Clinician Reviews

A combination therapy using the experimental drug relugolix was effective in treating pain and heavy bleeding from uterine fibroids for a full year, according to findings from a long-term extension study of the phase 3, open-label LIBERTY trials.

The drug was also well tolerated, with retention of bone mineral density and no new adverse events, said Ayman Al-Hendy, MD, PhD, who presented the results Oct. 17 at the virtual American Society for Reproductive Medicine 2020 Scientific Congress.

“Relugolix combination therapy represents a potential long-term treatment for women with heavy menstrual bleeding associated with uterine fibroids,” said Al-Hendy, a gynecologist and endoscopic surgeon at the University of Chicago.

Dr. Al-Hendy, who consults for the company that makes the drug, on Oct. 20 presented results showing improvement in quality of life with relugolix therapy.

“The fact that this longer-term study shows continued, persistent results at a year really gives us confidence that we’ll be able to use these drugs as a long-term therapy to treat fibroids,” Hugh S. Taylor, MD, president-elect of ASRM, said in an interview. Dr. Taylor, a professor and chair of ob.gyn. and reproductive sciences at Yale University, New Haven, Conn., was not involved in the study.

“A drug like this is so necessary,” Dr. Taylor continued. “We don’t have any other drugs on the market approved for long-term use.”

Relugolix is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist under investigation for long-term management of uterine fibroids. The once-daily combination therapy includes 40 mg relugolix, 1 mg estradiol, and 0.5 mg norethindrone acetate.
 

Extension study shows prolonged benefits

The extension trial enrolled women aged 18-50 years who were experiencing heavy menstrual bleeding from uterine fibroids and who completed the 24-week phase 3, double-blind, placebo-controlled LIBERTY 1 or 2 trials. Heavy menstrual bleeding was defined as bleeding in which at least 80 mL of blood was lost per cycle for two cycles or 160 mL was lost during one cycle. Ultrasound imaging was used to confirm the presence of fibroids.

In LIBERTY 1 and 2, women were randomly assigned to receive relugolix combination therapy, placebo, or relugolix alone for 12 weeks followed by combination therapy for the remaining 12 weeks (delayed group). Those trials found that relugolix combination therapy was effective through 6 months in reducing menstrual blood loss and pain in women with uterine fibroids without loss of bone mineral density.

LIBERTY 3 extended the trial to 52 weeks, with all participants receiving relugolix combination therapy.

As in the earlier trials, the primary endpoint was reduced menstrual blood loss. By the end of the study, women needed to have at least a 50% reduction in blood loss from the initial study’s baseline while maintaining a blood loss of <80 mL. The investigators also evaluated the mean percentage of menstrual blood loss reduction, amenorrhea rate, and improvements in anemia as secondary endpoints and assessed changes in bone mineral density.

The extension study enrolled 78% (n = 477) of the 610 women who completed the initial study; of those, 363 women completed the extension study.

Among the 163 women who began with relugolix combination therapy in the first two trials, 87.7% met the primary endpoint in a per-protocol analysis through week 52. The proportion of responders in the extension study was 75.6% among the group that formerly received placebo (n = 164) and 79.9% in the delayed group (n = 149).

The overall average reduction in menstrual blood volume was 89.9%. Most of the women experienced amenorrhea at the end of the year: 70.6% in the relugolix group, 57.9% in the group that formerly received placebo, and 68.5% in the delayed group.

Reductions in uterine volume and uterine fibroid volume were also sustained from week 24 to week 52. For the relugolix combination therapy group, the mean loss of uterine fibroid volume from baseline was 13.5% at week 24 and 18.3% at week 52. Similarly, the delayed group’s average loss in fibroid volume was 28.1% at week 24 and 33.9% at week 52. The placebo group, which only had a 7% loss in fibroid volume at week 24, had an 18.4% loss in volume from baseline at week 52.

Among patients with anemia, defined as hemoglobin concentrations of <10.5 g/dL at baseline, 59% of those in the original relugolix group saw an improvement of at least 2 g/dL hemoglobin. The women’s improvement in pain symptoms also continued through week 52, with a 51.3-point reduction in scores on the bleeding pain and discomfort scale from baseline to the end of the study.

Adverse events were the same in the extension study and in the initial study. Those most commonly reported were headache and hot flashes. No serious safety signals occurred. The average reduction in bone mineral density was 0.80% at week 52, indicating no concerning loss.
 

A new drug class to treat uterine fibroids

Relugolix is one of three GnRH antagonists being studied for the long-term treatment of fibroids. The Food and Drug Administration approved the combination of elagolix, estradiol, and norethindrone acetate (Oriahnn) in May. Linzagolix, another GnRH antagonist, is currently in clinical trials.

“We’ll have a whole class of new drugs that are likely to fulfill this long sought-after goal of reducing the need for surgery for fibroids and doing it without a lot of side effects,” Dr. Taylor said. “The quality-of-life improvements seen here, the lack of significant adverse effects – none that were surprising in long term – the relatively low reduction in bone mineral density in a year are all very exciting [and suggest] that this will be a safe and effective long-term treatment.”
 

Significant improvement in quality of life

In the presentation on quality of life with relugolix therapy, Dr. Al-Hendy shared results regarding the severity of women’s symptoms as well as health-related quality of life, as determined on the basis of the Uterine Fibroid Symptom and Health-Related Quality of Life (UFS-QoL) questionnaire at baseline, week 12, and week 24 in LIBERTY 1 and 2. Higher UFS-QoL scores correlate with more severe symptoms. With the subscale of health-related quality of life, higher scores indicate a better quality of life.

The substudy enrolled 253 patients who received relugolix combination therapy and 256 patients who received placebo. The average menstrual blood loss was 243 mL in the relugolix group and 215 mL in the placebo group at baseline. Mean fibroid volume was the same in both groups at baseline, 73 cm³.

The proportion of Black patients was similar in both groups: 48% of the relugolix group and 54% of the placebo group.

The severity of women’s symptoms dropped from a baseline UFS-QoL score of 57 to 22.4 at 6 months among those who received relugolix combination therapy. In the placebo group, the initial score of 59.6 only dropped to 46.9 (P < .0001, for –21.4 difference in change).

Health-related quality of life increased from 38.3 to 76.6 among those who received relugolix. In the placebo group, it increased from 35.7 to 48.2 (P < .0001, for 24.5 difference). Subscales of health-related quality of life – including concern, control, activities, energy/mood, self-consciousness, and sexual function – also all improved significantly in the relugolix group, compared with the placebo group (P < .0001).

“This is a condition we see all the time that’s easily diagnosed, and we have first-line drugs we’ve been using to treat them, but none are good long-term fixes,” Dr. Taylor said. The current first-line treatments, oral contraceptives, can stabilize bleeding, “but they don’t make the fibroids shrink, they don’t stop the bleeding, women continue to have breakthrough bleeding, and the fibroids can continue to grow.”

He said most of the estimated 600,000 hysterectomies performed in the United States each year are for uterine fibroids.

“It’s a major surgery that no one wants to go through if they don’t have to,” Dr. Taylor said. “Here we have a drug that really has potential to stop the growth of the fibroids, that can stop the bleeding or dramatically improve it, and, really, for the first time, directly impact the fibroids and give us a long-term alternative.”

The studies were funded by Myovant Sciences. Dr. Al-Hendy reported consulting for AbbVie, Bayer, and Myovant Sciences, and he owns a patent for novel diagnostics and therapeutics for uterine sarcoma. Dr. Taylor has disclosed no relevant financial relationships.

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

A combination therapy using the experimental drug relugolix was effective in treating pain and heavy bleeding from uterine fibroids for a full year, according to findings from a long-term extension study of the phase 3, open-label LIBERTY trials.

The drug was also well tolerated, with retention of bone mineral density and no new adverse events, said Ayman Al-Hendy, MD, PhD, who presented the results Oct. 17 at the virtual American Society for Reproductive Medicine 2020 Scientific Congress.

“Relugolix combination therapy represents a potential long-term treatment for women with heavy menstrual bleeding associated with uterine fibroids,” said Al-Hendy, a gynecologist and endoscopic surgeon at the University of Chicago.

Dr. Al-Hendy, who consults for the company that makes the drug, on Oct. 20 presented results showing improvement in quality of life with relugolix therapy.

“The fact that this longer-term study shows continued, persistent results at a year really gives us confidence that we’ll be able to use these drugs as a long-term therapy to treat fibroids,” Hugh S. Taylor, MD, president-elect of ASRM, said in an interview. Dr. Taylor, a professor and chair of ob.gyn. and reproductive sciences at Yale University, New Haven, Conn., was not involved in the study.

“A drug like this is so necessary,” Dr. Taylor continued. “We don’t have any other drugs on the market approved for long-term use.”

Relugolix is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist under investigation for long-term management of uterine fibroids. The once-daily combination therapy includes 40 mg relugolix, 1 mg estradiol, and 0.5 mg norethindrone acetate.
 

Extension study shows prolonged benefits

The extension trial enrolled women aged 18-50 years who were experiencing heavy menstrual bleeding from uterine fibroids and who completed the 24-week phase 3, double-blind, placebo-controlled LIBERTY 1 or 2 trials. Heavy menstrual bleeding was defined as bleeding in which at least 80 mL of blood was lost per cycle for two cycles or 160 mL was lost during one cycle. Ultrasound imaging was used to confirm the presence of fibroids.

In LIBERTY 1 and 2, women were randomly assigned to receive relugolix combination therapy, placebo, or relugolix alone for 12 weeks followed by combination therapy for the remaining 12 weeks (delayed group). Those trials found that relugolix combination therapy was effective through 6 months in reducing menstrual blood loss and pain in women with uterine fibroids without loss of bone mineral density.

LIBERTY 3 extended the trial to 52 weeks, with all participants receiving relugolix combination therapy.

As in the earlier trials, the primary endpoint was reduced menstrual blood loss. By the end of the study, women needed to have at least a 50% reduction in blood loss from the initial study’s baseline while maintaining a blood loss of <80 mL. The investigators also evaluated the mean percentage of menstrual blood loss reduction, amenorrhea rate, and improvements in anemia as secondary endpoints and assessed changes in bone mineral density.

The extension study enrolled 78% (n = 477) of the 610 women who completed the initial study; of those, 363 women completed the extension study.

Among the 163 women who began with relugolix combination therapy in the first two trials, 87.7% met the primary endpoint in a per-protocol analysis through week 52. The proportion of responders in the extension study was 75.6% among the group that formerly received placebo (n = 164) and 79.9% in the delayed group (n = 149).

The overall average reduction in menstrual blood volume was 89.9%. Most of the women experienced amenorrhea at the end of the year: 70.6% in the relugolix group, 57.9% in the group that formerly received placebo, and 68.5% in the delayed group.

Reductions in uterine volume and uterine fibroid volume were also sustained from week 24 to week 52. For the relugolix combination therapy group, the mean loss of uterine fibroid volume from baseline was 13.5% at week 24 and 18.3% at week 52. Similarly, the delayed group’s average loss in fibroid volume was 28.1% at week 24 and 33.9% at week 52. The placebo group, which only had a 7% loss in fibroid volume at week 24, had an 18.4% loss in volume from baseline at week 52.

Among patients with anemia, defined as hemoglobin concentrations of <10.5 g/dL at baseline, 59% of those in the original relugolix group saw an improvement of at least 2 g/dL hemoglobin. The women’s improvement in pain symptoms also continued through week 52, with a 51.3-point reduction in scores on the bleeding pain and discomfort scale from baseline to the end of the study.

Adverse events were the same in the extension study and in the initial study. Those most commonly reported were headache and hot flashes. No serious safety signals occurred. The average reduction in bone mineral density was 0.80% at week 52, indicating no concerning loss.
 

A new drug class to treat uterine fibroids

Relugolix is one of three GnRH antagonists being studied for the long-term treatment of fibroids. The Food and Drug Administration approved the combination of elagolix, estradiol, and norethindrone acetate (Oriahnn) in May. Linzagolix, another GnRH antagonist, is currently in clinical trials.

“We’ll have a whole class of new drugs that are likely to fulfill this long sought-after goal of reducing the need for surgery for fibroids and doing it without a lot of side effects,” Dr. Taylor said. “The quality-of-life improvements seen here, the lack of significant adverse effects – none that were surprising in long term – the relatively low reduction in bone mineral density in a year are all very exciting [and suggest] that this will be a safe and effective long-term treatment.”
 

Significant improvement in quality of life

In the presentation on quality of life with relugolix therapy, Dr. Al-Hendy shared results regarding the severity of women’s symptoms as well as health-related quality of life, as determined on the basis of the Uterine Fibroid Symptom and Health-Related Quality of Life (UFS-QoL) questionnaire at baseline, week 12, and week 24 in LIBERTY 1 and 2. Higher UFS-QoL scores correlate with more severe symptoms. With the subscale of health-related quality of life, higher scores indicate a better quality of life.

The substudy enrolled 253 patients who received relugolix combination therapy and 256 patients who received placebo. The average menstrual blood loss was 243 mL in the relugolix group and 215 mL in the placebo group at baseline. Mean fibroid volume was the same in both groups at baseline, 73 cm³.

The proportion of Black patients was similar in both groups: 48% of the relugolix group and 54% of the placebo group.

The severity of women’s symptoms dropped from a baseline UFS-QoL score of 57 to 22.4 at 6 months among those who received relugolix combination therapy. In the placebo group, the initial score of 59.6 only dropped to 46.9 (P < .0001, for –21.4 difference in change).

Health-related quality of life increased from 38.3 to 76.6 among those who received relugolix. In the placebo group, it increased from 35.7 to 48.2 (P < .0001, for 24.5 difference). Subscales of health-related quality of life – including concern, control, activities, energy/mood, self-consciousness, and sexual function – also all improved significantly in the relugolix group, compared with the placebo group (P < .0001).

“This is a condition we see all the time that’s easily diagnosed, and we have first-line drugs we’ve been using to treat them, but none are good long-term fixes,” Dr. Taylor said. The current first-line treatments, oral contraceptives, can stabilize bleeding, “but they don’t make the fibroids shrink, they don’t stop the bleeding, women continue to have breakthrough bleeding, and the fibroids can continue to grow.”

He said most of the estimated 600,000 hysterectomies performed in the United States each year are for uterine fibroids.

“It’s a major surgery that no one wants to go through if they don’t have to,” Dr. Taylor said. “Here we have a drug that really has potential to stop the growth of the fibroids, that can stop the bleeding or dramatically improve it, and, really, for the first time, directly impact the fibroids and give us a long-term alternative.”

The studies were funded by Myovant Sciences. Dr. Al-Hendy reported consulting for AbbVie, Bayer, and Myovant Sciences, and he owns a patent for novel diagnostics and therapeutics for uterine sarcoma. Dr. Taylor has disclosed no relevant financial relationships.

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

A combination therapy using the experimental drug relugolix was effective in treating pain and heavy bleeding from uterine fibroids for a full year, according to findings from a long-term extension study of the phase 3, open-label LIBERTY trials.

The drug was also well tolerated, with retention of bone mineral density and no new adverse events, said Ayman Al-Hendy, MD, PhD, who presented the results Oct. 17 at the virtual American Society for Reproductive Medicine 2020 Scientific Congress.

“Relugolix combination therapy represents a potential long-term treatment for women with heavy menstrual bleeding associated with uterine fibroids,” said Al-Hendy, a gynecologist and endoscopic surgeon at the University of Chicago.

Dr. Al-Hendy, who consults for the company that makes the drug, on Oct. 20 presented results showing improvement in quality of life with relugolix therapy.

“The fact that this longer-term study shows continued, persistent results at a year really gives us confidence that we’ll be able to use these drugs as a long-term therapy to treat fibroids,” Hugh S. Taylor, MD, president-elect of ASRM, said in an interview. Dr. Taylor, a professor and chair of ob.gyn. and reproductive sciences at Yale University, New Haven, Conn., was not involved in the study.

“A drug like this is so necessary,” Dr. Taylor continued. “We don’t have any other drugs on the market approved for long-term use.”

Relugolix is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist under investigation for long-term management of uterine fibroids. The once-daily combination therapy includes 40 mg relugolix, 1 mg estradiol, and 0.5 mg norethindrone acetate.
 

Extension study shows prolonged benefits

The extension trial enrolled women aged 18-50 years who were experiencing heavy menstrual bleeding from uterine fibroids and who completed the 24-week phase 3, double-blind, placebo-controlled LIBERTY 1 or 2 trials. Heavy menstrual bleeding was defined as bleeding in which at least 80 mL of blood was lost per cycle for two cycles or 160 mL was lost during one cycle. Ultrasound imaging was used to confirm the presence of fibroids.

In LIBERTY 1 and 2, women were randomly assigned to receive relugolix combination therapy, placebo, or relugolix alone for 12 weeks followed by combination therapy for the remaining 12 weeks (delayed group). Those trials found that relugolix combination therapy was effective through 6 months in reducing menstrual blood loss and pain in women with uterine fibroids without loss of bone mineral density.

LIBERTY 3 extended the trial to 52 weeks, with all participants receiving relugolix combination therapy.

As in the earlier trials, the primary endpoint was reduced menstrual blood loss. By the end of the study, women needed to have at least a 50% reduction in blood loss from the initial study’s baseline while maintaining a blood loss of <80 mL. The investigators also evaluated the mean percentage of menstrual blood loss reduction, amenorrhea rate, and improvements in anemia as secondary endpoints and assessed changes in bone mineral density.

The extension study enrolled 78% (n = 477) of the 610 women who completed the initial study; of those, 363 women completed the extension study.

Among the 163 women who began with relugolix combination therapy in the first two trials, 87.7% met the primary endpoint in a per-protocol analysis through week 52. The proportion of responders in the extension study was 75.6% among the group that formerly received placebo (n = 164) and 79.9% in the delayed group (n = 149).

The overall average reduction in menstrual blood volume was 89.9%. Most of the women experienced amenorrhea at the end of the year: 70.6% in the relugolix group, 57.9% in the group that formerly received placebo, and 68.5% in the delayed group.

Reductions in uterine volume and uterine fibroid volume were also sustained from week 24 to week 52. For the relugolix combination therapy group, the mean loss of uterine fibroid volume from baseline was 13.5% at week 24 and 18.3% at week 52. Similarly, the delayed group’s average loss in fibroid volume was 28.1% at week 24 and 33.9% at week 52. The placebo group, which only had a 7% loss in fibroid volume at week 24, had an 18.4% loss in volume from baseline at week 52.

Among patients with anemia, defined as hemoglobin concentrations of <10.5 g/dL at baseline, 59% of those in the original relugolix group saw an improvement of at least 2 g/dL hemoglobin. The women’s improvement in pain symptoms also continued through week 52, with a 51.3-point reduction in scores on the bleeding pain and discomfort scale from baseline to the end of the study.

Adverse events were the same in the extension study and in the initial study. Those most commonly reported were headache and hot flashes. No serious safety signals occurred. The average reduction in bone mineral density was 0.80% at week 52, indicating no concerning loss.
 

A new drug class to treat uterine fibroids

Relugolix is one of three GnRH antagonists being studied for the long-term treatment of fibroids. The Food and Drug Administration approved the combination of elagolix, estradiol, and norethindrone acetate (Oriahnn) in May. Linzagolix, another GnRH antagonist, is currently in clinical trials.

“We’ll have a whole class of new drugs that are likely to fulfill this long sought-after goal of reducing the need for surgery for fibroids and doing it without a lot of side effects,” Dr. Taylor said. “The quality-of-life improvements seen here, the lack of significant adverse effects – none that were surprising in long term – the relatively low reduction in bone mineral density in a year are all very exciting [and suggest] that this will be a safe and effective long-term treatment.”
 

Significant improvement in quality of life

In the presentation on quality of life with relugolix therapy, Dr. Al-Hendy shared results regarding the severity of women’s symptoms as well as health-related quality of life, as determined on the basis of the Uterine Fibroid Symptom and Health-Related Quality of Life (UFS-QoL) questionnaire at baseline, week 12, and week 24 in LIBERTY 1 and 2. Higher UFS-QoL scores correlate with more severe symptoms. With the subscale of health-related quality of life, higher scores indicate a better quality of life.

The substudy enrolled 253 patients who received relugolix combination therapy and 256 patients who received placebo. The average menstrual blood loss was 243 mL in the relugolix group and 215 mL in the placebo group at baseline. Mean fibroid volume was the same in both groups at baseline, 73 cm³.

The proportion of Black patients was similar in both groups: 48% of the relugolix group and 54% of the placebo group.

The severity of women’s symptoms dropped from a baseline UFS-QoL score of 57 to 22.4 at 6 months among those who received relugolix combination therapy. In the placebo group, the initial score of 59.6 only dropped to 46.9 (P < .0001, for –21.4 difference in change).

Health-related quality of life increased from 38.3 to 76.6 among those who received relugolix. In the placebo group, it increased from 35.7 to 48.2 (P < .0001, for 24.5 difference). Subscales of health-related quality of life – including concern, control, activities, energy/mood, self-consciousness, and sexual function – also all improved significantly in the relugolix group, compared with the placebo group (P < .0001).

“This is a condition we see all the time that’s easily diagnosed, and we have first-line drugs we’ve been using to treat them, but none are good long-term fixes,” Dr. Taylor said. The current first-line treatments, oral contraceptives, can stabilize bleeding, “but they don’t make the fibroids shrink, they don’t stop the bleeding, women continue to have breakthrough bleeding, and the fibroids can continue to grow.”

He said most of the estimated 600,000 hysterectomies performed in the United States each year are for uterine fibroids.

“It’s a major surgery that no one wants to go through if they don’t have to,” Dr. Taylor said. “Here we have a drug that really has potential to stop the growth of the fibroids, that can stop the bleeding or dramatically improve it, and, really, for the first time, directly impact the fibroids and give us a long-term alternative.”

The studies were funded by Myovant Sciences. Dr. Al-Hendy reported consulting for AbbVie, Bayer, and Myovant Sciences, and he owns a patent for novel diagnostics and therapeutics for uterine sarcoma. Dr. Taylor has disclosed no relevant financial relationships.

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

Researchers and several medical groups on Oct. 23 pressed for changes to the US Food and Drug Administration’s (FDA) current plans for deciding how to eventually clear vaccines for COVID-19, arguing tougher standards would help bolster confidence in these critical medicines.

The FDA’s Vaccines and Related Biological Products Advisory Committee met for a wide-ranging discussion beginning around 10 am. The FDA did not ask the panel to weigh in on any particular vaccine. Instead, the FDA asked for the panel’s feedback on a series of questions, including considerations for continuing phase 3 trials if a product were to get an interim clearance known as an emergency use authorization (EUA).

Speakers at the hearing made a variety of requests, including asking for data showing COVID-19 vaccines can prevent serious illness and urging transparency about the agency’s deliberations for each product to be considered.

FDA staff are closely tracking the crop of experimental vaccines that have made it into advanced stages of testing, including products from Pfizer Inc, AstraZeneca, Johnson & Johnson, and Moderna.
 

‘Time for a reset’

Among the speakers at the public hearing was Peter Lurie, MD, who served as an FDA associate commissioner from 2014 to 2017. Now the president of the Center for Science in the Public Interest, Lurie was among the speakers who asked the agency to make its independence clear.

President Donald Trump has for months been making predictions about COVID-19 vaccine approvals that have been overly optimistic. In one example, the president, who is seeking re-election on November 3, last month spoke about being able to begin distributing a vaccine in October.

“Until now the process of developing candidate vaccines has been inappropriately politicized with an eye on the election calendar, rather than the deliberate timeframe science requires,” Lurie told the FDA advisory panel. “Now is the time for a reset. This committee has a unique opportunity to set a new tone for vaccine deliberations going forward.”

Lurie asked the panel to press the FDA to commit to hold an advisory committee meeting on requests by drugmakers for EUAs. He also asked the panel to demand that informed consent forms and minutes from institutional review board (IRB) discussions of COVID-19 vaccines trials be made public.

Also among the speakers at the public hearing was Peter Doshi, PhD, an associate professor at the University of Maryland School of Pharmacy, who argued that the current trials won’t answer the right questions about the COVID-19 vaccines.

“We could end up with approved vaccines that reduce the risk of mild infection, but do not decrease the risk of hospitalization, ICU use, or death — either at all or by a clinically relevant amount,” Doshi told the panel.

In his presentation, he reiterated points he had made previously, including in an October 21 article in the BMJ, for which he is an associate editor. Doshi also raised these concerns in a September opinion article in The New York Times, co-authored with Eric Topol, MD, director of the Scripps Research Translational Institute and editor-in-chief of Medscape.
 

Risks of a ‘rushed vaccine’

Other complaints about the FDA’s approach included criticism of a 2-month follow-up time after vaccination, which was seen as too short. ECRI, a nonprofit organization that seeks to improve the safety, quality, and cost-effectiveness of medicines, has argued that approving a weak COVID-19 vaccine might worsen the pandemic.

In an October 21 statement, ECRI noted the risk of a partially effective vaccine, which could be welcomed as a means of slowing transmission of the virus. But public response and attitudes over the past 9 months in the United States suggest that people would relax their precautions as soon as a vaccine is available.

“Resulting infections may offset the vaccine’s impact and end up increasing the mortality and morbidity burden,” ECRI said in the brief.

“The risks and consequences of a rushed vaccine could be very severe if the review is anything shy of thorough,” ECRI Chief Executive Officer Marcus Schabacker, MD, PhD, said in a statement prepared for the hearing.

This article first appeared on Medscape.com.

Researchers and several medical groups on Oct. 23 pressed for changes to the US Food and Drug Administration’s (FDA) current plans for deciding how to eventually clear vaccines for COVID-19, arguing tougher standards would help bolster confidence in these critical medicines.

The FDA’s Vaccines and Related Biological Products Advisory Committee met for a wide-ranging discussion beginning around 10 am. The FDA did not ask the panel to weigh in on any particular vaccine. Instead, the FDA asked for the panel’s feedback on a series of questions, including considerations for continuing phase 3 trials if a product were to get an interim clearance known as an emergency use authorization (EUA).

Speakers at the hearing made a variety of requests, including asking for data showing COVID-19 vaccines can prevent serious illness and urging transparency about the agency’s deliberations for each product to be considered.

FDA staff are closely tracking the crop of experimental vaccines that have made it into advanced stages of testing, including products from Pfizer Inc, AstraZeneca, Johnson & Johnson, and Moderna.
 

‘Time for a reset’

Among the speakers at the public hearing was Peter Lurie, MD, who served as an FDA associate commissioner from 2014 to 2017. Now the president of the Center for Science in the Public Interest, Lurie was among the speakers who asked the agency to make its independence clear.

President Donald Trump has for months been making predictions about COVID-19 vaccine approvals that have been overly optimistic. In one example, the president, who is seeking re-election on November 3, last month spoke about being able to begin distributing a vaccine in October.

“Until now the process of developing candidate vaccines has been inappropriately politicized with an eye on the election calendar, rather than the deliberate timeframe science requires,” Lurie told the FDA advisory panel. “Now is the time for a reset. This committee has a unique opportunity to set a new tone for vaccine deliberations going forward.”

Lurie asked the panel to press the FDA to commit to hold an advisory committee meeting on requests by drugmakers for EUAs. He also asked the panel to demand that informed consent forms and minutes from institutional review board (IRB) discussions of COVID-19 vaccines trials be made public.

Also among the speakers at the public hearing was Peter Doshi, PhD, an associate professor at the University of Maryland School of Pharmacy, who argued that the current trials won’t answer the right questions about the COVID-19 vaccines.

“We could end up with approved vaccines that reduce the risk of mild infection, but do not decrease the risk of hospitalization, ICU use, or death — either at all or by a clinically relevant amount,” Doshi told the panel.

In his presentation, he reiterated points he had made previously, including in an October 21 article in the BMJ, for which he is an associate editor. Doshi also raised these concerns in a September opinion article in The New York Times, co-authored with Eric Topol, MD, director of the Scripps Research Translational Institute and editor-in-chief of Medscape.
 

Risks of a ‘rushed vaccine’

Other complaints about the FDA’s approach included criticism of a 2-month follow-up time after vaccination, which was seen as too short. ECRI, a nonprofit organization that seeks to improve the safety, quality, and cost-effectiveness of medicines, has argued that approving a weak COVID-19 vaccine might worsen the pandemic.

In an October 21 statement, ECRI noted the risk of a partially effective vaccine, which could be welcomed as a means of slowing transmission of the virus. But public response and attitudes over the past 9 months in the United States suggest that people would relax their precautions as soon as a vaccine is available.

“Resulting infections may offset the vaccine’s impact and end up increasing the mortality and morbidity burden,” ECRI said in the brief.

“The risks and consequences of a rushed vaccine could be very severe if the review is anything shy of thorough,” ECRI Chief Executive Officer Marcus Schabacker, MD, PhD, said in a statement prepared for the hearing.

This article first appeared on Medscape.com.

Researchers and several medical groups on Oct. 23 pressed for changes to the US Food and Drug Administration’s (FDA) current plans for deciding how to eventually clear vaccines for COVID-19, arguing tougher standards would help bolster confidence in these critical medicines.

The FDA’s Vaccines and Related Biological Products Advisory Committee met for a wide-ranging discussion beginning around 10 am. The FDA did not ask the panel to weigh in on any particular vaccine. Instead, the FDA asked for the panel’s feedback on a series of questions, including considerations for continuing phase 3 trials if a product were to get an interim clearance known as an emergency use authorization (EUA).

Speakers at the hearing made a variety of requests, including asking for data showing COVID-19 vaccines can prevent serious illness and urging transparency about the agency’s deliberations for each product to be considered.

FDA staff are closely tracking the crop of experimental vaccines that have made it into advanced stages of testing, including products from Pfizer Inc, AstraZeneca, Johnson & Johnson, and Moderna.
 

‘Time for a reset’

Among the speakers at the public hearing was Peter Lurie, MD, who served as an FDA associate commissioner from 2014 to 2017. Now the president of the Center for Science in the Public Interest, Lurie was among the speakers who asked the agency to make its independence clear.

President Donald Trump has for months been making predictions about COVID-19 vaccine approvals that have been overly optimistic. In one example, the president, who is seeking re-election on November 3, last month spoke about being able to begin distributing a vaccine in October.

“Until now the process of developing candidate vaccines has been inappropriately politicized with an eye on the election calendar, rather than the deliberate timeframe science requires,” Lurie told the FDA advisory panel. “Now is the time for a reset. This committee has a unique opportunity to set a new tone for vaccine deliberations going forward.”

Lurie asked the panel to press the FDA to commit to hold an advisory committee meeting on requests by drugmakers for EUAs. He also asked the panel to demand that informed consent forms and minutes from institutional review board (IRB) discussions of COVID-19 vaccines trials be made public.

Also among the speakers at the public hearing was Peter Doshi, PhD, an associate professor at the University of Maryland School of Pharmacy, who argued that the current trials won’t answer the right questions about the COVID-19 vaccines.

“We could end up with approved vaccines that reduce the risk of mild infection, but do not decrease the risk of hospitalization, ICU use, or death — either at all or by a clinically relevant amount,” Doshi told the panel.

In his presentation, he reiterated points he had made previously, including in an October 21 article in the BMJ, for which he is an associate editor. Doshi also raised these concerns in a September opinion article in The New York Times, co-authored with Eric Topol, MD, director of the Scripps Research Translational Institute and editor-in-chief of Medscape.
 

Risks of a ‘rushed vaccine’

Other complaints about the FDA’s approach included criticism of a 2-month follow-up time after vaccination, which was seen as too short. ECRI, a nonprofit organization that seeks to improve the safety, quality, and cost-effectiveness of medicines, has argued that approving a weak COVID-19 vaccine might worsen the pandemic.

In an October 21 statement, ECRI noted the risk of a partially effective vaccine, which could be welcomed as a means of slowing transmission of the virus. But public response and attitudes over the past 9 months in the United States suggest that people would relax their precautions as soon as a vaccine is available.

“Resulting infections may offset the vaccine’s impact and end up increasing the mortality and morbidity burden,” ECRI said in the brief.

“The risks and consequences of a rushed vaccine could be very severe if the review is anything shy of thorough,” ECRI Chief Executive Officer Marcus Schabacker, MD, PhD, said in a statement prepared for the hearing.

This article first appeared on Medscape.com.

The available data suggest that the risks posed by COVID-19 infection to patients with psoriasis, including those on therapies that affect immune function, are modest at most, according to a summary of published studies and expert opinions summarized at the annual Coastal Dermatology Symposium, held virtually.

For patients with psoriasis concerned about their outcome if infected with COVID-19, “there is no evidence to support stopping biologics or systemic agents, so I am asking my patients to continue,” Kristina C. Duffin, MD, professor and chair of dermatology at the University of Utah, Salt Lake City, said at the meeting.

The National Psoriasis Foundation, which created a COVID-19 task force and maintains a COVID-19 Resource Center on its website, has provided similar advice. Many statements are phrased cautiously and clinicians are encouraged to practice shared decision-making, but the NPF guidance supports continuing effective therapy – or, in newly diagnosed patients, starting effective therapy – among those who are not infected with SARS-CoV2.

Patients with a new diagnosis of psoriasis “should be aware that untreated psoriatic disease is associated with serious impact on physical and emotional health, and in the case of psoriatic arthritis, can lead to permanent joint damage and disability,” according to the NPF guidance.

Overall, the “existing data generally suggest” that most treatments for psoriasis and psoriatic arthritis “do not meaningfully alter the risks of contracting SARS-CoV2 or having a worse course of COVID-19 illness,” the current guidance states. Yet, because of limited data this “is not known with certainty.”

Chronic systemic steroids are an exception. In a review of recently published studies evaluating whether psoriasis or its therapies increase risk of adverse outcomes in patients with COVID-19 infection, Dr. Duffin pointed to several that associated systemic steroids with hospitalization or other markers of severe disease.

The NPF guidance also recommends avoiding chronic systemic steroids in patients with psoriasis during the current COVID-19 era “if possible.” In patients with psoriatic arthritis who require systemic steroids, the guidance recommends “the lowest dose necessary to achieve the desired therapeutic effect.”

This is not necessarily true in patients with psoriasis and COVID-19 infection. Based on the potential for systemic steroids to improve outcomes in hospitalized COVID-19 patients requiring oxygen, steroids “should not be withheld” even when the justification is concern about the potential risk of flares with withdrawal, according to the NPF guidance statement.

The NPF guidance specifically cautions against use of hydroxychloroquine or chloroquine for prevention or treatment of COVID-19. In addition to an uncertain benefit, these antimalarial drugs have been associated previously with flares of psoriasis.

Dr. Duffin agreed and went on to warn that COVID-19 infection itself is a potential trigger for flares. She cited two published case reports of flares associated with psoriasis. Although one patient had also been exposed to hydroxychloroquine, she said the risk of psoriasis-induced flare “makes sense” based on previous associations made between flares and other viral infections and stress.

In patients with psoriasis who contract COVID-19 infection, Dr. Duffin concurred with the NPF guidance that management decisions should be made on a “case-by-case basis.” Although the NPF guidance states that “most patients can restart psoriasis and/or psoriatic arthritis treatments after complete resolution of COVID-19 symptoms,” no specific advice was offered on the decision to stop treatments.

For protecting psoriasis patients from infection and managing COVID-19 in those who become infected, much of the NPF advice is consistent with that offered to patients without psoriasis. This involves practicing infection control that reduces risk of transmission. Both the NPF guidance and Dr. Duffin suggested telemedicine is appropriate for limiting in-patient visits under pandemic conditions.

Although patients with psoriasis are more likely than the general population to have the comorbidities associated with bad COVID-19 infection outcomes, according to the NPF guidance, Dr. Duffin called the overall data evaluating susceptibility among psoriasis patients “reassuring.” She cautioned that the data are still limited, but the evidence so far suggests that neither psoriasis nor biologics are independent risk factors for acquiring COVID-19 or having a worse outcome if infected.

Yet, more definitive data are needed, and Dr. Duffin advised clinicians and patients to consult the NPF website for updates. “More up-to-date information will certainly be added as we go forward,” she said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education.

This NPF task force on COVID-19 is meeting every 2 weeks, according to Joel M. Gelfand, MD, professor of dermatology, University of Pennsylvania, Philadelphia, and cochair of the task force. Dr. Gelfand reported that updates are based on a discussion of the available data.

“We will be releasing additional recommendations as necessary based on the developments,” he said in an interview. Updates are not necessarily required at this frequency but can be if appropriate. The goal is to keep recommendations current and evidence-based.

Dr. Duffin reported financial relationships with Amgen, AbbVie, Bristol-Myers Squibb, Boehringer-Ingelheim, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Siena, and UCB. Dr. Gelfand reported financial relationships with AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, Lilly, Pfizer, Roche, and UCB.

This publication and Global Academy for Medical Education are owned by the same parent company.
 

The available data suggest that the risks posed by COVID-19 infection to patients with psoriasis, including those on therapies that affect immune function, are modest at most, according to a summary of published studies and expert opinions summarized at the annual Coastal Dermatology Symposium, held virtually.

For patients with psoriasis concerned about their outcome if infected with COVID-19, “there is no evidence to support stopping biologics or systemic agents, so I am asking my patients to continue,” Kristina C. Duffin, MD, professor and chair of dermatology at the University of Utah, Salt Lake City, said at the meeting.

The National Psoriasis Foundation, which created a COVID-19 task force and maintains a COVID-19 Resource Center on its website, has provided similar advice. Many statements are phrased cautiously and clinicians are encouraged to practice shared decision-making, but the NPF guidance supports continuing effective therapy – or, in newly diagnosed patients, starting effective therapy – among those who are not infected with SARS-CoV2.

Patients with a new diagnosis of psoriasis “should be aware that untreated psoriatic disease is associated with serious impact on physical and emotional health, and in the case of psoriatic arthritis, can lead to permanent joint damage and disability,” according to the NPF guidance.

Overall, the “existing data generally suggest” that most treatments for psoriasis and psoriatic arthritis “do not meaningfully alter the risks of contracting SARS-CoV2 or having a worse course of COVID-19 illness,” the current guidance states. Yet, because of limited data this “is not known with certainty.”

Chronic systemic steroids are an exception. In a review of recently published studies evaluating whether psoriasis or its therapies increase risk of adverse outcomes in patients with COVID-19 infection, Dr. Duffin pointed to several that associated systemic steroids with hospitalization or other markers of severe disease.

The NPF guidance also recommends avoiding chronic systemic steroids in patients with psoriasis during the current COVID-19 era “if possible.” In patients with psoriatic arthritis who require systemic steroids, the guidance recommends “the lowest dose necessary to achieve the desired therapeutic effect.”

This is not necessarily true in patients with psoriasis and COVID-19 infection. Based on the potential for systemic steroids to improve outcomes in hospitalized COVID-19 patients requiring oxygen, steroids “should not be withheld” even when the justification is concern about the potential risk of flares with withdrawal, according to the NPF guidance statement.

The NPF guidance specifically cautions against use of hydroxychloroquine or chloroquine for prevention or treatment of COVID-19. In addition to an uncertain benefit, these antimalarial drugs have been associated previously with flares of psoriasis.

Dr. Duffin agreed and went on to warn that COVID-19 infection itself is a potential trigger for flares. She cited two published case reports of flares associated with psoriasis. Although one patient had also been exposed to hydroxychloroquine, she said the risk of psoriasis-induced flare “makes sense” based on previous associations made between flares and other viral infections and stress.

In patients with psoriasis who contract COVID-19 infection, Dr. Duffin concurred with the NPF guidance that management decisions should be made on a “case-by-case basis.” Although the NPF guidance states that “most patients can restart psoriasis and/or psoriatic arthritis treatments after complete resolution of COVID-19 symptoms,” no specific advice was offered on the decision to stop treatments.

For protecting psoriasis patients from infection and managing COVID-19 in those who become infected, much of the NPF advice is consistent with that offered to patients without psoriasis. This involves practicing infection control that reduces risk of transmission. Both the NPF guidance and Dr. Duffin suggested telemedicine is appropriate for limiting in-patient visits under pandemic conditions.

Although patients with psoriasis are more likely than the general population to have the comorbidities associated with bad COVID-19 infection outcomes, according to the NPF guidance, Dr. Duffin called the overall data evaluating susceptibility among psoriasis patients “reassuring.” She cautioned that the data are still limited, but the evidence so far suggests that neither psoriasis nor biologics are independent risk factors for acquiring COVID-19 or having a worse outcome if infected.

Yet, more definitive data are needed, and Dr. Duffin advised clinicians and patients to consult the NPF website for updates. “More up-to-date information will certainly be added as we go forward,” she said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education.

This NPF task force on COVID-19 is meeting every 2 weeks, according to Joel M. Gelfand, MD, professor of dermatology, University of Pennsylvania, Philadelphia, and cochair of the task force. Dr. Gelfand reported that updates are based on a discussion of the available data.

“We will be releasing additional recommendations as necessary based on the developments,” he said in an interview. Updates are not necessarily required at this frequency but can be if appropriate. The goal is to keep recommendations current and evidence-based.

Dr. Duffin reported financial relationships with Amgen, AbbVie, Bristol-Myers Squibb, Boehringer-Ingelheim, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Siena, and UCB. Dr. Gelfand reported financial relationships with AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, Lilly, Pfizer, Roche, and UCB.

This publication and Global Academy for Medical Education are owned by the same parent company.
 

The available data suggest that the risks posed by COVID-19 infection to patients with psoriasis, including those on therapies that affect immune function, are modest at most, according to a summary of published studies and expert opinions summarized at the annual Coastal Dermatology Symposium, held virtually.

For patients with psoriasis concerned about their outcome if infected with COVID-19, “there is no evidence to support stopping biologics or systemic agents, so I am asking my patients to continue,” Kristina C. Duffin, MD, professor and chair of dermatology at the University of Utah, Salt Lake City, said at the meeting.

The National Psoriasis Foundation, which created a COVID-19 task force and maintains a COVID-19 Resource Center on its website, has provided similar advice. Many statements are phrased cautiously and clinicians are encouraged to practice shared decision-making, but the NPF guidance supports continuing effective therapy – or, in newly diagnosed patients, starting effective therapy – among those who are not infected with SARS-CoV2.

Patients with a new diagnosis of psoriasis “should be aware that untreated psoriatic disease is associated with serious impact on physical and emotional health, and in the case of psoriatic arthritis, can lead to permanent joint damage and disability,” according to the NPF guidance.

Overall, the “existing data generally suggest” that most treatments for psoriasis and psoriatic arthritis “do not meaningfully alter the risks of contracting SARS-CoV2 or having a worse course of COVID-19 illness,” the current guidance states. Yet, because of limited data this “is not known with certainty.”

Chronic systemic steroids are an exception. In a review of recently published studies evaluating whether psoriasis or its therapies increase risk of adverse outcomes in patients with COVID-19 infection, Dr. Duffin pointed to several that associated systemic steroids with hospitalization or other markers of severe disease.

The NPF guidance also recommends avoiding chronic systemic steroids in patients with psoriasis during the current COVID-19 era “if possible.” In patients with psoriatic arthritis who require systemic steroids, the guidance recommends “the lowest dose necessary to achieve the desired therapeutic effect.”

This is not necessarily true in patients with psoriasis and COVID-19 infection. Based on the potential for systemic steroids to improve outcomes in hospitalized COVID-19 patients requiring oxygen, steroids “should not be withheld” even when the justification is concern about the potential risk of flares with withdrawal, according to the NPF guidance statement.

The NPF guidance specifically cautions against use of hydroxychloroquine or chloroquine for prevention or treatment of COVID-19. In addition to an uncertain benefit, these antimalarial drugs have been associated previously with flares of psoriasis.

Dr. Duffin agreed and went on to warn that COVID-19 infection itself is a potential trigger for flares. She cited two published case reports of flares associated with psoriasis. Although one patient had also been exposed to hydroxychloroquine, she said the risk of psoriasis-induced flare “makes sense” based on previous associations made between flares and other viral infections and stress.

In patients with psoriasis who contract COVID-19 infection, Dr. Duffin concurred with the NPF guidance that management decisions should be made on a “case-by-case basis.” Although the NPF guidance states that “most patients can restart psoriasis and/or psoriatic arthritis treatments after complete resolution of COVID-19 symptoms,” no specific advice was offered on the decision to stop treatments.

For protecting psoriasis patients from infection and managing COVID-19 in those who become infected, much of the NPF advice is consistent with that offered to patients without psoriasis. This involves practicing infection control that reduces risk of transmission. Both the NPF guidance and Dr. Duffin suggested telemedicine is appropriate for limiting in-patient visits under pandemic conditions.

Although patients with psoriasis are more likely than the general population to have the comorbidities associated with bad COVID-19 infection outcomes, according to the NPF guidance, Dr. Duffin called the overall data evaluating susceptibility among psoriasis patients “reassuring.” She cautioned that the data are still limited, but the evidence so far suggests that neither psoriasis nor biologics are independent risk factors for acquiring COVID-19 or having a worse outcome if infected.

Yet, more definitive data are needed, and Dr. Duffin advised clinicians and patients to consult the NPF website for updates. “More up-to-date information will certainly be added as we go forward,” she said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education.

This NPF task force on COVID-19 is meeting every 2 weeks, according to Joel M. Gelfand, MD, professor of dermatology, University of Pennsylvania, Philadelphia, and cochair of the task force. Dr. Gelfand reported that updates are based on a discussion of the available data.

“We will be releasing additional recommendations as necessary based on the developments,” he said in an interview. Updates are not necessarily required at this frequency but can be if appropriate. The goal is to keep recommendations current and evidence-based.

Dr. Duffin reported financial relationships with Amgen, AbbVie, Bristol-Myers Squibb, Boehringer-Ingelheim, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Siena, and UCB. Dr. Gelfand reported financial relationships with AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, Lilly, Pfizer, Roche, and UCB.

This publication and Global Academy for Medical Education are owned by the same parent company.
 

When assessing inflammatory dermatoses in children with skin of color, it may be necessary to train the eye to recognize subtle changes and colors other than red, a doctor suggested at the virtual American Academy of Pediatrics annual meeting.

First, doctors should see whether they can detect any erythema, said Latanya T. Benjamin, MD, associate professor of pediatric dermatology at Florida Atlantic University, Boca Raton. “If the answer is no because of the background competing chromophore, then shift your focus off of the erythema and perhaps onto other colors that the skin can demonstrate,” such as red-brown, violaceous, or grayish hues.

Comparing involved areas with normal skin also may help. “Sometimes you can pick up subtleties in colors that way,” Dr. Benjamin said.

Finally, look for other changes that could relate to the patient’s condition. For example, when diagnosing acne, Dr. Benjamin looks for pigmentary sequelae like hyperpigmentation. “If a patient has atopic dermatitis, is there hypopigmentation on other areas of the face?”

Consider cutaneous T-cell lymphoma in the differential diagnosis of generalized hypopigmented patches and plaques in patients with darker skin types, Dr. Benjamin noted. Other diagnoses that may result in hypopigmentation include pityriasis alba, vitiligo, tinea versicolor, ash-leaf macules, Hansen’s disease, postinflammatory hypopigmentation secondary to atopic dermatitis, and tinea corporis.

Be sensitive to the fact that changes in skin color can be “very annoying or devastating to the family,” even with medically benign conditions such as pityriasis alba, Dr. Benjamin added.

Detecting redness in brown skin tones can take practice, Candrice R. Heath, MD, a member of the board of directors for the Skin of Color Society, commented in an interview.

Furthermore, presentations vary. For instance, depictions of atopic dermatitis in educational materials may focus on red patches and plaques but “miss that there are several presentations in those with darker skin tones, including follicular prominence, hyperpigmented plaques, and coin-shaped lesions,” said Dr. Heath, assistant professor of dermatology at Temple University, Philadelphia.

“The skin of color population is growing,” noted Dr. Heath. “By 2023, there will be more children with skin of color than without in the United States.”

While Dr. Heath has lectured about skin of color as it relates to pediatric patients for years, “now with the nation’s renewed interest in disparities in health care, it is the perfect time to highlight conditions that present more commonly in skin of color and present differently in those with skin of color.”

Dr. Benjamin had no conflicts of interest. Dr. Heath serves as associate editor of Cutis, which is owned by the same company as this publication.

[email protected]

When assessing inflammatory dermatoses in children with skin of color, it may be necessary to train the eye to recognize subtle changes and colors other than red, a doctor suggested at the virtual American Academy of Pediatrics annual meeting.

First, doctors should see whether they can detect any erythema, said Latanya T. Benjamin, MD, associate professor of pediatric dermatology at Florida Atlantic University, Boca Raton. “If the answer is no because of the background competing chromophore, then shift your focus off of the erythema and perhaps onto other colors that the skin can demonstrate,” such as red-brown, violaceous, or grayish hues.

Comparing involved areas with normal skin also may help. “Sometimes you can pick up subtleties in colors that way,” Dr. Benjamin said.

Finally, look for other changes that could relate to the patient’s condition. For example, when diagnosing acne, Dr. Benjamin looks for pigmentary sequelae like hyperpigmentation. “If a patient has atopic dermatitis, is there hypopigmentation on other areas of the face?”

Consider cutaneous T-cell lymphoma in the differential diagnosis of generalized hypopigmented patches and plaques in patients with darker skin types, Dr. Benjamin noted. Other diagnoses that may result in hypopigmentation include pityriasis alba, vitiligo, tinea versicolor, ash-leaf macules, Hansen’s disease, postinflammatory hypopigmentation secondary to atopic dermatitis, and tinea corporis.

Be sensitive to the fact that changes in skin color can be “very annoying or devastating to the family,” even with medically benign conditions such as pityriasis alba, Dr. Benjamin added.

Detecting redness in brown skin tones can take practice, Candrice R. Heath, MD, a member of the board of directors for the Skin of Color Society, commented in an interview.

Furthermore, presentations vary. For instance, depictions of atopic dermatitis in educational materials may focus on red patches and plaques but “miss that there are several presentations in those with darker skin tones, including follicular prominence, hyperpigmented plaques, and coin-shaped lesions,” said Dr. Heath, assistant professor of dermatology at Temple University, Philadelphia.

“The skin of color population is growing,” noted Dr. Heath. “By 2023, there will be more children with skin of color than without in the United States.”

While Dr. Heath has lectured about skin of color as it relates to pediatric patients for years, “now with the nation’s renewed interest in disparities in health care, it is the perfect time to highlight conditions that present more commonly in skin of color and present differently in those with skin of color.”

Dr. Benjamin had no conflicts of interest. Dr. Heath serves as associate editor of Cutis, which is owned by the same company as this publication.

[email protected]

When assessing inflammatory dermatoses in children with skin of color, it may be necessary to train the eye to recognize subtle changes and colors other than red, a doctor suggested at the virtual American Academy of Pediatrics annual meeting.

First, doctors should see whether they can detect any erythema, said Latanya T. Benjamin, MD, associate professor of pediatric dermatology at Florida Atlantic University, Boca Raton. “If the answer is no because of the background competing chromophore, then shift your focus off of the erythema and perhaps onto other colors that the skin can demonstrate,” such as red-brown, violaceous, or grayish hues.

Comparing involved areas with normal skin also may help. “Sometimes you can pick up subtleties in colors that way,” Dr. Benjamin said.

Finally, look for other changes that could relate to the patient’s condition. For example, when diagnosing acne, Dr. Benjamin looks for pigmentary sequelae like hyperpigmentation. “If a patient has atopic dermatitis, is there hypopigmentation on other areas of the face?”

Consider cutaneous T-cell lymphoma in the differential diagnosis of generalized hypopigmented patches and plaques in patients with darker skin types, Dr. Benjamin noted. Other diagnoses that may result in hypopigmentation include pityriasis alba, vitiligo, tinea versicolor, ash-leaf macules, Hansen’s disease, postinflammatory hypopigmentation secondary to atopic dermatitis, and tinea corporis.

Be sensitive to the fact that changes in skin color can be “very annoying or devastating to the family,” even with medically benign conditions such as pityriasis alba, Dr. Benjamin added.

Detecting redness in brown skin tones can take practice, Candrice R. Heath, MD, a member of the board of directors for the Skin of Color Society, commented in an interview.

Furthermore, presentations vary. For instance, depictions of atopic dermatitis in educational materials may focus on red patches and plaques but “miss that there are several presentations in those with darker skin tones, including follicular prominence, hyperpigmented plaques, and coin-shaped lesions,” said Dr. Heath, assistant professor of dermatology at Temple University, Philadelphia.

“The skin of color population is growing,” noted Dr. Heath. “By 2023, there will be more children with skin of color than without in the United States.”

While Dr. Heath has lectured about skin of color as it relates to pediatric patients for years, “now with the nation’s renewed interest in disparities in health care, it is the perfect time to highlight conditions that present more commonly in skin of color and present differently in those with skin of color.”

Dr. Benjamin had no conflicts of interest. Dr. Heath serves as associate editor of Cutis, which is owned by the same company as this publication.

[email protected]

Multiple mouthwash and oral rinse products wiped out a human coronavirus closely related to the SARS-CoV-2 virus in a laboratory comparison study.

Listerine Antiseptic led the list of most effective mouthwashes for inactivating the coronavirus. Interestingly, a 1% nasal rinse solution of Johnson’s Baby Shampoo also worked, eliminating up to 99.9% of the viral load in the in vitro experiments.

In contrast, use of a neti pot nasal solution yielded no decrease in virus levels.

The study was published in the Journal of Medical Virology.

Because the mouthwash and hydrogen peroxide oral rinses in the study are widely available and easy to use, “I would recommend the use of the rinses on top of wearing mask and social distancing. This could add a layer of protection for yourself and others,” lead study author Craig Meyers, PhD, professor of microbiology and immunology and obstetrics and gynecology, Penn State College of Medicine in Hershey, Pennsylvania, told Medscape Medical News.

Meyers and colleagues found that efficacy aligned with duration of time the cell cultures were exposed to each mouthwash or rinse product. Although it varied, the products required at least 30 seconds to kill most of the virus. Waiting 1 or 2 minutes tended to fortify results.

“This study adds to and further confirms the recently published evidence from virologists in Germany that mouthwashes can inactivate the virus that causes COVID-19 in a test tube,” Valerie O’Donnell, PhD, co-director of the Systems Immunity Research Institute of Cardiff University, Cardiff, Wales, said when asked to comment on the study.

“While this is great to see, what is still lacking is in vivo evidence, since we know the virus will be continually shed in the mouth,” O’Donnell said. “So, the question now becomes, by how much could mouthwashes reduce viral load in the oropharynx of infected people, and if so, then for how long?”

Meyers noted that studies of people positive for COVID-19 using each product would be informative. It remains unknown, for example, if swishing, gargling, and/or spitting out mouthwash would add or decrease the efficacy demonstrated in the lab.

The investigators used the human coronavirus HCoV‐229e as a surrogate for SARS-CoV-2. They noted HCoV-229e is analogous, and SARS-CoV-2 would have been more expensive, less available, and would have required biosafety level 3 laboratory conditions.
 

Listerine Antiseptic leads the way

“Surprisingly, we found that several of these common products had strong virucidal properties, inactivating from 2 log10 [or 99%] to greater than 4 log10 [or 99.99%] of infectious human coronavirus,” the researchers note.

Timing of the essence?

Meyers and colleagues also tested a nasal rinse solution of 1% baby shampoo because it is sometimes used to treat people with chronic rhinosinusitis. They found 30 seconds led to < 90% to < 99.99% effectiveness, but that, by 2 minutes, efficacy climbed to > 99.9% to > 99.99%.

“Thirty seconds for some products just was not enough time for the efficacy to be observed,” Meyers said. “Whereas, after a minute or two the active ingredient had enough time to work. Thirty seconds may be at the border to see full efficacy.” More research is needed to confirm the timing and determine which active ingredients are driving the findings.

A future trial could test the efficacy of mouthwash products to reduce the viral load in people with COVID-19. “If we are able to get funding to continue, I would like to see a small clinical trial as the next step,” Meyers said.

Meyers and O’Donnell disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Multiple mouthwash and oral rinse products wiped out a human coronavirus closely related to the SARS-CoV-2 virus in a laboratory comparison study.

Listerine Antiseptic led the list of most effective mouthwashes for inactivating the coronavirus. Interestingly, a 1% nasal rinse solution of Johnson’s Baby Shampoo also worked, eliminating up to 99.9% of the viral load in the in vitro experiments.

In contrast, use of a neti pot nasal solution yielded no decrease in virus levels.

The study was published in the Journal of Medical Virology.

Because the mouthwash and hydrogen peroxide oral rinses in the study are widely available and easy to use, “I would recommend the use of the rinses on top of wearing mask and social distancing. This could add a layer of protection for yourself and others,” lead study author Craig Meyers, PhD, professor of microbiology and immunology and obstetrics and gynecology, Penn State College of Medicine in Hershey, Pennsylvania, told Medscape Medical News.

Meyers and colleagues found that efficacy aligned with duration of time the cell cultures were exposed to each mouthwash or rinse product. Although it varied, the products required at least 30 seconds to kill most of the virus. Waiting 1 or 2 minutes tended to fortify results.

“This study adds to and further confirms the recently published evidence from virologists in Germany that mouthwashes can inactivate the virus that causes COVID-19 in a test tube,” Valerie O’Donnell, PhD, co-director of the Systems Immunity Research Institute of Cardiff University, Cardiff, Wales, said when asked to comment on the study.

“While this is great to see, what is still lacking is in vivo evidence, since we know the virus will be continually shed in the mouth,” O’Donnell said. “So, the question now becomes, by how much could mouthwashes reduce viral load in the oropharynx of infected people, and if so, then for how long?”

Meyers noted that studies of people positive for COVID-19 using each product would be informative. It remains unknown, for example, if swishing, gargling, and/or spitting out mouthwash would add or decrease the efficacy demonstrated in the lab.

The investigators used the human coronavirus HCoV‐229e as a surrogate for SARS-CoV-2. They noted HCoV-229e is analogous, and SARS-CoV-2 would have been more expensive, less available, and would have required biosafety level 3 laboratory conditions.
 

Listerine Antiseptic leads the way

“Surprisingly, we found that several of these common products had strong virucidal properties, inactivating from 2 log10 [or 99%] to greater than 4 log10 [or 99.99%] of infectious human coronavirus,” the researchers note.

Timing of the essence?

Meyers and colleagues also tested a nasal rinse solution of 1% baby shampoo because it is sometimes used to treat people with chronic rhinosinusitis. They found 30 seconds led to < 90% to < 99.99% effectiveness, but that, by 2 minutes, efficacy climbed to > 99.9% to > 99.99%.

“Thirty seconds for some products just was not enough time for the efficacy to be observed,” Meyers said. “Whereas, after a minute or two the active ingredient had enough time to work. Thirty seconds may be at the border to see full efficacy.” More research is needed to confirm the timing and determine which active ingredients are driving the findings.

A future trial could test the efficacy of mouthwash products to reduce the viral load in people with COVID-19. “If we are able to get funding to continue, I would like to see a small clinical trial as the next step,” Meyers said.

Meyers and O’Donnell disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Multiple mouthwash and oral rinse products wiped out a human coronavirus closely related to the SARS-CoV-2 virus in a laboratory comparison study.

Listerine Antiseptic led the list of most effective mouthwashes for inactivating the coronavirus. Interestingly, a 1% nasal rinse solution of Johnson’s Baby Shampoo also worked, eliminating up to 99.9% of the viral load in the in vitro experiments.

In contrast, use of a neti pot nasal solution yielded no decrease in virus levels.

The study was published in the Journal of Medical Virology.

Because the mouthwash and hydrogen peroxide oral rinses in the study are widely available and easy to use, “I would recommend the use of the rinses on top of wearing mask and social distancing. This could add a layer of protection for yourself and others,” lead study author Craig Meyers, PhD, professor of microbiology and immunology and obstetrics and gynecology, Penn State College of Medicine in Hershey, Pennsylvania, told Medscape Medical News.

Meyers and colleagues found that efficacy aligned with duration of time the cell cultures were exposed to each mouthwash or rinse product. Although it varied, the products required at least 30 seconds to kill most of the virus. Waiting 1 or 2 minutes tended to fortify results.

“This study adds to and further confirms the recently published evidence from virologists in Germany that mouthwashes can inactivate the virus that causes COVID-19 in a test tube,” Valerie O’Donnell, PhD, co-director of the Systems Immunity Research Institute of Cardiff University, Cardiff, Wales, said when asked to comment on the study.

“While this is great to see, what is still lacking is in vivo evidence, since we know the virus will be continually shed in the mouth,” O’Donnell said. “So, the question now becomes, by how much could mouthwashes reduce viral load in the oropharynx of infected people, and if so, then for how long?”

Meyers noted that studies of people positive for COVID-19 using each product would be informative. It remains unknown, for example, if swishing, gargling, and/or spitting out mouthwash would add or decrease the efficacy demonstrated in the lab.

The investigators used the human coronavirus HCoV‐229e as a surrogate for SARS-CoV-2. They noted HCoV-229e is analogous, and SARS-CoV-2 would have been more expensive, less available, and would have required biosafety level 3 laboratory conditions.
 

Listerine Antiseptic leads the way

“Surprisingly, we found that several of these common products had strong virucidal properties, inactivating from 2 log10 [or 99%] to greater than 4 log10 [or 99.99%] of infectious human coronavirus,” the researchers note.

Timing of the essence?

Meyers and colleagues also tested a nasal rinse solution of 1% baby shampoo because it is sometimes used to treat people with chronic rhinosinusitis. They found 30 seconds led to < 90% to < 99.99% effectiveness, but that, by 2 minutes, efficacy climbed to > 99.9% to > 99.99%.

“Thirty seconds for some products just was not enough time for the efficacy to be observed,” Meyers said. “Whereas, after a minute or two the active ingredient had enough time to work. Thirty seconds may be at the border to see full efficacy.” More research is needed to confirm the timing and determine which active ingredients are driving the findings.

A future trial could test the efficacy of mouthwash products to reduce the viral load in people with COVID-19. “If we are able to get funding to continue, I would like to see a small clinical trial as the next step,” Meyers said.

Meyers and O’Donnell disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Although medical education is constantly evolving, unique and rapid developments in recent years have sparked controversy. The next generation of physicians is learning much differently from how established doctors once did. Training has shifted from an acute focus on disease to a wider approach that considers patients within the larger context of their community and society. Although many, like myself, see this as progress, others have expressed doubts about this and many other changes.

Amid the madness that is the year 2020, I’m grateful to have a moment to reflect on this subject. Five years ago, in celebration of Medscape’s 20th anniversary, I spoke with various leaders in medical education to learn how med ed had evolved since they were in school. Since then, I’ve gone from student to faculty. This year, for Medscape’s 25th anniversary, I reached out to current medical trainees to reflect on how much things have changed in such a short time.

From adjustments forced on us by COVID-19 to trends that predated the pandemic – including an increased emphasis on social justice and a decreased emphasis on other material – becoming a doctor no longer looks like it did just a half-decade ago.
 

Social justice is now in the curricula

More than ever, medical training has shifted toward humanism, population health, and social justice. Students are now being shown not only how to treat the patient in front of them but how to “treat” the larger communities they serve. Research skills around social drivers of health, such as structural racism, are increasingly becoming status quo.

In reflecting on her current experience, Emily Kahoud, a third-year medical student at New Jersey Medical School, Newark, told me about a course she took that was devoted to health equity. She applauded how her professors have incorporated this education into their courses. “It’s so nice and refreshing to be in a community that appreciates that.”

I, too, have seen this change firsthand. In addition to caring for patients and teaching at the University of North Carolina at Chapel Hill, I work with a team that develops curricula around social justice. We strive to integrate this material into existing courses and rotations. I believe that this is not only the right thing to teach trainees in order to help their future patients, but that it also reduces harm that many students experience. The “hidden curriculum” of medical school has long marginalized anyone who isn’t White and/or male.

Children, women, and the elderly were often referred to as “special populations” during my training. Even now, content about social and structural drivers of health is still most often relegated to separate courses rather than integrated into existing material. I hope to help improve this at my institution and that others are doing the same elsewhere.

If the current students I spoke with are any indication, further integration will be a welcomed change. Travis Benson, a third-year medical student at Harvard Medical School, Boston, appreciates where medical training is headed. Specifically, he is interested in inequities in the care of transgender patients. He says he has loved what his school has done with education on issues not previously considered part of med ed. “In the first week of school, we go on tours and spend time in community health centers and learn about the ‘Family Van,’ a mobile health care clinic that offers free care. I even had an opportunity to have a longitudinal clinic experience at a jail.”

While some critics argue that this learning goes too far, others argue that it has not gone far enough fast enough. In general, I consider the progress made in this area since my time in med school to be a very good thing. Medical students are now being taught to think about the science of medicine in the context of the larger human condition.
 

More technology, less preclinical time and cost

Beyond evolution in curricular content, technical and logistical changes have dramatically reshaped med ed. Since I started my training in 2012, most medical schools now no longer formally require students to attend lectures. Instead, they make them available online for students to view on demand. This undoubtedly makes schedules more flexible, allows students to learn at their own pace, and helps accommodate students with different needs.

Another big change: Preclinical years may now be as short as 1.5 years or less. This is a big draw for some students. Most choose to go to medical school to take care of patients. Shortening the preclinical years means students have more time immersed in patient care and less time dealing with medical minutiae.

That also means that they can spend more time thinking about professional development. Ramie Fathy, a fourth-year student, told me, “I came to Penn [University of Pennsylvania in Philadelphia] because of the shortened preclinical curriculum. That allowed more time on the back end to explore different specialties.” Although some established doctors worry about what scientific details may be left out, providing more hands-on experience sure seems like a good thing to me. Learning from textbooks can only take you so far in this profession.

Another, and more expected, development is the use of ever-advancing technology. Some schools now offer 3D virtual modeling for the study of anatomy, as well as a myriad of electronic visual aids for subjects like pathology and microbiology. Adapting to technological changes can be challenging, however, especially because more nontraditional students are being admitted to medical school each year.

Kahoud is one such nontraditional – older – student. She had some concerns about reliance on newer resources going in. “It [medical school] has become increasingly dependent on technology, even before COVID,” she said. “When you are not well versed in these tools it can definitely be a struggle.”

Thanks to the pandemic, remote learning is now the name of the game for many. As a result, instructors have had to amend their teaching styles to suit distance education, various untested applications and programs have been integrated into the curriculum, and students and administrators alike have had to find alternative ways to build a sense of community.

Is this a glimpse at the future for med ed? And if so, what may be lost or gained from this transition? Tino Delamerced, a third-year student at the Brown University, Providence, R.I., shared a likely very widely held hope: “If the preclinical years can be totally remote permanently, then can tuition be cheaper?”

Med ed debt keeps growing and remains a huge deterrent for potential students, especially those who are the first in their family to pursue medicine, come from a disadvantaged background, or have other people for whom they are financially responsible. Is it possible that the restrictions of COVID-19 could finally lead to cost cutting?

A bigger solution – free medical school – predated the pandemic. Institutions such as New York University have completely eliminated tuition, whereas others such as the Icahn School of Medicine at Mount Sinai (my alma mater) have limited the amount of debt with which a student graduates. You can imagine my frustration that the debt limit policy was enacted after I graduated.

Still, as optimistic as some have been at this movement that developed in the past 5 years, many think this specific evolution is little more than a “pipe dream.”
 

Current students score big with USMLE change

Beyond med school cost, another universally despised part of medical training that has seen a dramatic change is the licensing examination. My dedicated study period for the United States Medical Licensing Examination (USMLE) Step 1 was my worst time of medical school. Well, it was second to holding a retractor in the operating room for hours at a time.

Like everyone, I suspected that Step 1 would not be an accurate indicator of my ability to actually care for patients. As a practicing physician, I can now tell you for sure that this is the case. How lucky for the next generation, then, that the test is going to a pass/fail grading system.

Step 1 has always been important, as residency programs rely on the score to weed out applicants. Even if that screening emphasis simply gets shifted to scores on other examinations, this change still feels like progress. As Fathy told me, “There will likely be more emphasis on USMLE Step 2. But I think, based on practice questions I’ve done, that is more relevant to clinical abilities.” From my new vantage point, I can confirm that.

Not everyone is excited, though. Delamerced told me that he fears that the pass/fail Step 1 score may disparately affect students outside of allopathic medical schools. He said that the new scoring system “does not allow students to distinguish themselves via a standardized test score. That may hurt IMGs or DO students.”

Even then, Delamerced conceded that the change has some clear benefits. “For med students’ mental health, it’s probably a good thing.” From a population-based perspective, a medical student’s mental health often declines throughout school. Standardized exams are not the only cause, but we all know that it is a big contributor. The Step 1 switch can only help with that.
 

Finish faster or learn more?

In addition to evolution in the content and methods used to teach and assess current med students, the duration of med ed has also changed. Today’s students can choose to complete medical school in less than 4 years.

At the school where I work, the Fully Integrated Readiness for Service Training (FIRST) program allows certain students to complete their education in just 3 years. This program is for students who already know early on that they want to pursue a specialty included on our curated list. The goal of the program is to ultimately train physicians in family medicine, psychiatry, pediatrics, or general surgery in order to provide crucial care to those who need it most in our state.

Other medical schools offer accelerated MD programs for students based on various admissions criteria and specialty interest. The benefit of these programs is that shortening training time cuts down on debt for students.

Accelerated MD programs also aim to quickly increase the number of practicing physicians. This is especially important for primary care, which expects to see a growing gap in the years to come. That aim has come under some criticism, as some believe that the 4-year program was the standard for a reason. But when I reflect on it, I often wonder whether my fourth year was really worth $60,000. I spent a lot of that year traveling for residency interviews and watching Netflix between clinic electives.

Instead of finishing medical school faster, some students now have an opportunity to integrate additional training and education. Benson told me that, at Harvard, many students take a year off to pursue other opportunities. He said, “About 40% of students end up taking a fifth year to do either a master’s degree, global health, or research.” Benson said the additional learning opportunities are broad. “Some classmates even go to other schools altogether to get additional education.” Widened areas of learning are likely to produce better doctors, in my opinion.

This chance to look back on medical education has shown me that the ways in which it has changed rapidly in just the past few years are largely positive. Although COVID-19 has been an unwanted bane, it has also forced schools to integrate new technology and has placed an even brighter spotlight on health inequities and other areas in which education further improved. I hope that, when I look back on med ed in another 5 years, it has grown even more flexible and nimble in meeting the ever-changing needs of students and patients alike.

Alexa Mieses Malchuk, MD, MPH, was born and raised in Queens, New York. Social justice is what drew her to family medicine. As an academic physician at the University of North Carolina, she practices inpatient and outpatient medicine and serves as a medical educator for students and residents.
 

This article first appeared on Medscape.com.

Although medical education is constantly evolving, unique and rapid developments in recent years have sparked controversy. The next generation of physicians is learning much differently from how established doctors once did. Training has shifted from an acute focus on disease to a wider approach that considers patients within the larger context of their community and society. Although many, like myself, see this as progress, others have expressed doubts about this and many other changes.

Amid the madness that is the year 2020, I’m grateful to have a moment to reflect on this subject. Five years ago, in celebration of Medscape’s 20th anniversary, I spoke with various leaders in medical education to learn how med ed had evolved since they were in school. Since then, I’ve gone from student to faculty. This year, for Medscape’s 25th anniversary, I reached out to current medical trainees to reflect on how much things have changed in such a short time.

From adjustments forced on us by COVID-19 to trends that predated the pandemic – including an increased emphasis on social justice and a decreased emphasis on other material – becoming a doctor no longer looks like it did just a half-decade ago.
 

Social justice is now in the curricula

More than ever, medical training has shifted toward humanism, population health, and social justice. Students are now being shown not only how to treat the patient in front of them but how to “treat” the larger communities they serve. Research skills around social drivers of health, such as structural racism, are increasingly becoming status quo.

In reflecting on her current experience, Emily Kahoud, a third-year medical student at New Jersey Medical School, Newark, told me about a course she took that was devoted to health equity. She applauded how her professors have incorporated this education into their courses. “It’s so nice and refreshing to be in a community that appreciates that.”

I, too, have seen this change firsthand. In addition to caring for patients and teaching at the University of North Carolina at Chapel Hill, I work with a team that develops curricula around social justice. We strive to integrate this material into existing courses and rotations. I believe that this is not only the right thing to teach trainees in order to help their future patients, but that it also reduces harm that many students experience. The “hidden curriculum” of medical school has long marginalized anyone who isn’t White and/or male.

Children, women, and the elderly were often referred to as “special populations” during my training. Even now, content about social and structural drivers of health is still most often relegated to separate courses rather than integrated into existing material. I hope to help improve this at my institution and that others are doing the same elsewhere.

If the current students I spoke with are any indication, further integration will be a welcomed change. Travis Benson, a third-year medical student at Harvard Medical School, Boston, appreciates where medical training is headed. Specifically, he is interested in inequities in the care of transgender patients. He says he has loved what his school has done with education on issues not previously considered part of med ed. “In the first week of school, we go on tours and spend time in community health centers and learn about the ‘Family Van,’ a mobile health care clinic that offers free care. I even had an opportunity to have a longitudinal clinic experience at a jail.”

While some critics argue that this learning goes too far, others argue that it has not gone far enough fast enough. In general, I consider the progress made in this area since my time in med school to be a very good thing. Medical students are now being taught to think about the science of medicine in the context of the larger human condition.
 

More technology, less preclinical time and cost

Beyond evolution in curricular content, technical and logistical changes have dramatically reshaped med ed. Since I started my training in 2012, most medical schools now no longer formally require students to attend lectures. Instead, they make them available online for students to view on demand. This undoubtedly makes schedules more flexible, allows students to learn at their own pace, and helps accommodate students with different needs.

Another big change: Preclinical years may now be as short as 1.5 years or less. This is a big draw for some students. Most choose to go to medical school to take care of patients. Shortening the preclinical years means students have more time immersed in patient care and less time dealing with medical minutiae.

That also means that they can spend more time thinking about professional development. Ramie Fathy, a fourth-year student, told me, “I came to Penn [University of Pennsylvania in Philadelphia] because of the shortened preclinical curriculum. That allowed more time on the back end to explore different specialties.” Although some established doctors worry about what scientific details may be left out, providing more hands-on experience sure seems like a good thing to me. Learning from textbooks can only take you so far in this profession.

Another, and more expected, development is the use of ever-advancing technology. Some schools now offer 3D virtual modeling for the study of anatomy, as well as a myriad of electronic visual aids for subjects like pathology and microbiology. Adapting to technological changes can be challenging, however, especially because more nontraditional students are being admitted to medical school each year.

Kahoud is one such nontraditional – older – student. She had some concerns about reliance on newer resources going in. “It [medical school] has become increasingly dependent on technology, even before COVID,” she said. “When you are not well versed in these tools it can definitely be a struggle.”

Thanks to the pandemic, remote learning is now the name of the game for many. As a result, instructors have had to amend their teaching styles to suit distance education, various untested applications and programs have been integrated into the curriculum, and students and administrators alike have had to find alternative ways to build a sense of community.

Is this a glimpse at the future for med ed? And if so, what may be lost or gained from this transition? Tino Delamerced, a third-year student at the Brown University, Providence, R.I., shared a likely very widely held hope: “If the preclinical years can be totally remote permanently, then can tuition be cheaper?”

Med ed debt keeps growing and remains a huge deterrent for potential students, especially those who are the first in their family to pursue medicine, come from a disadvantaged background, or have other people for whom they are financially responsible. Is it possible that the restrictions of COVID-19 could finally lead to cost cutting?

A bigger solution – free medical school – predated the pandemic. Institutions such as New York University have completely eliminated tuition, whereas others such as the Icahn School of Medicine at Mount Sinai (my alma mater) have limited the amount of debt with which a student graduates. You can imagine my frustration that the debt limit policy was enacted after I graduated.

Still, as optimistic as some have been at this movement that developed in the past 5 years, many think this specific evolution is little more than a “pipe dream.”
 

Current students score big with USMLE change

Beyond med school cost, another universally despised part of medical training that has seen a dramatic change is the licensing examination. My dedicated study period for the United States Medical Licensing Examination (USMLE) Step 1 was my worst time of medical school. Well, it was second to holding a retractor in the operating room for hours at a time.

Like everyone, I suspected that Step 1 would not be an accurate indicator of my ability to actually care for patients. As a practicing physician, I can now tell you for sure that this is the case. How lucky for the next generation, then, that the test is going to a pass/fail grading system.

Step 1 has always been important, as residency programs rely on the score to weed out applicants. Even if that screening emphasis simply gets shifted to scores on other examinations, this change still feels like progress. As Fathy told me, “There will likely be more emphasis on USMLE Step 2. But I think, based on practice questions I’ve done, that is more relevant to clinical abilities.” From my new vantage point, I can confirm that.

Not everyone is excited, though. Delamerced told me that he fears that the pass/fail Step 1 score may disparately affect students outside of allopathic medical schools. He said that the new scoring system “does not allow students to distinguish themselves via a standardized test score. That may hurt IMGs or DO students.”

Even then, Delamerced conceded that the change has some clear benefits. “For med students’ mental health, it’s probably a good thing.” From a population-based perspective, a medical student’s mental health often declines throughout school. Standardized exams are not the only cause, but we all know that it is a big contributor. The Step 1 switch can only help with that.
 

Finish faster or learn more?

In addition to evolution in the content and methods used to teach and assess current med students, the duration of med ed has also changed. Today’s students can choose to complete medical school in less than 4 years.

At the school where I work, the Fully Integrated Readiness for Service Training (FIRST) program allows certain students to complete their education in just 3 years. This program is for students who already know early on that they want to pursue a specialty included on our curated list. The goal of the program is to ultimately train physicians in family medicine, psychiatry, pediatrics, or general surgery in order to provide crucial care to those who need it most in our state.

Other medical schools offer accelerated MD programs for students based on various admissions criteria and specialty interest. The benefit of these programs is that shortening training time cuts down on debt for students.

Accelerated MD programs also aim to quickly increase the number of practicing physicians. This is especially important for primary care, which expects to see a growing gap in the years to come. That aim has come under some criticism, as some believe that the 4-year program was the standard for a reason. But when I reflect on it, I often wonder whether my fourth year was really worth $60,000. I spent a lot of that year traveling for residency interviews and watching Netflix between clinic electives.

Instead of finishing medical school faster, some students now have an opportunity to integrate additional training and education. Benson told me that, at Harvard, many students take a year off to pursue other opportunities. He said, “About 40% of students end up taking a fifth year to do either a master’s degree, global health, or research.” Benson said the additional learning opportunities are broad. “Some classmates even go to other schools altogether to get additional education.” Widened areas of learning are likely to produce better doctors, in my opinion.

This chance to look back on medical education has shown me that the ways in which it has changed rapidly in just the past few years are largely positive. Although COVID-19 has been an unwanted bane, it has also forced schools to integrate new technology and has placed an even brighter spotlight on health inequities and other areas in which education further improved. I hope that, when I look back on med ed in another 5 years, it has grown even more flexible and nimble in meeting the ever-changing needs of students and patients alike.

Alexa Mieses Malchuk, MD, MPH, was born and raised in Queens, New York. Social justice is what drew her to family medicine. As an academic physician at the University of North Carolina, she practices inpatient and outpatient medicine and serves as a medical educator for students and residents.
 

This article first appeared on Medscape.com.

Although medical education is constantly evolving, unique and rapid developments in recent years have sparked controversy. The next generation of physicians is learning much differently from how established doctors once did. Training has shifted from an acute focus on disease to a wider approach that considers patients within the larger context of their community and society. Although many, like myself, see this as progress, others have expressed doubts about this and many other changes.

Amid the madness that is the year 2020, I’m grateful to have a moment to reflect on this subject. Five years ago, in celebration of Medscape’s 20th anniversary, I spoke with various leaders in medical education to learn how med ed had evolved since they were in school. Since then, I’ve gone from student to faculty. This year, for Medscape’s 25th anniversary, I reached out to current medical trainees to reflect on how much things have changed in such a short time.

From adjustments forced on us by COVID-19 to trends that predated the pandemic – including an increased emphasis on social justice and a decreased emphasis on other material – becoming a doctor no longer looks like it did just a half-decade ago.
 

Social justice is now in the curricula

More than ever, medical training has shifted toward humanism, population health, and social justice. Students are now being shown not only how to treat the patient in front of them but how to “treat” the larger communities they serve. Research skills around social drivers of health, such as structural racism, are increasingly becoming status quo.

In reflecting on her current experience, Emily Kahoud, a third-year medical student at New Jersey Medical School, Newark, told me about a course she took that was devoted to health equity. She applauded how her professors have incorporated this education into their courses. “It’s so nice and refreshing to be in a community that appreciates that.”

I, too, have seen this change firsthand. In addition to caring for patients and teaching at the University of North Carolina at Chapel Hill, I work with a team that develops curricula around social justice. We strive to integrate this material into existing courses and rotations. I believe that this is not only the right thing to teach trainees in order to help their future patients, but that it also reduces harm that many students experience. The “hidden curriculum” of medical school has long marginalized anyone who isn’t White and/or male.

Children, women, and the elderly were often referred to as “special populations” during my training. Even now, content about social and structural drivers of health is still most often relegated to separate courses rather than integrated into existing material. I hope to help improve this at my institution and that others are doing the same elsewhere.

If the current students I spoke with are any indication, further integration will be a welcomed change. Travis Benson, a third-year medical student at Harvard Medical School, Boston, appreciates where medical training is headed. Specifically, he is interested in inequities in the care of transgender patients. He says he has loved what his school has done with education on issues not previously considered part of med ed. “In the first week of school, we go on tours and spend time in community health centers and learn about the ‘Family Van,’ a mobile health care clinic that offers free care. I even had an opportunity to have a longitudinal clinic experience at a jail.”

While some critics argue that this learning goes too far, others argue that it has not gone far enough fast enough. In general, I consider the progress made in this area since my time in med school to be a very good thing. Medical students are now being taught to think about the science of medicine in the context of the larger human condition.
 

More technology, less preclinical time and cost

Beyond evolution in curricular content, technical and logistical changes have dramatically reshaped med ed. Since I started my training in 2012, most medical schools now no longer formally require students to attend lectures. Instead, they make them available online for students to view on demand. This undoubtedly makes schedules more flexible, allows students to learn at their own pace, and helps accommodate students with different needs.

Another big change: Preclinical years may now be as short as 1.5 years or less. This is a big draw for some students. Most choose to go to medical school to take care of patients. Shortening the preclinical years means students have more time immersed in patient care and less time dealing with medical minutiae.

That also means that they can spend more time thinking about professional development. Ramie Fathy, a fourth-year student, told me, “I came to Penn [University of Pennsylvania in Philadelphia] because of the shortened preclinical curriculum. That allowed more time on the back end to explore different specialties.” Although some established doctors worry about what scientific details may be left out, providing more hands-on experience sure seems like a good thing to me. Learning from textbooks can only take you so far in this profession.

Another, and more expected, development is the use of ever-advancing technology. Some schools now offer 3D virtual modeling for the study of anatomy, as well as a myriad of electronic visual aids for subjects like pathology and microbiology. Adapting to technological changes can be challenging, however, especially because more nontraditional students are being admitted to medical school each year.

Kahoud is one such nontraditional – older – student. She had some concerns about reliance on newer resources going in. “It [medical school] has become increasingly dependent on technology, even before COVID,” she said. “When you are not well versed in these tools it can definitely be a struggle.”

Thanks to the pandemic, remote learning is now the name of the game for many. As a result, instructors have had to amend their teaching styles to suit distance education, various untested applications and programs have been integrated into the curriculum, and students and administrators alike have had to find alternative ways to build a sense of community.

Is this a glimpse at the future for med ed? And if so, what may be lost or gained from this transition? Tino Delamerced, a third-year student at the Brown University, Providence, R.I., shared a likely very widely held hope: “If the preclinical years can be totally remote permanently, then can tuition be cheaper?”

Med ed debt keeps growing and remains a huge deterrent for potential students, especially those who are the first in their family to pursue medicine, come from a disadvantaged background, or have other people for whom they are financially responsible. Is it possible that the restrictions of COVID-19 could finally lead to cost cutting?

A bigger solution – free medical school – predated the pandemic. Institutions such as New York University have completely eliminated tuition, whereas others such as the Icahn School of Medicine at Mount Sinai (my alma mater) have limited the amount of debt with which a student graduates. You can imagine my frustration that the debt limit policy was enacted after I graduated.

Still, as optimistic as some have been at this movement that developed in the past 5 years, many think this specific evolution is little more than a “pipe dream.”
 

Current students score big with USMLE change

Beyond med school cost, another universally despised part of medical training that has seen a dramatic change is the licensing examination. My dedicated study period for the United States Medical Licensing Examination (USMLE) Step 1 was my worst time of medical school. Well, it was second to holding a retractor in the operating room for hours at a time.

Like everyone, I suspected that Step 1 would not be an accurate indicator of my ability to actually care for patients. As a practicing physician, I can now tell you for sure that this is the case. How lucky for the next generation, then, that the test is going to a pass/fail grading system.

Step 1 has always been important, as residency programs rely on the score to weed out applicants. Even if that screening emphasis simply gets shifted to scores on other examinations, this change still feels like progress. As Fathy told me, “There will likely be more emphasis on USMLE Step 2. But I think, based on practice questions I’ve done, that is more relevant to clinical abilities.” From my new vantage point, I can confirm that.

Not everyone is excited, though. Delamerced told me that he fears that the pass/fail Step 1 score may disparately affect students outside of allopathic medical schools. He said that the new scoring system “does not allow students to distinguish themselves via a standardized test score. That may hurt IMGs or DO students.”

Even then, Delamerced conceded that the change has some clear benefits. “For med students’ mental health, it’s probably a good thing.” From a population-based perspective, a medical student’s mental health often declines throughout school. Standardized exams are not the only cause, but we all know that it is a big contributor. The Step 1 switch can only help with that.
 

Finish faster or learn more?

In addition to evolution in the content and methods used to teach and assess current med students, the duration of med ed has also changed. Today’s students can choose to complete medical school in less than 4 years.

At the school where I work, the Fully Integrated Readiness for Service Training (FIRST) program allows certain students to complete their education in just 3 years. This program is for students who already know early on that they want to pursue a specialty included on our curated list. The goal of the program is to ultimately train physicians in family medicine, psychiatry, pediatrics, or general surgery in order to provide crucial care to those who need it most in our state.

Other medical schools offer accelerated MD programs for students based on various admissions criteria and specialty interest. The benefit of these programs is that shortening training time cuts down on debt for students.

Accelerated MD programs also aim to quickly increase the number of practicing physicians. This is especially important for primary care, which expects to see a growing gap in the years to come. That aim has come under some criticism, as some believe that the 4-year program was the standard for a reason. But when I reflect on it, I often wonder whether my fourth year was really worth $60,000. I spent a lot of that year traveling for residency interviews and watching Netflix between clinic electives.

Instead of finishing medical school faster, some students now have an opportunity to integrate additional training and education. Benson told me that, at Harvard, many students take a year off to pursue other opportunities. He said, “About 40% of students end up taking a fifth year to do either a master’s degree, global health, or research.” Benson said the additional learning opportunities are broad. “Some classmates even go to other schools altogether to get additional education.” Widened areas of learning are likely to produce better doctors, in my opinion.

This chance to look back on medical education has shown me that the ways in which it has changed rapidly in just the past few years are largely positive. Although COVID-19 has been an unwanted bane, it has also forced schools to integrate new technology and has placed an even brighter spotlight on health inequities and other areas in which education further improved. I hope that, when I look back on med ed in another 5 years, it has grown even more flexible and nimble in meeting the ever-changing needs of students and patients alike.

Alexa Mieses Malchuk, MD, MPH, was born and raised in Queens, New York. Social justice is what drew her to family medicine. As an academic physician at the University of North Carolina, she practices inpatient and outpatient medicine and serves as a medical educator for students and residents.
 

This article first appeared on Medscape.com.

Starting Nov. 2, all patients in the United States will have immediate access to clinical notes and thus will be able to read their doctors’ writings, as well as test results and reports from pathology and imaging.

FG Trade/iStock/Getty Images Plus

The 21st Century Cures Act mandates that patients have fast, electronic access to the following types of notes: consultations, discharge summaries, history, physical examination findings, imaging narratives, laboratory and pathology report narratives, and procedure and progress notes.

But this federal mandate, called “open notes” by many, is potentially confusing and frightening for patients, say some physicians. Others worry that the change will increase workload as clinicians tailor notes for patients and answer related questions.

The law means that inpatient and outpatient notes will be released immediately and that patients will have immediate access to testing and imaging results, including results from sexually transmitted disease tests, Pap tests, cancer biopsies, CT and PET scans, fetal ultrasounds, pneumonia cultures, and mammograms.

Such notes could contain sensitive information, and there is concern that patients could be shocked, confused, or annoyed by what they read, even with more run-of-the-mill notes.

Champions of open notes say that the benefits, including better provider-patient communication, greatly outweigh such risks.

“This is about convenience – a bit like online banking,” commented Charlotte Blease, PhD, resident scholar at OpenNotes, an advocacy nonprofit organization headquartered at the Beth Israel–Deaconess Medical Center in Boston. “But it’s a culture shift for doctors,” she said in an interview.

“It turns physician paternalism on its head,” said C. T. Lin, MD, chief medical information officer, UCHealth, Denver. The change requires “some letting go of old traditions” in medicine, he wrote in an August blog post, referring to the fact that a computer screen – and not a physician – may tell patients about a new health problem.

Dr. Lin summarized the experience at the University of Colorado Cancer Center, which has allowed patients to have access to oncology notes for the past 5 years: “No issues and highly appreciated by patients. We have nothing to fear but fear itself.”
 

A new audience

Other institutions have also been voluntarily implementing open notes.

UC Davis Health in Sacramento, Calif., has run an optional program for the past year. However, only about two dozen of approximately 1,000 staff physicians opted in to the program.

“This illustrates the point that it’s a new thing that physicians aren’t used to doing. They’ve traditionally written notes for the benefit of their colleagues, for billing, for their own reference,” Scott MacDonald, MD, an internist and electronic health record medical director at UC Davis Health, told this news organization.

“They’ve never –until recently – had the patient as one of the audiences for a note,” he said.

Liam Keating, MD, an otolaryngologist in Martinez, Calif., recalls that he once wrote “globus hystericus,” and the patient wanted to sue him for saying that the patient was hysterical. “I now just code ‘Globus’ (if I don’t jump straight to LPD [lateral pharyngeal diverticulum]),” he commented in response to a commentary on open notes.

Sensitive information occurs more often in certain specialties, for example, psychiatry, genetics, adolescent medicine, and oncology, experts say.

“Cancer is an area that is highly charged for patients and doctors alike,” Dr. MacDonald pointed out. When reading pathology or imaging notes, patients may learn that they have been diagnosed with cancer or that they have a recurrence “without the physician being able to contextualize it and explain things – that’s just new and scary,” he said.

California law dictates that providers cannot post cancer test results without talking with the patient first, said Dr. MacDonald, but not all states have such laws.
 

Adjustments needed – or not – with open notes

At UCHealth in Aurora, Colo., Robert Breeze, MD, vice-chair of neurosurgery, said he has adjusted his practice to accommodate open notes and to anticipate trouble spots.*

“When I order imaging or send pathology specimens, I have already discussed with the patient the possibilities, including cancer, and what we will do next. Patients deeply appreciate these discussions, before they see the results,” he commented in an institutional white paper issued in anticipation of the changes on Nov. 2.

This is called precounseling, said Trent Rosenbloom, MD, MPH, director of patient portals at Vanderbilt University Medical Center, Nashville, Tenn., which has been a pioneer in information sharing with patients. Their system does delay the release of information in the case of “complicated” results, such as from cancer biopsies, he said in an interview.

However, Christiaan Hoff, MD, PhD, a surgeon at the Medical Center Leeuwarden (the Netherlands), wonders how important it is for the physician to be present when the patient receives bad news, including news about cancer. “We may overestimate our added value in these situations,” he suggested.

“Our empathy may not outweigh” the disadvantages of the situation, and the “finer points of our explanation will often go unnoticed” by the stressed patient, he commented. Dr. Hoff was also responding to the commentary about open notes.

In that commentary, Jack West, MD, a medical oncologist at City of Hope Cancer Center, Duarte, Calif., was concerned about misunderstandings. Oncology is complex, and patients can struggle to understand their prognosis and planned treatment efficacy, especially in cases of metastatic disease, he wrote.

This concern is somewhat refuted by a study published Oct. 5 in Cancer Cell. Responses to two surveys involving 96 oncology clinicians at three U.S. centers found that almost half (44%) believed that their patients “would be confused” by open notes.

However, only 4% of the 3,418 cancer patients from the same surveys reported being confused by open notes. (A majority of participants had more than a high school education, and English was their primary language.)

“Patient and clinician views about open notes in oncology are not aligned, with patients expressing considerably more enthusiasm,” wrote the authors, led by Liz Salmi, senior strategist at OpenNotes, who has been treated for brain cancer.

“All clinicians are anxious at first,” Ms. Salmi told this news organization. “Those patients who have more serious or chronic conditions … are more likely to read their notes.”

The survey results echo the early experience reported from Sweden, where open notes was launched in 2012. “Patients have loved it from the beginning,” said Maria Haggland, PhD, of Uppsala MedTech Science Innovation Center.

However, when the scheme first launched, it was considered to be “very controversial,” and “there were a lot of complaints, from health care professionals, especially,” she added.

Over time, clinicians have embraced open notes, and the program has 7.2 million patient accounts in a country of 10 million people, she observed during an Oct. 5 webinar on open notes.
 

More work for already overworked clinicians?

An outstanding concern about open notes is that it will cause more work for health care professionals.

Traditionally, doctors have written notes using medical lexicon, including a lot of abbreviations and jargon for efficiency’s sake. Now that patients will read the notes, will clinicians have to spell out things in lay terms, alter their writing so as not to offend, and generally do more work?

William Harvey, MD, chief medical information officer, Tufts Medical Center, Boston, acknowledged that that may be the case.

In a forthcoming note to staff about the Nov. 2 start of open notes, Dr. Harvey will include a reminder to accommodate the patient as a reader. But that may or may not mean an increase in work volume, depending on the provider. “Clinical note writing is highly personal. There’s an art to it,” he said in an interview. “So it’s hard to give standard advice.”

Steven Reidbord, MD, a psychiatrist in private practice in San Francisco and a lecturer at California Pacific Medical Center, is particularly concerned about the impact of open notes on progress notes, which he calls a tool to develop strategies and make observations while working with a patient.

By watering down the language for patients, “you are trading away the technical precision and other advantages of having a professional language,” he told this news organization.

“These notes serve many masters already,” he said, referring to purposes such as utilization review and billing. “The more masters they serve, the less useful they are to get medical work done.”

Dr. MacDonald, the medical information officer, said the new law doesn’t mandate a change in writing style.

In a study published last year, researchers analyzed notes written by oncologists before and after adoption of open notes. They found that, on average, clinicians did not change their note writing. The investigators analyzed more than 100,000 clinical notes written by 35 oncologists at a single center.

Advocates for open notes emphasize that there are benefits for clinicians.

“Doctors are overworked. They’re overburdened. But empowered patients can help the doctor,” said OpenNotes’ Dr. Blease. She cited survey data that show that patients better understand their treatment plan and medication, which can cut down on physician workload.

Open notes are “what you make of it,” said Marlene Millen, MD, an internist at UC San Diego Health, which has had a pilot program for 3 years. Each day, Dr. Millen discusses a shared note with two or three patients. “I actually end all of my appointments with, ‘Don’t forget to read your note later,’ ” she told this news organization.

“I was a little afraid of this initially,” she said, but within the first 3 months of the pilot, about 15 patients gave her direct feedback on how much they appreciated her notes. “It seemed to really reassure them that they were getting good care.”

The persons quoted in this article have disclosed no relevant financial relationships.
 

Correction, 10/23/20: An earlier version of this article misstated the campus' location. 

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

Starting Nov. 2, all patients in the United States will have immediate access to clinical notes and thus will be able to read their doctors’ writings, as well as test results and reports from pathology and imaging.

FG Trade/iStock/Getty Images Plus

The 21st Century Cures Act mandates that patients have fast, electronic access to the following types of notes: consultations, discharge summaries, history, physical examination findings, imaging narratives, laboratory and pathology report narratives, and procedure and progress notes.

But this federal mandate, called “open notes” by many, is potentially confusing and frightening for patients, say some physicians. Others worry that the change will increase workload as clinicians tailor notes for patients and answer related questions.

The law means that inpatient and outpatient notes will be released immediately and that patients will have immediate access to testing and imaging results, including results from sexually transmitted disease tests, Pap tests, cancer biopsies, CT and PET scans, fetal ultrasounds, pneumonia cultures, and mammograms.

Such notes could contain sensitive information, and there is concern that patients could be shocked, confused, or annoyed by what they read, even with more run-of-the-mill notes.

Champions of open notes say that the benefits, including better provider-patient communication, greatly outweigh such risks.

“This is about convenience – a bit like online banking,” commented Charlotte Blease, PhD, resident scholar at OpenNotes, an advocacy nonprofit organization headquartered at the Beth Israel–Deaconess Medical Center in Boston. “But it’s a culture shift for doctors,” she said in an interview.

“It turns physician paternalism on its head,” said C. T. Lin, MD, chief medical information officer, UCHealth, Denver. The change requires “some letting go of old traditions” in medicine, he wrote in an August blog post, referring to the fact that a computer screen – and not a physician – may tell patients about a new health problem.

Dr. Lin summarized the experience at the University of Colorado Cancer Center, which has allowed patients to have access to oncology notes for the past 5 years: “No issues and highly appreciated by patients. We have nothing to fear but fear itself.”
 

A new audience

Other institutions have also been voluntarily implementing open notes.

UC Davis Health in Sacramento, Calif., has run an optional program for the past year. However, only about two dozen of approximately 1,000 staff physicians opted in to the program.

“This illustrates the point that it’s a new thing that physicians aren’t used to doing. They’ve traditionally written notes for the benefit of their colleagues, for billing, for their own reference,” Scott MacDonald, MD, an internist and electronic health record medical director at UC Davis Health, told this news organization.

“They’ve never –until recently – had the patient as one of the audiences for a note,” he said.

Liam Keating, MD, an otolaryngologist in Martinez, Calif., recalls that he once wrote “globus hystericus,” and the patient wanted to sue him for saying that the patient was hysterical. “I now just code ‘Globus’ (if I don’t jump straight to LPD [lateral pharyngeal diverticulum]),” he commented in response to a commentary on open notes.

Sensitive information occurs more often in certain specialties, for example, psychiatry, genetics, adolescent medicine, and oncology, experts say.

“Cancer is an area that is highly charged for patients and doctors alike,” Dr. MacDonald pointed out. When reading pathology or imaging notes, patients may learn that they have been diagnosed with cancer or that they have a recurrence “without the physician being able to contextualize it and explain things – that’s just new and scary,” he said.

California law dictates that providers cannot post cancer test results without talking with the patient first, said Dr. MacDonald, but not all states have such laws.
 

Adjustments needed – or not – with open notes

At UCHealth in Aurora, Colo., Robert Breeze, MD, vice-chair of neurosurgery, said he has adjusted his practice to accommodate open notes and to anticipate trouble spots.*

“When I order imaging or send pathology specimens, I have already discussed with the patient the possibilities, including cancer, and what we will do next. Patients deeply appreciate these discussions, before they see the results,” he commented in an institutional white paper issued in anticipation of the changes on Nov. 2.

This is called precounseling, said Trent Rosenbloom, MD, MPH, director of patient portals at Vanderbilt University Medical Center, Nashville, Tenn., which has been a pioneer in information sharing with patients. Their system does delay the release of information in the case of “complicated” results, such as from cancer biopsies, he said in an interview.

However, Christiaan Hoff, MD, PhD, a surgeon at the Medical Center Leeuwarden (the Netherlands), wonders how important it is for the physician to be present when the patient receives bad news, including news about cancer. “We may overestimate our added value in these situations,” he suggested.

“Our empathy may not outweigh” the disadvantages of the situation, and the “finer points of our explanation will often go unnoticed” by the stressed patient, he commented. Dr. Hoff was also responding to the commentary about open notes.

In that commentary, Jack West, MD, a medical oncologist at City of Hope Cancer Center, Duarte, Calif., was concerned about misunderstandings. Oncology is complex, and patients can struggle to understand their prognosis and planned treatment efficacy, especially in cases of metastatic disease, he wrote.

This concern is somewhat refuted by a study published Oct. 5 in Cancer Cell. Responses to two surveys involving 96 oncology clinicians at three U.S. centers found that almost half (44%) believed that their patients “would be confused” by open notes.

However, only 4% of the 3,418 cancer patients from the same surveys reported being confused by open notes. (A majority of participants had more than a high school education, and English was their primary language.)

“Patient and clinician views about open notes in oncology are not aligned, with patients expressing considerably more enthusiasm,” wrote the authors, led by Liz Salmi, senior strategist at OpenNotes, who has been treated for brain cancer.

“All clinicians are anxious at first,” Ms. Salmi told this news organization. “Those patients who have more serious or chronic conditions … are more likely to read their notes.”

The survey results echo the early experience reported from Sweden, where open notes was launched in 2012. “Patients have loved it from the beginning,” said Maria Haggland, PhD, of Uppsala MedTech Science Innovation Center.

However, when the scheme first launched, it was considered to be “very controversial,” and “there were a lot of complaints, from health care professionals, especially,” she added.

Over time, clinicians have embraced open notes, and the program has 7.2 million patient accounts in a country of 10 million people, she observed during an Oct. 5 webinar on open notes.
 

More work for already overworked clinicians?

An outstanding concern about open notes is that it will cause more work for health care professionals.

Traditionally, doctors have written notes using medical lexicon, including a lot of abbreviations and jargon for efficiency’s sake. Now that patients will read the notes, will clinicians have to spell out things in lay terms, alter their writing so as not to offend, and generally do more work?

William Harvey, MD, chief medical information officer, Tufts Medical Center, Boston, acknowledged that that may be the case.

In a forthcoming note to staff about the Nov. 2 start of open notes, Dr. Harvey will include a reminder to accommodate the patient as a reader. But that may or may not mean an increase in work volume, depending on the provider. “Clinical note writing is highly personal. There’s an art to it,” he said in an interview. “So it’s hard to give standard advice.”

Steven Reidbord, MD, a psychiatrist in private practice in San Francisco and a lecturer at California Pacific Medical Center, is particularly concerned about the impact of open notes on progress notes, which he calls a tool to develop strategies and make observations while working with a patient.

By watering down the language for patients, “you are trading away the technical precision and other advantages of having a professional language,” he told this news organization.

“These notes serve many masters already,” he said, referring to purposes such as utilization review and billing. “The more masters they serve, the less useful they are to get medical work done.”

Dr. MacDonald, the medical information officer, said the new law doesn’t mandate a change in writing style.

In a study published last year, researchers analyzed notes written by oncologists before and after adoption of open notes. They found that, on average, clinicians did not change their note writing. The investigators analyzed more than 100,000 clinical notes written by 35 oncologists at a single center.

Advocates for open notes emphasize that there are benefits for clinicians.

“Doctors are overworked. They’re overburdened. But empowered patients can help the doctor,” said OpenNotes’ Dr. Blease. She cited survey data that show that patients better understand their treatment plan and medication, which can cut down on physician workload.

Open notes are “what you make of it,” said Marlene Millen, MD, an internist at UC San Diego Health, which has had a pilot program for 3 years. Each day, Dr. Millen discusses a shared note with two or three patients. “I actually end all of my appointments with, ‘Don’t forget to read your note later,’ ” she told this news organization.

“I was a little afraid of this initially,” she said, but within the first 3 months of the pilot, about 15 patients gave her direct feedback on how much they appreciated her notes. “It seemed to really reassure them that they were getting good care.”

The persons quoted in this article have disclosed no relevant financial relationships.
 

Correction, 10/23/20: An earlier version of this article misstated the campus' location. 

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

Starting Nov. 2, all patients in the United States will have immediate access to clinical notes and thus will be able to read their doctors’ writings, as well as test results and reports from pathology and imaging.

FG Trade/iStock/Getty Images Plus

The 21st Century Cures Act mandates that patients have fast, electronic access to the following types of notes: consultations, discharge summaries, history, physical examination findings, imaging narratives, laboratory and pathology report narratives, and procedure and progress notes.

But this federal mandate, called “open notes” by many, is potentially confusing and frightening for patients, say some physicians. Others worry that the change will increase workload as clinicians tailor notes for patients and answer related questions.

The law means that inpatient and outpatient notes will be released immediately and that patients will have immediate access to testing and imaging results, including results from sexually transmitted disease tests, Pap tests, cancer biopsies, CT and PET scans, fetal ultrasounds, pneumonia cultures, and mammograms.

Such notes could contain sensitive information, and there is concern that patients could be shocked, confused, or annoyed by what they read, even with more run-of-the-mill notes.

Champions of open notes say that the benefits, including better provider-patient communication, greatly outweigh such risks.

“This is about convenience – a bit like online banking,” commented Charlotte Blease, PhD, resident scholar at OpenNotes, an advocacy nonprofit organization headquartered at the Beth Israel–Deaconess Medical Center in Boston. “But it’s a culture shift for doctors,” she said in an interview.

“It turns physician paternalism on its head,” said C. T. Lin, MD, chief medical information officer, UCHealth, Denver. The change requires “some letting go of old traditions” in medicine, he wrote in an August blog post, referring to the fact that a computer screen – and not a physician – may tell patients about a new health problem.

Dr. Lin summarized the experience at the University of Colorado Cancer Center, which has allowed patients to have access to oncology notes for the past 5 years: “No issues and highly appreciated by patients. We have nothing to fear but fear itself.”
 

A new audience

Other institutions have also been voluntarily implementing open notes.

UC Davis Health in Sacramento, Calif., has run an optional program for the past year. However, only about two dozen of approximately 1,000 staff physicians opted in to the program.

“This illustrates the point that it’s a new thing that physicians aren’t used to doing. They’ve traditionally written notes for the benefit of their colleagues, for billing, for their own reference,” Scott MacDonald, MD, an internist and electronic health record medical director at UC Davis Health, told this news organization.

“They’ve never –until recently – had the patient as one of the audiences for a note,” he said.

Liam Keating, MD, an otolaryngologist in Martinez, Calif., recalls that he once wrote “globus hystericus,” and the patient wanted to sue him for saying that the patient was hysterical. “I now just code ‘Globus’ (if I don’t jump straight to LPD [lateral pharyngeal diverticulum]),” he commented in response to a commentary on open notes.

Sensitive information occurs more often in certain specialties, for example, psychiatry, genetics, adolescent medicine, and oncology, experts say.

“Cancer is an area that is highly charged for patients and doctors alike,” Dr. MacDonald pointed out. When reading pathology or imaging notes, patients may learn that they have been diagnosed with cancer or that they have a recurrence “without the physician being able to contextualize it and explain things – that’s just new and scary,” he said.

California law dictates that providers cannot post cancer test results without talking with the patient first, said Dr. MacDonald, but not all states have such laws.
 

Adjustments needed – or not – with open notes

At UCHealth in Aurora, Colo., Robert Breeze, MD, vice-chair of neurosurgery, said he has adjusted his practice to accommodate open notes and to anticipate trouble spots.*

“When I order imaging or send pathology specimens, I have already discussed with the patient the possibilities, including cancer, and what we will do next. Patients deeply appreciate these discussions, before they see the results,” he commented in an institutional white paper issued in anticipation of the changes on Nov. 2.

This is called precounseling, said Trent Rosenbloom, MD, MPH, director of patient portals at Vanderbilt University Medical Center, Nashville, Tenn., which has been a pioneer in information sharing with patients. Their system does delay the release of information in the case of “complicated” results, such as from cancer biopsies, he said in an interview.

However, Christiaan Hoff, MD, PhD, a surgeon at the Medical Center Leeuwarden (the Netherlands), wonders how important it is for the physician to be present when the patient receives bad news, including news about cancer. “We may overestimate our added value in these situations,” he suggested.

“Our empathy may not outweigh” the disadvantages of the situation, and the “finer points of our explanation will often go unnoticed” by the stressed patient, he commented. Dr. Hoff was also responding to the commentary about open notes.

In that commentary, Jack West, MD, a medical oncologist at City of Hope Cancer Center, Duarte, Calif., was concerned about misunderstandings. Oncology is complex, and patients can struggle to understand their prognosis and planned treatment efficacy, especially in cases of metastatic disease, he wrote.

This concern is somewhat refuted by a study published Oct. 5 in Cancer Cell. Responses to two surveys involving 96 oncology clinicians at three U.S. centers found that almost half (44%) believed that their patients “would be confused” by open notes.

However, only 4% of the 3,418 cancer patients from the same surveys reported being confused by open notes. (A majority of participants had more than a high school education, and English was their primary language.)

“Patient and clinician views about open notes in oncology are not aligned, with patients expressing considerably more enthusiasm,” wrote the authors, led by Liz Salmi, senior strategist at OpenNotes, who has been treated for brain cancer.

“All clinicians are anxious at first,” Ms. Salmi told this news organization. “Those patients who have more serious or chronic conditions … are more likely to read their notes.”

The survey results echo the early experience reported from Sweden, where open notes was launched in 2012. “Patients have loved it from the beginning,” said Maria Haggland, PhD, of Uppsala MedTech Science Innovation Center.

However, when the scheme first launched, it was considered to be “very controversial,” and “there were a lot of complaints, from health care professionals, especially,” she added.

Over time, clinicians have embraced open notes, and the program has 7.2 million patient accounts in a country of 10 million people, she observed during an Oct. 5 webinar on open notes.
 

More work for already overworked clinicians?

An outstanding concern about open notes is that it will cause more work for health care professionals.

Traditionally, doctors have written notes using medical lexicon, including a lot of abbreviations and jargon for efficiency’s sake. Now that patients will read the notes, will clinicians have to spell out things in lay terms, alter their writing so as not to offend, and generally do more work?

William Harvey, MD, chief medical information officer, Tufts Medical Center, Boston, acknowledged that that may be the case.

In a forthcoming note to staff about the Nov. 2 start of open notes, Dr. Harvey will include a reminder to accommodate the patient as a reader. But that may or may not mean an increase in work volume, depending on the provider. “Clinical note writing is highly personal. There’s an art to it,” he said in an interview. “So it’s hard to give standard advice.”

Steven Reidbord, MD, a psychiatrist in private practice in San Francisco and a lecturer at California Pacific Medical Center, is particularly concerned about the impact of open notes on progress notes, which he calls a tool to develop strategies and make observations while working with a patient.

By watering down the language for patients, “you are trading away the technical precision and other advantages of having a professional language,” he told this news organization.

“These notes serve many masters already,” he said, referring to purposes such as utilization review and billing. “The more masters they serve, the less useful they are to get medical work done.”

Dr. MacDonald, the medical information officer, said the new law doesn’t mandate a change in writing style.

In a study published last year, researchers analyzed notes written by oncologists before and after adoption of open notes. They found that, on average, clinicians did not change their note writing. The investigators analyzed more than 100,000 clinical notes written by 35 oncologists at a single center.

Advocates for open notes emphasize that there are benefits for clinicians.

“Doctors are overworked. They’re overburdened. But empowered patients can help the doctor,” said OpenNotes’ Dr. Blease. She cited survey data that show that patients better understand their treatment plan and medication, which can cut down on physician workload.

Open notes are “what you make of it,” said Marlene Millen, MD, an internist at UC San Diego Health, which has had a pilot program for 3 years. Each day, Dr. Millen discusses a shared note with two or three patients. “I actually end all of my appointments with, ‘Don’t forget to read your note later,’ ” she told this news organization.

“I was a little afraid of this initially,” she said, but within the first 3 months of the pilot, about 15 patients gave her direct feedback on how much they appreciated her notes. “It seemed to really reassure them that they were getting good care.”

The persons quoted in this article have disclosed no relevant financial relationships.
 

Correction, 10/23/20: An earlier version of this article misstated the campus' location. 

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.

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.

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.