrol led to an increase in blood vessel dilation with increased blood flow.

The reason these estrogens appear to pose less risk yet still show therapeutic effects appears related to how they bind to the estrogen receptor and what their purpose is, Dr. Taylor told attendees.

“These fetal estrogens are really there probably for developmental programming,” he said. “It’s no wonder they may have some unique and favorable properties for therapeutic use. I’m really enthusiastic to see this explored further as a potential new hormonal therapy.”

Dr. Taylor disclosed no relevant financial relationships. Dr. Santoro reported stock ownership in Menogenix and consulting or advising for Ansh Labs, Menogenix, and Ogeda/Astellas.

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

Hormone therapy for menopausal symptoms has come a long way in the past decade, but some low risks remain, particularly for certain groups of women. But new naturally occurring estrogens are on the horizon and may provide safer options with similar efficacy for treating hot flashes and other symptoms, researchers report.

“Unfortunately, there is no such thing as the perfect estrogen that has all the things that makes it favorable and none of the negative,” Hugh S. Taylor, MD, told attendees at the virtual annual meeting of the North American Menopause Society. “It probably doesn’t exist. But there’s an opportunity for us to design better estrogens or take advantage of other naturally occurring estrogens that come closer to that goal of the ideal estrogen,” said Dr. Taylor, professor and chair of ob.gyn. and reproductive sciences at Yale University, New Haven, Conn.

Those naturally occurring estrogens are the fetal estrogens, estetrol and estriol, which are produced almost exclusively during pregnancy. Only estetrol has been investigated in clinical trials, and it does show some promise, Dr. Taylor said.

“If there’s a better cardiovascular effect without the breast cancer risk, this could be something everyone would want to take,” Dr. Taylor said in an interview. “It’s the first new estrogen we’ve had in many years, and it makes so much sense that we go back to a naturally occurring estrogen. We’ve never really been able to get a synthetic estrogen [that works].”
 

Hormone therapy still most effective for vasomotor symptoms

The primary benefits of hormone therapy for postmenopausal women are decreased hot flashes and night sweats and the prevention of bone loss, vaginal dryness, and vaginal atrophy. But as women age, particularly past age 70 years, the risks for stroke, heart disease, and breast cancer associated with hormone therapy begin to outweigh the benefits.

That leaves women who are still experiencing those symptoms in a quandary.

“Some people will take on substantial risks because they want to continue taking hormones,” Nanette F. Santoro, MD, a professor of ob.gyn. at the University of Colorado at Denver, Aurora, said in an interview. “If they understand what they’re doing and they tell me that they are that miserable, then I will continue their hormones.”

Dr. Santoro, who was not involved in Taylor’s work, said some patients have seen her because their primary care providers refused to continue prescribing them hormones at their age, despite serious vasomotor symptoms that interfered with their daily life.

“Women are sometimes not taken seriously, and I think that’s a problem,” Dr. Santoro said. “Women need to be able to make an informed choice about what kinds of risk they’re taking on. Many physicians’ rationales are that hot flashes never killed anybody. Well, they can sure make you miserable.”

Dr. Taylor echoed the importance of taking women’s symptoms seriously and helping them choose the most effective treatments to manage their symptoms.

“The rush of adrenaline, the anxiety, the palpitations, the heart racing, the sweating, all the night sweats [that mean] you can’t sleep at night, and the lack of adequate REM sleep – all these things add up and can really be disruptive to someone’s life,” Dr. Taylor said in an interview. “I think it’s important that we raise awareness of how severe it can be, about just how low the risks [of hormone therapy] are, and get people more comfortable using hormone therapy, but also continue to search for safer, better products that will eliminate even those low risks.”

A major development toward that goal in the past decade has been therapies that combine an estrogen with a selective estrogen receptor modulator (SERM), which have antiestrogen effects in the endometrium and breast without blocking estrogen in the bones and brain.

One such tissue-selective estrogen complex (TSEC) is the combination of bazedoxifene (20 mg) and conjugated estrogens (0.45 mg). Clinical trials showed that this TSEC reduced the frequency of hot flashes by 74%, compared with 47% with placebo. In addition, TSEC reduced the severity of hot flashes by 39%, compared with 13% with placebo. The combination also improved bone density at the spine and hip without promoting endometrial hyperplasia.

“It looks like it does exactly what we want,” Dr. Taylor told NAMS attendees. “The SERM is antagonizing the effects of the estrogens in the endometrium but not in the bone or brain.” It also led to a decrease in total cholesterol, and there was no increase in breast stimulation or density.

Another advance in recent years has been more choices and more precision with dosing, Dr. Santoro said.

“Where inroads have been made is in having women be aware of all the options they have and in getting the most convenient compounds to people,” she said, despite the confusion and misinformation that have arisen from the proliferation of bioidenticals. “You can dial in a dose for just about anybody.”
 

New estrogens in the pipeline

Neither of these developments, however, have eliminated the risks associated with hormone therapy for women of older age or for women at high risk for breast cancer. Although total elimination of risk may not be possible, recent research suggests that the naturally occurring fetal estrogens estriol and estetrol appear to have SERM-like properties, Dr. Taylor said. These estrogens are made only in pregnancy and appear to have evolved for a purpose different from that of estrone and estradiol.

“While both are weak estrogens by traditional standards, both have unique properties that make them very interesting for therapeutic use,” Dr. Taylor said. In particular, estetrol has a much longer half-life than estriol, making it more appropriate for therapeutic investigation.

A study of estetrol that was published in Menopause in August 2020 showed encouraging results. Despite a fairly sizable placebo effect, there was also a dose-response effect from estetrol on vasomotor symptoms. Low doses did not have much effect, but with higher doses (15 mg), there was a robust, significant improvement in the frequency and severity of hot flashes. So far, Dr. Taylor said, it looks like estetrol can be a highly effective treatment for vasomotor symptoms.

In addition, preclinical research suggests that estetrol may have a better safety profile than currently available therapies, though much more work is needed to know for sure. For example, a 2015 study found that it requires extremely high doses – well above therapeutic levels – for tumor growth to occur. Similarly, a 2019 study found that very high doses of estetrol or estriol were needed before it would stimulate breast cancer cell growth, likely because these are such weak estrogens, compared with estradiol, Dr. Taylor said.

There is currently less information on estetrol’s potential cardiovascular effects, but an animal model suggests positive effects, he said. Giving a mouse estetrol led to an increase in blood vessel dilation with increased blood flow.

The reason these estrogens appear to pose less risk yet still show therapeutic effects appears related to how they bind to the estrogen receptor and what their purpose is, Dr. Taylor told attendees.

“These fetal estrogens are really there probably for developmental programming,” he said. “It’s no wonder they may have some unique and favorable properties for therapeutic use. I’m really enthusiastic to see this explored further as a potential new hormonal therapy.”

Dr. Taylor disclosed no relevant financial relationships. Dr. Santoro reported stock ownership in Menogenix and consulting or advising for Ansh Labs, Menogenix, and Ogeda/Astellas.

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

Hormone therapy for menopausal symptoms has come a long way in the past decade, but some low risks remain, particularly for certain groups of women. But new naturally occurring estrogens are on the horizon and may provide safer options with similar efficacy for treating hot flashes and other symptoms, researchers report.

“Unfortunately, there is no such thing as the perfect estrogen that has all the things that makes it favorable and none of the negative,” Hugh S. Taylor, MD, told attendees at the virtual annual meeting of the North American Menopause Society. “It probably doesn’t exist. But there’s an opportunity for us to design better estrogens or take advantage of other naturally occurring estrogens that come closer to that goal of the ideal estrogen,” said Dr. Taylor, professor and chair of ob.gyn. and reproductive sciences at Yale University, New Haven, Conn.

Those naturally occurring estrogens are the fetal estrogens, estetrol and estriol, which are produced almost exclusively during pregnancy. Only estetrol has been investigated in clinical trials, and it does show some promise, Dr. Taylor said.

“If there’s a better cardiovascular effect without the breast cancer risk, this could be something everyone would want to take,” Dr. Taylor said in an interview. “It’s the first new estrogen we’ve had in many years, and it makes so much sense that we go back to a naturally occurring estrogen. We’ve never really been able to get a synthetic estrogen [that works].”
 

Hormone therapy still most effective for vasomotor symptoms

The primary benefits of hormone therapy for postmenopausal women are decreased hot flashes and night sweats and the prevention of bone loss, vaginal dryness, and vaginal atrophy. But as women age, particularly past age 70 years, the risks for stroke, heart disease, and breast cancer associated with hormone therapy begin to outweigh the benefits.

That leaves women who are still experiencing those symptoms in a quandary.

“Some people will take on substantial risks because they want to continue taking hormones,” Nanette F. Santoro, MD, a professor of ob.gyn. at the University of Colorado at Denver, Aurora, said in an interview. “If they understand what they’re doing and they tell me that they are that miserable, then I will continue their hormones.”

Dr. Santoro, who was not involved in Taylor’s work, said some patients have seen her because their primary care providers refused to continue prescribing them hormones at their age, despite serious vasomotor symptoms that interfered with their daily life.

“Women are sometimes not taken seriously, and I think that’s a problem,” Dr. Santoro said. “Women need to be able to make an informed choice about what kinds of risk they’re taking on. Many physicians’ rationales are that hot flashes never killed anybody. Well, they can sure make you miserable.”

Dr. Taylor echoed the importance of taking women’s symptoms seriously and helping them choose the most effective treatments to manage their symptoms.

“The rush of adrenaline, the anxiety, the palpitations, the heart racing, the sweating, all the night sweats [that mean] you can’t sleep at night, and the lack of adequate REM sleep – all these things add up and can really be disruptive to someone’s life,” Dr. Taylor said in an interview. “I think it’s important that we raise awareness of how severe it can be, about just how low the risks [of hormone therapy] are, and get people more comfortable using hormone therapy, but also continue to search for safer, better products that will eliminate even those low risks.”

A major development toward that goal in the past decade has been therapies that combine an estrogen with a selective estrogen receptor modulator (SERM), which have antiestrogen effects in the endometrium and breast without blocking estrogen in the bones and brain.

One such tissue-selective estrogen complex (TSEC) is the combination of bazedoxifene (20 mg) and conjugated estrogens (0.45 mg). Clinical trials showed that this TSEC reduced the frequency of hot flashes by 74%, compared with 47% with placebo. In addition, TSEC reduced the severity of hot flashes by 39%, compared with 13% with placebo. The combination also improved bone density at the spine and hip without promoting endometrial hyperplasia.

“It looks like it does exactly what we want,” Dr. Taylor told NAMS attendees. “The SERM is antagonizing the effects of the estrogens in the endometrium but not in the bone or brain.” It also led to a decrease in total cholesterol, and there was no increase in breast stimulation or density.

Another advance in recent years has been more choices and more precision with dosing, Dr. Santoro said.

“Where inroads have been made is in having women be aware of all the options they have and in getting the most convenient compounds to people,” she said, despite the confusion and misinformation that have arisen from the proliferation of bioidenticals. “You can dial in a dose for just about anybody.”
 

New estrogens in the pipeline

Neither of these developments, however, have eliminated the risks associated with hormone therapy for women of older age or for women at high risk for breast cancer. Although total elimination of risk may not be possible, recent research suggests that the naturally occurring fetal estrogens estriol and estetrol appear to have SERM-like properties, Dr. Taylor said. These estrogens are made only in pregnancy and appear to have evolved for a purpose different from that of estrone and estradiol.

“While both are weak estrogens by traditional standards, both have unique properties that make them very interesting for therapeutic use,” Dr. Taylor said. In particular, estetrol has a much longer half-life than estriol, making it more appropriate for therapeutic investigation.

A study of estetrol that was published in Menopause in August 2020 showed encouraging results. Despite a fairly sizable placebo effect, there was also a dose-response effect from estetrol on vasomotor symptoms. Low doses did not have much effect, but with higher doses (15 mg), there was a robust, significant improvement in the frequency and severity of hot flashes. So far, Dr. Taylor said, it looks like estetrol can be a highly effective treatment for vasomotor symptoms.

In addition, preclinical research suggests that estetrol may have a better safety profile than currently available therapies, though much more work is needed to know for sure. For example, a 2015 study found that it requires extremely high doses – well above therapeutic levels – for tumor growth to occur. Similarly, a 2019 study found that very high doses of estetrol or estriol were needed before it would stimulate breast cancer cell growth, likely because these are such weak estrogens, compared with estradiol, Dr. Taylor said.

There is currently less information on estetrol’s potential cardiovascular effects, but an animal model suggests positive effects, he said. Giving a mouse estetrol led to an increase in blood vessel dilation with increased blood flow.

The reason these estrogens appear to pose less risk yet still show therapeutic effects appears related to how they bind to the estrogen receptor and what their purpose is, Dr. Taylor told attendees.

“These fetal estrogens are really there probably for developmental programming,” he said. “It’s no wonder they may have some unique and favorable properties for therapeutic use. I’m really enthusiastic to see this explored further as a potential new hormonal therapy.”

Dr. Taylor disclosed no relevant financial relationships. Dr. Santoro reported stock ownership in Menogenix and consulting or advising for Ansh Labs, Menogenix, and Ogeda/Astellas.

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

Integrating ADHD care into practice work flows is vitally important for all practitioners who care for children, said Herschel Lessin, MD, a senior partner of the Children’s Medical Group in Poughkeepsie, N.Y.

O_Lypa/iStock/Getty Images

Although not necessarily “easy” to do, it’s far less overwhelming than it seems when doctors take the time to thoughtfully set up protocols, train others in the office, and use the ADHD Toolkit sold by the American Academy of Pediatrics, Dr. Lessin told attendees at the annual meeting of the AAP, held virtually this year. Dr. Lessin is a coeditor of the AAP’s ADHD Toolkit 3rd Ed., although he does not receive royalties from it. The toolkit includes patient handouts, clinicians tools, and rating scales that help practices incorporate ADHD care into their practices.

“The biggest complaint is: ‘But I don’t have enough time to do all of this stuff,’ ” Dr. Lessin said. “The reality is, once you’re comfortable with the visits and you know how they progress and flow, they can be done much more quickly.” He emphasized that practices can make money by integrating ADHD care into practice as long as they have a strategic plan and invest the time into training and protocols.

Dr. Lessin gave multiple reasons it’s important to integrate ADHD care into practices, starting with the condition’s prevalence and the importance of building a medical home for patients.

“ADHD affects 8%-10% of your patient population, a truly enormous number, yet many pediatricians do not treat ADHD in their practices, depriving their patients of needed care and depriving themselves from economic benefits of the visits and the revenue,” he said. The pediatrician added that more than 80% of ADHD care takes place in pediatric offices, but much of it is “badly diagnosed and poorly treated” in both primary care and specialty offices.

Jesse Hackell, MD, a private practice pediatrician in a suburb of New York City and vice president of the New York AAP Chapter 3, attended the session and agreed with Dr. Lessin that pediatricians are best suited to manage ADHD over other practitioners.

“One of the things he pointed out is that it’s a pediatric issue,” Dr. Hackell said. “We’re better at this than psychiatrists, than neurologists, than psychologists because we’re really focused on the whole lifestyle of the child, how it impacts them at home, how it impacts them at school, and how it impacts them in the social sphere.”

There’s also been a substantial increase in mental health issues as a proportion of visits, particularly recently with the pandemic and accompanying lockdowns. Youth already have limited access to mental health resources, making general pediatricians’ roles even more important. “Who else is going to provide this much needed service if not pediatricians?” Dr. Lessin asked.

Again, Dr. Hackell agreed, noting that the AAP’s toolkit is especially helpful in providing this care.

“It’s something that pediatricians have often been afraid to deal with and who farm them out to these other specialties, and I don’t think the children are served as well,” Dr. Hackell said. “If you do the right forms and questionnaires, you can actually make it work for the kids and work it for your office, which generates a lot of visits and generates revenue.”
 

Where to start

Dr. Lessin began by recommending that all pediatricians read the AAP’s clinical practice guidelines for ADHD along with its supplemental material (Process of Care Algorithm, and Systemic Barriers to Care of Children and Adolescents with ADHD).

“The first thing is you must educate yourself,” he said. “You have to learn the medicine and what are you able and comfortable doing because few of us were ever trained in our residency programs about ADHD care.”

Providers also need to learn to manage barriers to care, including referral sources and insurance company and medication hassles. Then you need to figure out how to structure the visits, determine the most appropriate visit settings, and learn to document and code appropriately. These are not quick 10-minute visits, Dr. Lessin said. Doctors must schedule enough time for them, although they may be able to do them faster with practice.

Dr. Lessin offered encouraging words for those feeling overwhelmed: “Overcome your anxiety. This is not as hard as it seems. It’s a little bit harder with comorbidities, but many chronic diseases we manage are far worse.”

In addition to reading the guidelines and review articles, seeking out mental health training programs, and learning the medications available, Dr. Lessin told attendees to get comfortable with the fact that a lot of treatment comes down to trial and error.

Again, he emphasized the value of the toolkit, which Dr. Hackell echoed.

“It’s a really nice roadmap to be able to follow and to explain how it requires two or three or four visits to treat these children well and get them started on treatment,” Dr. Hackell said. “It’s something that I recommend people use if they have not already done so to integrate ADHD care into their practices.”
 

Beginning the process

In figuring out how to structure visits, avoid addressing ADHD as a “by-the-way” issue, such as when a parent mentions it at the end of an appointment, Dr. Lessin said. Instead, start with an intake visit to determine whether you’re the right person to evaluate the child and hand out Parent and Teacher Evaluation scales to begin the process. Next, do the evaluation, discuss the process with the family, determine how treatment will work, and then look at comorbidities.

Visit settings can be traditional face-to-face visits, which are particularly helpful for intake visits, Dr. Lessin said, or telehealth, especially during the pandemic. In-person visits allow you more easily to make eye contact with the child and observe the parent and child behaviors and interactions, but telehealth often is adequate for titrating medication, discussing side effects, monitoring, and similar follow-up.

“Coding practices are absolutely necessary to make your practice viable, much less make money,” Dr. Lessin said. “Doing good for people and doing well for yourself are not mutually exclusive. You have to figure out a way to make it work economically for the practice or else you’re just not going to do it.”

He reminded pediatricians to code for evaluation, monitoring scales, and care coordination, and to be prepared for the big change of new coding rules coming in 2021.

“For better or worse, documentation is the key to survival in medical practice these days,” Dr. Lessin said. “This is true for all medical care these days, but it’s particularly true for ADHD because visits are all high intensity codes and should be coded as such.”

Templates are fine, he said, but box-checking isn’t enough; leave space for a narrative that explains the case complexity and decision-making.
 

Training staff is essential

It’s utterly essential to train all office staff, Dr. Lessin said. “I can’t tell you how important this step is because no matter how much you know or how well you understand what you want to do, you’re going to be frustrated at every turn if your staff and colleagues don’t get this stuff.”

That includes training those who make appointments, front desk staff, clinical staff, and practice colleagues regarding coding, scheduling, visit protocols, and similar procedures. Cheat sheets can be helpful here.

“They must understand the structure of the visits, what happens at each visit, the time requirements for each visit, and the standard follow-up,” including, for clinical staff, what handouts and rating scales to use, he said. “And if they aren’t sure what the parents needs or what you want, make sure they know to contact you.”

Colleagues also need to learn to properly document visits to justify coding and complexity, and not dump all patients on you.

One challenge that Dr. Lessin acknowledged as a common problem is that many pediatricians don’t have subspecialists they can refer patients to.

“Sadly, this is true almost everywhere, in rural and in big cities, near big medical centers and only local hospitals,” Dr. Lessin said. “This another reason why I think you need to learn and treat this illness to the extent you can. Your families need you.”

Dr. Hackell particularly appreciated this point, emphasizing again how important it is that pediatricians manage ADHD care of their patients.

“We see their day-to-day life, and that’s where this impacts these kids and families,” he said. “It’s really rewarding to do from my personal experience because you can really make a really big difference in these kids’ lives when they’re younger and even as they get older. When you get the rewards, it makes the work all worthwhile.”

Dr. Lessin and Dr. Hackell said they have no relevant financial disclosures.

Integrating ADHD care into practice work flows is vitally important for all practitioners who care for children, said Herschel Lessin, MD, a senior partner of the Children’s Medical Group in Poughkeepsie, N.Y.

O_Lypa/iStock/Getty Images

Although not necessarily “easy” to do, it’s far less overwhelming than it seems when doctors take the time to thoughtfully set up protocols, train others in the office, and use the ADHD Toolkit sold by the American Academy of Pediatrics, Dr. Lessin told attendees at the annual meeting of the AAP, held virtually this year. Dr. Lessin is a coeditor of the AAP’s ADHD Toolkit 3rd Ed., although he does not receive royalties from it. The toolkit includes patient handouts, clinicians tools, and rating scales that help practices incorporate ADHD care into their practices.

“The biggest complaint is: ‘But I don’t have enough time to do all of this stuff,’ ” Dr. Lessin said. “The reality is, once you’re comfortable with the visits and you know how they progress and flow, they can be done much more quickly.” He emphasized that practices can make money by integrating ADHD care into practice as long as they have a strategic plan and invest the time into training and protocols.

Dr. Lessin gave multiple reasons it’s important to integrate ADHD care into practices, starting with the condition’s prevalence and the importance of building a medical home for patients.

“ADHD affects 8%-10% of your patient population, a truly enormous number, yet many pediatricians do not treat ADHD in their practices, depriving their patients of needed care and depriving themselves from economic benefits of the visits and the revenue,” he said. The pediatrician added that more than 80% of ADHD care takes place in pediatric offices, but much of it is “badly diagnosed and poorly treated” in both primary care and specialty offices.

Jesse Hackell, MD, a private practice pediatrician in a suburb of New York City and vice president of the New York AAP Chapter 3, attended the session and agreed with Dr. Lessin that pediatricians are best suited to manage ADHD over other practitioners.

“One of the things he pointed out is that it’s a pediatric issue,” Dr. Hackell said. “We’re better at this than psychiatrists, than neurologists, than psychologists because we’re really focused on the whole lifestyle of the child, how it impacts them at home, how it impacts them at school, and how it impacts them in the social sphere.”

There’s also been a substantial increase in mental health issues as a proportion of visits, particularly recently with the pandemic and accompanying lockdowns. Youth already have limited access to mental health resources, making general pediatricians’ roles even more important. “Who else is going to provide this much needed service if not pediatricians?” Dr. Lessin asked.

Again, Dr. Hackell agreed, noting that the AAP’s toolkit is especially helpful in providing this care.

“It’s something that pediatricians have often been afraid to deal with and who farm them out to these other specialties, and I don’t think the children are served as well,” Dr. Hackell said. “If you do the right forms and questionnaires, you can actually make it work for the kids and work it for your office, which generates a lot of visits and generates revenue.”
 

Where to start

Dr. Lessin began by recommending that all pediatricians read the AAP’s clinical practice guidelines for ADHD along with its supplemental material (Process of Care Algorithm, and Systemic Barriers to Care of Children and Adolescents with ADHD).

“The first thing is you must educate yourself,” he said. “You have to learn the medicine and what are you able and comfortable doing because few of us were ever trained in our residency programs about ADHD care.”

Providers also need to learn to manage barriers to care, including referral sources and insurance company and medication hassles. Then you need to figure out how to structure the visits, determine the most appropriate visit settings, and learn to document and code appropriately. These are not quick 10-minute visits, Dr. Lessin said. Doctors must schedule enough time for them, although they may be able to do them faster with practice.

Dr. Lessin offered encouraging words for those feeling overwhelmed: “Overcome your anxiety. This is not as hard as it seems. It’s a little bit harder with comorbidities, but many chronic diseases we manage are far worse.”

In addition to reading the guidelines and review articles, seeking out mental health training programs, and learning the medications available, Dr. Lessin told attendees to get comfortable with the fact that a lot of treatment comes down to trial and error.

Again, he emphasized the value of the toolkit, which Dr. Hackell echoed.

“It’s a really nice roadmap to be able to follow and to explain how it requires two or three or four visits to treat these children well and get them started on treatment,” Dr. Hackell said. “It’s something that I recommend people use if they have not already done so to integrate ADHD care into their practices.”
 

Beginning the process

In figuring out how to structure visits, avoid addressing ADHD as a “by-the-way” issue, such as when a parent mentions it at the end of an appointment, Dr. Lessin said. Instead, start with an intake visit to determine whether you’re the right person to evaluate the child and hand out Parent and Teacher Evaluation scales to begin the process. Next, do the evaluation, discuss the process with the family, determine how treatment will work, and then look at comorbidities.

Visit settings can be traditional face-to-face visits, which are particularly helpful for intake visits, Dr. Lessin said, or telehealth, especially during the pandemic. In-person visits allow you more easily to make eye contact with the child and observe the parent and child behaviors and interactions, but telehealth often is adequate for titrating medication, discussing side effects, monitoring, and similar follow-up.

“Coding practices are absolutely necessary to make your practice viable, much less make money,” Dr. Lessin said. “Doing good for people and doing well for yourself are not mutually exclusive. You have to figure out a way to make it work economically for the practice or else you’re just not going to do it.”

He reminded pediatricians to code for evaluation, monitoring scales, and care coordination, and to be prepared for the big change of new coding rules coming in 2021.

“For better or worse, documentation is the key to survival in medical practice these days,” Dr. Lessin said. “This is true for all medical care these days, but it’s particularly true for ADHD because visits are all high intensity codes and should be coded as such.”

Templates are fine, he said, but box-checking isn’t enough; leave space for a narrative that explains the case complexity and decision-making.
 

Training staff is essential

It’s utterly essential to train all office staff, Dr. Lessin said. “I can’t tell you how important this step is because no matter how much you know or how well you understand what you want to do, you’re going to be frustrated at every turn if your staff and colleagues don’t get this stuff.”

That includes training those who make appointments, front desk staff, clinical staff, and practice colleagues regarding coding, scheduling, visit protocols, and similar procedures. Cheat sheets can be helpful here.

“They must understand the structure of the visits, what happens at each visit, the time requirements for each visit, and the standard follow-up,” including, for clinical staff, what handouts and rating scales to use, he said. “And if they aren’t sure what the parents needs or what you want, make sure they know to contact you.”

Colleagues also need to learn to properly document visits to justify coding and complexity, and not dump all patients on you.

One challenge that Dr. Lessin acknowledged as a common problem is that many pediatricians don’t have subspecialists they can refer patients to.

“Sadly, this is true almost everywhere, in rural and in big cities, near big medical centers and only local hospitals,” Dr. Lessin said. “This another reason why I think you need to learn and treat this illness to the extent you can. Your families need you.”

Dr. Hackell particularly appreciated this point, emphasizing again how important it is that pediatricians manage ADHD care of their patients.

“We see their day-to-day life, and that’s where this impacts these kids and families,” he said. “It’s really rewarding to do from my personal experience because you can really make a really big difference in these kids’ lives when they’re younger and even as they get older. When you get the rewards, it makes the work all worthwhile.”

Dr. Lessin and Dr. Hackell said they have no relevant financial disclosures.

Integrating ADHD care into practice work flows is vitally important for all practitioners who care for children, said Herschel Lessin, MD, a senior partner of the Children’s Medical Group in Poughkeepsie, N.Y.

O_Lypa/iStock/Getty Images

Although not necessarily “easy” to do, it’s far less overwhelming than it seems when doctors take the time to thoughtfully set up protocols, train others in the office, and use the ADHD Toolkit sold by the American Academy of Pediatrics, Dr. Lessin told attendees at the annual meeting of the AAP, held virtually this year. Dr. Lessin is a coeditor of the AAP’s ADHD Toolkit 3rd Ed., although he does not receive royalties from it. The toolkit includes patient handouts, clinicians tools, and rating scales that help practices incorporate ADHD care into their practices.

“The biggest complaint is: ‘But I don’t have enough time to do all of this stuff,’ ” Dr. Lessin said. “The reality is, once you’re comfortable with the visits and you know how they progress and flow, they can be done much more quickly.” He emphasized that practices can make money by integrating ADHD care into practice as long as they have a strategic plan and invest the time into training and protocols.

Dr. Lessin gave multiple reasons it’s important to integrate ADHD care into practices, starting with the condition’s prevalence and the importance of building a medical home for patients.

“ADHD affects 8%-10% of your patient population, a truly enormous number, yet many pediatricians do not treat ADHD in their practices, depriving their patients of needed care and depriving themselves from economic benefits of the visits and the revenue,” he said. The pediatrician added that more than 80% of ADHD care takes place in pediatric offices, but much of it is “badly diagnosed and poorly treated” in both primary care and specialty offices.

Jesse Hackell, MD, a private practice pediatrician in a suburb of New York City and vice president of the New York AAP Chapter 3, attended the session and agreed with Dr. Lessin that pediatricians are best suited to manage ADHD over other practitioners.

“One of the things he pointed out is that it’s a pediatric issue,” Dr. Hackell said. “We’re better at this than psychiatrists, than neurologists, than psychologists because we’re really focused on the whole lifestyle of the child, how it impacts them at home, how it impacts them at school, and how it impacts them in the social sphere.”

There’s also been a substantial increase in mental health issues as a proportion of visits, particularly recently with the pandemic and accompanying lockdowns. Youth already have limited access to mental health resources, making general pediatricians’ roles even more important. “Who else is going to provide this much needed service if not pediatricians?” Dr. Lessin asked.

Again, Dr. Hackell agreed, noting that the AAP’s toolkit is especially helpful in providing this care.

“It’s something that pediatricians have often been afraid to deal with and who farm them out to these other specialties, and I don’t think the children are served as well,” Dr. Hackell said. “If you do the right forms and questionnaires, you can actually make it work for the kids and work it for your office, which generates a lot of visits and generates revenue.”
 

Where to start

Dr. Lessin began by recommending that all pediatricians read the AAP’s clinical practice guidelines for ADHD along with its supplemental material (Process of Care Algorithm, and Systemic Barriers to Care of Children and Adolescents with ADHD).

“The first thing is you must educate yourself,” he said. “You have to learn the medicine and what are you able and comfortable doing because few of us were ever trained in our residency programs about ADHD care.”

Providers also need to learn to manage barriers to care, including referral sources and insurance company and medication hassles. Then you need to figure out how to structure the visits, determine the most appropriate visit settings, and learn to document and code appropriately. These are not quick 10-minute visits, Dr. Lessin said. Doctors must schedule enough time for them, although they may be able to do them faster with practice.

Dr. Lessin offered encouraging words for those feeling overwhelmed: “Overcome your anxiety. This is not as hard as it seems. It’s a little bit harder with comorbidities, but many chronic diseases we manage are far worse.”

In addition to reading the guidelines and review articles, seeking out mental health training programs, and learning the medications available, Dr. Lessin told attendees to get comfortable with the fact that a lot of treatment comes down to trial and error.

Again, he emphasized the value of the toolkit, which Dr. Hackell echoed.

“It’s a really nice roadmap to be able to follow and to explain how it requires two or three or four visits to treat these children well and get them started on treatment,” Dr. Hackell said. “It’s something that I recommend people use if they have not already done so to integrate ADHD care into their practices.”
 

Beginning the process

In figuring out how to structure visits, avoid addressing ADHD as a “by-the-way” issue, such as when a parent mentions it at the end of an appointment, Dr. Lessin said. Instead, start with an intake visit to determine whether you’re the right person to evaluate the child and hand out Parent and Teacher Evaluation scales to begin the process. Next, do the evaluation, discuss the process with the family, determine how treatment will work, and then look at comorbidities.

Visit settings can be traditional face-to-face visits, which are particularly helpful for intake visits, Dr. Lessin said, or telehealth, especially during the pandemic. In-person visits allow you more easily to make eye contact with the child and observe the parent and child behaviors and interactions, but telehealth often is adequate for titrating medication, discussing side effects, monitoring, and similar follow-up.

“Coding practices are absolutely necessary to make your practice viable, much less make money,” Dr. Lessin said. “Doing good for people and doing well for yourself are not mutually exclusive. You have to figure out a way to make it work economically for the practice or else you’re just not going to do it.”

He reminded pediatricians to code for evaluation, monitoring scales, and care coordination, and to be prepared for the big change of new coding rules coming in 2021.

“For better or worse, documentation is the key to survival in medical practice these days,” Dr. Lessin said. “This is true for all medical care these days, but it’s particularly true for ADHD because visits are all high intensity codes and should be coded as such.”

Templates are fine, he said, but box-checking isn’t enough; leave space for a narrative that explains the case complexity and decision-making.
 

Training staff is essential

It’s utterly essential to train all office staff, Dr. Lessin said. “I can’t tell you how important this step is because no matter how much you know or how well you understand what you want to do, you’re going to be frustrated at every turn if your staff and colleagues don’t get this stuff.”

That includes training those who make appointments, front desk staff, clinical staff, and practice colleagues regarding coding, scheduling, visit protocols, and similar procedures. Cheat sheets can be helpful here.

“They must understand the structure of the visits, what happens at each visit, the time requirements for each visit, and the standard follow-up,” including, for clinical staff, what handouts and rating scales to use, he said. “And if they aren’t sure what the parents needs or what you want, make sure they know to contact you.”

Colleagues also need to learn to properly document visits to justify coding and complexity, and not dump all patients on you.

One challenge that Dr. Lessin acknowledged as a common problem is that many pediatricians don’t have subspecialists they can refer patients to.

“Sadly, this is true almost everywhere, in rural and in big cities, near big medical centers and only local hospitals,” Dr. Lessin said. “This another reason why I think you need to learn and treat this illness to the extent you can. Your families need you.”

Dr. Hackell particularly appreciated this point, emphasizing again how important it is that pediatricians manage ADHD care of their patients.

“We see their day-to-day life, and that’s where this impacts these kids and families,” he said. “It’s really rewarding to do from my personal experience because you can really make a really big difference in these kids’ lives when they’re younger and even as they get older. When you get the rewards, it makes the work all worthwhile.”

Dr. Lessin and Dr. Hackell said they have no relevant financial disclosures.

The dermMentors™ Resident of Distinction Award™ recognizes top residents in dermatology. DermMentors.org and the dermMentors™ Resident of Distinction Award™ are sponsored by Beiersdorf Inc and administered by DermEd, Inc. The 2020 dermMentors™ Residents of Distinction™ presented new scientific research during the general sessions of the virtual 16th Annual Coastal Dermatology Symposium on October 16, 2020.

Overall Grand Prize
Topical Cantharidin Revisited: A Phase 2 Study Investigating a Commercially Viable Formulation of Cantharidin (VP-102) for the Treatment of Molluscum Contagiosum

Anthony K. Guzman, MD; Jessica L. Garelik, DO; Steven R. Cohen, MD, MPH, Department of Internal Medicine, Division of Dermatology, Albert Einstein College of Medicine, Bronx, New York 
Disclosures: None. 

Background 
Molluscum contagiosum (MC) is a common cutaneous infection caused by a DNA poxvirus, predominantly affecting children. There is a paucity of high-quality evidence on which to make clinical decisions in treating MC.¹ Cantharidin, a topical vesicant historically derived from a blister beetle, is a commonly used treatment for this condition. However, despite the prevalence of its use, cantharidin is not approved by the US Food and Drug Administration, is not standardized in formulation or treatment regimen, and is not always manufactured in accordance with good manufacturing practice (GMP), leading to a lack of commercial availability.^2,3

Objective 
To determine the efficacy and safety of VP-102, a novel, standardized, commercially viable cantharidin formulation produced under GMP for the treatment of MC.

Methods 
We conducted a 12-week, open-label pilot trial at a single outpatient dermatology clinic. Patients aged 2 to 17 years (N=30) with a clinical diagnosis of MC and fewer than 50 lesions were included. Patients were treated with a single-use vial containing a standardized 0.7% w/v cantharidin solution, produced under GMP (VP-102), applied with the wooden end of a cotton swab approximately every 21 days for up to 4 treatments or until complete lesion clearance. Patients were instructed to wash treatment off all lesions at either 6 hours (cohort 1: 14/30, 46.7%) or 24 hours (cohort 2: 16/30, 53.3%), or earlier if notable blistering occurred. Lesion counts and adverse events, including local skin reactions, were documented at each visit. Quality of life also was measured using the Children’s Dermatology Quality of Life Index at baseline and at the end of study (EOS). The primary end point was the percentage of patients achieving total clearance by EOS on day 84. 

Results 
The mean patient age was 5.8 years (range, 2–12 years). A total of 26 patients (86.7%) experienced at least 1 expected local skin reaction, such as blistering or erythema. No serious or unexpected treatment-related adverse events were encountered. A total of 25 patients pooled from both cohorts completed the study. Eleven patients (44.0%) achieved total lesion clearance by EOS. The mean (standard deviation) lesion count was significantly reduced from 23.0 (15.6) at baseline to 6.8 (11.7) at EOS (P<.0001). The mean (standard deviation) Children’s Dermatology Quality of Life Index score was markedly improved from 3.9 (5.6) at baseline to 0.38 (1.3) at EOS (P=.01).

Conclusions 
VP-102 was well tolerated with either a 6- or 24-hour exposure and was associated with a significantly reduced lesion count, improved quality of life, and complete clearance of MC lesions in nearly half of the patients.

References

1. van der Wouden JC, van der Sande R, Kruithof EJ, et al. Interventions for cutaneous molluscum contagiosum. Cochrane Database Syst Rev. 2017;5:CD004767.
2. Coloe J, Morrell DS. Cantharidin use among pediatric dermatologists in the treatment of molluscum contagiosum. Pediatr Dermatol. 2009;26:405-408.
3. Pompei DT, Rezzadeh KS, Viola KV, et al. Cantharidin therapy: practice patterns and attitudes of health care providers. J Am Acad Dermatol. 2013;68:1045-1046.

Up next: Autologous cell therapy for recessive dystrophic epidermolysis bullosa

Phase 1/2a Clinical Trial of Gene-Corrected Autologous Cell Therapy for Recessive Dystrophic Epidermolysis Bullosa

Shaundra Eichstadt, MD, Stanford University Department of Dermatology, Redwood City, California;  Tufts University Medical Center, Boston, Massachusetts 
Disclosures: None. 

Recessive dystrophic epidermolysis bullosa (RDEB) patients have mutations in the COL7A1 gene, thus lacking functional type VII collagen (C7) protein; they have marked skin fragility and blistering. This single-center phase 1/2a open-label study evaluated the long-term efficacy, safety, and patient-reported outcomes in RDEB patients treated with gene-corrected autologous cell therapy (ClinicalTrials.gov identifier NCT01263379). Autologous keratinocytes were isolated from participant skin biopsies. Epidermal sheets were prepared from cells transduced with a retrovirus carrying the full-length human COL7A1 gene. These gene-corrected autologous epidermal sheets measured 5×7 cm (35 cm²) and were transplanted onto 6 wound sites in each of 7 adult participants (N=42 sites) between 2013 and 2017. Participants were followed for 2 to 5 years. No participants experienced any serious related adverse events. Wound healing of 50% or more by Investigator Global Assessment was present in 95% (36/38) of treated wounds versus 0% (0/6) of untreated control wounds at 6 months (P<.0001). At year 1, 68% (26/38) of treated wounds had healing of 50% or more compared with 17% (1/6) of control wounds (P=.025). At year 2, 71% (27/38) of treated wounds had healing of 50% or more compared with 17% (1/6) of control wounds (P=.019). C7 expression persisted up to 2 years posttreatment in 2 participants. Treated wounds with 50% or more wound healing demonstrated improvement in patient-reported pain, itch, and wound durability. This study provides additional data to support the clinically meaningful benefit of treating chronic RDEB wounds with ex vivo, C7 gene-corrected autologous cell therapy. This approach was safe and promoted wound healing that was associated with improved patient-reported outcomes.

Up next: Skin toxicity in metastatic melanoma patients treated with ICIs

Nicholas Gulati, MD, PhD, NYU Grossman School of Medicine, New York, New York
Disclosures: None. 

Immune checkpoint inhibition (ICI) improves survival outcomes for patients with metastatic melanoma, but serious immune-related adverse events requiring intervention with immunosuppressive medications occur in a subset of patients. Skin toxicity (ST) has been reported to be associated with better response to ICI. However, understudied factors, such as ST severity and potential survivor bias, may influence the strength of these observed associations. To examine the potential confounding impact of such variables, we analyzed metastatic melanoma patients enrolled prospectively in a clinicopathological database with protocol-driven follow-up and treated with ICI. We tested the associations between developing ST, stratified as none (n=257), mild (n=86), and severe (n=44), and progression-free survival (PFS) and overall survival in univariable and multivariable analyses. We defined severe ST as a skin event that required treatment with systemic corticosteroids. To account for the possibility of longer survival leading to adverse events instead of the reverse, we treated ST as a time-dependent covariate in an adjusted model. Mild ST was significantly associated with improved PFS and overall survival (P=.001 and P=.018, respectively) in univariable analysis and with improved PFS in multivariable analysis (P=.020). However, these associations lost significance after adjusting for the time from treatment initiation to time of skin event (P>.05). Severe ST was not associated with improved outcomes. Our data reveal the influence of event severity and time to event as covariates in analyzing the relationship between ST and ICI outcomes. Further, we reinforce the importance of identifying baseline predictors of response and toxicity to ICI to optimize treatment selection and prophylactic care when indicated.

Up next: Risk of COVID-19 in patients receiving immunobiologic therapy

Nikolai Klebanov, MD, Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts
Disclosures: None. 

Importance
Data on the risks of immunosuppressive biologics in the context of coronavirus disease 2019 (COVID-19) infection are limited, creating uncertainty for patients and providers whether to continue therapy during the pandemic.

Objective
To investigate whether patients treated with biologics were at an increased risk for COVID-19 infection as well as all-cause mortality once infected. 

Design
A multicenter retrospective study of 7361 patients prescribed biologics and 74,910 matched controls, cross-referenced with COVID-19 infection and all-cause mortality data through June 19, 2020, from the Massachusetts Department of Public Health.

Participants 
Patients with at least 1 prescription for an immunosuppressive biologic in the Mass General Brigham health care system between July 1, 2019, and February 29, 2020. Multivariate logistic regression was used on matched data to calculate the odds ratio (OR) for COVID-19 infection status between patients on biologics and controls, adjusting for age, gender, race, Charlson Comorbidity index (CCI) severity grade, median income, and local infection rate. An analysis adjusting for individual comorbidities was also performed. Multivariate Poisson regression was performed on COVID-19 positive patients to compare the risk for all-cause mortality, adjusting for gender, CCI severity grade, median income, and local COVID-19 rate.

Setting 
Retrospective matched cohort.

Exposure 
Biologic immunosuppressants.

Main Outcomes and Measures 
Odds of COVID-19 diagnosis and all-cause mortality following the diagnosis.

Results 
7,361 patients treated with biologics and 74,910 matched controls were included in the analysis (mean age, 50.6 years; 56.0% women, 84.5% white; mean age-adjusted CCI 2.8). There were 87 (1.2%) infections and 7 deaths (8.0%) in patients treated with biologics and 1063 (1.4%) infections and 71 deaths (6.7%) in the control group. Patients treated with immunosuppressive biologics were not at significantly increased risk of COVID-19 diagnosis (OR 0.88, 95% CI 0.71-1.09; P=.25) or subsequent mortality (OR 1.26, 95% CI 0.57-2.76; P=.57). 

A total of 7361 patients treated with biologics and 74,910 matched controls were included in the analysis (mean age, 50.6 years; 56.0% women and 84.5% white; mean age-adjusted CCI, 2.8). There were 87 (1.2%) infections and 7 deaths (8.0%) in patients treated with biologics, and 1063 (1.4%) infections and 71 deaths (6.7%) in the control group. Patients treated with immunosuppressive biologics were not at increased risk for COVID-19 diagnosis (OR, 0.88; 95% CI, 0.71-1.09; P=.25) or subsequent mortality (OR 1.26; 95% CI 0.57-2.76; P=.57). 

Conclusions and Relevance 
Given an absence of evidence that patients treated with biologics are more susceptible to COVID-19, patients should be encouraged to continue their therapy to prevent disease progression during this pandemic.

Up next: Compliance With Systemic Medications for AD and Psoriasis

Importance
The management of moderate to severe atopic dermatitis (AD) is being revolutionized by the development of novel systemic therapeutics. However, these new therapeutics are being implemented using the same treatment paradigms that are used for psoriasis treatment (ie, patients on systemic medications require indefinite therapy). While use of systemic therapeutics indefinitely is acceptable to many psoriasis patients because psoriasis severity is frequently stable over long periods of time, AD is hallmarked by seasonal flares followed by periods of relative quiescence, making indefinite therapy less attractive to patients with AD. 

Objective
This whole-population cohort study describes systemic medication adherence patterns in AD and psoriasis patients. These patterns are then compared to determine whether systemic medications requiring indefinite therapy are adhered to at similar rates in the AD and psoriasis populations. The aim of this comparison is to assess whether drugs requiring indefinite therapy meet the needs of AD patients requiring systemic treatment.

Design, Setting, and Participants 
This is a retrospective cohort study using the national Veterans Administration (VA) health database to identify all veterans with psoriasis and AD who are receiving care at any VA location. Veterans with psoriasis and AD were identified using International Classification of Diseases, Ninth Revision and Tenth Revision codes. Veterans were included in the study if they received nonsteroidal systemic immunosuppressive or immunomodulatory medications for their psoriasis or AD. 

Main Outcome(s) and Measure(s)
All medications filled at a VA pharmacy are time stamped. This unique data recording allows for real-world adherence to be evaluated by comparing actual medication fill dates to expected medication fill dates based on refill interval. Patients who fill a medication more than 7 days after the expected refill date are classified as nonadherent. We described systemic medication adherence rates and assessed for seasonal variation in adherence patterns for AD and psoriasis patients. Cofounding variables, including history of mental illness, substance use disorder, and patient income, were recorded and included in the analysis. 

Conclusions and Relevance 

This study's unique data source provides insight into the ways adherence patterns differ between individuals with AD and psoriasis, and insights into the ways mental illness, substance use, and poverty affect adherence to systemic therapeutics among dermatology patients with inflammatory skin conditions. 

The dermMentors™ Resident of Distinction Award™ recognizes top residents in dermatology. DermMentors.org and the dermMentors™ Resident of Distinction Award™ are sponsored by Beiersdorf Inc and administered by DermEd, Inc. The 2020 dermMentors™ Residents of Distinction™ presented new scientific research during the general sessions of the virtual 16th Annual Coastal Dermatology Symposium on October 16, 2020.

Overall Grand Prize
Topical Cantharidin Revisited: A Phase 2 Study Investigating a Commercially Viable Formulation of Cantharidin (VP-102) for the Treatment of Molluscum Contagiosum

Anthony K. Guzman, MD; Jessica L. Garelik, DO; Steven R. Cohen, MD, MPH, Department of Internal Medicine, Division of Dermatology, Albert Einstein College of Medicine, Bronx, New York 
Disclosures: None. 

Background 
Molluscum contagiosum (MC) is a common cutaneous infection caused by a DNA poxvirus, predominantly affecting children. There is a paucity of high-quality evidence on which to make clinical decisions in treating MC.¹ Cantharidin, a topical vesicant historically derived from a blister beetle, is a commonly used treatment for this condition. However, despite the prevalence of its use, cantharidin is not approved by the US Food and Drug Administration, is not standardized in formulation or treatment regimen, and is not always manufactured in accordance with good manufacturing practice (GMP), leading to a lack of commercial availability.^2,3

Objective 
To determine the efficacy and safety of VP-102, a novel, standardized, commercially viable cantharidin formulation produced under GMP for the treatment of MC.

Methods 
We conducted a 12-week, open-label pilot trial at a single outpatient dermatology clinic. Patients aged 2 to 17 years (N=30) with a clinical diagnosis of MC and fewer than 50 lesions were included. Patients were treated with a single-use vial containing a standardized 0.7% w/v cantharidin solution, produced under GMP (VP-102), applied with the wooden end of a cotton swab approximately every 21 days for up to 4 treatments or until complete lesion clearance. Patients were instructed to wash treatment off all lesions at either 6 hours (cohort 1: 14/30, 46.7%) or 24 hours (cohort 2: 16/30, 53.3%), or earlier if notable blistering occurred. Lesion counts and adverse events, including local skin reactions, were documented at each visit. Quality of life also was measured using the Children’s Dermatology Quality of Life Index at baseline and at the end of study (EOS). The primary end point was the percentage of patients achieving total clearance by EOS on day 84. 

Results 
The mean patient age was 5.8 years (range, 2–12 years). A total of 26 patients (86.7%) experienced at least 1 expected local skin reaction, such as blistering or erythema. No serious or unexpected treatment-related adverse events were encountered. A total of 25 patients pooled from both cohorts completed the study. Eleven patients (44.0%) achieved total lesion clearance by EOS. The mean (standard deviation) lesion count was significantly reduced from 23.0 (15.6) at baseline to 6.8 (11.7) at EOS (P<.0001). The mean (standard deviation) Children’s Dermatology Quality of Life Index score was markedly improved from 3.9 (5.6) at baseline to 0.38 (1.3) at EOS (P=.01).

Conclusions 
VP-102 was well tolerated with either a 6- or 24-hour exposure and was associated with a significantly reduced lesion count, improved quality of life, and complete clearance of MC lesions in nearly half of the patients.

References

1. van der Wouden JC, van der Sande R, Kruithof EJ, et al. Interventions for cutaneous molluscum contagiosum. Cochrane Database Syst Rev. 2017;5:CD004767.
2. Coloe J, Morrell DS. Cantharidin use among pediatric dermatologists in the treatment of molluscum contagiosum. Pediatr Dermatol. 2009;26:405-408.
3. Pompei DT, Rezzadeh KS, Viola KV, et al. Cantharidin therapy: practice patterns and attitudes of health care providers. J Am Acad Dermatol. 2013;68:1045-1046.

Up next: Autologous cell therapy for recessive dystrophic epidermolysis bullosa

Phase 1/2a Clinical Trial of Gene-Corrected Autologous Cell Therapy for Recessive Dystrophic Epidermolysis Bullosa

Shaundra Eichstadt, MD, Stanford University Department of Dermatology, Redwood City, California;  Tufts University Medical Center, Boston, Massachusetts 
Disclosures: None. 

Recessive dystrophic epidermolysis bullosa (RDEB) patients have mutations in the COL7A1 gene, thus lacking functional type VII collagen (C7) protein; they have marked skin fragility and blistering. This single-center phase 1/2a open-label study evaluated the long-term efficacy, safety, and patient-reported outcomes in RDEB patients treated with gene-corrected autologous cell therapy (ClinicalTrials.gov identifier NCT01263379). Autologous keratinocytes were isolated from participant skin biopsies. Epidermal sheets were prepared from cells transduced with a retrovirus carrying the full-length human COL7A1 gene. These gene-corrected autologous epidermal sheets measured 5×7 cm (35 cm²) and were transplanted onto 6 wound sites in each of 7 adult participants (N=42 sites) between 2013 and 2017. Participants were followed for 2 to 5 years. No participants experienced any serious related adverse events. Wound healing of 50% or more by Investigator Global Assessment was present in 95% (36/38) of treated wounds versus 0% (0/6) of untreated control wounds at 6 months (P<.0001). At year 1, 68% (26/38) of treated wounds had healing of 50% or more compared with 17% (1/6) of control wounds (P=.025). At year 2, 71% (27/38) of treated wounds had healing of 50% or more compared with 17% (1/6) of control wounds (P=.019). C7 expression persisted up to 2 years posttreatment in 2 participants. Treated wounds with 50% or more wound healing demonstrated improvement in patient-reported pain, itch, and wound durability. This study provides additional data to support the clinically meaningful benefit of treating chronic RDEB wounds with ex vivo, C7 gene-corrected autologous cell therapy. This approach was safe and promoted wound healing that was associated with improved patient-reported outcomes.

Up next: Skin toxicity in metastatic melanoma patients treated with ICIs

Nicholas Gulati, MD, PhD, NYU Grossman School of Medicine, New York, New York
Disclosures: None. 

Immune checkpoint inhibition (ICI) improves survival outcomes for patients with metastatic melanoma, but serious immune-related adverse events requiring intervention with immunosuppressive medications occur in a subset of patients. Skin toxicity (ST) has been reported to be associated with better response to ICI. However, understudied factors, such as ST severity and potential survivor bias, may influence the strength of these observed associations. To examine the potential confounding impact of such variables, we analyzed metastatic melanoma patients enrolled prospectively in a clinicopathological database with protocol-driven follow-up and treated with ICI. We tested the associations between developing ST, stratified as none (n=257), mild (n=86), and severe (n=44), and progression-free survival (PFS) and overall survival in univariable and multivariable analyses. We defined severe ST as a skin event that required treatment with systemic corticosteroids. To account for the possibility of longer survival leading to adverse events instead of the reverse, we treated ST as a time-dependent covariate in an adjusted model. Mild ST was significantly associated with improved PFS and overall survival (P=.001 and P=.018, respectively) in univariable analysis and with improved PFS in multivariable analysis (P=.020). However, these associations lost significance after adjusting for the time from treatment initiation to time of skin event (P>.05). Severe ST was not associated with improved outcomes. Our data reveal the influence of event severity and time to event as covariates in analyzing the relationship between ST and ICI outcomes. Further, we reinforce the importance of identifying baseline predictors of response and toxicity to ICI to optimize treatment selection and prophylactic care when indicated.

Up next: Risk of COVID-19 in patients receiving immunobiologic therapy

Nikolai Klebanov, MD, Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts
Disclosures: None. 

Importance
Data on the risks of immunosuppressive biologics in the context of coronavirus disease 2019 (COVID-19) infection are limited, creating uncertainty for patients and providers whether to continue therapy during the pandemic.

Objective
To investigate whether patients treated with biologics were at an increased risk for COVID-19 infection as well as all-cause mortality once infected. 

Design
A multicenter retrospective study of 7361 patients prescribed biologics and 74,910 matched controls, cross-referenced with COVID-19 infection and all-cause mortality data through June 19, 2020, from the Massachusetts Department of Public Health.

Participants 
Patients with at least 1 prescription for an immunosuppressive biologic in the Mass General Brigham health care system between July 1, 2019, and February 29, 2020. Multivariate logistic regression was used on matched data to calculate the odds ratio (OR) for COVID-19 infection status between patients on biologics and controls, adjusting for age, gender, race, Charlson Comorbidity index (CCI) severity grade, median income, and local infection rate. An analysis adjusting for individual comorbidities was also performed. Multivariate Poisson regression was performed on COVID-19 positive patients to compare the risk for all-cause mortality, adjusting for gender, CCI severity grade, median income, and local COVID-19 rate.

Setting 
Retrospective matched cohort.

Exposure 
Biologic immunosuppressants.

Main Outcomes and Measures 
Odds of COVID-19 diagnosis and all-cause mortality following the diagnosis.

Results 
7,361 patients treated with biologics and 74,910 matched controls were included in the analysis (mean age, 50.6 years; 56.0% women, 84.5% white; mean age-adjusted CCI 2.8). There were 87 (1.2%) infections and 7 deaths (8.0%) in patients treated with biologics and 1063 (1.4%) infections and 71 deaths (6.7%) in the control group. Patients treated with immunosuppressive biologics were not at significantly increased risk of COVID-19 diagnosis (OR 0.88, 95% CI 0.71-1.09; P=.25) or subsequent mortality (OR 1.26, 95% CI 0.57-2.76; P=.57). 

A total of 7361 patients treated with biologics and 74,910 matched controls were included in the analysis (mean age, 50.6 years; 56.0% women and 84.5% white; mean age-adjusted CCI, 2.8). There were 87 (1.2%) infections and 7 deaths (8.0%) in patients treated with biologics, and 1063 (1.4%) infections and 71 deaths (6.7%) in the control group. Patients treated with immunosuppressive biologics were not at increased risk for COVID-19 diagnosis (OR, 0.88; 95% CI, 0.71-1.09; P=.25) or subsequent mortality (OR 1.26; 95% CI 0.57-2.76; P=.57). 

Conclusions and Relevance 
Given an absence of evidence that patients treated with biologics are more susceptible to COVID-19, patients should be encouraged to continue their therapy to prevent disease progression during this pandemic.

Up next: Compliance With Systemic Medications for AD and Psoriasis

Importance
The management of moderate to severe atopic dermatitis (AD) is being revolutionized by the development of novel systemic therapeutics. However, these new therapeutics are being implemented using the same treatment paradigms that are used for psoriasis treatment (ie, patients on systemic medications require indefinite therapy). While use of systemic therapeutics indefinitely is acceptable to many psoriasis patients because psoriasis severity is frequently stable over long periods of time, AD is hallmarked by seasonal flares followed by periods of relative quiescence, making indefinite therapy less attractive to patients with AD. 

Objective
This whole-population cohort study describes systemic medication adherence patterns in AD and psoriasis patients. These patterns are then compared to determine whether systemic medications requiring indefinite therapy are adhered to at similar rates in the AD and psoriasis populations. The aim of this comparison is to assess whether drugs requiring indefinite therapy meet the needs of AD patients requiring systemic treatment.

Design, Setting, and Participants 
This is a retrospective cohort study using the national Veterans Administration (VA) health database to identify all veterans with psoriasis and AD who are receiving care at any VA location. Veterans with psoriasis and AD were identified using International Classification of Diseases, Ninth Revision and Tenth Revision codes. Veterans were included in the study if they received nonsteroidal systemic immunosuppressive or immunomodulatory medications for their psoriasis or AD. 

Main Outcome(s) and Measure(s)
All medications filled at a VA pharmacy are time stamped. This unique data recording allows for real-world adherence to be evaluated by comparing actual medication fill dates to expected medication fill dates based on refill interval. Patients who fill a medication more than 7 days after the expected refill date are classified as nonadherent. We described systemic medication adherence rates and assessed for seasonal variation in adherence patterns for AD and psoriasis patients. Cofounding variables, including history of mental illness, substance use disorder, and patient income, were recorded and included in the analysis. 

Conclusions and Relevance 

This study's unique data source provides insight into the ways adherence patterns differ between individuals with AD and psoriasis, and insights into the ways mental illness, substance use, and poverty affect adherence to systemic therapeutics among dermatology patients with inflammatory skin conditions. 

The dermMentors™ Resident of Distinction Award™ recognizes top residents in dermatology. DermMentors.org and the dermMentors™ Resident of Distinction Award™ are sponsored by Beiersdorf Inc and administered by DermEd, Inc. The 2020 dermMentors™ Residents of Distinction™ presented new scientific research during the general sessions of the virtual 16th Annual Coastal Dermatology Symposium on October 16, 2020.

Overall Grand Prize
Topical Cantharidin Revisited: A Phase 2 Study Investigating a Commercially Viable Formulation of Cantharidin (VP-102) for the Treatment of Molluscum Contagiosum

Anthony K. Guzman, MD; Jessica L. Garelik, DO; Steven R. Cohen, MD, MPH, Department of Internal Medicine, Division of Dermatology, Albert Einstein College of Medicine, Bronx, New York 
Disclosures: None. 

Background 
Molluscum contagiosum (MC) is a common cutaneous infection caused by a DNA poxvirus, predominantly affecting children. There is a paucity of high-quality evidence on which to make clinical decisions in treating MC.¹ Cantharidin, a topical vesicant historically derived from a blister beetle, is a commonly used treatment for this condition. However, despite the prevalence of its use, cantharidin is not approved by the US Food and Drug Administration, is not standardized in formulation or treatment regimen, and is not always manufactured in accordance with good manufacturing practice (GMP), leading to a lack of commercial availability.^2,3

Objective 
To determine the efficacy and safety of VP-102, a novel, standardized, commercially viable cantharidin formulation produced under GMP for the treatment of MC.

Methods 
We conducted a 12-week, open-label pilot trial at a single outpatient dermatology clinic. Patients aged 2 to 17 years (N=30) with a clinical diagnosis of MC and fewer than 50 lesions were included. Patients were treated with a single-use vial containing a standardized 0.7% w/v cantharidin solution, produced under GMP (VP-102), applied with the wooden end of a cotton swab approximately every 21 days for up to 4 treatments or until complete lesion clearance. Patients were instructed to wash treatment off all lesions at either 6 hours (cohort 1: 14/30, 46.7%) or 24 hours (cohort 2: 16/30, 53.3%), or earlier if notable blistering occurred. Lesion counts and adverse events, including local skin reactions, were documented at each visit. Quality of life also was measured using the Children’s Dermatology Quality of Life Index at baseline and at the end of study (EOS). The primary end point was the percentage of patients achieving total clearance by EOS on day 84. 

Results 
The mean patient age was 5.8 years (range, 2–12 years). A total of 26 patients (86.7%) experienced at least 1 expected local skin reaction, such as blistering or erythema. No serious or unexpected treatment-related adverse events were encountered. A total of 25 patients pooled from both cohorts completed the study. Eleven patients (44.0%) achieved total lesion clearance by EOS. The mean (standard deviation) lesion count was significantly reduced from 23.0 (15.6) at baseline to 6.8 (11.7) at EOS (P<.0001). The mean (standard deviation) Children’s Dermatology Quality of Life Index score was markedly improved from 3.9 (5.6) at baseline to 0.38 (1.3) at EOS (P=.01).

Conclusions 
VP-102 was well tolerated with either a 6- or 24-hour exposure and was associated with a significantly reduced lesion count, improved quality of life, and complete clearance of MC lesions in nearly half of the patients.

References

1. van der Wouden JC, van der Sande R, Kruithof EJ, et al. Interventions for cutaneous molluscum contagiosum. Cochrane Database Syst Rev. 2017;5:CD004767.
2. Coloe J, Morrell DS. Cantharidin use among pediatric dermatologists in the treatment of molluscum contagiosum. Pediatr Dermatol. 2009;26:405-408.
3. Pompei DT, Rezzadeh KS, Viola KV, et al. Cantharidin therapy: practice patterns and attitudes of health care providers. J Am Acad Dermatol. 2013;68:1045-1046.

Up next: Autologous cell therapy for recessive dystrophic epidermolysis bullosa

Phase 1/2a Clinical Trial of Gene-Corrected Autologous Cell Therapy for Recessive Dystrophic Epidermolysis Bullosa

Shaundra Eichstadt, MD, Stanford University Department of Dermatology, Redwood City, California;  Tufts University Medical Center, Boston, Massachusetts 
Disclosures: None. 

Recessive dystrophic epidermolysis bullosa (RDEB) patients have mutations in the COL7A1 gene, thus lacking functional type VII collagen (C7) protein; they have marked skin fragility and blistering. This single-center phase 1/2a open-label study evaluated the long-term efficacy, safety, and patient-reported outcomes in RDEB patients treated with gene-corrected autologous cell therapy (ClinicalTrials.gov identifier NCT01263379). Autologous keratinocytes were isolated from participant skin biopsies. Epidermal sheets were prepared from cells transduced with a retrovirus carrying the full-length human COL7A1 gene. These gene-corrected autologous epidermal sheets measured 5×7 cm (35 cm²) and were transplanted onto 6 wound sites in each of 7 adult participants (N=42 sites) between 2013 and 2017. Participants were followed for 2 to 5 years. No participants experienced any serious related adverse events. Wound healing of 50% or more by Investigator Global Assessment was present in 95% (36/38) of treated wounds versus 0% (0/6) of untreated control wounds at 6 months (P<.0001). At year 1, 68% (26/38) of treated wounds had healing of 50% or more compared with 17% (1/6) of control wounds (P=.025). At year 2, 71% (27/38) of treated wounds had healing of 50% or more compared with 17% (1/6) of control wounds (P=.019). C7 expression persisted up to 2 years posttreatment in 2 participants. Treated wounds with 50% or more wound healing demonstrated improvement in patient-reported pain, itch, and wound durability. This study provides additional data to support the clinically meaningful benefit of treating chronic RDEB wounds with ex vivo, C7 gene-corrected autologous cell therapy. This approach was safe and promoted wound healing that was associated with improved patient-reported outcomes.

Up next: Skin toxicity in metastatic melanoma patients treated with ICIs

Nicholas Gulati, MD, PhD, NYU Grossman School of Medicine, New York, New York
Disclosures: None. 

Immune checkpoint inhibition (ICI) improves survival outcomes for patients with metastatic melanoma, but serious immune-related adverse events requiring intervention with immunosuppressive medications occur in a subset of patients. Skin toxicity (ST) has been reported to be associated with better response to ICI. However, understudied factors, such as ST severity and potential survivor bias, may influence the strength of these observed associations. To examine the potential confounding impact of such variables, we analyzed metastatic melanoma patients enrolled prospectively in a clinicopathological database with protocol-driven follow-up and treated with ICI. We tested the associations between developing ST, stratified as none (n=257), mild (n=86), and severe (n=44), and progression-free survival (PFS) and overall survival in univariable and multivariable analyses. We defined severe ST as a skin event that required treatment with systemic corticosteroids. To account for the possibility of longer survival leading to adverse events instead of the reverse, we treated ST as a time-dependent covariate in an adjusted model. Mild ST was significantly associated with improved PFS and overall survival (P=.001 and P=.018, respectively) in univariable analysis and with improved PFS in multivariable analysis (P=.020). However, these associations lost significance after adjusting for the time from treatment initiation to time of skin event (P>.05). Severe ST was not associated with improved outcomes. Our data reveal the influence of event severity and time to event as covariates in analyzing the relationship between ST and ICI outcomes. Further, we reinforce the importance of identifying baseline predictors of response and toxicity to ICI to optimize treatment selection and prophylactic care when indicated.

Up next: Risk of COVID-19 in patients receiving immunobiologic therapy

Nikolai Klebanov, MD, Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts
Disclosures: None. 

Importance
Data on the risks of immunosuppressive biologics in the context of coronavirus disease 2019 (COVID-19) infection are limited, creating uncertainty for patients and providers whether to continue therapy during the pandemic.

Objective
To investigate whether patients treated with biologics were at an increased risk for COVID-19 infection as well as all-cause mortality once infected. 

Design
A multicenter retrospective study of 7361 patients prescribed biologics and 74,910 matched controls, cross-referenced with COVID-19 infection and all-cause mortality data through June 19, 2020, from the Massachusetts Department of Public Health.

Participants 
Patients with at least 1 prescription for an immunosuppressive biologic in the Mass General Brigham health care system between July 1, 2019, and February 29, 2020. Multivariate logistic regression was used on matched data to calculate the odds ratio (OR) for COVID-19 infection status between patients on biologics and controls, adjusting for age, gender, race, Charlson Comorbidity index (CCI) severity grade, median income, and local infection rate. An analysis adjusting for individual comorbidities was also performed. Multivariate Poisson regression was performed on COVID-19 positive patients to compare the risk for all-cause mortality, adjusting for gender, CCI severity grade, median income, and local COVID-19 rate.

Setting 
Retrospective matched cohort.

Exposure 
Biologic immunosuppressants.

Main Outcomes and Measures 
Odds of COVID-19 diagnosis and all-cause mortality following the diagnosis.

Results 
7,361 patients treated with biologics and 74,910 matched controls were included in the analysis (mean age, 50.6 years; 56.0% women, 84.5% white; mean age-adjusted CCI 2.8). There were 87 (1.2%) infections and 7 deaths (8.0%) in patients treated with biologics and 1063 (1.4%) infections and 71 deaths (6.7%) in the control group. Patients treated with immunosuppressive biologics were not at significantly increased risk of COVID-19 diagnosis (OR 0.88, 95% CI 0.71-1.09; P=.25) or subsequent mortality (OR 1.26, 95% CI 0.57-2.76; P=.57). 

A total of 7361 patients treated with biologics and 74,910 matched controls were included in the analysis (mean age, 50.6 years; 56.0% women and 84.5% white; mean age-adjusted CCI, 2.8). There were 87 (1.2%) infections and 7 deaths (8.0%) in patients treated with biologics, and 1063 (1.4%) infections and 71 deaths (6.7%) in the control group. Patients treated with immunosuppressive biologics were not at increased risk for COVID-19 diagnosis (OR, 0.88; 95% CI, 0.71-1.09; P=.25) or subsequent mortality (OR 1.26; 95% CI 0.57-2.76; P=.57). 

Conclusions and Relevance 
Given an absence of evidence that patients treated with biologics are more susceptible to COVID-19, patients should be encouraged to continue their therapy to prevent disease progression during this pandemic.

Up next: Compliance With Systemic Medications for AD and Psoriasis

Importance
The management of moderate to severe atopic dermatitis (AD) is being revolutionized by the development of novel systemic therapeutics. However, these new therapeutics are being implemented using the same treatment paradigms that are used for psoriasis treatment (ie, patients on systemic medications require indefinite therapy). While use of systemic therapeutics indefinitely is acceptable to many psoriasis patients because psoriasis severity is frequently stable over long periods of time, AD is hallmarked by seasonal flares followed by periods of relative quiescence, making indefinite therapy less attractive to patients with AD. 

Objective
This whole-population cohort study describes systemic medication adherence patterns in AD and psoriasis patients. These patterns are then compared to determine whether systemic medications requiring indefinite therapy are adhered to at similar rates in the AD and psoriasis populations. The aim of this comparison is to assess whether drugs requiring indefinite therapy meet the needs of AD patients requiring systemic treatment.

Design, Setting, and Participants 
This is a retrospective cohort study using the national Veterans Administration (VA) health database to identify all veterans with psoriasis and AD who are receiving care at any VA location. Veterans with psoriasis and AD were identified using International Classification of Diseases, Ninth Revision and Tenth Revision codes. Veterans were included in the study if they received nonsteroidal systemic immunosuppressive or immunomodulatory medications for their psoriasis or AD. 

Main Outcome(s) and Measure(s)
All medications filled at a VA pharmacy are time stamped. This unique data recording allows for real-world adherence to be evaluated by comparing actual medication fill dates to expected medication fill dates based on refill interval. Patients who fill a medication more than 7 days after the expected refill date are classified as nonadherent. We described systemic medication adherence rates and assessed for seasonal variation in adherence patterns for AD and psoriasis patients. Cofounding variables, including history of mental illness, substance use disorder, and patient income, were recorded and included in the analysis. 

Conclusions and Relevance 

This study's unique data source provides insight into the ways adherence patterns differ between individuals with AD and psoriasis, and insights into the ways mental illness, substance use, and poverty affect adherence to systemic therapeutics among dermatology patients with inflammatory skin conditions. 

 
The dermMentors™ Resident of Distinction Award™ was presented to 5 dermatology residents at the virtual 16th Annual Coastal Dermatology Symposium, October 15–16, 2020. Recipients of the award include Shaundra Eichstadt, MD, Stanford University Department of Dermatology, Redwood City, California, and  Tufts University Medical Center, Boston, Massachusetts; Nicholas Gulati, MD, PhD, NYU Grossman School of Medicine, New York, New York; Anthony K. Guzman, MD, Albert Einstein College of Medicine, Bronx, New York; Nikolai Klebanov, MD, Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts; and Reid Waldman, MD, University of Connecticut, Farmington. The residents presented their research during the general sessions on October 16, 2020.

The overall grand prize was awarded to Dr. Guzman for his research entitled, “Topical Cantharidin Revisited: A Phase 2 Study Investigating a Commercially Viable Formulation of Cantharidin (VP-102) for the Treatment of Molluscum Contagiosum.” Dr. Guzman presented the results of a 12-week, open-label pilot trial at a single outpatient dermatology clinic to determine the efficacy and safety of VP-102, a novel, standardized, commercially viable cantharidin formulation produced under good manufacturing practice for the treatment of molluscum contagiosum. “VP-102 was well tolerated with either a 6- or 24-hour exposure and was associated with a significantly reduced lesion count, improved quality of life, and complete clearance of MC lesions in nearly half of the patients,” Dr. Guzman reported.

Presentations by the other residents included results of a clinical trial of gene-corrected autologous cell therapy for recessive dystrophic epidermolysis bullosa (Dr. Eichstadt), an analysis of the association between skin toxicity and better response in melanoma patients treated with immune checkpoint inhibitors (Dr. Gulati), a study of the risks of COVID-19 infection and mortality for patients on biologics (Dr. Klebanov), and a comparison of compliance rates of atopic dermatitis patients on systemic medications with those of psoriasis patients on systemic medications (Dr. Waldman). Access all of the abstracts presented by the top residents here. 

The dermMentors™ Resident of Distinction Award™ recognizes top residents in dermatology. DermMentors.org and the dermMentors™ Resident of Distinction Award™ are sponsored by Beiersdorf Inc and administered by DermEd, Inc. The 2020 dermMentors™ Residents of Distinction™ presented new scientific research during the general sessions of the virtual 16th Annual Coastal Dermatology Symposium on October 16, 2020.

 
The dermMentors™ Resident of Distinction Award™ was presented to 5 dermatology residents at the virtual 16th Annual Coastal Dermatology Symposium, October 15–16, 2020. Recipients of the award include Shaundra Eichstadt, MD, Stanford University Department of Dermatology, Redwood City, California, and  Tufts University Medical Center, Boston, Massachusetts; Nicholas Gulati, MD, PhD, NYU Grossman School of Medicine, New York, New York; Anthony K. Guzman, MD, Albert Einstein College of Medicine, Bronx, New York; Nikolai Klebanov, MD, Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts; and Reid Waldman, MD, University of Connecticut, Farmington. The residents presented their research during the general sessions on October 16, 2020.

The overall grand prize was awarded to Dr. Guzman for his research entitled, “Topical Cantharidin Revisited: A Phase 2 Study Investigating a Commercially Viable Formulation of Cantharidin (VP-102) for the Treatment of Molluscum Contagiosum.” Dr. Guzman presented the results of a 12-week, open-label pilot trial at a single outpatient dermatology clinic to determine the efficacy and safety of VP-102, a novel, standardized, commercially viable cantharidin formulation produced under good manufacturing practice for the treatment of molluscum contagiosum. “VP-102 was well tolerated with either a 6- or 24-hour exposure and was associated with a significantly reduced lesion count, improved quality of life, and complete clearance of MC lesions in nearly half of the patients,” Dr. Guzman reported.

Presentations by the other residents included results of a clinical trial of gene-corrected autologous cell therapy for recessive dystrophic epidermolysis bullosa (Dr. Eichstadt), an analysis of the association between skin toxicity and better response in melanoma patients treated with immune checkpoint inhibitors (Dr. Gulati), a study of the risks of COVID-19 infection and mortality for patients on biologics (Dr. Klebanov), and a comparison of compliance rates of atopic dermatitis patients on systemic medications with those of psoriasis patients on systemic medications (Dr. Waldman). Access all of the abstracts presented by the top residents here. 

The dermMentors™ Resident of Distinction Award™ recognizes top residents in dermatology. DermMentors.org and the dermMentors™ Resident of Distinction Award™ are sponsored by Beiersdorf Inc and administered by DermEd, Inc. The 2020 dermMentors™ Residents of Distinction™ presented new scientific research during the general sessions of the virtual 16th Annual Coastal Dermatology Symposium on October 16, 2020.

 
The dermMentors™ Resident of Distinction Award™ was presented to 5 dermatology residents at the virtual 16th Annual Coastal Dermatology Symposium, October 15–16, 2020. Recipients of the award include Shaundra Eichstadt, MD, Stanford University Department of Dermatology, Redwood City, California, and  Tufts University Medical Center, Boston, Massachusetts; Nicholas Gulati, MD, PhD, NYU Grossman School of Medicine, New York, New York; Anthony K. Guzman, MD, Albert Einstein College of Medicine, Bronx, New York; Nikolai Klebanov, MD, Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts; and Reid Waldman, MD, University of Connecticut, Farmington. The residents presented their research during the general sessions on October 16, 2020.

The overall grand prize was awarded to Dr. Guzman for his research entitled, “Topical Cantharidin Revisited: A Phase 2 Study Investigating a Commercially Viable Formulation of Cantharidin (VP-102) for the Treatment of Molluscum Contagiosum.” Dr. Guzman presented the results of a 12-week, open-label pilot trial at a single outpatient dermatology clinic to determine the efficacy and safety of VP-102, a novel, standardized, commercially viable cantharidin formulation produced under good manufacturing practice for the treatment of molluscum contagiosum. “VP-102 was well tolerated with either a 6- or 24-hour exposure and was associated with a significantly reduced lesion count, improved quality of life, and complete clearance of MC lesions in nearly half of the patients,” Dr. Guzman reported.

Presentations by the other residents included results of a clinical trial of gene-corrected autologous cell therapy for recessive dystrophic epidermolysis bullosa (Dr. Eichstadt), an analysis of the association between skin toxicity and better response in melanoma patients treated with immune checkpoint inhibitors (Dr. Gulati), a study of the risks of COVID-19 infection and mortality for patients on biologics (Dr. Klebanov), and a comparison of compliance rates of atopic dermatitis patients on systemic medications with those of psoriasis patients on systemic medications (Dr. Waldman). Access all of the abstracts presented by the top residents here. 

The dermMentors™ Resident of Distinction Award™ recognizes top residents in dermatology. DermMentors.org and the dermMentors™ Resident of Distinction Award™ are sponsored by Beiersdorf Inc and administered by DermEd, Inc. The 2020 dermMentors™ Residents of Distinction™ presented new scientific research during the general sessions of the virtual 16th Annual Coastal Dermatology Symposium on October 16, 2020.

Disparities driven by socioeconomic factors have been shown to affect outcomes for patients with a variety of cancer types. Researchers found that this was also true for patients with multiple myeloma, according to a report published in Hematology/Oncology and Stem Cell Therapy.

In particular, survival was affected by a variety of socioeconomic factors.

Researchers conducting the study queried the National Cancer Database for patients diagnosed with multiple myeloma between 2004 and 2016. Only those 56,102 patients who received systemic therapy as the first-line treatment were included, according to Thejus T. Jayakrishnan, MD, of Allegheny Health Network, Pittsburgh, and colleagues.

Enrollment rates for therapy were calculated using receiving systemic therapy as the incident event of interest (numerator) over time to initiation of therapy (denominator). The incident rate ratios were analyzed using Poisson regression. A multivariate Cox proportional hazards model was used for survival analysis of 50,543 patients, and differences were determined as hazard ratios.

Significant differences

The study showed that therapy enrollment was significantly affected by race and sex (P < .005), with the enrollment rate for women and for non-Hispanic Blacks both being lower versus men and non-Hispanic Whites, respectively.

Advanced age, earlier year of diagnosis, lack of insurance or Medicaid, and higher comorbidity were found to be associated with poor survival (HR >1), whereas being a woman or a non-Hispanic Black (who were speculated to have more favorable cytogenetic profiles), having a higher income, and having treatment at an academic center were all associated with improved survival (each category at HR <1).

“Disparities in [multiple myeloma] exist and are caused by a complex interplay of multiple factors, with socioeconomic factors such as insurance and income playing a dominant role. The disparities not only exact high human cost but also negatively impact the economics of health care,” the researchers concluded.

The study was not funded and the authors reported that they had no relevant disclosures.

[email protected]

SOURCE: Jayakrishnan TT et al. Hematol Oncol Stem Cell Ther. 2020 Oct 10. doi: 10.1016/j.hemonc.2020.09.005.

Disparities driven by socioeconomic factors have been shown to affect outcomes for patients with a variety of cancer types. Researchers found that this was also true for patients with multiple myeloma, according to a report published in Hematology/Oncology and Stem Cell Therapy.

In particular, survival was affected by a variety of socioeconomic factors.

Researchers conducting the study queried the National Cancer Database for patients diagnosed with multiple myeloma between 2004 and 2016. Only those 56,102 patients who received systemic therapy as the first-line treatment were included, according to Thejus T. Jayakrishnan, MD, of Allegheny Health Network, Pittsburgh, and colleagues.

Enrollment rates for therapy were calculated using receiving systemic therapy as the incident event of interest (numerator) over time to initiation of therapy (denominator). The incident rate ratios were analyzed using Poisson regression. A multivariate Cox proportional hazards model was used for survival analysis of 50,543 patients, and differences were determined as hazard ratios.

Significant differences

The study showed that therapy enrollment was significantly affected by race and sex (P < .005), with the enrollment rate for women and for non-Hispanic Blacks both being lower versus men and non-Hispanic Whites, respectively.

Advanced age, earlier year of diagnosis, lack of insurance or Medicaid, and higher comorbidity were found to be associated with poor survival (HR >1), whereas being a woman or a non-Hispanic Black (who were speculated to have more favorable cytogenetic profiles), having a higher income, and having treatment at an academic center were all associated with improved survival (each category at HR <1).

“Disparities in [multiple myeloma] exist and are caused by a complex interplay of multiple factors, with socioeconomic factors such as insurance and income playing a dominant role. The disparities not only exact high human cost but also negatively impact the economics of health care,” the researchers concluded.

The study was not funded and the authors reported that they had no relevant disclosures.

[email protected]

SOURCE: Jayakrishnan TT et al. Hematol Oncol Stem Cell Ther. 2020 Oct 10. doi: 10.1016/j.hemonc.2020.09.005.

Disparities driven by socioeconomic factors have been shown to affect outcomes for patients with a variety of cancer types. Researchers found that this was also true for patients with multiple myeloma, according to a report published in Hematology/Oncology and Stem Cell Therapy.

In particular, survival was affected by a variety of socioeconomic factors.

Researchers conducting the study queried the National Cancer Database for patients diagnosed with multiple myeloma between 2004 and 2016. Only those 56,102 patients who received systemic therapy as the first-line treatment were included, according to Thejus T. Jayakrishnan, MD, of Allegheny Health Network, Pittsburgh, and colleagues.

Enrollment rates for therapy were calculated using receiving systemic therapy as the incident event of interest (numerator) over time to initiation of therapy (denominator). The incident rate ratios were analyzed using Poisson regression. A multivariate Cox proportional hazards model was used for survival analysis of 50,543 patients, and differences were determined as hazard ratios.

Significant differences

The study showed that therapy enrollment was significantly affected by race and sex (P < .005), with the enrollment rate for women and for non-Hispanic Blacks both being lower versus men and non-Hispanic Whites, respectively.

Advanced age, earlier year of diagnosis, lack of insurance or Medicaid, and higher comorbidity were found to be associated with poor survival (HR >1), whereas being a woman or a non-Hispanic Black (who were speculated to have more favorable cytogenetic profiles), having a higher income, and having treatment at an academic center were all associated with improved survival (each category at HR <1).

“Disparities in [multiple myeloma] exist and are caused by a complex interplay of multiple factors, with socioeconomic factors such as insurance and income playing a dominant role. The disparities not only exact high human cost but also negatively impact the economics of health care,” the researchers concluded.

The study was not funded and the authors reported that they had no relevant disclosures.

[email protected]

SOURCE: Jayakrishnan TT et al. Hematol Oncol Stem Cell Ther. 2020 Oct 10. doi: 10.1016/j.hemonc.2020.09.005.

Although it appeared that the hair loss was preceded by some dry skin, the patch of hair loss was smooth and nonscarring, consistent with a diagnosis of alopecia areata (AA).

AA typically is found on the scalp in solitary areas but can affect the whole body, including the eyelashes and eyebrows. Affected hair typically is narrower at the proximal end, resembling an exclamation point, as the hair fails to grow and falls out. Sometimes, patches of alopecia may coalesce into a larger area. Nail changes may be noted, as well. Nails may become brittle, with pitting and/or longitudinal ridges. Patients are usually asymptomatic but may complain of pruritus.

AA is believed to be an autoimmune disorder. It affects males and females of all ages but is more common in children and young adults. AA is believed to result from a T-cell–mediated immune response that transitions the hair follicles from the growth phase to the resting phase. This leads to sudden hair loss and inhibition of regrowth of the hair. However, the hair follicle is not permanently destroyed as in other processes of alopecia. There is also an association between AA and other autoimmune disorders such as vitiligo, thyroid disease, and lupus.

The diagnosis usually is made clinically, as in this patient, but a definitive diagnosis can be made by biopsy and pathology. Other differential diagnoses to consider are trichotillomania, tinea, traumatic alopecia, and lupus.

In almost half of cases, AA is self-resolving; therefore, in first episodes of localized disease, watchful waiting is appropriate. Treatment is tailored to the individual patient and may be difficult. Intralesional corticosteroids often are used for mild cases. Typically, 10 mg/mL of a glucocorticoid is injected into the mid-dermis every 4 to 6 weeks; however, this treatment carries a risk of transient or even permanent atrophy of the injection site. Potent topical corticosteroids often are used, especially in children who do not tolerate intralesional injections, and success can be variable. Other topical treatments to consider are photochemotherapy (psoralen plus UVA), or an irritant agent such as anthralin and a vasodilator such as minoxidil. Regrowth can be expected in a few months to a year, but recurrence is common.

‌

Image courtesy of Stacy Nguy, MD, and text courtesy of Stacy Nguy, MD, and Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.

Although it appeared that the hair loss was preceded by some dry skin, the patch of hair loss was smooth and nonscarring, consistent with a diagnosis of alopecia areata (AA).

AA typically is found on the scalp in solitary areas but can affect the whole body, including the eyelashes and eyebrows. Affected hair typically is narrower at the proximal end, resembling an exclamation point, as the hair fails to grow and falls out. Sometimes, patches of alopecia may coalesce into a larger area. Nail changes may be noted, as well. Nails may become brittle, with pitting and/or longitudinal ridges. Patients are usually asymptomatic but may complain of pruritus.

AA is believed to be an autoimmune disorder. It affects males and females of all ages but is more common in children and young adults. AA is believed to result from a T-cell–mediated immune response that transitions the hair follicles from the growth phase to the resting phase. This leads to sudden hair loss and inhibition of regrowth of the hair. However, the hair follicle is not permanently destroyed as in other processes of alopecia. There is also an association between AA and other autoimmune disorders such as vitiligo, thyroid disease, and lupus.

The diagnosis usually is made clinically, as in this patient, but a definitive diagnosis can be made by biopsy and pathology. Other differential diagnoses to consider are trichotillomania, tinea, traumatic alopecia, and lupus.

In almost half of cases, AA is self-resolving; therefore, in first episodes of localized disease, watchful waiting is appropriate. Treatment is tailored to the individual patient and may be difficult. Intralesional corticosteroids often are used for mild cases. Typically, 10 mg/mL of a glucocorticoid is injected into the mid-dermis every 4 to 6 weeks; however, this treatment carries a risk of transient or even permanent atrophy of the injection site. Potent topical corticosteroids often are used, especially in children who do not tolerate intralesional injections, and success can be variable. Other topical treatments to consider are photochemotherapy (psoralen plus UVA), or an irritant agent such as anthralin and a vasodilator such as minoxidil. Regrowth can be expected in a few months to a year, but recurrence is common.

‌

Image courtesy of Stacy Nguy, MD, and text courtesy of Stacy Nguy, MD, and Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.

Although it appeared that the hair loss was preceded by some dry skin, the patch of hair loss was smooth and nonscarring, consistent with a diagnosis of alopecia areata (AA).

AA typically is found on the scalp in solitary areas but can affect the whole body, including the eyelashes and eyebrows. Affected hair typically is narrower at the proximal end, resembling an exclamation point, as the hair fails to grow and falls out. Sometimes, patches of alopecia may coalesce into a larger area. Nail changes may be noted, as well. Nails may become brittle, with pitting and/or longitudinal ridges. Patients are usually asymptomatic but may complain of pruritus.

AA is believed to be an autoimmune disorder. It affects males and females of all ages but is more common in children and young adults. AA is believed to result from a T-cell–mediated immune response that transitions the hair follicles from the growth phase to the resting phase. This leads to sudden hair loss and inhibition of regrowth of the hair. However, the hair follicle is not permanently destroyed as in other processes of alopecia. There is also an association between AA and other autoimmune disorders such as vitiligo, thyroid disease, and lupus.

The diagnosis usually is made clinically, as in this patient, but a definitive diagnosis can be made by biopsy and pathology. Other differential diagnoses to consider are trichotillomania, tinea, traumatic alopecia, and lupus.

In almost half of cases, AA is self-resolving; therefore, in first episodes of localized disease, watchful waiting is appropriate. Treatment is tailored to the individual patient and may be difficult. Intralesional corticosteroids often are used for mild cases. Typically, 10 mg/mL of a glucocorticoid is injected into the mid-dermis every 4 to 6 weeks; however, this treatment carries a risk of transient or even permanent atrophy of the injection site. Potent topical corticosteroids often are used, especially in children who do not tolerate intralesional injections, and success can be variable. Other topical treatments to consider are photochemotherapy (psoralen plus UVA), or an irritant agent such as anthralin and a vasodilator such as minoxidil. Regrowth can be expected in a few months to a year, but recurrence is common.

‌

Image courtesy of Stacy Nguy, MD, and text courtesy of Stacy Nguy, MD, and Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.

COVID-19–positive patients undergoing an invasive strategy for acute coronary syndrome presented hours later than uninfected historical controls, had a far higher incidence of cardiogenic shock, and their in-hospital mortality rate was four- to fivefold greater, according to data from the Global Multicenter Prospective COVID–ACS Registry. These phenomena are probably interrelated, according to Anthony Gershlick, MBBS, who presented the registry results at the Transcatheter Cardiovascular Therapeutics virtual annual meeting.

“We know that increasing ischemic time leads to bigger infarcts. And we know that bigger infarcts lead to cardiogenic shock, with its known higher mortality,” said Dr. Gershlick, professor of interventional cardiology at the University of Leicester (England).

“These data suggest that patients may have presented late, likely due to COVID concerns, and they had worse outcomes. If these data are borne out, future public information strategies need to be reassuring, proactive, simple, and more effective because we think patients stayed away,” the cardiologist added. “There are important public information messages to be taken from these data about getting patients to come to hospital during such pandemics.”

He presented prospectively collected registry data on 144 patients with confirmed ST-elevation MI (STEMI) and 122 with non-ST–elevation MI (NSTEMI), all COVID-19 positive on presentation at 85 hospitals in the United Kingdom, Europe, and North America during March through August of 2020. Since the initial message to the public early in the pandemic in many places was to try to avoid the hospital, the investigators selected for their no-COVID comparison group the data on more than 22,000 STEMI and NSTEMI patients included in two British national databases covering 2018-2019.

The COVID-positive STEMI patients were significantly younger, had more comorbidities, and had a higher mean heart rate and lower systolic blood pressure at admission than the non-COVID STEMI control group. Their median time from symptom onset to admission was 339 minutes, compared with 178 minutes in controls. Their door-to-balloon time averaged 83 minutes, versus 37 minutes in the era before the pandemic.

“I suspect that’s got something to do with the donning and doffing of personal protective equipment,” he said at the meeting sponsored by the Cardiovascular Research Foundation.

The in-hospital mortality rates were strikingly different: 27.1% in COVID-positive STEMI patients versus 5.7% in controls. Bleeding Academic Research Consortium type 3-5 bleeding was increased as well, by a margin of 2.8% to 0.3%. So was stroke, with a 2.1% in-hospital incidence in COVID-positive STEMI patients and a 0.1% rate in the comparator arm.

“But the biggest headline here for me was that the cardiogenic shock rate was 20.1% in the COVID-positive patients versus 8.7% in the non-COVID STEMI patients,” the cardiologist continued.

The same pattern held true among the COVID-positive NSTEMI patients: They were younger, sicker, and slower to present to the hospital than the non-COVID group. The in-hospital mortality rate was 6.6% in the COVID-positive NSTEMI patients, compared with 1.2% in the reference group. The COVID-positive patients had a 2.5% bleeding rate versus 0.1% in the controls. And the incidence of cardiogenic shock was 5%, compared with 1.4% in the controls from before the pandemic.

“Even though NSTEMI is traditionally regarded as lower risk, this is really quite dramatic. These are sick patients,” Dr. Gershlick observed.

Nearly two-thirds of in-hospital deaths in COVID-positive ACS patients were cardiovascular, and three-quarters of those cardiovascular deaths occurred in patients with cardiogenic shock. Thirty-two percent of deaths in COVID-positive ACS patients were of respiratory causes, and 4.9% were neurologic.

Notably, the ischemic time of patients with cardiogenic shock who died – that is, the time from symptom onset to balloon deployment – averaged 1,271 minutes, compared with 441 minutes in those who died without being in cardiogenic shock.

Session comoderator Sahil A. Parikh, MD, director of endovascular services at Columbia University Medical Center in New York, commented, “One of the striking things that is resonating with me is the high incidence of cardiogenic shock and the mortality. It’s akin to what we’ve seen in New York.”

[email protected]

COVID-19–positive patients undergoing an invasive strategy for acute coronary syndrome presented hours later than uninfected historical controls, had a far higher incidence of cardiogenic shock, and their in-hospital mortality rate was four- to fivefold greater, according to data from the Global Multicenter Prospective COVID–ACS Registry. These phenomena are probably interrelated, according to Anthony Gershlick, MBBS, who presented the registry results at the Transcatheter Cardiovascular Therapeutics virtual annual meeting.

“We know that increasing ischemic time leads to bigger infarcts. And we know that bigger infarcts lead to cardiogenic shock, with its known higher mortality,” said Dr. Gershlick, professor of interventional cardiology at the University of Leicester (England).

“These data suggest that patients may have presented late, likely due to COVID concerns, and they had worse outcomes. If these data are borne out, future public information strategies need to be reassuring, proactive, simple, and more effective because we think patients stayed away,” the cardiologist added. “There are important public information messages to be taken from these data about getting patients to come to hospital during such pandemics.”

He presented prospectively collected registry data on 144 patients with confirmed ST-elevation MI (STEMI) and 122 with non-ST–elevation MI (NSTEMI), all COVID-19 positive on presentation at 85 hospitals in the United Kingdom, Europe, and North America during March through August of 2020. Since the initial message to the public early in the pandemic in many places was to try to avoid the hospital, the investigators selected for their no-COVID comparison group the data on more than 22,000 STEMI and NSTEMI patients included in two British national databases covering 2018-2019.

The COVID-positive STEMI patients were significantly younger, had more comorbidities, and had a higher mean heart rate and lower systolic blood pressure at admission than the non-COVID STEMI control group. Their median time from symptom onset to admission was 339 minutes, compared with 178 minutes in controls. Their door-to-balloon time averaged 83 minutes, versus 37 minutes in the era before the pandemic.

“I suspect that’s got something to do with the donning and doffing of personal protective equipment,” he said at the meeting sponsored by the Cardiovascular Research Foundation.

The in-hospital mortality rates were strikingly different: 27.1% in COVID-positive STEMI patients versus 5.7% in controls. Bleeding Academic Research Consortium type 3-5 bleeding was increased as well, by a margin of 2.8% to 0.3%. So was stroke, with a 2.1% in-hospital incidence in COVID-positive STEMI patients and a 0.1% rate in the comparator arm.

“But the biggest headline here for me was that the cardiogenic shock rate was 20.1% in the COVID-positive patients versus 8.7% in the non-COVID STEMI patients,” the cardiologist continued.

The same pattern held true among the COVID-positive NSTEMI patients: They were younger, sicker, and slower to present to the hospital than the non-COVID group. The in-hospital mortality rate was 6.6% in the COVID-positive NSTEMI patients, compared with 1.2% in the reference group. The COVID-positive patients had a 2.5% bleeding rate versus 0.1% in the controls. And the incidence of cardiogenic shock was 5%, compared with 1.4% in the controls from before the pandemic.

“Even though NSTEMI is traditionally regarded as lower risk, this is really quite dramatic. These are sick patients,” Dr. Gershlick observed.

Nearly two-thirds of in-hospital deaths in COVID-positive ACS patients were cardiovascular, and three-quarters of those cardiovascular deaths occurred in patients with cardiogenic shock. Thirty-two percent of deaths in COVID-positive ACS patients were of respiratory causes, and 4.9% were neurologic.

Notably, the ischemic time of patients with cardiogenic shock who died – that is, the time from symptom onset to balloon deployment – averaged 1,271 minutes, compared with 441 minutes in those who died without being in cardiogenic shock.

Session comoderator Sahil A. Parikh, MD, director of endovascular services at Columbia University Medical Center in New York, commented, “One of the striking things that is resonating with me is the high incidence of cardiogenic shock and the mortality. It’s akin to what we’ve seen in New York.”

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COVID-19–positive patients undergoing an invasive strategy for acute coronary syndrome presented hours later than uninfected historical controls, had a far higher incidence of cardiogenic shock, and their in-hospital mortality rate was four- to fivefold greater, according to data from the Global Multicenter Prospective COVID–ACS Registry. These phenomena are probably interrelated, according to Anthony Gershlick, MBBS, who presented the registry results at the Transcatheter Cardiovascular Therapeutics virtual annual meeting.

“We know that increasing ischemic time leads to bigger infarcts. And we know that bigger infarcts lead to cardiogenic shock, with its known higher mortality,” said Dr. Gershlick, professor of interventional cardiology at the University of Leicester (England).

“These data suggest that patients may have presented late, likely due to COVID concerns, and they had worse outcomes. If these data are borne out, future public information strategies need to be reassuring, proactive, simple, and more effective because we think patients stayed away,” the cardiologist added. “There are important public information messages to be taken from these data about getting patients to come to hospital during such pandemics.”

He presented prospectively collected registry data on 144 patients with confirmed ST-elevation MI (STEMI) and 122 with non-ST–elevation MI (NSTEMI), all COVID-19 positive on presentation at 85 hospitals in the United Kingdom, Europe, and North America during March through August of 2020. Since the initial message to the public early in the pandemic in many places was to try to avoid the hospital, the investigators selected for their no-COVID comparison group the data on more than 22,000 STEMI and NSTEMI patients included in two British national databases covering 2018-2019.

The COVID-positive STEMI patients were significantly younger, had more comorbidities, and had a higher mean heart rate and lower systolic blood pressure at admission than the non-COVID STEMI control group. Their median time from symptom onset to admission was 339 minutes, compared with 178 minutes in controls. Their door-to-balloon time averaged 83 minutes, versus 37 minutes in the era before the pandemic.

“I suspect that’s got something to do with the donning and doffing of personal protective equipment,” he said at the meeting sponsored by the Cardiovascular Research Foundation.

The in-hospital mortality rates were strikingly different: 27.1% in COVID-positive STEMI patients versus 5.7% in controls. Bleeding Academic Research Consortium type 3-5 bleeding was increased as well, by a margin of 2.8% to 0.3%. So was stroke, with a 2.1% in-hospital incidence in COVID-positive STEMI patients and a 0.1% rate in the comparator arm.

“But the biggest headline here for me was that the cardiogenic shock rate was 20.1% in the COVID-positive patients versus 8.7% in the non-COVID STEMI patients,” the cardiologist continued.

The same pattern held true among the COVID-positive NSTEMI patients: They were younger, sicker, and slower to present to the hospital than the non-COVID group. The in-hospital mortality rate was 6.6% in the COVID-positive NSTEMI patients, compared with 1.2% in the reference group. The COVID-positive patients had a 2.5% bleeding rate versus 0.1% in the controls. And the incidence of cardiogenic shock was 5%, compared with 1.4% in the controls from before the pandemic.

“Even though NSTEMI is traditionally regarded as lower risk, this is really quite dramatic. These are sick patients,” Dr. Gershlick observed.

Nearly two-thirds of in-hospital deaths in COVID-positive ACS patients were cardiovascular, and three-quarters of those cardiovascular deaths occurred in patients with cardiogenic shock. Thirty-two percent of deaths in COVID-positive ACS patients were of respiratory causes, and 4.9% were neurologic.

Notably, the ischemic time of patients with cardiogenic shock who died – that is, the time from symptom onset to balloon deployment – averaged 1,271 minutes, compared with 441 minutes in those who died without being in cardiogenic shock.

Session comoderator Sahil A. Parikh, MD, director of endovascular services at Columbia University Medical Center in New York, commented, “One of the striking things that is resonating with me is the high incidence of cardiogenic shock and the mortality. It’s akin to what we’ve seen in New York.”

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