Tara Haelle

Women with polycystic ovarian syndrome (PCOS) before menopause appear to have a greater risk of stroke, heart attack, and other cardiovascular events after menopause, according to findings presented at the virtual American Society for Reproductive Medicine (ASRM) 2020 Scientific Congress.

“We found a PCOS diagnosis prior to menopause was associated with a 64% increased risk of cardiovascular disease after menopause independent of age at enrollment, race, body mass index, and smoking status,” presenter Jacob Christ, MD, a resident at the University of Washington in Seattle, told attendees. “Taken together, our results suggest that women with PCOS have more risk factors for future cardiovascular disease at baseline, and a present PCOS diagnosis prior to menopause is associated with an increased risk of cardiovascular disease after menopause.”

The results are important to consider in women seeking care related to fertility, according to Amanda N. Kallen, MD, assistant professor of reproductive endocrinology and infertility at Yale Medicine in New Haven, Conn.

“As fertility specialists, we often see women with PCOS visit us when they are having trouble conceiving, but often [they] do not return to our care once they’ve built their family,” said Dr. Kallen, who was not involved in the research.

“This excellent talk emphasized how critical it is for us as reproductive endocrinologists to have ongoing discussions with PCOS patients about long-term cardiovascular risks at every opportunity, and to emphasize that these risks persist long after the reproductive years have ended,” Dr. Kallen said in an interview.
 

Identifying women at higher risk

Characteristics of PCOS in adolescence are already understood, including hyperandrogenism, acne, irregular bleeding, and variable ages of menarche, Dr. Christ explained. Similarly, in women’s reproductive years, PCOS is linked to abnormal uterine bleeding, hirsutism, dyslipidemia, infertility, impaired glucose tolerance, gestational diabetes, and preeclampsia.

“What is less clear is if baseline cardiometabolic dysfunction during reproductive years translates into cardiovascular disease after menopause,” Dr. Christ said. “Menopausal changes may reduce risk of cardiovascular disease among PCOS women, as it is known that overall, androgen levels decline during menopause. Furthermore, ovarian aging may be delayed in PCOS women, which may be protective against cardiovascular disease.”

To learn more, the researchers completed a secondary analysis of data from the Study of Women’s Health Across the Nation (SWAN), a prospective cohort study. Women enrolled in the study were aged 42-52 years at baseline, had a uterus and at least one ovary, and menstruated within the previous 3 months. Women were considered to have PCOS if they had both biochemical hyperandrogenism and a history of irregular menses.

The researchers included participants in the secondary analysis if they had complete data on the women’s baseline menstrual status and total testosterone and if the women had at least one follow-up visit after menopause. Menopause was approximated as 51 years old if not otherwise reported (or 1 year after study entry if age 51 at entry). At the follow-up visit, women self-reported any cardiovascular disease events since menopause.

The study’s primary outcome was the first postmenopausal cardiovascular event. These included any of the following: myocardial infarction, cerebrovascular accident or stroke, angina, percutaneous coronary intervention or angioplasty, coronary artery bypass graft, heart failure, carotid artery procedure, peripheral artery disease or lower extremity procedure, renal artery procedure, deep vein thrombosis, pulmonary embolism, and abdominal aortic aneurysm.

Among 1,340 women included in the analysis, 174 (13%) women had PCOS and 1,166 did not. The average age at screening and at menopause were not significantly different between the groups, but they did differ based on other baseline characteristics.

More women with PCOS frequently smoked cigarettes (22%) vs. those without PCOS (12.7%), and women with PCOS had an average body mass index of 31.3, vs. 26.7 among those without PCOS. Women with PCOS also had higher systolic blood pressure (120.7 vs. 115.8 mm Hg), higher total cholesterol (202 vs. 192 mg/dL), and higher fasting blood glucose (103.7 vs. 89.2 mg/dL; P < .01 for all).

After the researchers controlled for age at enrollment, race, BMI, and smoking status, women with PCOS had 1.6 times greater odds of a cardiovascular event after menopause compared with women without PCOS (odds ratio [OR], 1.6; P = .029). Those with PCOS also had a significantly higher Atherosclerotic Cardiovascular Disease risk scores (P = .024), but their Framingham 10-year risk score was not significantly different from those without PCOS.

Although the findings are not necessarily surprising, the study’s value particularly lay in its size, prospective data collection, and rigorous methods, said Ginny Ryan, MD, MA, professor and division chief of reproductive endocrinology and infertility at the University of Washington in Seattle.

“While this study’s criteria used to identify subjects with PCOS selected a population with a particularly severe phenotype of PCOS and thus a higher risk population for cardiovascular disease, it is vital for women’s health providers to truly understand the medium- and long-term life-threatening associations found more commonly in many with PCOS,” Dr. Ryan, who attended the talk and was not involved in the research, said in an interview.

“This study emphasizes the importance of identifying PCOS before menopause, not just for the patient’s immediate well-being, but also so that appropriate counseling and referral can take place to optimize primary, secondary, and tertiary prevention efforts against CVD and related morbidity and mortality,” Dr. Ryan said. “Providers who focus on reproductive health and reproductive-aged women have the opportunity to play a vital role in optimizing the long-term health of their patients.”

Aside from being a prospective cohort with more than 2 decades of follow-up, the study’s other strengths included the definition of PCOS before menopause and use of multiple markers of postmenopausal cardiovascular disease, Dr. Christ said. The study’s main weaknesses were the exclusion of mild PCOS, the self-reporting of cardiovascular events, and the multiple ways of defining menopause.

Dr. Kallen is a consultant for Gynaesight and a reviewer for Healthline. Dr. Christ and Dr. Ryan have disclosed no relevant financial relationships.

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

Women with polycystic ovarian syndrome (PCOS) before menopause appear to have a greater risk of stroke, heart attack, and other cardiovascular events after menopause, according to findings presented at the virtual American Society for Reproductive Medicine (ASRM) 2020 Scientific Congress.

“We found a PCOS diagnosis prior to menopause was associated with a 64% increased risk of cardiovascular disease after menopause independent of age at enrollment, race, body mass index, and smoking status,” presenter Jacob Christ, MD, a resident at the University of Washington in Seattle, told attendees. “Taken together, our results suggest that women with PCOS have more risk factors for future cardiovascular disease at baseline, and a present PCOS diagnosis prior to menopause is associated with an increased risk of cardiovascular disease after menopause.”

The results are important to consider in women seeking care related to fertility, according to Amanda N. Kallen, MD, assistant professor of reproductive endocrinology and infertility at Yale Medicine in New Haven, Conn.

“As fertility specialists, we often see women with PCOS visit us when they are having trouble conceiving, but often [they] do not return to our care once they’ve built their family,” said Dr. Kallen, who was not involved in the research.

“This excellent talk emphasized how critical it is for us as reproductive endocrinologists to have ongoing discussions with PCOS patients about long-term cardiovascular risks at every opportunity, and to emphasize that these risks persist long after the reproductive years have ended,” Dr. Kallen said in an interview.
 

Identifying women at higher risk

Characteristics of PCOS in adolescence are already understood, including hyperandrogenism, acne, irregular bleeding, and variable ages of menarche, Dr. Christ explained. Similarly, in women’s reproductive years, PCOS is linked to abnormal uterine bleeding, hirsutism, dyslipidemia, infertility, impaired glucose tolerance, gestational diabetes, and preeclampsia.

“What is less clear is if baseline cardiometabolic dysfunction during reproductive years translates into cardiovascular disease after menopause,” Dr. Christ said. “Menopausal changes may reduce risk of cardiovascular disease among PCOS women, as it is known that overall, androgen levels decline during menopause. Furthermore, ovarian aging may be delayed in PCOS women, which may be protective against cardiovascular disease.”

To learn more, the researchers completed a secondary analysis of data from the Study of Women’s Health Across the Nation (SWAN), a prospective cohort study. Women enrolled in the study were aged 42-52 years at baseline, had a uterus and at least one ovary, and menstruated within the previous 3 months. Women were considered to have PCOS if they had both biochemical hyperandrogenism and a history of irregular menses.

The researchers included participants in the secondary analysis if they had complete data on the women’s baseline menstrual status and total testosterone and if the women had at least one follow-up visit after menopause. Menopause was approximated as 51 years old if not otherwise reported (or 1 year after study entry if age 51 at entry). At the follow-up visit, women self-reported any cardiovascular disease events since menopause.

The study’s primary outcome was the first postmenopausal cardiovascular event. These included any of the following: myocardial infarction, cerebrovascular accident or stroke, angina, percutaneous coronary intervention or angioplasty, coronary artery bypass graft, heart failure, carotid artery procedure, peripheral artery disease or lower extremity procedure, renal artery procedure, deep vein thrombosis, pulmonary embolism, and abdominal aortic aneurysm.

Among 1,340 women included in the analysis, 174 (13%) women had PCOS and 1,166 did not. The average age at screening and at menopause were not significantly different between the groups, but they did differ based on other baseline characteristics.

More women with PCOS frequently smoked cigarettes (22%) vs. those without PCOS (12.7%), and women with PCOS had an average body mass index of 31.3, vs. 26.7 among those without PCOS. Women with PCOS also had higher systolic blood pressure (120.7 vs. 115.8 mm Hg), higher total cholesterol (202 vs. 192 mg/dL), and higher fasting blood glucose (103.7 vs. 89.2 mg/dL; P < .01 for all).

After the researchers controlled for age at enrollment, race, BMI, and smoking status, women with PCOS had 1.6 times greater odds of a cardiovascular event after menopause compared with women without PCOS (odds ratio [OR], 1.6; P = .029). Those with PCOS also had a significantly higher Atherosclerotic Cardiovascular Disease risk scores (P = .024), but their Framingham 10-year risk score was not significantly different from those without PCOS.

Although the findings are not necessarily surprising, the study’s value particularly lay in its size, prospective data collection, and rigorous methods, said Ginny Ryan, MD, MA, professor and division chief of reproductive endocrinology and infertility at the University of Washington in Seattle.

“While this study’s criteria used to identify subjects with PCOS selected a population with a particularly severe phenotype of PCOS and thus a higher risk population for cardiovascular disease, it is vital for women’s health providers to truly understand the medium- and long-term life-threatening associations found more commonly in many with PCOS,” Dr. Ryan, who attended the talk and was not involved in the research, said in an interview.

“This study emphasizes the importance of identifying PCOS before menopause, not just for the patient’s immediate well-being, but also so that appropriate counseling and referral can take place to optimize primary, secondary, and tertiary prevention efforts against CVD and related morbidity and mortality,” Dr. Ryan said. “Providers who focus on reproductive health and reproductive-aged women have the opportunity to play a vital role in optimizing the long-term health of their patients.”

Aside from being a prospective cohort with more than 2 decades of follow-up, the study’s other strengths included the definition of PCOS before menopause and use of multiple markers of postmenopausal cardiovascular disease, Dr. Christ said. The study’s main weaknesses were the exclusion of mild PCOS, the self-reporting of cardiovascular events, and the multiple ways of defining menopause.

Dr. Kallen is a consultant for Gynaesight and a reviewer for Healthline. Dr. Christ and Dr. Ryan have disclosed no relevant financial relationships.

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

Women with polycystic ovarian syndrome (PCOS) before menopause appear to have a greater risk of stroke, heart attack, and other cardiovascular events after menopause, according to findings presented at the virtual American Society for Reproductive Medicine (ASRM) 2020 Scientific Congress.

“We found a PCOS diagnosis prior to menopause was associated with a 64% increased risk of cardiovascular disease after menopause independent of age at enrollment, race, body mass index, and smoking status,” presenter Jacob Christ, MD, a resident at the University of Washington in Seattle, told attendees. “Taken together, our results suggest that women with PCOS have more risk factors for future cardiovascular disease at baseline, and a present PCOS diagnosis prior to menopause is associated with an increased risk of cardiovascular disease after menopause.”

The results are important to consider in women seeking care related to fertility, according to Amanda N. Kallen, MD, assistant professor of reproductive endocrinology and infertility at Yale Medicine in New Haven, Conn.

“As fertility specialists, we often see women with PCOS visit us when they are having trouble conceiving, but often [they] do not return to our care once they’ve built their family,” said Dr. Kallen, who was not involved in the research.

“This excellent talk emphasized how critical it is for us as reproductive endocrinologists to have ongoing discussions with PCOS patients about long-term cardiovascular risks at every opportunity, and to emphasize that these risks persist long after the reproductive years have ended,” Dr. Kallen said in an interview.
 

Identifying women at higher risk

Characteristics of PCOS in adolescence are already understood, including hyperandrogenism, acne, irregular bleeding, and variable ages of menarche, Dr. Christ explained. Similarly, in women’s reproductive years, PCOS is linked to abnormal uterine bleeding, hirsutism, dyslipidemia, infertility, impaired glucose tolerance, gestational diabetes, and preeclampsia.

“What is less clear is if baseline cardiometabolic dysfunction during reproductive years translates into cardiovascular disease after menopause,” Dr. Christ said. “Menopausal changes may reduce risk of cardiovascular disease among PCOS women, as it is known that overall, androgen levels decline during menopause. Furthermore, ovarian aging may be delayed in PCOS women, which may be protective against cardiovascular disease.”

To learn more, the researchers completed a secondary analysis of data from the Study of Women’s Health Across the Nation (SWAN), a prospective cohort study. Women enrolled in the study were aged 42-52 years at baseline, had a uterus and at least one ovary, and menstruated within the previous 3 months. Women were considered to have PCOS if they had both biochemical hyperandrogenism and a history of irregular menses.

The researchers included participants in the secondary analysis if they had complete data on the women’s baseline menstrual status and total testosterone and if the women had at least one follow-up visit after menopause. Menopause was approximated as 51 years old if not otherwise reported (or 1 year after study entry if age 51 at entry). At the follow-up visit, women self-reported any cardiovascular disease events since menopause.

The study’s primary outcome was the first postmenopausal cardiovascular event. These included any of the following: myocardial infarction, cerebrovascular accident or stroke, angina, percutaneous coronary intervention or angioplasty, coronary artery bypass graft, heart failure, carotid artery procedure, peripheral artery disease or lower extremity procedure, renal artery procedure, deep vein thrombosis, pulmonary embolism, and abdominal aortic aneurysm.

Among 1,340 women included in the analysis, 174 (13%) women had PCOS and 1,166 did not. The average age at screening and at menopause were not significantly different between the groups, but they did differ based on other baseline characteristics.

More women with PCOS frequently smoked cigarettes (22%) vs. those without PCOS (12.7%), and women with PCOS had an average body mass index of 31.3, vs. 26.7 among those without PCOS. Women with PCOS also had higher systolic blood pressure (120.7 vs. 115.8 mm Hg), higher total cholesterol (202 vs. 192 mg/dL), and higher fasting blood glucose (103.7 vs. 89.2 mg/dL; P < .01 for all).

After the researchers controlled for age at enrollment, race, BMI, and smoking status, women with PCOS had 1.6 times greater odds of a cardiovascular event after menopause compared with women without PCOS (odds ratio [OR], 1.6; P = .029). Those with PCOS also had a significantly higher Atherosclerotic Cardiovascular Disease risk scores (P = .024), but their Framingham 10-year risk score was not significantly different from those without PCOS.

Although the findings are not necessarily surprising, the study’s value particularly lay in its size, prospective data collection, and rigorous methods, said Ginny Ryan, MD, MA, professor and division chief of reproductive endocrinology and infertility at the University of Washington in Seattle.

“While this study’s criteria used to identify subjects with PCOS selected a population with a particularly severe phenotype of PCOS and thus a higher risk population for cardiovascular disease, it is vital for women’s health providers to truly understand the medium- and long-term life-threatening associations found more commonly in many with PCOS,” Dr. Ryan, who attended the talk and was not involved in the research, said in an interview.

“This study emphasizes the importance of identifying PCOS before menopause, not just for the patient’s immediate well-being, but also so that appropriate counseling and referral can take place to optimize primary, secondary, and tertiary prevention efforts against CVD and related morbidity and mortality,” Dr. Ryan said. “Providers who focus on reproductive health and reproductive-aged women have the opportunity to play a vital role in optimizing the long-term health of their patients.”

Aside from being a prospective cohort with more than 2 decades of follow-up, the study’s other strengths included the definition of PCOS before menopause and use of multiple markers of postmenopausal cardiovascular disease, Dr. Christ said. The study’s main weaknesses were the exclusion of mild PCOS, the self-reporting of cardiovascular events, and the multiple ways of defining menopause.

Dr. Kallen is a consultant for Gynaesight and a reviewer for Healthline. Dr. Christ and Dr. Ryan have 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.

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.

In addition to screening adolescent patients at least once a year for substance use, it’s important that pediatricians build relationships with other behavioral health providers and develop a strategy for ensuring that teens with substance use issues continue returning to your practice as their medical home, according to Lucien Gonzalez, MD, assistant professor of psychiatry and behavioral sciences at the University of Minnesota, Minneapolis.

In a presentation at the annual meeting of the American Academy of Pediatrics, held virtually this year, Dr. Gonzalez discussed some of the common challenges pediatricians face in appropriately screening, diagnosing, and managing or referring youth when it comes to substance use.
 

Substance use screening

One of these included picking the right assessment tool and frequency for screening patients for substance use. A number of validated tools are out there, including the Screening to Brief Intervention (S2BI) and CRAFFT Screening Tool for Adolescent Substance Abuse. Regardless of which screening tool providers choose, “the important thing is to use a tool that is validated in the pediatric population and ideally has frequency results in it,” Dr. Gonzalez said.

In terms of frequency, screening young people at least once a year is fairly standard, but it may be necessary to screen adolescents more often or to screen them at acute visits.

“As many of you who work with adolescents know, you can’t always rely on the yearly well child visit because after a certain age, you start to see drop-off,” Dr. Gonzalez said. “They often aren’t coming for well child visits, and they often are then only showing up for acute visits.”

That means doctors need to think about how their clinics operate, how often they see their teen patients, and other factors – including how much can happen in a single year of adolescence – to ensure that screening captures these patients at least once a year, but more if that works within the practice.
 

Screening vs. diagnosis

Dr. Gonzalez also addressed the difference between screening and diagnosis, a very familiar distinction to physicians in other areas of medicine but often a source of confusion in the area of substance use.

“Screening is the presumptive identification of unrecognized disease in apparently healthy people who don’t have symptoms, using assessments that can be used rapidly,” Dr. Gonzalez said. “When we move into the diagnostic realm, these are people who present with symptoms or they have positive results on our screening test prompting further investigation.”

Sonia Khan, MD, a pediatrician and the medical director of the substance use disorder counseling program in the department of health and human services in Fremont, Calif., who heard the talk, particularly appreciated this point about screening versus diagnosis.

“As soon as you get a hint that there’s a problem with the kid, you’re no longer screening. You’re doing diagnostic investigation,” Dr. Khan, also the human relations commissioner for the city of Fremont, Calif., said in an interview. “Screening is about the kids you don’t know about. It seems like a small point to make a big deal out of, but it’s not.”

Sometimes a screening tool can serve as an introductory interview guide when beginning a clinical investigation with a patient who already shows symptoms, but that doesn’t mean it’s a screen.

Dr. Gonzalez emphasized the importance of not prescreening.

“A prescreener looks at a kid and decides whether or not they need to be screened,” Dr. Gonzalez said. “We have research that demonstrates that that doesn’t work. Physicians are not good at determining this by eyeballing it, and it’s fraught with bias. Universal screening with a validated screening tool is what works.”

Again, the idea of confronting one’s own personal biases and how they could interfere with screening really resonated with Dr. Khan.

“When it comes to the prescreening, if you’re only screening the ones you [think you] need to screen, you’re introducing bias into your screening,” she said. “It’s usually judgmental. It’s important to focus on really getting the bias out of what you’re doing because it’s a field fraught with bias and expectations.”


 

Brief interventions

Another area of confusion for many providers is what qualifies as a brief intervention and how to deliver it. The brief intervention needs to focus on increasing the patient’s knowledge, insights, and awareness when it comes to their own substance use and how it affects others. It should also support motivation in the patient to make behavioral changes. “It is always given in a nonjudgmental, supportive manner,” Dr. Gonzalez said.

Though motivational interviewing is often discussed as though it’s a brief intervention, it is actually the mechanism for delivering the intervention – not the intervention itself.

Dr. Gonzalez highly recommended that providers seek motivational interviewing training if they haven’t already. He went on to caution attendees about behavior goals in interventions: They should be the patient’s change goals, not the provider’s, and the provider is there to facilitate the teen’s clarification of those goals.

“It’s very important to use those listening skills that we have and honor their decision-making and listen to their language in establishing their own goals,” he said. It’s also important to keep cultural relevance and respect in mind when delivering the intervention. He shared a chart showing the dominant and nondominant groups along various demographic cultural influences, including age, disability status, faith, race/ethnicity, indigenous heritage, socioeconomic status, national origin, gender and sexuality.

For example, the dominant age groups are the young and middle-aged while the nondominant are children and elderly. The dominant faith in the United States is Christian or secular, and the dominant sexuality is heterosexual; the corresponding nondominant groups would be non-Christian and nonheterosexual. It’s important for providers to consider the child’s needs within that entire behavioral context to understand where they’re coming from.

“Have you ever characterized a kid’s situation with regard to substance use and diagnoses based on certain characteristics?” Dr. Gonzalez asked attendees. “We like to think that we don’t, but research on diagnostic disparities indicates otherwise.”

A way to help avoid this is to know who you are in the room and who you’re with in terms of dominant and nondominant groups. “Oftentimes a kid’s cultural make-up holds a big part of the answer to what they need,” Dr. Gonzalez said. He provided the example of a patient who was witnessing domestic violence in the home. A key part to helping him meet his goal of reducing cannabis and alcohol use was understanding his relationship with his dad, his response to trauma, and his depression, all within his cultural and religious background.
 

Preserving the medical home

Finally, when it comes to referrals, consider what are you referring a patient for and whom are you referring them to because not all programs and all clinicians are created equal. Create, build, and maintain relationships with as many behavioral health clinicians and practices as you can, he advised.

Further, it’s important to preserve the medical home, though that can require extra effort, particularly with children who have seen a lot of providers. Each physician will need to develop their own strategy for how to do this. Sometimes kids feel passed around and there’s poor communication within programs, leaving kids and their families feeling unwelcome at your practice.

“No child is a hot potato,” he said. Because they may feel like they’re being bounced around among different providers, programs, emergency departments, facilities, and such, it’s important to convey strongly that you want to continue to care for them.

“Whether we’ve been part of that or not, we become part of that,” Dr. Gonzalez said. “They may think that you don’t want to see them again. You want to keep them, and you might have to continue giving repeated messages. Sometimes we need to be very overt and repeat ourselves and say no, ‘I really, really, really want you to come back. This is your home and I want you to come back.’ ”

Dr. Gonzalez and Dr. Khan have no disclosures.

In addition to screening adolescent patients at least once a year for substance use, it’s important that pediatricians build relationships with other behavioral health providers and develop a strategy for ensuring that teens with substance use issues continue returning to your practice as their medical home, according to Lucien Gonzalez, MD, assistant professor of psychiatry and behavioral sciences at the University of Minnesota, Minneapolis.

In a presentation at the annual meeting of the American Academy of Pediatrics, held virtually this year, Dr. Gonzalez discussed some of the common challenges pediatricians face in appropriately screening, diagnosing, and managing or referring youth when it comes to substance use.
 

Substance use screening

One of these included picking the right assessment tool and frequency for screening patients for substance use. A number of validated tools are out there, including the Screening to Brief Intervention (S2BI) and CRAFFT Screening Tool for Adolescent Substance Abuse. Regardless of which screening tool providers choose, “the important thing is to use a tool that is validated in the pediatric population and ideally has frequency results in it,” Dr. Gonzalez said.

In terms of frequency, screening young people at least once a year is fairly standard, but it may be necessary to screen adolescents more often or to screen them at acute visits.

“As many of you who work with adolescents know, you can’t always rely on the yearly well child visit because after a certain age, you start to see drop-off,” Dr. Gonzalez said. “They often aren’t coming for well child visits, and they often are then only showing up for acute visits.”

That means doctors need to think about how their clinics operate, how often they see their teen patients, and other factors – including how much can happen in a single year of adolescence – to ensure that screening captures these patients at least once a year, but more if that works within the practice.
 

Screening vs. diagnosis

Dr. Gonzalez also addressed the difference between screening and diagnosis, a very familiar distinction to physicians in other areas of medicine but often a source of confusion in the area of substance use.

“Screening is the presumptive identification of unrecognized disease in apparently healthy people who don’t have symptoms, using assessments that can be used rapidly,” Dr. Gonzalez said. “When we move into the diagnostic realm, these are people who present with symptoms or they have positive results on our screening test prompting further investigation.”

Sonia Khan, MD, a pediatrician and the medical director of the substance use disorder counseling program in the department of health and human services in Fremont, Calif., who heard the talk, particularly appreciated this point about screening versus diagnosis.

“As soon as you get a hint that there’s a problem with the kid, you’re no longer screening. You’re doing diagnostic investigation,” Dr. Khan, also the human relations commissioner for the city of Fremont, Calif., said in an interview. “Screening is about the kids you don’t know about. It seems like a small point to make a big deal out of, but it’s not.”

Sometimes a screening tool can serve as an introductory interview guide when beginning a clinical investigation with a patient who already shows symptoms, but that doesn’t mean it’s a screen.

Dr. Gonzalez emphasized the importance of not prescreening.

“A prescreener looks at a kid and decides whether or not they need to be screened,” Dr. Gonzalez said. “We have research that demonstrates that that doesn’t work. Physicians are not good at determining this by eyeballing it, and it’s fraught with bias. Universal screening with a validated screening tool is what works.”

Again, the idea of confronting one’s own personal biases and how they could interfere with screening really resonated with Dr. Khan.

“When it comes to the prescreening, if you’re only screening the ones you [think you] need to screen, you’re introducing bias into your screening,” she said. “It’s usually judgmental. It’s important to focus on really getting the bias out of what you’re doing because it’s a field fraught with bias and expectations.”


 

Brief interventions

Another area of confusion for many providers is what qualifies as a brief intervention and how to deliver it. The brief intervention needs to focus on increasing the patient’s knowledge, insights, and awareness when it comes to their own substance use and how it affects others. It should also support motivation in the patient to make behavioral changes. “It is always given in a nonjudgmental, supportive manner,” Dr. Gonzalez said.

Though motivational interviewing is often discussed as though it’s a brief intervention, it is actually the mechanism for delivering the intervention – not the intervention itself.

Dr. Gonzalez highly recommended that providers seek motivational interviewing training if they haven’t already. He went on to caution attendees about behavior goals in interventions: They should be the patient’s change goals, not the provider’s, and the provider is there to facilitate the teen’s clarification of those goals.

“It’s very important to use those listening skills that we have and honor their decision-making and listen to their language in establishing their own goals,” he said. It’s also important to keep cultural relevance and respect in mind when delivering the intervention. He shared a chart showing the dominant and nondominant groups along various demographic cultural influences, including age, disability status, faith, race/ethnicity, indigenous heritage, socioeconomic status, national origin, gender and sexuality.

For example, the dominant age groups are the young and middle-aged while the nondominant are children and elderly. The dominant faith in the United States is Christian or secular, and the dominant sexuality is heterosexual; the corresponding nondominant groups would be non-Christian and nonheterosexual. It’s important for providers to consider the child’s needs within that entire behavioral context to understand where they’re coming from.

“Have you ever characterized a kid’s situation with regard to substance use and diagnoses based on certain characteristics?” Dr. Gonzalez asked attendees. “We like to think that we don’t, but research on diagnostic disparities indicates otherwise.”

A way to help avoid this is to know who you are in the room and who you’re with in terms of dominant and nondominant groups. “Oftentimes a kid’s cultural make-up holds a big part of the answer to what they need,” Dr. Gonzalez said. He provided the example of a patient who was witnessing domestic violence in the home. A key part to helping him meet his goal of reducing cannabis and alcohol use was understanding his relationship with his dad, his response to trauma, and his depression, all within his cultural and religious background.
 

Preserving the medical home

Finally, when it comes to referrals, consider what are you referring a patient for and whom are you referring them to because not all programs and all clinicians are created equal. Create, build, and maintain relationships with as many behavioral health clinicians and practices as you can, he advised.

Further, it’s important to preserve the medical home, though that can require extra effort, particularly with children who have seen a lot of providers. Each physician will need to develop their own strategy for how to do this. Sometimes kids feel passed around and there’s poor communication within programs, leaving kids and their families feeling unwelcome at your practice.

“No child is a hot potato,” he said. Because they may feel like they’re being bounced around among different providers, programs, emergency departments, facilities, and such, it’s important to convey strongly that you want to continue to care for them.

“Whether we’ve been part of that or not, we become part of that,” Dr. Gonzalez said. “They may think that you don’t want to see them again. You want to keep them, and you might have to continue giving repeated messages. Sometimes we need to be very overt and repeat ourselves and say no, ‘I really, really, really want you to come back. This is your home and I want you to come back.’ ”

Dr. Gonzalez and Dr. Khan have no disclosures.

In addition to screening adolescent patients at least once a year for substance use, it’s important that pediatricians build relationships with other behavioral health providers and develop a strategy for ensuring that teens with substance use issues continue returning to your practice as their medical home, according to Lucien Gonzalez, MD, assistant professor of psychiatry and behavioral sciences at the University of Minnesota, Minneapolis.

In a presentation at the annual meeting of the American Academy of Pediatrics, held virtually this year, Dr. Gonzalez discussed some of the common challenges pediatricians face in appropriately screening, diagnosing, and managing or referring youth when it comes to substance use.
 

Substance use screening

One of these included picking the right assessment tool and frequency for screening patients for substance use. A number of validated tools are out there, including the Screening to Brief Intervention (S2BI) and CRAFFT Screening Tool for Adolescent Substance Abuse. Regardless of which screening tool providers choose, “the important thing is to use a tool that is validated in the pediatric population and ideally has frequency results in it,” Dr. Gonzalez said.

In terms of frequency, screening young people at least once a year is fairly standard, but it may be necessary to screen adolescents more often or to screen them at acute visits.

“As many of you who work with adolescents know, you can’t always rely on the yearly well child visit because after a certain age, you start to see drop-off,” Dr. Gonzalez said. “They often aren’t coming for well child visits, and they often are then only showing up for acute visits.”

That means doctors need to think about how their clinics operate, how often they see their teen patients, and other factors – including how much can happen in a single year of adolescence – to ensure that screening captures these patients at least once a year, but more if that works within the practice.
 

Screening vs. diagnosis

Dr. Gonzalez also addressed the difference between screening and diagnosis, a very familiar distinction to physicians in other areas of medicine but often a source of confusion in the area of substance use.

“Screening is the presumptive identification of unrecognized disease in apparently healthy people who don’t have symptoms, using assessments that can be used rapidly,” Dr. Gonzalez said. “When we move into the diagnostic realm, these are people who present with symptoms or they have positive results on our screening test prompting further investigation.”

Sonia Khan, MD, a pediatrician and the medical director of the substance use disorder counseling program in the department of health and human services in Fremont, Calif., who heard the talk, particularly appreciated this point about screening versus diagnosis.

“As soon as you get a hint that there’s a problem with the kid, you’re no longer screening. You’re doing diagnostic investigation,” Dr. Khan, also the human relations commissioner for the city of Fremont, Calif., said in an interview. “Screening is about the kids you don’t know about. It seems like a small point to make a big deal out of, but it’s not.”

Sometimes a screening tool can serve as an introductory interview guide when beginning a clinical investigation with a patient who already shows symptoms, but that doesn’t mean it’s a screen.

Dr. Gonzalez emphasized the importance of not prescreening.

“A prescreener looks at a kid and decides whether or not they need to be screened,” Dr. Gonzalez said. “We have research that demonstrates that that doesn’t work. Physicians are not good at determining this by eyeballing it, and it’s fraught with bias. Universal screening with a validated screening tool is what works.”

Again, the idea of confronting one’s own personal biases and how they could interfere with screening really resonated with Dr. Khan.

“When it comes to the prescreening, if you’re only screening the ones you [think you] need to screen, you’re introducing bias into your screening,” she said. “It’s usually judgmental. It’s important to focus on really getting the bias out of what you’re doing because it’s a field fraught with bias and expectations.”


 

Brief interventions

Another area of confusion for many providers is what qualifies as a brief intervention and how to deliver it. The brief intervention needs to focus on increasing the patient’s knowledge, insights, and awareness when it comes to their own substance use and how it affects others. It should also support motivation in the patient to make behavioral changes. “It is always given in a nonjudgmental, supportive manner,” Dr. Gonzalez said.

Though motivational interviewing is often discussed as though it’s a brief intervention, it is actually the mechanism for delivering the intervention – not the intervention itself.

Dr. Gonzalez highly recommended that providers seek motivational interviewing training if they haven’t already. He went on to caution attendees about behavior goals in interventions: They should be the patient’s change goals, not the provider’s, and the provider is there to facilitate the teen’s clarification of those goals.

“It’s very important to use those listening skills that we have and honor their decision-making and listen to their language in establishing their own goals,” he said. It’s also important to keep cultural relevance and respect in mind when delivering the intervention. He shared a chart showing the dominant and nondominant groups along various demographic cultural influences, including age, disability status, faith, race/ethnicity, indigenous heritage, socioeconomic status, national origin, gender and sexuality.

For example, the dominant age groups are the young and middle-aged while the nondominant are children and elderly. The dominant faith in the United States is Christian or secular, and the dominant sexuality is heterosexual; the corresponding nondominant groups would be non-Christian and nonheterosexual. It’s important for providers to consider the child’s needs within that entire behavioral context to understand where they’re coming from.

“Have you ever characterized a kid’s situation with regard to substance use and diagnoses based on certain characteristics?” Dr. Gonzalez asked attendees. “We like to think that we don’t, but research on diagnostic disparities indicates otherwise.”

A way to help avoid this is to know who you are in the room and who you’re with in terms of dominant and nondominant groups. “Oftentimes a kid’s cultural make-up holds a big part of the answer to what they need,” Dr. Gonzalez said. He provided the example of a patient who was witnessing domestic violence in the home. A key part to helping him meet his goal of reducing cannabis and alcohol use was understanding his relationship with his dad, his response to trauma, and his depression, all within his cultural and religious background.
 

Preserving the medical home

Finally, when it comes to referrals, consider what are you referring a patient for and whom are you referring them to because not all programs and all clinicians are created equal. Create, build, and maintain relationships with as many behavioral health clinicians and practices as you can, he advised.

Further, it’s important to preserve the medical home, though that can require extra effort, particularly with children who have seen a lot of providers. Each physician will need to develop their own strategy for how to do this. Sometimes kids feel passed around and there’s poor communication within programs, leaving kids and their families feeling unwelcome at your practice.

“No child is a hot potato,” he said. Because they may feel like they’re being bounced around among different providers, programs, emergency departments, facilities, and such, it’s important to convey strongly that you want to continue to care for them.

“Whether we’ve been part of that or not, we become part of that,” Dr. Gonzalez said. “They may think that you don’t want to see them again. You want to keep them, and you might have to continue giving repeated messages. Sometimes we need to be very overt and repeat ourselves and say no, ‘I really, really, really want you to come back. This is your home and I want you to come back.’ ”

Dr. Gonzalez and Dr. Khan have no disclosures.

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

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

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

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

Changes from previous statement

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

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

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

Etiology and diagnosis of GSM

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

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

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

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

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

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

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

Management of GSM

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

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

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

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

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

Preparing patients for the boxed warning

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Changes from previous statement

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

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

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

Etiology and diagnosis of GSM

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

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

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

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

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

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

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

Management of GSM

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

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

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

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

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

Preparing patients for the boxed warning

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Changes from previous statement

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

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

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

Etiology and diagnosis of GSM

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

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

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

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

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

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

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

Management of GSM

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

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

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

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

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

Preparing patients for the boxed warning

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Large medical societies have an advantage

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

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

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

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

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

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

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

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

New ways of attracting and measuring attendance

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

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

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

Priority for having robust content

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

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

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

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

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

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

Missing out on networking and social interaction

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

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

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

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

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

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

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

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

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

Advantages of an online meeting

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Large medical societies have an advantage

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

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

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

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

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

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

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

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

New ways of attracting and measuring attendance

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

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

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

Priority for having robust content

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

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

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

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

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

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

Missing out on networking and social interaction

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

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

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

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

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

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

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

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

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

Advantages of an online meeting

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Large medical societies have an advantage

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

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

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

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

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

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

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

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

New ways of attracting and measuring attendance

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

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

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

Priority for having robust content

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

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

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

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

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

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

Missing out on networking and social interaction

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

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

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

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

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

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

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

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

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

Advantages of an online meeting

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

How police brutality affects children

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

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

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

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

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

The voice of pediatricians

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

How police brutality affects children

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

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

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

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

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

The voice of pediatricians

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

How police brutality affects children

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

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

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

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

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

The voice of pediatricians

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Hormone therapy still most effective for vasomotor symptoms

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

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

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

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

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

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

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

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

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

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

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

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

New estrogens in the pipeline

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

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

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

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

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

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

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

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

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

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

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

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

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

Hormone therapy still most effective for vasomotor symptoms

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

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

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

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

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

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

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

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

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

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

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

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

New estrogens in the pipeline

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

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

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

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

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

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

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

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

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

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

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

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

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

Hormone therapy still most effective for vasomotor symptoms

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

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

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

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

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

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

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

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

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

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

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

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

New estrogens in the pipeline

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

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

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

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

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

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

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

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

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

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

O_Lypa/iStock/Getty Images

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

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

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

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

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

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

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

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

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

Where to start

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

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

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

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

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

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

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

Beginning the process

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

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

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

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

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

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

Training staff is essential

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

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

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

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

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

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

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

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

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

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

O_Lypa/iStock/Getty Images

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

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

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

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

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

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

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

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

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

Where to start

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

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

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

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

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

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

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

Beginning the process

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

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

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

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

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

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

Training staff is essential

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

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

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

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

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

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

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

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

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

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

O_Lypa/iStock/Getty Images

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

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

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

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

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

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

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

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

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

Where to start

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

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

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

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

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

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

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

Beginning the process

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

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

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

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

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

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

Training staff is essential

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

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

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

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

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

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

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

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

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

Long-acting cabotegravir and rilpivirine (CAB/RPV) administered intramuscularly monthly or every 2 months yielded high rates of efficacy and a favorable safety profile in women with HIV, according to results from the ATLAS-2M study, presented at the HIV Glasgow 2020 Virtual Conference, held October 5-8. The women also reported high satisfaction with the regimen, compared with daily oral antiretroviral therapy.

Previously reported results had shown that the two-drug combination administered every 8 weeks (600 mg cabotegravir and 900 mg rilpivirine) was noninferior to injections every 4 weeks (400 mg cabotegravir and 600 mg rilpivirine) in adults with HIV during the open-label phase 3b ATLAS-2M trial. Further, the ATLAS and FLAIR phase 3 trials had shown the 4-week administration of the therapy to be noninferior to a daily oral three-drug antiretroviral therapy.

Paul Benn, MBBS, of ViiV Healthcare (which is seeking regulatory approval for CAB/RPV treatment), and his colleagues completed a planned subgroup analysis of women in the ATLAS-2M trial. The primary endpoint was the proportion of intention-to-treat participants with plasma HIV-1 RNA of at least 50 copies/mL with a noninferiority margin of 4% at 48 weeks. The secondary endpoint was the proportion of participants with HIV-1 RNA under 50 copies/mL with a noninferiority margin of 10%.

Among the 280 women enrolled, 137 were randomly assigned to receive injections every 8 weeks, and 143 to receive injections every 4 weeks. A majority of the women (56%) were White, the median age was 44 years, and just over half (53%) were treatment naive with cabotegravir and rilpivirine.

At 48 weeks, 3.6% of women in the 8-week group and 0% of women in the 4-week group had at least 50 copies/mL of HIV-1 RNA. In both arms, 91% of participants had HIV-1 RNA under 50 copies/mL. Plasma concentrations of cabotegravir and rilpivirine were similar between the women and the overall study population.

Confirmed virologic failure occurred in five women, all before week 24. Three of the women were subtype A/A1, and four of them had archived nonnucleoside reverse transcriptase inhibitor (NNRTI) resistance–associated mutations.

There were no significant differences in the safety profile between the groups; 99% of injection site reactions that occurred were mild to moderate and lasted a median 3-4 days. Fewer than 4% of participants discontinued because of adverse events – five women in the 8-week group and five women in the 4-week group. Four women cited injection site reactions as the reason for discontinuation.

Women not previously treated with CAB/RPV reported increased treatment satisfaction on the HIV Treatment Satisfaction Questionnaire, a score of 5.4 in the 8-week group and 3.9 in the 4-week group. Among those with prior CAB/RPV treatment, 88% preferred the 8-weekly injections, 8% preferred the 4-weekly injections, and 2% preferred oral dosing.

Long-acting CAB/RPV is an investigational formulation. In December 2019, the Food and Drug Administration denied approval to the formulation on the basis of manufacturing and chemistry concerns, according to a company press release.
 

This article first appeared on Medscape.com.

Long-acting cabotegravir and rilpivirine (CAB/RPV) administered intramuscularly monthly or every 2 months yielded high rates of efficacy and a favorable safety profile in women with HIV, according to results from the ATLAS-2M study, presented at the HIV Glasgow 2020 Virtual Conference, held October 5-8. The women also reported high satisfaction with the regimen, compared with daily oral antiretroviral therapy.

Previously reported results had shown that the two-drug combination administered every 8 weeks (600 mg cabotegravir and 900 mg rilpivirine) was noninferior to injections every 4 weeks (400 mg cabotegravir and 600 mg rilpivirine) in adults with HIV during the open-label phase 3b ATLAS-2M trial. Further, the ATLAS and FLAIR phase 3 trials had shown the 4-week administration of the therapy to be noninferior to a daily oral three-drug antiretroviral therapy.

Paul Benn, MBBS, of ViiV Healthcare (which is seeking regulatory approval for CAB/RPV treatment), and his colleagues completed a planned subgroup analysis of women in the ATLAS-2M trial. The primary endpoint was the proportion of intention-to-treat participants with plasma HIV-1 RNA of at least 50 copies/mL with a noninferiority margin of 4% at 48 weeks. The secondary endpoint was the proportion of participants with HIV-1 RNA under 50 copies/mL with a noninferiority margin of 10%.

Among the 280 women enrolled, 137 were randomly assigned to receive injections every 8 weeks, and 143 to receive injections every 4 weeks. A majority of the women (56%) were White, the median age was 44 years, and just over half (53%) were treatment naive with cabotegravir and rilpivirine.

At 48 weeks, 3.6% of women in the 8-week group and 0% of women in the 4-week group had at least 50 copies/mL of HIV-1 RNA. In both arms, 91% of participants had HIV-1 RNA under 50 copies/mL. Plasma concentrations of cabotegravir and rilpivirine were similar between the women and the overall study population.

Confirmed virologic failure occurred in five women, all before week 24. Three of the women were subtype A/A1, and four of them had archived nonnucleoside reverse transcriptase inhibitor (NNRTI) resistance–associated mutations.

There were no significant differences in the safety profile between the groups; 99% of injection site reactions that occurred were mild to moderate and lasted a median 3-4 days. Fewer than 4% of participants discontinued because of adverse events – five women in the 8-week group and five women in the 4-week group. Four women cited injection site reactions as the reason for discontinuation.

Women not previously treated with CAB/RPV reported increased treatment satisfaction on the HIV Treatment Satisfaction Questionnaire, a score of 5.4 in the 8-week group and 3.9 in the 4-week group. Among those with prior CAB/RPV treatment, 88% preferred the 8-weekly injections, 8% preferred the 4-weekly injections, and 2% preferred oral dosing.

Long-acting CAB/RPV is an investigational formulation. In December 2019, the Food and Drug Administration denied approval to the formulation on the basis of manufacturing and chemistry concerns, according to a company press release.
 

This article first appeared on Medscape.com.

Long-acting cabotegravir and rilpivirine (CAB/RPV) administered intramuscularly monthly or every 2 months yielded high rates of efficacy and a favorable safety profile in women with HIV, according to results from the ATLAS-2M study, presented at the HIV Glasgow 2020 Virtual Conference, held October 5-8. The women also reported high satisfaction with the regimen, compared with daily oral antiretroviral therapy.

Previously reported results had shown that the two-drug combination administered every 8 weeks (600 mg cabotegravir and 900 mg rilpivirine) was noninferior to injections every 4 weeks (400 mg cabotegravir and 600 mg rilpivirine) in adults with HIV during the open-label phase 3b ATLAS-2M trial. Further, the ATLAS and FLAIR phase 3 trials had shown the 4-week administration of the therapy to be noninferior to a daily oral three-drug antiretroviral therapy.

Paul Benn, MBBS, of ViiV Healthcare (which is seeking regulatory approval for CAB/RPV treatment), and his colleagues completed a planned subgroup analysis of women in the ATLAS-2M trial. The primary endpoint was the proportion of intention-to-treat participants with plasma HIV-1 RNA of at least 50 copies/mL with a noninferiority margin of 4% at 48 weeks. The secondary endpoint was the proportion of participants with HIV-1 RNA under 50 copies/mL with a noninferiority margin of 10%.

Among the 280 women enrolled, 137 were randomly assigned to receive injections every 8 weeks, and 143 to receive injections every 4 weeks. A majority of the women (56%) were White, the median age was 44 years, and just over half (53%) were treatment naive with cabotegravir and rilpivirine.

At 48 weeks, 3.6% of women in the 8-week group and 0% of women in the 4-week group had at least 50 copies/mL of HIV-1 RNA. In both arms, 91% of participants had HIV-1 RNA under 50 copies/mL. Plasma concentrations of cabotegravir and rilpivirine were similar between the women and the overall study population.

Confirmed virologic failure occurred in five women, all before week 24. Three of the women were subtype A/A1, and four of them had archived nonnucleoside reverse transcriptase inhibitor (NNRTI) resistance–associated mutations.

There were no significant differences in the safety profile between the groups; 99% of injection site reactions that occurred were mild to moderate and lasted a median 3-4 days. Fewer than 4% of participants discontinued because of adverse events – five women in the 8-week group and five women in the 4-week group. Four women cited injection site reactions as the reason for discontinuation.

Women not previously treated with CAB/RPV reported increased treatment satisfaction on the HIV Treatment Satisfaction Questionnaire, a score of 5.4 in the 8-week group and 3.9 in the 4-week group. Among those with prior CAB/RPV treatment, 88% preferred the 8-weekly injections, 8% preferred the 4-weekly injections, and 2% preferred oral dosing.

Long-acting CAB/RPV is an investigational formulation. In December 2019, the Food and Drug Administration denied approval to the formulation on the basis of manufacturing and chemistry concerns, according to a company press release.
 

This article first appeared on Medscape.com.

Women with HIV and men with HIV who have sex with women (MSW) have substantially different experiences with treatment than men with HIV who have sex with men (MSM), according to findings presented at the HIV Glasgow 2020 Virtual Meeting. MSM had better overall health outcomes than the other two groups, the study found, suggesting that MSW and women have unmet needs that require providers’ attention.

Chinyere Okoli of ViiV Healthcare Global Medical Affairs in Brentford, England, and her associates administered a Web-based survey about HIV-related perceptions and behaviors to 2,389 adults with HIV in 25 countries. The respondents included 1,018 MSM, 479 MSW, and 696 women.

In high-income countries, MSM respondents had been diagnosed a median 9 years earlier, MSW respondents a median 4 years earlier, and women respondents a median 5 years earlier. In middle-income countries, diagnosis was a median 3 years ago for MSM respondents and a median 6 years for MSW and women respondents.

Rates of suboptimal adherence to antiretroviral therapy (ART) were lowest (15.5%) among MSM, compared with MSW (38.8%) and women (28%). Similarly, viral nonsuppression had occurred in only 10.9% of MSM, whereas it had occurred in 43.2% of MSW and 37.1% of women. A little more than one-third (36.5%) of MSM had suboptimal overall health, whereas 47.2% of MSW and 46.2% of women had suboptimal overall health (P < .05).

A similar percentage of MSM (38%) and women (38.2%) reported polypharmacy; both percentages were significantly lower than for MSW (45.1%; P = .020). Yet MSW were less likely than the other two groups to have comorbidities unrelated to HIV: 46.1%, compared with 64.6% of MSM and 56.7% of women (P < .001).

Although a higher proportion (63%) of MSW than MSM (44%) or women (55%) were receiving a multitablet ART regimen, MSW were least likely to consider the impact of side effects when they began ART and were most likely to experience side effects. Only 45% of MSW prioritized minimizing side effects when they began receiving ART, and more than half (52%) were experiencing side effects with their current regimen.

By contrast, a majority of MSM (60%) prioritized minimizing side effects at ART initiation, and only 35% currently had side effects. Women fell in the middle with 48% considering side effects when starting ART and 49% reporting current side effects.

The proportion of respondents who said ART side effects were affecting their lives was not significantly different: 69% of MSM, 73% of MSW, and 74% of women. However, 56% of MSW reported skipping at least one dose in the past month because of side effects, which was more than twice the percentage of MSM (24%; P < .001). One-third of women (33%) reported skipping at least one dose.

MSW were also least comfortable talking to their health care provider about ART side effects: 55% reported discomfort, compared with 34% of MSM and 43% of women. A high majority of MSW (87.9%) said they experienced barriers to talking to their providers about relevant health concerns. The proportion who reported barriers was lower for MSM (59%) and women (72.7%; P < .001).

The substantial differences between MSM and MSW, which were even greater than those between MSW and women, suggest this population has the greatest amount of unmet needs, the researchers concluded. “Acknowledging these differences when planning/administering care can help narrow disparities,” they wrote.
 

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

Women with HIV and men with HIV who have sex with women (MSW) have substantially different experiences with treatment than men with HIV who have sex with men (MSM), according to findings presented at the HIV Glasgow 2020 Virtual Meeting. MSM had better overall health outcomes than the other two groups, the study found, suggesting that MSW and women have unmet needs that require providers’ attention.

Chinyere Okoli of ViiV Healthcare Global Medical Affairs in Brentford, England, and her associates administered a Web-based survey about HIV-related perceptions and behaviors to 2,389 adults with HIV in 25 countries. The respondents included 1,018 MSM, 479 MSW, and 696 women.

In high-income countries, MSM respondents had been diagnosed a median 9 years earlier, MSW respondents a median 4 years earlier, and women respondents a median 5 years earlier. In middle-income countries, diagnosis was a median 3 years ago for MSM respondents and a median 6 years for MSW and women respondents.

Rates of suboptimal adherence to antiretroviral therapy (ART) were lowest (15.5%) among MSM, compared with MSW (38.8%) and women (28%). Similarly, viral nonsuppression had occurred in only 10.9% of MSM, whereas it had occurred in 43.2% of MSW and 37.1% of women. A little more than one-third (36.5%) of MSM had suboptimal overall health, whereas 47.2% of MSW and 46.2% of women had suboptimal overall health (P < .05).

A similar percentage of MSM (38%) and women (38.2%) reported polypharmacy; both percentages were significantly lower than for MSW (45.1%; P = .020). Yet MSW were less likely than the other two groups to have comorbidities unrelated to HIV: 46.1%, compared with 64.6% of MSM and 56.7% of women (P < .001).

Although a higher proportion (63%) of MSW than MSM (44%) or women (55%) were receiving a multitablet ART regimen, MSW were least likely to consider the impact of side effects when they began ART and were most likely to experience side effects. Only 45% of MSW prioritized minimizing side effects when they began receiving ART, and more than half (52%) were experiencing side effects with their current regimen.

By contrast, a majority of MSM (60%) prioritized minimizing side effects at ART initiation, and only 35% currently had side effects. Women fell in the middle with 48% considering side effects when starting ART and 49% reporting current side effects.

The proportion of respondents who said ART side effects were affecting their lives was not significantly different: 69% of MSM, 73% of MSW, and 74% of women. However, 56% of MSW reported skipping at least one dose in the past month because of side effects, which was more than twice the percentage of MSM (24%; P < .001). One-third of women (33%) reported skipping at least one dose.

MSW were also least comfortable talking to their health care provider about ART side effects: 55% reported discomfort, compared with 34% of MSM and 43% of women. A high majority of MSW (87.9%) said they experienced barriers to talking to their providers about relevant health concerns. The proportion who reported barriers was lower for MSM (59%) and women (72.7%; P < .001).

The substantial differences between MSM and MSW, which were even greater than those between MSW and women, suggest this population has the greatest amount of unmet needs, the researchers concluded. “Acknowledging these differences when planning/administering care can help narrow disparities,” they wrote.
 

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

Women with HIV and men with HIV who have sex with women (MSW) have substantially different experiences with treatment than men with HIV who have sex with men (MSM), according to findings presented at the HIV Glasgow 2020 Virtual Meeting. MSM had better overall health outcomes than the other two groups, the study found, suggesting that MSW and women have unmet needs that require providers’ attention.

Chinyere Okoli of ViiV Healthcare Global Medical Affairs in Brentford, England, and her associates administered a Web-based survey about HIV-related perceptions and behaviors to 2,389 adults with HIV in 25 countries. The respondents included 1,018 MSM, 479 MSW, and 696 women.

In high-income countries, MSM respondents had been diagnosed a median 9 years earlier, MSW respondents a median 4 years earlier, and women respondents a median 5 years earlier. In middle-income countries, diagnosis was a median 3 years ago for MSM respondents and a median 6 years for MSW and women respondents.

Rates of suboptimal adherence to antiretroviral therapy (ART) were lowest (15.5%) among MSM, compared with MSW (38.8%) and women (28%). Similarly, viral nonsuppression had occurred in only 10.9% of MSM, whereas it had occurred in 43.2% of MSW and 37.1% of women. A little more than one-third (36.5%) of MSM had suboptimal overall health, whereas 47.2% of MSW and 46.2% of women had suboptimal overall health (P < .05).

A similar percentage of MSM (38%) and women (38.2%) reported polypharmacy; both percentages were significantly lower than for MSW (45.1%; P = .020). Yet MSW were less likely than the other two groups to have comorbidities unrelated to HIV: 46.1%, compared with 64.6% of MSM and 56.7% of women (P < .001).

Although a higher proportion (63%) of MSW than MSM (44%) or women (55%) were receiving a multitablet ART regimen, MSW were least likely to consider the impact of side effects when they began ART and were most likely to experience side effects. Only 45% of MSW prioritized minimizing side effects when they began receiving ART, and more than half (52%) were experiencing side effects with their current regimen.

By contrast, a majority of MSM (60%) prioritized minimizing side effects at ART initiation, and only 35% currently had side effects. Women fell in the middle with 48% considering side effects when starting ART and 49% reporting current side effects.

The proportion of respondents who said ART side effects were affecting their lives was not significantly different: 69% of MSM, 73% of MSW, and 74% of women. However, 56% of MSW reported skipping at least one dose in the past month because of side effects, which was more than twice the percentage of MSM (24%; P < .001). One-third of women (33%) reported skipping at least one dose.

MSW were also least comfortable talking to their health care provider about ART side effects: 55% reported discomfort, compared with 34% of MSM and 43% of women. A high majority of MSW (87.9%) said they experienced barriers to talking to their providers about relevant health concerns. The proportion who reported barriers was lower for MSM (59%) and women (72.7%; P < .001).

The substantial differences between MSM and MSW, which were even greater than those between MSW and women, suggest this population has the greatest amount of unmet needs, the researchers concluded. “Acknowledging these differences when planning/administering care can help narrow disparities,” they wrote.
 

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