Adolescent Medicine

SACRAMENTO, CALIF. – California has become the first state to require health insurance plans to cover at-home tests for sexually transmitted infections such as HIV, chlamydia, and syphilis – which could help quell the STI epidemic that has raged nearly unchecked as public health departments have focused on COVID-19.

The rule, part of a broader law addressing the STI epidemic, took effect Jan. 1 for people with state-regulated private insurance plans and will kick in sometime later for the millions of low-income Californians enrolled in the state’s Medicaid program.

By making it easier and cheaper for Californians to self-administer tests in the privacy of their homes, the provision could bring better disease monitoring to rural and underserved parts of the state, reduce the stigma patients experience when seeking care, and give them more control over their health, say experts on infectious diseases.

“This is the first law of its kind, and I’d say it’s kind of cutting-edge,” said Stephanie Arnold Pang, senior director of policy and government relations for the National Coalition of STD Directors. “We want to bring down every single barrier for someone to get STI testing, and out-of-pocket cost is a huge factor.”

But being first has its downsides. Because the concept of insurance coverage for home STI tests is so new, the state’s Medicaid program, Medi-Cal, could not establish by Jan. 1 the billing codes it needs to start paying for tests. Federal regulators also haven’t approved the tests for home use, which could make labs reluctant to process them. And a state analysis predicts most in-network health care providers won’t start prescribing home tests for at least a year until they adjust their billing and other practices.

Nevertheless, the situation is urgent and requires action, said state Sen. Richard Pan (D-Sacramento), a pediatrician who wrote the law.

“We have children born in California with syphilis,” Dr. Pan said. “You’d think that went away in the Victorian era.”

Even before COVID, sexually transmitted infections hit all-time highs in the United States and California for 6 years in a row, according to 2019 data from the Centers for Disease Control and Prevention. Rates of congenital syphilis, which babies contract from their mothers, illustrate the severity of the STI epidemic: Cases were up 279% from 2015 to 2019 nationally and 232% in California. Of the 445 cases of congenital syphilis in California in 2019, 37 were stillbirths.

The pandemic only worsened the problem because health departments were overwhelmed responding to the COVID emergency, and stay-at-home orders kept people away from clinics.

In surveys of public health programs across the country since May 2020, the National Coalition of STD Directors found that most respondents – up to 78% in one survey – have diverted some of their STI workforces to test and monitor COVID. A report that accompanied the most recent survey found that some STIs were “completely unchecked” because of reductions in clinic hours, diversion of resources, shortages of testing kits and staff burnout.

Some at-home STI tests screen for a single disease but other kits can collect and send samples to check for a variety of infections. Depending on the test, patients collect a drop of blood with a lancet, or swab their mouth, vagina, anus, or penis.

Some tests require patients to send samples to a lab for analysis, while some oral HIV tests give results at home in a few minutes.

Ivan Beas, a 25-year-old graduate student at University of California, Los Angeles, was getting tested frequently as part of a 2-year research study. When clinics closed during the pandemic, researchers sent him a home kit.

The kit, which tests for HIV, hepatitis C, herpes, syphilis, chlamydia, gonorrhea, and trichomoniasis, was packaged discreetly and came with easy instructions. It took Mr. Beas about 10 minutes to prick his finger, swab his mouth and send the samples to the lab.

Mr. Beas wanted to continue screening himself every few months after the study ended, he said, but the kit he used retails for $289, which is out of reach for him.

The last time he went to a clinic in person, “I spent 2 hours waiting to even be seen by a doctor because of how busy they are,” he said. Until Medi-Cal begins covering home tests, he said, he will have to find time to get tested for free at a Planned Parenthood clinic.

“If insurance were to cover it, I’d definitely do it more,” he said.

Under California’s new law, plans regulated by the state must cover home STI tests when ordered by a health care provider.  

Privately insured Californians can take advantage of the coverage immediately. How much they will owe out-of-pocket for the tests – if anything – depends on the type of plan they have, whether their provider is in-network, and whether they fall into a category the federal government has designated for free screening.

Medi-Cal patients almost never face out-of-pocket expenses, but they will have to wait for coverage because the Department of Health Care Services, which administers Medi-Cal, is working with the American Medical Association and the federal government to create billing codes. The reimbursement rates for those codes will then need federal approval.

The state doesn’t know how long that process will take, according to department spokesperson Anthony Cava.

The rule does not apply to the millions of Californians whose job-based health insurance plans are regulated by the federal government.

Other states and organizations have experimented with at-home STI tests. The public health departments in Alabama and the District of Columbia send free kits to residents who request them, but neither jurisdiction requires insurance coverage for them. The National Coalition of STD Directors is sending free kits to people through health departments in Philadelphia; Iowa; Virginia; Indiana; Puerto Rico; and Navajo County, Arizona. The list of recipients is expected to grow this month.

Iwantthekit.org, a project of Johns Hopkins University, has been sending free kits to Maryland residents since 2004, and to Alaskans since 2011. The program is funded by grants and works with local health departments.

Charlotte Gaydos, cofounder of the project, said that requests for test kits during the pandemic nearly tripled – and that she would expand to every state if she could bill insurance the way the California law mandates.

The tests fall into a murky regulatory area. While they have been approved by the Food and Drug Administration, none have been cleared for use at home. Patients are supposed to collect their own samples within the walls of a health facility, and some labs may not analyze samples collected at home.

Public health officials cited other potential challenges: Patients may not have the same access to counseling, treatment, or referrals to other services such as food banks that they would receive at clinics. And although patients are supposed to self-report the results of their tests to public health authorities, some people won’t follow through.

Vlad Carrillo, 31, experienced such trade-offs recently. Mr. Carrillo used to get tested at a San Francisco clinic, where they could get counseling and other services. But Carrillo lost their apartment during the pandemic and moved about 7 hours away to Bishop, the only incorporated city in rural Inyo County.

“Being away from the city, it took me a whole year to find a way to get tested,” Carrillo said.

Carrillo eventually got the kit through the mail, avoiding the stigma of going to the clinic in Bishop, which is “more focused on straight stuff,” like preventing pregnancy. Without the test, Carrillo couldn’t get PrEP, a medication to prevent HIV.

“Going without it for so long was really hard on me,” Carrillo said.

This story was produced by Kaiser Health News (KHN), which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

SACRAMENTO, CALIF. – California has become the first state to require health insurance plans to cover at-home tests for sexually transmitted infections such as HIV, chlamydia, and syphilis – which could help quell the STI epidemic that has raged nearly unchecked as public health departments have focused on COVID-19.

The rule, part of a broader law addressing the STI epidemic, took effect Jan. 1 for people with state-regulated private insurance plans and will kick in sometime later for the millions of low-income Californians enrolled in the state’s Medicaid program.

By making it easier and cheaper for Californians to self-administer tests in the privacy of their homes, the provision could bring better disease monitoring to rural and underserved parts of the state, reduce the stigma patients experience when seeking care, and give them more control over their health, say experts on infectious diseases.

“This is the first law of its kind, and I’d say it’s kind of cutting-edge,” said Stephanie Arnold Pang, senior director of policy and government relations for the National Coalition of STD Directors. “We want to bring down every single barrier for someone to get STI testing, and out-of-pocket cost is a huge factor.”

But being first has its downsides. Because the concept of insurance coverage for home STI tests is so new, the state’s Medicaid program, Medi-Cal, could not establish by Jan. 1 the billing codes it needs to start paying for tests. Federal regulators also haven’t approved the tests for home use, which could make labs reluctant to process them. And a state analysis predicts most in-network health care providers won’t start prescribing home tests for at least a year until they adjust their billing and other practices.

Nevertheless, the situation is urgent and requires action, said state Sen. Richard Pan (D-Sacramento), a pediatrician who wrote the law.

“We have children born in California with syphilis,” Dr. Pan said. “You’d think that went away in the Victorian era.”

Even before COVID, sexually transmitted infections hit all-time highs in the United States and California for 6 years in a row, according to 2019 data from the Centers for Disease Control and Prevention. Rates of congenital syphilis, which babies contract from their mothers, illustrate the severity of the STI epidemic: Cases were up 279% from 2015 to 2019 nationally and 232% in California. Of the 445 cases of congenital syphilis in California in 2019, 37 were stillbirths.

The pandemic only worsened the problem because health departments were overwhelmed responding to the COVID emergency, and stay-at-home orders kept people away from clinics.

In surveys of public health programs across the country since May 2020, the National Coalition of STD Directors found that most respondents – up to 78% in one survey – have diverted some of their STI workforces to test and monitor COVID. A report that accompanied the most recent survey found that some STIs were “completely unchecked” because of reductions in clinic hours, diversion of resources, shortages of testing kits and staff burnout.

Some at-home STI tests screen for a single disease but other kits can collect and send samples to check for a variety of infections. Depending on the test, patients collect a drop of blood with a lancet, or swab their mouth, vagina, anus, or penis.

Some tests require patients to send samples to a lab for analysis, while some oral HIV tests give results at home in a few minutes.

Ivan Beas, a 25-year-old graduate student at University of California, Los Angeles, was getting tested frequently as part of a 2-year research study. When clinics closed during the pandemic, researchers sent him a home kit.

The kit, which tests for HIV, hepatitis C, herpes, syphilis, chlamydia, gonorrhea, and trichomoniasis, was packaged discreetly and came with easy instructions. It took Mr. Beas about 10 minutes to prick his finger, swab his mouth and send the samples to the lab.

Mr. Beas wanted to continue screening himself every few months after the study ended, he said, but the kit he used retails for $289, which is out of reach for him.

The last time he went to a clinic in person, “I spent 2 hours waiting to even be seen by a doctor because of how busy they are,” he said. Until Medi-Cal begins covering home tests, he said, he will have to find time to get tested for free at a Planned Parenthood clinic.

“If insurance were to cover it, I’d definitely do it more,” he said.

Under California’s new law, plans regulated by the state must cover home STI tests when ordered by a health care provider.  

Privately insured Californians can take advantage of the coverage immediately. How much they will owe out-of-pocket for the tests – if anything – depends on the type of plan they have, whether their provider is in-network, and whether they fall into a category the federal government has designated for free screening.

Medi-Cal patients almost never face out-of-pocket expenses, but they will have to wait for coverage because the Department of Health Care Services, which administers Medi-Cal, is working with the American Medical Association and the federal government to create billing codes. The reimbursement rates for those codes will then need federal approval.

The state doesn’t know how long that process will take, according to department spokesperson Anthony Cava.

The rule does not apply to the millions of Californians whose job-based health insurance plans are regulated by the federal government.

Other states and organizations have experimented with at-home STI tests. The public health departments in Alabama and the District of Columbia send free kits to residents who request them, but neither jurisdiction requires insurance coverage for them. The National Coalition of STD Directors is sending free kits to people through health departments in Philadelphia; Iowa; Virginia; Indiana; Puerto Rico; and Navajo County, Arizona. The list of recipients is expected to grow this month.

Iwantthekit.org, a project of Johns Hopkins University, has been sending free kits to Maryland residents since 2004, and to Alaskans since 2011. The program is funded by grants and works with local health departments.

Charlotte Gaydos, cofounder of the project, said that requests for test kits during the pandemic nearly tripled – and that she would expand to every state if she could bill insurance the way the California law mandates.

The tests fall into a murky regulatory area. While they have been approved by the Food and Drug Administration, none have been cleared for use at home. Patients are supposed to collect their own samples within the walls of a health facility, and some labs may not analyze samples collected at home.

Public health officials cited other potential challenges: Patients may not have the same access to counseling, treatment, or referrals to other services such as food banks that they would receive at clinics. And although patients are supposed to self-report the results of their tests to public health authorities, some people won’t follow through.

Vlad Carrillo, 31, experienced such trade-offs recently. Mr. Carrillo used to get tested at a San Francisco clinic, where they could get counseling and other services. But Carrillo lost their apartment during the pandemic and moved about 7 hours away to Bishop, the only incorporated city in rural Inyo County.

“Being away from the city, it took me a whole year to find a way to get tested,” Carrillo said.

Carrillo eventually got the kit through the mail, avoiding the stigma of going to the clinic in Bishop, which is “more focused on straight stuff,” like preventing pregnancy. Without the test, Carrillo couldn’t get PrEP, a medication to prevent HIV.

“Going without it for so long was really hard on me,” Carrillo said.

This story was produced by Kaiser Health News (KHN), which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

SACRAMENTO, CALIF. – California has become the first state to require health insurance plans to cover at-home tests for sexually transmitted infections such as HIV, chlamydia, and syphilis – which could help quell the STI epidemic that has raged nearly unchecked as public health departments have focused on COVID-19.

The rule, part of a broader law addressing the STI epidemic, took effect Jan. 1 for people with state-regulated private insurance plans and will kick in sometime later for the millions of low-income Californians enrolled in the state’s Medicaid program.

By making it easier and cheaper for Californians to self-administer tests in the privacy of their homes, the provision could bring better disease monitoring to rural and underserved parts of the state, reduce the stigma patients experience when seeking care, and give them more control over their health, say experts on infectious diseases.

“This is the first law of its kind, and I’d say it’s kind of cutting-edge,” said Stephanie Arnold Pang, senior director of policy and government relations for the National Coalition of STD Directors. “We want to bring down every single barrier for someone to get STI testing, and out-of-pocket cost is a huge factor.”

But being first has its downsides. Because the concept of insurance coverage for home STI tests is so new, the state’s Medicaid program, Medi-Cal, could not establish by Jan. 1 the billing codes it needs to start paying for tests. Federal regulators also haven’t approved the tests for home use, which could make labs reluctant to process them. And a state analysis predicts most in-network health care providers won’t start prescribing home tests for at least a year until they adjust their billing and other practices.

Nevertheless, the situation is urgent and requires action, said state Sen. Richard Pan (D-Sacramento), a pediatrician who wrote the law.

“We have children born in California with syphilis,” Dr. Pan said. “You’d think that went away in the Victorian era.”

Even before COVID, sexually transmitted infections hit all-time highs in the United States and California for 6 years in a row, according to 2019 data from the Centers for Disease Control and Prevention. Rates of congenital syphilis, which babies contract from their mothers, illustrate the severity of the STI epidemic: Cases were up 279% from 2015 to 2019 nationally and 232% in California. Of the 445 cases of congenital syphilis in California in 2019, 37 were stillbirths.

The pandemic only worsened the problem because health departments were overwhelmed responding to the COVID emergency, and stay-at-home orders kept people away from clinics.

In surveys of public health programs across the country since May 2020, the National Coalition of STD Directors found that most respondents – up to 78% in one survey – have diverted some of their STI workforces to test and monitor COVID. A report that accompanied the most recent survey found that some STIs were “completely unchecked” because of reductions in clinic hours, diversion of resources, shortages of testing kits and staff burnout.

Some at-home STI tests screen for a single disease but other kits can collect and send samples to check for a variety of infections. Depending on the test, patients collect a drop of blood with a lancet, or swab their mouth, vagina, anus, or penis.

Some tests require patients to send samples to a lab for analysis, while some oral HIV tests give results at home in a few minutes.

Ivan Beas, a 25-year-old graduate student at University of California, Los Angeles, was getting tested frequently as part of a 2-year research study. When clinics closed during the pandemic, researchers sent him a home kit.

The kit, which tests for HIV, hepatitis C, herpes, syphilis, chlamydia, gonorrhea, and trichomoniasis, was packaged discreetly and came with easy instructions. It took Mr. Beas about 10 minutes to prick his finger, swab his mouth and send the samples to the lab.

Mr. Beas wanted to continue screening himself every few months after the study ended, he said, but the kit he used retails for $289, which is out of reach for him.

The last time he went to a clinic in person, “I spent 2 hours waiting to even be seen by a doctor because of how busy they are,” he said. Until Medi-Cal begins covering home tests, he said, he will have to find time to get tested for free at a Planned Parenthood clinic.

“If insurance were to cover it, I’d definitely do it more,” he said.

Under California’s new law, plans regulated by the state must cover home STI tests when ordered by a health care provider.  

Privately insured Californians can take advantage of the coverage immediately. How much they will owe out-of-pocket for the tests – if anything – depends on the type of plan they have, whether their provider is in-network, and whether they fall into a category the federal government has designated for free screening.

Medi-Cal patients almost never face out-of-pocket expenses, but they will have to wait for coverage because the Department of Health Care Services, which administers Medi-Cal, is working with the American Medical Association and the federal government to create billing codes. The reimbursement rates for those codes will then need federal approval.

The state doesn’t know how long that process will take, according to department spokesperson Anthony Cava.

The rule does not apply to the millions of Californians whose job-based health insurance plans are regulated by the federal government.

Other states and organizations have experimented with at-home STI tests. The public health departments in Alabama and the District of Columbia send free kits to residents who request them, but neither jurisdiction requires insurance coverage for them. The National Coalition of STD Directors is sending free kits to people through health departments in Philadelphia; Iowa; Virginia; Indiana; Puerto Rico; and Navajo County, Arizona. The list of recipients is expected to grow this month.

Iwantthekit.org, a project of Johns Hopkins University, has been sending free kits to Maryland residents since 2004, and to Alaskans since 2011. The program is funded by grants and works with local health departments.

Charlotte Gaydos, cofounder of the project, said that requests for test kits during the pandemic nearly tripled – and that she would expand to every state if she could bill insurance the way the California law mandates.

The tests fall into a murky regulatory area. While they have been approved by the Food and Drug Administration, none have been cleared for use at home. Patients are supposed to collect their own samples within the walls of a health facility, and some labs may not analyze samples collected at home.

Public health officials cited other potential challenges: Patients may not have the same access to counseling, treatment, or referrals to other services such as food banks that they would receive at clinics. And although patients are supposed to self-report the results of their tests to public health authorities, some people won’t follow through.

Vlad Carrillo, 31, experienced such trade-offs recently. Mr. Carrillo used to get tested at a San Francisco clinic, where they could get counseling and other services. But Carrillo lost their apartment during the pandemic and moved about 7 hours away to Bishop, the only incorporated city in rural Inyo County.

“Being away from the city, it took me a whole year to find a way to get tested,” Carrillo said.

Carrillo eventually got the kit through the mail, avoiding the stigma of going to the clinic in Bishop, which is “more focused on straight stuff,” like preventing pregnancy. Without the test, Carrillo couldn’t get PrEP, a medication to prevent HIV.

“Going without it for so long was really hard on me,” Carrillo said.

This story was produced by Kaiser Health News (KHN), which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

A specialty group is asking federal and state governments to preserve and expand access to telehealth services for children with developmental and behavioral problems.

Citing the success during the COVID-19 pandemic of telehealth for these patients, the Society for Developmental and Behavioral Pediatrics (SDBP) has issued a position statement in its official journal calling for continued use of video and telephone for home-based diagnostic assessments, medication management follow-ups, and therapeutic interventions for children  with autism spectrum disorder, attention-deficit/hyperactivity disorder, and other neurodevelopmental conditions.

“Telehealth offers plenty of opportunities for quick check-ins. It can offer some crisis management opportunities ... to address a parent’s concern about challenging behaviors or navigating school system issues or developmental needs,” lead author Robert D. Keder, MD, assistant professor of pediatrics at University of Connecticut, Farmington, and cochair of SDBP’s Advocacy Committee, told this news organization.

“The video visit does really offer us so much more. It’s so enriching and lets us as providers meet the child in their natural home environment. The real magic of a video visit is we haven’t done house calls as a medical society for decades. But now, literally, the power of telehealth lets us do a house call.”

In the face of the pandemic, emergency government policies allowed care to continue remotely via telehealth, including video and phone calls. The policies have allowed patients to have video visits in their own home, lifted provider licensure requirements for visits across state lines, and allowed reimbursement not only for video visits but also for telephone encounters.

As a result, the field of developmental and behavioral pediatrics (DBP) has recognized telehealth as a viable and useful model of care for children with neurodevelopmental disorders, said Neelkamal Soares, MD, a member of the society’s board and a coauthor of the position paper.

“Telehealth has been helpful in mitigating barriers families often face when attending in-person visits,” such as the lack of transportation and child care, missed work hours, and other issues, said Dr. Soares, professor of pediatric and adolescent medicine at Western Michigan University Stryker in Kalamazoo. At the same time, the growth in the use of the technology has highlighted additional obstacles to equitable access to care, including broadband connectivity, digital literacy, and the availability of interpretation and sign language services, he said.

Dr. Keder said telehealth has enabled him to better help with behavior management by observing children where they are most comfortable. Remote visits also allow him to consider information such as furniture arrangements and how that can affect the patient’s living conditions, and also sibling interactions, learning and homework, eating, and sleep.

Telemedicine conferences enable DBP specialists to facilitate care collaboration with different members of the patient’s care team. Consent from a family and a click of a button allows for therapists, early intervention specialists, teachers, school nurses, or even primary care providers the capacity to participate in a telehealth visit, he said.

Dr. Keder said the future of telehealth is uncertain. The policies from the pandemic may expire in the near term and vary from state to state. The goal of the policy statement is to advocate for legislation and policies that support ongoing, equitable, home-based telehealth care for patients seen by DBP providers while ensuring equitable access to DBP in general.

Kate Benton, PhD, a clinical psychologist with Lurie Children’s Hospital at Northwestern Medicine Central DuPage Hospital in Winfield, Ill., said the society has done an excellent job of explaining the need to maintain telehealth in light of the shortage of pediatricians, clinical psychologists, and other professionals in the field.

“Telehealth has opened new avenues for these patients who otherwise have difficulty seeing specialists. This is a population of children who without telehealth have significant challenges in getting access to care,” she said.

Wendy Fournier, mother of an autistic child and president of the National Autism Association, said telehealth can be beneficial for some individuals with the disorder.

“There are many aspects of in-person doctor visits that can be overwhelming, including bright lights, many people talking, waiting for the doctor, being comfortable with the doctor’s touch, etc.,” Ms. Fournier said in an interview. “All of these things can cause sensory and emotional dysregulation leading to overwhelming anxiety and fear.”

Visits to the doctor can be especially difficult for people who are nonverbal and unable to express their discomfort, said. 

“At my daughter’s last medical appointment, she could not stay in the exam room and pulled me out the door. Thankfully, we have an understanding and compassionate physician who finished our appointment in our car. I believe that telehealth visits should remain available as a necessary and vital accommodation for people with disabilities,” Ms. Fournier said.
 

False equivalence?

Dr. Soares said researchers have attempted to assess the evidence of telehealth benefits in such situations as ADHD, cognitive behavioral therapy, and parent training. 

“There is a paucity of published studies that specifically look at different conditions and compare in-person to telehealth visits, but these are ongoing in autism diagnostics and other areas by several SDBP members,” he said. “Stay tuned.”

Dr. Keder added that telehealth will never replace in-person visits, but the availability of this new option gives developmental pediatricians flexibility in strategies in treating and evaluating patients.

“Both are helpful and viable models. In the pandemic, we were forced out of necessity to embrace telehealth,” he said. “Because of this, we are seeing the power and benefits telehealth offers. Now many families like a mixture of alternating in person with telehealth visits.”

The policy statement cites research that finds patients are highly satisfied with telehealth and that telehealth may cost less than in-office visits.

The report stresses that equitable access to devices needed for telehealth visits is a concern because there is disproportionate access to required technology, especially in rural and underserved communities. The Federal Communications Commission has provided grants to eligible families to offset the cost, in part, for a laptop, desktop computer, or tablet. However, more is still needed, the group said.

The position paper calls for:

• Equitable access to the infrastructure and technology for telehealth, including greater access to broadband services in rural and underserved areas.
• Increased access to devices needed to connect children with neurodevelopmental disorders with critical health care services.
• Reimbursement of interpretation services for the people who are deaf and/or have limited English proficiency.
• Mitigation of geographic barriers to accessing DBP care.
• Permitting patients to access telehealth from their home or whichever physical location provides opportunities for safe and timely care, especially for established patients.
• Ensuring more engagement by state medical licensing boards to join the Interstate Medical Licensing Compact to provide care by telehealth when there is already an insufficient geographic distribution of that type of provider in a state, as is being conducted in the field of psychology.
• Ensuring ongoing reimbursement.
• Parity in reimbursement for telehealth in-person visits.
• Increased funding for research looking into outcomes, quality, and effectiveness of telehealth services at the federal and state levels.

“Our organization can work with families to educate lawmakers, insurance administrators, and organizational leaders about the value that telehealth holds in the care of their child and family,” Dr. Soares said. “We can also conduct research to add to the evidence based around the topic to further the science around telehealth outcomes and equivalency to in-person settings.”

“With the current workforce shortage in DBP and behavioral health it is more critical than ever to maintain access to care,” Dr. Keder added. “The pandemic has provided an opportunity to better harness the amazing power of telehealth to allow for access to equitable care for families. We hope that this statement moves legislators, leaders, and voters to continue to advocate for ongoing telehealth at both the state, federal, and organizational levels.”

Dr. Benton, Dr. Keder, and Dr. Soares have disclosed no financial conflicts of interest.

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

A specialty group is asking federal and state governments to preserve and expand access to telehealth services for children with developmental and behavioral problems.

Citing the success during the COVID-19 pandemic of telehealth for these patients, the Society for Developmental and Behavioral Pediatrics (SDBP) has issued a position statement in its official journal calling for continued use of video and telephone for home-based diagnostic assessments, medication management follow-ups, and therapeutic interventions for children  with autism spectrum disorder, attention-deficit/hyperactivity disorder, and other neurodevelopmental conditions.

“Telehealth offers plenty of opportunities for quick check-ins. It can offer some crisis management opportunities ... to address a parent’s concern about challenging behaviors or navigating school system issues or developmental needs,” lead author Robert D. Keder, MD, assistant professor of pediatrics at University of Connecticut, Farmington, and cochair of SDBP’s Advocacy Committee, told this news organization.

“The video visit does really offer us so much more. It’s so enriching and lets us as providers meet the child in their natural home environment. The real magic of a video visit is we haven’t done house calls as a medical society for decades. But now, literally, the power of telehealth lets us do a house call.”

In the face of the pandemic, emergency government policies allowed care to continue remotely via telehealth, including video and phone calls. The policies have allowed patients to have video visits in their own home, lifted provider licensure requirements for visits across state lines, and allowed reimbursement not only for video visits but also for telephone encounters.

As a result, the field of developmental and behavioral pediatrics (DBP) has recognized telehealth as a viable and useful model of care for children with neurodevelopmental disorders, said Neelkamal Soares, MD, a member of the society’s board and a coauthor of the position paper.

“Telehealth has been helpful in mitigating barriers families often face when attending in-person visits,” such as the lack of transportation and child care, missed work hours, and other issues, said Dr. Soares, professor of pediatric and adolescent medicine at Western Michigan University Stryker in Kalamazoo. At the same time, the growth in the use of the technology has highlighted additional obstacles to equitable access to care, including broadband connectivity, digital literacy, and the availability of interpretation and sign language services, he said.

Dr. Keder said telehealth has enabled him to better help with behavior management by observing children where they are most comfortable. Remote visits also allow him to consider information such as furniture arrangements and how that can affect the patient’s living conditions, and also sibling interactions, learning and homework, eating, and sleep.

Telemedicine conferences enable DBP specialists to facilitate care collaboration with different members of the patient’s care team. Consent from a family and a click of a button allows for therapists, early intervention specialists, teachers, school nurses, or even primary care providers the capacity to participate in a telehealth visit, he said.

Dr. Keder said the future of telehealth is uncertain. The policies from the pandemic may expire in the near term and vary from state to state. The goal of the policy statement is to advocate for legislation and policies that support ongoing, equitable, home-based telehealth care for patients seen by DBP providers while ensuring equitable access to DBP in general.

Kate Benton, PhD, a clinical psychologist with Lurie Children’s Hospital at Northwestern Medicine Central DuPage Hospital in Winfield, Ill., said the society has done an excellent job of explaining the need to maintain telehealth in light of the shortage of pediatricians, clinical psychologists, and other professionals in the field.

“Telehealth has opened new avenues for these patients who otherwise have difficulty seeing specialists. This is a population of children who without telehealth have significant challenges in getting access to care,” she said.

Wendy Fournier, mother of an autistic child and president of the National Autism Association, said telehealth can be beneficial for some individuals with the disorder.

“There are many aspects of in-person doctor visits that can be overwhelming, including bright lights, many people talking, waiting for the doctor, being comfortable with the doctor’s touch, etc.,” Ms. Fournier said in an interview. “All of these things can cause sensory and emotional dysregulation leading to overwhelming anxiety and fear.”

Visits to the doctor can be especially difficult for people who are nonverbal and unable to express their discomfort, said. 

“At my daughter’s last medical appointment, she could not stay in the exam room and pulled me out the door. Thankfully, we have an understanding and compassionate physician who finished our appointment in our car. I believe that telehealth visits should remain available as a necessary and vital accommodation for people with disabilities,” Ms. Fournier said.
 

False equivalence?

Dr. Soares said researchers have attempted to assess the evidence of telehealth benefits in such situations as ADHD, cognitive behavioral therapy, and parent training. 

“There is a paucity of published studies that specifically look at different conditions and compare in-person to telehealth visits, but these are ongoing in autism diagnostics and other areas by several SDBP members,” he said. “Stay tuned.”

Dr. Keder added that telehealth will never replace in-person visits, but the availability of this new option gives developmental pediatricians flexibility in strategies in treating and evaluating patients.

“Both are helpful and viable models. In the pandemic, we were forced out of necessity to embrace telehealth,” he said. “Because of this, we are seeing the power and benefits telehealth offers. Now many families like a mixture of alternating in person with telehealth visits.”

The policy statement cites research that finds patients are highly satisfied with telehealth and that telehealth may cost less than in-office visits.

The report stresses that equitable access to devices needed for telehealth visits is a concern because there is disproportionate access to required technology, especially in rural and underserved communities. The Federal Communications Commission has provided grants to eligible families to offset the cost, in part, for a laptop, desktop computer, or tablet. However, more is still needed, the group said.

The position paper calls for:

• Equitable access to the infrastructure and technology for telehealth, including greater access to broadband services in rural and underserved areas.
• Increased access to devices needed to connect children with neurodevelopmental disorders with critical health care services.
• Reimbursement of interpretation services for the people who are deaf and/or have limited English proficiency.
• Mitigation of geographic barriers to accessing DBP care.
• Permitting patients to access telehealth from their home or whichever physical location provides opportunities for safe and timely care, especially for established patients.
• Ensuring more engagement by state medical licensing boards to join the Interstate Medical Licensing Compact to provide care by telehealth when there is already an insufficient geographic distribution of that type of provider in a state, as is being conducted in the field of psychology.
• Ensuring ongoing reimbursement.
• Parity in reimbursement for telehealth in-person visits.
• Increased funding for research looking into outcomes, quality, and effectiveness of telehealth services at the federal and state levels.

“Our organization can work with families to educate lawmakers, insurance administrators, and organizational leaders about the value that telehealth holds in the care of their child and family,” Dr. Soares said. “We can also conduct research to add to the evidence based around the topic to further the science around telehealth outcomes and equivalency to in-person settings.”

“With the current workforce shortage in DBP and behavioral health it is more critical than ever to maintain access to care,” Dr. Keder added. “The pandemic has provided an opportunity to better harness the amazing power of telehealth to allow for access to equitable care for families. We hope that this statement moves legislators, leaders, and voters to continue to advocate for ongoing telehealth at both the state, federal, and organizational levels.”

Dr. Benton, Dr. Keder, and Dr. Soares have disclosed no financial conflicts of interest.

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

A specialty group is asking federal and state governments to preserve and expand access to telehealth services for children with developmental and behavioral problems.

Citing the success during the COVID-19 pandemic of telehealth for these patients, the Society for Developmental and Behavioral Pediatrics (SDBP) has issued a position statement in its official journal calling for continued use of video and telephone for home-based diagnostic assessments, medication management follow-ups, and therapeutic interventions for children  with autism spectrum disorder, attention-deficit/hyperactivity disorder, and other neurodevelopmental conditions.

“Telehealth offers plenty of opportunities for quick check-ins. It can offer some crisis management opportunities ... to address a parent’s concern about challenging behaviors or navigating school system issues or developmental needs,” lead author Robert D. Keder, MD, assistant professor of pediatrics at University of Connecticut, Farmington, and cochair of SDBP’s Advocacy Committee, told this news organization.

“The video visit does really offer us so much more. It’s so enriching and lets us as providers meet the child in their natural home environment. The real magic of a video visit is we haven’t done house calls as a medical society for decades. But now, literally, the power of telehealth lets us do a house call.”

In the face of the pandemic, emergency government policies allowed care to continue remotely via telehealth, including video and phone calls. The policies have allowed patients to have video visits in their own home, lifted provider licensure requirements for visits across state lines, and allowed reimbursement not only for video visits but also for telephone encounters.

As a result, the field of developmental and behavioral pediatrics (DBP) has recognized telehealth as a viable and useful model of care for children with neurodevelopmental disorders, said Neelkamal Soares, MD, a member of the society’s board and a coauthor of the position paper.

“Telehealth has been helpful in mitigating barriers families often face when attending in-person visits,” such as the lack of transportation and child care, missed work hours, and other issues, said Dr. Soares, professor of pediatric and adolescent medicine at Western Michigan University Stryker in Kalamazoo. At the same time, the growth in the use of the technology has highlighted additional obstacles to equitable access to care, including broadband connectivity, digital literacy, and the availability of interpretation and sign language services, he said.

Dr. Keder said telehealth has enabled him to better help with behavior management by observing children where they are most comfortable. Remote visits also allow him to consider information such as furniture arrangements and how that can affect the patient’s living conditions, and also sibling interactions, learning and homework, eating, and sleep.

Telemedicine conferences enable DBP specialists to facilitate care collaboration with different members of the patient’s care team. Consent from a family and a click of a button allows for therapists, early intervention specialists, teachers, school nurses, or even primary care providers the capacity to participate in a telehealth visit, he said.

Dr. Keder said the future of telehealth is uncertain. The policies from the pandemic may expire in the near term and vary from state to state. The goal of the policy statement is to advocate for legislation and policies that support ongoing, equitable, home-based telehealth care for patients seen by DBP providers while ensuring equitable access to DBP in general.

Kate Benton, PhD, a clinical psychologist with Lurie Children’s Hospital at Northwestern Medicine Central DuPage Hospital in Winfield, Ill., said the society has done an excellent job of explaining the need to maintain telehealth in light of the shortage of pediatricians, clinical psychologists, and other professionals in the field.

“Telehealth has opened new avenues for these patients who otherwise have difficulty seeing specialists. This is a population of children who without telehealth have significant challenges in getting access to care,” she said.

Wendy Fournier, mother of an autistic child and president of the National Autism Association, said telehealth can be beneficial for some individuals with the disorder.

“There are many aspects of in-person doctor visits that can be overwhelming, including bright lights, many people talking, waiting for the doctor, being comfortable with the doctor’s touch, etc.,” Ms. Fournier said in an interview. “All of these things can cause sensory and emotional dysregulation leading to overwhelming anxiety and fear.”

Visits to the doctor can be especially difficult for people who are nonverbal and unable to express their discomfort, said. 

“At my daughter’s last medical appointment, she could not stay in the exam room and pulled me out the door. Thankfully, we have an understanding and compassionate physician who finished our appointment in our car. I believe that telehealth visits should remain available as a necessary and vital accommodation for people with disabilities,” Ms. Fournier said.
 

False equivalence?

Dr. Soares said researchers have attempted to assess the evidence of telehealth benefits in such situations as ADHD, cognitive behavioral therapy, and parent training. 

“There is a paucity of published studies that specifically look at different conditions and compare in-person to telehealth visits, but these are ongoing in autism diagnostics and other areas by several SDBP members,” he said. “Stay tuned.”

Dr. Keder added that telehealth will never replace in-person visits, but the availability of this new option gives developmental pediatricians flexibility in strategies in treating and evaluating patients.

“Both are helpful and viable models. In the pandemic, we were forced out of necessity to embrace telehealth,” he said. “Because of this, we are seeing the power and benefits telehealth offers. Now many families like a mixture of alternating in person with telehealth visits.”

The policy statement cites research that finds patients are highly satisfied with telehealth and that telehealth may cost less than in-office visits.

The report stresses that equitable access to devices needed for telehealth visits is a concern because there is disproportionate access to required technology, especially in rural and underserved communities. The Federal Communications Commission has provided grants to eligible families to offset the cost, in part, for a laptop, desktop computer, or tablet. However, more is still needed, the group said.

The position paper calls for:

• Equitable access to the infrastructure and technology for telehealth, including greater access to broadband services in rural and underserved areas.
• Increased access to devices needed to connect children with neurodevelopmental disorders with critical health care services.
• Reimbursement of interpretation services for the people who are deaf and/or have limited English proficiency.
• Mitigation of geographic barriers to accessing DBP care.
• Permitting patients to access telehealth from their home or whichever physical location provides opportunities for safe and timely care, especially for established patients.
• Ensuring more engagement by state medical licensing boards to join the Interstate Medical Licensing Compact to provide care by telehealth when there is already an insufficient geographic distribution of that type of provider in a state, as is being conducted in the field of psychology.
• Ensuring ongoing reimbursement.
• Parity in reimbursement for telehealth in-person visits.
• Increased funding for research looking into outcomes, quality, and effectiveness of telehealth services at the federal and state levels.

“Our organization can work with families to educate lawmakers, insurance administrators, and organizational leaders about the value that telehealth holds in the care of their child and family,” Dr. Soares said. “We can also conduct research to add to the evidence based around the topic to further the science around telehealth outcomes and equivalency to in-person settings.”

“With the current workforce shortage in DBP and behavioral health it is more critical than ever to maintain access to care,” Dr. Keder added. “The pandemic has provided an opportunity to better harness the amazing power of telehealth to allow for access to equitable care for families. We hope that this statement moves legislators, leaders, and voters to continue to advocate for ongoing telehealth at both the state, federal, and organizational levels.”

Dr. Benton, Dr. Keder, and Dr. Soares have disclosed no financial conflicts of interest.

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

Early interventions that focus on clinical case management and psychiatric care, and not necessarily on individual psychotherapy, are effective for young patients with borderline personality disorder (BPD), new research suggests.

Findings from the Monitoring Outcomes of Borderline Personality Disorder in Youth (MOBY) trial also showed improved psychosocial functioning and reduced suicide ideation with these therapies.

The results suggest that, contrary to common belief, psychotherapy is not the only effective approach for early BPD, lead author Andrew M. Chanen, PhD, director of clinical programs and services and head of personality disorder research at Orygen, Melbourne, told this news organization.

“We can say that early diagnosis and early treatment is effective, and the treatment doesn’t need to involve individual psychotherapy but does need to involve clinical case management and psychiatric care,” said Dr. Chanen, a professorial fellow at the Centre for Youth Mental Health, University of Melbourne.

The findings were published online in JAMA Psychiatry.
 

Extreme sensitivity

Patients with BPD have “extreme sensitivity to interpersonal slights” and often exhibit intense and volatile emotions and impulsive behavior, Dr. Chanen noted. Many will self-harm, abuse drugs, or attempt suicide; the suicide rate among patients with BPD is 8%-10%.

The condition is typically diagnosed in puberty or early adulthood, affecting about 3% of young people and a little more than 1% of adults.

Because of their aggression and interpersonal difficulties, patients with BPD are often discriminated against by health professionals and end up not getting treated, said Dr. Chanen.

Those who are treated often receive individual psychotherapy, such as dialectical behavior therapy (DBT). That type of therapy, which teaches healthy ways to cope with stress and regulate emotions, is very effective, Dr. Chanen said.

The MOBY trial examined three treatment approaches: the Helping Young People Early (HYPE) model, HYPE combined with weekly “befriending,” and a general youth mental health service (YMHS) model combined with befriending.

A key element of HYPE is cognitive analytic therapy, a psychotherapy program focused on understanding problematic self-management and interpersonal relationship patterns. The model includes clinical case management, such as attending to housing, vocational and educational issues, other mental health needs, and physical health needs.

In the second model, the psychotherapy of the HYPE program was replaced with befriending, which involves chatting with a patient about neutral topics such as sports and avoiding emotionally loaded topics such as interpersonal problems.

For YMHS plus befriending, experts trained in treating young people, but not specialized in treating BPD, were involved in managing patients.

‘High satisfaction’

Researchers randomly assigned 139 participants aged 15-25 years (80.6% women; mean age, 19.1 years) with BPD to one of the treatment arms. Of these, 128 (92.1%) were included in the intent-to-treat analysis.

The primary endpoint was psychosocial functioning, as measured by the Inventory of Interpersonal Problems Circumplex Version and the Social Adjustment Scale–Self-Report. Secondary endpoints included suicidal ideation, suicide attempts, nonsuicidal self-injury, depression, substance use, and treatment satisfaction.

The investigators reported group averages, but the study’s noninferiority design did not allow for determining if one treatment had superior efficacy.

All groups improved significantly on the primary endpoint. At 12 months, there was a mean 28.91-point (23.8%) drop in interpersonal problems and a mean 0.55-point (19.3%) drop in social adjustment scores.

For secondary outcomes, mean improvements at 12 months ranged from 40.7% (17.64 points) on the depression scale to 52.7% (6.22 points) for suicide ideation.

“The only area where the treatment didn’t really have an impact was substance use,” said Dr. Chanen. “Satisfaction was high for all three interventions throughout the study, and it’s hard to improve on high satisfaction.”

‘Turns things upside down’

That patients across all groups had marked and sustained improvements “in ways you wouldn’t expect for BPD” supports the conclusion that the interventions had a true effect, Dr. Chanen said.

The results suggest early diagnosis and “a not very complicated treatment [will] drastically improve the lives of these young people,” he added.

They also imply there are effective alternatives to psychotherapy, which many individuals in the field insist is the only way to treat BPD. “This study turns things upside down and says actually it’s not. It’s the basics of treatment that are important,” Dr. Chanen said.

When a patient presents at the emergency department following a severe overdose, “it’s a reflex” for clinicians to refer that person to a psychotherapy program. “The problem is, these programs are not plentiful enough to be able to service the needs of this group,” Dr. Chanen noted.

On the other hand, the skills for clinical case management and psychiatric care “are available throughout the mental health systems,” he added.

The researchers are planning another analysis to determine whether age and sex predict better outcomes in these patients with BPD.
 

Unique contribution

Commenting for this news organization, John M. Oldham, MD, distinguished emeritus professor, Baylor College of Medicine, Houston, said a “unique and important contribution” of the study is the focus on early intervention.

“The general standard approach in psychiatry and the diagnostic world has been to not even consider anything until after somebody is 18 years of age, which is a mistake because these kids can become quite impaired earlier than that,” he said.

Dr. Oldham, who was not involved with the research, chaired the American Psychiatric Association workgroup that developed the 2001 evidence-based practice guideline for treating BPD, which recommended psychotherapy as the primary treatment. The guideline was last updated in 2005 – and another update is currently being developed, he noted.

There is an emerging trend toward “good psychiatric management” that focuses on level of functioning rather than on a specific strategy requiring a certificate of training that “not many people out there have,” said Dr. Oldham.

“You’re not going to make much headway with these kids if you’re going to be searching around for a DBT-certified therapist. What you need is to bring them in, get them to trust you, and in a sense be a kind of overall behavioral medicine navigator for them,” he added.

Dr. Oldham noted that, although the primary study outcome improved between 19% and 24%, “that means three-quarters of the people didn’t improve.”

He also pointed out this was only a 1-year trial. “Sometimes treatment for people with a personality disorder such as borderline takes a lot longer than that,” Dr. Oldham concluded.

The trial was funded by the National Health and Medical Research Council. Dr. Chanen reports receiving grants from the Australian government’s National Health and Medical Research Council during the conduct of the study and other support from the Helping Young People Early (HYPE) translational program outside the submitted work. He and another investigator cofounded and lead the HYPE clinical program, a government-funded program with continuous support, and the HYPE translational program, a not-for-profit training program. Dr. Oldham reported no relevant financial relationships.

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

Early interventions that focus on clinical case management and psychiatric care, and not necessarily on individual psychotherapy, are effective for young patients with borderline personality disorder (BPD), new research suggests.

Findings from the Monitoring Outcomes of Borderline Personality Disorder in Youth (MOBY) trial also showed improved psychosocial functioning and reduced suicide ideation with these therapies.

The results suggest that, contrary to common belief, psychotherapy is not the only effective approach for early BPD, lead author Andrew M. Chanen, PhD, director of clinical programs and services and head of personality disorder research at Orygen, Melbourne, told this news organization.

“We can say that early diagnosis and early treatment is effective, and the treatment doesn’t need to involve individual psychotherapy but does need to involve clinical case management and psychiatric care,” said Dr. Chanen, a professorial fellow at the Centre for Youth Mental Health, University of Melbourne.

The findings were published online in JAMA Psychiatry.
 

Extreme sensitivity

Patients with BPD have “extreme sensitivity to interpersonal slights” and often exhibit intense and volatile emotions and impulsive behavior, Dr. Chanen noted. Many will self-harm, abuse drugs, or attempt suicide; the suicide rate among patients with BPD is 8%-10%.

The condition is typically diagnosed in puberty or early adulthood, affecting about 3% of young people and a little more than 1% of adults.

Because of their aggression and interpersonal difficulties, patients with BPD are often discriminated against by health professionals and end up not getting treated, said Dr. Chanen.

Those who are treated often receive individual psychotherapy, such as dialectical behavior therapy (DBT). That type of therapy, which teaches healthy ways to cope with stress and regulate emotions, is very effective, Dr. Chanen said.

The MOBY trial examined three treatment approaches: the Helping Young People Early (HYPE) model, HYPE combined with weekly “befriending,” and a general youth mental health service (YMHS) model combined with befriending.

A key element of HYPE is cognitive analytic therapy, a psychotherapy program focused on understanding problematic self-management and interpersonal relationship patterns. The model includes clinical case management, such as attending to housing, vocational and educational issues, other mental health needs, and physical health needs.

In the second model, the psychotherapy of the HYPE program was replaced with befriending, which involves chatting with a patient about neutral topics such as sports and avoiding emotionally loaded topics such as interpersonal problems.

For YMHS plus befriending, experts trained in treating young people, but not specialized in treating BPD, were involved in managing patients.

‘High satisfaction’

Researchers randomly assigned 139 participants aged 15-25 years (80.6% women; mean age, 19.1 years) with BPD to one of the treatment arms. Of these, 128 (92.1%) were included in the intent-to-treat analysis.

The primary endpoint was psychosocial functioning, as measured by the Inventory of Interpersonal Problems Circumplex Version and the Social Adjustment Scale–Self-Report. Secondary endpoints included suicidal ideation, suicide attempts, nonsuicidal self-injury, depression, substance use, and treatment satisfaction.

The investigators reported group averages, but the study’s noninferiority design did not allow for determining if one treatment had superior efficacy.

All groups improved significantly on the primary endpoint. At 12 months, there was a mean 28.91-point (23.8%) drop in interpersonal problems and a mean 0.55-point (19.3%) drop in social adjustment scores.

For secondary outcomes, mean improvements at 12 months ranged from 40.7% (17.64 points) on the depression scale to 52.7% (6.22 points) for suicide ideation.

“The only area where the treatment didn’t really have an impact was substance use,” said Dr. Chanen. “Satisfaction was high for all three interventions throughout the study, and it’s hard to improve on high satisfaction.”

‘Turns things upside down’

That patients across all groups had marked and sustained improvements “in ways you wouldn’t expect for BPD” supports the conclusion that the interventions had a true effect, Dr. Chanen said.

The results suggest early diagnosis and “a not very complicated treatment [will] drastically improve the lives of these young people,” he added.

They also imply there are effective alternatives to psychotherapy, which many individuals in the field insist is the only way to treat BPD. “This study turns things upside down and says actually it’s not. It’s the basics of treatment that are important,” Dr. Chanen said.

When a patient presents at the emergency department following a severe overdose, “it’s a reflex” for clinicians to refer that person to a psychotherapy program. “The problem is, these programs are not plentiful enough to be able to service the needs of this group,” Dr. Chanen noted.

On the other hand, the skills for clinical case management and psychiatric care “are available throughout the mental health systems,” he added.

The researchers are planning another analysis to determine whether age and sex predict better outcomes in these patients with BPD.
 

Unique contribution

Commenting for this news organization, John M. Oldham, MD, distinguished emeritus professor, Baylor College of Medicine, Houston, said a “unique and important contribution” of the study is the focus on early intervention.

“The general standard approach in psychiatry and the diagnostic world has been to not even consider anything until after somebody is 18 years of age, which is a mistake because these kids can become quite impaired earlier than that,” he said.

Dr. Oldham, who was not involved with the research, chaired the American Psychiatric Association workgroup that developed the 2001 evidence-based practice guideline for treating BPD, which recommended psychotherapy as the primary treatment. The guideline was last updated in 2005 – and another update is currently being developed, he noted.

There is an emerging trend toward “good psychiatric management” that focuses on level of functioning rather than on a specific strategy requiring a certificate of training that “not many people out there have,” said Dr. Oldham.

“You’re not going to make much headway with these kids if you’re going to be searching around for a DBT-certified therapist. What you need is to bring them in, get them to trust you, and in a sense be a kind of overall behavioral medicine navigator for them,” he added.

Dr. Oldham noted that, although the primary study outcome improved between 19% and 24%, “that means three-quarters of the people didn’t improve.”

He also pointed out this was only a 1-year trial. “Sometimes treatment for people with a personality disorder such as borderline takes a lot longer than that,” Dr. Oldham concluded.

The trial was funded by the National Health and Medical Research Council. Dr. Chanen reports receiving grants from the Australian government’s National Health and Medical Research Council during the conduct of the study and other support from the Helping Young People Early (HYPE) translational program outside the submitted work. He and another investigator cofounded and lead the HYPE clinical program, a government-funded program with continuous support, and the HYPE translational program, a not-for-profit training program. Dr. Oldham reported no relevant financial relationships.

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

Early interventions that focus on clinical case management and psychiatric care, and not necessarily on individual psychotherapy, are effective for young patients with borderline personality disorder (BPD), new research suggests.

Findings from the Monitoring Outcomes of Borderline Personality Disorder in Youth (MOBY) trial also showed improved psychosocial functioning and reduced suicide ideation with these therapies.

The results suggest that, contrary to common belief, psychotherapy is not the only effective approach for early BPD, lead author Andrew M. Chanen, PhD, director of clinical programs and services and head of personality disorder research at Orygen, Melbourne, told this news organization.

“We can say that early diagnosis and early treatment is effective, and the treatment doesn’t need to involve individual psychotherapy but does need to involve clinical case management and psychiatric care,” said Dr. Chanen, a professorial fellow at the Centre for Youth Mental Health, University of Melbourne.

The findings were published online in JAMA Psychiatry.
 

Extreme sensitivity

Patients with BPD have “extreme sensitivity to interpersonal slights” and often exhibit intense and volatile emotions and impulsive behavior, Dr. Chanen noted. Many will self-harm, abuse drugs, or attempt suicide; the suicide rate among patients with BPD is 8%-10%.

The condition is typically diagnosed in puberty or early adulthood, affecting about 3% of young people and a little more than 1% of adults.

Because of their aggression and interpersonal difficulties, patients with BPD are often discriminated against by health professionals and end up not getting treated, said Dr. Chanen.

Those who are treated often receive individual psychotherapy, such as dialectical behavior therapy (DBT). That type of therapy, which teaches healthy ways to cope with stress and regulate emotions, is very effective, Dr. Chanen said.

The MOBY trial examined three treatment approaches: the Helping Young People Early (HYPE) model, HYPE combined with weekly “befriending,” and a general youth mental health service (YMHS) model combined with befriending.

A key element of HYPE is cognitive analytic therapy, a psychotherapy program focused on understanding problematic self-management and interpersonal relationship patterns. The model includes clinical case management, such as attending to housing, vocational and educational issues, other mental health needs, and physical health needs.

In the second model, the psychotherapy of the HYPE program was replaced with befriending, which involves chatting with a patient about neutral topics such as sports and avoiding emotionally loaded topics such as interpersonal problems.

For YMHS plus befriending, experts trained in treating young people, but not specialized in treating BPD, were involved in managing patients.

‘High satisfaction’

Researchers randomly assigned 139 participants aged 15-25 years (80.6% women; mean age, 19.1 years) with BPD to one of the treatment arms. Of these, 128 (92.1%) were included in the intent-to-treat analysis.

The primary endpoint was psychosocial functioning, as measured by the Inventory of Interpersonal Problems Circumplex Version and the Social Adjustment Scale–Self-Report. Secondary endpoints included suicidal ideation, suicide attempts, nonsuicidal self-injury, depression, substance use, and treatment satisfaction.

The investigators reported group averages, but the study’s noninferiority design did not allow for determining if one treatment had superior efficacy.

All groups improved significantly on the primary endpoint. At 12 months, there was a mean 28.91-point (23.8%) drop in interpersonal problems and a mean 0.55-point (19.3%) drop in social adjustment scores.

For secondary outcomes, mean improvements at 12 months ranged from 40.7% (17.64 points) on the depression scale to 52.7% (6.22 points) for suicide ideation.

“The only area where the treatment didn’t really have an impact was substance use,” said Dr. Chanen. “Satisfaction was high for all three interventions throughout the study, and it’s hard to improve on high satisfaction.”

‘Turns things upside down’

That patients across all groups had marked and sustained improvements “in ways you wouldn’t expect for BPD” supports the conclusion that the interventions had a true effect, Dr. Chanen said.

The results suggest early diagnosis and “a not very complicated treatment [will] drastically improve the lives of these young people,” he added.

They also imply there are effective alternatives to psychotherapy, which many individuals in the field insist is the only way to treat BPD. “This study turns things upside down and says actually it’s not. It’s the basics of treatment that are important,” Dr. Chanen said.

When a patient presents at the emergency department following a severe overdose, “it’s a reflex” for clinicians to refer that person to a psychotherapy program. “The problem is, these programs are not plentiful enough to be able to service the needs of this group,” Dr. Chanen noted.

On the other hand, the skills for clinical case management and psychiatric care “are available throughout the mental health systems,” he added.

The researchers are planning another analysis to determine whether age and sex predict better outcomes in these patients with BPD.
 

Unique contribution

Commenting for this news organization, John M. Oldham, MD, distinguished emeritus professor, Baylor College of Medicine, Houston, said a “unique and important contribution” of the study is the focus on early intervention.

“The general standard approach in psychiatry and the diagnostic world has been to not even consider anything until after somebody is 18 years of age, which is a mistake because these kids can become quite impaired earlier than that,” he said.

Dr. Oldham, who was not involved with the research, chaired the American Psychiatric Association workgroup that developed the 2001 evidence-based practice guideline for treating BPD, which recommended psychotherapy as the primary treatment. The guideline was last updated in 2005 – and another update is currently being developed, he noted.

There is an emerging trend toward “good psychiatric management” that focuses on level of functioning rather than on a specific strategy requiring a certificate of training that “not many people out there have,” said Dr. Oldham.

“You’re not going to make much headway with these kids if you’re going to be searching around for a DBT-certified therapist. What you need is to bring them in, get them to trust you, and in a sense be a kind of overall behavioral medicine navigator for them,” he added.

Dr. Oldham noted that, although the primary study outcome improved between 19% and 24%, “that means three-quarters of the people didn’t improve.”

He also pointed out this was only a 1-year trial. “Sometimes treatment for people with a personality disorder such as borderline takes a lot longer than that,” Dr. Oldham concluded.

The trial was funded by the National Health and Medical Research Council. Dr. Chanen reports receiving grants from the Australian government’s National Health and Medical Research Council during the conduct of the study and other support from the Helping Young People Early (HYPE) translational program outside the submitted work. He and another investigator cofounded and lead the HYPE clinical program, a government-funded program with continuous support, and the HYPE translational program, a not-for-profit training program. Dr. Oldham reported no relevant financial relationships.

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

For many adolescents, the first visit to a gynecologist can be intimidating. The prospect of meeting a new doctor who will ask prying, deeply personal questions about sex and menstruation is scary. And, in all likelihood, a parent, older sibling, or friend has warned them about the notorious pelvic exam.

The exact timing of when adolescent patients should start seeing a gynecologist varies based on when a patient starts puberty. Primary care physicians and pediatricians can help teens transition by referring patients to an adolescent-friendly practice and clearing up some of the misconceptions that surround the first gynecology visit. Gynecologists, on the other side of the referral, can help patients transition by guaranteeing confidentiality and creating a safe space for young patients.

This news organization interviewed three experts in adolescent health about when teens should start having their gynecological needs addressed and how their physicians can help them undergo that transition.
 

Age-appropriate care

“Most people get very limited information about their reproductive health,” said Anne-Marie E. Amies Oelschlager, MD, a pediatric and adolescent gynecologist at Seattle Children’s, Seattle, and a member of the American College of Obstetricians and Gynecologists (ACOG) clinical consensus committee on gynecology.

Official guidelines from ACOG call for the initial reproductive health visit to take place between the ages of 13 and 15 years. The exact age may vary, however, depending on the specific needs of the patient.

For example, some patients begin menstruating early, at age 9 or 10, said Mary Romano, MD, MPH, a pediatrician and adolescent medicine specialist at Vanderbilt Children’s Hospital, Nashville, Tenn. Pediatricians who are uncomfortable educating young patients about menstruation should refer the patient to a gynecologist or a pediatric gynecologist for whom such discussions are routine.

If a patient does not have a menstrual cycle by age 14 or 15, that also should be addressed by a family physician or gynecologist, Dr. Romano added.

“The importance here is addressing the reproductive health of the teen starting really at the age of 10 or 12, or once puberty starts,” said Patricia S. Huguelet, MD, a pediatric and adolescent gynecologist at Children’s Hospital Colorado, Aurora. In those early visits, the physician can provide “anticipatory guidance,” counseling the teen on what is normal in terms of menstruation, sex, and relationships, and addressing what is not, she said.

Ideally, patients who were designated female at birth but now identify as male or nonbinary will meet with a gynecologist early on in the gender affirmation process and a gynecologist will continue to consult as part of the patient’s interdisciplinary care team, added Dr. Romano, who counsels LGBTQ+ youth as part of her practice. A gynecologist may support these patients in myriad ways, including helping those who are considering or using puberty blockers and providing reproductive and health education to patients in a way that is sensitive to the patient’s gender identity.
 

Patient referrals

Some pediatricians and family practice physicians may be talking with their patients about topics such as menstrual cycles and contraception. But those who are uncomfortable asking adolescent patients about their reproductive and sexual health should refer them to a gynecologist or specialist in adolescent medicine, Dr. Romano advised.

“The biggest benefit I’ve noticed is often [patients] come from a pediatrician or family medicine provider and they often appreciate the opportunity to talk to a doctor they haven’t met before about the more personal questions they may have,” Dr. Amies Oelschlager said.

Referring adolescents to a specialist who has either trained in adolescent medicine or has experience treating that age group has benefits, Dr. Romano said. Clinicians with that experience understand adolescents are not “mini-adults” but have unique developmental and medical issues. How to counsel and educate them carries unique challenges, she said.

For example, heavy menstrual bleeding is a leading reason a patient – either an adult or an adolescent – presents to a gynecologist, Dr. Huguelet said. But the pathology differs vastly for those two age groups. For patients in their 30s and 40s, polyps and fibroids are common problems associated with heavy bleeding. Those conditions are rare in adolescents, whereas bleeding disorders are common, she said.

Most patients will continue to see their pediatricians and primary care providers for other issues. And in some areas, gynecologists can reinforce advice from pediatricians, such as encouraging patients to get the HPV vaccine, Dr. Amies Oelschlager said.
 

Common misconceptions

Primary care physicians can also dispel common misconceptions teens – and their parents – have about gynecology. Some parents may believe that certain methods of birth control cause cancer or infertility, have concerns about the HPV vaccine, or think hormonal therapies are harmful, Dr. Amies Oelschlager said. But the biggest misconception involves the infamous pelvic exam.

“Lots of patients assume that every time they go to the gynecologist they are going to have a pelvic exam,” she said. “When I say, ‘We don’t have to do that,’ they are so relieved.”

Guidelines have changed since the parents of today’s teens were going to the gynecologist for the first time. Many patients now do not need an initial Pap smear until age 25, following a recent guideline change by the American Cancer Society. (ACOG is considering adopting the same stance but still recommends screening start at 21.) “Most patients do not need an exam, even when it comes to sexual health and screening [for sexually transmitted infections], that can be done without an exam,” Dr. Huguelet said.
 

Confidentiality and comfort

On the other side of the referral, gynecologists should follow several best practices to treat adolescent patients. Arguably the most important part of the initial gynecologic visit is to give patients the option of one-on-one time with the physician with no parent in the room. During that time, the physician should make it clear that what they discuss is confidential and will not be shared with their parent or guardian, Dr. Huguelet said. Patients should also have the option of having a friend or another nonparent individual in the room with them during this one-on-one time with the physician, particularly if the patient does not feel comfortable discussing sensitive subjects completely on her own.

Adolescents receive better care, disclose more, and perceive they are getting better care when the process is confidential, Dr. Romano said. Confidentiality does have limits, however, which physicians should also make sure their patients understand, according to the ACOG guidelines for the initial reproductive visit. These limitations can vary by state depending on issues related to mandatory reporting, insurance billing, and legal requirements of patient notifications of specific services such as abortion.

The use of electronic medical records has raised additional challenges when it comes to communicating privately with adolescent patients, Dr. Amies Oelschlager said. In her practice, she tries to ensure the adolescent is the one with the login information for their records. If not, her office will have the patient’s cell number to text or call securely.

“We feel strongly adolescents should be able to access reproductive health care, mental health care, and care for substance abuse disorders without parental notification,” Dr. Amies Oelschlager said.

Telehealth visits can also be helpful for adolescents coming to gynecology for the first time. And taking the time to establish a rapport with patients at the start of the visit is key, Dr. Huguelet said. By directing questions to the adolescent patient rather than the parent, Dr. Huguelet said, the physician demonstrates that the teen’s treatment needs come first.

ACOG has guidelines on other steps gynecology practices, including those that see both adults and teens, can take to make their offices and visits adolescent-friendly. These steps include asking patients about their preferred names and pronouns at the start of the visit or as part of the initial intake form, training office staff to be comfortable with issues related to adolescent sexuality and gender and sexual diversity among patients, providing a place for teens to wait separately from obstetrics patients, and having age-appropriate literature on hand for adolescents to learn about reproductive health.

After that first reproductive health visit, gynecologists and primary care providers should partner to ensure the whole health of their patients is being addressed, Dr. Huguelet said.

“Collaboration is always going to better serve patients in any area,” said Dr. Romano, “and certainly this area is no different.”

Dr. Amies Oelschlager, Dr. Romano, and Dr. Huguelet have disclosed no relevant financial relationships.

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

For many adolescents, the first visit to a gynecologist can be intimidating. The prospect of meeting a new doctor who will ask prying, deeply personal questions about sex and menstruation is scary. And, in all likelihood, a parent, older sibling, or friend has warned them about the notorious pelvic exam.

The exact timing of when adolescent patients should start seeing a gynecologist varies based on when a patient starts puberty. Primary care physicians and pediatricians can help teens transition by referring patients to an adolescent-friendly practice and clearing up some of the misconceptions that surround the first gynecology visit. Gynecologists, on the other side of the referral, can help patients transition by guaranteeing confidentiality and creating a safe space for young patients.

This news organization interviewed three experts in adolescent health about when teens should start having their gynecological needs addressed and how their physicians can help them undergo that transition.
 

Age-appropriate care

“Most people get very limited information about their reproductive health,” said Anne-Marie E. Amies Oelschlager, MD, a pediatric and adolescent gynecologist at Seattle Children’s, Seattle, and a member of the American College of Obstetricians and Gynecologists (ACOG) clinical consensus committee on gynecology.

Official guidelines from ACOG call for the initial reproductive health visit to take place between the ages of 13 and 15 years. The exact age may vary, however, depending on the specific needs of the patient.

For example, some patients begin menstruating early, at age 9 or 10, said Mary Romano, MD, MPH, a pediatrician and adolescent medicine specialist at Vanderbilt Children’s Hospital, Nashville, Tenn. Pediatricians who are uncomfortable educating young patients about menstruation should refer the patient to a gynecologist or a pediatric gynecologist for whom such discussions are routine.

If a patient does not have a menstrual cycle by age 14 or 15, that also should be addressed by a family physician or gynecologist, Dr. Romano added.

“The importance here is addressing the reproductive health of the teen starting really at the age of 10 or 12, or once puberty starts,” said Patricia S. Huguelet, MD, a pediatric and adolescent gynecologist at Children’s Hospital Colorado, Aurora. In those early visits, the physician can provide “anticipatory guidance,” counseling the teen on what is normal in terms of menstruation, sex, and relationships, and addressing what is not, she said.

Ideally, patients who were designated female at birth but now identify as male or nonbinary will meet with a gynecologist early on in the gender affirmation process and a gynecologist will continue to consult as part of the patient’s interdisciplinary care team, added Dr. Romano, who counsels LGBTQ+ youth as part of her practice. A gynecologist may support these patients in myriad ways, including helping those who are considering or using puberty blockers and providing reproductive and health education to patients in a way that is sensitive to the patient’s gender identity.
 

Patient referrals

Some pediatricians and family practice physicians may be talking with their patients about topics such as menstrual cycles and contraception. But those who are uncomfortable asking adolescent patients about their reproductive and sexual health should refer them to a gynecologist or specialist in adolescent medicine, Dr. Romano advised.

“The biggest benefit I’ve noticed is often [patients] come from a pediatrician or family medicine provider and they often appreciate the opportunity to talk to a doctor they haven’t met before about the more personal questions they may have,” Dr. Amies Oelschlager said.

Referring adolescents to a specialist who has either trained in adolescent medicine or has experience treating that age group has benefits, Dr. Romano said. Clinicians with that experience understand adolescents are not “mini-adults” but have unique developmental and medical issues. How to counsel and educate them carries unique challenges, she said.

For example, heavy menstrual bleeding is a leading reason a patient – either an adult or an adolescent – presents to a gynecologist, Dr. Huguelet said. But the pathology differs vastly for those two age groups. For patients in their 30s and 40s, polyps and fibroids are common problems associated with heavy bleeding. Those conditions are rare in adolescents, whereas bleeding disorders are common, she said.

Most patients will continue to see their pediatricians and primary care providers for other issues. And in some areas, gynecologists can reinforce advice from pediatricians, such as encouraging patients to get the HPV vaccine, Dr. Amies Oelschlager said.
 

Common misconceptions

Primary care physicians can also dispel common misconceptions teens – and their parents – have about gynecology. Some parents may believe that certain methods of birth control cause cancer or infertility, have concerns about the HPV vaccine, or think hormonal therapies are harmful, Dr. Amies Oelschlager said. But the biggest misconception involves the infamous pelvic exam.

“Lots of patients assume that every time they go to the gynecologist they are going to have a pelvic exam,” she said. “When I say, ‘We don’t have to do that,’ they are so relieved.”

Guidelines have changed since the parents of today’s teens were going to the gynecologist for the first time. Many patients now do not need an initial Pap smear until age 25, following a recent guideline change by the American Cancer Society. (ACOG is considering adopting the same stance but still recommends screening start at 21.) “Most patients do not need an exam, even when it comes to sexual health and screening [for sexually transmitted infections], that can be done without an exam,” Dr. Huguelet said.
 

Confidentiality and comfort

On the other side of the referral, gynecologists should follow several best practices to treat adolescent patients. Arguably the most important part of the initial gynecologic visit is to give patients the option of one-on-one time with the physician with no parent in the room. During that time, the physician should make it clear that what they discuss is confidential and will not be shared with their parent or guardian, Dr. Huguelet said. Patients should also have the option of having a friend or another nonparent individual in the room with them during this one-on-one time with the physician, particularly if the patient does not feel comfortable discussing sensitive subjects completely on her own.

Adolescents receive better care, disclose more, and perceive they are getting better care when the process is confidential, Dr. Romano said. Confidentiality does have limits, however, which physicians should also make sure their patients understand, according to the ACOG guidelines for the initial reproductive visit. These limitations can vary by state depending on issues related to mandatory reporting, insurance billing, and legal requirements of patient notifications of specific services such as abortion.

The use of electronic medical records has raised additional challenges when it comes to communicating privately with adolescent patients, Dr. Amies Oelschlager said. In her practice, she tries to ensure the adolescent is the one with the login information for their records. If not, her office will have the patient’s cell number to text or call securely.

“We feel strongly adolescents should be able to access reproductive health care, mental health care, and care for substance abuse disorders without parental notification,” Dr. Amies Oelschlager said.

Telehealth visits can also be helpful for adolescents coming to gynecology for the first time. And taking the time to establish a rapport with patients at the start of the visit is key, Dr. Huguelet said. By directing questions to the adolescent patient rather than the parent, Dr. Huguelet said, the physician demonstrates that the teen’s treatment needs come first.

ACOG has guidelines on other steps gynecology practices, including those that see both adults and teens, can take to make their offices and visits adolescent-friendly. These steps include asking patients about their preferred names and pronouns at the start of the visit or as part of the initial intake form, training office staff to be comfortable with issues related to adolescent sexuality and gender and sexual diversity among patients, providing a place for teens to wait separately from obstetrics patients, and having age-appropriate literature on hand for adolescents to learn about reproductive health.

After that first reproductive health visit, gynecologists and primary care providers should partner to ensure the whole health of their patients is being addressed, Dr. Huguelet said.

“Collaboration is always going to better serve patients in any area,” said Dr. Romano, “and certainly this area is no different.”

Dr. Amies Oelschlager, Dr. Romano, and Dr. Huguelet have disclosed no relevant financial relationships.

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

For many adolescents, the first visit to a gynecologist can be intimidating. The prospect of meeting a new doctor who will ask prying, deeply personal questions about sex and menstruation is scary. And, in all likelihood, a parent, older sibling, or friend has warned them about the notorious pelvic exam.

The exact timing of when adolescent patients should start seeing a gynecologist varies based on when a patient starts puberty. Primary care physicians and pediatricians can help teens transition by referring patients to an adolescent-friendly practice and clearing up some of the misconceptions that surround the first gynecology visit. Gynecologists, on the other side of the referral, can help patients transition by guaranteeing confidentiality and creating a safe space for young patients.

This news organization interviewed three experts in adolescent health about when teens should start having their gynecological needs addressed and how their physicians can help them undergo that transition.
 

Age-appropriate care

“Most people get very limited information about their reproductive health,” said Anne-Marie E. Amies Oelschlager, MD, a pediatric and adolescent gynecologist at Seattle Children’s, Seattle, and a member of the American College of Obstetricians and Gynecologists (ACOG) clinical consensus committee on gynecology.

Official guidelines from ACOG call for the initial reproductive health visit to take place between the ages of 13 and 15 years. The exact age may vary, however, depending on the specific needs of the patient.

For example, some patients begin menstruating early, at age 9 or 10, said Mary Romano, MD, MPH, a pediatrician and adolescent medicine specialist at Vanderbilt Children’s Hospital, Nashville, Tenn. Pediatricians who are uncomfortable educating young patients about menstruation should refer the patient to a gynecologist or a pediatric gynecologist for whom such discussions are routine.

If a patient does not have a menstrual cycle by age 14 or 15, that also should be addressed by a family physician or gynecologist, Dr. Romano added.

“The importance here is addressing the reproductive health of the teen starting really at the age of 10 or 12, or once puberty starts,” said Patricia S. Huguelet, MD, a pediatric and adolescent gynecologist at Children’s Hospital Colorado, Aurora. In those early visits, the physician can provide “anticipatory guidance,” counseling the teen on what is normal in terms of menstruation, sex, and relationships, and addressing what is not, she said.

Ideally, patients who were designated female at birth but now identify as male or nonbinary will meet with a gynecologist early on in the gender affirmation process and a gynecologist will continue to consult as part of the patient’s interdisciplinary care team, added Dr. Romano, who counsels LGBTQ+ youth as part of her practice. A gynecologist may support these patients in myriad ways, including helping those who are considering or using puberty blockers and providing reproductive and health education to patients in a way that is sensitive to the patient’s gender identity.
 

Patient referrals

Some pediatricians and family practice physicians may be talking with their patients about topics such as menstrual cycles and contraception. But those who are uncomfortable asking adolescent patients about their reproductive and sexual health should refer them to a gynecologist or specialist in adolescent medicine, Dr. Romano advised.

“The biggest benefit I’ve noticed is often [patients] come from a pediatrician or family medicine provider and they often appreciate the opportunity to talk to a doctor they haven’t met before about the more personal questions they may have,” Dr. Amies Oelschlager said.

Referring adolescents to a specialist who has either trained in adolescent medicine or has experience treating that age group has benefits, Dr. Romano said. Clinicians with that experience understand adolescents are not “mini-adults” but have unique developmental and medical issues. How to counsel and educate them carries unique challenges, she said.

For example, heavy menstrual bleeding is a leading reason a patient – either an adult or an adolescent – presents to a gynecologist, Dr. Huguelet said. But the pathology differs vastly for those two age groups. For patients in their 30s and 40s, polyps and fibroids are common problems associated with heavy bleeding. Those conditions are rare in adolescents, whereas bleeding disorders are common, she said.

Most patients will continue to see their pediatricians and primary care providers for other issues. And in some areas, gynecologists can reinforce advice from pediatricians, such as encouraging patients to get the HPV vaccine, Dr. Amies Oelschlager said.
 

Common misconceptions

Primary care physicians can also dispel common misconceptions teens – and their parents – have about gynecology. Some parents may believe that certain methods of birth control cause cancer or infertility, have concerns about the HPV vaccine, or think hormonal therapies are harmful, Dr. Amies Oelschlager said. But the biggest misconception involves the infamous pelvic exam.

“Lots of patients assume that every time they go to the gynecologist they are going to have a pelvic exam,” she said. “When I say, ‘We don’t have to do that,’ they are so relieved.”

Guidelines have changed since the parents of today’s teens were going to the gynecologist for the first time. Many patients now do not need an initial Pap smear until age 25, following a recent guideline change by the American Cancer Society. (ACOG is considering adopting the same stance but still recommends screening start at 21.) “Most patients do not need an exam, even when it comes to sexual health and screening [for sexually transmitted infections], that can be done without an exam,” Dr. Huguelet said.
 

Confidentiality and comfort

On the other side of the referral, gynecologists should follow several best practices to treat adolescent patients. Arguably the most important part of the initial gynecologic visit is to give patients the option of one-on-one time with the physician with no parent in the room. During that time, the physician should make it clear that what they discuss is confidential and will not be shared with their parent or guardian, Dr. Huguelet said. Patients should also have the option of having a friend or another nonparent individual in the room with them during this one-on-one time with the physician, particularly if the patient does not feel comfortable discussing sensitive subjects completely on her own.

Adolescents receive better care, disclose more, and perceive they are getting better care when the process is confidential, Dr. Romano said. Confidentiality does have limits, however, which physicians should also make sure their patients understand, according to the ACOG guidelines for the initial reproductive visit. These limitations can vary by state depending on issues related to mandatory reporting, insurance billing, and legal requirements of patient notifications of specific services such as abortion.

The use of electronic medical records has raised additional challenges when it comes to communicating privately with adolescent patients, Dr. Amies Oelschlager said. In her practice, she tries to ensure the adolescent is the one with the login information for their records. If not, her office will have the patient’s cell number to text or call securely.

“We feel strongly adolescents should be able to access reproductive health care, mental health care, and care for substance abuse disorders without parental notification,” Dr. Amies Oelschlager said.

Telehealth visits can also be helpful for adolescents coming to gynecology for the first time. And taking the time to establish a rapport with patients at the start of the visit is key, Dr. Huguelet said. By directing questions to the adolescent patient rather than the parent, Dr. Huguelet said, the physician demonstrates that the teen’s treatment needs come first.

ACOG has guidelines on other steps gynecology practices, including those that see both adults and teens, can take to make their offices and visits adolescent-friendly. These steps include asking patients about their preferred names and pronouns at the start of the visit or as part of the initial intake form, training office staff to be comfortable with issues related to adolescent sexuality and gender and sexual diversity among patients, providing a place for teens to wait separately from obstetrics patients, and having age-appropriate literature on hand for adolescents to learn about reproductive health.

After that first reproductive health visit, gynecologists and primary care providers should partner to ensure the whole health of their patients is being addressed, Dr. Huguelet said.

“Collaboration is always going to better serve patients in any area,” said Dr. Romano, “and certainly this area is no different.”

Dr. Amies Oelschlager, Dr. Romano, and Dr. Huguelet have disclosed no relevant financial relationships.

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

The nation’s Surgeon General, Vice Admiral Vivek H. Murthy, MD, MBA, recently released an advisory report on the current state of youth mental health and recommendations to improve well-being. This action follows a number of emergency declarations that have been made by professional organizations such as the American Academy of Child and Adolescent Psychiatry (AACAP), the American Academy of Pediatrics (AAP), and other health care groups to raise awareness about the alarming increase of depression, suicide, anxiety, and other mental health problems in youth.

These reports can be helpful in focusing attention and resources for important public health problems. Many still reference the 1999 report from former Surgeon General David Satcher, MD, PhD, which offered a number of eye-opening statistics regarding the prevalence of mental health conditions and the amount of disability associated with them.

Sadly, the present report indicates that many of these indices have grown worse in the past 20 years. For example, the advisory notes that, even before COVID-19, fully half of female high school students reported persistent feelings of sadness or hopelessness (up 40% from 2009). The report then goes on to cite a number of studies documenting even further rises in youth mental health problems associated with the pandemic.

Most of the advisory, however, is devoted to actions that can be taken by different groups, including young people themselves, parents, educators, the government, and even social media and video game companies, to support mental health and well-being. Multiple online resources are provided at the end of each of these sections.

One of the segments is aimed at health care organizations and professionals. While first making a fairly sweeping statement that “our health care system today is not set up optimally to support the mental health and well-being of children and youth,” this part then outlines five broad recommendations that might help improve the fit. These include the following.

• Increase prevention efforts, such as coordination to enrichment programs and referrals for economic and legal supports for families in need.
• Screen routinely for mental health conditions and link those who screen in with appropriate care.
• Identify mental health needs in parents and caregivers such as depression and substance use that can have negative effects on children.
• Increase partnerships between health care groups and community organizations.
• Build multidisciplinary teams that are culturally appropriate and maximally engage children and caretakers in the decision-making process.

The current report is downloadable for free (see reference below) and it is certainly worthwhile for pediatricians to take a look. Dr. Murthy writes, regarding the current state of mental health, that “it would be a tragedy if we beat back one public health crisis only to allow another to grow in its place.”

The report also outlines specific areas where additional research is needed, such as data on racial and sexual minorities and research on innovative and scalable therapies. In addition to the online resources that are provided, the report is backed by over 250 references.

Since its release, the report has generally been well received, and, indeed, there is much to support. The well-known Child Mind Institute in New York tweeted that “this document is a wake-up call for the country and a long-overdue statement of leadership from the federal government.”

Many of the recommendations are admittedly somewhat commons sense, but there are some that are much less so. For example, one recommendation to youth themselves is to serve others – something that may first come across as counterintuitive but can indeed help children and adolescents develop a sense of purpose and self-worth. The call for pediatric health care professionals to screen parents in addition to the patients themselves will likely result in some debate as well. The recommendation to reduce access to lethal means, including the specific naming of firearms, is also a welcome addition. This report also rightly puts a spotlight on the role of societal factors such as racism and poverty in the development of mental health problems and in getting access to quality treatment.

Also worth noting is how much of the advisory examined the role of media in both the problem and the solution. While recognizing that technology, smartphones, and social media are here to stay, a number of suggestions were given to parents, media organizations, journalists, and entertainment companies to reduce the negative impacts these mediums can have. Explicitly recognized in the report is that “there can be tension between what’s best for the technology company and what’s best for the individual user or society.” Also acknowledged was that the link between media of various types and mental health is complex and inconsistent with there being a strong need for additional work in this area when it comes to academic research as well as product development within these companies themselves.

Yet while there is much to like about the advisory, there remain some areas that seem lacking. For example, the text about what causes mental health conditions gets a little dualistic in mentioning biological and environmental factors without much appreciation that these are hardly independent domains. Perhaps more substantially, there was surprisingly little airtime devoted to an enormous issue that underlies so many other challenges related to mental health care – namely an inadequate workforce that gets smaller by the minute. The topic was treated much too superficially with lots of vague calls to “expand” the workforce that lacked substance or detail.

Overall, however, the new Surgeon General’s Advisory is a welcome document that offers updated knowledge of our current challenges and provides practical responses that truly could make a difference. Now all we have to do is put these recommendations into action.

Dr. Rettew is a child and adolescent psychiatrist and medical director of Lane County Behavioral Health in Eugene, Ore. His latest book is “Parenting Made Complicated: What Science Really Knows About the Greatest Debates of Early Childhood.” You can follow him on Twitter and Facebook @PediPsych.

Reference

“Protecting Youth Mental Health – The U.S. Surgeon General’s Advisory,” U.S. Department of Health & Human Services (2021).

The nation’s Surgeon General, Vice Admiral Vivek H. Murthy, MD, MBA, recently released an advisory report on the current state of youth mental health and recommendations to improve well-being. This action follows a number of emergency declarations that have been made by professional organizations such as the American Academy of Child and Adolescent Psychiatry (AACAP), the American Academy of Pediatrics (AAP), and other health care groups to raise awareness about the alarming increase of depression, suicide, anxiety, and other mental health problems in youth.

These reports can be helpful in focusing attention and resources for important public health problems. Many still reference the 1999 report from former Surgeon General David Satcher, MD, PhD, which offered a number of eye-opening statistics regarding the prevalence of mental health conditions and the amount of disability associated with them.

Sadly, the present report indicates that many of these indices have grown worse in the past 20 years. For example, the advisory notes that, even before COVID-19, fully half of female high school students reported persistent feelings of sadness or hopelessness (up 40% from 2009). The report then goes on to cite a number of studies documenting even further rises in youth mental health problems associated with the pandemic.

Most of the advisory, however, is devoted to actions that can be taken by different groups, including young people themselves, parents, educators, the government, and even social media and video game companies, to support mental health and well-being. Multiple online resources are provided at the end of each of these sections.

One of the segments is aimed at health care organizations and professionals. While first making a fairly sweeping statement that “our health care system today is not set up optimally to support the mental health and well-being of children and youth,” this part then outlines five broad recommendations that might help improve the fit. These include the following.

• Increase prevention efforts, such as coordination to enrichment programs and referrals for economic and legal supports for families in need.
• Screen routinely for mental health conditions and link those who screen in with appropriate care.
• Identify mental health needs in parents and caregivers such as depression and substance use that can have negative effects on children.
• Increase partnerships between health care groups and community organizations.
• Build multidisciplinary teams that are culturally appropriate and maximally engage children and caretakers in the decision-making process.

The current report is downloadable for free (see reference below) and it is certainly worthwhile for pediatricians to take a look. Dr. Murthy writes, regarding the current state of mental health, that “it would be a tragedy if we beat back one public health crisis only to allow another to grow in its place.”

The report also outlines specific areas where additional research is needed, such as data on racial and sexual minorities and research on innovative and scalable therapies. In addition to the online resources that are provided, the report is backed by over 250 references.

Since its release, the report has generally been well received, and, indeed, there is much to support. The well-known Child Mind Institute in New York tweeted that “this document is a wake-up call for the country and a long-overdue statement of leadership from the federal government.”

Many of the recommendations are admittedly somewhat commons sense, but there are some that are much less so. For example, one recommendation to youth themselves is to serve others – something that may first come across as counterintuitive but can indeed help children and adolescents develop a sense of purpose and self-worth. The call for pediatric health care professionals to screen parents in addition to the patients themselves will likely result in some debate as well. The recommendation to reduce access to lethal means, including the specific naming of firearms, is also a welcome addition. This report also rightly puts a spotlight on the role of societal factors such as racism and poverty in the development of mental health problems and in getting access to quality treatment.

Also worth noting is how much of the advisory examined the role of media in both the problem and the solution. While recognizing that technology, smartphones, and social media are here to stay, a number of suggestions were given to parents, media organizations, journalists, and entertainment companies to reduce the negative impacts these mediums can have. Explicitly recognized in the report is that “there can be tension between what’s best for the technology company and what’s best for the individual user or society.” Also acknowledged was that the link between media of various types and mental health is complex and inconsistent with there being a strong need for additional work in this area when it comes to academic research as well as product development within these companies themselves.

Yet while there is much to like about the advisory, there remain some areas that seem lacking. For example, the text about what causes mental health conditions gets a little dualistic in mentioning biological and environmental factors without much appreciation that these are hardly independent domains. Perhaps more substantially, there was surprisingly little airtime devoted to an enormous issue that underlies so many other challenges related to mental health care – namely an inadequate workforce that gets smaller by the minute. The topic was treated much too superficially with lots of vague calls to “expand” the workforce that lacked substance or detail.

Overall, however, the new Surgeon General’s Advisory is a welcome document that offers updated knowledge of our current challenges and provides practical responses that truly could make a difference. Now all we have to do is put these recommendations into action.

Dr. Rettew is a child and adolescent psychiatrist and medical director of Lane County Behavioral Health in Eugene, Ore. His latest book is “Parenting Made Complicated: What Science Really Knows About the Greatest Debates of Early Childhood.” You can follow him on Twitter and Facebook @PediPsych.

Reference

“Protecting Youth Mental Health – The U.S. Surgeon General’s Advisory,” U.S. Department of Health & Human Services (2021).

The nation’s Surgeon General, Vice Admiral Vivek H. Murthy, MD, MBA, recently released an advisory report on the current state of youth mental health and recommendations to improve well-being. This action follows a number of emergency declarations that have been made by professional organizations such as the American Academy of Child and Adolescent Psychiatry (AACAP), the American Academy of Pediatrics (AAP), and other health care groups to raise awareness about the alarming increase of depression, suicide, anxiety, and other mental health problems in youth.

These reports can be helpful in focusing attention and resources for important public health problems. Many still reference the 1999 report from former Surgeon General David Satcher, MD, PhD, which offered a number of eye-opening statistics regarding the prevalence of mental health conditions and the amount of disability associated with them.

Sadly, the present report indicates that many of these indices have grown worse in the past 20 years. For example, the advisory notes that, even before COVID-19, fully half of female high school students reported persistent feelings of sadness or hopelessness (up 40% from 2009). The report then goes on to cite a number of studies documenting even further rises in youth mental health problems associated with the pandemic.

Most of the advisory, however, is devoted to actions that can be taken by different groups, including young people themselves, parents, educators, the government, and even social media and video game companies, to support mental health and well-being. Multiple online resources are provided at the end of each of these sections.

One of the segments is aimed at health care organizations and professionals. While first making a fairly sweeping statement that “our health care system today is not set up optimally to support the mental health and well-being of children and youth,” this part then outlines five broad recommendations that might help improve the fit. These include the following.

• Increase prevention efforts, such as coordination to enrichment programs and referrals for economic and legal supports for families in need.
• Screen routinely for mental health conditions and link those who screen in with appropriate care.
• Identify mental health needs in parents and caregivers such as depression and substance use that can have negative effects on children.
• Increase partnerships between health care groups and community organizations.
• Build multidisciplinary teams that are culturally appropriate and maximally engage children and caretakers in the decision-making process.

The current report is downloadable for free (see reference below) and it is certainly worthwhile for pediatricians to take a look. Dr. Murthy writes, regarding the current state of mental health, that “it would be a tragedy if we beat back one public health crisis only to allow another to grow in its place.”

The report also outlines specific areas where additional research is needed, such as data on racial and sexual minorities and research on innovative and scalable therapies. In addition to the online resources that are provided, the report is backed by over 250 references.

Since its release, the report has generally been well received, and, indeed, there is much to support. The well-known Child Mind Institute in New York tweeted that “this document is a wake-up call for the country and a long-overdue statement of leadership from the federal government.”

Many of the recommendations are admittedly somewhat commons sense, but there are some that are much less so. For example, one recommendation to youth themselves is to serve others – something that may first come across as counterintuitive but can indeed help children and adolescents develop a sense of purpose and self-worth. The call for pediatric health care professionals to screen parents in addition to the patients themselves will likely result in some debate as well. The recommendation to reduce access to lethal means, including the specific naming of firearms, is also a welcome addition. This report also rightly puts a spotlight on the role of societal factors such as racism and poverty in the development of mental health problems and in getting access to quality treatment.

Also worth noting is how much of the advisory examined the role of media in both the problem and the solution. While recognizing that technology, smartphones, and social media are here to stay, a number of suggestions were given to parents, media organizations, journalists, and entertainment companies to reduce the negative impacts these mediums can have. Explicitly recognized in the report is that “there can be tension between what’s best for the technology company and what’s best for the individual user or society.” Also acknowledged was that the link between media of various types and mental health is complex and inconsistent with there being a strong need for additional work in this area when it comes to academic research as well as product development within these companies themselves.

Yet while there is much to like about the advisory, there remain some areas that seem lacking. For example, the text about what causes mental health conditions gets a little dualistic in mentioning biological and environmental factors without much appreciation that these are hardly independent domains. Perhaps more substantially, there was surprisingly little airtime devoted to an enormous issue that underlies so many other challenges related to mental health care – namely an inadequate workforce that gets smaller by the minute. The topic was treated much too superficially with lots of vague calls to “expand” the workforce that lacked substance or detail.

Overall, however, the new Surgeon General’s Advisory is a welcome document that offers updated knowledge of our current challenges and provides practical responses that truly could make a difference. Now all we have to do is put these recommendations into action.

Dr. Rettew is a child and adolescent psychiatrist and medical director of Lane County Behavioral Health in Eugene, Ore. His latest book is “Parenting Made Complicated: What Science Really Knows About the Greatest Debates of Early Childhood.” You can follow him on Twitter and Facebook @PediPsych.

Reference

“Protecting Youth Mental Health – The U.S. Surgeon General’s Advisory,” U.S. Department of Health & Human Services (2021).

Children with peanut allergies treated with peanut oral immunotherapy for 3 years can tolerate increasingly higher exposures to peanuts. But avoidance of peanut-protein exposure for just a single month after the treatment leads to rapid and substantial decreases in tolerance, findings from a small study show.

The findings “underscore the fact that the desensitization achieved with peanut oral immunotherapy is a transient immune state,” report the authors of the study, published in December in The Journal of Allergy and Clinical Immunology: In Practice.

Therefore, “adherence to dosing [in peanut immunotherapy] is very important, and clinicians should expect a decline in tolerance with lapse in dosing,” first author Carla M. Davis, MD, director of the Texas Children’s Hospital Food Allergy Program at Baylor College of Medicine, Houston, told this news organization.

Oral immunotherapy, involving small exposures to peanut protein to build up desensitization, has been shown to mitigate allergic reactions, and, as reported by this news organization, the first peanut oral immunotherapy drug recently received approval from the U.S. Food and Drug Administration.

However, current approaches involve very low daily exposure of about 300 mg of peanut protein, equivalent to only about one to two peanuts, and research is lacking regarding the maximum tolerated doses, as well as on how long the tolerance is sustained if maintenance therapy is discontinued. “For the peanut-allergic population that would like to eat more than 1-2 peanuts, an achievable dose is currently unknown,” the study authors write. “The critical question, of the maximum tolerated dose achieved after POIT, has not been answered.”

To evaluate those issues in their phase 2 study, Dr. Davis and her colleagues enrolled 28 subjects between the ages of 5 and 13 with a diagnosis of eosinophilic esophagitis and peanut allergy.

The treatment protocol included a 1-year buildup phase of oral immunotherapy, followed by a 2-year daily maintenance phase with a dose of 3,900 mg of peanut protein.

After consenting, 11 patients dropped out of the study due to a lack of interest, and two more withdrew after failing to tolerate their first dose, leaving 15 who started treatment in the study, with a mean age of 8.7 years (range, 5.2-12.5 years), and 47% female.

Twelve patients reached the maintenance dose of 3,900 mg over a median of 13 months, and double-blind, placebo-controlled peanut challenges showed that, on average, their mean maximum cumulative tolerated dose after 12 months increased by 12,063 mg (P < .001), and the mean dose triggering a reaction increased by 15,667 mg.

Of the 12 patients, 11 (91.7%) were able to successfully tolerate at least 10,725 mg after 12 months of treatment, and six patients (50.0%) successfully tolerated at least 15,225 mg.

Two patients were able to tolerate up to the maximum cumulative target dose of 26,225 mg, equivalent to more than 105 peanuts.

“The ability to tolerate [greater than] 100 peanuts following peanut oral immunotherapy has never before been demonstrated and gives insight into the potential for food oral immunotherapy to be utilized in a subset of patients who have an immunologic phenotype accepting of this therapy,” the authors write.

“Understanding the risk of ingestion of peanut protein higher than the prescribed peanut oral immunotherapy maintenance dose will improve the safe, practical use of [the therapy],” they add.
 

Tolerance plummets with avoidance

In the protocol’s third phase, after the 3-year buildup and maintenance therapy, daily peanut exposure was avoided for 30 days, and among the six patients who participated, the mean maximum cumulative tolerated dose declined to just 2,783 mg, and the reaction dose dropped to 4,614 mg (P = .03).

“This was a disappointing finding, because we thought the desensitization would last longer after such a long period of treatment,” Dr. Davis said.

While the avoidance period was only a month, Dr. Davis said she expects the rebound in sensitivity would continue if avoidance was prolonged. “Other studies indicate the decline in tolerance would continue over time, [and] we believe it would continue to decline,” she said.

Further analysis of peanut allergy biomarkers showed significant decreases in skin prick test wheal size and cytokine expression within the first 6 weeks of initiation of the peanut oral immunotherapy. The patterns were reversed during the 1-month avoidance, with both measures increasing.

Of note, the changes in biomarkers varied significantly among the participants.

In terms of adverse events, eight patients (53%) required one or two doses of epinephrine during the study, with all but two patients receiving the epinephrine during the 12-month buildup phase, consistent with previous studies.

In commenting on the study, Richard L. Wasserman, MD, PhD, medical director of pediatric allergy and immunology at Medical City Children’s Hospital, Dallas, noted that the findings pertain to the subset of peanut oral immunotherapy patients (about 30%) who want to be able to eat peanuts.

“Most families just want protection against accidental ingestion, and these observations don’t relate to those patients,” he said in an interview.

Dr. Wasserman noted that his approach with patients is to wait until 3 years of daily maintenance after buildup (as opposed to 2 years in the study) before considering an avoidance challenge.

“When our patients pass a sustained unresponsiveness challenge, we recommend continued exposure of 2,000 mg at least weekly,” he explained.

Dr. Wasserman added that the study’s findings on biomarker changes were notable.

“The eventual reduction in peanut serum IgE in all of their patients is very interesting,” he said. “Many of our patients’ peanut serum IgE plateaus after 2 or 3 years.”

And he added, “This report suggests that we should be making patients aware that they may further decrease their peanut serum IgE by increasing their maintenance dose.”

The study was funded by the Scurlock Foundation/Waring Family Foundation and the Texas Children’s Hospital food allergy program. Dr. Davis is a consultant for Aimmune, DBV, and Moonlight Therapeutics. Dr. Wasserman is a consultant for Aimmune and DBV.

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

Children with peanut allergies treated with peanut oral immunotherapy for 3 years can tolerate increasingly higher exposures to peanuts. But avoidance of peanut-protein exposure for just a single month after the treatment leads to rapid and substantial decreases in tolerance, findings from a small study show.

The findings “underscore the fact that the desensitization achieved with peanut oral immunotherapy is a transient immune state,” report the authors of the study, published in December in The Journal of Allergy and Clinical Immunology: In Practice.

Therefore, “adherence to dosing [in peanut immunotherapy] is very important, and clinicians should expect a decline in tolerance with lapse in dosing,” first author Carla M. Davis, MD, director of the Texas Children’s Hospital Food Allergy Program at Baylor College of Medicine, Houston, told this news organization.

Oral immunotherapy, involving small exposures to peanut protein to build up desensitization, has been shown to mitigate allergic reactions, and, as reported by this news organization, the first peanut oral immunotherapy drug recently received approval from the U.S. Food and Drug Administration.

However, current approaches involve very low daily exposure of about 300 mg of peanut protein, equivalent to only about one to two peanuts, and research is lacking regarding the maximum tolerated doses, as well as on how long the tolerance is sustained if maintenance therapy is discontinued. “For the peanut-allergic population that would like to eat more than 1-2 peanuts, an achievable dose is currently unknown,” the study authors write. “The critical question, of the maximum tolerated dose achieved after POIT, has not been answered.”

To evaluate those issues in their phase 2 study, Dr. Davis and her colleagues enrolled 28 subjects between the ages of 5 and 13 with a diagnosis of eosinophilic esophagitis and peanut allergy.

The treatment protocol included a 1-year buildup phase of oral immunotherapy, followed by a 2-year daily maintenance phase with a dose of 3,900 mg of peanut protein.

After consenting, 11 patients dropped out of the study due to a lack of interest, and two more withdrew after failing to tolerate their first dose, leaving 15 who started treatment in the study, with a mean age of 8.7 years (range, 5.2-12.5 years), and 47% female.

Twelve patients reached the maintenance dose of 3,900 mg over a median of 13 months, and double-blind, placebo-controlled peanut challenges showed that, on average, their mean maximum cumulative tolerated dose after 12 months increased by 12,063 mg (P < .001), and the mean dose triggering a reaction increased by 15,667 mg.

Of the 12 patients, 11 (91.7%) were able to successfully tolerate at least 10,725 mg after 12 months of treatment, and six patients (50.0%) successfully tolerated at least 15,225 mg.

Two patients were able to tolerate up to the maximum cumulative target dose of 26,225 mg, equivalent to more than 105 peanuts.

“The ability to tolerate [greater than] 100 peanuts following peanut oral immunotherapy has never before been demonstrated and gives insight into the potential for food oral immunotherapy to be utilized in a subset of patients who have an immunologic phenotype accepting of this therapy,” the authors write.

“Understanding the risk of ingestion of peanut protein higher than the prescribed peanut oral immunotherapy maintenance dose will improve the safe, practical use of [the therapy],” they add.
 

Tolerance plummets with avoidance

In the protocol’s third phase, after the 3-year buildup and maintenance therapy, daily peanut exposure was avoided for 30 days, and among the six patients who participated, the mean maximum cumulative tolerated dose declined to just 2,783 mg, and the reaction dose dropped to 4,614 mg (P = .03).

“This was a disappointing finding, because we thought the desensitization would last longer after such a long period of treatment,” Dr. Davis said.

While the avoidance period was only a month, Dr. Davis said she expects the rebound in sensitivity would continue if avoidance was prolonged. “Other studies indicate the decline in tolerance would continue over time, [and] we believe it would continue to decline,” she said.

Further analysis of peanut allergy biomarkers showed significant decreases in skin prick test wheal size and cytokine expression within the first 6 weeks of initiation of the peanut oral immunotherapy. The patterns were reversed during the 1-month avoidance, with both measures increasing.

Of note, the changes in biomarkers varied significantly among the participants.

In terms of adverse events, eight patients (53%) required one or two doses of epinephrine during the study, with all but two patients receiving the epinephrine during the 12-month buildup phase, consistent with previous studies.

In commenting on the study, Richard L. Wasserman, MD, PhD, medical director of pediatric allergy and immunology at Medical City Children’s Hospital, Dallas, noted that the findings pertain to the subset of peanut oral immunotherapy patients (about 30%) who want to be able to eat peanuts.

“Most families just want protection against accidental ingestion, and these observations don’t relate to those patients,” he said in an interview.

Dr. Wasserman noted that his approach with patients is to wait until 3 years of daily maintenance after buildup (as opposed to 2 years in the study) before considering an avoidance challenge.

“When our patients pass a sustained unresponsiveness challenge, we recommend continued exposure of 2,000 mg at least weekly,” he explained.

Dr. Wasserman added that the study’s findings on biomarker changes were notable.

“The eventual reduction in peanut serum IgE in all of their patients is very interesting,” he said. “Many of our patients’ peanut serum IgE plateaus after 2 or 3 years.”

And he added, “This report suggests that we should be making patients aware that they may further decrease their peanut serum IgE by increasing their maintenance dose.”

The study was funded by the Scurlock Foundation/Waring Family Foundation and the Texas Children’s Hospital food allergy program. Dr. Davis is a consultant for Aimmune, DBV, and Moonlight Therapeutics. Dr. Wasserman is a consultant for Aimmune and DBV.

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

Children with peanut allergies treated with peanut oral immunotherapy for 3 years can tolerate increasingly higher exposures to peanuts. But avoidance of peanut-protein exposure for just a single month after the treatment leads to rapid and substantial decreases in tolerance, findings from a small study show.

The findings “underscore the fact that the desensitization achieved with peanut oral immunotherapy is a transient immune state,” report the authors of the study, published in December in The Journal of Allergy and Clinical Immunology: In Practice.

Therefore, “adherence to dosing [in peanut immunotherapy] is very important, and clinicians should expect a decline in tolerance with lapse in dosing,” first author Carla M. Davis, MD, director of the Texas Children’s Hospital Food Allergy Program at Baylor College of Medicine, Houston, told this news organization.

Oral immunotherapy, involving small exposures to peanut protein to build up desensitization, has been shown to mitigate allergic reactions, and, as reported by this news organization, the first peanut oral immunotherapy drug recently received approval from the U.S. Food and Drug Administration.

However, current approaches involve very low daily exposure of about 300 mg of peanut protein, equivalent to only about one to two peanuts, and research is lacking regarding the maximum tolerated doses, as well as on how long the tolerance is sustained if maintenance therapy is discontinued. “For the peanut-allergic population that would like to eat more than 1-2 peanuts, an achievable dose is currently unknown,” the study authors write. “The critical question, of the maximum tolerated dose achieved after POIT, has not been answered.”

To evaluate those issues in their phase 2 study, Dr. Davis and her colleagues enrolled 28 subjects between the ages of 5 and 13 with a diagnosis of eosinophilic esophagitis and peanut allergy.

The treatment protocol included a 1-year buildup phase of oral immunotherapy, followed by a 2-year daily maintenance phase with a dose of 3,900 mg of peanut protein.

After consenting, 11 patients dropped out of the study due to a lack of interest, and two more withdrew after failing to tolerate their first dose, leaving 15 who started treatment in the study, with a mean age of 8.7 years (range, 5.2-12.5 years), and 47% female.

Twelve patients reached the maintenance dose of 3,900 mg over a median of 13 months, and double-blind, placebo-controlled peanut challenges showed that, on average, their mean maximum cumulative tolerated dose after 12 months increased by 12,063 mg (P < .001), and the mean dose triggering a reaction increased by 15,667 mg.

Of the 12 patients, 11 (91.7%) were able to successfully tolerate at least 10,725 mg after 12 months of treatment, and six patients (50.0%) successfully tolerated at least 15,225 mg.

Two patients were able to tolerate up to the maximum cumulative target dose of 26,225 mg, equivalent to more than 105 peanuts.

“The ability to tolerate [greater than] 100 peanuts following peanut oral immunotherapy has never before been demonstrated and gives insight into the potential for food oral immunotherapy to be utilized in a subset of patients who have an immunologic phenotype accepting of this therapy,” the authors write.

“Understanding the risk of ingestion of peanut protein higher than the prescribed peanut oral immunotherapy maintenance dose will improve the safe, practical use of [the therapy],” they add.
 

Tolerance plummets with avoidance

In the protocol’s third phase, after the 3-year buildup and maintenance therapy, daily peanut exposure was avoided for 30 days, and among the six patients who participated, the mean maximum cumulative tolerated dose declined to just 2,783 mg, and the reaction dose dropped to 4,614 mg (P = .03).

“This was a disappointing finding, because we thought the desensitization would last longer after such a long period of treatment,” Dr. Davis said.

While the avoidance period was only a month, Dr. Davis said she expects the rebound in sensitivity would continue if avoidance was prolonged. “Other studies indicate the decline in tolerance would continue over time, [and] we believe it would continue to decline,” she said.

Further analysis of peanut allergy biomarkers showed significant decreases in skin prick test wheal size and cytokine expression within the first 6 weeks of initiation of the peanut oral immunotherapy. The patterns were reversed during the 1-month avoidance, with both measures increasing.

Of note, the changes in biomarkers varied significantly among the participants.

In terms of adverse events, eight patients (53%) required one or two doses of epinephrine during the study, with all but two patients receiving the epinephrine during the 12-month buildup phase, consistent with previous studies.

In commenting on the study, Richard L. Wasserman, MD, PhD, medical director of pediatric allergy and immunology at Medical City Children’s Hospital, Dallas, noted that the findings pertain to the subset of peanut oral immunotherapy patients (about 30%) who want to be able to eat peanuts.

“Most families just want protection against accidental ingestion, and these observations don’t relate to those patients,” he said in an interview.

Dr. Wasserman noted that his approach with patients is to wait until 3 years of daily maintenance after buildup (as opposed to 2 years in the study) before considering an avoidance challenge.

“When our patients pass a sustained unresponsiveness challenge, we recommend continued exposure of 2,000 mg at least weekly,” he explained.

Dr. Wasserman added that the study’s findings on biomarker changes were notable.

“The eventual reduction in peanut serum IgE in all of their patients is very interesting,” he said. “Many of our patients’ peanut serum IgE plateaus after 2 or 3 years.”

And he added, “This report suggests that we should be making patients aware that they may further decrease their peanut serum IgE by increasing their maintenance dose.”

The study was funded by the Scurlock Foundation/Waring Family Foundation and the Texas Children’s Hospital food allergy program. Dr. Davis is a consultant for Aimmune, DBV, and Moonlight Therapeutics. Dr. Wasserman is a consultant for Aimmune and DBV.

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

Maria Trent, MD, MPH, was studying ways clinicians can leverage technology to care for adolescents years before COVID-19 exposed the challenges and advantages of telehealth.

Dr. Trent, a pediatrician and adolescent medicine specialist and professor of pediatrics at Johns Hopkins University, Baltimore, has long believed that the phones in her patients’ pockets have the potential to improve the sexual health of youth. The pandemic has only made that view stronger.

“They’re a generation that’s really wired and online,” Dr. Trent told this news organization. “I think that we can meet them in that space.”

Her research has incorporated texting, apps, and videos. Out of necessity, technology increasingly became part of patient care during the pandemic. “We had to stretch our ability to do some basic triage and assessments of patients online,” Dr. Trent said.

Even when clinics are closed, doctors might be able to provide initial care remotely, such as writing prescriptions to manage symptoms or directing patients to a lab for testing.

Telemedicine could allow a clinician to guide a teenager who thinks they might be pregnant to take a store-bought test and avoid possible exposure to COVID-19 in the ED, for instance.

But doctors have concerns about the legal and practical limits of privacy and confidentiality. Who else is at home listening to a phone conversation? Are parents accessing the patient’s online portal? Will parents receive an explanation of benefits that lists testing for a sexually transmitted infection, or see a testing kit that is delivered to their home?

When a young patient needs in-person care, transportation can be a barrier. And then there’s the matter of clinicians being able to bill for telehealth services.

Practices are learning how to navigate these issues, and relevant laws vary by state.

“I think this is going to become part of standard practice,” Dr. Trent said. “I think we have to do the hard work to make sure that it’s safe, that it’s accessible, and that it is actually improving care.”
 

Texts, apps, videos

In one early study, Dr. Trent and colleagues found that showing adolescents with pelvic inflammatory disease a 6-minute video may improve treatment rates for their sexual partners.

Another study provided preliminary evidence that text messaging support might improve clinic attendance for moderately long-acting reversible contraception.

A third trial showed that adolescents and young adults with pelvic inflammatory disease who were randomly assigned to receive text-message prompts to take their medications and provide information about the doses they consumed had greater decreases in Neisseria gonorrhoeae and Chlamydia trachomatis infections, compared with patients who received standard care.

Dr. Trent and coinvestigators are assessing a technology-based intervention for youth with HIV, in which patients can use an app to submit videos of themselves taking antiretroviral therapy and report any side effects. The technology provides a way to monitor patients remotely and support them between visits, she said.
 

Will pandemic-driven options remain?

In 2020, Laura D. Lindberg, PhD, principal research scientist at the Guttmacher Institute in New York, and coauthors discussed the possible ramifications of the pandemic on the sexual and reproductive health of adolescents and young adults.

If telemedicine options driven by COVID-19 are here to stay, adolescents and young adults could be “the age group most likely to continue that approach rather than returning to traditional in-person visits,” the researchers wrote. “Innovations in health care service provision, such as use of telemedicine and obtaining contraceptives and STI testing by mail, will help expand access to [sexual and reproductive health] care for young people.”

At the 2021 annual conference of the American Academy of Pediatrics, Dr. Trent described telehealth as a viable way to provide sexual and reproductive health care to adolescents and young adults, including anticipatory guidance, contraception counseling, coordination of follow-up care and testing, and connecting patients to resources.

Her presentation cited several websites that can help patients receive testing for STIs, including Yes Means Test, the Centers for Disease Control and Prevention’s GetTested page, and I Want the Kit. Planned Parenthood has telehealth options, and the Kaiser Family Foundation compiled information about 26 online platforms that were providing contraception or STI services.
 

Who else is in the room?

“There’s only so much time in the day and so many patients you can see, regardless of whether you have telehealth or not,” said David L. Bell, MD, MPH, president of the Society for Adolescent Health and Medicine and a coauthor of the Perspectives on Sexual and Reproductive Health paper. In addition, “you never know who else is in the room” with the patient on the other end, added Dr. Bell, a professor of population and family health and pediatrics at the Columbia University Medical Center and medical director of the Young Men’s Clinic, both in New York.

In some respects, young patients may not be able to participate in telehealth visits the same way they would in a medical office, Dr. Trent acknowledged. Encouraging the use of headphones is one way to help protect confidentiality when talking with patients who are at home and might not be alone.

But if patients are able to find a private space for remote visits, they might be more open than usual. In that way, telemedicine could provide additional opportunities to address issues like substance use disorders and mental health, as well, she said.

“Then, if they need something, we have to problem solve,” Dr. Trent said. Next steps may involve engaging a parent or getting the patient to a lab or the clinic.
 

Sex ed may be lacking

The Perspectives article also raised concerns that the pandemic might exacerbate shortcomings in sex education, which already may have been lacking.

“Before the pandemic, schools were a key source of formal sex education for young people,” the authors wrote. “Sex education, which was already limited in many areas of the country, has likely not been included in the national shift to online learning. Even when in-person schooling resumes, missed sex education instruction is unlikely to be made up, given the modest attention it received prior to the pandemic.”

A recently published study in the Journal of Adolescent Health indicates that American teenagers currently receive less formal sex education than they did 25 years ago, with “troubling” inequities by race.

Researchers surveyed adolescents about what they had learned about topics such as how to say no to sex, methods of birth control and where to get them, and STIs.

Dr. Lindberg and Leslie M. Kantor, PhD, MPH, professor and chair of the department of urban-global public health at Rutgers University, Newark, N.J., conducted the analysis.

“Pediatricians and other health care providers that work with children and adolescents have a critical role to play in providing information about sexuality to both the patients and to the parents,” said Dr. Kantor, who also coauthored the Perspectives article with Dr. Lindberg and Dr. Bell. The new research “shows that doctors play an even more critical role, because they can’t assume that their patients are going to get the information that they need in a timely way from schools.”

By age 15, 21% of girls and 20% of boys have had sexual intercourse at least once, according to data from the 2015-2017 National Survey of Family Growth. By age 17, the percentages were 53% of girls and 48% of boys. By age 20, the percentages were 79% of women and 77% of men. The CDC’s 2021 guidelines on treatment and screening for STIs note that prevalence rates of certain infections – such as chlamydia and gonorrhea in females – are highest among adolescents and young adults.

Those trends underscore the importance of counseling on sexual health that clinicians can provide, but time constraints may limit how much they can discuss in a single session with a patient. To cover all topics that are important to parents and patients, doctors may need to discuss sexual and reproductive health sooner and more frequently.

Young people are getting more and more explicit information from their phones and media, yet educators are giving them less information to navigate these topics and learn what’s real, Dr. Kantor said. That mismatch can be toxic. In a December 2021 interview with Howard Stern, the pop star Billie Eilish said she started watching pornography at about age 11 and frequently watched videos that were violent. “I think it really destroyed my brain and I feel incredibly devastated that I was exposed to so much porn,” Ms. Eilish told Mr. Stern.

Researchers and a psychologist told CNN that the singer’s story may be typical. It also highlights a need to be aware of kids’ online activities and to have conversations about how pornography may not depict healthy interactions, they said.

Beyond discussing a plan for preventing pregnancy and STIs, Dr. Kantor encouraged discussions about what constitutes healthy relationships, as well as check-ins about intimate partner violence and how romantic relationships are going.

“I think for pediatricians and for parents, it’s a muscle,” she said. “As you bring up these topics more, listen, and respond, you get more comfortable with it.”

Dr. Trent has served as an advisory board member on a sexual health council for Trojan (Church & Dwight Company) and has received research funding from Hologic and research supplies from SpeeDx. Dr. Bell has received funds from the Merck Foundation, Merck, and Gilead. Dr. Kantor had no disclosures.

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

Maria Trent, MD, MPH, was studying ways clinicians can leverage technology to care for adolescents years before COVID-19 exposed the challenges and advantages of telehealth.

Dr. Trent, a pediatrician and adolescent medicine specialist and professor of pediatrics at Johns Hopkins University, Baltimore, has long believed that the phones in her patients’ pockets have the potential to improve the sexual health of youth. The pandemic has only made that view stronger.

“They’re a generation that’s really wired and online,” Dr. Trent told this news organization. “I think that we can meet them in that space.”

Her research has incorporated texting, apps, and videos. Out of necessity, technology increasingly became part of patient care during the pandemic. “We had to stretch our ability to do some basic triage and assessments of patients online,” Dr. Trent said.

Even when clinics are closed, doctors might be able to provide initial care remotely, such as writing prescriptions to manage symptoms or directing patients to a lab for testing.

Telemedicine could allow a clinician to guide a teenager who thinks they might be pregnant to take a store-bought test and avoid possible exposure to COVID-19 in the ED, for instance.

But doctors have concerns about the legal and practical limits of privacy and confidentiality. Who else is at home listening to a phone conversation? Are parents accessing the patient’s online portal? Will parents receive an explanation of benefits that lists testing for a sexually transmitted infection, or see a testing kit that is delivered to their home?

When a young patient needs in-person care, transportation can be a barrier. And then there’s the matter of clinicians being able to bill for telehealth services.

Practices are learning how to navigate these issues, and relevant laws vary by state.

“I think this is going to become part of standard practice,” Dr. Trent said. “I think we have to do the hard work to make sure that it’s safe, that it’s accessible, and that it is actually improving care.”
 

Texts, apps, videos

In one early study, Dr. Trent and colleagues found that showing adolescents with pelvic inflammatory disease a 6-minute video may improve treatment rates for their sexual partners.

Another study provided preliminary evidence that text messaging support might improve clinic attendance for moderately long-acting reversible contraception.

A third trial showed that adolescents and young adults with pelvic inflammatory disease who were randomly assigned to receive text-message prompts to take their medications and provide information about the doses they consumed had greater decreases in Neisseria gonorrhoeae and Chlamydia trachomatis infections, compared with patients who received standard care.

Dr. Trent and coinvestigators are assessing a technology-based intervention for youth with HIV, in which patients can use an app to submit videos of themselves taking antiretroviral therapy and report any side effects. The technology provides a way to monitor patients remotely and support them between visits, she said.
 

Will pandemic-driven options remain?

In 2020, Laura D. Lindberg, PhD, principal research scientist at the Guttmacher Institute in New York, and coauthors discussed the possible ramifications of the pandemic on the sexual and reproductive health of adolescents and young adults.

If telemedicine options driven by COVID-19 are here to stay, adolescents and young adults could be “the age group most likely to continue that approach rather than returning to traditional in-person visits,” the researchers wrote. “Innovations in health care service provision, such as use of telemedicine and obtaining contraceptives and STI testing by mail, will help expand access to [sexual and reproductive health] care for young people.”

At the 2021 annual conference of the American Academy of Pediatrics, Dr. Trent described telehealth as a viable way to provide sexual and reproductive health care to adolescents and young adults, including anticipatory guidance, contraception counseling, coordination of follow-up care and testing, and connecting patients to resources.

Her presentation cited several websites that can help patients receive testing for STIs, including Yes Means Test, the Centers for Disease Control and Prevention’s GetTested page, and I Want the Kit. Planned Parenthood has telehealth options, and the Kaiser Family Foundation compiled information about 26 online platforms that were providing contraception or STI services.
 

Who else is in the room?

“There’s only so much time in the day and so many patients you can see, regardless of whether you have telehealth or not,” said David L. Bell, MD, MPH, president of the Society for Adolescent Health and Medicine and a coauthor of the Perspectives on Sexual and Reproductive Health paper. In addition, “you never know who else is in the room” with the patient on the other end, added Dr. Bell, a professor of population and family health and pediatrics at the Columbia University Medical Center and medical director of the Young Men’s Clinic, both in New York.

In some respects, young patients may not be able to participate in telehealth visits the same way they would in a medical office, Dr. Trent acknowledged. Encouraging the use of headphones is one way to help protect confidentiality when talking with patients who are at home and might not be alone.

But if patients are able to find a private space for remote visits, they might be more open than usual. In that way, telemedicine could provide additional opportunities to address issues like substance use disorders and mental health, as well, she said.

“Then, if they need something, we have to problem solve,” Dr. Trent said. Next steps may involve engaging a parent or getting the patient to a lab or the clinic.
 

Sex ed may be lacking

The Perspectives article also raised concerns that the pandemic might exacerbate shortcomings in sex education, which already may have been lacking.

“Before the pandemic, schools were a key source of formal sex education for young people,” the authors wrote. “Sex education, which was already limited in many areas of the country, has likely not been included in the national shift to online learning. Even when in-person schooling resumes, missed sex education instruction is unlikely to be made up, given the modest attention it received prior to the pandemic.”

A recently published study in the Journal of Adolescent Health indicates that American teenagers currently receive less formal sex education than they did 25 years ago, with “troubling” inequities by race.

Researchers surveyed adolescents about what they had learned about topics such as how to say no to sex, methods of birth control and where to get them, and STIs.

Dr. Lindberg and Leslie M. Kantor, PhD, MPH, professor and chair of the department of urban-global public health at Rutgers University, Newark, N.J., conducted the analysis.

“Pediatricians and other health care providers that work with children and adolescents have a critical role to play in providing information about sexuality to both the patients and to the parents,” said Dr. Kantor, who also coauthored the Perspectives article with Dr. Lindberg and Dr. Bell. The new research “shows that doctors play an even more critical role, because they can’t assume that their patients are going to get the information that they need in a timely way from schools.”

By age 15, 21% of girls and 20% of boys have had sexual intercourse at least once, according to data from the 2015-2017 National Survey of Family Growth. By age 17, the percentages were 53% of girls and 48% of boys. By age 20, the percentages were 79% of women and 77% of men. The CDC’s 2021 guidelines on treatment and screening for STIs note that prevalence rates of certain infections – such as chlamydia and gonorrhea in females – are highest among adolescents and young adults.

Those trends underscore the importance of counseling on sexual health that clinicians can provide, but time constraints may limit how much they can discuss in a single session with a patient. To cover all topics that are important to parents and patients, doctors may need to discuss sexual and reproductive health sooner and more frequently.

Young people are getting more and more explicit information from their phones and media, yet educators are giving them less information to navigate these topics and learn what’s real, Dr. Kantor said. That mismatch can be toxic. In a December 2021 interview with Howard Stern, the pop star Billie Eilish said she started watching pornography at about age 11 and frequently watched videos that were violent. “I think it really destroyed my brain and I feel incredibly devastated that I was exposed to so much porn,” Ms. Eilish told Mr. Stern.

Researchers and a psychologist told CNN that the singer’s story may be typical. It also highlights a need to be aware of kids’ online activities and to have conversations about how pornography may not depict healthy interactions, they said.

Beyond discussing a plan for preventing pregnancy and STIs, Dr. Kantor encouraged discussions about what constitutes healthy relationships, as well as check-ins about intimate partner violence and how romantic relationships are going.

“I think for pediatricians and for parents, it’s a muscle,” she said. “As you bring up these topics more, listen, and respond, you get more comfortable with it.”

Dr. Trent has served as an advisory board member on a sexual health council for Trojan (Church & Dwight Company) and has received research funding from Hologic and research supplies from SpeeDx. Dr. Bell has received funds from the Merck Foundation, Merck, and Gilead. Dr. Kantor had no disclosures.

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

Maria Trent, MD, MPH, was studying ways clinicians can leverage technology to care for adolescents years before COVID-19 exposed the challenges and advantages of telehealth.

Dr. Trent, a pediatrician and adolescent medicine specialist and professor of pediatrics at Johns Hopkins University, Baltimore, has long believed that the phones in her patients’ pockets have the potential to improve the sexual health of youth. The pandemic has only made that view stronger.

“They’re a generation that’s really wired and online,” Dr. Trent told this news organization. “I think that we can meet them in that space.”

Her research has incorporated texting, apps, and videos. Out of necessity, technology increasingly became part of patient care during the pandemic. “We had to stretch our ability to do some basic triage and assessments of patients online,” Dr. Trent said.

Even when clinics are closed, doctors might be able to provide initial care remotely, such as writing prescriptions to manage symptoms or directing patients to a lab for testing.

Telemedicine could allow a clinician to guide a teenager who thinks they might be pregnant to take a store-bought test and avoid possible exposure to COVID-19 in the ED, for instance.

But doctors have concerns about the legal and practical limits of privacy and confidentiality. Who else is at home listening to a phone conversation? Are parents accessing the patient’s online portal? Will parents receive an explanation of benefits that lists testing for a sexually transmitted infection, or see a testing kit that is delivered to their home?

When a young patient needs in-person care, transportation can be a barrier. And then there’s the matter of clinicians being able to bill for telehealth services.

Practices are learning how to navigate these issues, and relevant laws vary by state.

“I think this is going to become part of standard practice,” Dr. Trent said. “I think we have to do the hard work to make sure that it’s safe, that it’s accessible, and that it is actually improving care.”
 

Texts, apps, videos

In one early study, Dr. Trent and colleagues found that showing adolescents with pelvic inflammatory disease a 6-minute video may improve treatment rates for their sexual partners.

Another study provided preliminary evidence that text messaging support might improve clinic attendance for moderately long-acting reversible contraception.

A third trial showed that adolescents and young adults with pelvic inflammatory disease who were randomly assigned to receive text-message prompts to take their medications and provide information about the doses they consumed had greater decreases in Neisseria gonorrhoeae and Chlamydia trachomatis infections, compared with patients who received standard care.

Dr. Trent and coinvestigators are assessing a technology-based intervention for youth with HIV, in which patients can use an app to submit videos of themselves taking antiretroviral therapy and report any side effects. The technology provides a way to monitor patients remotely and support them between visits, she said.
 

Will pandemic-driven options remain?

In 2020, Laura D. Lindberg, PhD, principal research scientist at the Guttmacher Institute in New York, and coauthors discussed the possible ramifications of the pandemic on the sexual and reproductive health of adolescents and young adults.

If telemedicine options driven by COVID-19 are here to stay, adolescents and young adults could be “the age group most likely to continue that approach rather than returning to traditional in-person visits,” the researchers wrote. “Innovations in health care service provision, such as use of telemedicine and obtaining contraceptives and STI testing by mail, will help expand access to [sexual and reproductive health] care for young people.”

At the 2021 annual conference of the American Academy of Pediatrics, Dr. Trent described telehealth as a viable way to provide sexual and reproductive health care to adolescents and young adults, including anticipatory guidance, contraception counseling, coordination of follow-up care and testing, and connecting patients to resources.

Her presentation cited several websites that can help patients receive testing for STIs, including Yes Means Test, the Centers for Disease Control and Prevention’s GetTested page, and I Want the Kit. Planned Parenthood has telehealth options, and the Kaiser Family Foundation compiled information about 26 online platforms that were providing contraception or STI services.
 

Who else is in the room?

“There’s only so much time in the day and so many patients you can see, regardless of whether you have telehealth or not,” said David L. Bell, MD, MPH, president of the Society for Adolescent Health and Medicine and a coauthor of the Perspectives on Sexual and Reproductive Health paper. In addition, “you never know who else is in the room” with the patient on the other end, added Dr. Bell, a professor of population and family health and pediatrics at the Columbia University Medical Center and medical director of the Young Men’s Clinic, both in New York.

In some respects, young patients may not be able to participate in telehealth visits the same way they would in a medical office, Dr. Trent acknowledged. Encouraging the use of headphones is one way to help protect confidentiality when talking with patients who are at home and might not be alone.

But if patients are able to find a private space for remote visits, they might be more open than usual. In that way, telemedicine could provide additional opportunities to address issues like substance use disorders and mental health, as well, she said.

“Then, if they need something, we have to problem solve,” Dr. Trent said. Next steps may involve engaging a parent or getting the patient to a lab or the clinic.
 

Sex ed may be lacking

The Perspectives article also raised concerns that the pandemic might exacerbate shortcomings in sex education, which already may have been lacking.

“Before the pandemic, schools were a key source of formal sex education for young people,” the authors wrote. “Sex education, which was already limited in many areas of the country, has likely not been included in the national shift to online learning. Even when in-person schooling resumes, missed sex education instruction is unlikely to be made up, given the modest attention it received prior to the pandemic.”

A recently published study in the Journal of Adolescent Health indicates that American teenagers currently receive less formal sex education than they did 25 years ago, with “troubling” inequities by race.

Researchers surveyed adolescents about what they had learned about topics such as how to say no to sex, methods of birth control and where to get them, and STIs.

Dr. Lindberg and Leslie M. Kantor, PhD, MPH, professor and chair of the department of urban-global public health at Rutgers University, Newark, N.J., conducted the analysis.

“Pediatricians and other health care providers that work with children and adolescents have a critical role to play in providing information about sexuality to both the patients and to the parents,” said Dr. Kantor, who also coauthored the Perspectives article with Dr. Lindberg and Dr. Bell. The new research “shows that doctors play an even more critical role, because they can’t assume that their patients are going to get the information that they need in a timely way from schools.”

By age 15, 21% of girls and 20% of boys have had sexual intercourse at least once, according to data from the 2015-2017 National Survey of Family Growth. By age 17, the percentages were 53% of girls and 48% of boys. By age 20, the percentages were 79% of women and 77% of men. The CDC’s 2021 guidelines on treatment and screening for STIs note that prevalence rates of certain infections – such as chlamydia and gonorrhea in females – are highest among adolescents and young adults.

Those trends underscore the importance of counseling on sexual health that clinicians can provide, but time constraints may limit how much they can discuss in a single session with a patient. To cover all topics that are important to parents and patients, doctors may need to discuss sexual and reproductive health sooner and more frequently.

Young people are getting more and more explicit information from their phones and media, yet educators are giving them less information to navigate these topics and learn what’s real, Dr. Kantor said. That mismatch can be toxic. In a December 2021 interview with Howard Stern, the pop star Billie Eilish said she started watching pornography at about age 11 and frequently watched videos that were violent. “I think it really destroyed my brain and I feel incredibly devastated that I was exposed to so much porn,” Ms. Eilish told Mr. Stern.

Researchers and a psychologist told CNN that the singer’s story may be typical. It also highlights a need to be aware of kids’ online activities and to have conversations about how pornography may not depict healthy interactions, they said.

Beyond discussing a plan for preventing pregnancy and STIs, Dr. Kantor encouraged discussions about what constitutes healthy relationships, as well as check-ins about intimate partner violence and how romantic relationships are going.

“I think for pediatricians and for parents, it’s a muscle,” she said. “As you bring up these topics more, listen, and respond, you get more comfortable with it.”

Dr. Trent has served as an advisory board member on a sexual health council for Trojan (Church & Dwight Company) and has received research funding from Hologic and research supplies from SpeeDx. Dr. Bell has received funds from the Merck Foundation, Merck, and Gilead. Dr. Kantor had no disclosures.

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

The Food and Drug Administration has accepted a new drug application (NDA) for roflumilast, a topical phosphodiesterase type 4 (PDE4) inhibitor for treating psoriasis in adults and adolescents, according to a statement from the manufacturer.

Roflumilast cream (also known as ARQ-151) is a small molecule inhibitor of PDE4, an enzyme that increases proinflammatory mediators and decreases anti-inflammatory mediators. PDE4 is an established treatment target in dermatology: The FDA approved PDE-4 inhibitor crisaborole (Eucrisa) as a topical treatment for mild to moderate atopic dermatitis in 2016, and an oral PDE-4 inhibitor, orismilast, is being studied for the treatment of plaque psoriasis.

Topical roflumilast, if approved, would be the first topical PDE4 inhibitor for psoriasis in particular, according to the Arcutis Biotherapeutics statement. The cream is designed for use on the entire body, including the face and sensitive intertriginous areas.

The NDA is based on data from a pair of phase 3 randomized, double-blind 8-week studies known as DERMIS 1 and DERMIS 2 (Trials of PDE4 Inhibition with Roflumilast for the Management of Plaque Psoriasis” One and Two) and a long-term phase 2b open-label study.

DERMIS 1 and DERMIS 2 were identical multinational, multicenter studies designed to assess the safety and efficacy of 0.3% roflumilast cream. In the studies, roflumilast met its primary endpoint and patients treated with it demonstrated an Investigator Global Assessment (IGA) success rate of 42.4% compared with 6.1% for the vehicle control (P < .0001), and 37.5% compared with 6.9% for the vehicle control (P < .0001), in the DERMIS 1 and 2 trials, respectively, according to Arcutis.

In the phase 2b study, the treatment effect lasted for 52-64 weeks. Roflumilast was well tolerated across the three studies.

Overall, the most common adverse events reported in the studies were diarrhea (3%), headache (2%), insomnia (1%), nausea (1%), upper respiratory tract infections (1%), and urinary tract infections (1%).

Roflumilast also showed statistically significant improvement compared to a vehicle on secondary endpoints including Intertriginous IGA (I-IGA) Success, Psoriasis Area Severity Index-75 (PASI-75), reductions in itch as measured by the Worst Itch-Numerical Rating Scale (WI-NRS), and patient perceptions of symptoms based on the Psoriasis Symptoms Diary (PSD).

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of July 29, 2022, according to the manufacturer’s statement. An oral formulation of roflumilast was approved by the FDA in 2011, for reducing the risk of exacerbations of chronic obstructive pulmonary disease (COPD) in patients with severe COPD.

The Food and Drug Administration has accepted a new drug application (NDA) for roflumilast, a topical phosphodiesterase type 4 (PDE4) inhibitor for treating psoriasis in adults and adolescents, according to a statement from the manufacturer.

Roflumilast cream (also known as ARQ-151) is a small molecule inhibitor of PDE4, an enzyme that increases proinflammatory mediators and decreases anti-inflammatory mediators. PDE4 is an established treatment target in dermatology: The FDA approved PDE-4 inhibitor crisaborole (Eucrisa) as a topical treatment for mild to moderate atopic dermatitis in 2016, and an oral PDE-4 inhibitor, orismilast, is being studied for the treatment of plaque psoriasis.

Topical roflumilast, if approved, would be the first topical PDE4 inhibitor for psoriasis in particular, according to the Arcutis Biotherapeutics statement. The cream is designed for use on the entire body, including the face and sensitive intertriginous areas.

The NDA is based on data from a pair of phase 3 randomized, double-blind 8-week studies known as DERMIS 1 and DERMIS 2 (Trials of PDE4 Inhibition with Roflumilast for the Management of Plaque Psoriasis” One and Two) and a long-term phase 2b open-label study.

DERMIS 1 and DERMIS 2 were identical multinational, multicenter studies designed to assess the safety and efficacy of 0.3% roflumilast cream. In the studies, roflumilast met its primary endpoint and patients treated with it demonstrated an Investigator Global Assessment (IGA) success rate of 42.4% compared with 6.1% for the vehicle control (P < .0001), and 37.5% compared with 6.9% for the vehicle control (P < .0001), in the DERMIS 1 and 2 trials, respectively, according to Arcutis.

In the phase 2b study, the treatment effect lasted for 52-64 weeks. Roflumilast was well tolerated across the three studies.

Overall, the most common adverse events reported in the studies were diarrhea (3%), headache (2%), insomnia (1%), nausea (1%), upper respiratory tract infections (1%), and urinary tract infections (1%).

Roflumilast also showed statistically significant improvement compared to a vehicle on secondary endpoints including Intertriginous IGA (I-IGA) Success, Psoriasis Area Severity Index-75 (PASI-75), reductions in itch as measured by the Worst Itch-Numerical Rating Scale (WI-NRS), and patient perceptions of symptoms based on the Psoriasis Symptoms Diary (PSD).

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of July 29, 2022, according to the manufacturer’s statement. An oral formulation of roflumilast was approved by the FDA in 2011, for reducing the risk of exacerbations of chronic obstructive pulmonary disease (COPD) in patients with severe COPD.

The Food and Drug Administration has accepted a new drug application (NDA) for roflumilast, a topical phosphodiesterase type 4 (PDE4) inhibitor for treating psoriasis in adults and adolescents, according to a statement from the manufacturer.

Roflumilast cream (also known as ARQ-151) is a small molecule inhibitor of PDE4, an enzyme that increases proinflammatory mediators and decreases anti-inflammatory mediators. PDE4 is an established treatment target in dermatology: The FDA approved PDE-4 inhibitor crisaborole (Eucrisa) as a topical treatment for mild to moderate atopic dermatitis in 2016, and an oral PDE-4 inhibitor, orismilast, is being studied for the treatment of plaque psoriasis.

Topical roflumilast, if approved, would be the first topical PDE4 inhibitor for psoriasis in particular, according to the Arcutis Biotherapeutics statement. The cream is designed for use on the entire body, including the face and sensitive intertriginous areas.

The NDA is based on data from a pair of phase 3 randomized, double-blind 8-week studies known as DERMIS 1 and DERMIS 2 (Trials of PDE4 Inhibition with Roflumilast for the Management of Plaque Psoriasis” One and Two) and a long-term phase 2b open-label study.

DERMIS 1 and DERMIS 2 were identical multinational, multicenter studies designed to assess the safety and efficacy of 0.3% roflumilast cream. In the studies, roflumilast met its primary endpoint and patients treated with it demonstrated an Investigator Global Assessment (IGA) success rate of 42.4% compared with 6.1% for the vehicle control (P < .0001), and 37.5% compared with 6.9% for the vehicle control (P < .0001), in the DERMIS 1 and 2 trials, respectively, according to Arcutis.

In the phase 2b study, the treatment effect lasted for 52-64 weeks. Roflumilast was well tolerated across the three studies.

Overall, the most common adverse events reported in the studies were diarrhea (3%), headache (2%), insomnia (1%), nausea (1%), upper respiratory tract infections (1%), and urinary tract infections (1%).

Roflumilast also showed statistically significant improvement compared to a vehicle on secondary endpoints including Intertriginous IGA (I-IGA) Success, Psoriasis Area Severity Index-75 (PASI-75), reductions in itch as measured by the Worst Itch-Numerical Rating Scale (WI-NRS), and patient perceptions of symptoms based on the Psoriasis Symptoms Diary (PSD).

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of July 29, 2022, according to the manufacturer’s statement. An oral formulation of roflumilast was approved by the FDA in 2011, for reducing the risk of exacerbations of chronic obstructive pulmonary disease (COPD) in patients with severe COPD.

In the November 2021 issue of Pediatric News are two stories that on the surface present viewpoints that couldn’t be more divergent. On page 1 under the headline “Gender dysphoria” you will read about a position statement by the Royal Australian and New Zealand College of Psychiatrists (RANZCP) in which they strongly recommend a mental health evaluation for any child or adolescent with gender dysphoria “before any firm decisions are made on whether to prescribe hormonal treatments to transition, or perform surgeries.”

On page 6 is another story titled “Gender-affirming care ‘can save lives’ new research shows” that reports on a research study in which transgender and binary young people who received a year of gender-affirming care experienced less depression and fewer suicidal thoughts. Dr. David J. Inwards-Breland, chief of adolescent and young adult medicine at Rady Children’s Hospital in San Diego and one of the authors of the study is quoted as saying “The younger we can provide gender-affirming care, the less likely [our patients are] to have depression and then negative outcomes.” One can’t avoid the impression that he is in favor of moving ahead without delay in prescribing gender-affirming care.

Where does the new recommendation by the RANZCP fit in with this sense of urgency? Does requiring a mental health evaluation constitute a delay in the institution of gender-affirming care that could increase the risk of negative mental health outcomes for gender dysphoric patients?

In one of the final paragraphs in the Pediatric News article one learns that Dr. Inwards-Breland would agree with the folks of RANZCP. He acknowledges that his study relied on screening and not diagnostic testing and says that “future studies should look at a mental health evaluation and diagnosis by a mental health provider.”

When we drill into the details there are two issues that demand clarification. First, what kind of time course are we talking about for a mental health evaluation? Are we talking weeks, or months, hopefully not years? This of course depends on the availability of mental health services for the specific patient and the depth of the evaluation required. How long a delay is acceptable?

Second, will the evaluation be performed by a provider free of bias? Can it be performed without creating the impression that the patient needs to see a mental health provider because there is something wrong with being trans and we can fix it? One would hope these evaluations would be performed in the spirit of wanting to learn more about the patient with the goal of making the process go more smoothly.

Listening to neighborhood discussions around the fire pit I find that the RANZCP plea for a broader and deeper look at each gender-dysphoric child strikes a chord with the general population. More and more people are realizing that gender-dysphoria happens and that for too long it was closeted with unfortunate consequences. However, there is a feeling, in fact one in which I share, that the rapid rise in its prevalence contains an element of social contagion. And, some irreversible decisions are being made without sufficient consideration. This may or not be a valid concern but it seems to me a thorough and sensitively done mental health evaluation might minimize the collateral damage from some gender-affirming care and at least help those patients for whom it is prescribed transition more smoothly.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

In the November 2021 issue of Pediatric News are two stories that on the surface present viewpoints that couldn’t be more divergent. On page 1 under the headline “Gender dysphoria” you will read about a position statement by the Royal Australian and New Zealand College of Psychiatrists (RANZCP) in which they strongly recommend a mental health evaluation for any child or adolescent with gender dysphoria “before any firm decisions are made on whether to prescribe hormonal treatments to transition, or perform surgeries.”

On page 6 is another story titled “Gender-affirming care ‘can save lives’ new research shows” that reports on a research study in which transgender and binary young people who received a year of gender-affirming care experienced less depression and fewer suicidal thoughts. Dr. David J. Inwards-Breland, chief of adolescent and young adult medicine at Rady Children’s Hospital in San Diego and one of the authors of the study is quoted as saying “The younger we can provide gender-affirming care, the less likely [our patients are] to have depression and then negative outcomes.” One can’t avoid the impression that he is in favor of moving ahead without delay in prescribing gender-affirming care.

Where does the new recommendation by the RANZCP fit in with this sense of urgency? Does requiring a mental health evaluation constitute a delay in the institution of gender-affirming care that could increase the risk of negative mental health outcomes for gender dysphoric patients?

In one of the final paragraphs in the Pediatric News article one learns that Dr. Inwards-Breland would agree with the folks of RANZCP. He acknowledges that his study relied on screening and not diagnostic testing and says that “future studies should look at a mental health evaluation and diagnosis by a mental health provider.”

When we drill into the details there are two issues that demand clarification. First, what kind of time course are we talking about for a mental health evaluation? Are we talking weeks, or months, hopefully not years? This of course depends on the availability of mental health services for the specific patient and the depth of the evaluation required. How long a delay is acceptable?

Second, will the evaluation be performed by a provider free of bias? Can it be performed without creating the impression that the patient needs to see a mental health provider because there is something wrong with being trans and we can fix it? One would hope these evaluations would be performed in the spirit of wanting to learn more about the patient with the goal of making the process go more smoothly.

Listening to neighborhood discussions around the fire pit I find that the RANZCP plea for a broader and deeper look at each gender-dysphoric child strikes a chord with the general population. More and more people are realizing that gender-dysphoria happens and that for too long it was closeted with unfortunate consequences. However, there is a feeling, in fact one in which I share, that the rapid rise in its prevalence contains an element of social contagion. And, some irreversible decisions are being made without sufficient consideration. This may or not be a valid concern but it seems to me a thorough and sensitively done mental health evaluation might minimize the collateral damage from some gender-affirming care and at least help those patients for whom it is prescribed transition more smoothly.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

In the November 2021 issue of Pediatric News are two stories that on the surface present viewpoints that couldn’t be more divergent. On page 1 under the headline “Gender dysphoria” you will read about a position statement by the Royal Australian and New Zealand College of Psychiatrists (RANZCP) in which they strongly recommend a mental health evaluation for any child or adolescent with gender dysphoria “before any firm decisions are made on whether to prescribe hormonal treatments to transition, or perform surgeries.”

On page 6 is another story titled “Gender-affirming care ‘can save lives’ new research shows” that reports on a research study in which transgender and binary young people who received a year of gender-affirming care experienced less depression and fewer suicidal thoughts. Dr. David J. Inwards-Breland, chief of adolescent and young adult medicine at Rady Children’s Hospital in San Diego and one of the authors of the study is quoted as saying “The younger we can provide gender-affirming care, the less likely [our patients are] to have depression and then negative outcomes.” One can’t avoid the impression that he is in favor of moving ahead without delay in prescribing gender-affirming care.

Where does the new recommendation by the RANZCP fit in with this sense of urgency? Does requiring a mental health evaluation constitute a delay in the institution of gender-affirming care that could increase the risk of negative mental health outcomes for gender dysphoric patients?

In one of the final paragraphs in the Pediatric News article one learns that Dr. Inwards-Breland would agree with the folks of RANZCP. He acknowledges that his study relied on screening and not diagnostic testing and says that “future studies should look at a mental health evaluation and diagnosis by a mental health provider.”

When we drill into the details there are two issues that demand clarification. First, what kind of time course are we talking about for a mental health evaluation? Are we talking weeks, or months, hopefully not years? This of course depends on the availability of mental health services for the specific patient and the depth of the evaluation required. How long a delay is acceptable?

Second, will the evaluation be performed by a provider free of bias? Can it be performed without creating the impression that the patient needs to see a mental health provider because there is something wrong with being trans and we can fix it? One would hope these evaluations would be performed in the spirit of wanting to learn more about the patient with the goal of making the process go more smoothly.

Listening to neighborhood discussions around the fire pit I find that the RANZCP plea for a broader and deeper look at each gender-dysphoric child strikes a chord with the general population. More and more people are realizing that gender-dysphoria happens and that for too long it was closeted with unfortunate consequences. However, there is a feeling, in fact one in which I share, that the rapid rise in its prevalence contains an element of social contagion. And, some irreversible decisions are being made without sufficient consideration. This may or not be a valid concern but it seems to me a thorough and sensitively done mental health evaluation might minimize the collateral damage from some gender-affirming care and at least help those patients for whom it is prescribed transition more smoothly.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

More than a week after the rollout of the new, gender-neutral approach to the risk mitigation program for isotretinoin, frustration and glitches are still an issue, according to dermatologists, pharmacists, and patients.

When the new website and call center launched Dec. 13, hours-long hold times and repeated crashing of the website were reported as the norm, not the exception, triggering the American Academy of Dermatology Association (AADA) to request – and get – an emergency meeting on Dec. 16 with the U.S. Food and Drug Administration, which mandates the risk evaluation and mitigation strategy (REMS) for isotretinoin due to the teratogenicity of the acne medication.

At that meeting, ‘’the FDA and HHS [U.S. Department of Health and Human Services] acknowledged the concerns of dermatologists and the need for stakeholders to work collaboratively to find a solution,” Ilona Frieden, MD, chair of the AADA’s iPLEDGE workgroup and professor of dermatology at the University of California, San Francisco, said in an email interview. At the meeting, the AADA representatives described the severe impact on patient access to treatment that is resulting from the issues. The AADA also ‘’reiterated our call for a temporary pause to the program while stakeholders work to resolve the urgent issues with the platform,” she said.

The new approach, which is intended to make the experience more inclusive for transgender patients, reduces the previous three risk categories (females of reproductive potential, females not of reproductive potential, and males) to just two (those capable of getting pregnant and those not capable). The program requires physicians, patients, and pharmacists who prescribe, use, or dispense the drug to be registered, with requirements that include the use of two forms of an effective contraceptive and regular pregnancy tests by patients capable of becoming pregnant.

With reduced or no access during the technology glitches, access to the medicine was delayed for some patients. And dermatologists, pharmacists, and their staffs reported grueling hold times trying to reach the call center when the website had issues.

While the FDA agreed to help find a solution, it noted that the solution ‘’was to be found with dermatologists and pharmacists who are on the ground living the program every day,” Dr. Frieden said. No timeline for solving the issues was provided, so on Dec. 21, the AADA asked the FDA for a constructive dialogue among stakeholders within the next 24 hours, Dr. Frieden told this news organization.

While Dr. Frieden sees progress, ‘’we are disappointed that this situation continues to drag on for more than a week later, with more patients losing access to their needed medication each day.” While some prescribers have been able to log onto the portal and enter the information required, confirming some patients, large gaps remain, she said. Patients and pharmacists still report difficulties logging on. When that happens and they try to reach the call center, there are often hours-long hold times, dropped calls, or a message saying to call back.

The iPLEDGE administrator is Syneos Health, but a spokesperson for Syneos, Gary Gatyas, said the company does not maintain the system or the contact center.

So who does manage the call center and website? “The AADA has asked stakeholders, including Syneos Health, for clarification on who manages the call center and website but has not received a response,” Dr. Frieden said. “In the meeting [Dec. 16], representatives from the FDA made clear that the iPLEDGE sponsors are ultimately responsible for this REMS program,” Dr. Frieden said.

According to the FDA, isotretinoin manufacturers are part of the iPLEDGE program. On the iPLEDGE website, 12 isotretinoin products are listed, made by eight different companies.

One dermatologist maneuvering the new website who registered successfully as a provider told this news organization that he received a follow-up survey from United BioSource about the new website. This news organization contacted that company to confirm it runs the website but has not yet received a response.

Meanwhile, dermatologists continue to help frustrated patients cope with the new website and registration details. Neil S. Goldberg, MD, a dermatologist in Westchester County, New York, heard from two mothers who helped their teen daughters complete the forms by attesting they would use abstinence as contraception but then couldn’t figure out how to answer another question. As a result, their answers were interpreted as the patients saying they were using abstinence but didn’t commit to not having sexual contact with a partner capable of impregnating them. So Dr. Goldberg got an automated message back from the iPLEDGE program that the answers were a mismatch.

And in the comments section following a previous story on the problematic rollout, one reader offered a suggestion for reducing hold times to the call center: choose the Spanish option.

Dr. Frieden and Dr. Goldberg have no relevant disclosures.

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

More than a week after the rollout of the new, gender-neutral approach to the risk mitigation program for isotretinoin, frustration and glitches are still an issue, according to dermatologists, pharmacists, and patients.

When the new website and call center launched Dec. 13, hours-long hold times and repeated crashing of the website were reported as the norm, not the exception, triggering the American Academy of Dermatology Association (AADA) to request – and get – an emergency meeting on Dec. 16 with the U.S. Food and Drug Administration, which mandates the risk evaluation and mitigation strategy (REMS) for isotretinoin due to the teratogenicity of the acne medication.

At that meeting, ‘’the FDA and HHS [U.S. Department of Health and Human Services] acknowledged the concerns of dermatologists and the need for stakeholders to work collaboratively to find a solution,” Ilona Frieden, MD, chair of the AADA’s iPLEDGE workgroup and professor of dermatology at the University of California, San Francisco, said in an email interview. At the meeting, the AADA representatives described the severe impact on patient access to treatment that is resulting from the issues. The AADA also ‘’reiterated our call for a temporary pause to the program while stakeholders work to resolve the urgent issues with the platform,” she said.

The new approach, which is intended to make the experience more inclusive for transgender patients, reduces the previous three risk categories (females of reproductive potential, females not of reproductive potential, and males) to just two (those capable of getting pregnant and those not capable). The program requires physicians, patients, and pharmacists who prescribe, use, or dispense the drug to be registered, with requirements that include the use of two forms of an effective contraceptive and regular pregnancy tests by patients capable of becoming pregnant.

With reduced or no access during the technology glitches, access to the medicine was delayed for some patients. And dermatologists, pharmacists, and their staffs reported grueling hold times trying to reach the call center when the website had issues.

While the FDA agreed to help find a solution, it noted that the solution ‘’was to be found with dermatologists and pharmacists who are on the ground living the program every day,” Dr. Frieden said. No timeline for solving the issues was provided, so on Dec. 21, the AADA asked the FDA for a constructive dialogue among stakeholders within the next 24 hours, Dr. Frieden told this news organization.

While Dr. Frieden sees progress, ‘’we are disappointed that this situation continues to drag on for more than a week later, with more patients losing access to their needed medication each day.” While some prescribers have been able to log onto the portal and enter the information required, confirming some patients, large gaps remain, she said. Patients and pharmacists still report difficulties logging on. When that happens and they try to reach the call center, there are often hours-long hold times, dropped calls, or a message saying to call back.

The iPLEDGE administrator is Syneos Health, but a spokesperson for Syneos, Gary Gatyas, said the company does not maintain the system or the contact center.

So who does manage the call center and website? “The AADA has asked stakeholders, including Syneos Health, for clarification on who manages the call center and website but has not received a response,” Dr. Frieden said. “In the meeting [Dec. 16], representatives from the FDA made clear that the iPLEDGE sponsors are ultimately responsible for this REMS program,” Dr. Frieden said.

According to the FDA, isotretinoin manufacturers are part of the iPLEDGE program. On the iPLEDGE website, 12 isotretinoin products are listed, made by eight different companies.

One dermatologist maneuvering the new website who registered successfully as a provider told this news organization that he received a follow-up survey from United BioSource about the new website. This news organization contacted that company to confirm it runs the website but has not yet received a response.

Meanwhile, dermatologists continue to help frustrated patients cope with the new website and registration details. Neil S. Goldberg, MD, a dermatologist in Westchester County, New York, heard from two mothers who helped their teen daughters complete the forms by attesting they would use abstinence as contraception but then couldn’t figure out how to answer another question. As a result, their answers were interpreted as the patients saying they were using abstinence but didn’t commit to not having sexual contact with a partner capable of impregnating them. So Dr. Goldberg got an automated message back from the iPLEDGE program that the answers were a mismatch.

And in the comments section following a previous story on the problematic rollout, one reader offered a suggestion for reducing hold times to the call center: choose the Spanish option.

Dr. Frieden and Dr. Goldberg have no relevant disclosures.

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

More than a week after the rollout of the new, gender-neutral approach to the risk mitigation program for isotretinoin, frustration and glitches are still an issue, according to dermatologists, pharmacists, and patients.

When the new website and call center launched Dec. 13, hours-long hold times and repeated crashing of the website were reported as the norm, not the exception, triggering the American Academy of Dermatology Association (AADA) to request – and get – an emergency meeting on Dec. 16 with the U.S. Food and Drug Administration, which mandates the risk evaluation and mitigation strategy (REMS) for isotretinoin due to the teratogenicity of the acne medication.

At that meeting, ‘’the FDA and HHS [U.S. Department of Health and Human Services] acknowledged the concerns of dermatologists and the need for stakeholders to work collaboratively to find a solution,” Ilona Frieden, MD, chair of the AADA’s iPLEDGE workgroup and professor of dermatology at the University of California, San Francisco, said in an email interview. At the meeting, the AADA representatives described the severe impact on patient access to treatment that is resulting from the issues. The AADA also ‘’reiterated our call for a temporary pause to the program while stakeholders work to resolve the urgent issues with the platform,” she said.

The new approach, which is intended to make the experience more inclusive for transgender patients, reduces the previous three risk categories (females of reproductive potential, females not of reproductive potential, and males) to just two (those capable of getting pregnant and those not capable). The program requires physicians, patients, and pharmacists who prescribe, use, or dispense the drug to be registered, with requirements that include the use of two forms of an effective contraceptive and regular pregnancy tests by patients capable of becoming pregnant.

With reduced or no access during the technology glitches, access to the medicine was delayed for some patients. And dermatologists, pharmacists, and their staffs reported grueling hold times trying to reach the call center when the website had issues.

While the FDA agreed to help find a solution, it noted that the solution ‘’was to be found with dermatologists and pharmacists who are on the ground living the program every day,” Dr. Frieden said. No timeline for solving the issues was provided, so on Dec. 21, the AADA asked the FDA for a constructive dialogue among stakeholders within the next 24 hours, Dr. Frieden told this news organization.

While Dr. Frieden sees progress, ‘’we are disappointed that this situation continues to drag on for more than a week later, with more patients losing access to their needed medication each day.” While some prescribers have been able to log onto the portal and enter the information required, confirming some patients, large gaps remain, she said. Patients and pharmacists still report difficulties logging on. When that happens and they try to reach the call center, there are often hours-long hold times, dropped calls, or a message saying to call back.

The iPLEDGE administrator is Syneos Health, but a spokesperson for Syneos, Gary Gatyas, said the company does not maintain the system or the contact center.

So who does manage the call center and website? “The AADA has asked stakeholders, including Syneos Health, for clarification on who manages the call center and website but has not received a response,” Dr. Frieden said. “In the meeting [Dec. 16], representatives from the FDA made clear that the iPLEDGE sponsors are ultimately responsible for this REMS program,” Dr. Frieden said.

According to the FDA, isotretinoin manufacturers are part of the iPLEDGE program. On the iPLEDGE website, 12 isotretinoin products are listed, made by eight different companies.

One dermatologist maneuvering the new website who registered successfully as a provider told this news organization that he received a follow-up survey from United BioSource about the new website. This news organization contacted that company to confirm it runs the website but has not yet received a response.

Meanwhile, dermatologists continue to help frustrated patients cope with the new website and registration details. Neil S. Goldberg, MD, a dermatologist in Westchester County, New York, heard from two mothers who helped their teen daughters complete the forms by attesting they would use abstinence as contraception but then couldn’t figure out how to answer another question. As a result, their answers were interpreted as the patients saying they were using abstinence but didn’t commit to not having sexual contact with a partner capable of impregnating them. So Dr. Goldberg got an automated message back from the iPLEDGE program that the answers were a mismatch.

And in the comments section following a previous story on the problematic rollout, one reader offered a suggestion for reducing hold times to the call center: choose the Spanish option.

Dr. Frieden and Dr. Goldberg have no relevant disclosures.

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